Australia’s NHMRC publishes flawed report despite concerns raised during public consultation

Australia’s NHMRC publishes flawed report despite concerns raised during public consultation12 March 2015

Although the HRI welcomes thorough research in homeopathy, only studies carried out using appropriate and rigorous scientific methods can produce meaningful results. We therefore lament the recent publication by Australia’s National Health and Medical Research Council (NHMRC), which fails to meet this standard.

During a public consultation on the draft version of this report, HRI and others highlighted deep flaws in how the NHMRC had analysed the evidence on homeopathy. None of these serious problems were addressed in the final publication. This raises questions as to whether the public consultation was ever meant to have any impact on the final report, leading to serious concerns about the conduct of this governmental body.

We maintain that the conclusions of the NHMRC report are inconsistent with the evidence.

The inaccuracy of the NHMRCs conclusions stem primarily from one fundamental flaw at the heart of this report – the NHMRC reviewers considered the results of all trials for one condition together as a whole, even though the individual trials were assessing very different types of homeopathic treatment.

To illustrate this flaw, the NHMRC reviewers asked, “Is homeopathy effective for condition A?’, working from the premise that a positive trial showing that one homeopathic treatment is effective is somehow negated by a negative trial which shows that a completely different homeopathic treatment for that same condition is ineffective. This is a bizarre and unprecedented way of assessing scientific evidence. In conventional research the question asked would be, “Is treatment X effective for condition A?”, not “Is conventional medicine effective for condition A?” based on combining the results of all drug trials together. Some treatments work, some don’t. The whole point of medical research is to establish which treatments are useful and which are of no value. This is no different in homeopathy.

This single methodological flaw explains why the NHMRCs has failed to find any ‘reliable’ evidence that homeopathy is effective for any of the 61 conditions under consideration.

Secondly, we are deeply perplexed as to the reasons for the exclusion of some of the best evidence for key clinical conditions. In brief:

Jacobs et al performed meta-analysis a meta-analysis of the treatment of childhood diarrhea using homeopathy in 2003, N=242 in placebo controlled trials, p-value = 0.008. This meta-analysis was excluded … why? [Link] Wiesenauer & Lüdtke conducted a meta-analysis into the treatment of hayfever in 1996, N=752 in placebo controlled RCTs, p-value <0.0001. This meta-analysis was excluded. Again we ask ourselves why? [Link] Schneider et al conducted a meta-analysis of non-inferiority trials of homeopathy compared to usual care for the treatment of vertigo, N=1388, non-inferiority was clearly demonstrated. Again excluded, again why? [Link]

A Cochrane review by Mathie et al inspected the evidence for the treatment of influenza using homeopathy concluded in favor of homeopathy (N=1259, placebo RCTs, p=0.001) yet this evidence was simply ignored in the final conclusions on the grounds of possible bias in the underlying studies [Link].

The NHMRC also need to justify their use of N=150 as a line between reliable and unreliable trials and they certainly need to explain why size is relevant at all when the findings are statistically significant.

Furthermore we do not see how there could be any justification for the absence of a homeopathy expert on the NHMRC review board. The presence of such an expert would potentially have prevented many of the issues raised here and would definitely have reassured the public about allegations of bias on the part of the NHMRC.

We note that the conclusions of the NHMRC report are at odds with the conclusions of the recent extensive meta-analysis of RCTs using homeopathy performed by Mathie and co-workers which concludes in favour of an effect of homeoapthy[Link].

The HRI does not dispute the fact that there are few high-quality, positive studies in homeopathy and that these need independent replication, but we do dispute the NHMRC’s failure to identify these positive studies in their Information Paper as promising studies which should be repeated.

Despite the considerable means spent on this report and great profession of due process and absence of bias, as demonstrated above the NHMRC has failed both in terms of the process they used and in the fairness of their assessment of the evidence.

The NHMRC documents can be found here, with the final statement here.

The HRI’s response to the initial draft can be found here, and our submission to the NHMRC can be found here. https://www.hri-research.org/2015/03/nhmrc-publishes-flawed-report-despite-concerns-raised-during-public-consultation/

Just some research to do with homeopathy; a tiny bibliography G & M ...argh! compiled by Elena Cecchetto

