Induction, Do I Really Need It? book by Sara Wickman
/https://www.birthinternational.com/products/books/induction-do-i-really-need
GlaxoSmithKline documents show autism from vaccines
/GlaxoSmithKline documents show autism from vaccines Revealed in Italian lawsuit, impossible in US
An Italian court recently awarded damages to a boy who developed autism as an injury from the GlaxoSmithKline's Infanrix Hexa vaccine, a combined vaccine for polio, diphtheria, tetanus, hepatitis B, pertussis and Haemophilus influenza type B. A key component of the trial was internal GlaxoSmithKline documents that revealed at least five acknowledged cases of autism resulting from Infanrix Hexa among the children enrolled in the trials for the shot. These documents were revealed during the trial through the discovery process, a basic legal right in civil suits in which the plaintiff and defendant can compell the other side to produce relevant documents. This is possible in the US in product liability trials for every product EXCEPT vaccines. The National Vaccine Injury Compensation Act provides vaccine manufacturers with complete liability immunity and it takes away the right to discovery by anyone injured by a vaccine. There is no chance that these documents would have ever been revealed in the US.
Please read this article about the Italian trial by Mary Holand that was published on the Age of Autism.
http://www.ageofautism.com/2015/01/recent-italian-court-decisions-on-vaccines-and-autism.html Confidential GSK Report p33-47 chartPlease share this message with family and friends and please share on social networks.
Scientific Proof That Being Thankful Improves Your Health
/During Thanksgiving week, people around the United States express gratitude for the bounty of their lives, but many may not realize that in doing so, they’re also improving the quality of their health and increasing their life expectancies. The scientific evidence is conclusive when it comes to mood, outlook, and health. Happy people live up to 10 years longer than unhappy people, and optimists have a 77% lower risk of heart disease than pessimists.
But how can YOU become happier and more optimistic in your world view?
The How Of Happiness
In Sonja Lyubomirsky’s The How Of Happiness, she teaches us how 50% of our propensity for happiness is based on a genetic set point, something we can’t influence very much, 10% is based on life circumstances (such as getting the promotion, finding The One, or achieving the creative dream), and 40% is “intentional activity” that we can influence with our behavior.
That means we can be up to 40% happier in our lives without changing our circumstances one bit, and one of the key intentional activities is the practice of gratitude.
Research shows that consistently grateful people are happier, more energetic, more hopeful, more helpful, more empathic, more spiritual, more forgiving, and less materialistic. They’re also less likely to be depressed, anxious, lonely, envious, neurotic, or sick.
The Evidence
In one study, one group of participants were asked to name five things they’re grateful for every day, while another group was asked to list five hassles. Those expressing gratitude were not only happier and more optimistic, they reported fewer physical symptoms (such as headache, cough, nausea, or acne). Other gratitude studies have shown that those with chronic illnesses demonstrate clinical improvement when practicing regular gratitude.
Severely depressed people instructed to list grateful thoughts on a website daily were found to be significantly less depressed by the end of the study when compared to depressed people who weren’t asked to express gratitude. And we know that depression is a significant risk factor for disease.
For more surprising scientific proof about how to be ultimately healthy, read Mind Over Medicine or watch my public television special Heal Yourself: Mind Over Medicine (check listings here). (Hint: Being generous and radical self care are good for your health, so try giving generously of your time and love this holiday season while also focusing on your own self care!)
How Does Gratitude Boost Happiness?
According to Dr. Lyubomirsky, gratitude:
Promotes savoring of positive life experiences Bolsters self-worth and self-esteem Helps people cope with stress and trauma Encourages caring acts and moral behavior Helps build social bonds, strengthen existing relationships, and nurture new relationships (and we know lonely people have twice the rate of heart disease as those with strong social connections) Inhibits harmful comparisons Diminishes or deters negative feelings such as anger, bitterness, and greed Thwarts hedonistic adaptation (the ability to adjust your set point to positive new circumstances so that we don’t appreciate the new circumstance and it has little affect on our overall health or happiness) How to practice gratitude
You don’t have to wait for Thanksgiving to enjoy the benefits to your health and happiness that accompany gratitude.
1. Keep a gratitude journal.
Ponder 3 to 5 things you’re currently grateful for (it’s okay if these are mundane things!) and write them down. Data suggests that doing this once per week may be most beneficial, but if you find that doing it daily works best for you, go for it!
2. Cultivate an attitude of gratitude.
Journaling may not be your cup of tea, so you might be better off just training yourself to think grateful thoughts. Try noticing one ungrateful thought you have each day and switching it around to something you can be grateful for.
3. Vary your gratitude practice.
Try journaling, thinking grateful thoughts, speaking what you’re grateful for at dinner time, making art about what you’re grateful for, but shake it up! We tend to get bored easily, so the practice of gratitude works better when we change how we’re grateful.
4. Express gratitude directly to others.
Call a friend, write a letter, share your grateful thoughts with family members, or speak to a colleague at work about what you’re grateful for.
What are you thankful for? Share your gratitude here in the comments. And thank you for caring what I write about. I’m super grateful for you!
Source:- http://www.mindbodygreen.com/0-11819/scientific-proof-that-being-thankful-improves-your-health.html http://greenyatrablog.com/scientific-proof-that-being-thankful-improves-your-health/
Binoy Kampmark: Crusades against Vaccination Monday, 5 January 2015, 9:56 am Opinion: Binoy Kampmark
/Binoy Kampmark: Crusades against Vaccination Monday, 5 January 2015, 9:56 am Opinion: Binoy Kampmark
Crusades against Vaccination: Tenpenny Heads to Oz By Dr Binoy Kampmark
It would be a cardinal sin to presume that all science, cold and hard as it can be, is the stuff of fluffy paradigms, knowledge constellations that are pure speculation and subject of postmodern dismissal. It is all fine and good to question gravity as a relative, imagined concept till you step outside the window of the fifth floor to test the theorem.
That all said, science is not immune to trenchant lobbies of interpretation that resist revision, opponents and revisionists. The dogmatic high priests of the beaker and test tube tend to be furrowing away, and will make a point of keeping things as they are. No alternatives are allowed.
When people get hold of science, the superstitions are not necessarily far away. The medical profession has famously killed a good number of human beings, largely based on the assumption that it knew the healing truth and treated its subjects accordingly. The old argument, suggested through time, is that a doctor is as capable a killer as any well armed general.
It is that context we find ourselves in, a battle of certain, dogmatic quacks in a continuum of maladjusted quackery. There are those doctors who feel that any form of treatment that avoids manufactured drugs is fundamentally wrong, a problem that often finds itself in the uncomfortable realm of pharmaceutical sponsorship. If you are ill, a chemical rebalancing is required, with the blessings of big Pharma. The homeopathic retort to this resorts to other forms of cure, some of them equally quack-adjusted.
Everything that Ohio-based Dr. Sherri Tenpenny has been involved it suggests how medical science, and the way it is subsequently deployed in broader public debates, can become political fanfare and militant insurgency. The veteran osteopath has busied herself with one campaign for years: that against vaccination programs. The bulk of her views can be found in Saying No to Vaccines.
While her views are those of a concerned quack, she is finding other quacks insisting that she is a vile imposter, an individual who is determined to deny science in the name of killing people, notably helpless children. This has come to the fore with a promise by Tenpenny to deliver a series of seminars in Australia urging parents not to vaccinate their children.
Tenpenny is hardly one of those who is willing to add to the inventory of the morgue, but because she doesn’t tend to conform to the standard high priest code of medical science, she is bound to be a pariah in chief.
A glance at her various opinion pieces over time suggest an understandable concern about the way the vaccine industry is manipulated. Where corporations meet vaccine production, gaming is bound to happen. There have been concerns, for instance, about the use of injected animal cells. “No matter how careful manufacturers try to be, animal cells, animal DNA and culture contamination viruses end up in the final vials,” wrote Tenpenny for The Huffington Post (Mar 18) in 2010. The concerns there were directly connected with arrangements made between Novartis and US authorities.
Much of Tenpenny’s insistence is on choice, or at the very least, the battle over choice. Her detractors, ignoring the problems in some vaccination programs, have already made the choice for the prospective patient: vaccination is required and good, and all, therefore, need it. All those who resist are heretical at the least, murderous at the worst. There is, in other words, no room for contest.
The language from Australian critics of Tenpenny, who have begun something of a school ground spat against the entry of an individual into Australia to speak about a topic they disagree upon, suggests how barrel scraping the exercise has become. Their assumption is childish at best: a person is suggesting a contrary view on vaccination, and for that reason, ought to be canned, bagged and prevented from having a say on the blessed island continent. For that reason, she is a co-commander of the league of death, spreading woe among the community.
“A dangerous person is coming to Australia,” came the shrill pronouncement from Amy Stockwell on the site Mamamia (Jan 4). On getting to Australia, “She will spread a dangerous message.” On sounding like the defenders of the ultimate censorship regime, the author actually adds jest to the Tenpenny argument, showing how such dogmatism is precisely what we do not need in the medical debate.
In a fashionable Stalinistic refrain, she suggests that “the new Immigration Minister (and former Health Minister), Peter Dutton has an opportunity to take a stand against deadly misinformation and the people that peddle it.” To that end, the minister is urged in the language of maternal tribalism, “to reject Sherri Tenpenny’s application for a visa to travel to Australia and ensure that her misinformation and lies do not threat the lives of children in this country.”
The language is almost cartoonish in its gangsterish venom, and finds form in Australian responses that assume that government knows best, and ministers know better. This is paternalism at its worst. NSW Health Minister Julia Skinner, to take one example, comes up with the hellish idea that, “There is nothing to fear from vaccination but much to fear from the devastating consequences of leaving children unprotected against potentially fatal diseases.”
Naturally, the other side of the campaign against the likes of those who feel that there are problems with centrally administered vaccination programs lies in attacking the homeopathic industry, which does offer an alternative, however kooky it seems to those in big pharma or the medical orthodoxy.
Jeremy McAnulty, Acting NSW Chief Health Officer, is clear that, “Homeopathic medicines do not provide protection against diseases such as whooping cough, measles, diphtheria, and meningitis. People who receive a homeopathic vaccine should not be lulled into a false sense of security that their children are protected” (Daily Telegraph, Jan 4).
The continuum of quackery and the hysteric reflex coming out of those who refuse to allow a medical practitioner to give seminars in a distant country says much of the featherweight types who see rules of visitation as rules of exclusion. Down with the quacks, it seems and up with the others!
*****
Dr. Binoy Kampmark was as Commonwealth Scholar at Selwyn College, Cambridge. He lectures at RMIT University, Melbourne. Email: bkampmark@gmail.com
http://www.scoop.co.nz/stories/HL1501/S00015/binoy-kampmark-crusades-against-vaccination.htm
Additive homeopathy in cancer patients: Retrospective survival data from a homeopathic outpatient unit at the Medical University of Vienna.
/Additive homeopathy in cancer patients: Retrospective survival data from a homeopathic outpatient unit at the Medical University of Vienna.Gaertner K1, Müllner M2, Friehs H2, Schuster E3, Marosi C2, Muchitsch I4, Frass M5, Kaye AD6. Author information Abstract BACKGROUND:
Current literature suggests a positive influence of additive classical homeopathy on global health and well-being in cancer patients. Besides encouraging case reports, there is little if any research on long-term survival of patients who obtain homeopathic care during cancer treatment. DESIGN:
Data from cancer patients who had undergone homeopathic treatment complementary to conventional anti-cancer treatment at the Outpatient Unit for Homeopathy in Malignant Diseases, Medical University Vienna, Department of Medicine I, Vienna, Austria, were collected, described and a retrospective subgroup-analysis with regard to survival time was performed. Patient inclusion criteria were at least three homeopathic consultations, fatal prognosis of disease, quantitative and qualitative description of patient characteristics, and survival time. RESULTS:
In four years, a total of 538 patients were recorded to have visited the Outpatient Unit Homeopathy in Malignant Diseases, Medical University Vienna, Department of Medicine I, Vienna, Austria. 62.8% of them were women, and nearly 20% had breast cancer. From the 53.7% (n=287) who had undergone at least three homeopathic consultations within four years, 18.7% (n=54) fulfilled inclusion criteria for survival analysis. The surveyed neoplasms were glioblastoma, lung, cholangiocellular and pancreatic carcinomas, metastasized sarcoma, and renal cell carcinoma. Median overall survival was compared to expert expectations of survival outcomes by specific cancer type and was prolonged across observed cancer entities (p<0.001). CONCLUSION:
Extended survival time in this sample of cancer patients with fatal prognosis but additive homeopathic treatment is interesting. However, findings are based on a small sample, and with only limited data available about patient and treatment characteristics. The relationship between homeopathic treatment and survival time requires prospective investigation in larger samples possibly using matched-pair control analysis or randomized trials.
Copyright © 2014 Elsevier Ltd. All rights reserved. KEYWORDS:
Cancer; Cholangiocellular cancer; Glioblastoma; Homeopathy; Lung; Metastasized sarcoma; Pancreatic carcinomas; Renal cell carcinoma
http://www.ncbi.nlm.nih.gov/pubmed/24731904
Homeopathy for ADHD: Hocus Pocus or Science? By Deborah Mitchell
/Parents of children with attention deficit/hyperactivity disorder (ADHD) face daily challenges and questions concerning how to best cope with, manage, and help their kids. Moms and dads who are not satisfied with a purely conventional medicine approach, typically because of questionable safety and effectiveness of medications, often turn to other options. Should parents consider homeopathy for ADHD? Some practitioners and researchers vote yes, and they point to the success they have witnessed in their practice and their studies. Many others, however, are not convinced about the value of homeopathy in general nor its use for this neurodevelopmental condition in particular.
Recently I interviewed Beth Landau-Halpern, a Toronto-based, classically trained homeopath who uses a wide range of natural approaches to treat ADHD, including nutritional medicine, relaxation techniques, and natural supplements along with homeopathy. Many but not all of her patients are already taking medications. Her natural therapies can both complement and enhance a child’s treatment program.
Homeopathy and ADHD: Two Studies
Landau-Halpern talked about her involvement in two studies of homeopathy and ADHD as well as about her experiences with her treatment approach overall. The two studies—one pilot study already completed and a new study currently underway that was initiated based on the findings of the first—involved evaluation of the impact of homeopathic remedies on children with ADHD.
The particulars of the first study were explained to me by one of Landau-Halpern’s colleagues, David Brulé, a research associate at the University of Toronto and owner of Riverdale Homeopathic Clinic.A total of 35 children were enrolled in the study, which involved an initial consultation with one of two homeopaths and then nine follow-up consultations.
Eighty percent of the participants completed all 10 consultations over an average of 12.1 months. During that time, a mean of three homeopathic remedies were prescribed for the children from a selection of more than three dozen options. The two found to be the most effective were phosphorus and tuberculinum. Parents were questioned about their child’s diet, but while Brulé said “diet works” for kids with ADHD, this factor was not emphasized in the study.
Overall the findings were positive: 63 percent achieved significant improvement in behavioral symptoms, and the benefits were generally observed at the seventh to eighth consultation. All of this good news prompted the researchers to plan another, larger study, which is now underway.
Based on her observations of participants in this study, Landau-Halpern explained that “most of the clients responded well to the homeopathic remedies, although it sometimes took a few months to find the most beneficial remedy.” This caveat was especially true, she said, among kids who were taking medication since “many of their ‘symptoms’ were masked” by the drugs. Overall, she believed the children’s behavioral symptoms were the most affected by the remedies, “those that the stimulant drugs don’t really affect in any case.”
What about the effect of diet and natural supplements on these patients who were taking homeopathic remedies? Landau-Halpern pointed out that many of the parents were finding it difficult to deal with the challenges of ADHD, so she did not normally introduce dietary suggestions. At the same time, she emphasized that “an optimized diet is obviously important” as are supplements, although she did not stress them in the study.
The new study, which currently is recruiting participants, will follow 180 children with ADHD. Unlike the earlier study, parents will be asked if they are using therapeutic dietary changes. (Download the announcement for recruitment into the new study.)
