Table 2 Summary of findings including GRADE quality assessment for comparison between elagolix and placebo
Certainty assessment | No of patients | Effect | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other consideration | Elagolix | Placebo | Relative (95% CI) | Absolute (95% CI) | |
Reduction of menstrual blood loss of less than 80 ml | |||||||||||
4 | Randomized trials | Not serious a | Serious b | Not serious | Not serious | None | 414/485 (85.4%) | 80/834 (20.8%) | RR 4.81 (2.45 to 9.45) | 794 more per 1000 (from 302 more to 1,000 more) | ⨁⨁⨁◯ MODERATE |
Reduction of more than 50% menstrual blood loss | |||||||||||
4 | Randomized trials | Not serious | Serious c | Not serious | Not serious | None | 416/485 (85.8%) | 78/384 (20.3%) | RR 4.87 (2.55 to 9.31) | 362 more per 1000 (from 231 to 528 more) | ⨁⨁⨁◯ MODERATE |
Improvement in hemoglobin level | |||||||||||
4 | Randomized trials | Not serious | Not serious | Not serious | Serious | None | 196/320 (61.3%) | 58/234 (24.8%) | RR 2.46 (1.93 to 3.13) | 786 more per 1000 (from 315 to 1000 more) | ⨁⨁⨁◯ MODERATE |
Adverse event (Hot flush) | |||||||||||
4 | Randomized trials | Not serious | Not serious e | Not serious | Serious d | None | 259/501 (51.7%) | 25/389 (6.4%) | RR 7.47 (4.99 to 11.18) | 416 more per 1000 (from 256 to 654 more) | ⨁⨁⨁◯ MODERATE |
Uterine volume | |||||||||||
4 | Randomized trials | Not serious | Serious f | Not serious | Not serious | None | 424 | 359 | – | MD 34.5 lower (43.48 lower to 25.53 lower) | ⨁⨁⨁◯ MODERATE |
Fibroid volume | |||||||||||
4 | Randomized trials | Not serious | Serious g | Not serious | Not serious | None | 406 | 344 | – | MD 31.39 lower (44.69 lower to 18.09 lower) | ⨁⨁⨁◯ MODERATE |
Symptom severity | |||||||||||
4 | Randomized trials | Not serious | very serious h | Not serious | Not serious | None | 445 | 369 | – | MD 31.54 lower (41.85 lower to 21.22 lower) | ⨁⨁◯◯ LOW |
Health-related quality of life | |||||||||||
4 | Randomized trials | Not serious | Very serious | Not serious | Not serious | None | 443 | 369 | – | MD 30.64 higher (20.14 higher to 41.15 higher) | ⨁⨁◯◯ LOW |
Bone mineral density (Lumbar spine) | |||||||||||
3 | Randomized trials | Not serious | Not serious | Not serious | Serious | None | 281 | 293 | – | MD 2.82 lower (3.3 lower to 2.35 lower) | ⨁⨁⨁◯ MODERATE |
Bone mineral density (Total hip) | |||||||||||
3 | Randomized trials | Not serious | Not serious | Not serious | Serious | None | 281 | 293 | - | MD 1.97 lower (2.37 lower to 1.57 lower) | ⨁⨁⨁◯ MODERATE |
Bone mineral density (Femoral neck) | |||||||||||
3 | Randomized trials | Not serious | Not serious | Not serious | Serious | None | 281 | 293 | – | MD 1.92 lower (2.61 lower to 1.23 lower) | ⨁⨁⨁◯ MODERATE |