Progesterone receptor modulators for endometriosis

Jing Fu; Hao Song; Min Zhou; Huili Zhu; Yuhe Wang; Hengxi Chen; Wei Huang

doi:10.1002/14651858.CD009881.pub2

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Figure 1

Study flow diagram.

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Figure 2

Risk of bias graph: review authors' judgements about each risk of bias item presented as percentages across all included studies.

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Figure 3

Risk of bias summary: review authors' judgements about each risk of bias item for each included study.

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Figure 4

Forest plot of comparison: 1 Effectiveness of mifepristone versus placebo, patient‐assessed outcomes, outcome: 1.1 Dysmenorrhoea at three months.

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Figure 5

Forest plot of comparison.

2 Mifepristone versus placebo, patient‐assessed outcomes, outcome: 2.1 Amenorrhoea at three months.

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Figure 6

Forest plot of comparison: side effects at three months, mifepristone versus placebo, patient‐assessed outcomes, outcome: 2.2 Hot flushes at three months.

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Figure 7

Forest plot of comparison: 7 Gestrinone versus leuprolin for six months: efficacy and side effects, outcome: 7.1 Painful periods, visual analogue scale.

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Figure 8

Forest plot of comparison: 7 Gestrinone versus leuprolin for six months: efficacy and side effects, outcome: 7.3 Pain on intercourse, visual analogue scale.

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Analysis 1.1

Comparison 1 Effectiveness of mifepristone versus placebo, patient‐assessed outcomes, Outcome 1 Dysmenorrhoea at 3 months.

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Analysis 1.2

Comparison 1 Effectiveness of mifepristone versus placebo, patient‐assessed outcomes, Outcome 2 Dyspareunia at 3 months.

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Analysis 2.1

Comparison 2 Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes, Outcome 1 Amenorrhoea at 3 months.

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Analysis 2.2

Comparison 2 Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes, Outcome 2 Amenorrhoea at 3 months: subgroup analysis.

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Analysis 2.3

Comparison 2 Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes, Outcome 3 Hot flushes at 3 months.

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Analysis 2.4

Comparison 2 Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes, Outcome 4 Hot flushes at 3 months: subgroup analysis.

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Analysis 2.5

Comparison 2 Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes, Outcome 5 Nausea at 3 months.

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Analysis 2.6

Comparison 2 Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes, Outcome 6 Vomiting at 3 months.

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Analysis 2.7

Comparison 2 Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes, Outcome 7 Fatigue/Tiredness at 3 months.

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Analysis 3.1

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 1 Prevalence of dysmenorrhoea.

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Analysis 3.2

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 2 Dysmenorrhoea score 0‐10 VAS scale.

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Analysis 3.3

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 3 Prevalence of dyspareunia.

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Analysis 3.4

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 4 Dyspareunia score 0‐10 VAS scale.

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Analysis 3.5

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 5 Prevalence of pelvic pain.

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Analysis 3.6

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 6 Prevalence of amenorrhoea.

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Analysis 3.7

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 7 Prevalence of hot flushes.

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Analysis 3.8

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 8 Prevalence of nausea.

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Analysis 3.9

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 9 Prevalence of vomiting.

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Analysis 3.10

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 10 Prevalence of fatigue/tiredness.

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Analysis 3.11

Comparison 3 Mifepristone lower dose versus higher dose: efficacy and side effects at six months, Outcome 11 Prevalence of endometrial thickness > 20 mm.

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Analysis 4.1

Comparison 4 Gestrinone versus danazol for six months: efficacy and side effects, Outcome 1 None or mild pelvic pain.

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Analysis 4.2

Comparison 4 Gestrinone versus danazol for six months: efficacy and side effects, Outcome 2 None or mild dysmenorrhoea.

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Analysis 4.3

Comparison 4 Gestrinone versus danazol for six months: efficacy and side effects, Outcome 3 None or mild dyspareunia.

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Analysis 4.4

Comparison 4 Gestrinone versus danazol for six months: efficacy and side effects, Outcome 4 Adverse effects.

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Analysis 5.1

Comparison 5 Gestrinone versus leuprolin for six months: efficacy and side effects, Outcome 1 Painful periods, visual analogue scale.