Works CitedAdler, Ubiratan C., Stephanie Krüger, Michael Teut, Rainer Lüdtke, Iris Bartsch, Lena Schützler, Friedericke Melcher, Stefan N. Willich, Klaus Linde, and Claudia M. Witt. "Homeopathy for Depression - DEP-HOM: Study Protocol for a Randomized, Partially Double-blind, Placebo Controlled, Four Armed Study." Trials 12.1 (2011): 43-49. Web. 9 Jan. 2015. . Adler, Ubiratan C., Stephanie Krüger, Michael Teut, Rainer Lüdtke, Lena Schützler, Friederike Martins, Stefan N. Willich, Klaus Linde, and Claudia M. Witt. "Homeopathy for Depression: A Randomized, Partially Double-Blind, Placebo-Controlled, Four-Armed Study (DEP-HOM)." PLoS ONE 8.9 (2013): 1-9. Web. 9 Jan. 2015. . Ainsworth, Steve. "Time to Consign Homeopathy to the History Books?" Practice Nurse 42.10 (2012): 34-35. Web. 9 Jan. 2015. . Akaeva, T. V., and K. N. Mkhitaryan. "Foundation of Concept of Constitutional Homeopathic Remedy by Using Electropuncture Methods." International Journal of High Dilution Resarch 13.47 (2014): 132-33. Web. 9 Jan. 2015. . Almirantis, Yannis. "Homeopathy – between Tradition and Modern Science: Remedies as Carriers of Significance." Homeopathy 102.2 (2013): 114-22. Web. 9 Jan. 2015. . Amalcaburio, Rosane, Luiz Carlos Pinheiro Machado Filho, Luciana Aparecida Honorato, and Nelton Antônio Menezes. "Homeopathic Remedies in a Semi-intensive Alternative System of Broiler Production." International Journal of High Dilution Resarch 8.26 (2009): 33-39. Web. 9 Jan. 2015. . Arlt, S., W. Padberg, M. Drillich, and W. Heuwieser. "Efficacy of Homeopathic Remedies as Prophylaxis of Bovine Endometritis." Journal of Dairy Science 92.10 (2009): 4945-953. Web. 9 Jan. 2015. . Arora, Shagun, Ayushi Aggarwal, Priyanka Singla, Saras Jyoti, and Simran Tandon. "Anti-proliferative Effects of Homeopathic Medicines on Human Kidney, Colon and Breast Cancer Cells." Homeopathy: The Journal Of The Faculty Of Homeopathy 102.4 (2013): 274-82. Web. 9 Jan. 2015. . Banerjee, A., Sb Chakrabarty, Sr Karmakar, A. Chakrabarty, Sj Biswas, S. Haque, D. Das, S. Paul, B. Mandal, B. Naoual, P. Belon, and Ar Khuda-Bukhsh. "Can Homeopathy Bring Additional Benefits to Thalassemic Patients on Hydroxyurea Therapy? Encouraging Results of a Preliminary Study." Homoeopathic Heritage 34.4 (2009): 33-40. Web. 9 Jan. 2015. . Banerjee, Antara, Sudipa Basu Chakrabarty, Susanta Roy Karmakar, Amit Chakrabarty, Surjyo Jyoti Biswas, Saiful Haque, Debarsi Das, Saili Paul, Biswapati Mandal, Boujedaini Naoual, Philippe Belon, and Anisur Rahman Khuda-Bukhsh. "Can Homeopathy Bring Additional Benefits to Thalassemic Patients on Hydroxyurea Therapy? Encouraging Results of a Preliminary Study." Evidence-based Complementary & Alternative Medicine (eCAM) 7.1 (2010): 129-36. Web. 9 Jan. 2015. . Bell, Ir, Aj Brooks, A. Howerter, N. Jackson, and Ge Schwartz. "Acute Electroencephalographic Effects From Repeated Olfactory Administration of Homeopathic Remedies in Individuals With Self-reported Chemical Sensitivity." Alternative Therapies in Health & Medicine 19.1 (2013): 46-57. Web. 9 Jan. 2015. . Bell, Iris, R., Amy Howerter, Nicholas Jackson, Audrey, J. Brooks, and Gary, E. Schwartz. "Multiweek Resting EEG Cordance Change Patterns from Repeated Olfactory Activation with Two Constitutionally Salient Homeopathic Remedies in Healthy Young Adults." Journal of Alternative & Complementary Medicine 18.5 (2012): 445-53. Web. 9 Jan. 2015. . Bell, Iris, R., Amy Howerter, Nicholas Jackson, Mikel Aickin, Richard, R. Bootzin, and Audrey, J. Brooks. "Nonlinear Dynamical Systems Effects of Homeopathic Remedies on Multiscale Entropy and Correlation Dimension of Slow Wave Sleep EEG in Young Adults with Histories of Coffee-induced Insomnia." Homeopathy 101.3 (2012): 182-92. Web. 9 Jan. 2015. . Bell, Iris R., and Gary E. Schwartz. "Adaptive Network Nanomedicine: An Integrated Model for Homeopathic Medicine." Frontiers In Bioscience (Scholar Edition) 5 (2013): 685-708. Web. 9 Jan. 2015. . Bell, Iris, R. "Homeopathy as Systemic Adaptational Nanomedicine: The Nanoparticle-Cross-Adaptation-Sensitization Model." American Journal of Homeopathic Medicine 105.3 (2012): 116-30. Web. 9 Jan. 2015. . Bellavite, Paolo, Marta Marzotto, Debora Olioso, Elisabetta Moratti, and Anita Conforti. "High-dilution Effects Revisited. 2. Pharmacodynamic Mechanisms." Homeopathy: The Journal Of The Faculty Of Homeopathy 103.1 (2014): 22-43. Web. 9 Jan. 2015. . Bellavite, Paolo, Paolo Magnani, Marta Marzotto, and Anita Conforti. "Assays of Homeopathic Remedies in Rodent Behavioural and Psychopathological Models." Homeopathy: The Journal Of The Faculty Of Homeopathy 98.4 (2009): 208-27. Web. 9 Jan. 2015. . Carter, Jenny, and Gillian Aston. "Use of Homeopathic Arnica among Childbearing Women: A Survey." British Journal of Midwifery 20.4 (2012): 254-61. Web. 9 Jan. 2015. . Clayton, L. "Top Ten: Homeopathic Remedies for Pregnancy and Birth." Essentially MIDIRS 3.5 (2012): 27-31. Web. 9 Jan. 2015. . Copeland, Annette. "A STUDY TO DETERMINE THE EFFECTIVENESS OF HOMEOPATHIC WEIGHT LOSS REMEDIES: HCG NON-HCG ~vs~ NON-HCG." Original Internist 18.3 (2011): 107-16. Web. 9 Jan. 2015. . Csupor, Dezső, Klára Boros, and Judit Hohmann. "Low Potency Homeopathic Remedies and Allopathic Herbal Medicines: Is There an Overlap?" PLoS ONE 8.9 (2013): 1-5. Web. 9 Jan. 2015. . Drozdov, V. V. "Optimization of Coprological Studies in Animals with the Use of Homeopathic Nux Vomica 6CH." International Journal of High Dilution Resarch 13.47 (2014): 139. Web. 9 Jan. 2015. . F, Treuherz. "School Suffers Salmonella Outbreak - How One Homeopath Helped 100 Students." Homoeopath 32.3 (2013): 8. Web. 9 Jan. 2015. . Frei, Heiner. "H1N1 Influenza: A Prospective Outcome Study with Homeopathy and Polarity Analysis." American Journal of Homeopathic Medicine 107.3 (2014): 114-22. Web. 9 Jan. 2015. . Frenkel, M. "Homeopathy in Cancer Care." Alternative Therapies in Health & Medicine 16.3 (2010): 12-16. Web. 9 Jan. 2015. . H, Mollinger, Schneider R, and Walach H. "Homeopathic Pathogenetic Trials Produce Specific Symptoms Different from Placebo." Forschende Komplementarmedizin 16.2 (2009): 105. Web. 9 Jan. 2015. . H, Stevenson. "Breast Cancer Study: The Cytotoxic Effects of Homeopathic Remedies on Breast Cancer Cells." Homeopath Pract (2010): 46. Web. 9 Jan. 2015. . Hechavarria Torres, Maricel, Gricel Benítez Rodríguez, and Leidys Pérez Reyes. "Efectividad Del Tratamiento Homeopático En Pacientes Con Síndrome Depresivo. (Spanish)." Medisan 18.2 (2014): 302-08. Web. 9 Jan. 2015. . Hellhammer, Juliane, and Melanie Schubert. "Effects of a Homeopathic Combination Remedy on the Acute Stress Response, Well-Being, and Sleep: A Double-Blind, Randomized Clinical Trial." Journal of Alternative & Complementary Medicine 19.2 (2013): 161-69. Web. 9 Jan. 2015. . Hostanska, Katarina, Matthias Rostock, Stephan Baumgartner, and Reinhard Saller. "Effect of Two Homeopathic Remedies at Different Degrees of Dilutions on the Wound Closure of 3T3 Fibroblasts in in Vitro Scratch Assay." International Journal of High Dilution Resarch 11.40 (2012): 164-65. Web. 9 Jan. 2015. . Hostanska, Katarina, Matthias Rostock, Stephan Baumgartner, and Reinhard Saller. "Effect of Two Homeopathic Remedies at Different Degrees of Dilutions on the