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Alternative Treatments for Hot Flashes (cont.)

Why are some doctors reluctant to recommend nonprescription therapies for menopause symptoms?

Nonprescription products are not controlled by the FDA because they are considered food supplements by law. Because they are not regulated like prescription medications, their ingredients and potency vary from manufacturer to manufacturer, and even from bottle to bottle from the same manufacturer. Also, careful testing and proof of safety is not required as it is with prescription medications. (The only way the FDA can recall a nonprescription product is by proving that it is dangerous.) Furthermore, there are so many nonprescription products available that a doctor cannot possibly know exactly what is in each preparation. Moreover, not one of these products has been scientifically proven to be safe.

So, how well have the nonprescription alternatives to hormone therapy been tested? Not one study has adhered to all of the stringent requirements that are necessary for approval of prescription medicines.

  1. Specifically, sugar pills (placebos) have not been included in many studies of nonprescription alternative medications. Therefore, it is not possible to know if the product worked at all, since any effects seen with the product might have been seen with a placebo.
  1. Many studies evaluated women who were taking products without supervision. Obviously, these women were aware that they were taking something to improve their symptoms. Thus, the element of objectivity was eliminated, and bias was introduced.
  1. Most available studies have been carried out for only a few months. Physicians do not want to recommend a product that hasn't been proven safe over the long-term.
  1. Lastly, each study seems to have a different way of judging whether the medication helps. Some analyze hot flashes alone, while others evaluate a group of symptoms without specifically segregating out hot flashes. Other studies examine multiple but individual symptoms. Even the studies that evaluate hot flashes may record different factors; the number of hot flashes per day, the severity of the hot flashes, or the duration of the hot flashes, etc.

It is confusing, even for doctors who are experts in the field, to evaluate these studies and properly counsel women. For more, please read "Evaluating Treatment Products, A Doctors' Perspective."



Next: What alternative treatments for menopause have been scientifically studied? »

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