In her private practice, Landau-Halpern often recommends supplements for children with ADHD, especially omega-3 fatty acids. In addition she suggests B vitamins, iron, magnesium, vitamin D, zinc, and multivitamins, depending on the individual child. She also addresses diet.
When looking at the diet of a child who has ADHD, Landau-Halpern pointed out that while every child responds to preservatives, artificial colors, and artificial flavors differently, “in general, they have absolutely no place in any child’s diet—ADHD or not.” She also emphasized that eliminating these substances “can bring about huge improvements in all sorts of pathological behaviors and physical symptoms.”
In fact, cutting out foods that contain preservatives and artificial additives is the first advice she offers parents of kids with ADHD. Why? Because it works. “For some children, simply removing foods that impair their neurological function can make an enormous difference,” and that includes refined, processed foods containing artificial ingredients and preservatives as well as those to which children have a hypersensitivity.
A review in Current Psychiatry Reports that evaluated evidence for dietary and nutritional treatments, as well as homeopathy, for ADHD noted that “Controlled studies support the elimination of artificial food dyes to reduce ADHD symptoms, and that multivitamin/mineral supplements and especially essential fatty acids are suggested. Evidence for the effectiveness of homeopathy for ADHD, however, was reported to be minimal.
Read more about kids and artificial colors
That could be changing, however, as researchers continue to conduct more comprehensive studies. Therefore, for parents of children with ADHD, alternative and complementary options such as homeopathy and nutritional medicine, including the elimination of artificial dyes and flavors and preservatives, should be considered and discussed with the appropriate healthcare professionals.
http://naturallysavvy.com/nest/homeopathy-for-adhd-hocus-pocus-or-science
Complementary and alternative medicine for cancer patients: results of the EPAAC survey on integrative oncology centres in Europe. Rossi E1, Vita A, Baccetti S, Di Stefano M, Voller F, Zanobini A.
/AbstractBACKGROUND:
The Region of Tuscany Health Department was included as an associated member in WP7 "Healthcare" of the European Partnership for Action Against Cancer (EPAAC), initiated by the EU Commission in 2009. AIMS:
The principal aim was to map centres across Europe prioritizing those that provide public health services and operating within the national health system in integrative oncology (IO). METHODS:
A cross-sectional descriptive survey design was used to collect data. A questionnaire was elaborated concerning integrative oncology therapies to be administered to all the national health system oncology centres or hospitals in each European country. These institutes were identified by convenience sampling, searching on oncology websites and forums. The official websites of these structures were analysed to obtain more information about their activities and contacts. RESULTS:
Information was received from 123 (52.1 %) out of the 236 centres contacted until 31 December 2013. Forty-seven out of 99 responding centres meeting inclusion criteria (47.5 %) provided integrative oncology treatments, 24 from Italy and 23 from other European countries. The number of patients seen per year was on average 301.2 ± 337. Among the centres providing these kinds of therapies, 33 (70.2 %) use fixed protocols and 35 (74.5 %) use systems for the evaluation of results. Thirty-two centres (68.1 %) had research in progress or carried out until the deadline of the survey. The complementary and alternative medicines (CAMs) more frequently provided to cancer patients were acupuncture 26 (55.3 %), homeopathy 19 (40.4 %), herbal medicine 18 (38.3 %) and traditional Chinese medicine 17 (36.2 %); anthroposophic medicine 10 (21.3 %); homotoxicology 6 (12.8 %); and other therapies 30 (63.8 %). Treatments are mainly directed to reduce adverse reactions to chemo-radiotherapy (23.9 %), in particular nausea and vomiting (13.4 %) and leucopenia (5 %). The CAMs were also used to reduce pain and fatigue (10.9 %), to reduce side effects of iatrogenic menopause (8.8 %) and to improve anxiety and depression (5.9 %), gastrointestinal disorders (5 %), sleep disturbances and neuropathy (3.8 %). CONCLUSIONS:
Mapping of the centres across Europe is an essential step in the process of creating a European network of centres, experts and professionals constantly engaged in the field of integrative oncology, in order to increase, share and disseminate the knowledge in this field and provide evidence-based practice.
http://www.ncbi.nlm.nih.gov/pubmed/25471177
Epilepsy in dogs and cats; Homeopathy has a major role to play, writes John Saxton
/http://www.britishhomeopathic.org/bha-charity/how-we-can-help/articles/epilepsy-in-dogs-and-cats/
Epilepsy in dogs and cats
Homeopathy has a major role to play, writes John Saxton
The first problem to overcome in treating epilepsy is the fact that we are dealing with a condition that, in most cases, has very violent symptoms. The salivation, muscular spasms, sometimes involuntary howling that can occur, together with the incoordination of the recovery period, produce an understandable state of revulsion in many owners, compounded by a feeling of helplessness, especially when they witness it for the first time.
This has two consequences with regard to treatment. The first is that there can be an undue concentration on the presenting symptom rather than on the whole picture, and an undue emphasis in treatment on preventing further fits at any price. Hahnemann laid great stress on the fact that disease can only be cured “if the physician clearly perceives what has to be cured… in each individual case of disease”, and this applies to epilepsy just as much as to any other condition. True epilepsy is not an acute condition but is part of a chronic disease pattern, in many instances what Hahnemann referred to as a “one-sided disease”. The really successful approach to its treatment is constitutional.
The second consequence is that accurate observation and reporting of the exact symptoms of a fit can be difficult. In one sense this is not as important as it may seem, as many of the features are local or common symptoms, but useful information can be obtained from this area of the picture.
Another factor affecting the disease picture is that many cases that present for homeopathic treatment are already receiving conventional anticonvulsant drugs. These may be failing to control the situation adequately and/or there may be concerns over the side effects of their long-term use. One of the commonest drugs used is phenobarbitone and one of the other standard medications, Mysoline, is broken down in the body into barbiturate. Long-term use of these agents can pose a strain on the liver. In addition, from the homeopathic point of view, this approach represents a degree of suppression of the case, with all the problems that that implies. However, in spite of this it cannot be stressed too strongly that such treatments must not be withdrawn suddenly, and any changes must take place under veterinary supervision. However homeopathy right from the start gives the best chance of a cure.
More cases of epilepsy are seen in dogs than in cats. Cats, unlike dogs, are a species that cannot synthesis the amino acid Taurine and hence care is taken to add it to their diet. One of the effects of Taurine in the body is as a controller of nervous impulses, and supplementing the diet of dogs to give higher levels can raise the threshold at which fits are triggered. Although not homeopathic, its use can be beneficial in the overall management of a case. Other ways of reducing the susceptibility to fits involves the use of herbal preparations, which can be helpful on occasions.
In some ways the cases where there is complete control of the fits by conventional medication are the most difficult. The picture is distorted and also the assessment of progress following a remedy is extremely difficult. Other changes in the body, usually behavioural, may give an indication of some action by the remedy, but a reduction of the medication is often the only way of ascertaining any beneficial effect. In contrast those cases where there are still some fits occurring do offer a yardstick by which to judge progress.
Because we are dealing with a chronic disease, often treatment will throw up symptoms in other areas as the whole case is revealed. The major systems that are associated are the skin and the bowels, and there may be a “see-saw” between the symptoms.
The question of potency is an important consideration when prescribing the constitutional remedy. This is one of those conditions where the last thing we want is an aggravation! Hence caution is advisable and more moderate potencies are often initially employed, even in those cases where the indications for a particular remedy are strong. Of course in any acute episode where a remedy is being used to control a fit then high potencies are very useful, as there is a high-energy output from the condition at that time.
The causes of epilepsy are many and it would not be appropriate here to consider all the factors that can possibly be linked, but one in particular is worthy of mention. That is vaccination. It is well documented that vaccinations, both primary and boosters, can on occasion produce convulsions. No animal with a history of convulsions, from whatever cause, should be given a vaccination without very good reason. Silica, having both convulsions and “ailments from vaccination” in its picture is extremely useful here.
Homeopathic treatment falls into two types. One is the full constitutional approach, aimed at obtaining a complete cure as this offers the best hope of success. Sometimes an “acute” remedy is used in addition. The other involves a compromise with the use of both homeopathic and conventional medications. The aim here is to use homeopathy to reduce the dependence on heavy medication, thereby increasing the safety margins and improving the quality of life for the patient.
Case histories Coco was a four-year-old golden retriever. She had had several fits over the previous three years, but these had been fairly mild and “very occasional”, with a quick recovery. No conventional treatment had been given as the fits were mild and infrequent. However, the latest two fits had been more severe and frequent, and although apparently recovered she now appeared “not quite her usual self”.
The fits had lasted about five minutes. There was no incontinence or howling, just a general spasm of the whole body with the head thrown back over the right shoulder. She had been vaccinated regularly with no apparent ill effects and there were no other health problems, only a behavioural inconvenience. Coco had lived with three other neutered bitches all her life and was friendly towards them. However, she would frequently mount any one of them, and if they protested run off and hide.
Originally her owner had planned to breed with her and so she was not neutered as a puppy. Her seasons had been regular but abnormally mild. Neutered at around 21/2 years of age did nothing to change the sexual behaviour. She was wary of other dogs and if approached would initially “freeze” and escape at the first opportunity. If she finally got to know another dog she was friendly and playful. Her appetite was steady, preferring dry food, and not drinking as much as her companions. She liked cuddles from the owner. She was tolerant of heat but was happy to let others be near the fire.
She was given Pulsatilla 200c for three days, with Cicuta virosa M in case of an attack. She was re-presented two months later having had a mild fit. The Cicuta had not been given. The owner reported she was “more like her old self”. Pulsatilla 200c was repeated. She has had no more fits and is now more confident with other dogs.
Zeberdee was a seven-yearold sheltie, an epileptic for three years. There was no known family history of epilepsy. The first fit had occurred within 24 hours of a booster vaccination. His only other health problem was chronic eczema and he had had kennel cough. He was on a high dose of phenobarbitone four times daily but the fits still occurred every three weeks. During them he would hyperventilate, be on his side with legs thrashing about in an incoordinated manner, salivate profusely, and pass urine. There was usually one scream before the fit. All but the last fit had occurred at night. He recovered in about an hour and was then ravenously hungry, being very sensitive to noise during that time. His owner had given Bufo 30c on two occasions and this had increased the intervals to five and eight weeks respectively, but he had now reverted to his three weekly pattern.
He was described as friendly to dogs and ladies but wary of men. He liked to play but disliked being cuddled. He was frightened of thunder, fireworks, and very wary in a crowd. He disliked the fire and preferred to be outside in all weathers, but would lie in the sun. His appetite was always good, his thirst normal, and he did not suffer from flatulence. Treatment was started with a combined vaccine nosode 30c, for four days. This was followed by Lycopodium 200c for two days. There were then two mild fits, each lasting about one minute, and each six weeks apart. He was reported as being more confident with men but otherwise unchanged. Lycopodium 200 was repeated. There were no more fits for five months, then one violent one daily for three days. Hyoscyamus 30c stopped the sequence and Lycopodium M was given for one day. There have now been no fits for over a year and his medication has been withdrawn. His eczema has also improved.
Some of the most useful remedies in the epileptic situation
Aconite Useful for both attendant and patient! The sudden onset fits the picture, and fear is sometimes seen just prior to the fit.
Belladonna Another remedy where suddenness is a feature, together with the violence of the convulsions. There is great sensitivity during the fit, and the slightest external stimulus will keep it going. The attack usually involves a single fit rather than a cluster. As the acute of Calc carb, it is often of use where that is the indicated constitutional remedy.
Bufo This has the reputation of the keynote of fits occurring during sleep. In actual fact the link is to night and sleep combined. The other feature is worse in a warm room. There is often a howl at the start of the fit.
Cicuta virosa A distinctive feature here is that during the spasms the head is thrown back and to the side, so that the muzzle rests on the shoulder blade facing towards the tail.
Cocculus A very useful remedy, its connection with vertigo gives it its place in this context.
Hyoscyamus Related to Belladonna and Stramonium, this is also an excellent “local” remedy. Its picture is characterised by excessive movements of the face, both prior to a fit and at other times.
Kali brom As Potassium bromide this is used as a conventional anti-convulsant, and it is also employed as a homeopathic remedy. The timing of the fits is often linked to oestrus, and there is marked excitement before they start.
Nux vom Together with Ignatia the main ingredient is strychnine. These two, together with the remedy Strychninum have a role to play.
John Saxton BVetMed MRCVS VetFFHom qualified in 1964 and five years later started his own practice in Leeds, concentrating on the small animal side. He became interested in homeopathy in the late 1970s and was awarded his Fellowship in 1996. He teaches regularly in the UK and examines in veterinary homeopathy for the Faculty of Homeopathy.
