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More PMS Drug Therapy Studies

PMS was discussed here last week in the context of pharmaceutical treatments (specifically Prozac). There are other treatments available. Two that have been tried in the past have been progesterone and alprazolam (an anxiolytic similar to valium). Unfortunately, small scale studies with conflicting results have not clarifies whether or not these were effective treatments. However, both have adherents and are popular treatments for PMS, also known as premenstrual dysmorphic disorder.

This week in JAMA the results of a study of the effect of progesterone, alprazolam, and placebo on the symptoms of PMS were described. The purpose of this study was to determine the effectiveness of the two drugs as compared to each other and compared to a placebo. The study was a double-blind study with three treatment arms. The mean dosage of alprazolam was 1.5 mg/day t, and the mean dosage of micronised progesterone was 1760 (3 doses). However, the dosage was flexible so that the therapy would be most effective for the individual patient. The study also recruited enough women so as to attain a good sample size and provide definitive results.

Alprazolam was shown to be superior in reducing symptoms of PMS as compared with progesterone and placebo. Improvement, defined as a 50% improvement of symptoms over baseline, was 37% for the group treated with alprazolam, as compared with 29% on progesterone, and 30% with placebo. The alprazolam tended to work better on the symptoms associated with mood disturbances (irritability, sadness) rather than the physical symptoms which for progesterone worked better (breast swelling, water retention), but the overall ranking of reduction of symptoms was greater for alprazolam. Alprazolam has been to shown to be an effective therapy that has the advantage of being taken in the luteal phase of a womanÕs cycle to control PMS symptoms. Progesterone has shown to be no more effective than placebo in the control of these same symptoms.

What this means is that there is another alternative for women who suffer from severe PMS. Women should discuss this alternative with their doctors to find the treatment option that works best for that individual patient. Women currently on progesterone for PMS symptoms should contact their doctor to discuss whether or not to continue the drug.

(For more information, please see ÒA Double-blind Trial of Oral Progesterone, Alprazolam, and Placebo in Treatment of Severe Premenstrual SyndromeÓ JAMA Jul 5, 1995. 274:1. p. 51-57.)

Prozac: A Cure for PMS??

Women who suffer from late luteal phase dysphoric disorder, otherwise known as premenstrual dysphoric disorder or premenstrual syndrome (PMS) is estimated to affect 3-8% of women. Defined as a cluster of symptoms that occur in the week preceding the start of menses and resolve with the onset, it is often characterized by tension, irritability and a depressed mood. Since it shares some characteristics of depression and anxiety states, it has been suggested that it may be linked to serotinergic dysregulation as well. Fluoxetine, or Prozac, which works by inhibiting the uptake of serotonin, has been suggested as a potential treatment for this disorder.

A multicenter randomized double blind placebo controlled trial was conducted on women who had regular periods and no major psychiatric disorders but who did suffer from PMS. After a placebo ÒwashoutÓ period, they received either placebo, 20mg of fluoxetine, or 60 mg of fluoxetine daily for 6 cycles. Women were asked to rank how they felt on standardized scales for tension, irritability, and dysphoria. There was a significant reduction in tension with the two groups on Prozac as compared to the women on placebo. The higher dosed group however did report a high level of side effects.

Women, therefore, who suffer from PMS may want to consult with their doctor to see if Prozac might be an effective way of reducing the signs and symptoms of PMS. Upcoming trials will explore whether or not a single dose mid-cycle may be as effective, instead of the daily dose in this specific trial.

(For more information, see ÒFluoxetine in the Treatment of Premenstrual DysphoriaÓ NEJM Jun 8, 1995. 332:23, p. 1529-34)


 
 

If you have any questions, comments, or suggestions, please mail me at pms@premenstrualsyndrome.com
 
 

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