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Early effects of metformin in women with polycystic ovary syndrome: a prospective randomized, double-blind, placebo-controlled trial.
J Clin Endocrinol Metab. 2006 Mar; 91(3):946-52.JC

Abstract

CONTEXT

Metformin is successfully used in the treatment of cycle disorders and anovulation in women with polycystic ovary syndrome (PCOS). No data of the exact point and the impact of insulin resistance (IR) on metformin's efficacy exist.

OBJECTIVE

The objective of the study was to evaluate the early potential effects of metformin treatment, their time of onset, and the role of IR on metformin's efficacy.

DESIGN

This was a prospective randomized, double-blind, placebo-controlled trial.

SETTING

The study was conducted at the University of Heidelberg, Heidelberg, Germany.

PATIENTS

The patient population was 45 oligo-/anovulatory PCOS women with typical ovaries.

INTERVENTIONS

Women were stratified for IR (32 of 13) and then randomly allocated to receive either metformin (n = 22) or placebo (n = 23) and were assessed before and every 4 wk within a treatment period of 12 wk.

MAIN OUTCOME MEASURES

Menstrual disturbance and markers of insulin metabolism were measured.

RESULTS

The main outcome criterion menstrual disturbance was successfully improved in the metformin-treated group, depending on IR (12 of 15 vs. three of 17), whereas women without IR (four of seven vs. four of six) had no significant amelioration of their menstrual irregularities (P < 0.05). Estradiol levels increased continuously only in the treatment group (P < 0.005), indicating an improvement of ovulatory function. Sixty-seven percent of metformin-treated women had at least one ovulation, compared with only 45% in the placebo group, shown by biphasic body temperature curves. Insulin sensitivity improved within 4 wk after beginning of metformin as shown by an increased area under the curve glucose to insulin ratio, compared with baseline (P < 0.005).

CONCLUSIONS

IR is a baseline predictor of clinical efficacy in metformin treatment in PCOS women measured by improved menstrual cyclicity and ovulatory function.

Authors+Show Affiliations

Women's University Hospital, Department of Gynecological Endocrinology and Reproductive Medicine and Department of Obstetrics and Gynecology, Vossstr. 9, 69115 Heidelberg, Germany. stefan.eisenhardt@med.uni-heidelberg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Journal Article
Randomized Controlled Trial

Language

eng

PubMed ID

16352680

Citation

Eisenhardt, S, et al. "Early Effects of Metformin in Women With Polycystic Ovary Syndrome: a Prospective Randomized, Double-blind, Placebo-controlled Trial." The Journal of Clinical Endocrinology and Metabolism, vol. 91, no. 3, 2006, pp. 946-52.
Eisenhardt S, Schwarzmann N, Henschel V, et al. Early effects of metformin in women with polycystic ovary syndrome: a prospective randomized, double-blind, placebo-controlled trial. J Clin Endocrinol Metab. 2006;91(3):946-52.
Eisenhardt, S., Schwarzmann, N., Henschel, V., Germeyer, A., von Wolff, M., Hamann, A., & Strowitzki, T. (2006). Early effects of metformin in women with polycystic ovary syndrome: a prospective randomized, double-blind, placebo-controlled trial. The Journal of Clinical Endocrinology and Metabolism, 91(3), 946-52.
Eisenhardt S, et al. Early Effects of Metformin in Women With Polycystic Ovary Syndrome: a Prospective Randomized, Double-blind, Placebo-controlled Trial. J Clin Endocrinol Metab. 2006;91(3):946-52. PubMed PMID: 16352680.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Early effects of metformin in women with polycystic ovary syndrome: a prospective randomized, double-blind, placebo-controlled trial. AU - Eisenhardt,S, AU - Schwarzmann,N, AU - Henschel,V, AU - Germeyer,A, AU - von Wolff,M, AU - Hamann,A, AU - Strowitzki,T, Y1 - 2005/12/13/ PY - 2005/12/15/pubmed PY - 2006/6/8/medline PY - 2005/12/15/entrez SP - 946 EP - 52 JF - The Journal of clinical endocrinology and metabolism JO - J Clin Endocrinol Metab VL - 91 IS - 3 N2 - CONTEXT: Metformin is successfully used in the treatment of cycle disorders and anovulation in women with polycystic ovary syndrome (PCOS). No data of the exact point and the impact of insulin resistance (IR) on metformin's efficacy exist. OBJECTIVE: The objective of the study was to evaluate the early potential effects of metformin treatment, their time of onset, and the role of IR on metformin's efficacy. DESIGN: This was a prospective randomized, double-blind, placebo-controlled trial. SETTING: The study was conducted at the University of Heidelberg, Heidelberg, Germany. PATIENTS: The patient population was 45 oligo-/anovulatory PCOS women with typical ovaries. INTERVENTIONS: Women were stratified for IR (32 of 13) and then randomly allocated to receive either metformin (n = 22) or placebo (n = 23) and were assessed before and every 4 wk within a treatment period of 12 wk. MAIN OUTCOME MEASURES: Menstrual disturbance and markers of insulin metabolism were measured. RESULTS: The main outcome criterion menstrual disturbance was successfully improved in the metformin-treated group, depending on IR (12 of 15 vs. three of 17), whereas women without IR (four of seven vs. four of six) had no significant amelioration of their menstrual irregularities (P < 0.05). Estradiol levels increased continuously only in the treatment group (P < 0.005), indicating an improvement of ovulatory function. Sixty-seven percent of metformin-treated women had at least one ovulation, compared with only 45% in the placebo group, shown by biphasic body temperature curves. Insulin sensitivity improved within 4 wk after beginning of metformin as shown by an increased area under the curve glucose to insulin ratio, compared with baseline (P < 0.005). CONCLUSIONS: IR is a baseline predictor of clinical efficacy in metformin treatment in PCOS women measured by improved menstrual cyclicity and ovulatory function. SN - 0021-972X UR - https://www.unboundmedicine.com/medline/citation/16352680/Early_effects_of_metformin_in_women_with_polycystic_ovary_syndrome:_a_prospective_randomized_double_blind_placebo_controlled_trial_ L2 - https://academic.oup.com/jcem/article-lookup/doi/10.1210/jc.2005-1994 DB - PRIME DP - Unbound Medicine ER -