Editorial: Studying a Study

By Len Monheit

In the spirit of holiday brevity, I’ll be extremely quick today.

Earlier this week, a National Institutes of Aging and NCCAM funded study on black cohosh, published in the Annals of Internal Medicine, observed that the herb used in the study provided no benefit relative to placebo, when used by itself, or with other herbs, to relieve hot flashes in some 351 women aged 45 to 55, going through menopause. Reuters Health article describing the study results

The next day, Enzymatic Therapy, distributors of Remifemin® black cohosh, a well studied and characterized product from Shaper & Brummer GmbH, Salzgitter, Germany, issued a release outlining the study history and results for Remifemin, with little or no fanfare or media pickup.

Yesterday, the American Botanical Council issued a release attempting to put the latest study results into context as but one study, inconsistent with previous positive results, and at that, a study that did not employ the most characterized and previously studied extracts. (The current trial, according to the ABC release used” (1) a black cohosh extract (CimiPure®, produced by Pure World Inc. of Hackensack, NJ), (2) a multi-herb pill with black cohosh and 9 other ingredients* (Progyne, Progena, Albuquerque, NM), (3) the same multi-herb pill plus counseling to ensure the increased consumption of dietary soy, (4) conventional hormone replacement therapy (estrogen with or without progestin.”)

The accompanying editorial positioned the current study as a definitive result, claiming black cohosh is ‘not effective’.

The ABC release went on to point out several study details that might have impacted results, including product preparation and storage, high placebo results, lack of data on secondary trial outcomes, with a general major observation that taking a single study result without the context of other previous studies, is inappropriate.

One can certainly wonder why this publicly funded study had some obvious (potential) flaws. One can also wonder what product and field expertise went into the study design and execution. One can also ask why the editorial, rather than the body of science appeared to provide input into the study coverage and presentation. And finally, one can wonder why the context presented by industry, appears to fall on deaf ears.

It is obvious that expert input into design and execution is required. Presumably, our experts are well positioned, well-connected, reasonably resourced, and the high quality, well-characterized, shelf-stable superior products are on the selection list, especially for publicly funded studies.

One can’t help but ask – why does this keep happening?

On the flip side, just as one negative study must be placed in context with the entire research body on a particular subject, so too must be a small positive study. How often have we as an industry touted a small-scale (in-vitro even) trial with barely significant results, as the definitive answer on a particular supplement or natural health product. We relay can’t have it both ways, ideally the rules will be consistent and so too will be the coverage.

Maybe, I’m just too much of an idealist…..

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