Lopez Laureen M, Bernholc Alissa, Chen Mario, Grey Thomas W, Otterness Conrad, Westhoff Carolyn, Edelman Alison, Helmerhorst Frans M
Clinical and Epidemiological Sciences, FHI 360, 359 Blackwell St, Suite 200, Durham, North Carolina, USA, 27701.
Cochrane Database Syst Rev. 2016 Aug 18;2016(8):CD008452. doi: 10.1002/14651858.CD008452.pub4.
Obesity has reached epidemic proportions around the world. Effectiveness of hormonal contraceptives may be related to metabolic changes in obesity or to greater body mass or body fat. Hormonal contraceptives include oral contraceptives (OCs), injectables, implants, hormonal intrauterine contraception (IUC), the transdermal patch, and the vaginal ring. Given the prevalence of overweight and obesity, the public health impact of any effect on contraceptive efficacy could be substantial.
To examine the effectiveness of hormonal contraceptives in preventing pregnancy among women who are overweight or obese versus women with a lower body mass index (BMI) or weight.
Until 4 August 2016, we searched for studies in PubMed (MEDLINE), CENTRAL, POPLINE, Web of Science, ClinicalTrials.gov, and ICTRP. We examined reference lists of pertinent articles to identify other studies. For the initial review, we wrote to investigators to find additional published or unpublished studies.
All study designs were eligible. The study could have examined any type of hormonal contraceptive. Reports had to contain information on the specific contraceptive methods used. The primary outcome was pregnancy. Overweight or obese women must have been identified by an analysis cutoff for weight or BMI (kg/m(2)).
Two authors independently extracted the data. One entered the data into RevMan and a second verified accuracy. The main comparisons were between overweight or obese women and women of lower weight or BMI. We examined the quality of evidence using the Newcastle-Ottawa Quality Assessment Scale. Where available, we included life-table rates. We also used unadjusted pregnancy rates, relative risk (RR), or rate ratio when those were the only results provided. For dichotomous variables, we computed an odds ratio with 95% confidence interval (CI).
With 8 studies added in this update, 17 met our inclusion criteria and had a total of 63,813 women. We focus here on 12 studies that provided high, moderate, or low quality evidence. Most did not show a higher pregnancy risk among overweight or obese women. Of five COC studies, two found BMI to be associated with pregnancy but in different directions. With an OC containing norethindrone acetate and ethinyl estradiol (EE), pregnancy risk was higher for overweight women, i.e. with BMI ≥ 25 versus those with BMI < 25 (reported relative risk 2.49, 95% CI 1.01 to 6.13). In contrast, a trial using an OC with levonorgestrel and EE reported a Pearl Index of 0 for obese women (BMI ≥ 30) versus 5.59 for nonobese women (BMI < 30). The same trial tested a transdermal patch containing levonorgestrel and EE. Within the patch group, obese women in the "treatment-compliant" subgroup had a higher reported Pearl Index than nonobese women (4.63 versus 2.15). Of five implant studies, two that examined the six-capsule levonorgestrel implant showed differences in pregnancy by weight. One study showed higher weight was associated with higher pregnancy rate in years 6 and 7 combined (reported P < 0.05). In the other, pregnancy rates differed in year 5 among the lower weight groups only (reported P < 0.01) and did not involve women weighing 70 kg or more.Analysis of data from other contraceptive methods indicated no association of pregnancy with overweight or obesity. These included depot medroxyprogesterone acetate (subcutaneous), levonorgestrel IUC, the two-rod levonorgestrel implant, and the etonogestrel implant.
AUTHORS' CONCLUSIONS: The evidence generally did not indicate an association between higher BMI or weight and effectiveness of hormonal contraceptives. However, we found few studies for most contraceptive methods. Studies using BMI, rather than weight alone, can provide information about whether body composition is related to contraceptive effectiveness. The contraceptive methods examined here are among the most effective when used according to the recommended regimen.We considered the overall quality of evidence to be low for the objectives of this review. More recent reports provided evidence of varying quality, while the quality was generally low for older studies. For many trials the quality would be higher for their original purpose rather than the non-randomized comparisons here. Investigators should consider adjusting for potential confounding related to BMI or contraceptive effectiveness. Newer studies included a greater proportion of overweight or obese women, which helps in examining effectiveness and side effects of hormonal contraceptives within those groups.