Wound Closure of 3T3 Fibroblasts in in Vitro Scratch Assay." International Journal of High Dilution Resarch 11.40 (2012): 164-65. Web. 9 Jan. 2015. . Ir, Bell, Koithan M, and Brooks Aj. "Testing the Nanoparticle-allostatic Cross-adaptation-sensitization Model for Homeopathic Remedy Effects." Homeopathy 102.1 (2013): 66. Web. 9 Jan. 2015. . J, Siebenwirth, Ludtke R, Remy W, Rakoski J, Borelli S, and Ring J. "Effectiveness of a Classical Homeopathic Treatment in Atopic Eczema. A Randomised Placebo-controlled Double-blind Clinical Trial." Forschende Komplementarmedizin 16.5 (2009): 315. Web. 9 Jan. 2015. . Jha, Charndra Kant, and Jeanne Madison. "Strategies for Reinventing and Reinforcing the Disrupted Biography of People with HIV in Nepal." Health Sociology Review 22.2 (2013): 221-32. Web. 9 Jan. 2015. . K, Chatfield, Mathie Rt, and Fisher P. "Comment 2 On: Homeopathy Has Clinical Benefits in Rheumatoid Arthritis Patients That Are Attributable to the Consultation Process but Not the Homeopathic Remedy: A Randomized Controlled Trial." Rheumatology (oxford) 50.8 (2011): 1529. Web. 9 Jan. 2015. . Kawakami, Ana Paula, Lika Osugui, Amarylis Toledo César, Silvia Waisse Priven, Vania Maria De Carvalho, and Leoni Villano Bonamin. "In Vitro Growth of Uropathogenic Escherichia Coli Isolated from a Snow Leopard Treated with Homeopathic and Isopathic Remedies: A Pilot Study." International Journal of High Dilution Resarch 8.27 (2009): 41-44. Web. 9 Jan. 2015. . Kay, Peter, H., Saqib Rashid, and Nikunj Panchal. "Advances in Homeopathy: Targeting of Health Promoting Genes Using Sequence Specific Homeopathic DNA Remedies." Homoeopathic Heritage 40.7 (2014): 22-24. Web. 9 Jan. 2015. . Lenger, Karin, Rajendra P. Bajpai, and Manfred Spielmann. "Identification of Unknown Homeopathic Remedies by Delayed Luminescence." Cell Biochemistry And Biophysics 68.2 (2014): 321-34. Web. 9 Jan. 2015. . M, Teut. "Homeopathic Treatment of Patients with Dementia." Am J Homeopath Med 103.3 (2010): 120. Web. 9 Jan. 2015. . Majewsky, Vera, Claudia Scherr, Sebastian P. Arlt, Peter Klocke, and Stephan Baumgartner. "Reproducibility of Effects of the Homeopathic Dilutions 14x - 30x of Gibberellic Acid on Growth of Lemna Gibba L." International Journal of High Dilution Resarch 11.40 (2012): 196-97. Web. 9 Jan. 2015. . Majewsky, Vera, Claudia Scherr, Sebastian, Patrick Arlt, Jonas Kiener, Kristina Frrokaj, Tobias Schindler, Peter Klocke, and Stephan Baumgartner. "Reproducibility of Effects of Homeopathically Potentised Gibberellic Acid on the Growth of Lemna Gibba L. in a Randomised and Blinded Bioassay." Homeopathy 103.2 (2014): 113-26. Web. 9 Jan. 2015. . Malhi, Luvdeep, and Ram S. Saini. "Homeopathy as an Adjunct to Allopathic Therapy." UBC Medical Journal 3.2 (2012): 32-34. Web. 9 Jan. 2015. . Marino, Francesco, V. "Homeopathy and Celiac Disease: A Contribution toward Healing." American Journal of Homeopathic Medicine 105.1 (2012): 4-15. Web. 9 Jan. 2015. . Medhurst, Robert. "Homoeopathy for Eczema." Journal of the Australian Traditional-Medicine Society 19.2 (2013): 104-06. Web. 9 Jan. 2015. . Molski, M. "Quasi-quantum Phenomena: The Key to Understanding Homeopathy." Homeopathy 99.2 (2010): 104-12. Web. 9 Jan. 2015. . Novosadyuk, Tatiana. "Effect of Dinamization as a Characteristic of Potentiation of Homeopathic Remedies." International Journal of High Dilution Resarch 12.44 (2013): 86-87. Web. 9 Jan. 2015. . P, Beeraka. "The Pharmacological Action of Homeopathic Remedies." Simillimum 22.3 (2009): 66. Web. 9 Jan. 2015. . Peckham, Emily J., E. Andrea Nelson, Joanne Greenhalgh, Katy Cooper, E. Rachel Roberts, and Anurag Agrawal. "Homeopathy for Treatment of Irritable Bowel Syndrome." The Cochrane Database Of Systematic Reviews 11 (2013): CD009710. Web. 9 Jan. 2015. . Posadzki, P., A. Alotaibi, and E. Ernst. "Adverse Effects of Homeopathy: A Systematic Review of Published Case Reports and Case Series." International Journal Of Clinical Practice 66.12 (2012): 1178-188. Web. 9 Jan. 2015. . Rattan, Suresh I. S., and Taru Deva. "Testing the Hormetic Nature of Homeopathic Interventions through Stress Response Pathways." Human & Experimental Toxicology 29.7 (2010): 551-54. Web. 9 Jan. 2015. . S, Piraneo, Maier J, Nervetti G, Duca P, Valli C, Milanesi A, Pagano F, Scaglione D, Osio M, and Nascimbene C. "A Randomized Controlled Clinical Trial Comparing the Outcomes of Homeopathic-phytotherapeutic and Conventionai Therapy of Whiplash in an Emergency Department." Homoeopathic Links 25.1 (2012): 50. Web. 9 Jan. 2015. . S, Zaidan. "Belladonna, Hyoscyamus and Stramonium Pharmaceutical Drugs or Homeopathic Remedies. The Effect of These Plants in Treating Mental Illnesses: A Comparative Study." Homeopath Int 2012.2 (2012): 12. Web. 9 Jan. 2015. . Saeed-ul-Hassan, Syed, Imran Tariq, Ayesha Khalid, and Sabiha Karim. "Comparative Clinical Study on the Effectiveness of Homeopathic Combination Remedy with Standard Maintenance Therapy for Dengue Fever." Tropical Journal of Pharmaceutical Research 12.5 (2013): 767-70. Web. 9 Jan. 2015. . Saha, Santu Kumar, Sourav Roy, and Anisur Rahman Khuda-Bukhsh. "Evidence in Support of Gene Regulatory Hypothesis: Gene Expression Profiling Manifests Homeopathy Effect as More than Placebo." International Journal of High Dilution Resarch 12.45 (2013): 162-67. Web. 9 Jan. 2015. . Sampath, Sathish, Akilavalli Narasimhan, Raveendar Chinta, K. R Janardanan Nair, Anil Khurana, Debadatta Nayak, Alok Kumar, and Balasubramanian Karundevi. "Effect of Homeopathic Preparations of Syzygium Jambolanum and Cephalandra Indica on Gastrocnemius Muscle of High Fat and High Fructose-induced Type-2 Diabetic Rats." Homeopathy: The Journal Of The Faculty Of Homeopathy 102.3 (2013): 160-71. Web. 9 Jan. 2015. . T, Quak, Rudofsky L, and Dugue R. "Asthma Bronchiale - Verschreibung Von Ambra Grisea Aufgrund Eines Auffallenden Lokalsymptoms." Allgem Homoopath Zeit 256.5 (2011): 8. Web. 9 Jan. 2015. . Teixeira, Marcus Zulian. "'Paradoxical Pharmacology': Therapeutic Strategy Used by the 'homeopathic Pharmacology' for More than Two Centuries." International Journal of High Dilution Resarch 13.49 (2014): 207-26. Web. 9 Jan. 2015. . Teixeira, Marcus Zulian. "Scientific Evidence of the Homeopathic Epistemological Model." International Journal of High Dilution Resarch 10.34 (2011): 46-64. Web. 9 Jan. 2015. . Thompson, E.A., A. Shaw, J. Nichol, S. Hollinghurst, A.J. Henderson, T. Thompson, and D. Sharp. "The Feasibility of a Pragmatic Randomised Controlled Trial to Compare Usual Care with Usual Care plus Individualised Homeopathy, in Children Requiring Secondary Care for Asthma." Homeopathy 100.3 (2011): 122-30. Web. 9 Jan. 2015. . Von Hagens, C., P. Schiller, B. Godbillon, J. Osburg, C. Klose, R. Limprecht, and T. Strowitzki. "Treating Menopausal Symptoms with a Complex Remedy or Placebo: A Randomized Controlled Trial." Climacteric 15.4 (2012): 358-67. Web. 9 Jan. 2015. . Zuzak, Tycho Jan, Christine Rauber-Lüthy, and Ana Paula Simões-Wüst. "Accidental Intakes of Remedies from Complementary and Alternative Medicine in Children—analysis of Data from the Swiss Toxicological Information Centre." European Journal of Pediatrics 169.6 (2010): 681-88. Web. 9 Jan. 2015. . Show me the research 2014