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Analysis 5.2

Comparison 5 Gestrinone versus leuprolin for six months: efficacy and side effects, Outcome 2 Painful periods, verbal rating scale.

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Analysis 5.3

Comparison 5 Gestrinone versus leuprolin for six months: efficacy and side effects, Outcome 3 Pain on intercourse, visual analogue scale.

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Analysis 5.4

Comparison 5 Gestrinone versus leuprolin for six months: efficacy and side effects, Outcome 4 Pain on intercourse, verbal rating scale.

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Analysis 5.5

Comparison 5 Gestrinone versus leuprolin for six months: efficacy and side effects, Outcome 5 Non‐menstrual pain, visual analogue scale.

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Analysis 5.6

Comparison 5 Gestrinone versus leuprolin for six months: efficacy and side effects, Outcome 6 Side effects.

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Analysis 6.1

Comparison 6 Gestrinone 1.25 mg versus gestrinone 2.5 mg: efficacy and side effects, Outcome 1 improvement in pain.

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Analysis 6.2

Comparison 6 Gestrinone 1.25 mg versus gestrinone 2.5 mg: efficacy and side effects, Outcome 2 Side effect.

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Summary of findings for the main comparison. Mifepristone versus placebo for endometriosis

Mifepristone versus placebo for endometriosis
Patient or population: women with symptomatic endometriosis Settings: gynaecology clinic Intervention: progesterone receptor modulator (mifepristone) Comparison: placebo
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Mifepristone
Prevalence of dysmenorrhoea Follow‐up: 3 months	402 per 1000	51 per 1000 (26 to 103)	OR 0.08 (0.04 to 0.17)	352 (1)	⊕⊕⊕⊝ Moderate^a,b
Prevalence of dyspareunia Follow‐up: 3 months	288 per 1000	85 per 1000 (43 to 171)	OR 0.23 (0.10 to 0.51)	223 (1)	⊕⊕⊝⊝ Low^a,c
Side effects: amenorrhoea Follow‐up: 3 months	11 per 1000	884 per 1000 (507 to 983)	OR 686.16 (92.29 to 5101.33)	360 (1)	⊕⊕⊕⊝ High	239/270 events in the mifepristone group vs 1/90 in the placebo group
Side effects: hot flushes Follow‐up: 3 months	11 per 1000	243 per 1000 (42 to 701)	OR 28.79 (3.93 to 210.73)	360 (1)	⊕⊕⊕⊝ High	66/270 events in the mifepristone group vs 1/90 in the placebo group
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: 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
^aDowngraded one level for serious imprecision (wide confidence intervals and/or very few events) ^bOutcome applied only to women with dysmenorrhoea at baseline, but this was 352/360 women randomised, so not downgraded for indirectness ^cOutcome applied only to women with dyspareunia at baseline, which was 223/360 women randomised. Downgraded one level for serious indirectness

Summary of findings for the main comparison. Mifepristone versus placebo for endometriosis

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Summary of findings 2. Gestrinone versus danazol for endometriosis

Gestrinone versus danazol for endometriosis
Patient or population: women with symptomatic endometriosis Settings: gynaecology clinic Intervention: progesterone receptor modulator (gestrinone) Comparison: danazol
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Danazol	Gestrinone
Pelvic pain: none or mild	890 per 1000	852 per 1000 (727 to 927)	OR 0.71 (0.33 to 1.56)	230 (2)	⊕⊕⊝⊝ Very low^a,b,c
Dysmenorrhoea: none or mild Follow‐up: 6 months	721 per 1000	650 per 1000 (502 to 775)	OR 0.72 (0.39 to 1.33)	214 (2)	⊕⊝⊝⊝ Very low^a,b,c
Dyspareunia: none or mild Follow‐up: 6 months	889 per 1000	869 per 1000 (748 to 937)	OR 0.83 (0.37 to 1.86)	222 (2)	⊕⊝⊝⊝ Very low^a,b,c
Side effects: hirsutism Follow‐up: 6 months	248 per 1000	464 per 1000 (345 to 587)	OR 2.63 (1.60 to 4.32)	302 (2)	⊕⊝⊝⊝ Very low^b,c,d	I² = 68%
Decreased breast size Follow‐up: 6 months	477 per 1000	360 per 1000 (257 to 472)	OR 0.62 (0.38 to 0.98)	302 (2)	⊕⊕⊝⊝ Low^b,c
Side effects: hot flushes Follow‐up: 6 months	425 per 1000	368 per 1000 (270 to 482)	OR 0.79 (0.50 to 1.26)	302 (2 studies)	⊕⊝⊝⊝ Very low^b,c,d	I² = 72%
Side effects: acne Follow‐up: 6 months	556 per 1000	644 per 1000 (529 to 744)	OR 1.45 (0.90 to 2.33)	302 (2 studies)	⊕⊕⊝⊝ Low^b,c
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: 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
^aAssessed in all randomised participants. Not all were symptomatic at baseline (although results show no significant differences in baseline symptoms between groups). Outcome therefore applies only to a select subgroup of participants: downgraded one level for serious indirectness ^bDowngraded one level for serious risk of bias associated with poor reporting of study methods, high attrition in one study, and high risk of other bias in both studies ^cImprecision of results (wide confidence intervals and/or few events), downgraded one level for serious imprecision ^dDowngraded one level for serious inconsistency

