In a recent study published in the journal BMC Women’s Health, researchers evaluated the efficacy of clomiphene and dexamethasone in treating polycystic ovary syndrome (PCOS).
PCOS is a gynecological disease affecting a substantial proportion of females of reproductive age. Affected individuals have irregular secretion of luteinizing (LH) and follicle-stimulating (FSH) hormones, as well as insulin resistance. The disease primarily results from an increased LH-to-FSH ratio and elevated secretion of gonadotropin-releasing hormone. Nevertheless, the etiology of PCOS is complex and debatable.
Clomiphene citrate has been considered the primary medication to induce ovulation in infertile PCOS patients. Further, dexamethasone can inhibit aromatase and regulate estrogen levels. Studies suggest that a combined dexamethasone and clomiphene therapy may improve ovulation and pregnancy outcomes in PCOS patients, albeit the evidence is unclear.
Study: A meta-analysis of efficacy on dexamethasone and clomiphene in the treatment of polycystic ovary syndrome patients. Image Credit: SewCreamStudio / Shutterstock
About the study
In the present study, researchers meta-analyzed the safety and efficacy of the combined clomiphene and dexamethasone treatment in PCOS patients. They searched PubMed, Cochrane Library, Embase, VIP Information Chinese Journal Service Platform, Wan Fang Medical Network, and China National Knowledge Infrastructure for relevant randomized controlled trials (RCTs) till January 2023. The team included RCTs that assessed the effects of the combined regimen in PCOS patients.
RCTs published in English or Chinese were included. Abstracts/titles were screened after deduplication, and full texts were reviewed for eligibility. The following data were extracted from the included studies: author and publication details, sample size, treatment measures, and outcomes. The Cochrane risk of bias tool was used to examine the quality of included studies and categorize them as having high, low, or unclear levels.
Standardized mean differences and corresponding 95% confidence intervals (CIs) were computed for continuous variables. Relative risk and corresponding 95% CIs were estimated for dichotomous variables. The I-squared statistic and the chi-squared test were performed to evaluate heterogeneity. Subgroup and sensitivity analyses were undertaken if there was substantial heterogeneity. Egger’s test, Begg’s test, and funnel plots were used to assess publication bias.
Findings
Overall, the team identified 211 records through database searches. After removing 54 duplicates and excluding 114 articles after title/abstract screening, they included 12 RCTs for analysis following a full-text review. A majority of RCTs had a low risk of bias. Eight studies reported on the number of pregnancies; no heterogeneity was observed among studies after pooling their data.
As such, a fixed-effect model was used to analyze the outcome; this revealed that the combined clomiphene and dexamethasone regimen could improve the pregnancy rate in PCOS patients. No publication bias was noted. Similarly, eight studies described the number of ovulations; there was no heterogeneity among these studies when data were pooled.
Analysis suggested that the combined treatment could improve the ovulation rate among PCOS patients. Ten studies reported LH levels, and heterogeneity was observed after data pooling. As such, a random-effects model was used; consistently, the combined treatment was likely to improve LH levels in PCOS patients.
Estradiol levels were reported in seven studies; heterogeneity was observed among them. As such, the random-effects model indicated that the combined regimen could effectively improve estradiol levels in PCOS patients. Eight studies reported on testosterone; analysis showed that the combined therapy could elevate its levels in those with PCOS. Progesterone levels were reported in four studies, and the combined therapy could enhance the hormone levels in PCOS patients.
Adverse effects were described in six studies. The combined treatment had an insignificant impact on the incidence of adverse effects in PCOS patients. Further, six and three studies reported vertigo and vomiting, respectively; the combined treatment had no significant impact on the incidence of vertigo or vomiting in PCOS patients.
Conclusions
In sum, the findings suggest that the combined clomiphene and dexamethasone treatment in PCOS patients could significantly elevate ovulation and pregnancy rates. The sample size was small, and there were variations in the quality of the studies, which might have impacted the reproducibility and generalizability of the findings.
Besides, the heterogeneity in estradiol and LH levels might result from the differences in therapeutic doses and treatment duration among studies. While the combined treatment did not elevate the risks of adverse effects, monitoring and reporting inconsistencies might mask safety concerns. Further large-scale, high-quality RCTs are required to validate these results.
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