Journal of Medicine and the Person April 2015, Volume 13, Issue 1, pp 18-22 Date: 22 Oct 2014 Biology and sign theory: homeopathy emerging as a biosemiotic system Leoni V. Bonamin, Silvia Waisse Journal of Medicine and the Person

Abstract Diluted above Avogadro’s number, homeopathic medicines allegedly do not contain any molecule of their starting-materials. As Western science is historically based on the notion of matter, alternative epistemological models are needed to account for the biological actions of homeopathic high dilutions. One such model is provided by biosemiotics, an interdisciplinary field devoted to the integration of biology and semiotics based on the fundamental belief that sign production and interpretation is one of the immanent and intrinsic features of life. Several experimental studies show that the information carried by high dilutions might be evidenced by means of measurable biological effects ranging from intranuclear epigenetic phenomena to inheritable adaptive processes, and regulatory physiological and behavioral phenomena. Therefore, when the action of homeopathic medicines is considered from the semiotic point of view, they become an endless source for studies aiming not only at therapeutic applications, but also to achieve a more refined understanding of living beings and their relationships with the environment.

http://link.springer.com/article/10.1007/s12682-014-0191-4

According to the philosopher Agne
`
s Lagache
(1940–2009), ‘‘Living beings are informed-informing
structures, a network of relationships between their content
and their surroundings. As a consequence, some biological
elements should not be considered as material things, but
as semantic objects. A sematic object is one that performs
the functions associated to mediation’’ [
17
]. Together,
Lagache and the immunologist Madeleine Bastide
(1935–2007) formulated, along the 1980s and 1990s, the
theoretical model known as ‘‘paradigm of corporeal sig-
nifiers’’, which among other features, is seemingly able to
account for the action of the homeopathic medicines based
on the principle of meaningfulness that rules over infor-
mation systems [
17
].

Theoretical aspects of autism: Causes—A review Helen V. Ratajczak

Theoretical aspects of autism: Causes—A reviewHelen V. Ratajczak Abstract Autism, a member of the pervasive developmental disorders (PDDs), has been increasing dramatically since its description by Leo Kanner in 1943. First estimated to occur in 4 to 5 per 10,000 children, the incidence of autism is now 1 per 110 in the United States, and 1 per 64 in the United Kingdom, with similar incidences throughout the world. Searching information from 1943 to the present in PubMed and Ovid Medline databases, this review summarizes results that correlate the timing of changes in incidence with environmental changes. Autism could result from more than one cause, with different manifestations in different individuals that share common symptoms. Documented causes of autism include genetic mutations and/or deletions, viral infections, and encephalitis following vaccination. Therefore, autism is the result of genetic defects and/or inflammation of the brain. The inflammation could be caused by a defective placenta, immature blood-brain barrier, the immune response of the mother to infection while pregnant, a premature birth, encephalitis in the child after birth, or a toxic environment.

Keywords: Autism; autism spectrum disorder; pervasive developmental disorder

http://www.rescuepost.com/files/theoretical-aspects-of-autism-causes-a-review1.pdf

The whole detox April 7, 2014

http://drinkanddrugsnews.com/tag/tracy-woodward-gagetta/ Studying homeopathy led Tracy Woodward Gagetta to explore an innovative titration system for drug detoxification, as she explains

After training and working in the fields of mental health and addictions, I developed a dilution titration system to reduce the withdrawal symptoms of and cravings for heroin, while studying for a degree in homeopathy. This was originally a research proposal for my graduating year, but soon developed into a titration for different drug detoxes, called the Tauto-Mod titration system.

The first pilot project was funded by the Homeopathy Action Trust and was a one-day-a-week project in a rehabilitation centre in Luton and a homeless day programme in Slough. After results proved positive for the programme, the detox was then taken on by South Westminster Drug and Alcohol Service (SWDAS) to be used in conjunction with a range of other interventions at the service. Detoxification from opioids and alcohol in this service is carried out under medical supervision, and employs a range of NICE approved drug (allopathic) therapies, with adjuvant evidence based psychosocial interventions. The homeopathic treatment outlined in this article was additional to this.

Since the pilot started at SWDAS in April 2013, 45 clients have taken part in the detox and study. Out of these clients, 60 per cent had self-referred after attending a guest speaker group and hearing about the detox from other clients. Seventy per cent were male and 30 per cent female, with a dropout rate (attending less than three appointments) of six clients in total. Alcohol clients had the highest overall attendance, at 55 per cent. Among all the clients, there was an overall retention rate of 80 per cent for weekly appointments and a successful completion rate of 61 per cent (including those detoxing from the programme, remaining abstinent and/or no longer using the primary drug.) Of those on the programme, nine clients were also on a drug replacement therapy prescription, including detoxing from methadone.

The drugs we detox, and which were included in the SWDAS study, are alcohol, cocaine/crack, heroin, cannabis, methadone, benzodiazepines, amphetamines, methamphetamine, GBL and ketamine.

The Tauto-Mod system adopts a tautopathic approach, which involves the drug or substance that has caused the illness and/or toxicity in the client being prescribed at a high dilution. This system is believed to work in accordance with the ‘hormesis concept’.

Hormesis in toxicity involves providing a low-dose stimulation (the drug in high dilution) to cells in order to trigger a restorative process – that is, the compensatory response to damage. It is proposed that these low doses of toxins or other stressors might activate the repair mechanisms of the body. In layman’s terms, the Tauto-Mod system works primarily at the cellular level to flush toxins from the body, thus reducing cravings, withdrawal symptoms and long-term toxicity.

The recording of results and the prescribing of the appropriate dilution occurs weekly and is based on whether the symptoms for each drug present as nil, mild, moderate or severe for each titration chart. For example, a client presenting with mostly moderate to severe withdrawal and toxicity symptoms will be prescribed the appropriate tautopathic medication at low dilution. The more amelioration of symptoms recorded in subsequent weeks, the more the dilution of the tautopathic medicine is increased. Clients are recommended in most cases to take a couple of doses daily. This is to ensure they are receiving the full effects of the medication, particularly as most are still using the drug on top of their tautopathic prescription and maybe taking conventional medications alongside this system.

Tauto-Mod involves weekly titration charts that record symptom levels for each drug misused per person. Depending on the level of severity of symptoms, the client is then prescribed the drug at a specified dilution level. The higher the level of symptoms and toxicity, the lower the dilution of the drug. The system titrates upwards only, which differs from conventional methods of prescribing methadone. The premise is that the higher the dilution, the more this method is believed to work on the mental/emotional level once most of the physical symptoms have been alleviated by the lower dilution preparations.

The expectation of the Tauto-Mod detox is that the patient attends weekly appointments to observe and record shifts in symptoms and prescription. This also allows the practitioner to liaise directly with the project workers and medical staff to ensure the best treatment is provided and to flag any risks and concerns, as well as positive progress. Substance misusers often live chaotic lifestyles, so it is not always possible to see the patient on a weekly basis for a minimum of 12 weeks; however, so far at SWDAS, the attendance rate has been high and surpassed expectations.