Summary of findings 2. Gestrinone versus danazol for endometriosis

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Summary of findings 3. Gestrinone versus leuprolin for endometriosis

Gestrinone versus leuprolin for endometriosis
Patient or population: women with symptomatic endometriosis Settings: gynaecology clinic Intervention: progesterone receptor modulator (gestrinone) Comparison: leuprolin
Outcomes	*Illustrative comparative risks (95% CI)**		Relative effect (95% CI)	No. of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Leuprolin	Gestrinone
Dysmenorrhoea, verbal rating scale Follow‐up: 6 months	In control group, mean score for dysmenorrhoea on verbal rating scale was 0.04 points	Mean score in gestrinone group was 0.35 points higher (0.12 to 0.58 higher)		55 (1)	⊕⊕⊝⊝ Low^a	Verbal rating scale defines dysmenorrhoea according to limitation of ability to work (mild = 1, moderate = 2, incapacitated = 3)
Dyspareunia, verbal rating scale Follow‐up: 6 months	In control group, mean score for dyspareunia on verbal rating scale was 0.43 points	Mean score in gestrinone group was 0.33 points lower (0.62 to 0.04 lower)		52 (1)	⊕⊕⊝⊝ Low^a	Verbal rating scale defines dyspareunia according to limitation of sexual activity (discomfort tolerated = 1; pain interrupts intercourse = 2, intercourse avoided owing to pain = 3)
Amenorrhoea Follow‐up: 6 months	962 per 1000	500 per 1000 (26 to 908)	OR 0.04 (0.01 to 0.38)	49 (1)	⊕⊕⊝⊝ Low^b	Only 55 events overall
Spotting or bleeding Follow‐up: 6 months	38 per 1000	475 per 1000 (94 to 887)	OR 22.92 (2.64 to 198.66)	49 (1)	⊕⊕⊝⊝ Low^b	Only 12 events overall
Side effects: hot flushes Follow‐up: 6 months	679 per 1000	297 per 1000 (112 to 571)	OR 0.20 (0.06 to 0.63)	55 (1)	⊕⊕⊝⊝ Low^b	Only 27 events overall
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: 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
^aDowngraded two levels for very serious imprecision: confidence intervals were compatible with no clinically meaningful difference between groups, or with small benefit in one group ^bDowngraded two levels for very serious imprecision: small overall sample size (n = 55) and low event rates

Summary of findings 3. Gestrinone versus leuprolin for endometriosis

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Table 1. Data unsuitable for analysis

Outcome

Study

Comparison

Measure

Int group

Control group

P value

Combined non‐pelvic pain,

dysmenorrhoea, and

dyspareunia

Chwalisz 2004

Asoprisnil: 5 mg (n = 31),

10 mg (n = 33), 25 mg (n = 32)

Placebo (n = 34)

Mean reduction at 3 months

on 0‐4 pain scale

0.5 points for each dose

< 0.1 points

< 0.05

Table 1. Data unsuitable for analysis

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Comparison 1. Effectiveness of mifepristone versus placebo, patient‐assessed outcomes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Dysmenorrhoea at 3 months Show forest plot	1	352	Odds Ratio (M‐H, Fixed, 95% CI)	0.08 [0.04, 0.17]

