The reproductive and metabolic effect of rosiglitazone on Chinese women with polycystic ovarian syndrome--a double-blind randomized placebo-controlled study.

OBJECTIVE

To investigate whether an insulin sensitizer has any effect on amenorrhea and clinical and biochemical hyperandrogenism in Chinese women with polycystic ovarian syndrome (PCOS).

DESIGN

Randomized controlled double-blind trial.

SETTING

A tertiary referral center, Hong Kong.

PATIENT(S): Chinese women who fulfilled the Rotterdam criteria of PCOS (n = 70).

INTERVENTION(S): Rosiglitazone 4 mg daily for the first month followed by 4 mg twice daily for 11 months.

MAIN OUTCOME MEASURE(S): Menstrual status as well as clinical and biochemical hyperandrogenism.

RESULT(S): There is a significantly higher rate of regular menses among the treatment arm (16 [50.0%] of 32 vs 4 [11.8%] of 34) at 6 months and the improvement appeared to be sustained (10 [41.7%] of 24 vs 6 [20.0%] of 30) at 12 months. There was no change in the acne and hirsutism scores as well as serum T levels in both arms.

CONCLUSION(S): We found a possible benefit in menstrual cyclicity but a lack of improvement in hyperandrogenism in our Chinese population.

CLINICAL TRIAL REGISTRATION NUMBER

ChiCTR-TRC-09000670 (Chinese Clinical Trial Registry).