This programme also has a second system running parallel to the tautopathic prescriptions. Since the addictions sector is now acknowledging that we must focus on the client’s underlying reasons for becoming a substance misuser in the first place, the project also prescribes dilution medications for any associated mental and physical health symptoms, ensuring that the client receives holistic support in their recovery. Mental health issues, such as depression, anxiety, delusions and paranoia, are prescribed for with relevant homeopathic medications. The same follows for any physical health symptoms such as restless leg syndrome, chronic coughs, headaches and constipation. This holistic approach allows the client to develop a sense of overall wellness and attempts to pre-emptively address any reasons why the service user may relapse in the future, such as past trauma and life changing events.

With the aim of rolling this out to other services in south east England and eventually nationwide, I realised I needed help from someone else in the industry and partnered with Mark Dempster, practising psychotherapist, drugs counsellor and author of Nothing to Declare. He was very enthusiastic about an ‘innovative detoxification system that has limitless potential in the future’ and said that ‘a titration system fit for purpose which can accommodate the needs of developing drug trends and markets has to be a good thing.’

As the system is not only a clinical treatment programme but also a study, progressive services and boroughs throughout the country now have the opportunity to benefit from our results, helping to obtain more positive outcomes as well as being part of this exciting study. This service has worked well in an integrated health care system and can be accessed at most levels of treatment.

The aim is to ensure that the service user can access a holistic treatment system that is tailor-made to their needs, expectations and long-term health goals. The substance misuse field is finally addressing the issue of long-term methadone maintenance. However, there is still great scope for investigation into complementary and unconventional therapies, their worth to the sector, and the holistic side of treatment.

Tracy Woodward Gagetta is CEO and founder of Restorative Recovery Prescribing Ltd. For more information on the Tauto-Mod system, visit www.recoveryprescribing.com http://drinkanddrugsnews.com/tag/tracy-woodward-gagetta/

Homeopathy an effective alternative

Homeopathy an effective alternative Published on Mon Mar 16 2015 Re: Scientists skeptical of study on ADHD care, March 6 Scientists skeptical of study on ADHD care, March 6

As a medical doctor, I use homeopathy on a daily basis to fill in gaps or improve on the conventional therapies I also use in family practice. There is no doubt that homeopathy works – even in children and in skeptical patients that are willing to give it a try (particularly if they have tried everything else without benefit); sometime even in patients’ pets. Sure, good interaction and placebo play a role, just as in any therapeutic encounter, but that does not explain the results I observe. When a group of “top” scientists declare that there is no evidence to support homeopathy, you cannot but wonder at their agenda. In fact, there have been several meta-analyses and governmental assessments that show homeopathy is effective (BMJ 1991, Lancet 1997, Eur J. Clin Pharmacology 2000, Swiss Federal Office for Public Health 2006). There are numerous positive trials, many of fair to high quality. Medical doctors around the world have accepted homeopathy based on sound evidence and the personal experience that confirms it. In Belgium, for example, 4000 doctors prescribe homeopathic medicines routinely. Homeopathy is inexpensive, convenient, integrates well with conventional medicine, and patient satisfaction and safety are excellent. It is included in the national health schemes of Great Britain, France, Switzerland, Brazil, Mexico, India and many other countries. The recent discovery of nanoparticles in homeopathic ultra-dilutions has undermined the “implausibility argument” or “I can’t understand how it works, therefore it can’t work.” This type of flat-earth thinking is not helpful in promoting better healthcare and has no place in medical practice or research. The main reason pseudo-scientists become quack-busters and criticize therapies such as homeopathy is fear. Perceived as a threat to their world-view, they use the labels “unscientific” or “implausible” to defend themselves against the barbarians at the gate. It is not really an issue of evidence or science. It’s a subconscious defense mechanism that cannot be overcome, even if the research is piled up to the ceiling. It may be disguised as defending the public, but as Shakespeare says: “The lady doth protest too much.” The potential benefits of homeopathy demand research such as Dr. Heather Boon’s ADHD study at University of Toronto, and we should not let fixed thinkers get in the way of progress in medicine. In fact, the criticism here should be levelled at McGill University for permitting its Office for Science and Society to exist and Dr. Joe Schwarcz to continue to “interpret science for the public.” Dr. Stephen Malthouse, past president, Canadian Complementary Medical Association, Denman Island, B.C.

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The impact of NHS based primary care complementary therapy services on health outcomes and NHS costs: a review of service audits and evaluations Lesley Wye*, Deborah Sharp and Alison Shaw

Open Access Highly Accessed Research article The impact of NHS based primary care complementary therapy services on health outcomes and NHS costs: a review of service audits and evaluations

Lesley Wye*, Deborah Sharp and Alison Shaw

* Corresponding author: Lesley Wye lesley.wye@bristol.ac.uk

Author Affiliations

Academic Unit of Primary Health Care, University of Bristol, 25 Belgrave Road, Bristol, BS8 2AA, UK

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BMC Complementary and Alternative Medicine 2009, 9:5 doi:10.1186/1472-6882-9-5

The electronic version of this article is the complete one and can be found online at: http://www.biomedcentral.com/1472-6882/9/5

Received: 28 October 2008 Accepted: 6 March 2009 Published: 6 March 2009

© 2009 Wye 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 aim of this study was to review evaluations and audits of primary care complementary therapy services to determine the impact of these services on improving health outcomes and reducing NHS costs. Our intention is to help service users, service providers, clinicians and NHS commissioners make informed decisions about the potential of NHS based complementary therapy services. Methods

We searched for published and unpublished studies of NHS based primary care complementary therapy services located in England and Wales from November 2003 to April 2008. We identified the type of information included in each document and extracted comparable data on health outcomes and NHS costs (e.g. prescriptions and GP consultations). Results

Twenty-one documents for 14 services met our inclusion criteria. Overall, the quality of the studies was poor, so few conclusions can be made. One controlled and eleven uncontrolled studies using SF36 or MYMOP indicated that primary care complementary therapy services had moderate to strong impact on health status scores. Data on the impact of primary care complementary therapy services on NHS costs were scarcer and inconclusive. One controlled study of a medical osteopathy service found that service users did not decrease their use of NHS resources. Conclusion

To improve the quality of evaluations, we urge those evaluating complementary therapy services to use standardised health outcome tools, calculate confidence intervals and collect NHS cost data from GP medical records. Further discussion is needed on ways to standardise the collection and reporting of NHS cost data in primary care complementary therapy services evaluations. Background

To make informed decisions about the usefulness of complementary therapies, service users, clinicians and NHS commissioners need good quality information on the contribution complementary therapies can make to improving health outcomes and reducing NHS costs. Although there has been extensive debate on the best way to assess the impact of complementary therapy treatments on health outcomes [1-3], randomised controlled trials tend to dominate. Randomised controlled trials are conducted in tightly controlled experimental environments in which a particular intervention is targeted to a medically defined symptom (e.g. acupuncture for migraine headaches). When treatments are removed from this experimental context and integrated into the real world of healthcare service delivery, these tight controls disappear and local contextual factors may alter the impact of the treatments. Hence, in investigating the potential usefulness of complementary therapies as part of mainstream healthcare provision, research into the effectiveness of treatments and the impact of services is necessary.

