Comment: The quality of evidence is downgraded by imprecise results (one trial only) and upgraded by large magnitude of effect.
A Cochrane review [Abstract] 1 included 10 studies with a total of 960 subjects. 2 RCTs compared mifepristone versus placebo or versus a different dose of mifepristone, one RCT compared asoprisnil versus placebo, one ulipristal versus leuprolide acetate, and 4 compared gestrinone versus danazol, gonadotropin-releasing hormone (GnRH) analogues, or a different dose of gestrinone. The quality of evidence ranged from high to very low. At three months, the mifepristone group had lower rates of dysmenorrhoea T1 suggesting that if 40% of women taking placebo experience dysmenorrhoea, then between 3% and 10% of women taking mifepristone will do so. The mifepristone group also had lower rates of dyspareunia but higher rates of side effects T1. There was insufficient evidence to show differences between different doses of mifepristone. However, subgroup analysis suggested that the 2.5 mg dose may be less effective than 5 mg or 10 mg for treating dysmenorrhoea or dyspareunia. Evidence was insufficient to show differences, if present, between gestrinone and danazol in rate of pain relief, dysmenorrhoea, or dyspareunia. Only one small trial (n=38)assessed ulipristal.
| Outcome - Follow-up 3 months | Relative effect(95% CI) | Assumed risk- Control - Placebo | Corresponding risk - Intervention - Mifepristone (95% CI) | No. of participants(studies) Quality of evidence |
|---|---|---|---|---|
| Prevalence of dysmenorrhoea | OR 0.08 (0.04 to 0.17) | 402 per 1000 | 51 per 1000(26 to 103) | 352(1) Moderate |
| Prevalence of dyspareunia | OR 0.23 (0.10 to 0.51) | 288 per 1000 | 85 per 1000(43 to 171) | 223(1) Low |
| Side effects: amenorrhoea | OR 686.16 (92.29 to 5101.33) | 11 per 1000 | 884 per 1000(507 to 983) | 360(1) High |
| Side effects: hot flushes | OR 28.79 (3.93 to 210.73) | 11 per 1000 | 243 per 1000(42 to 701) | 360(1) High |
Date of latest search: 18 December 2018
Primary/Secondary Keywords