肥胖在全球已达到流行程度。激素避孕方法的有效性可能与肥胖引起的代谢变化有关,也可能与更高的体重或体脂有关。激素避孕方法包括口服避孕药(OCs)、注射剂、植入剂、激素宫内节育器(IUC)、透皮贴剂和阴道环。鉴于超重和肥胖的普遍存在,任何对避孕效果的影响对公共卫生的影响都可能很大。
比较超重或肥胖女性与体重指数(BMI)较低或体重较轻的女性使用激素避孕方法预防妊娠的有效性。
截至2016年8月4日,我们检索了PubMed(MEDLINE)、CENTRAL、POPLINE、Web of Science、ClinicalTrials.gov和ICTRP中的研究。我们查阅了相关文章的参考文献列表以识别其他研究。在初步综述中,我们写信给研究人员以查找其他已发表或未发表的研究。
所有研究设计均符合要求。研究可以考察任何类型的激素避孕方法。报告必须包含所使用的具体避孕方法的信息。主要结局是妊娠。超重或肥胖女性必须通过体重或BMI(kg/m²)的分析临界值来确定。
两位作者独立提取数据。一人将数据录入RevMan,另一人核实准确性。主要比较是超重或肥胖女性与体重较轻或BMI较低的女性之间的比较。我们使用纽卡斯尔-渥太华质量评估量表检查证据质量。如有可用数据,我们纳入了生命表率。当仅提供未调整的妊娠率、相对风险(RR)或率比时,我们也使用这些数据。对于二分变量,我们计算了95%置信区间(CI)的比值比。
本次更新增加了8项研究,17项符合我们的纳入标准,共有63813名女性。我们在此重点关注提供了高、中或低质量证据的12项研究。大多数研究未显示超重或肥胖女性的妊娠风险更高。在5项复方口服避孕药(COC)研究中,2项发现BMI与妊娠有关,但方向不同。对于含有醋酸炔诺酮和炔雌醇(EE)的口服避孕药,超重女性(即BMI≥25)的妊娠风险高于BMI<25的女性(报告的相对风险为2.49,95%CI为1.01至6.13)。相比之下,一项使用含有左炔诺孕酮和炔雌醇的口服避孕药的试验报告,肥胖女性(BMI≥30)的Pearl指数为0,而非肥胖女性(BMI<30)为5.59。同一试验测试了含有左炔诺孕酮和炔雌醇的透皮贴剂。在贴剂组中,“依从治疗”亚组的肥胖女性报告的Pearl指数高于非肥胖女性(4.63对2.15)。在5项植入剂研究中,2项研究六枚左炔诺孕酮植入剂的研究显示妊娠情况因体重而异。一项研究显示,在第6年和第7年合计时,体重越高妊娠率越高(报告的P<0.05)。在另一项研究中,仅在体重较轻的组中第5年妊娠率有所不同(报告的P<0.01),且未涉及体重70kg及以上的女性。对其他避孕方法数据的分析表明,妊娠与超重或肥胖无关。这些方法包括醋酸甲羟孕酮长效注射剂(皮下注射)、左炔诺孕酮宫内节育器、双棒左炔诺孕酮植入剂和依托孕烯植入剂。
证据总体上未表明较高的BMI或体重与激素避孕方法的有效性之间存在关联。然而,我们发现针对大多数避孕方法的研究较少。使用BMI而非仅体重进行的研究可以提供有关身体组成是否与避孕效果相关的信息。此处考察的避孕方法按照推荐方案使用时是最有效的方法之一。我们认为本综述目标的证据总体质量较低。较新的报告提供了质量各异的证据,而较旧研究的质量总体较低。对于许多试验,就其原始目的而言质量会更高,而非此处的非随机比较。研究人员应考虑对与BMI或避孕效果相关的潜在混杂因素进行调整。较新的研究纳入了更大比例的超重或肥胖女性,这有助于考察这些人群中激素避孕方法的有效性和副作用。