Biological effects of high-diluted substances and periodic table of elements
/Int J High Dilution Res 2012; 11(40):192-193 Proceedings of the XXVI GIRI Symposium; 2012 Sep20-22; Florence (Italy)Poster Section Biological effects of high-diluted substances and periodic table of elements Cloe Taddei-Ferretti1,2 1Istituto di Cibernetica “E. Caianiello”, CNR, Pozzuoli, Italy 2Scuola Italiana di Medicina Omeopatica Hahnemanniana, Rome, Italy ABSTRACT Background and Aims. There are several experimental evidences for the effects of high-diluted substances (see e.g. C. Taddei-Ferretti, A. Cotugno 1997, on effects of high-diluted drugs on the prevention and control of mice teratogenicity induced by purine derivatives; N.C. Sukul, C. Taddei-Ferretti, S.P. Sinha Babu, A. De, B. Nandi, A. Sukul, R. Dutta-Nag 2000, on high-diluted Nux vomica countering alcohol-induced loss of righting reflex in toads). Also the physical characterization and mechanism of action of high-diluted drugs have been studied (see e.g. N.C. Sukul, A. Sukul, High dilution effects: Physical and biochemical basis 2004). However, further experimental researches are needed to clarify how physical characteristics of a drug are linked to its global biological effects. Considerations on some high-diluted mineral remedies will be developer here. Methods. In Organon, sect. 119, S. Hahnemann writes: «As certainly each species of plants is different from every other one with regard to external appearance, way of life and growth, taste and smell, and as certainly each mineral, each salt is different from the others with regard to external, internal, physical and chemical qualities [...], so certainly all these vegetal and mineral substances have pathogenetic – and thus also curative – effects different among themselves [...]». This statement may be taken as basis for considering the characteristics of some elements, as ordered in the periodic table, in relation to those of some high-diluted mineral remedies. Conclusions. The elements were previously ordered in the periodic table according to the atomic weight chemically determined, and later more precisely according to the atomic number (number of protons). Then also the electronic configuration was taken into account: properties depending on atomic mass and deep electrons are not periodical, while chemical and several physical properties are linked to external electrons which have periodical configuration. In particular, let us consider the group of elements C, P, S, Cl and the group of elements Ca, Mg, K, Na. One may conclude that the four elements of the first group (respectively receiver-or-donor of 4 electrons, receiver of 3, of 2, of 1 electron), which, according to H. Bernard, are linked to the fixed human constitutions, are close among themselves in the periodic table, while they are very distant from the four elements of the second group (respectively donor of 2, of 2, of 1, of 1 electron), which are close among themselves and are linked to the changing constitutional stages. Key words: biological effects, high-diluted substances, human constitutions, periodic table, physical characteristics 192 Int J High Dilution Res 2012; 11(40):192-193 Proceedings of the XXVI GIRI Symposium; 2012 Sep20-22; Florence (Italy) Licensed to GIRI Support: the author declares that this study received no funding Conflict of interest: the author declares there is no conflict of interest Received: 01 June 2012; Revised: 10 August 2012; Published: 30 September 2012. Correspondence author: Cloe Taddei-Ferretti, cloetadfer@libero.it How to cite this article: Taddei-Ferretti C. Biological effects of high-diluted substances and periodic table of elements. Int J High Dilution Res [online]. 2012 [cited YYYY Month dd]; 11(40):192-193. Proceedings of the XXVI GIRI Symposium; 2012 Sep 20-22; Florence (Italy). GIRI; 2012; Available from: http://www.feg.unesp.br/~ojs/index.php/ijhdr/article/view/613/603 193 Copyright of International Journal of High Dilution Resarch is the property of International Journal of High Dilution Research and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Histamine at high dilution reduces spectral density in delta band in sleeping rats
/Homeopathy (2005) 94, 86–91 r 2005 The Faculty of Homeopathydoi:10.1016/j.homp.2004.10.002, available online at http://www.sciencedirect.com ORIGINAL PAPER Histamine at high dilution reduces spectral density in delta band in sleeping rats G Ruiz-Vega1,, B Poitevin2 and L Pe ́ rez-Ordaz1 1Laboratorio de Biofı ́sica, Instituto de Fı ́sica y Matema ́ticas, Universidad Michoacana de San Nicola ́s de Hidalgo, Morelia, Michoaca ́n, Me ́xico 2Association Franc-aise por la Recherche en Homeopathie Histamine is a central neurotransmitter, it increases arousal via H1 receptors. This study examines the effect of ultra-diluted histamine on arousal through changes in the sleep pattern of Wistar rats. The spectral density in delta (0.5–2.5 Hz) band, one of the three major spectral components of the sleep-electroencephalogram, was analyzed against time. Rats were randomized to receive histamine 30c (histamine 30c, 0.05ml every 20min during the first 2h orally), histamine intraperitoneal pre-treatment/histamine 30c (histamine 6 mg/kg i.p., followed by histamine 30c) or solvent control. The mean delta band spectral density was lower in the histamine 30c and histamine pretreat- ment/histamine 30c groups than the control group. Significant differences between histamine 30c and baseline during the first 2 h imply an immediate effect. These results also suggest a dynamic process in which the system spontaneously evolves between two locally stationary states according to a power law. From the time perspective, the system approaches, asymptotically, an equifinal state. Homeopathy (2005) 94, 86–91. Keywords: histamine; ultra-diluted; homeostatic; self-response; sleep pattern; homeopathy increase wakefulness and decrease slow wave sleep; while H3 receptors play an active part in these mechanisms by regulating histamine release.11,12 As a highly diluted stimulus applied during the sleep cycle of healthy subjects, histamine would be expected to increase arousal, according to the similia principle; which in turn promoting a homeostatic host response. Sleep loss, either pharmacological or mechanical, provokes a counteraction, called ‘sleep homeostasis’, which involves an increase in non-REM sleep intensity. The main marker of the intensity of non-REM sleep is EEG slow-wave activity, defined as the spectral density in delta band, which normally declines in the course of sleep time and increases in the sleep deprivation.13 In this study, we evaluated sleep intensity as the spectral density in 0.5–2.5Hz band, calculated over the completenoise-freefile.Thisassumptionreliesonthe fact that this domain constitutes the main frequency of non-REM sleep.14 It exceeds those of waking and rapid-eye-movement (REM) sleep by an order of magnitude,15 and closely correlates to slow wave non-REM activity. This marker has been described in previouspapers.16–18 We assessed the effect ultra-low-dose (ULD) hista- mine on arousal using this parameter. In addition, as the effect of the combination of pharmacological and ultra-low-dose of the same compound has been formerly reported previously,18–20 we also investigated the combination of pharmacological+ULD histamine. Materials and methods Animals Young adult male Wistar rats weighing between 250 and 350 g ðn 1⁄4 36Þ; were used. All procedures complied withMexicanFederalRegulationsfortheUseandCare of Laboratory Animals (NOM-062-ZOO-1999). Rats were feed ad libitum on standard diet (Purina, Mexico) and randomized in three groups treated as follows: Solvent (orally), Histamine 30c (orally), Histamine pre-treatment/Histamine 30c: histamine intraperitoneally (6 mg/kg i.p.) followed by histamine 30c orally. The oral dosage was 0.05 ml each 20 min during the first 2h. Pre-treatment was one i.p. injection of histamine (histamine dihydrochloride) in double dis- tilled water. Rats were anaesthetized (40mg/kg pentobarbital), three 1.5mm diameter stainless-steel electrodes (resis- tanceo0.1 O) were implanted in the animals’ cranium after trepanation with a hand-held Foredom drill, securedwithdentalresinandconnectedtoa15A54 Grassmultichannelamplifier(Astro-Med,Inc.West Warwick, RI, USA). A bipolar EEG was recorded through two of these electrodes, which were implanted bilaterally in the parietal region, and the third one in ARTICLE IN PRESS Biological effect of highly diluted histamine G Ruiz-Vega et al the frontal area for reference (ground). Trepanation points were spotted stereotaxically at the following coordinates: 3.8 mm posterior to Bregma and 4.5 mm lateral to the side of central line for the bilateral electrodes.21 After surgery the animals were allowed to recover for 6 days; a further 1-day habituation period took place, in which the electrodes were connected to the signal amplifier by a cable that allowed freedom of movement. During the pre-operation and recovery periods, rats were maintained under a steady light–- dark cycle. Next day baseline was recorded without any mechanical or pharmacological disturbance. The next day treatment measurements started. Sleep deprivation could be the consequence of pharmacological or mechanical stimuli (the repetitive sleepdisturbancefororaltreatmenteach20minduring 2 h); or superimposed effect of both. Hence, in order to estimate objectively the possible effect of the highly diluted histamine in histamine pre-treatment/ hista- mine30cgroupparalleltestswerecarriedoutwithtwo additional groups (12 animals per group): Histamine i.p.(6mg/kg,i.p.)andsaline,withnosleepdisturbance due to repetitive oral administration. These were supplementary ‘positive controls’. Materials Histamine hydrochloride was obtained from Sigma Chemical Co. (St Louis, MO, USA). Saline solution (0.9% NaCl) was obtained from PiSA, Laboratorios Mexicanos. Ultra-high diluted histamine and the solvent (87% alcohol/water) were acquired from Laboratorios Medicor (Mexico). Preparation of the histamine 30c involved 30 successive centesimal dilu- tions (1/99 vol%). The final concentration is theoreti- cally equivalent to 0.9 1061 M. Experimental set-up Rats were housed individually in wooden cages built to avoid external disturbances but allowing observa- tion. Daylight was provided so as not to alter the circadianhistaminepattern.22Eachsubjectwascon- nected to a 15A54 Grass amplifier module, its controls set as follows: sensitivity 20.0mV/div, display gain 1, band-pass filter 0.3–30Hz, line filter on. The output wassampledat8Hzandonlinedigitizedwitha National Instruments AT-MIO-64E-3 card and Poly- Views v 2. software (Astro-Med). Output was stored in a computer for mathematical analysis. Sampling frequency was chosen taking into account delta band features14 as well as the Nyquist theorem.23 Experimental procedure Six rats were tested at a time, one to a cage, two for eachgroup(fortechnicalreasons,1sessionwasrun withonly5subjects).Measurementsstartedtheday after baseline recording . At this time rats were fed their regular diet and purified water ad libitum. At 10.00, t 1⁄4 0 (t, time in hours), rats from histamine 87 Homeopathy 88 Biological effect of highly diluted histamine G Ruiz-Vega et al pre-treatment/ histamine 30c group received a single dose of histamine i.p., simultaneously oral treatment was initiated for all three groups. On the completion of 8h recording session, the tests concluded for the six subjects and the process was repeated with six new ones until all were tested. Mathematical analysis of datawascarriedout‘blind’.Eachrecordwassplitinto 1-hperiodsandepisodescontainingEEGartefacts (disconnections or body movement) were visually identified (blind) and omitted from further analysis. Becauseofexcessivenoisyevents,oneanimalwas discarded in histamine 30c group. The 280 series of 1 h data(35ratsx8hperrat)weresubjectedtoafast fourier transform (FFT) algorithm and the spectral density was computed for the specified bands in every file (STATISTICAs, StatSoft, Tulsa, OK, USA). Due to different lengths of noisy periods, the records were of different sizes. In order to have a common reference, the spectral density in the delta band was analyzed as percentage of the spectral density in the whole frequency range (0–2.5 Hz). Analysis of data Results arose from a between–groups and repeated measures approach, comparing the mean value in the groups, but considering their own baseline record as SOLVENT Homeopathy 90 90 88 88 86 86 84 84 82 82 80 80 78 78 76 76 74 74 72 72 70 70 68 68 (a) HISTAMINE PRETREATMENT/HISTAMINE 30c (b) 90 88 86 84ec ddd84 c c d 82 d 80 78 76 74 72 70 68 (c) c ecd 90 88 86 82 80 78 76 74 72 70 68 (d) BASELINE AND POSITIVE ip CONTROL BASELINE SALINE ip Histamine ip ARTICLE IN PRESS Figure 1. Variation for spectral density in delta band in all groups. Mean spectral density, sd vs time, t. sd (%) in y-axis, time in hours in the x-axis from t 1⁄4 0 to 8. Each value is mean 7 SEM in (a–c). A similar pattern is seen in (a–c); histamine 30c exhibits, at t 1⁄4 1; 2 the lowest value as well as the greatest increase rate in the middle stage. As time goes on, all groups tend to baseline state. In (d), baseline exhibits a moderate enhancement up to t 1⁄4 5; a slight decrease tendency is developed after that, as expected in the absence of sleep disturbance. A similar pattern is observed for all ‘positive’ controls, which overlapped. aDifferent from baseline, Po0:01; bPo0.05. cDifferent from solvent, Po0:01; dPo0.05. eDifferent from histamine 30c, Po0:01: well. Comparison between-groups was by ANOVA, specifying the repeated measures (ie baseline/stimulus) as the within-subject factor. A multiple comparison procedure, the Newman–Keuls post-hoc test, was performed to determine significant differences between pairs of the three experimental groups. To avoid bias duetoextremevalues,outliersthatwereoutsidethe rangeof72sd,wereidentifiedandexcluded:3,2and 1 in solvent, histamine 30c and histamine pre- treatment/ histamine 30c groups respectively. Statis- ticalanalysiswascarriedoutwithSTATISTICAs. Results 1. Solvent orally: Sleep disturbance due to oral dosing was seen, but no other significant difference from baseline was measured. In fact, the spectral density in delta band increases smoothly from a minimum at t 1⁄4 1 (t 1⁄4 time in hours), due to repetitive awakenings for oral administration, to a maximum at t 1⁄4 5; a small decrease was observed during the following 3 h, as expected from the circadian pattern24 (Figure 1a). 2. Histamine 30c orally: Spectral density in the delta band was less than solvent through the whole HISTAMINE 30c c a b c d d d recording period, the difference was highly significant ðPo0:01Þ during the first 4 h. However, if was different from baseline only in the first 2 h (Figure 1b). 3. Histamine pre-treatment/ histamine 30c: This group was significantly different from solvent through- out , but there was no difference from baseline at any time. The difference from the histamine 30c group was significant only in the first 2 h (Figure 1c). 4. Positive controls: histamine and saline i.p.: Baseline recordings showed a slight increase in delta spectral densityatt1⁄42;afterwards,asmoothtendencyto decline was observed. A similar pattern was seen for the positive controls, no differences from baseline were detected at any time. Since delta activity subsides spontaneously from the first to the second non-REM stage in absence of sleep deprivation24 the baseline pattern is as expected outcome when there is no sleep loss. The ‘positive’ control (histamine i.p. only) results were as expected, since i.p. histamine does not cross the blood brain barrier (Figure 1d).25,26 Three time periods were identified: 1. t 1⁄4 022: Oral dosing was given in period. Highly significant differences ðPo0:01Þ; were found for histamine 30c compared to both baseline and solvent. The pre-treated group was not different from its baseline. Solvent values were approximately con- stant. 