1.1 Mifepristone 2.5 mg	1	114	Odds Ratio (M‐H, Fixed, 95% CI)	0.24 [0.09, 0.64]
1.2 Mifepristone 5 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	0.02 [0.00, 0.16]
1.3 Mifepristone 10 mg	1	118	Odds Ratio (M‐H, Fixed, 95% CI)	0.02 [0.00, 0.17]
2 Dyspareunia at 3 months Show forest plot	1	223	Odds Ratio (M‐H, Fixed, 95% CI)	0.23 [0.10, 0.51]

2.1 Mifepristone 2.5 mg	1	74	Odds Ratio (M‐H, Fixed, 95% CI)	0.62 [0.18, 2.13]
2.2 Mifepristone 5 mg	1	73	Odds Ratio (M‐H, Fixed, 95% CI)	0.04 [0.00, 0.40]
2.3 Mifepristone 10 mg	1	76	Odds Ratio (M‐H, Fixed, 95% CI)	0.13 [0.03, 0.60]

Comparison 1. Effectiveness of mifepristone versus placebo, patient‐assessed outcomes

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Comparison 2. Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Amenorrhoea at 3 months Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 Mifepristone all doses	1	360	Odds Ratio (M‐H, Fixed, 95% CI)	686.16 [92.29, 5101.33]
2 Amenorrhoea at 3 months: subgroup analysis Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 Mifepristone 2.5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	207.67 [27.50, 1568.36]
2.2 Mifepristone 5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	3916.0 [348.75, 43971.52]
2.3 Mifepristone 10 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	3916.0 [348.75, 43971.52]
3 Hot flushes at 3 months Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 Mifepristone all doses	1	360	Odds Ratio (M‐H, Fixed, 95% CI)	28.79 [3.93, 210.73]
4 Hot flushes at 3 months: subgroup analysis Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 Mifepristone 2.5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	19.24 [2.49, 148.54]
4.2 Mifepristone 5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	23.82 [3.11, 182.24]
4.3 Mifepristone 10 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	46.76 [6.21, 351.92]
5 Nausea at 3 months Show forest plot	1	360	Odds Ratio (M‐H, Fixed, 95% CI)	1.72 [0.20, 15.03]

5.1 Mifepristone 2.5 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
5.2 Mifepristone 5 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	1.02 [0.04, 25.76]
5.3 Mifepristone 10 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	2.44 [0.12, 48.60]
6 Vomiting at 3 months Show forest plot	1	360	Odds Ratio (M‐H, Fixed, 95% CI)	1.02 [0.10, 10.01]

6.1 Mifepristone 2.5 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	1.02 [0.04, 25.76]
6.2 Mifepristone 5 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
6.3 Mifepristone 10 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	1.02 [0.04, 25.76]
7 Fatigue/Tiredness at 3 months Show forest plot	1	360	Odds Ratio (M‐H, Fixed, 95% CI)	5.48 [0.71, 42.27]

7.1 Mifepristone 2.5 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	3.92 [0.21, 73.08]
7.2 Mifepristone 5 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	0.0 [0.0, 0.0]
7.3 Mifepristone 10 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	7.11 [0.40, 125.92]

Comparison 2. Side effects at three months, mifepristone versus placebo, patient‐assessed outcomes

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Comparison 3. Mifepristone lower dose versus higher dose: efficacy and side effects at six months

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Prevalence of dysmenorrhoea Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

1.1 2.5 mg vs 5 mg	1	170	Odds Ratio (M‐H, Fixed, 95% CI)	0.85 [0.22, 3.29]
1.2 5 mg vs 10 mg	1	173	Odds Ratio (M‐H, Fixed, 95% CI)	1.22 [0.32, 4.71]
2 Dysmenorrhoea score 0‐10 VAS scale Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

2.1 5 mg vs 25 mg	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
3 Prevalence of dyspareunia Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