To date, however, the majority of research has been into the therapeutic effectiveness of complementary therapy treatments, with approximately 1500 trial based papers published annually [4]. More recently, the cost effectiveness of complementary therapy treatments has become a focus. A review of 14 studies of complementary therapy treatments meeting quality criteria found that seven treatments were cost effective, including guided imagery, relaxation and potassium diets for cardiac patients and osteopathy and chiropractic for neck pain [5]. Another economic review of five complementary therapy treatments concluded that four treatments resulted in additional costs to the NHS compared to usual care, largely to cover the costs of the practitioner. They also found that the estimates of cost of the complementary therapy treatments compared favourably with other interventions approved for use in the NHS [6]. Nonetheless, although research evidence on the clinical and cost effectiveness of complementary therapy treatments is growing, we have less information on the impact of complementary therapy services on health outcomes or NHS costs.

One attempt to address this was a report by Christopher Smallwood and colleagues published in 2005 [7]. Drawing on three case sites where complementary therapy services were provided in NHS settings, the authors came to the conclusion that [In the] majority of cases, specific conditions have improved, as have patients' general health and sense of well-being... [and] there seems to be good reason to believe that a number of CAM (complementary and alternative) treatments offer the possibility of significant savings in cost [7].

Perhaps unsurprisingly, given the controversy surrounding NHS provision of complementary therapies, the credibility of this report was challenged [8]. Notwithstanding, these were possibly overly bold assertions, in light of the limited quantity and questionable quality of some of the case study data. Aim of this study

In a previous exercise, we collected evaluations of 25 complementary therapy services to identify the methodologies used to assess services [9]. In addition, we explored the relationship between evaluation content and methodology and NHS funding and found that a favourable report did not necessarily result in NHS funding. Subsequently, we interviewed NHS funders and found that although health outcome information was useful, information on the impact of complementary therapy services on NHS resource utilisation (e.g. GP consultations, prescription and hospital services) was necessary to inform commissioning decisions [10].

We have since continued to collect service evaluations and the purpose of this paper is to report on the data contained within this larger collection of documents. Specifically, our aim is to identify the potential impact of primary care complementary therapy services on health outcomes and NHS costs, as reported in complementary therapy service evaluations. The target audiences for this paper are NHS commissioners, who may be considering provision of complementary therapy services, and current and future providers of NHS based complementary therapy services, who can build on the experiences of colleagues conducting earlier evaluations. Methods Search strategy

Because the majority of complementary therapy services are located within primary care, we limited our review to this sector. We collected published and unpublished evaluations from November 2003 to April 2008. A rigorous, comprehensive searching strategy was devised including:

Contacting colleagues at the Foundation for Integrated Health, mid-Devon Primary Care Research Group and the Universities of Bristol, Sheffield, Thames Valley and Westminster, who had conducted evaluations and/or were networked to identify others who had.

Telephoning professional complementary therapy organisations e.g. Society of Homeopaths, British Council of Acupuncture, General Chiropractic Council, General Osteopathic Council.

Identifying potential studies from bibliographies of reports previously collected.

Searching the database of registered users for the SF36 and MYMOP questionnaires.

Searching PubCAM, AMED (Allied and Complementary Medicine) and Google Scholar.

Hand searching the archives of several journals including Complementary Therapies in Medicine, Homeopathy and Acupuncture in Medicine.

Search terms were: audit, general practice, primary care, complementary, alternative, homeopathy, acupuncture, evaluation and service. A full list of all evaluations located is available on request. Inclusion and exclusion criteria

We included documents if the service was located within England or Wales, was delivered by NHS clinicians or professional therapists and was situated in a NHS primary care setting. An exception was the inclusion of the Lewisham service [11]. Although outpatient hospital based, this evaluation was included because it was one of only two which employed a randomised controlled trial methodology and was similar to other primary care based services. We excluded evaluations if:

they reported throughput alone (e.g. numbers of patient seen)

they described solely the setting up of the service

the service setting was private, a charity or outside England or Wales

the service was part of an acute hospital department e.g. physiotherapists using acupuncture for pain

Because of the lack of high quality evaluations, no studies were excluded on methodological grounds. Data extraction and analysis

We devised a proforma to identify the type of information contained in the reports including health outcome tools (e.g. SF36, SF12, MYMOP, Glasgow Homeopathic Hospital Outcome Score, etc.) and NHS cost data (i.e. hospital, GP consultation or prescription costs). We then selected evaluations which collected health status data, using SF36 or MYMOP. These outcome tools were chosen because they were the most commonly used standardised health status questionnaires and so comparison across different services was easier.

The SF36 is a questionnaire which asks the service user to assess their health status in eight domains, including physical functioning, role physical, social functioning, pain, vitality, mental health, role emotional and general health [12]. For example, for 'physical functioning' respondents are asked to score a number of statements about their specific abilities to climb stairs or walk a mile while for 'role physical', respondents score statements about the extent of their ability to perform physical tasks generally. Although there is considerable debate about interpretation of SF36 scores, it is generally held that an improvement of 10 points or more indicates a strong effect (see http://www.sf36.org webcite 'norm based scoring and interpretation').

MYMOP asks the service user to identify and then rate the first and second priority symptoms that "bother" them the most, an activity affected by those symptoms and overall wellbeing on a scale of 0 to 6 [13]. In some cases, a profile score, which amalgamates the scores from symptoms 1 and 2, wellbeing and activity, is calculated. An improvement of 1 point or more is considered clinically significant (see http://www.pms.ac.uk/mymop webcite).

In addition to selecting evaluations with SF36 and MYMOP health status data, we also selected evaluations with extractable NHS cost data obtained from medical records. Once all relevant documents were identified, we then extracted details including:

number of service users

data collection time points

baseline and follow up health status scores

baseline and follow up rates and costs of prescriptions, GP consultations and hospital consultations

confidence intervals

p values.

If confidence intervals were missing and it was possible, we calculated the confidence intervals ourselves.

We gathered the results from individual service evaluations into outcome specific tables (i.e. SF36, MYMOP, prescriptions and GP consultations) and compared results across the services. For costs relating to use of hospital services, the data could not be combined into one table and so the data from the two relevant complementary therapy services are presented separately. We considered synthesizing the data for each table, but decided against this as the therapies offered, service models and ways of collecting the data differed considerably between sites. Results

In total, we collected 49 documents for 40 services. Further details about the methodology and content of the reports have been published previously [9]. Of the documents collected, we found 21 documents for 14 services contained extractable data on NHS costs and/or health status. Details of the services and evaluation documents are summarised in Additional file 1.

Additional file 1. Supplementary table one. Evaluations of NHS based primary care complementary therapy services with standardised health outcome and NHS cost data

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This file can be viewed with: Microsoft Word ViewerOpen Data Health status – SF36

Of the 14 services meeting our criteria, six administered and reported SF36 data that could be extracted (Additional file 2) [11,14-17]. Confidence intervals were available for four of the six service evaluations. Across the evaluations, four of the eight SF36 domains consistently have confidence intervals which do not cross zero for the average difference between baseline and follow up scores (role physical, social functioning, pain and vitality). This suggests that the complementary therapy services in this review have had a positive effect on the scores for the health status domains for these samples of service users. The pain scores showed the largest change. The fewest changes across these four services appear to have been made in role emotional, mental health and general health.

