Homeopatia na świecie
i w Polsce

"W 2009 roku w Szwajcarii odbyło się referendum, które zaowocowało włączeniem homeopatii do obowiązkowego systemu ubezpieczeń medycznych. I jest to zapisane w Konstytucji."

Homeopatia w szpitalach

"Wyniki badań prowadzonych przez profesora Michalea Frassa wykazały, że leczenie Homeopatyczne ma wpływ na odległy wynik leczenia pacjentów leczonych z powodu sepsy na oddziale intensywnej opieki medycznej."

Research in homeopathy - dr Peter Fisher

Dr Peter Fisher
Clinical Director
Royal London Homoeopathic Hospital
Great Ormond Street
London WC1N 3HR

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www.uclh.nhs.uk/rlhh

 

Summary

All four comprehensive reviews of randomised controlled trials (RCTs) of homeopathy have concluded that, overall, homeopathy probably differs from placebo. Systematic reviews of RCTs with a specific focus on particular medical areas have been positive for homeopathy in 10 cases, non-conclusive in 8, and negative in 5. The paper by Shang et al, published in the Lancet in 2005 included a meta-analysis, but was not a systematic review.

134 RCTs had been published in the peer-reviewed literature by the end of 2007. In terms of statistically significant findings, positive effects of homeopathy have been reported in 59 trials (44% of the total) and negative findings in 8 (6%), while 67 (50%) were not conclusive either way.

The clinical evidence favours homeopathy being effective in childhood diarrhoea, treatment of influenza, osteoarthritis and other rheumatic diseases, post-operative ileus and seasonal allergic rhinitis.

Controlled but unrandomised, cost-effectiveness and observational studies universally show that most patients report significant clinical improvement from homeopathic treatment, and suggest that integrating homeopathy into medical practice, especially at the primary care level, results in better outcomes for similar cost. Many patients use it because of adverse reactions to other treatments; systematic reviews have shown more adverse effects in active than placebo groups in RCTs, but adverse effects are mild and transient.

                       

Homeopathy is implausible principally because of its use of high dilutions, including ‘ultramolecular’ dilutions. There is evidence from physical science of specific structural modifications in water, induced by the homeopathic preparation process, which might be capable of storing information.

Introduction

Research is a method for answering questions, and the question depends on who is asking it. Non-homeopathic doctors may ask whether it has specific effects, sceptical scientists question how such effects could be mediated. Third party payers want to know if it is cost-effective. Homeopathic practitioners want to optimise their clinical results or conduct homeopathic pathogenetic trials (provings). Most importantly, patients want to know if homeopathic treatment is likely to benefit them, whether it is safe and how it compares to other treatments.

 

 

Systematic reviews and meta-analyses of clinical trials of homeopathy

Systematic reviews and meta-analyses of randomised controlled trials (RCTs) are considered the strongest form of research evidence. A number of comprehensive and condition- or treatment-specific systematic reviews of homeopathy have been published.

Comprehensive systematic reviews

Most comprehensive systematic reviews and meta-analyses conclude that homeopathy differs from placebo. A meta-analysis published in The Lancet (Linde et al., 1997)[i] included 186 placebo-controlled studies of homeopathy, from which data for analysis could be extracted from 89. The overall mean odds ratio for these 89 clinical trials was 2.45 (95% confidence interval, 2.05–2.93) in favour of homeopathy. This means that the chances that homeopathy would be of benefit were approximately 2 to 3 times greater than placebo. The main conclusion was that the results “were not compatible with the hypothesis that the effects of homoeopathy are completely due to placebo”.

Homeopathic Medicine Research Group, a joint group of researchers in conventional medicine and homeopathy, appointed by the Directorate General XII of the European Commission, produced an overview of clinical research in homeopathy and identified 184 clinical trials.[ii] They meta-analysed the highest quality placebo-controlled RCTs, including a total of 2,001 patients, and found strong evidence that homeopathy was more effective than placebo (P < 0.001), but concluded that “the strength of this evidence is low because of the low methodological quality of the trials”.

In August 2005, Shang et al. published a review comparing 110 placebo-controlled trials of homeopathy and 110 trials of conventional medicine.[iii] Homeopathy and conventional medicine showed a similar positive treatment effect overall. Twenty-one homeopathy trials and 9 in conventional medicine were judged “of higher quality”. From these, the results of 14 unspecified “large trials of higher quality” (8 homeopathy, 6 conventional medicine) were analysed. The authors concluded that there was “weak evidence for a specific effect of homoeopathic remedies, but strong evidence for specific effects of conventional interventions. This finding is compatible with the notion that the clinical effects of homoeopathy are placebo effects.”

