GRADE table 1(Question 2): Among healthy women or among a general population of women of reproductive age, do those who use Sino-implant (II) have an increased risk for serious adverse events or other relevant outcomes compared with those who do not use Sino-implant (II)? (Indirect evidence)

OutcomeType and number of studies (number of participants)LimitationsInconsistencyImprecisionIndirectnessOther factorsQualityEstimate of effect
Sino-implant (II) vs Sino-implant (I) or Norplant in healthy women
Ectopic pregnancy4 RCTs (24 972)Serious limitations
(4 fair)		No serious inconsistencySerious imprecisionNo indirectnessNoneLowVery few ectopic pregnancies and no clear difference in risk in 4 RCTs of SI (II) vs SI (I) or Norplant
Weight gain3 RCTs (n=4443);
1 cohort study (n=617)		Serious limitations
(2 fair- and 1 poor-quality RCT, 1 very poor-quality cohort study)		No serious inconsistencyNo serious imprecisionNo indirectnessNoneModerateNo difference between SI (II) and SI (I) or Norplant in weight gain in 3 studies; less weight gain with SI (II) than control (no method or non-hormonal) in 1 study
Blood loss, change in haemoglobin2 RCTs (n=389)Serious limitations
(1 fair, 1 poor)		No serious inconsistencySerious imprecisionNo indirectnessNoneLowNo clear difference in blood loss or haemoglobin levels with SI (II) vs SI (I) or Norplant
Bone mineral density (BMD)1 cross-sectional study (n=166)Very serious limitations (1 poor)Cannot determine
(1 study)		Very serious imprecisionSerious indirectness
(intermediate outcome)		NoneVery lowNo difference between SI (II), SI (I) and Norplant in BMD after ≥ 3 years
Blood pressure (BP)1 RCT (n=2297);
1 cohort study (n=617)		Very serious limitations (1 fair-quality RCT, 1 very poor-quality cohort study)No serious inconsistencyNo serious imprecisionNo indirectnessVariability in measures of blood pressure effectsLow1 RCT found very few cases of increased BP with SI (II), SI (I), or Norplant; 1 cohort study found higher BP with control (no method or non-hormonal) than SI (II)
Other adverse events2 RCTs (n=22 672)Serious limitations
(2 fair)		No serious inconsistencyNo serious imprecisionNo indirectnessVariability in outcomes measuredVery lowNo difference between SI (II) and SI (I) or Norplant in various adverse events or reasons for removal
Effects of weight on contraceptive efficacy in women using Sino-implant (II)
Pregnancy2 RCTs (n=10 940)Serious limitations
(2 fair)		Serious inconsistencySerious imprecisionNo indirectnessNoneVery low1 RCT found higher pregnancy rate in women ≥ 70 kg than women < 60 kg (P not reported); 1 RCT found no association between weight and risk of pregnancy

BMD: bone mineral density; BP: blood pressure; RCT: randomized controlled trial; SI (I): Sino-implant (I); SI (II): Sino-implant (II).

From: I, Development of the Medical eligibility criteria for contraceptive use, fifth edition

Cover of Medical Eligibility Criteria for Contraceptive Use
Medical Eligibility Criteria for Contraceptive Use. 5th edition.
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