2. t 1⁄4 225: During this stage the host response to sleep deprivation was observed; a continuous increase in the spectral density in delta band was observed for the two histamine 30c groups but not in positive controls (which has not suffered sleep deprivation due to dosing) (Figure 1d). A linear relationship between log(spectral density, sd) vs log(time, t) was found. Figure 2 shows the fitting parameters and the correla- tion between experimental data (full line) and the linear model (dashed line). The function is presented as the general form log y1⁄4bþm log x, Histamine 30c PreTreat/Hist 30c Solvent 4.50 4.46 4.42 4.38 4.34 4.30 4.26 0.6 0.8 1.0 1.2 log (time, t) Solvent: log(sd) = 4.41 + 0.04*log(t), R = 99.4% Hist pre-treat: log(sd) = 4.32 + 0.06*log(t), R = 99.3% HIstamine 30c: log(sd) = 4.19 + 0.15*log(t), R = 97.9% Solvent Hist pre-treat/histamine 30 Histamine 30c 1.4 1.6 1.8 Figure 2. Log–log fitting for mean spectral density in delta band. log (sd) vs log (t) from t 1⁄4 2 to 5. Linear fitting was chosen because of its high correlation, R. Fitting function as dashed line. ARTICLE IN PRESS this time 0 2345 2345 2345 Figure 3. Rate of change for the spectral density in delta band. Time in hours in the x-axis. Values of histamine 30c group and pre-treated group are approximately 3.5 and 1.5 times those of solvent respectively. There is a decreasing trend from maximum at t 1⁄4 2; ie, immediately after the end of dosing. The changes evaluated are d(sd) during a time interval dt in Eq. (1) for each group. where y1⁄4sd; x1⁄4t; m1⁄4slope, b1⁄4intercept with y-axis. The Quasi-Newton method was employed in the regression parameters estimate, calculations were performedwithSTATISTICAs.Thisrelationcanbe changed to the form y 1⁄4 Cxa (1) where C 1⁄4 ExpðbÞ;a 1⁄4 m. The change rate, in this interval, was also calculated from dy/dt in the Eq. (1) for each group. Changes in the stimulated groups were different from those of solvent. These results are shown in Figure 3 where a gradual decrement is observed in all groups. The rate for histamine 30c was the greatest; it was approxi- mately 3.5 times faster than solvent; in contrast, histamine pre-treatment/ histamine 30c group rate was E1.4 times faster than solvent. 3. t 1⁄4 528: The rising spectral density seen in the precedingperiodstopped;insteadasmoothdeclining tendency begun. No difference from baseline was identified for histamine 30c and histamine pre-treat- ment/ histamine 30c groups, but they remained significantly different from solvent control. Discussion The statistical analysis compared the values of treatmentgroupswiththoseofsolventcontroland their own pretreatment baseline. The three treatment groups were under similar experimental conditions, ie., repetitive sleep disturbance for oral dosing (each 20min for the first 2h). Hence, it was expected that three groups developed a similar trend in time, which in fact they did (Figure 1). The consistency of the solvent group through the whole period implies the lack of treatment effect: the values were similar to Biological effect of highly diluted histamine G Ruiz-Vega et al 6 5 4 3 2 1 89 log (spectral density, sd) Homeopathy 90 Biological effect of highly diluted histamine G Ruiz-Vega et al baseline. These results confirm the accuracy of the selected marker. The histamine 30c results demonstrate that ULD histamine modifies the sleep pattern; the decrease in spectral density during the first 2h in histamine 30c group agrees with the experimental hypothesis suggest- ing an increase in wakefulness. The sleep pattern is characterized by three major rhythms: delta, slow (E0.3Hz) and spin spindle rhythms;27 however, the spectral density in delta band characterizes the system behavior under sleep perturbation. The histamine pre-treated (6 mg/kg i.p.) group also exhibited an initial decrement in the spectral density, however in contrast with histamine 30c it was not different from baseline. In order not to overestimate the possible effect of the highly diluted histamine in these rats, additional ‘positive’ controls were included (histamine 6mg/kg i.p. and saline i.p.). This was to control for the effect of histamine i.p. alone without any sleep disturbance due to oral administration. These results confirm the accuracy of the outcome measuresincesleeplosswasnotdetectedwithi.p. histamine (Figure 1d); this conforms with the conven- tional blood brain barrier model.25,26 The experimental results with the administration of the combination of two doses19,20 ie. pharmacological/ ULD doses, suggest that the ULD dose neutralizes the action of the substantial dose. However, i.p. histamine alone had no effect (Figure 1d). We cannot claim neutralization of non-existent effect! It would be possible to suggest that pharmacological dose has inhibited the response to the ultra-low-dose stimulus. Additional work is required to address this issue. TheEq.(1),y1⁄4Cxa;correspondstothegeneral form of the mathematical relations known as power laws; their main feature is self-similarity or scale invariance,28inturnassociatedwithfractality.The fractal concept was coined to describe irregular geometric forms that lack a characteristic (single) scale of length, but can also be applied to self-similar phenomena evolving in time.29,30 The expression self- organized critically (SOC) has been introduced,31 to describe the tendency of dissipative systems to drive themselves to a critical state, which is identified as an attractor for the dynamics. Power laws are ubiquitous in nature; they have been identified in diverse natural phenomena including the restoring force in a linear spring, Newton’s law of gravity, membrane channel openings, human writing, biological evolution, eco- nomics, music, earthquake structure, etc., which suggest that SOC might be an universal phenomen- on.28,29 The three experimental groups show a SOC tendency. They evolved between two different homeo- staticstates,bothofthemattainedspontaneouslyand conventionally recognized:32 (1) The conscious state of quiet wakefulness through the first 2h when the subject was disturbed by dosing ARTICLE IN PRESS every 20min; hence, the sleep cycle was prevented from evolving in spite of the animal being at the beginning of its circadian sleep cycle. (2) The unconscious stable state of NREM sleep in the last 3 h, which is asymptotically reached. Because of this feature, it is identified as a globally stable and attractive state. After the stimulus administration, the system spon- taneously evolved to NREM sleep, characterized by the dominance of delta rhythm. The immediate response system, between t 1⁄4 2 and 5, evolved accord- ing to a power function. The periods of transition from an active to a resting state are described by an asymptotic decline of the variable (metabolic rate, breathing rate and tidal volume), such asymptotic decrease is characterized by the change of rate which gradually evolves from a maximum to a minimum when the system approaches to the lowest value and reaches the resting state.32 In our case, the variable does not decline, because deltaoscillationsarethemainfeatureofNREMsleep, its prevalence (expressed as the percentage) in contrast, increases. However, as time goes by, the rate of change diminished as it gets closer to its final value (Figure 3). Because the rate of change in the histamine 30c group was significantly higher than solvent, a synergic effect of the ultra-low-dose stimulus may be suggested. In addition, when certain final state is specific for a given system in determined circumstances, no matter the initial conditions, the tendency to reach such a steady state is termed ‘equifinality’.32 Because from different initial conditions the three experimental groupsevolvedtoreachthesameequifinalstate(ie, no difference from baseline), it is assumed that the system has been self-organized in time to reach a global attractor,whichinturnimpliesfractality.Theadapt- ability of response is crucial to confer robustness under unexpected circumstances. Robustness and fractality are generic characteristics of SOC,33 it is not unreason- able to think of homeostasis as a fractal process for restoring the dynamics of health. The concept of fractal physiology30 as adaptive processes which guarantee to respond to unpredictable stimuli and stresses is widely accepted. The high correlation between our experimental data and the SOC model suggests that the system has evolved from one state to another one according to a power law. Conclusion These results suggest that histamine 30c induced not only a transient sleep loss, reflected by the initial decreaseinthespectraldensityindeltaband,butalsoa synergic effect on the immediate host response. A self- similar pattern was identified after dosing: the system evolved driven by a threshold dynamics between two critical states; which implies the organism was impelled Homeopathy 1 Khandelwal JK, Hough LB, Green JP. Histamine and some of 60:914–918. 2 Babe KS, Serafin WE. Histamine, bradykinin, and their antagonists. In: Goodman & Gilman’s, The Pharmacological Basis of Therapeutics. New York: McGraw Hill, 1996, pp. 581–593. 3 Toyota H, Dugovic C, Koehl M, Laposky AD, Weber C, Ngo K, Wu Y, Lee DH, Yanai K, Sakurai E, Watanabe T, Liu C, Chen J, Barbier AJ, Turek FW, Fung-Leung WP, Lovenberg TW. Behavioral characterization of mice lacking histamine H(3) receptors. Mol Pharmacol 2002; 62(2): 389–397. 4 Orsetti M, Ferretti C, Gamalero R, Ghi P. Histamine H3- receptor blockade in the rat nucleus basalis magnocellularis improves place recognition memory. Psychopharmacology (Berl) 2002; 159(2): 133–137. 5 Miyazaki S, Onodera K, Imaizumi M, Timmerman H. Effects of clobenpropit (VUF-9153) a, histamine H3-receptor antago- nist, on learning and memory, and on cholinergic and monoaminergic systems in mice. Life Sci 1997; 61(4): 355–361. DoutremepuichCh.Combinationoftwodosesofacetyl salicylic acid: experimental study of arterial thrombosis. Thromb Res 1998; 90: 215–221. 20 Reber A, Poitevin B, Leroy MH, Nzobounsana. Optokinetic and vestibulo-ocular reflex adjustment by GABA antagonists. Behav Brain Res 1996; 81: 89–97. 21 Paxinos G, Watson Ch. The Rat Brain in Stereotaxic Coordinates, 2nd edn. New York: Academic Press, 1986. 22 Tuomisto L. Involvement of histamine in circadian and other rhythms. In: Watanabe T, Wada H (eds). Histaminergic Neurons: Morphology and Function. Boca Raton, FL: CRC Press, Inc., 1991, pp 283–295. 23 LabVIEWs. Analysis VI Reference Manual. National Instru- ments Corporation, 1993. 24 Steriade M, Amzica F. Coalescence of sleep rhythms and their chronology in corticothalamic networks. Sleep Res Online 1998; 1(1): 1–10. 25 Mayhan WG. Role of nitric oxide in histamine-induced increases in permeability of the blood–brain barrier. Brain Res 1996; 743: 70–76. ARTICLE IN PRESS to leave its initial stationary state because of the ULD histamine. Acknowledgements This research was supported by a grant from ScientistResearchCouncilfromUniversityofMi- choacan. We thank Rafael Villalobos-Molina and Daniel Garcı ́a-Garrido. References meopathy 2003; 92: 19–29. itsmetabolitesinhumanbodyfluids.KlinWochenschr1982; 19Belougne-MalfatiE,AguejoufO,DoutremepuichF,BelonP, 6 Sainte-Laudy J, Belon P. Inhibition of human basophil activation by high dilutions of histamine. Agents Actions 1993;38:C245–C247. 26DeliMA,Ne ́methL,FalusA,A`braha ́mCS.EffectsofN,N- 7 Sainte-Laudy J, Belon P. Application of flow cytometry to the analysis of the immuno suppressive effect of histamine dilutions on human basophil activation: effect of cimetidine. Inflamm Res 1997; 46(Supple ́ ment 1): 27–28. 8 Poitevin B, Davenas E, Benveniste J. In vitro immunological degranulation of human basophils is modulated by lung histamine and Apis mellifica. Br J Clin Pharm 1988; 25: 439–444. 9 Brown V, Ennis M. Flow-cytometric analysis of basophil activation: inhibition by histamine at concentionnal and homeopathic concentrations. Inflamm Res 2001; 50: S47–S48. 10 Monti JE. Involvement of histamine in the control of the waking stat. Life Sci 1993; 53: 1331–1338. 11ArrangJM,GarbargM,LancelotJC,LecomteJM,PollardH, RobbaM,SchunackW,SchwartzJC.Highlypotentand selective ligands for a new class H3 of histamine receptor. Invest Radiol Suppl 1988; 1: S130–S132. 12 Arrang JM, Garbarg M, Lancelot JC, Lecomte JM, Pollard H, Robba M, Schunack W, Schwartz JC. The third histamine receptor. Highly potent and selective ligands. Int Arch Allergy Appl Immunol 1989; 88(1–2): 79–81. 13 Schwierin B, Borbe ́ ly AA, Tobler I. Effects of N6-cyclopenty- ladenosine and caffeine on sleep regulation in the rat. Eu J Pharmacol 1996; 300: 163–171. diethyl-2-4-(phenylmethyl)phenoxyethamine on the blood–- brain barrier permeability in the rat. EuropJ Pharmacol 2000; 387: 63–72. 27 Contreras D, Steriade M. Cellular basis of EEG slow rhythms: a study of dynamic corticothalamic relationships. J Neurosc 1995; 15(1): 604–622. 28 Schroeder M. Fractal, Chaos, Power Laws. New York: W.H. Freeman and Company, 1991, pp 103, 122. 29 Bak P, Creutz M. Fractals and self.organized criticality. In: Bunde A, Havlin S. (eds). Fractals in Science. Berlin: Springer, 1994, pp 27–47. 30 Goldberger AL, Amaral LAN, Hausdorff JM, Ivanov PCh, Peng CK, Stanley HE. Fractal dynamics in physiology: Alterationswithdiseaseandaging.ColloquiumofTheNational AcademyofSciences,March23–24,2001. 31 Bak P, Tang C, Wiesenfeld K. Self-organized criticality: an explanation of 1/f noise. Phys.Rev. Lett 1987; 59: 381–384. 32 Recordati G, Bellini TG. A definition of internal constancy and homeostasis in the context of non-equilibrium thermo- dynamics. Exp Physiol 2004; 89(1): 27–38. 33 Carlson JM, Doyle J. Complexity and robustness. Colloquium of The National Academy of Sciences, March 23–24, 2001. Biological effect of highly diluted histamine G Ruiz-Vega et al 14 Rechtschaffen A, Kales A (eds). A Manual of Standardized Terminology, Techniques and Score System for Sleep Stages of Human Subjects. Bethesda, MD: US Department of Health, Education and Welfare, 1968. 15 Borbe ́ ly AA, Tobler I, Hanagasioglu M. Effect of sleep deprivation on sleep and EEG spectra in the rat. Behav Brain Res 1984; 14: 171–182. 16 Ruiz-Vega G, Pe ́ rez-Ordaz L, Proa-Flores P, Aguilar-Dı ́ az Y. An evaluation of Coffea cruda on rats. Br Hom J 2000; 89: 122–126. 91 17 Ruiz-Vega G, Va ́ zquez E, Pe ́ rez-Ordaz Sa ́ nchez-Dı ́ az L, Leo ́ n-Hue ́ ramo N. Comparative O, Cruz- effect of Coffea cruda potencies on rats. Homeopathy 2002; 91: 80–84. 18 Ruiz-Vega G, Pe ́ rez-Ordaz L, Corte ́ s-Galva ́ n, Jua ́ rez-G FM. A kineticapproachtocaffeine–Coffeacrudainteraction.Ho- Homeopathy
Journal of the Australian Traditional-Medicine Society September 2007 Volume 13 Issue 3 Update On Research
/Journal of the Australian Traditional-Medicine Society September 2007 Volume 13 Issue 3Update On Research In Homœopathy Robert Medhurst Previous issues of this journal contained summaries of some of the more notable pieces of research carried out on homœopathy and as a means of keeping you up to date on this subject, more of these follow. If you use homœopathy in your clinical practice this sort of information is useful to be aware of. Those of us who practise this modality are often asked to justify it by something other than anecdote, and given the difficulty that orthodox medicine and science has in accepting a mechanism for it, controlled clinical evidence in homœopathy is of great help in being able to do this. Human Studies Frass M, Linkesch M, Banyai S et al. Adjunctive homeo- pathic treatment in patients with severe sepsis: a ran- domized, double-blind, placebo-controlled trial in an intensive care unit. Homeopathy 2005;94(2):75—80. In this study, 70 people admitted to an intensive care unit suffering from severe sepsis were treated either with individ- ualised homœopathic treatment or placebo. On reviewing the signs of sepsis, organ failures, need for mechanical ventila- tion and other parameters at 180 days after beginning treat- ment, 76% of the patients using homœopathy met survival criteria versus 50% of those on placebo. Frei H, Everts R, von Ammon K et al. Homeopathic treatment of children with attention deficit hyperactivity disorder: a randomised, double blind, placebo controlled crossover trial. Eur J Pediat 2005;164(12):758—767. Eighty-three children diagnosed as suffering from ADHD using DSMIV criteria were treated with individually pre- scribed homœopathic medicines. Using the Connor’s Global Index scale it was determined that 63 of these children responded to treatment. These children were then ran- domised to receive either placebo or homœopathic medi- cines for 6 weeks and at this point were crossed over to receive placebo if they had been using the homœopathics or vice versa. At the end of this period it was found that homœopathic therapy provided significantly better results than placebo. Haila S, Koskinen A, Tenovuo J. Effects of homeopathic treatment on salivary flow rate and subjective symptoms in patients with oral dryness: a randomized trial. Homeopathy 2005;94(3):175—181. In this blind, placebo-controlled study, 28 people diagnosed with xerostomia (dryness of the mouth) were randomly assigned to receive either placebo or individually prescribed homœopathic medicines. Assessed using unstimulated and wax-stimulated salivary flow rates and visual analogue scales at the end of the trial, only 26 of those people using homœopathic treatment and none using placebo were found to have had significant relief. Following the assessment of these results those on placebo were switched to homœopath- ic therapy, after which all experienced relief from their xerostomia. Sevar R. Audit of outcome in 455 consecutive patients treated with homeopathic medicines. Homeopathy 2005;94(4):215—221. This study examined the effect of individualised homœo- pathic treatment of 455 consecutive patients in a homœo- pathic medical clinic who had previously had unsuccessful orthodox medical treatment or were considered to be unsuit- able for orthodox medical treatment. Of these, 67% derived benefit