3.1 2.5 mg vs 5 mg	1	108	Odds Ratio (M‐H, Fixed, 95% CI)	6.37 [0.74, 54.81]
3.2 5 mg vs 10 mg	1	109	Odds Ratio (M‐H, Fixed, 95% CI)	0.52 [0.05, 5.90]
4 Dyspareunia score 0‐10 VAS scale Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Totals not selected

4.1 5 mg vs 25 mg	1		Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]
5 Prevalence of pelvic pain Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 2.5 mg vs 5 mg	1	110	Odds Ratio (M‐H, Fixed, 95% CI)	1.81 [0.63, 5.17]
5.2 5 mg vs 10 mg	1	120	Odds Ratio (M‐H, Fixed, 95% CI)	3.97 [0.79, 19.97]
6 Prevalence of amenorrhoea Show forest plot	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

6.1 2.5 mg vs 5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	0.45 [0.21, 0.97]
6.2 5 mg vs 10 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	1.10 [0.47, 2.56]
6.3 5 mg vs 25 mg	1	26	Odds Ratio (M‐H, Fixed, 95% CI)	0.61 [0.08, 4.41]
7 Prevalence of hot flushes Show forest plot	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

7.1 2.5 mg vs 5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	0.84 [0.38, 1.89]
7.2 5 mg vs 10 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	0.75 [0.35, 1.58]
7.3 5 mg vs 25 mg	1	26	Odds Ratio (M‐H, Fixed, 95% CI)	3.24 [0.12, 87.13]
8 Prevalence of nausea Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

8.1 2.5 mg vs 5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	2.02 [0.18, 22.71]
8.2 5 mg vs 10 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	1.0 [0.06, 16.24]
9 Prevalence of vomiting Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

9.1 2.5 mg vs 5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	3.03 [0.12, 75.46]
9.2 5 mg vs 10 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.20]
10 Prevalence of fatigue/tiredness Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

10.1 2.5 mg vs 5 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	13.92 [0.77, 250.94]
10.2 5 mg vs 10 mg	1	180	Odds Ratio (M‐H, Fixed, 95% CI)	0.03 [0.00, 0.54]
11 Prevalence of endometrial thickness > 20 mm Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

11.1 5 mg vs 25 mg	1	26	Odds Ratio (M‐H, Fixed, 95% CI)	1.41 [0.28, 7.13]

Comparison 3. Mifepristone lower dose versus higher dose: efficacy and side effects at six months

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Comparison 4. Gestrinone versus danazol for six months: efficacy and side effects

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 None or mild pelvic pain Show forest plot	2	230	Odds Ratio (M‐H, Fixed, 95% CI)	0.71 [0.33, 1.56]

2 None or mild dysmenorrhoea Show forest plot	2	214	Odds Ratio (M‐H, Fixed, 95% CI)	0.72 [0.39, 1.33]

3 None or mild dyspareunia Show forest plot	2	222	Odds Ratio (M‐H, Fixed, 95% CI)	0.83 [0.37, 1.86]

4 Adverse effects Show forest plot	2		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 Acne	2	302	Odds Ratio (M‐H, Fixed, 95% CI)	1.45 [0.90, 2.33]
4.2 Seborrhoea	2	302	Odds Ratio (M‐H, Fixed, 95% CI)	2.73 [1.67, 4.46]
4.3 Hirsutism	2	302	Odds Ratio (M‐H, Fixed, 95% CI)	2.63 [1.60, 4.32]
4.4 Voice problems	2	302	Odds Ratio (M‐H, Fixed, 95% CI)	0.70 [0.34, 1.43]
4.5 Swelling hands/feet	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	1.40 [0.82, 2.38]
4.6 Hot flushes	2	302	Odds Ratio (M‐H, Fixed, 95% CI)	0.79 [0.50, 1.26]
4.7 Decreased breast size	2	302	Odds Ratio (M‐H, Fixed, 95% CI)	0.62 [0.38, 0.98]
4.8 Leg or muscle cramps	2	302	Odds Ratio (M‐H, Fixed, 95% CI)	0.49 [0.30, 0.78]
4.9 Headache	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	1.36 [0.84, 2.21]
4.10 Nausea	2	302	Odds Ratio (M‐H, Fixed, 95% CI)	1.36 [0.84, 2.19]
4.11 Vomiting	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	0.67 [0.32, 1.43]
4.12 Loss of appetite	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	1.31 [0.72, 2.37]
4.13 Hunger	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	0.59 [0.36, 0.97]
4.14 Dizziness	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	1.24 [0.75, 2.05]
4.15 Tiredness	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	1.44 [0.84, 2.45]
4.16 Faintness	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	1.23 [0.54, 2.76]
4.17 Skin rash	1	264	Odds Ratio (M‐H, Fixed, 95% CI)	1.71 [0.91, 3.20]
4.18 Weight gain	1	38	Odds Ratio (M‐H, Fixed, 95% CI)	0.34 [0.09, 1.27]
4.19 Vaginal dryness	1	38	Odds Ratio (M‐H, Fixed, 95% CI)	0.18 [0.01, 4.00]
4.20 Raised liver transaminases	1	38	Odds Ratio (M‐H, Fixed, 95% CI)	0.18 [0.01, 4.00]

