Clinical Trials (1998-2002)

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Clinical Trials 03-07

Clinical Trials 98-02

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The following are Appendices I and II published in a Research Report of the National Center for Complimentary and Alternative Medicine of the National Institute of Health reproduced from Publication No. D183 (PDF), April 2003. This information is in the public domain.

 

Appendix I.

Clinical Trials on Homeopathy Published from 1998 to 2002j

 

Citation Description Findings
Vickers and Smith, 20026 Seven trials were included in the review (three prevention and four treatment trials); only two studies had sufficient information for complete data extraction. The homeopathic remedy oscillococcinum appears safe and effective in reducing the duration of influenza, but has no effect on prevention.
Lewith et al., 20024 Randomized, double-blinded, placebo-controlled trial of 242 participants aged 18 to 55 years. Trial compared an oral homeopathic treatment to placebo in asthmatic people allergic to house dust. Authors found the homeopathic treatment "no better than placebo." They noted "some differences between the homeopathic immunotherapy and placebo for which we have no explanation."
Oberbaum et al., 20017 Randomized, double-blinded, placebo-controlled trial in 32 children; 30 completed the study. Traumeel S, a homeopathic skin cream, may significantly reduce the severity and length of pain and inflammation of the tissues lining the inside of the mouth from chemotherapy in children being treated with bone marrow transplantation.
Taylor et al., 20008 Randomized, double-blinded, placebo-controlled trial of 51 participants aged 17 years or older (50 completed the study). Team tested the hypothesis that homeopathy is a placebo by examining effects of an oral homeopathic preparation in patients with perennial allergic rhinitis. They found a "significant objective improvement in nasal airflow" compared with the placebo group. However, both groups reported subjective improvement in "nasal symptoms" (with no statistically significant difference between groups). Authors concluded that the objective evidence supports that "homeopathic dilutions differ from placebo."
Jacobs et al., 20009 Randomized, double-blinded, placebo-controlled trial of 126 children; 116 completed the study. Individualized homeopathic treatments improved digestive problems in children with acute childhood diarrhea. Results are consistent with findings of a previous study.
Weiser et al., 199910 Randomized, double-blinded trial of 146 people. For the treatment of hay fever, a homeopathic nasal spray is as efficient and well tolerated as a conventional therapy, cromolyn sodium.
Rastogi et al., 199911 Randomized, double-blinded, placebo-controlled trial of 100 people between 18 and 50 (71 percent male/29 percent female). A subgroup of patients with HIV in the symptomatic phase, receiving treatment, had increased levels of CD4 cells at the end of the trial; the placebo subgroup did not.
Vickers et al., 199812 Randomized, double-blinded, placebo-controlled trial of 519 people; 400 completed the study. Homeopathic remedies, including arnica, are not effective for muscle soreness following long-distance running.
Weiser et al., 199813 Randomized, double-blinded, controlled trial of 119 people; 105 completed the study. The homeopathic treatment vertigoheel, and the standard treatment of betahistine, are equally effective in reducing the frequency, duration, and intensity of vertigo attacks.

j. Due to the large number of trials, these studies have been selected to give a representative overview of the findings published in peer-reviewed scientific and medical journals in English and indexed in the National Library of Medicine's MEDLINE database.

Appendix II.

Systematic Reviews and Meta-Analysesk of Clinical Trials of Homeopathy

 
Citation Description Findings
Ernst, 20025 Analyzed 17 systematic reviews (including meta-analyses) of controlled clinical trials for homeopathy. Author found that the reviews failed to provide strong evidence in favor of homeopathy. No homeopathic remedy was proven by convincing evidence to yield clinical effects that are different from placebo or from other control intervention for any medical condition. Positive recommendations for use of homeopathy in clinical practice are not supported, and "homeopathy cannot be viewed as an evidence-based form of therapy" until more convincing results are available.
Linde et al., 200114 Analyzed the methodological quality of 207 randomized trials collected for 5 previously published reviews on homeopathy, two herbal medicines (St. John's wort and echinacea), and acupuncture. Authors found that the majority of trials had major weaknesses in methodology and/or reporting. Homeopathy trials were "less frequently randomized...and reported less details on dropouts and withdrawals" than the other types.
Cucherat et al., 20002 Analyzed 16 randomized, controlled trials (17 comparisons were made) comparing homeopathic treatment to placebo. Work was part of a report prepared for the European Union on the effectiveness of homeopathy. Authors found that the "strength of evidence remains low" because of trial flaws and other limitations. They added that "at least one [of the tested homeopathic treatments] shows an added effect relative to placebo." Group recommended that homeopathy be studied further using the same methods used to study conventional medicine.
Ernst and Pittler, 199815 Systematic review of eight trials. Rigorous clinical trials indicate arnica is not more effective than a placebo; most trials studied use of arnica for tissue trauma.
Linde et al., 19971 Analyzed 89 trials. Each trial was controlled; compared homeopathy to a placebo; was either randomized or double-blinded; and yielded a written report. Authors concluded that their results were not compatible with a hypothesis that the clinical effects of homeopathy are completely due to placebo. However, they found insufficient evidence that homeopathy is clearly efficacious for any single clinical condition. They stated that further research is warranted if it is rigorous and systematic.
Kleijnen et al., 19913 Assessed 105 controlled trials of homeopathy, 68 randomized. Authors found a positive trend in the evidence, regardless of the quality of the trial or the method of homeopathy used. They cautioned, however, that definitive conclusions about homeopathy could not be drawn, because many of the trials were not of good quality and the role of publication bias was unknown.
Systematic Reviews of Clinical Trials on Single Medical Conditions
Long and Ernst, 200116 Systematic review of four osteoarthritis clinical trials. Research on homeopathic treatment for osteoarthritis is insufficient to reliably assess the clinical effectiveness of homeopathic treatment of osteoarthritis.
Jonas et al., 200017 Meta-analysis of six controlled clinical trials. Controlled clinical trials indicate that homeopathic remedies appear to work better than a placebo in studies of rheumatic syndromes, but there are too few studies to draw definitive conclusions, and efficacy results are mixed.

k. In a systematic review, data from a set of studies on a particular question or topic are collected, analyzed, and critically reviewed. A meta-analysis uses statistical techniques to analyze results from individual studies.

