Summary of findings 2. Misoprostol compared to placebo to reduce blood loss during myomectomy for fibroids.
Misoprostol compared to placebo to reduce blood loss during myomectomy for fibroids | ||||||
Patient or population: Women with fibroids Settings: Middle and high income countries Intervention: Misoprostol Comparison: Placebo | ||||||
Outcomes | Illustrative comparative risks (95% CI) | Relative effect (95% CI) | No of participants (studies) | Quality of the evidence (GRADE) | Comments | |
Placebo | Misoprostol | |||||
Blood loss (ml) Estimated blood loss during myomectomy | The mean blood loss in placebo group was 322.39 ml | The mean blood loss in misoprostol group was 97.88 ml lower (125.52 to 70.24 lower) | MD ‐97.88 (‐125.52 to ‐70.24) | 89 (2 studies) | ⊕⊕⊕⊝ moderate1 | We rated down the quality of evidence (by 1) because the data were derived from two small studies and we could not rule out the possibility of publication bias |
Need for blood transfusion Number of participants who received blood transfusion | 87 per 1000 | 31 per 1000 (4 to 217) | OR 0.36 (0.05 to 2.5) | 89 (2 studies) | ⊕⊕⊝⊝ low1 | We rated down the quality of evidence (by 2) because (i) we could not conclusively rule out the possibility of publication bias and (ii) the pooled effect had wide confidence intervals |
Duration of surgery (min) Operative time | The mean duration of surgery in placebo group was 69.57 min for abdominal myomectomy and 77 min for laparoscopic myomectomy | The mean duration of surgery in misoprostol group was 9.50 min lower (15.90 lower to 3.10 lower) in abdominal myomectomy and 9 min higher (1.63 lower to 19.63 higher) in laparoscopic myomectomy |
MD ‐9.50 (‐15.90 to ‐3.10) for abdominal myomectomy & MD 9.00 (‐1.63 to 19.63) for laparoscopic myomectomy |
25
(1 study) for abdominal myomectomy & 64 (1 study) for laparoscopic myomectomy |
⊕⊕⊝⊝ low1 | We rated down the quality of evidence (by 2) because (i) we could not conclusively rule out the possibility of publication bias and (ii) the pooled effect had wide confidence intervals We did not rate down the evidence due to heterogeneity because this could be explained by the type of myomectomy (laparoscopy versus laparotomy) |
CI: Confidence interval; MD: mean difference; OR: Odds ratio | ||||||
GRADE Working Group grades of evidence High quality: Further research is very unlikely to change our confidence in the estimate of effect. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. |
1In one trial the method of allocation concealment was not reported and in the other trial, allocation concealment was achieved using sequentially numbered opaque sealed envelopes.