Research in Homeopathy, Issues and controversies

4. Issues and controversies

Research reviews

Clinical trials

Clinical trials

The fibromyalgia and chronic fatigue syndrome trials are important examples of well-designed placebo-controlled trials of individualised homeopathy; they have reported positive clinical findings in a sensible way. The asthma and Arnica in hand surgery trials are recent instances where negative conclusions have been inappropriately drawn from studies of inferior research design.

Fibromyalgia ¹⁵
This study was a double-blind, randomised, placebo-controlled trial of homeopathy. Physician-confirmed fibromyalgia patients (N=53; mean age 49 years; 94% women) were treated in a homeopathic private practice setting. Participants were randomized to receive oral daily liquid LM (1/50,000 dilution factor) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo. Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths at baseline, 2 months and 4 months.

The work replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy. This latest study has demonstrated that individualized homeopathy is significantly better than placebo in improving the quality of life and global health of persons with fibromyalgia. And a significantly higher proportion of patients in the homeopathy group experienced at least a 25% improvement in tender-point pain on examination (13/26; 50%) compared with those on placebo (4/27; 15%). (This study is given in the list of medical conditions listed in Table 2.)

Chronic fatigue syndrome ³²
This trial aimed to evaluate homeopathic treatment in reducing subjective symptoms of chronic fatigue syndrome (CFS). Using a triple-blind design (patient and homeopath blind to group assignment, and data analyst blind to group until after initial analyses), the authors randomly assigned patients to homeopathic medicine or indistinguishable placebo. 86 patients had complete data from monthly consultations with a professional homeopath over a period of 6 months; 43 of these patients received placebo. Main outcome measures were scores on sub-scales of the Multidimensional Fatigue Inventory (MFI). 47% of patients in the homeopathy group showed clinically significant improvement on the MFI general fatigue sub-scale, compared with just 28% in the placebo group. Eleven patients (26%) in the homeopathy group showed clinical improvements on all subscales of the MFI compared to 4 (9%) of the placebo group (P=0.09). The study has therefore shown some clinically important effects in a cohort of patients with a condition that is very difficult to treat with any method of therapy. (This study is given in the list of medical conditions listed in Table 2.)

Asthma ⁶⁴
A randomised, double-blind, placebo-controlled trial design was used to study of the effects of adjunctive, individualised, homeopathy compared with placebo in 96 children with mild to moderate asthma. The main outcome measure was an asthma-specific Quality of Living (QoL) scale, administered at baseline and follow-up at 12 months. Other outcomes included severity, distress, peak flow rates, use of medication, symptom scores, days off school, asthma events, and global assessment of change. The authors observed a number of changes that fell below the level of clinical or statistical significance, and concluded that homeopathic remedies did not differ from placebo in this group of asthmatic children.

Regrettably, however, the QoL measure was inappropriate, and a conclusion of this kind is not justified. The children enrolled had QoL scores virtually identical to those of non-asthmatic children in a large-scale validation study. Furthermore, the QoL scale does not discriminate between non-asthmatic and mildly asthmatic children. No improvement at all could have been expected! Other measures analysed as secondary outcomes consistently favoured homeopathy: for the severity sub-scales the improvement was statistically highly significant (P=0.01), with 95% confidence intervals not including zero. The authors did not adequately discuss such findings. Quite clearly, further investigation (and improved reporting) is warranted.

Arnica in hand surgery ⁶⁵
This double-blind, placebo-controlled, randomised trial had three parallel arms: adults undergoing elective surgery for carpal tunnel syndrome were randomised to take three tablets daily of homeopathic Arnica 30C or 6C or placebo for 7 days before surgery and 14 days after surgery. It was designed as a preliminary investigation. 62 patients were included in the analysis. Primary outcome measures were pain (McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). The authors reported no inter-group differences in pain (P=0.79) or bruising (P=0.45) at day four; swelling and use of analgesic medication also were reported not to differ between placebo and Arnica groups. Their published conclusion was that homeopathic Arnica has no advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery. The authors attributed the widely-known benefits of Arnica for bruising to be merely a myth reinforced by biased anecdote.

Inspection of the data reveals important discrepancies from these conclusions. The placebo group actually required 45% more post-operative analgesia than one of the homeopathy groups (Arnica 6c). If confirmed, this result is certainly clinically relevant. The Arnica 6c group also had lower pain scores. Of course, these two variables are inversely related (i.e. for the same underlying pain level, patients taking more analgesia will report lower pain scores than those taking less). Therefore, analysing these variables separately underestimates the effect size - in this case, the pain-reducing effect of Arnica 6c. The paper fails to comment on this point.

This trial was intended as a preliminary investigation; in such a study, 'absence of proof' should not be misinterpreted as 'proof of absence'. The authors 'moved the goal posts' by analysing it as a definitive trial, and drawing conclusions that it was not capable of delivering. Viewed as a feasibility study, it suggests that Arnica 6c may be associated with useful benefits in terms of post-operative pain. It could inform a larger study, including sample size calculation, outcome measures and their timing. Such a study should ensure patient eligibility is limited to those for whom Arnica is actually the correct simillimum.