Additional file 2. Supplementary table two. SF36 scores from six complementary therapy service evaluations without control groups

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Of those using the SF36, only the Lewisham service also administered this questionnaire to a waiting list control group. The Lewisham service provided homeopathy, acupuncture and osteopathy delivered by professional therapists for over 20 different conditions. The baseline SF36 was administered before the first treatment and follow up occurred at the last session or three months after baseline (whichever came first). One hundred and seventy nine people in the treatment group and 151 in the control group completed baseline and follow up SF36 questionnaires. Results suggest a moderate to strong improvement for seven of the eight SF36 areas; only physical functioning showed no change [11]. Health status – MYMOP

Of the 14 services included in the review, nine reported MYMOP data, but only seven provided extractable data (Additional file 3). In comparing the scores for the five services with confidence intervals, overall the first symptom identified by service users showed the greatest change followed by the second symptom. The average change in score was consistently greater than one, and in some cases it was closer to a two and half point difference. This suggests that these complementary therapy services had a substantial effect on health status scores, as measured by MYMOP, for these service users. Only the confidence intervals for the activity domain for the Sheffield service crossed zero (average difference 1.9, 95% CI -0.4 to 4.2), which suggests that the Sheffield complementary therapy service did not have a positive impact on the activity scores for this sample of service users. This may be understandable as service users were suffering from the menopause and symptoms do not tend to impact on activity levels.

Additional file 3. Supplementary table three. MYMOP scores for seven service evaluations without control groups

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This file can be viewed with: Microsoft Word ViewerOpen Data NHS costs

The quality and quantity of data on NHS costs was less robust or available than data for health status. Seven evaluations reported cost data extracted from GP medical records, one of which used randomised controlled trial methodology. Although all of the reports had methodological flaws, two were of especially poor quality (Newcastle [18] and St. Margaret's [19]). In these evaluations, a sub-sample of patients was identified (unclear as to how selected), relevant medical records were extracted and then the findings for the sub-samples were extrapolated across the entire service populations, resulting in guesstimates of potential savings. Nonetheless, as both of these evaluations justified further funding of these services by the NHS, and in the absence of better cost data, they are reported here.

A recurring methodological problem is that NHS cost data are less easily standardised than health status data. We found that the different evaluations used different ways to calculate costs. For example, prescription data was collected and analysed as average costs of prescriptions per month per patient, average number of prescriptions per month per patient, proportion of patients who reduced their number of prescriptions overall, total number of prescriptions and total cost savings of reduction in prescriptions by the entire sample. GP consultation data were more homogeneous in that all data were reported as consultation rates, but the time period varied between average consultation rates per patient per month, per six months or per year.

In looking at prescription costs, three out of six uncontrolled evaluations reported that service users reduced their prescriptions substantially by 57% (Coventry [20]), 45% (Glastonbury [21]) and 39% (Newcastle [18]). St. Margaret's reported potential savings of £8944. Results from the Impact evaluation suggested that there was no change in the number of prescriptions (change of 0.04, 95% CI -0.99 to 0.87) [16]. The prescription costs for service users of Get Well UK increased after using the service (average baseline cost per patient per month £3.24, 95% CI £1.80 to £4.80 and average follow up cost per patient per month £3.75, 95% CI £1.74 to £6.49) [22]. (Additional file 4)

Additional file 4. Supplementary table four. Changes in prescriptions identified in six service evaluations without control groups

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In looking at GP consultation rates, three of the six uncontrolled evaluations reported that their sample of service users consulted their GPs about a third less often (Glastonbury [21] Newcastle [18] and Coventry [20]), while the St. Margaret's evaluation [19] found that service users consulted their GPs over two thirds less often. The results for the Impact service evaluation found that there was almost no change (change of 0.14, 95% CI -0.97, 1.83) [22]. Data from Get Well UK indicated that GP consultation rates amongst their sample of service users increased from an average of 0.5 per patient per month (95% CI 0.4, 0.7) at baseline to an average of 0.8 (95% CI 0.6 to 1.1) at follow up. Moreover, the Get Well UK evaluation suggested an increase in GP consultation costs per patient per month with an average baseline cost of £11.27 (95% CI £8.60, £13.90) and an average follow up cost of £17.53 (95% CI £11.40, £24.00) [22]. To put consultation rate data into context, the average practice consultation rate per listed patient per month in England was 0.44 in 2006 [23]. (Additional file 5)

Additional file 5. Supplementary table five. Changes in GP consultation rates identified in service evaluations without control groups

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The Get Well UK and Glastonbury reports provided data on secondary care consultations. The Get Well UK evaluation found that the rates of secondary care referrals and diagnostic tests combined per month were reduced (average combined of 1.38 at baseline to average combined of 0.70 at follow up), as were their corresponding costs (mean £112.64 at baseline to mean £64.72 at follow up) [22]. The Glastonbury evaluation found that usage of physiotherapy, x-rays, blood and urine, tests and consultant referrals were all reduced for a sub-sample of 41 patients with a total saving of over £2500 [21].

Only the Randomised Osteopathic Manipulation Study (ROMANS) collected NHS cost data for a control group. This was a pragmatic randomised controlled trial to evaluate a medical osteopathy service [24]. Two hundred and one patients with neck and back pain were randomised into two groups: usual GP care or medical osteopathy from a single GP practitioner. Service users in the active group received three to four medical osteopathy consultations. Medical record data on healthcare utilisation for 101 people in the usual care group and 86 in the medical osteopathy group were collected. Data for over twenty different NHS healthcare activities were collected, including rates for prescriptions, GP consultations and secondary care activities such as consultant and physiotherapy consultations. When calculating costs for all conditions suffered by the osteopathy service users and non-users, there was no difference between the medical osteopathy group and the control group (average total costs £22, 95% CI -£159, £142). Costs related to spinal pain were higher in the group using medical osteopathy than those who did not (average cost difference of £65, 95% CI £32, £155). This might be partly explained by the inclusion of the costs of the medical osteopathy consultations themselves [25]. (Table 1)

Table 1. NHS healthcare utilisation rates for ROMANS medical osteopathy service users and non-users for six months (during and after) Discussion Summary of key points

Few services collected data on health status using standardised health outcome tools and even fewer collected data on NHS costs. Of those that did, the quality of the evaluations was variable.

In comparing research into the effectiveness of complementary therapy treatments and the impact of complementary therapy services on health outcomes, we found that service evaluations were largely positive. All service evaluations collecting data on health status (SF36 or MYMOP) without a control group showed a substantial improvement in scores. When data were also collected for a control group (Lewisham), health status scores continued to demonstrate positive changes. With regard to the SF36, across evaluations both with and without a control group, the greatest changes were consistently found in role physical, social functioning, pain and vitality. Although more studies are needed, this suggests that NHS complementary therapy services may have an impact on health outcomes.

Data from complementary therapy service evaluations on NHS costs were much scarcer and less robust. Uncontrolled service evaluations found increases, decreases and no change in prescriptions and GP consultations. Both uncontrolled evaluations found decreases in secondary care usage. The only controlled study investigating the impact of a complementary therapy service on NHS costs (ROMANS) found that the medical osteopathy service made no impact on healthcare utilisation costs for all conditions. Costs associated only with spinal pain, which included the costs of the medical osteopathy consultations, were increased. Strengths and limitations

A strength of this study is that this is the first comprehensive attempt to collect and review the growing number of evaluations of NHS complementary therapy services in primary care. However, because of the scarcity of good quality data, we can draw few conclusions about the impact of these services on health status and NHS costs.

