Wyatt K, Dimmock P, Jones P, Obhrai M, O'Brien S. Efficacy of progesterone and progestogens in management of premenstrual syndrome: systematic review. BMJ 2001; 323:776-80.
* BACKGROUND Progestational therapy has been claimed effective in patients with PMS for many years. In the United States, progesterone or progestogen products account for 60% to 70% of prescriptions for PMS symptoms.
* POPULATION STUDIED The authors searched for clinical trials of progesterone or progestogens in the management of PMS. A systematic search of multiple databases in all languages yielded the reports of clinical trials included in this review. A search of references cited and contact with pharmaceutical companies completed the list of trials for evaluation. The report does not indicate whether searches were performed by more than one person. Trials were included if patients had a pretreatment diagnosis of PMS. Ten trials of progesterone therapy, evaluating 531 patients, remained for analysis. For progestogen therapy, analysis included 4 trials comprising a total of 378 patients. Although the authors do not describe the patients from the included trials in detail, they probably represent patients seen in family practice settings.
* STUDY DESIGN AND VALIDITY The authors of this meta-analysis evaluated all trials for quality using 2 separate rating scales. The quality of available studies was low. The authors independently extracted data in duplicate from the trials selected for analysis.
The authors eliminated trials from consideration if patients did not have a pretreatment diagnosis of PMS. It is not clear whether some trials were eliminated because of poor quality. The pooled trials were statistically homogeneous, indicating that the studies were comparable enough to combine their data. The authors, who also looked for publication bias, considered each specific type of progestational agent separately to ensure the comparison of like treatments. The validity of the review is excellent, although the low quality of the studies available for evaluation reduces our confidence in the results.
* OUTCOMES MEASURED The authors defined their primary outcome as the reduction in overall symptoms of PMS. The authors summarized outcomes by intention to treat, where possible. They calculated a standardized mean difference in effect of treatment and converted this statistic to an odds ratio (OR).
* RESULTS Trials of progesterone suppositories or pessaries showed a marginal effect in favor of placebo (OR = 0.93; 95% CI, 0.91-0.95). Oral micronized progesterone had marginal benefit (OR = 1.30; 95% CI, 1.25-1.36). When all trials of progesterone were combined, there was a small, but clinically insignificant, effect (OR = 1.05; 95% CI, 1.03-1.08). Trials of progestogen therapy showed a clinically insignificant effect in favor of the drug (OR = 1.07; 95% CI, 1.03-1.11). Patients given active treatment had a nonsignificant increase in dropout rate because of side effects (OR = 1.65; 95% CI, 0.86-3.21).
RECOMMENDATIONS FOR CLINICAL PRACTICE
Progesterone and progestogen therapy should no longer be prescribed for PMS. This systematic review shows that published evidence does not support use of such therapy. Evidence of effectiveness in reducing overall symptoms of PMS is better for other therapies. Similar systematic reviews by the same group of authors show benefit from the use of selective serotonin-reuptake inhibitors (SSRIs) (1) and vitamin [B.sub.6]. (2) For women with PMS symptoms that require pharmacologic management, SSRIs provide effective first-line therapy. Vitamin [B.sub.6] is also likely to be of benefit, although the quality of the evidence is poor. Nonmedication measures may help, but they have not been systematically studied. Calcium therapy and chasteberry fruit extract have been reviewed in previous POEMs and have been found effective.
(1.) Dimmock P, Wyatt K, Jones P, O'Brien S. Efficacy of selective serotonin-reuptake inhibitors in premenstrual syndrome: a systematic review. Lancet 2000; 356:1131-6.
(2.) Wyatt K, Dimmock P, Jones P, O'Brien S. Efficacy of vitamin [B.sub.6] in the treatment of premenstrual syndrome: systematic review. BMJ 1999; 318:1375-81.
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