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. Author manuscript; available in PMC: 2015 Nov 16.
Published in final edited form as: Cochrane Database Syst Rev. 2011 Apr 13;(4):CD008815. doi: 10.1002/14651858.CD008815.pub2

Characteristics of included studies [ordered by study ID]

Ball 1991
Methods Randomized controlled trial, likely conducted in Oxford, England. No information on method for randomization, except stratified according to prior OC use; “single-blind” (unspecified). Main study examined effects of progestin-only OC on lipoprotein levels, glucose tolerance, coagulation factors, and blood pressure.
Participants 51 women, 17 to 41 years, requesting oral contraceptives (OC). New OC users had not used an OC or hormone therapy for 3 months; switchers were changing from low-dose combined OC. Exclusion criteria: hypertension (diastolic blood pressure (BP) > 100 mm Hg, systolic BP > 140 mm Hg), smoking > 20 cigarettes/day, or diabetes.
Interventions Progestin-only pills: norethisterone (NET) 350 μg (N=23) versus levonorgestrel (LNG) 30 μg (N=23); 6 treatment cycles.
Outcomes Mean change in weight from baseline to month 6
Notes
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear No information
Incomplete outcome data addressed? All outcomes Yes Five women did not return for follow up, and were excluded from the analysis (groups not specified). Nine withdrew after 3 months (1 NET; 8 LNG). Analysis for weight included 39 women at 6 months; loss 12/51 = 24%.
Bonny 2009
Methods Prospective study in 4 urban adolescent health clinics in large metropolitan area (USA); enrollment 2002 to 2003; part of a larger 2-year study that examined hormonal contraception and bone mineral density
Participants Postmenarchal girls 12 to 18 years of age. Inclusion criteria: requesting contraception and selecting DMPA or OC; those who did not want hormonal contraception were eligible for control group. Exclusion criteria: pregnancy or DMPA use in past 6 months; OC use in past 3 months; alcohol or drug dependence; medical condition (e.g., renal disease) or medication use (e.g., corticosteroids) associated with outcomes of interest; contraindication to estrogen use; weight > 250 lbs (upper limit for dual energy x-ray absorptiometry [DEXA] scanner); and need for confidential contraceptive care.
Interventions Choice of:
1) Depot medroxyprogesterone acetate (DMPA) (N=15): randomized to additional monthly injections of placebo (N=8) or estradiol cypionate 5 mg (E2C) (N=7)
2) Control (no hormonal contraception) (N=18)
Outcomes Change in total body fat (%) and in lean body mass (%) from baseline to 6 months.
Notes Researchers also developed multivariate models for change in total body fat and change in lean body mass; models adjusted for potential confounders. However, the analysis also included a third group of those who chose OCs (N=18), which we did not include in our review. Type of OC was not specified and might have included progestin-only OCs as well as combination OCs, so the OC group was excluded here.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear No information
Incomplete outcome data addressed? All outcomes Unclear To remain in study, participants had to adhere to DMPA by appointment. No information on controls.
Castle 1978
Methods Prospective study in family planning center in Salisbury, Rhodesia; enrollment Jun to Dec 1976
Participants 1000 Black women seeking contraception. Ages ranged from ‘under 20’ to 40 years or older.
Interventions 1) DMPA 150 mg every 3 months (N=500)
2) DMPA 450 mg every 6 months (N=500)
Outcomes Mean increase in weight at 6 months
Notes Weight measured at each visit while participant wore only a gown
Risk of bias
Item Authors’ judgement Description
Allocation concealment? No Allocation by patient request
Incomplete outcome data addressed? All outcomes Yes Withdrawals from study were 21 for DMPA 150 mg and 17 for DMPA 450 mg. Losses to follow-up: 39% DMPA 150 mg and 23% DMPA 450 mg.
Espey 2000
Methods Retrospective chart review at 3 Indian Health Service facilities in southwestern USA
Participants Female members of Navajo tribe. Inclusion criteria: 18 to 40 years old, completed at least 5 consecutive injections of DMPA at 10- to 14-week intervals, and had weights recorded at 1 - or 2-year intervals. Exclusion criteria: history of diabetes or thyroid disease; women in postpartum group who had pre-eclampsia or multiple gestations within index pregnancy.