from homœopathic therapy, and 33% were able to stop or maintain a substantial reduction in their pharmaceu- tical drug therapy. Baars EW, De Bruin A. The effect of Gencydo injections on hayfever symptoms: a therapeutic causality report. J Altern Complement Med 2005;11(5):863—869. In this study, 13 Dutch medical practitioners submitted patients (who between them had a mean history of hayfever of 9 years) for therapy involving injections of Gyncedo, a combination homœopathic product. All but one patient were given the medication before the onset of the hayfever season and all were given it during the hayfever season. Of these 13, during the course of the trial 9 people found no increase in nasal and non-nasal hayfever symptoms when the hayfever season began or during it and only 1 of the 13 felt compelled to use conventional hayfever medication. Animal Studies Ruiz-Vega G, Poitevin B, Perez-Ordaz L. Histamine at high dilution reduces spectral density in delta band in sleeping rats. Homeopathy 2005;94(2):86—91. Histamine in material doses is a central nervous system stim- ulant operating via H1 receptors. The researchers in this study examined the effects of histamine in 30C homœopath- ic potency on the sleep patterns of rats. Using the spectral density of the delta band in the sleep electroencephalogram to measure the effects of the remedy, which is higher during periods on non-REM sleep, researchers found that histamine 30C produced an increase in wakefulness when compared to controls. Sukul NC, Ghosh S, Sinhababu SP. Reduction in the number of infective Trichinella spiralis larvae in mice by use of homeopathic drugs. Forsch Komplementarmed Klass Naturheilkd 2005;12(4):202—205. Trichinellosis, a disease caused by Trichinella spiralis which occurs in humans and animals, was the subject of this trial. Mice infected with this organism were given Podophyllum mother tincture, Cina 30C, Santonin 30C, or ethanol 30C as 155 Journal of the Australian Traditional-Medicine Society September 2007 Volume 13 Issue 3 a control substance. After 120 days the mice were examined for the presence of the T. spiralis larvae and this was com- pared with the larval load before therapy. At 120 days the mice given Podophyllum had their larval load reduced by 61% when compared to the control, those given Santonin had a reduction of 81% and the mice given Cina had a reduc- tion of 84%. Aziz DM, Enbergs H. Stimulation of bovine sperm mito- chondrial activity by homeopathic dilutions of monensin. Homeopathy 2005;94(4):229—232. Mitochondrial activity is an important marker for the health of sperm. It is linked to sperm motility and in research labo- ratories monensin is commonly used as an inhibitor for sperm mitochondrial activity. The researchers in this study examined the effects of the 5th to the 14th decimal potencies of monensin on the activity of the mitochondria of sperm taken from mature bulls. All of the potencies produced a stimulatory effect on the bull sperm mitochondrial activity, with the 9X producing the strongest of these effects. Plant Studies Brizzi M, Lazzarato L, Nani D, Borghini F, Peruzzi M, Betti L. A biostatistical insight into the As(2)O(3) high dilution effects on the rate and variability of wheat seedling growth. Forsch Komplementarmed Klass Naturheilkd 2005;12(5):277—283. Wheat seedlings previously stressed with sub-lethal doses of arsenic, a substance known to be lethal to this plant, were treated with various potencies of Arsenicum album (5X, 15X, 25X, 35X and 45X), equivalent potencies of water and- equivalent unsuccussed dilutions of arsenic trioxide. The stem lengths of the seedlings was assessed at day 7 and it Medhurst R. Update on Research in Homœopathy. was found that the 45X potencies of Arsenicum and the water but not the diluted arsenic trioxide induced an increase in seedling height. Binder M, Baumgartner S, Thurneysen A. The effects of a 45x potency of Arsenicum album on wheat seedling growth — a reproduction trial. Forsch Komplement- armed Klass Naturheilkd 2005;12(5):284—291. In a repeat performance of the previous trial, wheat seedlings previously exposed to sub-lethal doses arsenic were cultivat- ed in either Arsenicum album 45X, water 45X or unpoten- tised water, and the seedling height measured at 7 days. The experiment was independently reproduced 8 times and after the results were collated the wheat seedlings cultivated in Arsenicum 45X showed a significant reduction in height when compared to the 2 controls. This is a reversal of results seen in previous studies of this type, but does confirm a reproducible effect of this particular homœopathic medicine under these experimental conditions. In Vitro Studies Oberbaum M, Glatthaar-Saalmüller B, Stolt P, Weiser M. Antiviral activity of Engystol: an in vitro analysis. J Altern Complement Med 2005;11(5):855—862. Cultured tissue cells infected with Herpes simplex virus 1 (HSV-1), human rhinovirus (HRV), adeno 5 (A5V) and res- piratory syncitial virus were exposed to Engystol, a homœo- pathic combination product. These cells were then assayed for virus clearance using plaque reduction, virus titration and Elisa methods. The results of these assays showed an 80% reduction in HSV-1 specific proteins, a 73% reduction in A5V specific proteins and a reduction in infectivity of RSV by 37% and HRV by 20%. The ATMS Simon Schot Education Grants ($10,000) Proudly sponsored by Marsh (ATMS insurance broker) What is the Purpose of the Grants? The purpose of the grants is to encourage and assist 10 ATMS accredited members to undertake further education in complementary medicine. The grants will subsidise a diploma course or higher qualification course at an ATMS recognised course or a research project in com- plementary medicine at an appropriate tertiary institution. How Do the Grants Work? The grants consist of 10 prizes of $1,000 each. The grants will be paid direct- ly to the institution. The ten winners will be decided by a draw to be held in March 2008. For demographic reasons, no less than 5 winners will be residents of NSW. How To Apply for the Grants? The grants are open to all ATMS Accredited members. To apply send a let- ter to ATMS with your name, address, telephone number, ATMS membership number and the name of the ATMS accredited course or research project you wish to undertake if successful. The winners must com- mence the course no later than 2009. Send your letter to: Simon Schot Education Grant, ATMS, PO Box 1027 Meadowbank NSW 2114 Telephone (02) 9809 6800, fax (02) 9809 7570, email: marie@atms.com.au The deadline to apply for the Education Grants is 1 March 2008 156 
Repetitions of fundamental research models for homeopathically prepared dilutions beyond 10-23: a bibliometric study
/Int J High Dilutions Res 2011; 10(35):78-78 Proceedings of the XXIV GIRI Symposium; 2010 Nov 05; Monte Carlo (Monaco)Repetitions of fundamental research models for homeopathically prepared dilutions beyond 10-23: a bibliometric study Peter Christian Endler Interuniversity College Graz, Castle of Seggau, Austria ABSTRACT Introduction: Repeatability of experiments is an important criterion of modern research and a major challenge for homeopathic basic research. There is a lack of a recent overview about basic research studies in high homeopathic potencies that have been subjected to laboratory-internal, multicenter or independent repetition trials. Methods: We considered biochemical, immunological, botanical, cell biological and zoological studies on high potencies, i.e. beyond a dilution of 10-23. Main sources of information were reviews, personal contact with members of the homeopathic basic research community, and the MEDLINE and HOMBREX databases. Studies were extracted from the publications and grouped into models. Studies were further sorted according to repetition type (laboratory-internal, multicenter, or independent) and results achieved. Results: A total of 107 studies have been found. From these, 30 were initial studies. In the attempt to reproduce one of these initial studies, 53 follow up studies yielded comparable effects (35 laboratory- internal, 8 multicenter, 10 independent repetitions), eight studies showed a consistent, yet different result from the initial study (2 laboratory-internal, 2 multicenter, 4 independent repetitions), and 16 studies yielded zero effects (5 laboratory-internal, 2 multicenter, 9 independent repetitions). When all repetitive studies are considered, 69% reported effects comparable to that of the initial study, 10% different effects, and 21% zero effects. Independently performed repetition studies reported 44% comparable effects, 17% different effects, and 39% zero effects. Conclusions: We identified 24 experimental models in basic research on high homeopathic potencies, which were repeatedly investigated. 22 models were reproduced with comparable results, 6 models with different results, and repetition showed no results for 15 models. Independent reproductions with either comparable or different results were found for seven models. We encourage further repetition trials of published studies, in order to learn more about the model systems used and in order to test their repeatability [1]. [1] Endler PC, Thieves K, Reich C, Matthiessen P, Bonamin L, Scherr C, Baumgartner S. Repetitions of fundamental research models for homeopathically prepared dilutions beyond 10-23: a bibliometric study. Homeopathy. 2010; 99: 25-36. Licensed to GIRI Support: authors declare that this study received no funding Conflict of interest: authors declare there is no conflict of interest Correspondence author: P. Christian Endler, college@inter-uni.net , http://www.inter-uni.net How to cite this article: P.C Endler. Repetitions of fundamental research models for homeopathically prepared dilutions beyond 10-23: a bibliometric study. Int J High Dilution Res [online]. 2011 [cited YYYY Month dd]; 10(35): 78-78. Proceedings of the XXIV GIRI Symposium; 2010 Nov 05; Monte Carlo (Monaco). GIRI; 2010. [cited YYYY Month dd]; Available from: http://www.feg.unesp.br/~ojs/index.php/ijhdr/article/view/441/470 78 Copyright of International Journal of High Dilution Resarch is the property of International Journal of High Dilution Research and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
An Exploratory Study on Scientific Investigations in Homeopathy Using Medical Analyzer
/THE JOURNAL OF ALTERNATIVE AND COMPLEMENTARY MEDICINE Volume 17, Number 8, 2011, pp. 705–710a Mary Ann Liebert, Inc. DOI: 10.1089/acm.2010.0334 Abstract An Exploratory Study on Scientific Investigations in Homeopathy Using Medical Analyzer Nirupama Mishra, MD(Homoeo),1 K. Charan Muraleedharan, MD(Homoeo),1 Akalpita Sriniwas Paranjpe, PhD,2 Devendra Kumar Munta, MD(Homoeo),1 Hari Singh, BSc(Hon), DHMS,3 and Chaturbhuja Nayak, MD(Homoeo)3 Background: The action of homeopathic medicines, in ultra-high dilution, is not directly observable. An attempt was made to explore autonomic response of selective homeopathic medicines, in healthy persons, using Medical Analyzer System (Electronics Division, Bhabha Atomic Research Centre, Mumbai, India). Objective: The objective of the study was to observe the action of homeopathic medicines on physiologic variability of heart rate and blood flow. Material and methods: Pre- and postinterventional variability spectra of heart rate and blood flow of 77 subjects were recorded with the Medical Analyzer System, administering homeopathic preparations of Aconitum napellus (6c, 10M), Arsenicum album (200c, 1M), Gelsemium sempervirens (200c, 1M), Phosphorus (200c, 1M), Pulsatilla nigricans (200c) and Sulphur (200c, 1M) versus placebo control. The amplitude of the peaks viz. low-frequency, medium-frequency, and high-frequency was measured for postintervention analysis. An increase in the am- plitude of any valid peak by 100% or a decrease by 50% was considered as significant change. Results: Aconitum napellus produced a response in heart rate variability (HRV) with 30c potency and in blood flow variability with 1M potency. Sulphur 200c and 1M, Gelsemium 200c and Pulsatilla 200c, produced a 62.5% response in HRV against the placebo response of 16.6%. Gelsemium, Phosphorus, and Sulphur produced a re- sponse in blood flow variability with a 1M potency, similar to the response of Aconitum napellus 1M. Conclusions: These data suggest that it is possible to record the response of homeopathic medicines on physi- ologic parameters of the autonomic nervous system. Introduction Even while constitutional medicines offered by the homeopathic system of medicine have subjectively es- tablished their curative value over the past 2 centuries, the system has not found wide acceptance, mainly due to paucity of objective scientific data. The concentration of medicinal substance in 1 g of homeopathic preparation of 12c or above is less than 1 · 10 - 24 g, which is beyond the material existence as per Avogadro’s number, and hence, cannot contain a single molecule of the medicinal substance. Since analytical methods are the prerequisite for obtaining any scientific data, several attempts were made in the past to establish analytical meth- ods on homeopathic potencies. Spectroscopic analysis with nuclear magnetic resonance or infrared1–4 did not show any significant difference in the spectrum of pure carrier solvent material (alcohol) and homeopathic preparation. Paranjpe5 gave a physicist’s view to the action of homeopathic medi- cines. Using antigen–antibody reaction, Davenas et al. re- ported a positive reaction with homeopathic dilutions of antibodies (dilution with agitation), which was absent in - 120 simple dilutions up to a concentration of 10 . They also observed the necessity of - OH group in the solvent for ob- taining a positive antigen–antibody reaction.6 However, these experiments could not be reproduced. A new technique, physiologic variability analysis, can study the functioning of the autonomic nervous system (ANS) through variations in a physiologic parameter in a subject resting in the supine position to estimate the input contribution of different body systems to ANS.7 Several other studies have indicated that diseases of different organs of the body such as diabetes mellitus, myocardial infarction, hyperthyroidism, tuberculosis, and autoimmune deficiency syndrome cause specific alterations in physiologic parameters’ variability.8–11 Jindal et al. measured central and peripheral blood flow using impedance plethysmography (IPG), before 1Regional Research Institute for Homoeopathy, CCRH, Mumbai, India. 2Bhabha Atomic Research Centre, Mumbai, India. 3Central Council for Research in Homoeopathy, New Delhi, India. 