OBJECTIVE: To obtain data from a pilot randomized trial on the effect of metformin therapy and lifestyle modification on ovulation and androgen concentrations in women with polycystic ovary syndrome (PCOS). DESIGN: Prospective, randomized, placebo-controlled pilot trial. SETTING: Academic medical center. PATIENT(S): Thirty-eight overweight or obese women with PCOS. INTERVENTION(S): All subjects were randomized to one of four 48-week interventions: metformin 850 mg two times per day, lifestyle modification plus metformin 850 mg two times per day, lifestyle modification plus placebo, or placebo alone. MAIN OUTCOME MEASURE(S): Recruitment, dropout, and compliance with a long-term lifestyle intervention in PCOS; preliminary estimates of treatment effect on ovulation, as measured by weekly urinary pregnanediol glucuronide, and on total T and free androgen index. RESULT(S): It was necessary to screen seven women to have one subject randomized. The dropout rate was 39%, with the majority of dropouts occurring within the first 24 weeks. Mean body mass index was >39 mg/kg(2). Modest weight reduction was found in all treatment groups, with the most significant reduction occurring with the combination of metformin and lifestyle intervention. Significant androgen reduction occurred in the combination group only. Ovulation rates did not differ significantly between groups. However, when data were analyzed by presence or absence of weight reduction in subjects, independent of treatment group, the estimated odds ratio for weight loss was 9.0 (95% confidence interval 1.2-64.7) with respect to regular ovulation. If weight loss occurred during metformin therapy, the odds ratio for regular ovulation was 16.2 (95% confidence interval 4.4-60.2). CONCLUSION(S): Key methodologic issues for a large-scale, randomized trial of lifestyle intervention in PCOS include minimizing early dropout from the lifestyle intervention and including a range of body mass index that is not skewed toward severe obesity. Weight reduction might play the most significant role in restoration of ovulation in obese women with PCOS.
RCT Entities:
OBJECTIVE: To obtain data from a pilot randomized trial on the effect of metformin therapy and lifestyle modification on ovulation and androgen concentrations in women with polycystic ovary syndrome (PCOS). DESIGN: Prospective, randomized, placebo-controlled pilot trial. SETTING: Academic medical center. PATIENT(S): Thirty-eight overweight or obesewomen with PCOS. INTERVENTION(S): All subjects were randomized to one of four 48-week interventions: metformin 850 mg two times per day, lifestyle modification plus metformin 850 mg two times per day, lifestyle modification plus placebo, or placebo alone. MAIN OUTCOME MEASURE(S): Recruitment, dropout, and compliance with a long-term lifestyle intervention in PCOS; preliminary estimates of treatment effect on ovulation, as measured by weekly urinary pregnanediol glucuronide, and on total T and free androgen index. RESULT(S): It was necessary to screen seven women to have one subject randomized. The dropout rate was 39%, with the majority of dropouts occurring within the first 24 weeks. Mean body mass index was >39 mg/kg(2). Modest weight reduction was found in all treatment groups, with the most significant reduction occurring with the combination of metformin and lifestyle intervention. Significant androgen reduction occurred in the combination group only. Ovulation rates did not differ significantly between groups. However, when data were analyzed by presence or absence of weight reduction in subjects, independent of treatment group, the estimated odds ratio for weight loss was 9.0 (95% confidence interval 1.2-64.7) with respect to regular ovulation. If weight loss occurred during metformin therapy, the odds ratio for regular ovulation was 16.2 (95% confidence interval 4.4-60.2). CONCLUSION(S): Key methodologic issues for a large-scale, randomized trial of lifestyle intervention in PCOS include minimizing early dropout from the lifestyle intervention and including a range of body mass index that is not skewed toward severe obesity. Weight reduction might play the most significant role in restoration of ovulation in obesewomen with PCOS.
Authors: Gwinnett Ladson; William C Dodson; Stephanie D Sweet; Anthony E Archibong; Allen R Kunselman; Laurence M Demers; Peter A Lee; Nancy I Williams; Ponjola Coney; Richard S Legro Journal: Fertil Steril Date: 2011-06-30 Impact factor: 7.329
Authors: Juan Pablo Domecq; Gabriela Prutsky; Rebecca J Mullan; Vishnu Sundaresh; Amy T Wang; Patricia J Erwin; Corrine Welt; David Ehrmann; Victor M Montori; Mohammad Hassan Murad Journal: J Clin Endocrinol Metab Date: 2013-10-03 Impact factor: 5.958
Authors: Meike A Q Mutsaerts; Henk Groen; Nancy C W ter Bogt; Johanna H T Bolster; Jolande A Land; Wanda J E Bemelmans; Walter K H Kuchenbecker; Peter G A Hompes; Nick S Macklon; Ronald P Stolk; Fulco van der Veen; Jacques W M Maas; Nicole F Klijn; Eugenie M Kaaijk; Gerrit J E Oosterhuis; Peter X J M Bouckaert; Jaap M Schierbeek; Yvonne M van Kasteren; Annemiek W Nap; Frank J Broekmans; Egbert A Brinkhuis; Carolien A M Koks; Jan M Burggraaff; Adrienne S Blankhart; Denise A M Perquin; Marie H Gerards; Robert J A B Mulder; Ed T C M Gondrie; Ben W J Mol; Annemieke Hoek Journal: BMC Womens Health Date: 2010-06-25 Impact factor: 2.809
Authors: Alberly Perez; Victor A Alos; Adam Scanlan; Catarina M Maia; Adam Davey; Robert C Whitaker; Gary D Foster; Ronald T Ackermann; Matthew J O'Brien Journal: Contemp Clin Trials Date: 2015-10-24 Impact factor: 2.226