Gallo Maria F, Legardy-Williams Jennifer, Hylton-Kong Tina, Rattray Carole, Kourtis Athena P, Jamieson Denise J, Steiner Markus J
Division of Epidemiology, College of Public Health, The Ohio State University, Columbus, Ohio; the Division of Reproductive Health, Centers for Disease Control and Prevention, Atlanta, Georgia; the Comprehensive Health Centre/Epidemiology Research and Training Unit and the University Hospital of the West Indies, the Ministry of Health, Kingston, Jamaica; and the Contraceptive Technology Innovation Division, FHI 360, Durham, North Carolina.
Obstet Gynecol. 2016 Mar;127(3):573-576. doi: 10.1097/AOG.0000000000001289.
To evaluate initiation of a two-rod, 150-mg levonorgestrel contraceptive implant on women's perceived and observed body weight.
We conducted a secondary analysis of data from an open, randomized controlled trial of adult, nonpregnant, human immunodeficiency virus-negative women attending a public clinic in Kingston, Jamaica, who were assigned to initiate implant use either immediately or after a 3-month delay. The primary objective of the parent study was to assess the effect of initiation of the implant on the frequency of condom use. We compared study arms during follow-up using one-sided χ tests for differences in perceived weight gain and loss, one-sided Wilcoxon-Mann-Whitney tests for median gain in measured weight, and logistic regression with generalized estimating equations for risk of gaining greater than 2 kg.
From 2012 to 2014, women were assigned to the implant (n=208) or delay arm (n=206). At 3 months, more women in the implant arm (15.3%) reported perceived weight gain than in the control arm (4.3%) (P=.01). Despite differences in perception, the implant and control arms did not differ significantly in median weight gain at 1-month (0.0 kg and 0.0 kg, respectively; P=.44) and 3-month visits (0.5 kg and 0.0 kg, respectively; P=.27). Study arms did not differ in risk of gaining greater than 2 kg (odds ratio 0.9, 95% confidence interval 0.6-1.3).
We found no evidence of weight gain from short-term implant use. Through the power of the nocebo effect, the practice of counseling women to expect possible weight gain from initiating implant use could lead them to perceive weight gain even in its absence and contribute to the early discontinuation of this highly effective contraceptive method.
评估植入含150毫克左炔诺孕酮的双棒式避孕器对女性自我感知及观察到的体重的影响。
我们对一项开放、随机对照试验的数据进行了二次分析,该试验的对象为牙买加金斯敦一家公共诊所的成年、未怀孕、人类免疫缺陷病毒阴性的女性,她们被分配为立即开始使用避孕器或延迟3个月后开始使用。母研究的主要目的是评估开始使用避孕器对避孕套使用频率的影响。我们在随访期间比较了各研究组,使用单侧χ检验来分析自我感知的体重增加和减少的差异,使用单侧Wilcoxon-Mann-Whitney检验来分析测量体重的中位数增加情况,并使用广义估计方程的逻辑回归来分析体重增加超过2千克的风险。
2012年至2014年,女性被分配到植入组(n = 208)或延迟组(n = 206)。3个月时,植入组中更多女性(15.3%)报告自我感知体重增加,高于对照组(4.3%)(P = .01)。尽管在感知上存在差异,但植入组和对照组在1个月(分别为0.0千克和0.0千克;P = .44)和3个月随访时(分别为0.5千克和0.0千克;P = .27)的体重中位数增加没有显著差异。各研究组在体重增加超过2千克的风险方面没有差异(比值比0.9,95%置信区间0.6 - 1.3)。
我们没有发现短期使用避孕器会导致体重增加的证据。由于反安慰剂效应的影响,在咨询女性时告知她们开始使用避孕器可能会导致体重增加,这可能会使她们即使在体重没有增加的情况下也感知到体重增加,并促使她们过早停用这种高效的避孕方法。