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International Journal of Epidemiology 2001;30:526-531
© International Epidemiological Association 2001


Theory and Methods

The methodological quality of randomized controlled trials of homeopathy, herbal medicines and acupuncture

Klaus Lindea,b, Wayne B Jonasc, Dieter Melchartb and Stefan Willicha

a Institute for Social Medicine & Epidemiology, Charité, Humboldt-University, Berlin, Germany.
b Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität, Kaiserstr. 9, 80801 München, Germany.
c Department of Family Medicine, Uniformed Services University of the Health Sciences, Bethesda, Maryland, USA.

Dr med. Klaus Linde, Centre for Complementary Medicine Research, Department of Internal Medicine II, Technische Universität, Kaiserstr. 9, 80801 München, Germany. E-mail: Klaus.Linde{at}lrz.tu-muenchen.de

Abstract

Background To investigate the methodological quality of randomized controlled trials in three areas of complementary medicine.

Methods The methodological quality of 207 randomized trials collected for five previously published systematic reviews on homeopathy, herbal medicine (Hypericum for depression, Echinacea for common cold), and acupuncture (for asthma and chronic headache) was assessed using a validated scale (the Jadad scale) and single quality items.

Results While the methodological quality of the trials was highly variable, the majority had important shortcomings in reporting and/or methodology. Major problems in most trials were the description of allocation concealment and the reporting of drop-outs and withdrawals. There were relevant differences in single quality components between the different complementary therapies: For example, acupuncture trials reported adequate allocation concealment less often (6% versus 32% of homeopathy and 26% of herb trials), and trials on herbal extracts had better summary scores (mean score 3.12 versus 2.33 for homeopathy and 2.19 for acupuncture trials). Larger trials published more recently in journals listed in Medline and in English language scored significantly higher than trials not meeting these criteria.

Conclusion Trials of complementary therapies often have relevant methodological weaknesses. The type of weaknesses varies considerably across interventions.

KEY MESSAGES

  • Aspects of the methodological quality of 207 randomized trials of homeopathy, herbal medicines, and acupuncture were reviewed.
  • The majority of trials had important shortcomings; major problems were the reporting of allocation concealment and the reporting and handling of drop-outs and withdrawals.
  • The extent of specific quality problems differed considerably between the different areas.
  • Larger trials published more recently in journals listed in Medline and in English language had better methodological quality.

Keywords Alternative medicine, homeopathy, acupuncture, Hypericum, Echinacea, controlled clinical trials, randomized controlled trials, meta-analysis

Accepted 21 September 2000


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