Comparison 4. Gestrinone versus danazol for six months: efficacy and side effects

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Comparison 5. Gestrinone versus leuprolin for six months: efficacy and side effects

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Painful periods, visual analogue scale Show forest plot	1	55	Mean Difference (IV, Fixed, 95% CI)	0.82 [0.15, 1.49]

2 Painful periods, verbal rating scale Show forest plot	1	55	Mean Difference (IV, Fixed, 95% CI)	0.35 [0.12, 0.58]

3 Pain on intercourse, visual analogue scale Show forest plot	1	52	Mean Difference (IV, Fixed, 95% CI)	‐1.16 [‐2.08, ‐0.24]

4 Pain on intercourse, verbal rating scale Show forest plot	1	52	Mean Difference (IV, Fixed, 95% CI)	‐0.33 [‐0.62, ‐0.04]

5 Non‐menstrual pain, visual analogue scale Show forest plot	1	55	Mean Difference (IV, Fixed, 95% CI)	‐0.41 [‐1.76, 0.94]

6 Side effects Show forest plot	1	813	Odds Ratio (M‐H, Fixed, 95% CI)	0.65 [0.42, 1.01]

6.1 Seborrhoea	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	3.23 [0.13, 82.71]
6.2 Swelling hands/feet	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	5.59 [0.26, 121.96]
6.3 Hot flushes	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	0.20 [0.06, 0.63]
6.4 Leg or muscle cramps	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	0.33 [0.01, 8.55]
6.5 Headache	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	0.20 [0.06, 0.63]
6.6 Nausea	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.06, 17.49]
6.7 Dizziness	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	2.16 [0.18, 25.32]
6.8 Skin rash	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	3.23 [0.13, 82.71]
6.9 Vaginal dryness	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 4.21]
6.10 Mood changes	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	0.67 [0.10, 4.34]
6.11 Joint pain	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	2.16 [0.18, 25.32]
6.12 Drowsiness	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	2.16 [0.18, 25.32]
6.13 Tachycardia	1	55	Odds Ratio (M‐H, Fixed, 95% CI)	1.04 [0.06, 17.49]
6.14 Amenorrhoea	1	49	Odds Ratio (M‐H, Fixed, 95% CI)	0.04 [0.01, 0.38]
6.15 Spotting or bleeding	1	49	Odds Ratio (M‐H, Fixed, 95% CI)	22.92 [2.64, 198.66]

Comparison 5. Gestrinone versus leuprolin for six months: efficacy and side effects

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Comparison 6. Gestrinone 1.25 mg versus gestrinone 2.5 mg: efficacy and side effects

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 improvement in pain Show forest plot	1	10	Odds Ratio (M‐H, Fixed, 95% CI)	0.27 [0.01, 8.46]

2 Side effect Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

2.1 Noted any side effect	1	12	Odds Ratio (M‐H, Fixed, 95% CI)	0.04 [0.00, 1.12]
2.2 Discontinued because of headaches	1	12	Odds Ratio (M‐H, Fixed, 95% CI)	0.28 [0.01, 8.42]
2.3 Irregular bleeding	1	12	Odds Ratio (M‐H, Fixed, 95% CI)	2.5 [0.16, 38.60]

Comparison 6. Gestrinone 1.25 mg versus gestrinone 2.5 mg: efficacy and side effects

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