T. Wongwananuruk, Nalinee Panichyawat, Tachjaree Panchalee, P. Jirakittidul, S. Angsuwathana, Korakot Sirimai, Manopchai Thamkhantho, G. Chiravacharadej
{"title":"一项随机对照试验:30-μg炔雌醇/2-mg醋酸氯麦地那酮或30-μg炔雌醇/3-mg溴螺酮避孕药对体重变化的影响","authors":"T. Wongwananuruk, Nalinee Panichyawat, Tachjaree Panchalee, P. Jirakittidul, S. Angsuwathana, Korakot Sirimai, Manopchai Thamkhantho, G. Chiravacharadej","doi":"10.1080/13625187.2019.1688290","DOIUrl":null,"url":null,"abstract":"Abstract Objectives: The aim of this study was to compare changes in body weight in women using a combined oral contraceptive (COC) consisting of 30-μg ethinylestradiol (EE) and 2-mg chlormadinone acetate (CMA) or a COC consisting of 30-μg EE and 3-mg drospirenone (DRSP). Methods: This randomised double-blind controlled trial (ClinicalTrials.gov NCT01608698) was conducted at a university hospital-based clinic in Thailand between June 2012 and September 2015. A total of 102 women were enrolled in the study, 99 of whom were randomised to EE/CMA (n = 45) or EE/DRSP (n = 54). Each participant was treated for six cycles. Body weight and other parameters as well as side effects were recorded at baseline and at the end of the third and sixth cycles of treatment. Results: A significant difference was observed in mean body weight change between the EE/CMA and EE/DRSP groups from both baseline to third cycle (0.51 ± 1.36 kg vs –0.43 ± 1.56 kg; p = .003) and baseline to sixth cycle (1.00 ± 1.84 kg vs –0.20 ± 2.23 kg; p = .013). The mean difference in body mass index and waist circumference had a similar trend to that of the mean difference in body weight. There was no significant difference in side effects between groups. Conclusion: A COC containing 30-µg EE/3-mg DRSP tended to confer a significantly more favourable change in body weight over a 6-month period compared with a COC containing 30-µg EE/2-mg CMA, which was associated with an increase in body weight.","PeriodicalId":22423,"journal":{"name":"The European Journal of Contraception & Reproductive Health Care","volume":"1 1","pages":"43 - 48"},"PeriodicalIF":0.0000,"publicationDate":"2019-11-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"3","resultStr":"{\"title\":\"Comparison of change in body weight between contraception containing 30-μg ethinylestradiol/2-mg chlormadinone acetate or 30-μg ethinylestradiol/3-mg drospirenone: a randomised controlled trial\",\"authors\":\"T. Wongwananuruk, Nalinee Panichyawat, Tachjaree Panchalee, P. Jirakittidul, S. Angsuwathana, Korakot Sirimai, Manopchai Thamkhantho, G. Chiravacharadej\",\"doi\":\"10.1080/13625187.2019.1688290\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"Abstract Objectives: The aim of this study was to compare changes in body weight in women using a combined oral contraceptive (COC) consisting of 30-μg ethinylestradiol (EE) and 2-mg chlormadinone acetate (CMA) or a COC consisting of 30-μg EE and 3-mg drospirenone (DRSP). Methods: This randomised double-blind controlled trial (ClinicalTrials.gov NCT01608698) was conducted at a university hospital-based clinic in Thailand between June 2012 and September 2015. A total of 102 women were enrolled in the study, 99 of whom were randomised to EE/CMA (n = 45) or EE/DRSP (n = 54). Each participant was treated for six cycles. Body weight and other parameters as well as side effects were recorded at baseline and at the end of the third and sixth cycles of treatment. Results: A significant difference was observed in mean body weight change between the EE/CMA and EE/DRSP groups from both baseline to third cycle (0.51 ± 1.36 kg vs –0.43 ± 1.56 kg; p = .003) and baseline to sixth cycle (1.00 ± 1.84 kg vs –0.20 ± 2.23 kg; p = .013). The mean difference in body mass index and waist circumference had a similar trend to that of the mean difference in body weight. There was no significant difference in side effects between groups. 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引用次数: 3
摘要
摘要目的:比较30 μg炔雌醇(EE)和2 mg醋酸氯麦地那酮(CMA)组成的复方口服避孕药(COC)和30 μg EE和3 mg降螺酮(DRSP)组成的复方口服避孕药(COC)对女性体重的影响。方法:这项随机双盲对照试验(ClinicalTrials.gov NCT01608698)于2012年6月至2015年9月在泰国一家大学医院诊所进行。研究共纳入102名女性,其中99名随机分为EE/CMA组(n = 45)或EE/DRSP组(n = 54)。每位参与者治疗6个周期。在基线和第三和第六个治疗周期结束时记录体重和其他参数以及副作用。结果:EE/CMA组和EE/DRSP组从基线到第三周期的平均体重变化有显著差异(0.51±1.36 kg vs -0.43±1.56 kg;P = 0.003)和基线至第六个周期(1.00±1.84 kg vs -0.20±2.23 kg;p = .013)。体重指数和腰围的平均差值与体重的平均差值有相似的变化趋势。两组间副作用无显著差异。结论:与含有30µg EE/2 mg CMA的COC相比,含有30µg EE/3 mg DRSP的COC在6个月的时间内倾向于给体重带来更有利的变化,这与体重增加有关。
Comparison of change in body weight between contraception containing 30-μg ethinylestradiol/2-mg chlormadinone acetate or 30-μg ethinylestradiol/3-mg drospirenone: a randomised controlled trial
Abstract Objectives: The aim of this study was to compare changes in body weight in women using a combined oral contraceptive (COC) consisting of 30-μg ethinylestradiol (EE) and 2-mg chlormadinone acetate (CMA) or a COC consisting of 30-μg EE and 3-mg drospirenone (DRSP). Methods: This randomised double-blind controlled trial (ClinicalTrials.gov NCT01608698) was conducted at a university hospital-based clinic in Thailand between June 2012 and September 2015. A total of 102 women were enrolled in the study, 99 of whom were randomised to EE/CMA (n = 45) or EE/DRSP (n = 54). Each participant was treated for six cycles. Body weight and other parameters as well as side effects were recorded at baseline and at the end of the third and sixth cycles of treatment. Results: A significant difference was observed in mean body weight change between the EE/CMA and EE/DRSP groups from both baseline to third cycle (0.51 ± 1.36 kg vs –0.43 ± 1.56 kg; p = .003) and baseline to sixth cycle (1.00 ± 1.84 kg vs –0.20 ± 2.23 kg; p = .013). The mean difference in body mass index and waist circumference had a similar trend to that of the mean difference in body weight. There was no significant difference in side effects between groups. Conclusion: A COC containing 30-µg EE/3-mg DRSP tended to confer a significantly more favourable change in body weight over a 6-month period compared with a COC containing 30-µg EE/2-mg CMA, which was associated with an increase in body weight.