705 706 MISHRA ET AL. and after the administration of homeopathic medicines to pa- tients. They recorded increase in blood flow with Sepia officinalis CM and Sulphur 1M.12 As a natural extension of these obser- vations, Jindal et al. had recorded heart rate variability (HRV) and blood flow variability (BFV) after administration of Sulphur 1M, Gelsemium 10M, and Phosphorus 30c and observed unique changes.13 The Central Council for Research in Homoeopathy, India, took the initiative to extend these studies with a predefined protocol and meticulous methodology at the Regional Re- search Institute of Homoeopathy, Mumbai. The present article describes the effect of homeopathic potencies of Aconitum napellus, Arsenicum album, Gelsemium sempervirens, Phosphorus, Pulsatilla nigricans, and Sulphur on HRV and BFV. Objective The objective of this investigation was to observe the changes produced in the variability spectrum of HRV and BFV following administration of placebo and different po- tencies of certain homeopathic medicines. Materials and Methods The study group comprised 77 healthy volunteers ages 18–35 years. Laboratory investigations such as complete blood count, erythrocyte sedimentation rate, liver function tests, renal function tests, blood glucose level, serum lipid profile, electrocardiogram, and chest radiograph were done for all the subjects whose written consent was obtained after explaining the details of the study. Medical Analyzer System (Electronics Division, Bhabha Atomic Research Centre, Mumbai, India) records the vari- ability spectrum of heart rate and peripheral blood flow. This system is based on the principle of IPG and records blood volume changes in any part of the body noninvasively by measuring its electrical impedance, which is inversely pro- FIG. 1. Heart rate variabil- ity (HRV) spectrum in a con- trol subject. The lower graph shows HRV in the time do- main and the upper one shows the same in the fre- quency domain. The complex time domain variations lead to definite peaks in the fre- quency domain. The peaks, their amplitudes, and power are given in the table at the bottom of the figure. portional to blood volume changes. The rate of change of impedance thus gives the rate of change of blood volume. The pulsatile blood flow during ventricular systole is reflected as well-formed peaks in IPG, and the instantaneous heart rate is derived from the time elapsed between two consecutive peaks. The blood flow index (blood flow in milliliters per 1000 cm3 of body tissue per cardiac cycle) is obtained from the amplitude of the peak and gross electrical impedance of the body segment.10 A 5-minute record of instantaneous heart rate and blood flow values thus obtained is interpolated to obtain periodic values of these parameters as a prereq- uisite before Fourier transformation. The subsequent Four- ier transform depicts the contribution of various rhythms that cause variability in the physiologic parameters and re- presented by low-frequency (L), medium-frequency (M), and high-frequency (H) peaks (Fig. 1). ‘‘L’’ generally denotes sympathetic action, whereas ‘‘M’’ and ‘‘H’’ denote parasym- pathetic and/or vagal action. In view of the multiple readings required in this protocol, the system software was upgraded to incorporate the average variability spectrum, for HRV and BFV obtained from multiple readings in situ, pre- and post- intervention, and display these on a PC monitor.14 Medicines coming in the top grade on repertory search related to cardiorespiratory functions such as variations in pulse, respiration, breathing, and so on were considered for deciding on trial drugs. For rubric selection, ‘‘Complete Repertory’’ by Roger van Zandvoort15 was consulted. In such a group, both polychrests as well as remedies having specific action on these parameters were included. As pla- cebo, plain globules soaked with dispensing alcohol were used. Since it was an exploratory study, two different pro- tocols were followed for the experiments. Protocol 1 was designed for the Aconitum napellus group of 27 subjects. On the first day, pre- and postintervention data for placebo were obtained. Placebo was replaced by Aconite 6c, Aconite 30c, Aconite 200c, Aconite 1M, and Aconite 10M on  HOMEOPATHIC MEDICINES, HEART RATE VARIABILITY, BLOOD FLOW VARIABILITY 707 the 2nd, 3rd, 4th, 5th, and 6th days, respectively. Data analysis was done for each of the days. Protocol 2 was designed for a group of 50 subjects and com- prised Arsenic 200c (n = 5), Arsenic 1M (n = 5), Gelsemium 200c (n = 5), Gelsemium 1M (n = 5), Phosphorus 200c (n = 5), Phosphorus 1M (n = 6), Pulsatilla 200c (n = 4), Sulphur 200c (n = 10), and Sulphur 1M (n = 5). In this case, pre- and postintervention data were recorded with placebo on the 1st day and with any one of the selected medicines and potency on the 2nd day. Since the study has been exploratory in nature, it was the intention of the authors to investigate all possibilities under this study. Protocol 1 was designed to meticulously investi- gate the effect of a particular medicine in different potencies. Protocol 2 was designed in such a manner that a large number of medicines could quickly be screened for their action on variability spectrum. Data for both of the protocols were collected as follows. With the subject in the supine position, the IPG signal was recorded from the wrist of the subject for 5 minutes and three such consecutive observations were taken. The subject was then administered the desired substance (placebo or medi- cine) followed by recording of three similar readings again to obtain the postintervention data of HRV and BFV. The pre- and postintervention data were then analyzed using the software described above, which gave out average spectra of multiple readings. In the postintervention analysis, a change was considered significant if the amplitude of any valid peak either increased by 100% (designated as ‘‘+’’) or decreased by 50% (desig- nated as ‘‘-’’) as compared to the pre-intervention amplitude. These high thresholds were intentionally fixed in order to have reliable findings. Amplitude of the peak had been chosen for postintervention analysis in place of area under the same because the former had the advantage of noise elimination. A postintervention decrease in the first peak (L-) and increase in the third peak (H + ) were discarded because these changes commonly occur due to prolonged rest. Results Typical pre- and postintervention average variability spectra are depicted in Figures 2 and 3. As can be seen from Figure 2, the placebo has not elicited any response in either spectra (HRV or BFV). The medicine has produced change in both HRV and BFV as illustrated in Figure 3. Table 1 summarizes the results of intervention in HRV. Under Protocol 1, Aconite 30c has shown response in HRV. From Protocol 2, it is seen that the maximum response has been obtained in 200c potency, namely, Gelsemium 200c, Pulsatilla 200c, and Sulphur 200c accounting for 68.42%. The exception in this group is Sulphur 1M, which has shown some response in HRV and together, they account for 62.5% response in HRV as against 16.6% of placebo response. Table 2 summarizes the response in BFV. From Protocol 1, Aconite 1M has shown response in BFV in 53.9% of the study sample as against placebo response of 25.92%. From Protocol 2, Gelsemium 1M, Phosphorus 1M, and Sulphur 1M have shown response in BFV, the exception here being Phosphorus 200c, which has shown a similar response. Response produced by medicines is 40% as against placebo response of 0%. Other potencies of Aconite from Protocol 1 and both po- tencies of Arsenic in Protocol 2 have not shown any response either in HRV or in BFV. Discussion This exploratory study on HRV and BFV with homeo- pathic medicines on a defined protocol was the first of its kind using average spectra of multiple readings. The results show that certain medicines and potencies have action on either HRV or BFV (Tables 1 and 2). Though the study was on an elaborate scale with defined protocol and multiple readings per setting, it was still ex- ploratory in nature and, therefore, the study protocol and interpretation of results were not strictly in conformity with conventional pharmacologic trials of modern medicine. Some deviations were made in the analysis of variability data. Hitherto, the variability spectrum was analyzed on the basis of area under different peaks, which represents the contribution of a particular rhythm in autonomic control. Though this approach has the simplicity of machine-generated results, it completely overlooks the amplitude of a particular peak, which signifies the coordination of a particular rhythm in autonomic control. For instance, a narrow peak with high amplitude may have the same area as that of a very broad peak with very low amplitude; in reality, the narrow peak with high amplitude represents better coordination in the ANS. This has led to using the amplitude of the peak in variability spectrum to differentiate the response. Furthermore, the spectrum was analyzed between 0.02 Hz and 0.50 Hz as compared to the FIG. 2. Pre- and postplacebo heart rate variability (HRV) and blood flow variability (BFV) average spectrum. The graphs on the top give HRV and BFV before and the ones in the bot- tom give HRV and BFV after placebo. There was a 20% de- crease in the first peak in the HRV spectrum, which is not significant. Similarly, there is a 25% increase in the first peak in the BFV spectrum, which is also not significant as per the crite- ria.  708 MISHRA ET AL. FIG. 3. Pre- and post- intervention average spectrum of heart rate variability (HRV) and blood flow variability (BFV) after Sulphur 1M. In HRV, the third peak is decreased in amplitude to almost half, whereas in BFV the first peak amplitude has nearly doubled. 0.00–0.50 Hz conventionally used. This was because the zero frequency component of variability sometimes suppresses the higher frequency components and can lead to incorrect infer- ence. Since our interest was to study the various rhythms controlling ANS and not the zero frequency component, the deviation was justified. In conducting the experiments, even though a separate placebo group has not been tested, placebo was administered on the first day of the experiment and medicinal intervention on following day(s) in all the subjects, irrespective of the group or medicine they belong to. This was done so that subjects act as their own control because physiologic response of every individual is different even in similar circumstances. To keep the variables at minimum, in all the subjects the experiments were conducted under similar conditions, and for each individual, the same timing was maintained throughout the experiment. The experiment began with the Aconite group, as per Protocol 1, and various potencies were used in ascending order in each of the individuals. The observed outcome was potency specific. Aconite 30c produced a peak in HRV (Fig. 4A) and Aconite 1M produced a similar peak in BFV Table 1. Response in Heart Rate Variability After Intervention (Fig. 4B). It shows that Aconite acts at one level in 30c potency and another level in 1M potency. Other potencies did not show any remarkable changes either in HRV or BFV. The results in the second group of subjects under Protocol 2 also revealed similar observations. Gelsemium 200c, Pulsa- tilla 200c, Sulphur 200c, and Sulphur 1M (1M potency is an exception here) produced response peaks in HRV (Table 1) and Gelsemium 1M, Phosphorus 1M, Sulphur 1M, and Phos- phorus 200c (200c potency is an exception in this group), produced response peaks in BFV (Table 2). Arsenic did not produce any response in either of the potencies. The obser- vations were consistent with those of Aconite: lower potency produced a response in HRV and higher potency produced a response in BFV, with the exception of Sulphur 1M in HRV and Phosphorus 200c in BFV. A pattern seems to emerge from these experiments: me- dium potencies such as 30c and 200c have probable action on HRV and higher potency such as 1M has probable action on BFV. It is noteworthy that HRV and BFV are derived from the same data, yet the changes produced in both are by different potencies of the same medicine. To illustrate, the change in HRV at Aconite 30c is not reflected in BFV, and Table 2. Response in Blood Flow Variability After Intervention Intervention Aconitum napellus 30c (27 subjects) Placebo Medicine Gelsemium 200c (5 subjects) Placebo Medicine Pulsatilla 200c (4 subjects) Placebo Medicine Sulphur 200c (10 subjects) Placebo Medicine Sulphur 1M (5 subjects) Placebo Medicine Total number of volunteers/ number responded (%) 27/12 (44.4%) 27/15 (55.5%) 5/1 (20%) 5/3 (60%) 4/1 (25%) 4/3 (75%) 10/1 (10%) 10/7 (70%) 5/1 (20%) 5/2 (40%) Intervention Aconite 1M (27 subjects) Placebo Medicine Gelsemium 1M (5 subjects) Placebo Medicine Phosphorus 1M (6 subjects) Placebo Medicine Phosphorus 200c (5 subjects) Placebo Medicine Sulphur 1M (5 subjects) Placebo Medicine Total number of volunteers/ number responded (%) 27/7 (25.92%) 26/14 (53.9%) 5/0 (0%) 5/2 (40%) 6/1 (16.66%) 6/2 (33.33%) 5/0 (0%) 5/2 (40%) 5/0 (0%) 5/2 (40%)  HOMEOPATHIC MEDICINES, HEART RATE VARIABILITY, BLOOD FLOW VARIABILITY 709 A. Heart rate variability (HRV) response to various eliminate subjective bias and objectively demonstrated the action of the homeopathic medicines. Second, responses were observed in 30c, 200c, and 1M potencies, which are well beyond Avogadro’s number. These are observations from exploratory experiments in emerging areas of physiologic variability and need validation by re- peated experiments of this type. Detection of response was the primary objective of this study, which has been achieved. The number of subjects in each group was small; hence it was not possible to show the statistical significance of the results, an aspect that is intended to be covered in future studies. Conclusions Selective response has been detected with the adminis- tration of different potencies of various homeopathic medi- cines in HRV and BFV, and the exploratory study has provided directions for future trials. Reproducibility of these observations in a larger sample size will be necessary for validation of this study’s results. Acknowledgments The authors are grateful to Dr. G.D. Jindal, Electronics Division, Bhabha Atomic Research Centre, Mumbai for pro- viding the expertise needed for the study. They thank all of the students, interns, and faculty members of CMP Homo- eopathic Medical College, Mumbai for enthusiastic participa- tion in the study as volunteers. The authors acknowledge the contributions of Mrs. Uma A. Clerk and other staff of the Regional Research Institute for Homoeopathy, Mumbai. Disclosure Statement No competing financial interests exist. References 1. Smith RB, Boericke GW. Changes caused by succussion on NMR patterns and bioassay of bradykin triacetate succes- sions and dilutions. J Am Inst Hom 1968;16:197–212. 2. Weingartner O. NMR features that relate to homoeopathic sulphur potencies. Berlin J Res Homoeopathy 1990;1: 61–68. 3. Anick DJ. High sensitivity 1H-NMR spectroscopy of homo- eopathic remedies made in water. BMC Complement Altern Med 2004;4:15. 4. Rey L. Thermoluminiscence of ultra-high dilutions of lithium chloride and sodium chloride. Physica A 2003;323:67–74. 5. Paranjpe AS. Action of homoeopathic medicines: A physicist view. Q Bull Central Council Res Homoeopathy 1989;10:26. 6. Davenas F, Beauvais F, Amara J, et al. Human basophil degranulation triggered by very dilute antiserum against IgE. Nature 1988;333:816–818. 7. Camm AJ, Malik M, et al. Heart rate variability: Standards of measurement, physiological interpretation and clinical use. Circulation 1996;93:1043–1065. 8. Bianchi A, Bontempi B, Cerutti S, et al. Spectral analysis of heart rate variability signal and respiration in diabetic sub- jects. Med Biol Eng Comput 1990;28:205–211. 9. Bigger JT, Fleiss JL, Steinman RC, et al. Frequency domain measures of heart period variability and mortality after myocardial infarction. Circulation 1992;85:167–171. 10. Jindal GD, Ananthakrishnan TS, Kataria SK, Deshpande Alaka K. An Introduction to Impedance Cardiovasography. FIG. 4. potencies of Aconite napellus. B. Blood flow variability (BFV) response to various potencies of Aconite napellus. change in BFV at Aconite 1M is not reflected in HRV. This may be indicative of the selective action of different potencies of the same medicine. Plotting of the same shows a peak in HRV response, with Aconite 30c (Fig. 4A) and a peak in BFV response with Aconite 1M (Fig. 4B). These peaks separate the response of Aconite 30 and 1M from the rest of the inter- ventions in this group. The response has been counted positive, irrespective of its nature. For instance, significant increase or decrease in either of the L, M, or H peaks has been counted as response. In future such studies, the authors may explore the possibility of analyzing response with respect to a particular peak or parameter. This was an exploratory study on variability in physio- logic parameters, conducted for the first time on this subject hitherto unexplored in a systematic manner with homeo- pathic medicines. Eliciting an autonomic tone of healthy subjects with the help of homeopathic medicine is a process similar to that of a ‘‘homeopathic pathogenetic trial’’ in which, when a medicinal substance is given to a group of healthy provers, some symptoms of the medicine are elicited in a number of proving subjects, yet there are few symptoms that appear in 1 or 2 subjects only. Some subjects do not prove any of the symptoms of a medicine. This perhaps ex- plains why some of the medicines/potencies did not show any response. A few observations emerge from the experiments. First, the autonomic nervous system is not under voluntary con- trol, and recording signals from the ANS immediately after intervention (within 5–15 minutes of intervention) helped 710 MISHRA ET AL. External Report, BARC/2001/E/003, 2001. Mumbai: Bhab- ha Atomic Research Centre. 11. Jindal GD, Ananthakrishnan TS, Mandlik Sadhana A, et al. Medical Analyzer for the Study of Physiological Variability and Disease Characterization. External report, BARC/2003/ E012, 2003. Mumbai: Bhabha Atomic Research Centre. 12. Jindal GD, Parajpe AS, Singh H, et al. Role of non-invasive techniques in the evaluation of non-conventional medicines. In: Proceedings, National Symposium Cum Workshop on Advances in Imaging and Image Processing, vol. VI. Mumbai: Biomedical Engineering Society of India, 1988; 9.1–9.9. 13. Jindal GD, Ananthakrishnan TS, Katara SK, et al. Objective monitoring of response of homoeopathic medicines using Med- ical Analyzer. Natl J Homoeopathy 2004;VI:206–207. 14. Jain RK, Sinha V, Mishra N, et al. Development of software for assessment of therapeutic response by physiological variability. IETE J Res 2008;54:223–230. 15. van Zandvoort R. Complete Repertory: CARA Professional, vol. 1.4. West Bridgeford, Nottingham, England: Miccant Ltd. Address correspondence to: K. Charan Muraleedharan, MD(Homoeo) Regional Research Institute for Homoeopathy CCRH Hall no. 4, Shopping Center, Sector 9, CBD Belapur Navi Mumbai 400 614, Maharashtra India E-mail: rrihmumbai@gmail.com Copyright of Journal of Alternative & Complementary Medicine is the property of Mary Ann Liebert, Inc. and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use.