Interventions DMPA initiation
a) Interval (N=1 15): first injection at least 20 weeks past pregnancy of 20 weeks or more gestation
b) Postpartum (N=57): first injection at 5 to 8 weeks after delivery of singleton pregnancy of 20 weeks or more gestation
Outcomes Mean weight gain (lbs) for DMPA at 1 and 2 years by initiation group
Notes For another group, not included in this review, method of contraception was reportedly extracted from charts but specifics were not provided. Discussion noted that group “more frequently used” IUD or tubal ligation and also included COC users.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear Not applicable (NA)
Incomplete outcome data addressed? All outcomes Yes Women with incomplete records were excluded from this retrospective review. However, at 2 years, weight data were not available for 70% of the interval group and 49% of the postpartum group.
Moore 1995
Methods Retrospective chart review at rural obstetrics and gynecology clinic in Arizona (USA)
Participants Women who used the contraceptive method and were 15 to 30 years old. Exclusion criteria: prior hormonal contraceptive therapy, height < 62 inches (152.4 cm) or > 70 inches (177.8 cm), weight < 100 lbs (45.5 kg) or > 180 lbs (81.8 kg), presence of diabetes, history of thyroid disease, < 12 months postpartum.
Interventions 1) Norplant (N=50)
2) DMPA 150 mg (M=50)
Outcomes Weight gain (kg) at 1 year by treatment group.
Notes Researchers also analyzed weight gain in model adjusted for age, height, weight, and parity. That analysis included a third group of OC users, which we excluded from this review. Type of OC was not specified and may have included progestin-only OCs as well as combination OCs.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear NA
Incomplete outcome data addressed? All outcomes Yes NA
Pantoja 2010
Methods Retrospective chart review at a university department of obstetrics and gynecology in Campina, Brazil. Chart data spanned Jan 1991 to Dec 2000.
Participants Women who chose DMPA and used the method continuously for 3 years or more and women who used TCu380A IUD for similar time period. Exclusion criteria: diabetes mellitus, hyper- or hypothyroidism, chronic renal failure, rheumatic diseases requiring chronic use of corticoids, and any type of organ transplant. Mean age was 33.5 years in both groups.
Interventions 1) DMPA (N=379)
2) TCu380A IUD (N=379)
Outcomes Change in weight (kg) at 1, 2, and 3 years by contraceptive group and baseline BMI (kg/m2) group (BMI < 25; 25 to 29.9; >= 30)
Notes After pairing for age and baseline BMI, the samples were 379 for each contraceptive group. Weight and height were measured at baseline (time of method initiation) and annually thereafter.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear NA
Incomplete outcome data addressed? All outcomes Yes NA; charts were selected for those with 3 years of continuous use.
Salem 1984
Methods Prospective study in postpartum clinic of university hospital in Assiut, Egypt. Study focused on effect of Norplant use on lactating women and on lactation performance and infant growth.
Participants 150 lactating women. Inclusion criteria: normal delivery of normal living baby and exclusively breastfeeding, one month after delivery, and infant weight at least 3500 gm. Mean age was 29 years for each group.
Interventions Acceptors (50 in each group):
1) Norplant
2) Barrier, “local,” or no contraceptive method
3) CuT380A IUD
Outcomes Weight gain at 6 months by study group
Notes
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear NA
Incomplete outcome data addressed? All outcomes Yes Excluded data: 1 in Norplant group who lost her baby and wanted to get pregnant; 2 who got pregnant in group with barrier, local, or no contraceptive.
Salem 1988
Methods Randomized controlled trial of DMPA and NET-EN in family planning center in Assiut, Egypt. Random numbers table was prepared by WHO. Study examined performance of 2 injectables regarding side effects, continuation, and termination.
Participants 400 women attending family planning clinic. Inclusion criteria: 18 to 40 years old, proven fertility and frequent risk of pregnancy, regular menstrual cycles, willing to rely on one method. Exclusion criteria: breast-feeding; cardiovascular disease; liver disease; known or suspected breast malignancy, genital malignancy, uterine fibroids; undiagnosed vaginal bleeding; suspected pregnancy.