But this review gave absolutely no indication of which trials its conclusions were based (no literature citations, no information on diagnoses or number of patients). It was criticised for lack of transparency, absence of sensitivity analysis (for instance not reporting the result of the analysis of the 21 trials of higher quality), and failure to adhere to the QUOROM guidelines for reporting of systematic reviews. The UK Database of Abstracts of Reviews of Effects (DARE), does not class this paper as systematic review.[iv]

Systematic reviews of randomised clinical trials in specific clinical situations

The following systematic reviews focused on particular clinical situations or homeopathic medicines have been published:

Ten of these 23 reviews yielded conclusions that were positive for homeopathy:

  • Allergies and upper respiratory tract infections [v]
  • Childhood diarrhoea [vi]
  • Influenza [vii]
  • Post-operative ileus [viii]
  • Rheumatic diseases [ix]
  • Seasonal allergic rhinitis (hay fever) [x], [xi], [xii]
  • Upper respiratory tract diseases, including otitis media [xiii]
  • Vertigo.[xiv]

Eight reviews were non-conclusive (generally due to lack of high-quality evidence):

The other 5 reviews have concluded there was little or no evidence for homeopathy:

  • Ailments of childhood and adolescence [ix]
  • Attention deficit hyperactivity disorder [x]
  • Cancer [xi]
  • Delayed-onset muscle soreness [xii]
  • Headache and migraine prevention.[xiii]

Arnica has been the subject of three systematic reviews. Two found insufficient evidence overall to support the efficy of this medicine, [xiv], [xv] but a meta-analysis of three trials of Arnica in knee surgery concluded that it is effective compared to placebo.[xvi]

Randomised clinical trials of homeopathy – the original research literature

A review of clinical trials in homeopathy reported from 1975 to 2002 found 93 studies comparing homeopathy with placebo or other treatment.[xvii] Positive effects of homeopathy were found in 50. The evidence favoured a positive treatment effect of homeopathy in: allergic rhinitis, childhood diarrhoea, fibromyalgia, influenza, pain, side effects of radio-/chemotherapy, sprains, and upper respiratory tract infection. Reviewing 12 systematic reviews of homeopathy for specific medical conditions, Jonas et al. (2003) reached similar conclusions: homeopathy may be effective for allergies, childhood diarrhoea, influenza and postoperative ileus, but not for treatment of migraine, delayed-onset muscle soreness or prevention of influenza.[xviii]

Single RCTs of homeopathy have been conducted in clinical areas including asthma,[xix] life-threatening sepsis,[xx] and stomatitis induced by cancer chemotherapy,[xxi] fibromyalgia,[xxii], [xxiii] chronic fatigue syndrome,[xxiv] premenstrual syndrome,[xxv] post-partum bleeding,[xxvi] and Arnica for various clinical conditions.[xxvii], [xxviii] Most of these have yielded positive results.

In some clinical situations, both RCTs and clinical observational studies have been conducted, providing a fuller picture of the possible role of homeopathy. Such areas include upper respiratory tract and ear infections in children,[xxix], [xxx], [xxxi] attention deficit hyperactivity disorder (ADHD),[xxxii], [xxxiii] and homeopathy for symptoms related to cancer treatment.[xxxiv], [xxxv], [xxxvi]

 

Cost effectiveness of homeopathy

Cost effectiveness studies in the public and insured primary care sectors in France and Germany suggest that integration of homeopathy is associated with better outcomes for equivalent costs. These studies were of ‘quasi-experimental’ design (i.e. different treatments were compared, but patients were not assigned randomly to the different treatments).

Witt and colleagues compared homeopathic and conventional GPs’ outcomes in chronic diagnoses commonly treated in general practice (adults – headache, low back pain, depression, insomnia, sinusitis; children – atopic asthma, dermatitis, rhinitis).[xxxvii],[xxxviii] 493 patients were treated by 101 homeopathic and 59 conventional GPs. The patients treated by the two groups of GPs were generally similar. The conclusion was that patients who sought homeopathic treatment had better outcomes for similar cost. Some of the same authors conducted a 12 month cohort study comparing homeopathic and conventional treatment of eczema in children. The two groups had similar improvements in perception of eczema symptoms (assessed by patients or parents) and disease-related quality of life.[xxxix]

Trichard et al. compared two treatment approaches (‘homeopathic strategy’ vs. ‘antibiotic strategy’) used in routine medical practice by allopathic and homeopathic GPs in the management of recurrent acute rhino-pharyngitis in 499 children aged between 18 months and 4 years.[xl] The GPs using homeopathy had significantly better results in terms of clinical effectiveness, complications, parents' quality of life and time lost from work, for lower cost to social security.

Clinical observational studies

The clinical areas in which research on homeopathy has been done do not match well with those for which it is used in practice. Reasons for this include model simplicity (for instance isopathic treatment of allergies has been relatively extensively investigated because it is a simple model), expediency and commercial motives. In practice homeopathy is frequently used for clinical problems, for instance dermatological or gastrointestinal conditions where there is little or no RCT evidence. But observational studies look at what happens to patients who receive homeopathic treatment. A comprehensive observational study at the Bristol Homoeopathic Hospital included over 6,500 consecutive patients with over 23,000 attendances in a 6-year period.[xli] At follow-up, 70% of patients reported improved health, 50% major improvement. The best treatment responses were reported in childhood eczema or asthma, and in inflammatory bowel disease, irritable bowel syndrome, menopausal problems and migraine.