Outcome related to impact on daily living: preliminary validation of the ORIDL instrument
/BMC Health Services ResearchBioMed Central Research article Open Access Outcome related to impact on daily living: preliminary validation of the ORIDL instrument David Reilly*1, Stewart W Mercer2, Annemieke P Bikker1 and Tansy Harrison1 Address: 1AdHom Academic Departments, Centre for Integrative Care, Glasgow Homœopathic Hospital, 1053 Great Western Road, Glasgow G12 OXQ, Scotland, UK and 2General Practice and Primary Care, Division of Community-based Sciences University of Glasgow, Glasgow G12 9LX, Scotland, UK Email: David Reilly* - davidreilly1@compuserve.com; Stewart W Mercer - sm83z@clinmed.gla.ac.uk; Annemieke P Bikker - A.Bikker@btinternet.com; Tansy Harrison - tansyharrison@hotmail.com * Corresponding author Published: 2 September 2007 Received: 7 December 2006 BMC Health Services Research 2007, 7:139 doi:10.1186/1472-6963-7-139 This article is available from: http://www.biomedcentral.com/1472-6963/7/139 Accepted: 2 September 2007 © 2007 Reilly et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: The challenge of finding practical, patient-rated outcome measures is a key issue in the evaluation of health care systems and interventions. The ORIDL (Outcome in Relation to Impact on Daily Living) instrument (formerly referred to as the Glasgow Homoeopathic Hospital Outcomes Scale or GHHOS) has been developed to measure patient's views of the outcome of their care by asking about change, and relating this to impact on daily life. The aim of the present paper is to describe the background and potential uses of the ORIDL, and to report on its preliminary validation in a series of three studies in secondary and primary care. Methods: In the first study, 105 patients attending the Glasgow Homoeopathic Hospital (GHH) were followed-up at 12 months and changes in health status were measured by the EuroQol (EQOL) and the ORIDL. In the second study, 187 new patients at the GHH were followed-up at 3, 12, and 33 months, using the ORIDL, the Short Form 12 (SF-12), and the Measure Yourself Medical Outcome Profile (MYMOP). In study three, 323 patients in primary care were followed for 1 month post-consultation using the ORIDL and MYMOP. In all 3 studies the Patient Enablement Instrument (PEI) was also used as an outcome measure. Results: Study 1 showed substantial improvements in main complaint and well-being over 12 months using the ORIDL, with two-thirds of patients reporting improvements in daily living. These improvements were not significantly correlated with changes in serial measures of the EQOL between baseline and 12 months, but were correlated with the EQOL transitions measure. Study 2 showed step-wise improvements in ORIDL scores between 3 and 33 months, which were only weakly associated with similar changes in SF-12 scores. However, MYMOP change scores correlated well with ORIDL scores at all time points. Study 3 showed similar high correlations between ORIDL scores and MYMOP scores. In all 3 studies, ORIDL scores were also significantly correlated with PEI-outcome scores. Conclusion: There is significant agreement between patient outcomes assessed by the ORIDL and the EQOL transition scale, the MYMOP, and the PEI-outcome instrument, suggesting that the ORIDL may be a valid and sensitive tool for measuring change in relation to impact on life. (page number not for citation purposes) Page 1 of 10 BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Background The challenge of finding practical, patient-focussed, clini- cally-relevant outcome measures is a key issue in the increasing call for patient-centred care and clinical govern- ance in health systems around the world [1,2]. However, there are relatively few patient-rated outcome measures that seek to measure change from the patients' perspec- tive, using simple concepts such as change in main prob- lems or symptoms and well-being [3,4]. Furthermore, it is difficult to know from these measures how meaningful any reported changes are in terms of impact on the indi- viduals' daily life. The ORIDL (Outcome in Relation to Impact on Daily Liv- ing) instrument measures patients' views of the outcome of care [5]. Created initially for evaluating experimental clinics [6], its increasing adoption under its former name, the Glasgow Homoepathic Hospital Outcome Scale (GHHOS), in a number of centres [7-11] and studies [12- 17] has created a need to study its validity which has not previously been explored. It differs from many other scales by asking about change directly, and by relating outcome to the effect of the intervention on impact on daily life. In the present paper we report on a series of studies in which we have had the opportunity to compare the ORIDL with three validated measures in secondary (integrative care) and primary (conventional care) set- tings. Methods The rationale behind the development of the ORIDL was to base the instrument on the type of dialogue that the doctor (or other health care professional) and patient would have to evaluate outcome in the clinical encounter. For example, a dialogue may be as follows: Doctor: Well, was there any effect from what we did? Patient: Yes, I think it helped... Doctor: Yes, but was it a useful effect? Can you give me an example? Patient: Yes, it was really useful, I was able to get about more and go to the shops. Doctor: Really? And is that a major change, a really marked benefit, or is it less than that? Patient: No, this is really marked, it's the best thing I've had for the problem. I'm not saying It has cured it or any- thing, I mean I still have the problem, but I could live with it now. The aim was to embed the essence of these dialogues in the design of the instrument, but allow it to be standard- ised in a way that would allow a questionnaire based ver- sion of the scale to measure the participants' opinions on the effects of the intervention (not their view on the natu- ral progression of the health problems being considered). The validation studies took place in the outpatient unit of GHH, an NHS-funded Centre for Integrative care, and in primary conventional care in an area of high deprivation in Glasgow. Ethical approval was obtained for all 3 studies from the West of Glasgow University NHS Trust. Written consent was obtained from all patients. In the GHH study 1, four senior doctors took part and the participants were adult out-patients attending the GHH for various periods of time (see ref 12 for details). In GHH Study 2, nine doc- tors took part (not including 2 of the 4 senior doctors who took part in study 1) and the participants were all new outpatients above 12 years of age whom the doctors saw in the 3 months from September to December 2002, as reported previously [14]. In study 3, five GP Principals took part working in the same Practice, and the partici- pants were adult patients registered with the practice. The ORIDL offers nine options for the participant to choose. In study 1, the format used to elicit patients' views was as shown in Figure 1. In study 2, a different format was used to elicit patients' views on these 9 options, as shown in Figure 2. This ques- tion was then repeated for 'your overall well-being'. In study 3, the format used in study 1 was adopted (Figure 1), but modified to 'the overall effect of your treatment by your GP' as it was a primary care study of general practi- tioners. A score of 2 or above was used as a 'ORIDL threshold' score as the wording at this level records an effect on qual- ity of daily living as perceived by the patient. Choosing timings and targets The target and timing of use of the ORIDL is chosen by the participants and the context, and so reporting needs to make clear what choices were used. We have used ORIDL in the current studies for patients' views. It is less explored for recording practitioners own views. Presenting results Individual results can be recorded in the medical casenotes as need be, perhaps beside the intervention they refer to, or as overall results. This has been useful in clinical prac- tice at the GHH as a 'shorthand' code allowing the care team to share a sense of the value or otherwise of interven- tions. Group results can be presented graphically to show Page 2 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 The following questions ask you, compared to how you were when you first attended GHH, what has been the overall effect of your treatment at Glasgow Homoeopathic Hospital on your main complaint, and general feeling of well-being with the problem up to the present time?” Please complete the 2 boxes using the scale shown above: 1.The main complaint for which you came for treatment 2. Your overall well-being +4 Cured /Back to normal +3 Major Improvement +2 Moderate improvement, affecting daily living +1 Slight improvement, no effect on daily living 0 No change/Unsure -1 Slight deterioration, no effect on daily living -2 Moderate deterioration, affecting daily living -3 Major deterioration -4 Disastrous deterioration FOiRguIDrLe f1ormat in study 1 ORIDL format in study 1. the range of results for a group or cohort of patients, as reported in the present paper. Procedure Immediately before their consultation, the patients were asked to complete the EQOL [18] (Study 1, GHH) or the SF-12 [18] (Study 2; GHH) and during the consultation (with the practitioner) they did the initial MYMOP [3] (Study 2; GHH, Study 3; Primary Care). After the consul- tation they completed demographic questions and put the forms in a sealed collection box. In Study 1, the patients were posted a follow up questionnaire containing the EuroQOL and ORIDL (main complaint and well-being) at 12 months after baseline assessment. In Study 2, the patients were posted follow up questionnaires at 3 months, 12 months and 33 months after initial consulta- tion (baseline assessment) containing the SF-12, MYMOP, and ORIDL. In Study 3, patients were posted a follow up questionnaire at 3–4 weeks after contact consul- tation (baseline assessment). In studies 1 and 2, non- responders received two postal reminders, in study 3, 1 postal reminder followed by a telephone call. Validated measures used to compare with ORIDL The Measure Yourself Medical Outcome Profile (MYMOP) has four items which are completed during the consultation [3]. The patients choose (with regard to their main problem) up to two main symptoms and one activ- ity of daily living, which are scored for severity over the past week on a seven-point scale (from 0 = "As good as it could be", to 6 = "As bad as it could be"). In a similar way a general well being question is completed. By adding up the scores to all the items and dividing the total by the number of answered items an overall profile score is cal- culated. On the follow up questionnaire the wording of the chosen symptoms and activity are copied and scored again by the patients [3]. The EuroQOL-5D (EQOL) and the Short Form 12 (SF-12) are both widely used self-completed instruments to meas- ure health status [18,19]. In the EQOL, five domains make up the descriptive system of the instrument; mobil- ity, self-care, usual activities, pain/discomfort, and anxi- ety/depression. There are three possible responses for each domain. Results can be presented descriptively, or scores added to give an un-weighted total score or an index (weighted) score can be calculated from published tables togiveaco-efficientbetweenzeroandone.Inaddition the EQOL has a VAS component which asks the patient to rate their current health status on a visual analogue scale from 0 (worst imaginable health state) to 100 (best imag- inable health status). Finally, the EQOL also includes a transition measure, asking patients to rate their current health state against the previous 12 months (Better, Same Worse). In the SF-12, twelve questions comprise several concepts, such as physical functioning, social functioning, and bodily pain. The responses are weighted and com- bined to derive two summary scales: (1) the physical com- ponent score (PCS), which is an indicator of physical health (2) the mental component score (MCS), which is an indicator of mental health. The two scores range Page 3 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 The following questions ask you what the overall effect your treatment has had on your main complaints, general feeling of well-being, and your coping with the problem up to present time. The questions are asked in such a way that they reflect the dialogue you may have during the consultation with your doctor or practitioner. Please, answer the questions by ticking the boxes and then follow either the arrows to the next question or the instructions next to boxes. 1. Your main complaint(s)... (please tick boxes) 1. “Has the treatment caused any improvement or deterioration in your main complaint(s)?” +1 Yes, it improved 0 No, no change (Please go to Q.2) -1 Yes, it got worse 2................ “Is/was this change enough to affect the quality of your daily living?” +2 Yes, it improved No, no change (Please go to Q.2) -2 Yes, it got worse 3............................... “Is/was this change very marked, a major effect?” +3 Yes, a major improvement No, no change (Please go to Q.2) -3 Yes, a major deterioration 4. “Is/was this change a complete resolution or disastrous deterioration of the problem?” +4 Yes, a complete resolution No, neither -4 Yes, a disastrous deterioration FOiRguIDrLe f2ormat in study 2 ORIDL format in study 2. between 0 and 100 and higher scores imply better overall health. The Patient Enablement Instrument (PEI) is a six-item measure that was developed and validated to measure the immediate outcome of consultations in primary care [20]. However, we have recently used the PEI to measure patients views on enablement over time [14] and qualita- tive work suggests it may be a useful outcome for patients in terms of changes in self-concept [21]. Therefore we have reported on the PEI as a longer-term outcome meas- ure (PEI-Outcome) in the present paper. Participants Study 1 (GHH) – patients completed the follow-up study at 12 months, patient details have been reported else- where [12,22]. Study 2 (GHH) – patients completed the follow up ques- tionnaire at three months, at twelve months, and 33 months. Details of the patients characteristics have been previously reported [14]. An additional time points at 20 months was included using the ORIDL only. Study 3 (Primary Care) – patients completed the follow up questionnaire at 1 month. Analysis The data were analysed through the statistical package SPSS. Comparisons between the ORIDL scores with the change scores (i.e. the difference between the scores from the first and follow up questionnaires) of the EQOL, MYMOP and SF-12 was assessed by using Spearman's rank correlation coefficient. Through independent sam- ples t-tests it was checked whether people who had scores below the ORIDL threshold (< +2) had significantly lower change scores on the MYMOP and SF-12 than the people who had scores above the ORIDL threshold (+2 and above). Results Study 1: ORIDL and EQOL scores over 12 month 105 patients consented to follow-up, and 74 returned the questionnaire at 12 months (75% response rate). Of these 74, there were 5 missing values (6.8%) for ORIDL (both main complaint and well-being). Missing values for EQOL ranged from 6.8–10.9%, (mean 9.0%). Page 4 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Figure 3 shows the distribution of ORIDL scores at 12 months post contact consultation in patients attending the GHH. The majority of patients reported overall improvements in their main complaint and well-being, with some 68% and 77% reporting improvements in quality of daily living (ORIDL scores of 2+ or better) in main complaint and well-being, respectively. However, the lack of a 'ceiling effect' should also be noted, with no patient recording a score of plus 4 ('cured'). With the EQOL, small but statistically significant improvements (p < 0.001, chi-squred) between baseline and follow-up scores were observed for usual activities (13% of patients showing improvement), pain/discom- fort (22% showing improvement) and anxiety/depression (13% showing improvement). No significant changes were found in mobility or self-care (results not shown). A significant but small difference in EQOL VAS score was found between baseline and follow-up (baseline; mean Health State Today 62.5, follow-up: mean Health State Today 68.6, p = 0.001) signifying a small improvement in perceived overall health status. The EQOL transition score (Health state today compared with 12 months ago) showed much larger perceived changes, with 66% of patients reporting 'better', 21 % 'same' and 13% 'worse' health state. Table 1 shows the correlations between ORIDL and EQOL scores. No significant correlations were found between the ORIDL and the EQOL total score for the change in the 5 domains between baseline and follow-up (calculated as either a weighted or un-weighted total scores). Changes in the individual domains of the EQOL were also not signif- icantly correlated with the ORIDL, except for a weak cor- relation (rho 0.25, p = 0.04) between EQOL-Mobility and ORIDL-Well-Being (results not shown). EQOL-VAS change showed a weak but significant correlation with ORIDL-wellbeing score but not with ORIDL-main com- plaint (Table 1). However, EQOL-transitions score (per- ceived change over the last 12 months) were highly correlated with both components of the ORIDL (Table 1). Similarly PEI-Outcome scores (change in enablement over 12 months) were also significantly related to ORIDL scores (Table 1). The correlation between ORIDL-main complaint and ORIDL-well being was 0.724, p < 0.001. gFOoiRgwuIDHrLeosm3coreeospoatvheirc 1H2omspoitnatlh(sSitnudpyat1ie)nts attending the Glas- ORIDL scores over 12 months in patients attending the Glas- gow Homoeopathic Hospital (Study 1). Study 2: ORIDL and MYMOP and SF-12 scores at 3 months, 12 months, and 33 months in new patients 187 new patients consented to follow-up, and question- naire response rates were 117 (63%), 76 (41%) and 75 (40%) at 3, 12, and 33 months respectively. Missing val- ues for ORIDL items at the different time points ranged from 0.9 – 6.4% (mean 3.4%). Missing values for MYMOP symptom 1 and well-being items ranged from 40 30 20 10 0 -2.00 -1.00 .00 ORIDL-MC 1.00 2.00 3.00 17 33 35 6 4 4 50 40 30 20 10 0 3 41 36 9 6 6 -2.00 -1.00 .00 ORIDL-WB 1.00 2.00 3.00 Table 1: Spearman's correlations between ORIDL and EQOL at GHH (study 1) ORIDL-main complaint ORIDL-well being 0.083 (63) 0.029 (63) 0.261 (64) * 0.546 (67)*** 0.487 (67)*** Change in EQOL Score (un-weighted) Change in EQOL Score (Weighted) Change in EQOL – VAS EQOL – transition scale PEI Outcome * p < 0.05, ** p < 0.01, *** p < 0.001 0.201 (63) 0.115 (63) 0.152 (64) 0.643 *** (66) 0.418 ***(67) (page number not for citation purposes) Page 5 of 10 Percent Percent BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 5.3–15.8% (mean 11.0%) and for SF-12 items from 4.0– 22.4% (mean 13.6%). Figure 4 shows the ORIDL scores (expressed as % scoring 2+ or above) of new patients attending the GHH followed prospectively up to 33 months. As can be seen there was a slow but steady improvement in main complaint and well-being in terms of effect on daily life over the 33 month period. The baseline and follow-up scores at 3 months and 12 months for the SF-12 and the MYMOP have been pub- lished previously (Bikker et al 2005) and showed no changes in SF-12 scores but significant improvement in MYMOP scores. Similarly, SF-12 scores showed no signif- icant changes between baseline and 33 months for either the physical or mental health components (results not shown). MYMOP scores did however show significant improvements (paired t-test) in scores for symptoms (baseline 4.24, 33 months 3.16, p < 0.001), well-being (baseline 3.50, 33 months 2.84, p < 0.01), and profile score (baseline 4.02, 33 months 3.18, p < 0.001). Table 2 shows the correlations between ORIDL and MYMOP, SF-12 and PEI-outcome at 3,12, and 33 months. As can be seen, ORIDL scores were only weakly related to SF-12 change scores at all 3 time points, with few signifi- cant correlations. However, ORIDL and MYMOP change scores were much more highly correlated, showing signif- icant relationships to each other at all time points and for all components reported (MYMOP symptom change, MYMOP well-being change, and MYMOP profile change all significantly related to both ORIDL main complaint and ORIDL well-being). There was no indication that the strength of the correlation between ORIDL and MYMOP weakened with time (i.e., correlations at 33 months were as strong, if not stronger, than at 3 months). The strongest correlations with ORIDL was generally with the change in MYMOP profile score. IFmiogpnurtorhevse4amteGnHtsHin(dStauildyyliv2i)ng reported by the ORIDL over 33 Improvements in daily living reported by the ORIDL over 33 months at GHH (Study 2). Table 2 also shows that the PEI-outcome measure also correlated significantly with the ORIDL at 3 months and 12 months (PEI-outcome was not measured at 33 months). 