Lack of evidence for adherence to good manufacturing practice guidelines
TUESDAY, March 10, 2015 (HealthDay News) — Limited evidence supports use of herbal remedies in gastrointestinal disorders, and the lack of quality control must be considered, according to research published in the March issue of Clinical Gastroenterology and Hepatology.
Gerald Holtmann, M.D., Ph.D., M.B.A., from Princess Alexandra Hospital Brisbane, and Nicholas J. Talley, M.D., Ph.D., from the University of Newcastle — both in Australia — examined the evidence for herbal preparations used for gastrointestinal conditions.
The researchers found that there is limited evidence to support the use of some well-characterized preparations for functional gastrointestinal disorders. Immunomodulatory activity has been seen for a number of herbal preparations, with limited positive results in placebo-controlled trials for inflammatory bowel disease. Herbal preparations can lead to serious adverse events, including hepatic failure. Quality control should be considered when prescribing herbal medicines. Evidence for stringent adherence to good manufacturing practice guidelines is absent for many herbal preparations. The composition and concentration of the active ingredients in plant extracts may be affected by unpredictable environmental conditions; furthermore, commercial herbal products frequently combine multiple chemical families with possible medicinal utility. Some of these ingredients may be beneficial, but the concentration and dose of these constituents should be monitored.
“Appropriate scientific evidence for the claimed clinical benefits should become mandatory worldwide, and the standards for production and safety monitoring should comply with established standards for chemically defined products,” the authors write. “If these principles were adopted, the full value of herbal remedies may come to light.”
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