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Homeopathy 2018; 107(04): 229-243
Systematic Review and Meta-Analysis of Randomised, Other-than-Placebo Controlled, Trials of Individualised Homeopathic Treatment
Robert T. Mathie (2), Susanne Ulbrich-Zürni (2), Petter Viksveen (3), E. Rachel Roberts (1), Elizabeth S. Baitson (1), Lynn A. Legg (4), Jonathan R. T. Davidson (5)
1. Homeopathy Research Institute, London, United Kingdom
2. Department of Research, Swiss Homeopathy Association, Zürich, Switzerland
3. Faculty of Health Sciences, University of Stavanger, Stavanger, Norway
4. Department of Biomedical Engineering, University of Strathclyde, Glasgow, United Kingdom
5. Department of Psychiatry and Behavioral Science, Duke University Medical Center, Durham, North Carolina, United States
Abstract
Background: This study focuses on randomised controlled trials (RCTs) of individualised homeopathic treatment (IHT) in which the control (comparator) group was other than placebo (OTP).
Aims: To determine the comparative effectiveness of IHT on health-related outcomes in adults and children for any clinical condition that has been the subject of at least one OTP-controlled trial. For each study, to assess the risk of bias and to determine whether its study attitude was predominantly ‘pragmatic’ or ‘explanatory’.
Methods: Systematic review. For each eligible trial, published in the peer-reviewed literature up to the end of 2015, we assessed its risk of bias (internal validity) using the seven-domain Cochrane tool, and its relative pragmatic or explanatory attitude (external validity) using the 10-domain PRECIS tool. We grouped RCTs by whether they examined IHT as an alternative treatment (study design Ia), adjunctively with another intervention (design Ib), or compared with a no-intervention group (design II). For each RCT, we identified a ‘main outcome measure’ to use in meta-analysis: ‘relative effect size’ was reported as odds ratio (OR; values >1 favouring homeopathy) or standardised mean difference (SMD; values<0 favouring homeopathy).
Results: Eleven RCTs, representing 11 different medical conditions, were eligible for study. Five of the RCTs (four of which in design Ib) were judged to have pragmatic study attitude, two were explanatory, and four were equally pragmatic and explanatory. Ten trials were rated ‘high risk of bias’ overall: one of these, a pragmatic study with design Ib, had high risk of bias solely regarding participant blinding (a bias that is intrinsic to such trials); the other trial was rated ‘uncertain risk of bias’ overall. Eight trials had data that were extractable for analysis: for four heterogeneous trials with design Ia, the pooled OR was statistically non-significant; collectively for three clinically heterogeneous trials with design Ib, there was a statistically significant SMD favouring adjunctive IHT; in the remaining trial of design 1a, IHT was non-inferior to fluoxetine in the treatment of depression.
Conclusions: Due to the low quality, the small number and the heterogeneity of studies, the current data preclude a decisive conclusion about the comparative effectiveness of IHT. Generalisability of findings is limited by the variable external validity identified overall; the most pragmatic study attitude was associated with RCTs of adjunctive IHT. Future OTP-controlled trials in homeopathy should aim, as far as possible, to promote both internal validity and external validity.
Free full text:
https://www.thieme-connect.com/products/ejournals/html/10.1055/s-0038-1667129
Excerpts:
"There are several distinct forms of homeopathy, the main types being ‘individualised’ (or ‘classical’) homeopathy, ‘clinical’ homeopathy, ‘complex’ homeopathy and isopathy. In individualised homeopathy—as originally defined by its founder, Samuel Hahnemann—typically a single homeopathic medicine is selected on the basis of the ‘symptom picture’ of a patient, including his/her mental, general and constitutional type. In clinical homeopathy, one or more homeopathic medicines are administered for standard clinical situations or conventional diagnoses. In complex homeopathy, several homeopathic medicines are combined in a fixed (‘complex’) formulation. Isopathy is the use of homeopathic medicines prepared from the causative agent of the disease itself, or from a product of the disease process, to treat the condition.[1]
"Our previous reviews focused on individualised or non-individualised homeopathy in the context of placebo-controlled randomised controlled trials (RCTs).[2] [3] The current study focuses again on the ‘whole-person’ therapeutic approach of individualised homeopathic treatment (IHT): individualised consultation together with the consequently prescribed homeopathic medicine/s (and sometimes including dietary and/or lifestyle recommendations). The context here is an RCT in which the control (comparator) group is something other than placebo (OTP), and which can be regarded as a ‘comparative effectiveness’ study. Whereas for placebo-controlled trials of IHT, we investigated whether individually prescribed homeopathic medicines can have effects above those of placebos,[2] our study of OTP-controlled trials aims to ascertain the comparative effectiveness of IHT as a whole entity: that is, the package of homeopathic care that includes the prescribed medicines.