Interventions 200 in each group:
1) DMPA 150 mg every 3 months
2) Norethisterone enanthate (NET-EN) 200 mg every 2 months Study duration was 1 year
Outcomes Mean change in weight at 1 year by contraceptive group. Units were not specified (kg or lbs).
Notes Report had mean change for those who had an increase, decrease, or no change in weight. Review authors calculated combined weight change means and standard deviations.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Yes Sealed envelopes contained assignments
Incomplete outcome data addressed? All outcomes Yes Losses to follow up were reportedly 19% for DMPA and 13.3% for NET-EN. One-year method continuation rates were 68.8% DMPA and 57.1% NET-EN. Those who finished the study were 54% and 47%, respectively.
Sivin 1998
Methods Randomized controlled trial at 7 centers, including USA and Finland. Study focused on effectiveness of reformulated 2-rod LNG implant versus 6-rod implant. Randomization by “linear congruential method”; blocks of 50 per clinic. Enrollment from 1990 to 1994.
Participants 1200 healthy women, 18 to 40 years old, who sought implant contraception. Inclusion criteria: no contraindications to implant use, willing to undergo study procedures. Exclusion criteria: cancer, severe cardiovascular problem, hyperlipidemia, diabetes mellitus, mental illness, epilepsy, severe or frequent headaches, undiagnosed genital bleeding, hyperprolactinaemia or bloody breast discharge, pelvic inflammatory disease since last pregnancy or ectopic pregnancy.
Interventions Levonorgestrel implants
1) Norplant: 6 capsules, containing levonorgestrel 216 mg (total)
2) LNG rod (Jadelle): 2 rods containing levonorgestrel 150 mg (total); different elastomer in core than earlier implant
Follow up: 1, 3, 6 months, and then semi-annually up to 5 years
Outcomes Mean weight change per year by implant group.
Weight change was also presented for the 10th, 50th, and 90th percentiles of body weight (at admission).
Notes Weighing method not specified
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Yes Implants were in sealed opaque envelopes that were numbered sequentially, according to randomization lists.
Incomplete outcome data addressed? All outcomes Yes Two sets of Norplant were contaminated and not used (1198 analyzed)
Sule 2005
Methods Retrospective chart review at family planning clinic at a university hospital in Zaria, Nigeria. Study examined hormonal contraceptives and weight changes.
Participants All new clients registered between 01 Jan 1993 and 31 Dec 1995 and followed for at least 1 year (N=516). Included were those who used hormonal contraceptives (COC, DMPA, NET-EN, or Norplant); IUD users were considered to be controls.
Interventions Users of
1) Norplant (N=188)
2) Combined oral contraceptives (COC) (N=38)
3) IUD (N=136) (non-hormonal)
Outcomes Mean weight gain or loss by contraceptive group at 1 year and 3 years
Notes Report had mean change for those who had an increase, decrease, or no change in weight. Review authors calculated combined weight change means and standard deviations. Injectable users were not used in this review, as DMPA and NET-EN had been grouped for analysis.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear NA
Incomplete outcome data addressed? All outcomes Yes Researchers selected charts with at least one year of data. Only 236 were followed for 3 years, producing an overall loss of 54%: Norplant 31 %, COC 95%, and IUD 56%.
Taneepanichskul 1998
Methods Retrospective study in family planning clinic at a hospital in Bangkok, Thailand. Study examined weight change in long-term users of DMPA versus IUD.
Participants 100 women, aged 37 to 50 years, attending family planning clinic. Inclusion criteria: used DMPA or IUD for 120 months, followed “regularly,” no history of smoking or alcohol intake. IUD users had not used any hormonal contraceptive. Exclusion criteria: developed chronic disease or metabolic disorder during DMPA or IUD use.
Interventions Chosen:
1) DMPA (N=50)
2) Copper T380A IUD (N=50)
Outcomes Mean change in body weight by 120 months
Notes Weight was measured in standard manner at 120 months; methods used previously were not specified.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear NA
Incomplete outcome data addressed? All outcomes Yes Excluding those who developed a chronic disease or disorder during method use may have biased the results. Weight gain is associated with development of some diseases and disorders.
