Beyond the myth of expensive clinical study: assessment of traditional medicines.

Clinical studies with human subjects represent the only assessment of effectiveness and safety that can translate into medical practice, and national or local health policy. There are several reasons why traditional medicines (in fact medicinal plants and other alternative or complementary medicines) should be subjected to more clinical research with patient observation and follow-up: firstly, this would help to select products of interest for further investigations in ethnopharmacology; secondly, it could translate into immediate recommendations for the population using the assessed local treatments. Contrary to a commonly held myth, clinical studies can be conducted at relatively low cost, if one works with local/regional research institutes and with doctoral students, focusing on meaningful clinical measures rather than sophisticated laboratory analyses. This paper describes special designs of clinical studies, appropriate for traditional medicines and tested in the field, including: the retrospective treatment-outcome population survey, the prognosis- outcome method (with modern physicians observing progress of patients treated by a traditional healer), the dose-escalating prospective study (detecting a dose-response phenomenon in humans). It is suggested that this approach offers the best cost-effective course of action for obtaining maximal benefits from traditional medicines, especially those used for treating endemic diseases.