"Two essentially different comparator options exist for OTP study design of RCTs: (I) other therapeutic intervention (e.g. a conventional medicine or a physical therapy), which can be sub-divided into (a) trials in which IHT is given as an alternative to the comparator intervention, and (b) trials in which IHT combined with the other intervention is compared with the other intervention alone (the ‘[A+B] versus B’ approach); (II) no therapeutic intervention (usually waiting-list controls).
"Some systematic reviews (SRs) of homeopathy have focused on specific clinical conditions, typically examining placebo-controlled trials, with conclusions about efficacy of homeopathic medicines that are variously positive,[4] [5] [6] negative[7] [8] [9] or non-conclusive.[10] [11] [12] Other SRs have adopted a ‘global’ or ‘comprehensive’ approach, examining the RCT research literature on homeopathy in general, including the broad spectrum of clinical conditions that have been researched, and by all forms of homeopathy. Most of these comprehensive SRs reached the cautious conclusion that, overall, the effect of a homeopathic medicine differs from that of placebo.[2] [13] [14] [15] [16] [17] One comprehensive SR concluded that there was ‘weak evidence for a specific effect of homoeopathic remedies…compatible with the notion that the clinical effects of homoeopathy are placebo effects’.[18]"
"Only one general SR has considered solely RCTs of IHT that were controlled by an OTP intervention.[19]"
[Discussion]
"None of the 11 studies was judged to comprise reliable evidence (i.e. there were no A- or B1*-rated trials), 10 being assessed as high risk of bias. Three of the 11 articles failed to yield data suitable for meta-analysis..."
"The low intrinsic quality and number of studies preclude any clear conclusions about comparative effectiveness of IHT."
"The homeopathy community expresses reasonable concern about the sensitivity of the placebo-controlled trial design to detect a treatment effect of its medicines.[37] Indeed, the wider Complementary/Alternative Medicine (CAM) community also recognises that research on a ‘whole system of care’, such as IHT, should avoid focus solely on ‘active ingredients’ (i.e. the efficacy of the medicine).[38]"
"Unless the ‘double-dummy’ approach is adopted, OTP-controlled trials have expected high risk of bias regarding blinding of participants. In fact, our SR has highlighted that low risk of bias in OTP research may be feasible only in double-dummy trials (A138, Adler; A148, van Erp)..."
"Some observers might argue, nevertheless, that the Cochrane-type system for rating internal validity is inappropriate for more pragmatically orientated trials of ‘whole-system’ interventional approaches such as homeopathy."
"It should also be noted that ‘[A+B] versus B’ trial design in individualised CAM therapy has been criticised as being prone to ‘false positive’ results due to ‘non-specific effects’ of the intervention.[39]"
[Conclusions]
"Due to the low quality, the small number and the extreme heterogeneity of studies, no decisive conclusion is currently possible regarding comparative effectiveness of IHT on health-related outcomes, assessed within the context of OTP-controlled trials. Generalisability of findings is limited by the variable extent of external validity observed overall. To date, the highest quality and the most pragmatic study attitude for RCTs of IHT is associated with the ‘[A+B] versus A’ approach."
Comment: the ‘[A+B] versus A’ approach has often been criticized by Edzard Ernst as one almost guaranteed to give positive results.