A 500-patient survey at the Royal London Homoeopathic Hospital showed that many patients were able to reduce or stop conventional medication following homeopathic treatment.[xlii] The size of the effect varied between diagnoses: for skin complaints, for example, 72% of patients reported being able to stop or reduce their conventional medication; there was no reduction for cancer patients. In both these surveys, many of the patients were suffering from difficult-to-treat ‘effectiveness gap’ conditions.[xliii]

Some observational studies have also addressed costs issues. For example, Frenkel & Hermoni reported that homeopathic intervention led to modest economic savings and modest reductions in the use of medications commonly used to treat allergic conditions and their complications.[xliv] One homeopathic GP practice in London recorded costs of homeopathic medicines and calculated the costs of conventional drugs that would otherwise have been prescribed for 100 patients.[xlv] Average cost savings were £60 per patient. The majority of patients’ health improved and most did not report any side effects.

 

Safety

The available evidence suggests that patients' confidence in the safety of homeopathy is justified: the hazards from homeopathic products are modest in comparison with those of conventional medicine.[xlvi] A systematic review of the safety of homeopathy, including a search of the English-language literature between 1970 and 1995, came to the following conclusions: homeopathic medicines may provoke adverse effects, but these are generally mild and transient; adverse effects of homeopathy are under-reported; there are cases of 'mistaken identity' where herbal medicines were described as homeopathic.[xlvii] The main risks associated with homeopathy are indirect, relating to the prescriber rather than the medicine.[xlviii] In two studies, adverse reactions were observed in approximately 2.7% of the patients;[xlix], [l] in a third study, 7.8% of homeopathy patients had adverse reactions, compared to 22.3% in the corresponding group receiving conventional treatment.[li]

Basic Science

Although the basic idea of homeopathy is similarity, its most controversial claim concerns the properties of ultra-molecular dilutions. Avogadro’s Constant, the number of particles (atoms or molecules) in a gram mole of a substance, is of the order of 1023. In homeopathic terminology, 1023 corresponds to a 23X or 12C dilution. Homeopathic preparations in dilution less than those contain material traces of the original substance; those in high (ultra-molecular) dilution are unlikely to do so. Because of the lack of a plausible mechanism of action of ultramolecular dilutions, many scientists have a low Bayesian ‘prior’ for homeopathy.

For this reason, basic science research is important. The most widespread hypothesis to explain the mechanism of action of homeopathic dilutions refers to ‘memory of water’ effects: ‘Under appropriate circumstances, water retains information about substances with which it has previously been in contact and may then transmit that information to pre-sensitised biosystems’. Standard physico-chemical techniques,[lii],[liii] thermoluminescence,[liv],[lv] Raman and UV–VIS spectroscopy[lvi],[lvii] and other methods[lviii] have shown that water displays large changes in its physico-chemical properties as a function of its history. It remains to be proven whether such changes have the features to account for effects of homeopathic medicines in-vivo. [lix]

The largest body of research on biological models in homeopathy is based on experimental intoxication. A critical review and meta-analysis focused on 135 experiments published in 105 articles exploring the protective effect of homeopathic dilutions against toxins.[lx] The studies were extremely diverse and included many different experimental models: more than 70% of the high quality studies reported positive effects. A more recent meta-analysis evaluated 67 in-vitro biological experiments in 75 research publications and found high-potency effects were reported in nearly 75% of all replicated studies; however, no positive result was stable enough to be reproduced by all investigators.[lxi]

One example of a series of in-vitro experiments in homeopathy is the model of the allergic response to antibody using the human basophil degranulation test. The earliest study contentiously reported inhibition of degranulation with ultra-molecular dilutions of anti-IgE.[lxii] These initial experiments did not prove to be reproducible.[lxiii], [lxiv] Subsequent studies using a modified method, and using ultra-molecular dilutions of histamine, have shown positive results. These findings have been reproduced in several independent laboratories,[lxv],[lxvi],[lxvii] as well as in a multi-centre series of experiments.[lxviii]

 

Conclusions

Given its wide use, homeopathy is very under-researched, despite this a notable number of positive findings have been reported. Systematic reviews of RCTs of homeopathy in the following conditions are broadly positive: childhood diarrhoea, influenza (treatment), osteoarthritis, post-operative ileus, seasonal allergic rhinitis, rheumatic diseases. There is replicated RCT evidence that homeopathy may be effective in childhood diarrhoea, fibromyalgia, influenza, migraine, osteoarthritis, otitis media, vertigo and seasonal allergic rhinitis.

 

There is also evidence from individual RCTs that homeopathy may be effective in chronic fatigue syndrome premenstrual syndrome), post-partum bleeding, sepsis, stomatitis, symptoms related to cancer treatment, and ADHD.

Controlled but unrandomised, cost-effectiveness and observational studies show universally positive results, often in difficult-to-treat ‘effectiveness gap’ conditions[i].

The main barrier to scientific acceptance of homeopathy is its use of very high ‘ultra-molecular’ dilutions. The leading hypothesis to explain the effects of such dilutions centres on the storage of information by aqueous solutions: there is some evidence from physical science of specific structural modifications in water, induced by the homeopathic preparation process, which might be capable of storing information.

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