Sharon Begley's botanical gift

The Wall Street Journal's Science Journal correspondent today "bestows holiday gifts" (sub req'd) on researchers, drugs, and other approaches that have advanced health and medicine, or set it back.

Given yesterday's discussion of the failed efficacy trial for black cohosh, I chuckled at this one:

To the herbal supplement called saw palmetto, taken by some 2.5 million men in the U.S., which failed to help urinary problems any better than a placebo: a framed copy of the 1994 law that lets dietary supplements be sold even if there is no evidence of their efficacy.

The funny thing is that I wrote about the serious issues on this particular study back at the old blog in February.

So, I'll repeat what I said then: if the US NIH is going to spend millions of dollars on randomized, controlled trials of herbal/botanical medicines or supplements, some effort would be better invested first in the appropriate basic science and pharmacokinetic studies necessary for appropriate dosing with a scientifically-qualified supplement exhibiting quantified and predictable bioavailability of the key active principle(s)...or to determine whether a trial is even indicated by the accumulated evidence.

Until these conditions are addressed, I predict a continued string of negative outcomes in clinical botanical trials, even for agents that appear very promising based on traditional uses.

More like this

This post appeared originally on 8 Feb 2006 at the old site for this blog. A frequent reader and commenter, Joe, suggested that I repost it here as it illustrates many common problems with clinical trials of botanical medicines. You'd think the funding folks would learn at the NIH National Center…
As we discussed briefly on Tuesday, trial results published in the Annals of Internal Medicine revealed that alternative botanical supplements containing black cohosh were without benefit relative to placebo in treating the vasomotor symptoms (e.g., hot flashes, night sweats) of peri- and…
We've discussed previously the use of herbal extracts from black cohosh (Actea racemosa) for relief from hot flashes and other vasomotor symptoms of menopause and perimenopause. A clinical trial in Annals of Internal Medicine last December, showed that one black cohosh extract was no better than…
You didn't think this one would go by without my commenting on it, did you? Even though Abel and Tara have already ably commented on it, I can't help but jump in because the article echoes one of the common threads of this blog since the very beginning. Besides, as I've said before, just because…

Yes, I'm also stumped why sub-therapeutic doses of supplements, or whatever, are studied.

When the understandable lack of efficacy ensues, and the laughter at even doing the study in the first place dies down, we're still left with the fundamental question: is the tested item effective or not?

By John J. Coupal (not verified) on 02 Jan 2007 #permalink