Tankeyoon 1976
Methods Prospective metabolic study in Bangkok, Thailand. Study focused on metabolic effects of the contraceptive methods.
Participants Two groups of 16 healthy women attending the family planning clinic. Inclusion criteria: > 6 weeks postpartum and no other steroid use for past 3 months. Age range was 18 to 38 years.
Interventions 1) DMPA 150 mg (3-month intervals) (N=16)
2) COC: d-norgestrel 50 μg + EE 50 μg (N=16)
Follow up at 1, 2, 3, 6, 9, 12 months
Outcomes Percent of cases with >= 1 kg increase or decrease in body weight by contraceptive method
Notes
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear No information
Incomplete outcome data addressed? All outcomes Unclear Losses by 12 months: DMPA 2/16 (13%); COC 4/16 (25%)
Reasons for missing data not specified.
Tuchman 2005
Methods Retrospective chart review at urban, hospital-based, teen health center (USA)
Participants 222 females, aged 12 to 21 years, attending health center for contraception between 01 Jan 2001 and 31 Dec 2001. Inclusion criteria: first-time use of oral or injectable contraceptive. ‘New start’ was defined as no OC in past 3 months or DMPA in past 6 months prior to new method initiation.
Interventions Choice of:
1) DMPA every 3 months
2) Medroxyprogesterone acetate + estradiol cypionate 5 mg (MPA/E2C) monthly
2) COC
Outcomes Mean weight change (kg) and mean percent weight change at 3, 6, 9, 12 months by contraceptive method
Notes Standardized weight and height measures described. Measures closest to baseline and each follow up were used.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear NA
Incomplete outcome data addressed? All outcomes Yes Numbers were provided for those who continued method use at each follow-up time. At 12 months, discontinuation rates were 54% to 58%.
Westhoff 2007
Methods Randomized controlled trial at sites in North and South America. Trial was evaluator-blinded.
Participants Women, 18 to 49 years old, sexually active and wanting long-term contraception. Inclusion criteria: no OC use for past 2 months, regular menstruation in past 3 months, willing to rely on DMPA for a year. Exclusion criteria: used OCs, implants, or hormonal IUD in past 2 months or DMPA-IM in past 10 months, pregnant or infertile, abnormal Pap, undiagnosed genital bleeding, other contraindications to hormonal contraceptives.
Interventions DMPA-SC 104 mg (N=266) or DMPA-IM 150 mg (N=268) every 3 months for 3 years
Outcomes Weight change at 36 months
Notes Weight assessed as safety endpoint. Researchers also analyzed weight change by BMI group: <= 25, 25 to 30, > 30 kg/m2. Report notes that no consistent differences were found by BMI groups.
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear No information
Incomplete outcome data addressed? All outcomes Unclear By 3 years, continuation in the study was 25% for DMPA-SC 104 and 21% for DMPA-IM 150. Reasons for discontinuation were unclear.
WHO 1983
Methods Phase III randomized controlled trial in 13 centers in Africa, Asia, Central and South America, and Europe. No information on method for randomization and whether any blinding was done (e.g., assessors).
Participants Non-breastfeeding women who chose injectable contraception. Exclusion criteria: contraindication for long-acting contraceptive methods. Mean age was 27.4 years.
Interventions 1) DMPA 150 mg at 90-day intervals (N=1587)
2) NET-EN 200 mg at 60-day intervals (N=789)
3) NET-EN 200 mg at 60-day intervals for 6 months then 84-day intervals (N=796)
Outcomes Mean weight change at 12 and 24 months by contraceptive group
Notes Method for measuring weight not mentioned
Risk of bias
Item Authors’ judgement Description
Allocation concealment? Unclear No information
Incomplete outcome data addressed? All outcomes Yes Losses to follow up were reportedly 10.7% DMPA, 8.9% NET-EN 60 days, and 9.8% NET-EN 84 days.
Life-table rates for total discontinuation were 71 to 74.