50 40 30 20 10 44 24 37 20 3 months Time (months) 12 months 20 months 33 months 50 40 30 20 10 0 40 15 35 13 3 months Time (months) 12 months 20 months 33 months Table 2: Spearman's correlation between ORIDL and SF-12, MYMOP, and PEI at GHH (study 2) ORIDL – main complaint ORIDL – well being 12 months 0.152 (57) 0.040 (57) 0.487** *(62) 0.485*** (69) 0.439** *(63) 0.640*** (63) SF-12 PCS Change SF-12 MCS Change MYMOP Change inProfile MYMOP Change in Symptoms MYMOP Change in Well-Being PEI Overall Outcome 3 months 0.214* (90) 0.245* (90) 0.444*** (90) 0.433*** (109) 0.334** (102) 0.451** (105) 12 months 0.186 (56) 0.015 (56) 33 months 0.224 (63) 0.334** (63) 3 months 0.211* (90) 0.235* (90) 0.400** (99) 0.435** *(109) 0.333** (101) 0.528*** (104) 33 months 0.336** (63) 0.388** (63) 0.541*** (68) 0.446***(70) 0.383** (64) - Page 6 of 10 0.474*** (61) 0.444** *(68) 0.314* (62) 0.586***(62) - 0.499** *(68) 0.440 ** *(70) 0.390** (64) * p < 0.05, ** p < 0.01, *** p < 0.001 (page number not for citation purposes) ORIDL-WB Score +2 or above (%) ORIDL-MC Score +2 or above (%) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Table 3: Spearman's correlation of ORIDL with MYMOP and PEI in primary care (study 3) 40 30 20 10 0 29 22 6 17 18 3 3 -2.00 -1.00 .00 ORIDL-main complaint 1.00 2.00 3.00 4.00 50 40 30 20 10 0 40 17 15 15 4 3 4 -3.00 -2.00 ORIDL-well being -1.00 .00 1.00 2.00 3.00 4.00 MYMOP Profile Score MYMOP Symptom 1 Score MYMOP Well-Being Score PEI Outcome *** p < 0.001 ORIDL- main complaint 0.510*** 0.553*** 0.358*** 0.572*** ORIDL- well being 0.437*** 0.409*** 0.385*** 0.584*** FOiRguIDrLe o5utcomes in primary care at 1 month ORIDL outcomes in primary care at 1 month. Study 3 (Primary Care): ORIDL and MYMOP at 1 month post-baseline 323 patients consented to follow-up, and 159 returned the questionnaire at 1 month (49% response rate). Of these 159, missing values (6.8%) for ORIDL main com- plaint and well-being items were 10% and 11%, respec- tively. Missing values for MYMOP symptom 1 and well- being items ranged from 2.0–7.0% (mean 4.7%). Missing values for PEI ranged from 2.6–5.0% (mean 4.0). Figure 5 shows the distribution of ORIDL scores 1 month after contact consultation in primary care. The percent reporting a significant impact of daily living for main complaint is 43% and for well-being is 34%. The percent- age reporting no change (a score of zero) was 29% for main complaint and 40% for well-being. This was similar to the percentage showing no change (a change score of zero) for the MYMOP (32% for symptom 1, 41% for well- being). For MYMOP scores at baseline and 1 month significant improvements were found in symptom (baseline 4.50, 1 month 3.58, p < 0.001) and profile score (baseline 4.07,1 month 3.64, p < 0.001) but not in well-being (baseline 3.53, 1 month 3.53). Table 3 shows the relationship between ORIDL and MYMOP and PEI in primary care. ORIDL components were highly and significantly correlated with all MYMOP change scores, with the highest correlations found between ORIDL -main complaint and MYMOP symptom change and profile change. A significant relationship between MYMOP well-being change and the ORIDL items was also found. PEI-outcome was highly correlated with the ORIDL items. The ORIDL threshold score (+2) Scores of ≥ +2 on the ORIDL denotes a meaningful change in the outcome to the patient (i.e. sufficient to improve daily living), so it was hypothesised that patients with scores of +2 and above would have significantly higher results on the change scores of the MYMOP compare with patients with ORIDL scores below +2. As Table 4 shows, this was the case in all instances in all three studies and at all time points measured. Discussion The development of the ORIDL instrument arose from directly asking patients questions of clinical relevance: 'Did the treatment work?', 'Was it any good?', 'Is this serv- ice helping reduce suffering?' Determining outcome is always challenging, 'proof' changes as it emerges from a complex of scientific, cultural and personal factors – an 'Evidence Mosaic' – determined as much by who is asking the question, why and when, as by any abstract notion of pure science [23]. The ORIDL scale contributes by being rooted in the patient's experience of how the outcome of care has affected their daily life. As the scale (under its former name of GHHOS) has come into use in clinical and research contexts in recent years by virtue of its high face validity and practical ease of use, this paper's aim was to formalise its introduction, comment on its practical use, and take forward issues of validity. Page 7 of 10 (page number not for citation purposes) Percent Percent BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Table 4: Mean change in MYMOP profile scores in ORIDL categories 2+ or better versus less than 2+ n 73 GHH 12 mths Mean (SD, n) GHH 33 mths Mean (SD, n) GP 1 mth Mean (SD, n) 0.027 (1.47) 47 ORIDL-main complaint MYMOP Change (Profile) GHH (3 mths) Mean (SD) < 2+ 0.00 (1.38) 2+ or better 1.49 (1.17) 26 1.61 (0.98) 14 ORIDL-well being < 2+ 2+ or better 0.14 1.09 (1.48) (1.24) 73 26 0.38 1.58 (1.51) (0.536) 53 9 p-value <0.01 <0.05 <0.01 <0.001 P-value <0.001 <0.01 0.15 (1.49) 3236 4028 0.25 1.31 (1.26) (1.42) 106 37 <0.001 0.31 0.99 (1.36) (1.32) 114 28 1.40 (1.27) <0.001 0.32 1.48 (1.46) (1.29) In the present series of studies, the ORIDL instrument showed significant and moderate-high correlations with the MYMOP at all time-points examined and in both the secondary (integrative) care setting of the GHH (Study 2) and in the primary (conventional) care setting (Study 3). This is an important finding, given that the MYMOP is now a well established instrument used to chart changes in patients symptoms and well-being, and is known to be to be more responsive to change than other widely-used tools such as the SF-36 [3] and the EuroQOL [23]. Fur- thermore, the consistency of the relationship between the ORIDL and the MYMOP, even up to 33 months after ini- tial baseline measurement, suggest a stability to the changes captured by the ORIDL. This is again of consider- able importance, given that academic opinion is divided on the use of transition measures versus serial measures when measuring health outcome. Whereas some argue that measuring change retrospectively (as in ORIDL) is highly fallible because it depends on accurate memory of the past [24,25], others take the opposite view, with evi- dence to show that patients' retrospective assessments are more sensitive, and correlate better with patient satisfac- tion and physical and biological indicators of change in disease state [26,27]. These two opposing academic views of psychometrics and 'clinimetrics' have not been recon- ciled as yet, and it has been argued that both may be valid and important depending on the context [20,26]. The ORIDL scale was created by a clinician (DR) and thus reflects this direct approach of asking patients about change, as carried out by clinicians in practice. However, by anchoring the scale in the concept of improvement in daily living, it may be that the ORIDL has a meaning not found in other transition scales. There was, as we expected, less correlation between the ORIDL and the EQOL, and the SF12, similar to the weak relationship shown between the EQOL and the MYMOP [28] and the SF-36 and the MYMOP [2], reflecting the pre- viously reported poor sensitivity to change by these two widely used tools. The significant correlations found between the EQOL transition scale and the ORIDL, and the PEI-outcome instrument and the ORIDL are new find- ings, not reported previously in the literature, though the use of the PEI as an outcome measure has been reported previously [14,21]. The response rate in the present series of studies varied, with a high response rate in study one (75%), but a diminishing response rate in study two (from 60–40%) and a 49% response rate in study three. However, we have no evidence to suggest the lower response rates were related to the ORIDL. It may well relate to the length of questionnaire and the context of the study. For example, study 3 was set in a primary care centre in an area of high socio-economic deprivation, where low response rates to postal follow-up is common (S Mercer, unpublished data). The fact that the number of missing items for ORIDL was low in all three studies, and around the same or less than the other instruments (MYMOP, EQOL, SF- 12), would support the face validity of the tool. However, qualitative work with patients is required to confirm this. Qualitative work is also required to allow us to establish the best way of presenting the ORIDL choices to patients. In the present work study 2 used a different format from the other two studies (as shown in the methods) but we have no information at present as to which format patients find easiest to understand. Page 8 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 The current data should only be seen as part of a wider pic- ture of validation. Previous studies have found clinically coherent correlations between indicators of consultation quality and outcomes measured by ORIDL [10-12,20]. In terms of its clinical potential, any measurement scale can only give a simplified version of what goes on and cannot hope to capture and represent the richness and complexity of daily clinical care. However, as a contribution to patient-centred outcome measures, ORIDL has two key characteristics. Firstly, it is modelled on how patients and doctors already assess care in daily practice (i.e., by asking about change directly), and secondly, it anchors the out- come to the patient's assessment of significant deteriora- tion or improvement in terms of daily living. Further work is required to establish how many patients are needed per doctor in order to establish a reliable ORIDL score for individual doctors [25], if a comparison between doctors is desired. Further qualitative research is also required to assess patients' views on the ORIDL and this will be of major importance in trying to validate the instrument further. Strengths and weaknesses of the ORIDL Overall, we feel the scale has the following strengths: 1. It is quick and simple to use and its results are easy to communicate. 2. It is generic and so flexibly adaptive to different contexts and targets. 3. It aims to link outcome to the experience of daily living. 1. It is a broad-brush measure (and so lacks detail and pre- cision) and would often need supplemented by other measures if more detailed results are needed. 2. It is subjective, even though anchored in experience of daily living. 3. It is only as good as the participants' views, and shares all the strengths and weaknesses of ordinary clinical prac- tice. 4. It focuses only on the participants' views of the impact of the care – other issues like 'How?', or 'Duration?, or 'Why – e.g: placebo?', or, objective verification – need to be addressed through other approaches. 5. It can be used without a measured baseline, so is subject to the bias of recall, and the shift in perception as health status changes. Conclusion Given the current search for appropriate outcome meas- ures of routine care [29,30] we think it is worthwhile to try to relate measures of outcome to the patients' view of its impact on their daily lives. Clearly further work is required to validate the accuracy of the ORIDL in assess- ing such change. However, our experience and data to date suggest that the ORIDL scale may prove of value in tracking routine care in clinical practice and in evaluating healthcare interventions. Competing interests The author(s) declare that they have no competing inter- ests. 4. It models how patients and practitioners already asses care in daily busy practice. 5. It can be used in routine clinical practice without dis- rupting the care process. 6. It may allow comparison across different contexts of healthcare in the degree of useful impact achieved by the intervention. 7. It establishes a useful shared language, for example, whatever the context if you say a patient experienced '+2' then others know that this was change was at least suffi- cient to impact on the quality of daily living. 8. It can be used without measuring a previous baseline, capturing the participants' views of any change over time. Some of its weaknesses are: Authors' contributions DR devised the ORIDL and co-supervised the research in studies 1 and 2. He wrote the initial version of the manu- script and contributed to modifications. He contributed in addition intellectual input at all stages. SWM carried out the data collection and analysis in Studies 1 and 3, and re-analysed part of the data in Study 2. He re-shaped the initial version of the manuscript, and led the re-writ- ing of subsequent versions. He also contributed intellec- tual input at all stages. APB carried out part of the data collection in Study 2, and analysed part of the data, and contributed to writing and modifying drafts of the manu- script. She contributed intellectually, especially to the interpretation of the data. TH carried out part of the data collection in Study 2, and contributed to the final version of the manuscript. All authors read and approved the final manuscript. Page 9 of 10 (page number not for citation purposes) BMC Health Services Research 2007, 7:139 http://www.biomedcentral.com/1472-6963/7/139 Acknowledgements Stewart Mercer is supported by a Primary Care Research Career Award from the Chief Scientist Office of the Scottish Executive. The AdHom Aca- demic Departments are supported by the AdHominem Charity. References 1. Swage T: Clinical governance in health care practice. Butter- worth Heinemann 2004. ISBN0750644532 2. Gill TM, Feinstein AR: A critical appraisal of the quality of qual- ity-of-life measurements. JAMA 1994, 272:619-626. 3. Paterson C: Measuring outcomes in primary care: a patient generated measure, MYMOP, compared with the SF-36 health survey. BMJ 1996, 312:1016-1020. 4. Paterson C: In pursuit of patient-centred outcomes: a qualita- tive evaluation of the 'Measure Yourself Medical Outcome Profile'. J Health Service Res Pol 2002, 5:27-36. 5. The Academic Departments of the Centre forIntegrative Care [http://www.adhom.com] 6. Reilly D, Taylor MA: Experimental integrated clinics. Comp Ther Med 1993, 1(Supplement 1):16-17. 7. Sevar R: Audit of outcome in 455 consecutive patients treated with homeopathic medicines. Homeopathy 2005, 94:215-21. 8. Neville-Smith R: Community hospital clinic: Audit of the first 12 months activity. Brit Hom J 1999, 88:20-23. 9. Sevar R: Audit of outcome in 829 consecutive patients treated with homeopathic medicine. Brit Hom J 2000, 89:178-187. 10. Richardson WR: Patient benefit survey: Liverpool regional department of homoeopathic medicine. Brit Hom J 2001, 90:158-162. 11. Riley D, et al.: Homeopathy and conventional medicine: An outcomes study comparing effectiveness in a primary care setting. J Alt Comp Med 2001, 7:149-159. 12. Mercer S, Reilly D, Watt G: The importance of empathy in the enablement of patients attending the Glasgow Homoeo- pathic Hospital. BJGP 2002, 52:901-905. 13. MacPherson H, Mercer SW, Scullion T, Thomas KJ: Empathy, ena- blement, and outcome: an exploratory study on acupunc- ture patients' perceptions. J Alt Comp Med 2003, 9:869-76. 14. Bikker AP, Mercer SW, Reilly D: A pilot prospective study on the consultation and relational empathy, patient enablement, and health changes over 12 months in patients going to the Glasgow Homoeopathic Hospital. J Alt Comp Med 2005, 11:591-600. 15. Greenwood JE: The challenge to find a safe and effective cure for verruca pedis. Podiatry Now 2004, 8:20-24. 16. Thompson EA, Montgomery A, Douglas D, Reilly D: A pilot, rand- omized, double-blinded, placebo-controlled trial of individu- alized homeopathy for symptoms of estrogen withdrawal in breast-cancer survivors. J Alt Comp Med 2005, 11(1):13-20. 17. Ricciotti F, Bernardini C, D'Aco L, Giannuzzi AL, Passali GC, Passali D: Pilot study on chronic rhinosinusitis in order to evaluate efficacy and tolerability of a standard antibiotic treatment (Amoxicillin and Clavulanic Acid) associated to an homeo- pathic complex (Dr. Reckeweg R1). Rivista Italiana di Otorinolarin- gologia Audiologia e Foniatria 2005, 25:109-117. 18. The EuroQol Group: EuroQol – a new facility for the measure- ment of health related quality of life. Health Policy 1990, 16:199-208. 19. Ware J, Kosinski M, Keller SD: A 12-Item Short-Form Health Survey: Construction of scales and preliminary tests of relia- bility and validity. Medical Care 1996, 34:220-233. 20. Howie J, Heaney DJ, Maxwell M, Walker JJ: A Comparison of a Patient Enablement Instrument (PEI) against two estab- lished satisfaction scales as an outcome measure of primary care consultations. Fam Pract 1997, 15:165-171. 21. Paterson C: Measuring change in self-concept: a qualitative evaluation of outcome questionnaires in people having acu- puncture for their chronic health problems. BMC Comp Alt Med 2006, 6:7. doi: 10.1186/1472-6682-6-7 22. Mercer SW: Practitioner empathy, patient enablement, and health outcomes of patients attending the Glasgow Homoe- opathic Hospital : a retrospective and prospective compari- son. Wien Med Wochenschr 2005, 155:498-501. 23. Reilly D, Taylor M: The Evidence Profile. Developing Inte- grated Medicine. Comp Ther Med 1993, 1:11-12. 24. Paterson C, Langan CE, McKaig GA, Anderson PM, Maclaine GDH, Rose LB, et al.: Assessing patient outcomes in acute exacerba- tions of chronic bronchitis: The measure your medical out- come profile (MYMOP), medical outcomes study 6-item general health survey (MOS-6A) and EuroQol (EQ-5D). Qual Life Res 2000, 9:521-527. 25. Guyatt GH, Norman GR, Jumiper EF, Griffith LE: A critical look at transition ratings. J Clin Epidemiol 2002, 55:900-908. 26. Steiner DL, Norman GR: Health measurement scales 3rd edition. Oxford: Oxford University Press; 2003. 27. Fischer D, Stewart AL, Bloch DA, Lorig K, Laurent D, Holman H: Capturing the patient's view of change as a clinical outcome measure. JAMA 1999, 282:1157-1162. 28. Ziebland S, Fitzpatrick R, Jenkinson C, Mowat A, Mowat A: Compar- ison of two approaches to measuring change in health status in rheumatoid arthritis: the Health Assessment Question- naire (HAQ) and modified HAQ. Ann Rheum Dis 1992, 51:1202-1205. 29. Paterson C: Seeking the patient's perspective: a qualitative assessment of EuroQol, COOP-WONCA Charts and MYMOP. QualLife Res 2004, 13:871-881. 30. Verhoef MJ, Vanderheyden LC, Dryden T, Mallory D, Ware M: Eval- uating complementary and alternative medicine interven- tions: in search of appropriate patient-centred outcome measures. BMC Comp Alt Med 2006, 6:38. doi:10.1186/1472-6882- 6-38 Pre-publication history The pre-publication history for this paper can be accessed here: http://www.biomedcentral.com/1472-6963/7/139/pre pub Publish with Bio Med Central and ever y scientist can read your work free of charge "BioMed Central will be the most significant development for disseminating the results of biomedical researc h in our lifetime." 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