One limitation of this study is that very few evaluations met our selection criteria of reporting standardised health status or NHS cost data. A second limitation is that amongst those who did, there were gaps in the reporting of the data collection processes and inconsistencies across the evaluations that made comparison difficult e.g. varying data collection time points, different health outcome tools, prescriptions calculated as rates, costs and total savings etc. A third limitation is that only two service evaluations collected data for control groups. Control groups are used to demonstrate that any changes that have occurred can be attributed to the intervention (in this case a complementary therapy service) and would not have occurred anyway. This is necessary to assure some (scientifically minded) clinicians and Primary Care Trust managers of the potential impact of complementary therapies on health outcomes and NHS costs [26]. Implications

Because NHS based complementary therapy services are often marginalised, face constant battles to secure funding [27] and have limited access to research expertise, those services that do carry out service evaluations deserve congratulations. Nonetheless, evaluations of NHS primary care complementary therapy services need greater rigour to provide better understanding of the impact these services can make on health outcomes and NHS costs. An earlier attempt to address this was the BESTCAM Delphi exercise which aimed to improve the content of complementary therapy service evaluations by identifying useful data collection items [28]. Our intention is to focus on improvements in the process of data collection and reporting.

The following figure illustrates a suggested scale of quality markers for evaluations of complementary therapy services. (Figure 1) At a basic level, those evaluating complementary therapy services could collect data on health outcomes with standardised outcome tools such as MYMOP and SF36, rather than designing their own questionnaires. Although there are many such tools available, we found that MYMOP and SF36 were most commonly used in complementary therapy service evaluations. In comparing SF36 to MYMOP, the SF36 allows for better identification of the domains where complementary therapy services may score the largest improvement, but MYMOP is more patient oriented. Both of these are available without charge on the Internet (see http://www.sf-36.org webcite and http://www.pms.ac.uk/mymop webcite).

thumbnailFigure 1. Quality markers for evaluations of NHS primary care complementary therapy services.

A further step in improving the quality of evaluations of NHS complementary therapy services would be the inclusion of confidence intervals around estimates. Confidence intervals provide valuable information on the range of values that might occur and give an indication of the strength of the impact of an intervention (in this case, a complementary therapy service). So, for example, for the first symptom for the CHIPs service [29] there was an average improvement of 1.9 for service users between baseline and follow up MYMOP scores on a six point scale. Using confidence intervals, we can say that we are 95% confident that the value of that difference within this population will fall somewhere between 1.5 and 2.3, which suggests a moderately strong impact. If a confidence interval crosses zero, this suggests that the service does not have an impact on improving the score for that domain. Although potentially daunting, confidence intervals are not difficult to calculate and instructions can be found in Additional file 6.

Additional file 6. How to calculate confidence intervals

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A further improvement in the quality of evaluations would be the collection of NHS cost data from GP medical records. This is a significant undertaking, as it requires obtaining permission to access medical records from GP surgeries (and possibly ethics approval see http://www.nres.npsa.nhs.uk webcite), an understanding of medical terminology and extensive time. Furthermore, there is great variety in the way NHS cost data are collected as, unlike health status data, there are not standardised tools. However, the evaluations in this review showed a trend towards the calculation of GP consultation rates as average rates per patient over six or twelve months. Further research is needed into the optimum way of collecting and calculating prescription and secondary care data.

Once NHS cost data are collected, a further rung on the quality marker scale would be to calculate confidence intervals for cost data in addition to health status data.

Each of the first four stages on the quality marker triangle would require increasing confidence with research language and skills, although all of them could conceivably be undertaken with little or no academic involvement. However, the final step on the quality marker scale, to collect standardised health status and NHS cost data with confidence intervals for treatment and control groups, i.e. complementary therapy service users and non-users, would require significant engagement with academic researchers, possibly from a registered clinical trial unit (see http://www.ukcrn.org.uk webcite). But such an endeavour would also necessitate substantial outside funding. This could help explain why so few randomised controlled trials of complementary therapy services have taken place. Moreover, even if conducting randomised controlled trials were less challenging, we do not know the extent to which randomised controlled trials actually influence clinicians and NHS commissioners' decisions around complementary therapy service provision [10]. Conclusion

In reviewing complementary therapy service evaluations, we found that uncontrolled health status data suggest that such services improve health outcome scores, but the data on the impact of these services on NHS costs are scarcer and inconclusive. Moreover, the overall quality of these evaluations was poor. To improve the quality of evaluations and increase understanding of the impact these services may have, we urge those evaluating complementary therapy services to use standardised health outcome tools, calculate confidence intervals and consider the collection of NHS cost data from GP medical records. Furthermore, discussion with the wider NHS healthcare community is needed on the optimum ways to standardise the collection and reporting of NHS cost data in evaluations of complementary therapy services. Competing interests

The authors declare that they have no competing interests. Authors' contributions

Funding for the study was obtained by AS and DS. The study was conceived by LW. The majority of the data were collected and analysed by LW, with assistance from AS and DS especially at the interpretative stages. LW drafted the manuscript and DS made substantive revisions. Acknowledgements

Thanks to Alan Montgomery for statistical advice and to Boo Armstrong and Clare Emmett for commenting on earlier drafts.

Funding for LW and AS was provided by the National Co-ordinating Centre for Research Capacity Development. References

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http://www.biomedcentral.com/1472-6882/9/5

GlaxoSmithKline Fined $488.8M for 'Massive Bribery Network'

Friday, September 19, 2014

China has fined the British pharmaceuticals giant GlaxoSmithKline (GSK) $488.8 million (3 billion Yuan) for a "massive bribery network" to get doctors and hospitals to use its products. Five former employees were sentenced to two to four years in jail, but ordered deported instead of imprisoned, according to state news agency Xinhua today.

The guilty verdict was delivered after a one day closed door trail in Changsha, the capital city of Hunan province. The fine was the biggest ever imposed by a Chinese court.

The court gave Mark Reilly, former head of GSK Chinese operations, a three-year prison sentence with a four-year reprieve, which meant he is set to be deported instead of serving his time in a Chinese jail. His co-defendants received two to four years prison sentences with reprieves.

Reilly was accused of operating a "massive bribery network" in May. The police said it is believed Reilly authorized his salespeople to pay doctors, hospital officials and health institutions to use GSK's products since 2009.

Chinese authorities first announced the investigation on GSK in July 2013. The police said the company had funneled up to 3 billion Yuan to travel agencies to facilitate bribes to doctors and officials. The money was the exact amount of the fine.

Throughout 2012 a stream of anonymous emails alleging bribery authorized by senior staff at GSK were sent to Chinese regulators, according to media reports. Atthe beginning of 2013, the anonymous emails began to arrive at GSK headquarter in London, along with a sex tape of Mark Reilly and his Chinese girlfriend, according to media reports.

The charges claim that GSK hired Shanghai-based investigator Peter Humphrey and his American wife, Yu Yingzeng, to locate the whistleblower. The Humphreys were detained and charged with illegally obtaining phone logs, travel records and other data which then they put in a report to GSK.

GSK released a statement of apologies to the Chinese government and people on its website.

"GSK Plc has reflected deeply and learned from its mistakes, has taken steps to comprehensively rectify the issues identified at the operations of GSKCI, and must work hard to regain the trust of the Chinese people," the statement said.

The statement also said future commitments include investment in Chinese science, improved access of its products in both city and rural areas across the country through greater expansion of production and flexible pricing.

Taking bribery from drug companies and over prescribing medicine to patients is a common hidden rule among doctors in China. It is not uncommon for patients give doctors red envelopes with cash as a blunt plea for them to do a good job on surgeries.

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