Number-needed-to-treat and placebo-controlled trials.
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Biomedical subjects
Publications and source records attributed to A J Vickers.
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OBJECTIVE: To determine whether homeopathic Arnica 30X can reduce muscle soreness following long-distance running more than a placebo. DESIGN: Randomized, double-blind placebo-controlled trial. SETTING: Long-distance runs taking place in the community. SUBJECTS: A total of 519 runners anticipating delayed-onset muscles soreness after long-distance races. INTERVENTIONS: A homeopathic medicine (Arnica 30x) and an indistinguishable placebo. OUTCOME MEASURES: Subjects completed a visual analog scale and Likert scale of muscle soreness every morning and evening for the 5 days following their race. Race time was also recorded. The main outcome measure was mean 2-day visual analog scores. RESULTS: Results were obtained from 400 subjects. Groups were well matched at baseline. Mean 2-day visual analog soreness scores for Arnica and placebo were 45.2 mm and 41.0 mm, respectively. The 95% confidence interval was between 8.81 mm in favor of placebo and 0.51 mm in favor of Arnica. No differences were found for Likert scores or race time. CONCLUSION: Homeopathic Arnica 30x is ineffective for muscle soreness following long-distance running.
OBJECTIVE: To pilot a model for determining whether a homoeopathic medicine is superior to placebo for delayed onset muscle soreness (DOMS). DESIGN: Randomised double blind placebo controlled trial. SETTING: Physiotherapy department of a homoeopathic hospital. SUBJECTS: Sixty eight healthy volunteers (average age 30; 41% men) undertook a 10 minute period of bench stepping carrying a small weight and were randomised to a homoeopathic medicine or placebo. OUTCOME MEASURES: Mean muscle soreness in the five day period after the exercise test, symptom free days, maximum soreness score, days to no soreness, days on medication. RESULTS: The difference between group means was 0.17 in favour of placebo with 95% confidence intervals +/- 0.50. Similar results were found for other outcome measures. CONCLUSION: The study did not find benefit of the homoeopathic remedy in DOMS. Bench stepping may not be an appropriate model to evaluate the effects of a treatment on DOMS because of wide variation between subject soreness scores.
The effects of acupuncture on health are generally hard to assess. Stimulation of the P6 acupuncture point is used to obtain an antiemetic effect and this provides an excellent model to study the efficacy of acupuncture. Thirty-three controlled trials have been published worldwide in which the P6 acupuncture point was stimulated for treatment of nausea and/or vomiting associated with chemotherapy, pregnancy, or surgery. P6 acupuncture was equal or inferior to control in all four trials in which it was administered under anaesthesia; in 27 of the remaining 29 trials acupuncture was statistically superior. A second analysis was restricted to 12 high-quality randomized placebo-controlled trials in which P6 acupuncture point stimulation was not administered under anaesthesia. Eleven of these trials, involving nearly 2000 patients, showed an effect of P6. The reviewed papers showed consistent results across different investigators, different groups of patients, and different forms of acupuncture point stimulation. Except when administered under anaesthesia, P6 acupuncture point stimulation seems to be an effective antiemetic technique. Researchers are faced with a choice between deciding that acupuncture does have specific effects, and changing from 'Does acupuncture work?' to a set of more practical questions; or deciding that the evidence on P6 antiemesis does not provide sufficient proof, and specifying what would constitute acceptable evidence.
OBJECTIVE: To determine whether health shop staff give specific therapeutic recommendations to someone who describes symptoms associated with serious pathology and to determine whether they refer this person to conventional medical care. DESIGN: Quantitative survey using participant observation. SETTING: Health food shops selling herbal, homeopathic or nutritional remedies in inner London. METHOD: A researcher visited 29 health food shops and claimed to be suffering from severe, daily headaches of recent onset. The researcher recorded on tape whether the health shop staff took diagnostic information; recommended any therapeutic intervention; asked about or recommended seeing a general practitioner (GP); asked about use of conventional drugs. Coding of the interactions was carried out independently by two researchers. RESULTS: Whereas all but two shops recommended a specific therapeutic intervention, less than one in four advised a GP consultation. Forty-two different interventions were recommended. There was little consistency in the advice given. CONCLUSION: Health food shops need to review the circumstances in which they should venture to provide advice and the basis on which they make any therapeutic recommendations. Shops selling over-the-counter herbal, homeopathic and health food products are a common feature of UK high streets. Such shops could be a useful source of health information and advice to their customers, but could also lead to harm, for example by delaying treatment of known benefit, if their recommendations were to be inaccurate or inappropriate.