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Review
. 2016 Aug 18;2016(8):CD008452.
doi: 10.1002/14651858.CD008452.pub4.

Hormonal contraceptives for contraception in overweight or obese women

Laureen M Lopez  1 , Alissa Bernholc, Mario Chen, Thomas W Grey, Conrad Otterness, Carolyn Westhoff, Alison Edelman, Frans M Helmerhorst
Affiliations
Review

Hormonal contraceptives for contraception in overweight or obese women

Laureen M Lopez et al. Cochrane Database Syst Rev. .

Abstract

Background: 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.

Objectives: 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.

Search methods: 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 For the initial review, we wrote to investigators to find additional published or unpublished studies.

Selection criteria: 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)).

Data collection and analysis: 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).

Main results: 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.

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Conflict of interest statement

Some of the trials in Grubb 1995 were conducted at FHI 360 (formerly Family Health International), where review authors are employed (LL, AB, MC, TG) or were employed (DAG, CO). None of the review authors were involved in Grubb 1995.

L Lopez. A Bernholc, T Grey, M Chen, C Otterness, FM Helmerhorst have no interests to declare.

A Edelman: Agile Pharmaceutical, consultant and served on an advisory board; Merck, trainer and served as an expert advisor; Up To Date, Inc, continuing author; FHI 360 (where review was conducted), serves on Data and Safety Monitoring Board for novel contraceptive injectable (review authors from FHI 360 are not involved in that project).

C Westhoff conducted Westhoff 2012a and studies in Table 27. She is advisor to Agile Therapeutics, which funded Kaunitz 2014, and consults with Bayer and Merck.

Figures

1
1
Study flow diagram, 2016
2
2
Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.
3
3
Risk of bias summary: review authors' judgements about each risk of bias item for each included study.
1.2
1.2. Analysis
Comparison 1 COC: norgestimate (NGM) 180/215/250 µg + EE 25, Outcome 2 Breakthrough bleeding or spotting (cycle 6): weight (lb) >155 versus ≤ 123.
1.3
1.3. Analysis
Comparison 1 COC: norgestimate (NGM) 180/215/250 µg + EE 25, Outcome 3 Breakthrough bleeding or spotting (cycle 6): weight (lb) > 155 versus 124 to 155.
1.4
1.4. Analysis
Comparison 1 COC: norgestimate (NGM) 180/215/250 µg + EE 25, Outcome 4 Breakthrough bleeding or spotting (cycle 13): weight (lb) > 155 versus ≤ 123.
1.5
1.5. Analysis
Comparison 1 COC: norgestimate (NGM) 180/215/250 µg + EE 25, Outcome 5 Breakthrough bleeding or spotting (cycle 13): weight (lb) > 155 versus 124 to 155.
2.2
2.2. Analysis
Comparison 2 COC: norethindrone acetate 1 mg + EE 20 µg, Outcome 2 Breakthrough bleeding or spotting (cycle 6): weight (lb) > 155 versus ≤ 123.
2.3
2.3. Analysis
Comparison 2 COC: norethindrone acetate 1 mg + EE 20 µg, Outcome 3 Breakthrough bleeding or spotting (cycle 6): weight (lb) > 155 versus 124 to 155.
2.4
2.4. Analysis
Comparison 2 COC: norethindrone acetate 1 mg + EE 20 µg, Outcome 4 Breakthrough bleeding or spotting (cycle 13): weight (lb) > 155 versus ≤ 123.
2.5
2.5. Analysis
Comparison 2 COC: norethindrone acetate 1 mg + EE 20 µg, Outcome 5 Breakthrough bleeding or spotting (cycle 13): weight (lb) > 155 versus 124 to 155.
4.2
4.2. Analysis
Comparison 4 COC: levonorgestrel 100 µg + EE 20/10 µg (extended regimen), Outcome 2 Pregnancies by BMI group at 1 year.
4.4
4.4. Analysis
Comparison 4 COC: levonorgestrel 100 µg + EE 20/10 µg (extended regimen), Outcome 4 Pregnancies by weight group at 1 year.
5.3
5.3. Analysis
Comparison 5 COC: levonorgestrel 100 µg + EE 20 µg, Outcome 3 Compliance.
16.5
16.5. Analysis
Comparison 16 Skin patch: levonorgestrel 120 µg + EE 30 μg, Outcome 5 Compliance.
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