PubMed · 6762371
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M Livingston. 1982. LSD--a generation later.. https://pubmed.ncbi.nlm.nih.gov/6762371/
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The number of studies designed specifically to demonstrate therapeutic equivalence or alternatively non-inferiority of pharmaceutical treatments has increased dramatically in recent years, during which time awareness of the methodological issues has increased. Regulatory authorities have been quick to recognize the need for specific support and have either published or initiated the creation of relevant guidance. Common misconceptions prevail however regarding sample size estimation and the choice of the most appropriate patient population to analyse while other areas such as equivalence margin specification and covariate adjustment have been neglected. This paper challenges some of the regulatory advice and the interpretation that others have made of this guidance with the aim of stimulating further debate.
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OBJECTIVE: There has been a recent proliferation of medical reference texts intended to guide practitioners whose patients use herbal therapies. We systematically assessed six herbal reference texts to evaluate the information they contain on herbal toxicity. METHODS: We selected six major herbal references published from 1996 to 2000 to evaluate the adequacy of their toxicological information in light of published adverse events. To identify herbs most relevant to toxicology, we reviewed herbal-related calls to our regional California Poison Control System, San Francisco division (CPCS-SF) in 1998 and identified the 12 herbs (defined as botanical dietary supplements) most frequently involved in these CPCS-SF referrals. We searched Medline (1966 to 2000) to identify published reports of adverse effects potentially related to these same 12 herbs. We scored each herbal reference text on the basis of information inclusiveness for the target 12 herbs, with a maximal overall score of 3. RESULTS: The herbs, identified on the basis of CPCS-SF call frequency were: St John's wort, ma huang, echinacea, guarana, ginkgo, ginseng, valerian, tea tree oil, goldenseal, arnica, yohimbe and kava kava. The overall herbal reference scores ranged from 2.2 to 0.4 (median 1.1). The Natural Medicines Comprehensive Database received the highest overall score and was the most complete and useful reference source. All of the references, however, lacked sufficient information on management of herbal medicine overdose, and several had incorrect overdose management guidelines that could negatively impact patient care. CONCLUSION: Current herbal reference texts do not contain sufficient information for the assessment and management of adverse health effects of botanical therapies.