The C.A.M. Report
Complementary and Alternative Medicine: Fair, Balanced, and to the Point
  • About this web log

    This blog ran from 2006 to 2016 and was intended as an objective and dispassionate source of information on the latest CAM research. Since my background is in pharmacy and allopathic medicine, I view all CAM as advancing through the development pipeline to eventually become integrated into mainstream medical practice. Some will succeed while others fail. But all are treated fairly here.

  • About the author

    John Russo, Jr., PharmD, is president of The MedCom Resource, Inc. Previously, he was senior vice president of medical communications at, a complementary and alternative medicine website.

  • Common sense considerations

    The material on this weblog is for informational purposes. It is not medical advice or counsel. Be smart, consult your health professional before using CAM.

  • Recent Posts

  • Recent Comments

    Hot flashes: What’s the proper study duration?

    Because hot flashes usually persist for years after menopause, meaningful hot flash therapy should be effective for a long time.

    So, how long should patients be followed?

    The FDA requires 12 weeks for industry-initiated hot flash trials, whereas most academic-initiated trials range from 4 to 12 weeks.

    Researchers from Buffalo, New York searched for a middle ground.

    First, the details.

    • They identified studies showing a nonhormonal hot flash therapy to be effective early on only to become ineffective later (ie, short-term but not long-term efficacy).
    • They considered the longest early time point of efficacy from the studies plus 1 additional week as the minimum treatment duration to assess long-term effectiveness.

    And, the results.

    • 3 target studies were identified.
    • They included Bellergal Retard (ergotamine/belladonna/phenobarbital), soy, and venlafaxine (Effexor)
    • At 2, 6, and 7 weeks, respectively, was the last time they were effective before subsequently losing benefit.

    The bottom line?

    The authors concluded that 8 weeks is the minimum duration for a study of treatment of hot flushes.

    The answer to this question is important because for a pharmaceutical company and researcher, time is money. It’s also important for healthcare providers and patients attempting to find the best treatment for hot flashes.

    I think any researcher of hot flush treatment would be hard pressed to defend 8 weeks rather than 12 based on the results presented in this study.

    So, why is this study important?

    Only because it’s an example of just 1 of many issues researchers must deal with when contemplating and designing a study.

    The government of Australia has published The Australian Clinical Trial Handbook. It’s a practical guide to the conduct of clinical studies to international standards of good clinical practice. It addressed this and other issues, and is worthwhile for anyone contemplating a CAM study.

    3/7/10 21:46 JR

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