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Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial.

Abstract

BACKGROUND

Our aim was to assess the effects of metformin on menstrual frequency, fasting plasma glucose (FPG), insulin resistance assessed as HOMA-index, weight, waist/hip ratio, blood pressure (BP), serum lipids, and testosterone levels in women with polycystic ovary syndrome (PCOS) METHODS: In a randomized, controlled, double-blinded setup, 56 women aged 18-45 with PCOS were treated with either metformin 850 mg or placebo twice daily for 6 months. After a wash-out period of 3 months participants received the alternate treatment for 6 months. The changes in the measured parameters were analysed by intention-to-treat and per protocol.

RESULTS

There were no changes in menstrual frequency. In the intention-to-treat analysis, weight and systolic BP were reduced on metformin treatment (p=0.009 and 0.047, respectively), while high-density lipoprotein (HDL) increased (p=0.001). On placebo, weight and FPG increased (p<0.05). Post-hoc subgrouping according to BMI revealed reductions in testosterone (p=0.013), FPG (p=0.018), insulin (p=0.045) and HOMA-index (p=0.022) in obese women. Per protocol analysis showed the following differences between the changes on placebo and metformin (mean (5 - 95 % percentiles): weight (-4.2 (-7.0, -1.9) kg, p<0.001), FPG (-0.23 (-0.44, -0.01) mmol/l, p=0.041), insulin (-4.17 (-8.10, -0.23) mIU/l, p=0.039) and HOMA index (-1.50 (-2.53, -0.47) mIU/l*mmol/l, p=0.006). Weight, FPG and HOMA index were lower after metformin than after placebo.

CONCLUSIONS

Metformin treatment lowered weight and systolic blood pressure and increased HDL in women with PCOS. In post-hoc analysis it increased insulin sensitivity and lowered testosterone in obese women. Non-obese women did not benefit from metformin.

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  • Publisher Full Text
  • Authors+Show Affiliations

    ,

    Department of Obstetrics and Gynaecology, Aarhus University Hospital, Skejby, DK-8200, Aarhus N, Denmark. ditte.trolle@dadlnet.dk

    , ,

    Source

    Human reproduction (Oxford, England) 22:11 2007 Nov pg 2967-73

    MeSH

    Adolescent
    Adult
    Body Weight
    Cross-Over Studies
    Double-Blind Method
    Female
    Humans
    Insulin
    Metformin
    Middle Aged
    Obesity
    Placebos
    Polycystic Ovary Syndrome
    Testosterone
    Treatment Outcome

    Pub Type(s)

    Journal Article
    Randomized Controlled Trial
    Research Support, Non-U.S. Gov't

    Language

    eng

    PubMed ID

    17766923

    Citation

    Trolle, B, et al. "Efficacy of Metformin in Obese and Non-obese Women With Polycystic Ovary Syndrome: a Randomized, Double-blinded, Placebo-controlled Cross-over Trial." Human Reproduction (Oxford, England), vol. 22, no. 11, 2007, pp. 2967-73.
    Trolle B, Flyvbjerg A, Kesmodel U, et al. Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial. Hum Reprod. 2007;22(11):2967-73.
    Trolle, B., Flyvbjerg, A., Kesmodel, U., & Lauszus, F. F. (2007). Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial. Human Reproduction (Oxford, England), 22(11), pp. 2967-73.
    Trolle B, et al. Efficacy of Metformin in Obese and Non-obese Women With Polycystic Ovary Syndrome: a Randomized, Double-blinded, Placebo-controlled Cross-over Trial. Hum Reprod. 2007;22(11):2967-73. PubMed PMID: 17766923.
    * Article titles in AMA citation format should be in sentence-case
    TY - JOUR T1 - Efficacy of metformin in obese and non-obese women with polycystic ovary syndrome: a randomized, double-blinded, placebo-controlled cross-over trial. AU - Trolle,B, AU - Flyvbjerg,A, AU - Kesmodel,U, AU - Lauszus,F F, Y1 - 2007/08/31/ PY - 2007/9/4/pubmed PY - 2008/5/3/medline PY - 2007/9/4/entrez SP - 2967 EP - 73 JF - Human reproduction (Oxford, England) JO - Hum. Reprod. VL - 22 IS - 11 N2 - BACKGROUND: Our aim was to assess the effects of metformin on menstrual frequency, fasting plasma glucose (FPG), insulin resistance assessed as HOMA-index, weight, waist/hip ratio, blood pressure (BP), serum lipids, and testosterone levels in women with polycystic ovary syndrome (PCOS) METHODS: In a randomized, controlled, double-blinded setup, 56 women aged 18-45 with PCOS were treated with either metformin 850 mg or placebo twice daily for 6 months. After a wash-out period of 3 months participants received the alternate treatment for 6 months. The changes in the measured parameters were analysed by intention-to-treat and per protocol. RESULTS: There were no changes in menstrual frequency. In the intention-to-treat analysis, weight and systolic BP were reduced on metformin treatment (p=0.009 and 0.047, respectively), while high-density lipoprotein (HDL) increased (p=0.001). On placebo, weight and FPG increased (p<0.05). Post-hoc subgrouping according to BMI revealed reductions in testosterone (p=0.013), FPG (p=0.018), insulin (p=0.045) and HOMA-index (p=0.022) in obese women. Per protocol analysis showed the following differences between the changes on placebo and metformin (mean (5 - 95 % percentiles): weight (-4.2 (-7.0, -1.9) kg, p<0.001), FPG (-0.23 (-0.44, -0.01) mmol/l, p=0.041), insulin (-4.17 (-8.10, -0.23) mIU/l, p=0.039) and HOMA index (-1.50 (-2.53, -0.47) mIU/l*mmol/l, p=0.006). Weight, FPG and HOMA index were lower after metformin than after placebo. CONCLUSIONS: Metformin treatment lowered weight and systolic blood pressure and increased HDL in women with PCOS. In post-hoc analysis it increased insulin sensitivity and lowered testosterone in obese women. Non-obese women did not benefit from metformin. SN - 0268-1161 UR - https://www.unboundmedicine.com/medline/citation/17766923/Efficacy_of_metformin_in_obese_and_non_obese_women_with_polycystic_ovary_syndrome:_a_randomized_double_blinded_placebo_controlled_cross_over_trial_ L2 - https://academic.oup.com/humrep/article-lookup/doi/10.1093/humrep/dem271 DB - PRIME DP - Unbound Medicine ER -