Table 5 Summary of findings, including GRADE quality assessment for the comparison between elagolix and elagolix with estradiol/norethindrone acetate
Certainty assessment | No of patients | Effect | Certainty | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|
No of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other consideration | Elagolix | Elagolix with estradiol plus norethindrone acetate | Relative (95% CI) | Absolute (95% CI) | |
Reduction of menstrual blood loss less than 80 ml | |||||||||||
5 | Randomized trials | Not serious | Serious | Not serious | Not serious | None | 393/459 (85.6%) | 716/906 (79.0%) | RR 1.08 (1.00 to 1.16) | 63 more per 1,000 (from 0 fewer to 126 more) | ⨁⨁⨁◯ MODERATE |
Reduction of more than 50% menstrual blood loss | |||||||||||
5 | Randomized trials | Not serious | Not serious | Not serious | Not serious | None | 396/459 (86.3%) | 722/906 (79.7%) | RR 1.08 (1.01 to 1.15) | 64 more per 1,000 (from 8 to 120 more) | ⨁⨁⨁⨁ HIGH |
Improvement in hemoglobin level | |||||||||||
5 | Randomized trials | Not serious | Serious | Not serious | Serious | None | 206/319 (64.6%) | 370/580 (63.8%) | RR 0.99 (0.80 to 1.22) | 6 fewer per 1,000 (from 128 fewer to 140 more) | ⨁⨁◯◯ LOW |
Adverse event (Hot flush) | |||||||||||
5 | Randomized trials | Not serious | Not serious | Not serious | Serious a | None | 258/474 (54.4%) | 190/929 (20.5%) | RR 2.67 (2.30 to 3.10) | 342 more per 1000 (from 266 to 429 more) | ⨁⨁⨁◯ MODERATE |
Uterine volume | |||||||||||
5 | Randomized trials | Not serious | Serious b | Not serious | Not serious | None | 422 | 828 | – | MD 17.47 lower (27.54 lower to 7.4 lower) | ⨁⨁⨁◯ MODERATE |
Fibroid volume | |||||||||||
5 | Randomized trials | Not serious | Not serious | Not serious | Not serious | None | 408 | 800 | – | MD 23.18 lower (28.98 lower to 17.38 lower) | ⨁⨁⨁⨁ HIGH |
Symptom severity | |||||||||||
5 | Randomized trials | Not serious | Not serious | Not serious | Not serious | None | 429 | 859 | – | MD 9.05 lower (9.68 lower to 8.43 lower) | ⨁⨁⨁⨁ HIGH |
Health-related quality of life | |||||||||||
5 | Randomized trials | Not serious | Very serious c | Not serious | Not serious | None | 428 | 859 | – | MD 9.94 higher (5.82 higher to 14.06 higher) | ⨁⨁◯◯ LOW |
Bone mineral density (Lumbar spine) | |||||||||||
4 | Randomized trials | Not serious | Not serious | Not serious | Serious | none | 362 | 764 | – | MD 2.63 lower (3.12 lower to 2.14 lower) | ⨁⨁⨁◯ MODERATE |
Bone mineral density (Total hip) | |||||||||||
4 | Randomized trials | Not serious | Not serious | Not serious | Serious | None | 362 | 764 | – | MD 1.93 lower (2.56 lower to 1.31 lower) | ⨁◯◯◯ VERY LOW |
Bone mineral density (Femoral neck) | |||||||||||
4 | Randomized trials | Not serious | Not serious | Not serious | Serious | None | 362 | 764 | – | MD 0.77 lower (1.84 lower t0 0.3 higher) | ⨁◯◯◯ VERY LOW |