Summary of findings 3. Combined oral contraceptive pill compared to levonorgestrel‐releasing intrauterine system for heavy menstrual bleeding.
Combined oral contraceptive pill compared to levonorgestrel‐releasing intrauterine system for heavy menstrual bleeding | ||||||
Patient or population: heavy menstrual bleeding Setting: primary care Intervention: Combined oral contraceptive pill Comparison: levonorgestrel‐releasing intrauterine system | ||||||
Outcomes | Anticipated absolute effects* (95% CI) | Relative effect (95% CI) | № of participants (studies) | Certainty of the evidence (GRADE) | Comments | |
Risk with levonorgestrel‐releasing intrauterine system | Risk with Combined oral contraceptive pill | |||||
Treatment success (PBAC < 100 at end of treatment or no requirement for alternative treatment ) follow up: mean 12 months | 868 per 1,000 | 581 per 1,000 (373 to 760) | OR 0.21 (0.09 to 0.48) | 151 (2 RCTs) | ⊕⊕⊝⊝ LOW 1 | Participants were not blinded |
Satisfaction with treatment follow up: mean 12 months | 842 per 1,000 | 607 per 1,000 (242 to 882) | OR 0.29 (0.06 to 1.40) | 37 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | Participants were not blinded |
Other primary menstrual bleeding outcomes: semi‐objectively assessed menstrual blood loss, subjectively assessed menstrual blood loss | No study reported these outcomes in this comparison | |||||
Adverse effects ‐ Any adverse events | 850 per 1,000 | 895 per 1,000 (555 to 983) | OR 1.50 (0.22 to 10.14) | 39 (1 RCT) | ⊕⊝⊝⊝ VERY LOW 1 2 | Individual adverse effects did not differ by group |
*The risk in the intervention group (and its 95% confidence interval) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). CI: Confidence interval; RR: Risk ratio; OR: Odds ratio; | ||||||
GRADE Working Group grades of evidence High certainty: We are very confident that the true effect lies close to that of the estimate of the effect Moderate certainty: We are moderately confident in the effect estimate: The true effect is likely to be close to the estimate of the effect, but there is a possibility that it is substantially different Low certainty: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low certainty: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect |
1 Risk of bias downgraded two levels because lack of blinding may have had a substantial effect on the measurement of this outcome; also it was unclear whether the involvement of the funder might have influenced the findings
2 Precision downgraded level because effects measured in only one trial