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Meta-analysis of estrogen therapy in the management of urogenital atrophy in postmenopausal women: second report of the Hormones and Urogenital Therapy Committee

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Abstract

Objective: To evaluate the efficacy of estrogen therapy in the treatment of postmenopausal women with symptoms and signs associated with urogenital atrophy, by meta-analysis of available data.

Methods: We searched the literature (Excerpta Medica, Biosis, MEDLINE, and hand search) for studies published between January 1969 and April 1995. Criteria for inclusion were English-language articles, peer-reviewed original publications, and urogenital atrophy assessed by at least one of the following outcomes: patient symptoms, physician report, pH, or cytologic change. Data had to allow comparison between treated and control groups in controlled trials or an estimated change from baseline in uncontrolled series. Meta-analytic methods were applied separately to controlled clinical trials and uncontrolled studies.

Results: Of the 77 relevant articles reviewed, nine contained ten randomized controlled trials. Meta-analysis of these using the Stouffer method revealed a statistically significant benefit of estrogen therapy for all outcomes studied. In 54 uncontrolled case series, the patient symptoms were treated by 24 different treatment modalities. All routes of administration appeared to be effective and maximum benefit was obtained between 1 and 3 months after the start of treatment. As expected, the least systemic absorption of estrogen was seen with estriol (administered orally or vaginally), then vaginal estradiol as measured by pretherapy and posttherapy serum estradiol and estrone.

Conclusion: Estrogen is efficacious in the treatment of urogenital atrophy and low-dose vaginal estradiol preparations are as effective as systemic estrogen therapy in the treatment of urogenital atrophy in postmenopausal women.

Section snippets

Materials and methods

The literature review included a search of the databases of Excerpta Medica, Biosis, and MEDLINE, as well as a hand search of the relevant journals published between January 1969 (the start date of MEDLINE) and April 1995. The search was limited to English-language articles.

To be considered for inclusion, articles had to be original publications in a peer-reviewed journal, the subjects had to have urogenital atrophy, and the outcome of therapy had to be reported by one or more of the following

Results

Seventy-seven articles were reviewed and 58 were used for the meta-analysis. Of the 19 articles not used in the analysis, six did not contain outcomes that were considered in the meta-analysis, 11 had data that were inadequate for analysis, and two could not be classified appropriately.

Ten placebo controlled trials from nine articles were used to address the first aim of whether estrogen had a significant effect on urogenital atrophy. Table 2 describes the placebo controlled trials. From the

Discussion

Although this meta-analysis has clearly shown that estrogen therapy is beneficial for the treatment of symptoms and signs of urogenital atrophy, it is difficult to draw conclusions. The studies reviewed were heterogeneous and lacked standardization of patient selection, diagnostic criteria, study design, therapeutic intervention, follow up and, particularly, outcome variables. In addition, bias toward publication of positive results as well as variability in execution and implementation of

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The authors thank Pharmacia and Upjohn for providing financial support for this study.

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