	4. Issues and controversies
Photograph Details	Research reviews Professor Iris Bell Dr Wayne Jonas University of York Clinical trials Fibromyalgia Chronic fatigue syndrome Asthma Arnica in hand surgery Clinical trials The fibromyalgia and chronic fatigue syndrome trials are important examples of well-designed placebo-controlled trials of individualised homeopathy; they have reported positive clinical findings in a sensible way. The asthma and Arnica in hand surgery trials are recent instances where negative conclusions have been inappropriately drawn from studies of inferior research design. Fibromyalgia ¹⁵ This study was a double-blind, randomised, placebo-controlled trial of homeopathy. Physician-confirmed fibromyalgia patients (N=53; mean age 49 years; 94% women) were treated in a homeopathic private practice setting. Participants were randomized to receive oral daily liquid LM (1/50,000 dilution factor) potencies with an individually chosen homeopathic remedy or an indistinguishable placebo. Homeopathic visits involved joint interviews and concurrence on remedy selection by two experienced homeopaths at baseline, 2 months and 4 months. The work replicates and extends a previous 1-month placebo-controlled crossover study in fibromyalgia that pre-screened for only one homeopathic remedy. This latest study has demonstrated that individualized homeopathy is significantly better than placebo in improving the quality of life and global health of persons with fibromyalgia. And a significantly higher proportion of patients in the homeopathy group experienced at least a 25% improvement in tender-point pain on examination (13/26; 50%) compared with those on placebo (4/27; 15%). (This study is given in the list of medical conditions listed in Table 2.)	Table of contents Homeopathy: the great debate Clinical research in homeopathy Veterinary homeopathy Issues and controversies Mechanism of action Is homeopathy safe? Is homeopathy cost effective? BHA/Faculty’s research strategy References Research discussion forum C O N T A C T U S S I T E M A P H O M E
	Chronic fatigue syndrome ³² This trial aimed to evaluate homeopathic treatment in reducing subjective symptoms of chronic fatigue syndrome (CFS). Using a triple-blind design (patient and homeopath blind to group assignment, and data analyst blind to group until after initial analyses), the authors randomly assigned patients to homeopathic medicine or indistinguishable placebo. 86 patients had complete data from monthly consultations with a professional homeopath over a period of 6 months; 43 of these patients received placebo. Main outcome measures were scores on sub-scales of the Multidimensional Fatigue Inventory (MFI). 47% of patients in the homeopathy group showed clinically significant improvement on the MFI general fatigue sub-scale, compared with just 28% in the placebo group. Eleven patients (26%) in the homeopathy group showed clinical improvements on all subscales of the MFI compared to 4 (9%) of the placebo group (P=0.09). The study has therefore shown some clinically important effects in a cohort of patients with a condition that is very difficult to treat with any method of therapy. (This study is given in the list of medical conditions listed in Table 2.) Asthma ⁶⁴ A randomised, double-blind, placebo-controlled trial design was used to study of the effects of adjunctive, individualised, homeopathy compared with placebo in 96 children with mild to moderate asthma. The main outcome measure was an asthma-specific Quality of Living (QoL) scale, administered at baseline and follow-up at 12 months. Other outcomes included severity, distress, peak flow rates, use of medication, symptom scores, days off school, asthma events, and global assessment of change. The authors observed a number of changes that fell below the level of clinical or statistical significance, and concluded that homeopathic remedies did not differ from placebo in this group of asthmatic children. Regrettably, however, the QoL measure was inappropriate, and a conclusion of this kind is not justified. The children enrolled had QoL scores virtually identical to those of non-asthmatic children in a large-scale validation study. Furthermore, the QoL scale does not discriminate between non-asthmatic and mildly asthmatic children. No improvement at all could have been expected! Other measures analysed as secondary outcomes consistently favoured homeopathy: for the severity sub-scales the improvement was statistically highly significant (P=0.01), with 95% confidence intervals not including zero. The authors did not adequately discuss such findings. Quite clearly, further investigation (and improved reporting) is warranted. Arnica in hand surgery ⁶⁵ This double-blind, placebo-controlled, randomised trial had three parallel arms: adults undergoing elective surgery for carpal tunnel syndrome were randomised to take three tablets daily of homeopathic Arnica 30C or 6C or placebo for 7 days before surgery and 14 days after surgery. It was designed as a preliminary investigation. 62 patients were included in the analysis. Primary outcome measures were pain (McGill Pain Questionnaire) and bruising (colour separation analysis) at four days after surgery. Secondary outcome measures were swelling (wrist circumference) and use of analgesic medication (patient diary). The authors reported no inter-group differences in pain (P=0.79) or bruising (P=0.45) at day four; swelling and use of analgesic medication also were reported not to differ between placebo and Arnica groups. Their published conclusion was that homeopathic Arnica has no advantage over placebo in reducing postoperative pain, bruising and swelling in patients undergoing elective hand surgery. The authors attributed the widely-known benefits of Arnica for bruising to be merely a myth reinforced by biased anecdote. Inspection of the data reveals important discrepancies from these conclusions. The placebo group actually required 45% more post-operative analgesia than one of the homeopathy groups (Arnica 6c). If confirmed, this result is certainly clinically relevant. The Arnica 6c group also had lower pain scores. Of course, these two variables are inversely related (i.e. for the same underlying pain level, patients taking more analgesia will report lower pain scores than those taking less). Therefore, analysing these variables separately underestimates the effect size - in this case, the pain-reducing effect of Arnica 6c. The paper fails to comment on this point. This trial was intended as a preliminary investigation; in such a study, 'absence of proof' should not be misinterpreted as 'proof of absence'. The authors 'moved the goal posts' by analysing it as a definitive trial, and drawing conclusions that it was not capable of delivering. Viewed as a feasibility study, it suggests that Arnica 6c may be associated with useful benefits in terms of post-operative pain. It could inform a larger study, including sample size calculation, outcome measures and their timing. Such a study should ensure patient eligibility is limited to those for whom Arnica is actually the correct simillimum.
	Home \| Faculty of Homeopathy \| British Homeopathic Association \| Research in homeopathy © 2000 - 2007 British Homeopathic Association. Site developed by Chord9 Ltd.