References

  1. Linde, K., Clausius, N., Ramirez, G., Melchart, D., Eitel, F., Hedges, L.V., and Jonas, W.B. "Are the Clinical Effects of Homeopathy Placebo Effects? A Meta-Analysis of Placebo-Controlled Trials." Lancet. 1997. 350(9081):834-43.

  2. Cucherat, M., Haugh, M.C., Gooch, M., and Boissel, J.-P. "Evidence of Clinical Efficacy of Homeopathy: A Meta-Analysis of Clinical Trials." European Journal of Clinical Pharmacology. 2000. 56(1):27-33.

  3. Kleijnen, J., Knipschild, P., and ter Riet, G. "Clinical Trials of Homeopathy." British Medical Journal. 1991. 302(6782):316-23.

  4. Lewith, G.T., Watkins, A.D., Hyland, M.E., Shaw, S., Broomfield, J.A., Dolan, G., and Holgate, S.T. "Use of Ultramolecular Potencies of Allergen To Treat Asthmatic People Allergic to House Dust Mite: Double Blind Randomised Controlled Clinical Trial." British Medical Journal. 2002. 324(7336):520-4.

  5. Ernst, E. "A Systematic Review of Systematic Reviews of Homeopathy." British Journal of Clinical Pharmacology. 2002. 54(6):577-82.

  6. Vickers, A.J. and Smith, C. "Homoeopathic Oscillococcinum for Preventing and Treating Influenza and Influenza-Like Syndromes." Cochrane Database of Systematic Reviews. 2002. (2):CD001957.

  7. Oberbaum, M., Yaniv, I., Ben-Gal, Y., Stein, J., Ben-Zvi, N., Freedman, L. S., and Branski, D. "A Randomized, Controlled Clinical Trial of the Homeopathic Medication Traumeel S in the Treatment of Chemotherapy-Induced Stomatitis in Children Undergoing Stem Cell Transplantation." Cancer. 2001. 92(3):684-90.

  8. Taylor, M.A., Reilly, D., Llewellyn-Jones, R.H., McSharry, C., and Aitchison, T.C. "Randomised Controlled Trial of Homoeopathy versus Placebo in Perennial Allergic Rhinitis with Overview of Four Trial Series." British Medical Journal. 2000. 321(7259):471-6.

  9. Jacobs, J., Jimenez, L.M., Malthouse, S., Chapman, E., Crothers, D., Masuk, M., and Jonas, W.B. "Homeopathic Treatment of Acute Childhood Diarrhea: Results from a Clinical Trial in Nepal." Journal of Alternative and Complementary Medicine. 2000. 6(2):131-9.

  10. Weiser, M., Gegenheimer, L.H., and Klein, P. "A Randomized Equivalence Trial Comparing the Efficacy and Safety of Luffa comp.-Heel Nasal Spray with Cromolyn Sodium Spray in the Treatment of Seasonal Allergic Rhinitis." Forschende Komplementärmedizin. 1999. 6(3):142-8.

  11. Rastogi, D.P., Singh, V.P., Singh, V., Dey, S.K., and Rao, K. "Homeopathy in HIV Infection: A Trial Report of Double-Blind Placebo Controlled Study." British Homeopathic Journal. 1999. 88(2):49-57.

  12. Vickers, A.J., Fisher, P., Smith, C., Wyllie, S.E., and Rees, R. "Homeopathic Arnica 30x Is Ineffective for Muscle Soreness After Long-Distance Running: A Randomized, Double-Blind, Placebo-Controlled Trial." The Clinical Journal of Pain. 1998. 14(3):227-31.

  13. Weiser, M., Strosser, W., and Klein, P. "Homeopathic vs Conventional Treatment of Vertigo: A Randomized Double-Blind Controlled Clinical Study." Archives of Otolaryngology-Head & Neck Surgery. 1998. 124(8):879-85.

  14. Linde, K., Jonas, W.B., Melchart, D., and Willich, S. "The Methodological Quality of Randomized Controlled Trials of Homeopathy, Herbal Medicines and Acupuncture." International Journal of Epidemiology. 2001. 30(3):526-31.

  15. Ernst, E. and Pittler, M.H. "Efficacy of Homeopathic Arnica: A Systematic Review of Placebo-Controlled Clinical Trials." Archives of Surgery. 1998. 133(11):1187-90.

  16. Long, L. and Ernst, E. "Homeopathic Remedies for the Treatment of Osteoarthritis: A Systematic Review." British Homeopathic Journal. 2001. 90(1):37-43.

  17. Jonas, W.B., Linde, K., and Ramirez, G. "Homeopathy and Rheumatic Disease." Rheumatic Disease Clinics of North America. 2000. 26(1):117-23.

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