The director and deputy director of the Office of Clinical and Regulatory Affairs of the National Center for Complementary and Alternative Medicine (NCCAM) wrote this editorial in the Medical Journal of Australia entitled “Complementary and alternative medicine in 2006: optimising the dose of the intervention.” In its research of various herbal and “natural” remedies NCCAM study protocols have selected doses and preparations already in popular use. Apparently they’ve now figured out that’s not the way to go about it, finally realizing that they should have been doing dose finding studies the way mainstream drug research does in phase I and II trials.
Here’s a statement from the introduction of the editorial: “…..one initial approach taken by NCCAM was to sponsor large trials of supplements using doses representative of those commonly used. The rationale included the concern that if the common dose is unsafe, it would be important to alert the public. Moreover, these doses were often used in smaller, less well-controlled studies. However, NCCAM found that this is not an optimal research strategy. As NCCAM defines its priorities and strategies for the next few years, we recognise that reinvestigation and optimisation of customary procedures, especially dose, is needed if NCCAM is to make informed statements.”
The authors also state: “In addition, the literature is unlikely to be conclusive because the manner in which an intervention is commonly used is unlikely to optimise the many factors that together could make an intervention successful.”
Admitting that NCCAM’s assumptions were wrong the authors imply that we should disregard negative results in studies of CAM---if only we discover the right dose or the right conditions we will eventually prove efficacy. They write “In addition, the literature is unlikely to be conclusive because the manner in which an intervention is commonly used is unlikely to optimise the many factors that together could make an intervention successful.” And “Early ‘negative’ results present a particular challenge for CAM, given that some people are very sceptical of the field in general, and will seize upon early results of such trials as demonstrating that a CAM treatment is ineffective entirely.”
Such is the sorry state of “research” in alternative medicine.