Summary of findings 5. GnRHa treatment versus other medical therapies before any surgery for uterine fibroids.
| Gonadotropin‐hormone releasing analogue (GnRHa) treatment versus other medical therapies before any surgery for uterine fibroids | ||||||
| Patient or population: women with uterine fibroids Settings: hospitals or outpatient clinics (only preoperative outcomes) Intervention: GnRHa treatment versus other medical therapies before any surgery | ||||||
| Outcomes | Illustrative comparative risks* (95% CI) | Relative effect (95% CI) | No of Participants (studies) | Quality of the evidence (GRADE) | Comments | |
| Assumed risk | Corresponding risk | |||||
| Control (other medical therapies) | GnRHa pretreatment | |||||
| Uterine volume (cm³) | See comment | Not estimable | ‐ | ‐ | Studies too heterogeneous for pooling. One study comparing a GnRHa with a SERM and another study comparing GnRHA with mifepristone found no difference between groups. One trial comparing GnRHa with ulipristal acetate found a greater reduction with GnRHa (‐47%) compared to 5 mg (‐20%) and 10 mg (‐22%) ulipristal acetate | |
| Fibroid volume (cm³) | Fibroid volume in the other treatment group (cabergoline) ranged from 86 cm³ to 278 cm³ | Mean fibroid volume in the intervention groups was 12.71 greater (5.92 lower to 31.34 higher) | ‐ | 110 (2 studies) | ⊕⊕⊝⊝ low1,2 | 2 additional studies with skewed data not suitable for pooling reported no differences between groups (GnRHa vs. raloxifene, GnRHa vs. ulipristal acetate) One additional study found a greater reduction with GnRHa when compared to multiple doses of fulvestrant |
| Preoperative haemoglobin (g/dL) | Mean haemoglobin at end of preoperative treatment in ulipristal acetate group was 12.9 g/dL | Mean haemoglobin at end of preoperative treatment in the intervention groups was 0.2 lower (0.6 lower to 0.2 higher) | ‐ | 188 (1 study) | ⊕⊕⊕⊝ moderate3 | |
| Preoperative bleeding: Reduction in bleeding to PBAC < 75 ulipristal acetate 5 mg | Study population | OR 0.71 (0.3 to 1.68) | 199 (1 study) | ⊕⊕⊕⊝ moderate3 | ||
| 898 per 1000 | 862 per 1000 (725 to 937) | |||||
| Moderate | ||||||
| 898 per 1000 | 862 per 1000 (725 to 937) | |||||
|
Preoperative bleeding: Reduction in bleeding to PBAC < 75 ulipristal acetate 10 mg |
Study population | OR 0.39 (0.14 to 1.06) | 203 (1 study) | ⊕⊕⊕⊝ moderate3 | ||
| 941 per 1000 | 862 per 1000 (691 to 944) | |||||
| Moderate | ||||||
| 941 per 1000 | 861 per 1000 (691 to 944) | |||||
| Adverse events (hot flushes) | 213 per 1000 | 691 per 1000 | OR 12.30 (4.04 to 37.48) | 453 (5 studies) | ⊕⊕⊝⊝ low4 |
These findings were for hot flushes (GnRHa compared to raloxifene, ulipristal acetate, mifepristone, cabergoline and lynestrenol). Headache (with comparators raloxifene, ulipristal acetate, cabergoline and lynestrenol), sleep disorder (vs. lynestrenol) and bone sensitivity (vs. cabergoline) were also increased with GnRHa compared to other medical treatments but fewer studies contributed data. There were no other significant differences. No studies compared total numbers of adverse events |
| The basis for the assumed risk is the mean control group risk across studies. The corresponding risk (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; OR: Odds ratio. | ||||||
| GRADE Working Group grades of evidence High quality: We are very confident that the true effect lies close to that of the estimate of the effect Moderate quality: 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 quality: Our confidence in the effect estimate is limited: The true effect may be substantially different from the estimate of the effect Very low quality: We have very little confidence in the effect estimate: The true effect is likely to be substantially different from the estimate of effect | ||||||
1 Evidence quality downgraded 1 level because of limitations in study design (unclear risk of selection and attrition bias and lack of blinding). 2 Evidence quality downgraded 1 level because of imprecision (two small trials with wide confidence intervals). 3 Evidence quality downgraded 1 level (study had pharmaceutical support and it was not possible to determine whether this had influenced the findings). 4 Evidence level downgraded one level for serious limitations in study design (the majority of the studies had significant risk of bias and downgraded one level because of inconsistency (variation between estimates in the studies).