Danazol for pelvic pain associated with endometriosis

Cindy Farquhar; Andrew Prentice; Amita A Singla; Vanessa Selak

doi:10.1002/14651858.CD000068.pub2

Danazol para el dolor pélvico asociado con endometriosis

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Referencias

Referencias de los estudios incluidos en esta revisión

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estudios excluidos
otras referencias

Bianchi S, Agnoli B, Sgherzi MR, Candiani M, Busacca M. Effect of three‐month treatment with danazol after laparoscopic surgery for stage III‐IV endometriosis: a randomized clinical trial. Fertility and Sterility1999.

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Bianchi S, Busacca M, Agnoli B, Candiani M, Calia C, Vignali M. Effect of three‐month treatment with danazol after laparoscopic surgery for stage III‐IV endometriosis: a randomized clinical trial. Fertility and Sterility 1999;Suppl:22‐3.

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Kauppila A, Telimaa S, Ronnberg L, Vuori J. Placebo‐controlled study on serum concentrations of CA‐125 before and after treatment of endometriosis with danazol or high‐dose medroxyprogesterone acetate alone or after surgery. Fertility & Sterility 1988;49:37‐41.

Telimaa S, Puolakka J, Ronnberg L, Kauppila A. Placebo‐controlled comparison of danazol and medroxyprogesterone acetate in the treatment of endometriosis. Gynecological Endocrinology 1987;1:13‐23.

Telimaa S, Ronnberg L, Kauppila A. Placebo‐controlled comparison of danazol and high‐dose medroxyprogesterone acetate in the treatment of endometriosis after conservative surgery. Gynecological Endocrinology 1987;1:363‐71.

Telimaa S, Apter D, Reinila M, Ronnberg L, Kauppila A. Placebo‐controlled comparison of hormonal and biochemical effects of danazol and high‐dose medroxyprogesterone acetate. European Journal of Obstetrics Gynecology and Reproductive Biology 1990;36:97‐105.

Referencias de los estudios excluidos de esta revisión

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estudios incluidos
otras referencias

Bayer S, Seibel M, Saffan D, Berger M, Taymor M. Efficacy of danazol treatment for minimal endometriosis in infertile women. A prospective, randomized study. Journal of Reproductive Medicine 1988;33:179‐83.

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Mamood TA. The impact of treatment on the natural history of endometriosis. Human Reproduction 1990;5:965‐70.

Mamood TA. Peritoneal fluid volume and sex steroids in the preovulatory period in mild endometriosis. British Journal of Obstetrics and Gynaecology 1991;98:179‐83.

Morgante G, Ditto A, La Marca A, De Leo V. Low dose danazol after combined surgical and medical therapy reduces the incidence of pelvic pain in women with moderate and severe endometriosis. Human Reproduction 1999;14(9):2371‐4.

Nezhat CH, Nezhat F, Borhan S, Seidman DS, Nezhat CR. Is hormonal treatment efficacious in the management of ovarian cysts in women with histories of endometriosis?. Human Reproduction 1996;11:874‐7..

Seibel M, Berger M, Weinstein F, Taymor M. The effectiveness of danazol on subsequent fertility in minimal endometriosis. Fertility and Sterility 1982;38:534‐7.

Telimaa S. Danazol and medroxyprogesterone acetate inefficacious in the treatment of infertility in endometriosis. Fertility and Sterility 1988;50:872‐5.

Referencias adicionales

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estudios incluidos
estudios excluidos

Barbieri RL. Endometriosis 1990 ‐ current treatment approaches. Drugs 1990;39(4):502‐10.

Hughes E, Fedorkow D, Collins J, Vandekerckhove P. Ovulation suppression for endometriosis (Cochrane Review). Cochrane Database of Systematic Reviews 2007, Issue 3.

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McLaren J, Prentice A. New aspects of pathogenesis of endometriosis. Current Opinion in Obstetrics & Gynecology 1996;6:85‐91.

Prentice A, Deary AJ, Bland E. Progestagens and anti‐progestagens for pain associated with endometriosis. Cochrane Database of Systematic Reviews 2000, Issue 2.

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Rock JA, Markham SM. Pathogenesis of endometriosis. Lancet 1992;340:1264‐7.

C Yap, S Furness, C Farquhar. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database of Systematic Reviews 2004, Issue 3. Art. No.: CD003678. DOI: 10.1002/14651858.CD003678.pub2. Pre and post operative medical therapy for endometriosis surgery. Cochrane Database of Systematic Reviews 2004, Issue 3.

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Characteristics of studies

Characteristics of included studies [ordered by study ID]

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estudios excluidos

Bianchi 1999

Methods	Randomised, placebo‐controlled open trial Method of randomisation: not specified Exclusions post randomisation: none
Participants	Country: Italy 77 women <41 yrs old with moderate or severe endometriosis who had undergone laparoscopic surgery
Interventions	Danazol 600 mg/day for 3 months versus no treatment
Outcomes	Pelvic pain recurrence, pregnancy
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Kauppila 1988

Methods	Randomised, placebo‐controlled double blind trial Method of randomisation: not specified Exclusions postrandomisation: none Unusual study design: factorial
Participants	Country: Finland 87 patients divided into two groups of 47 and 40 to undergo laparoscopy or laparotomy respectively. Patients in each group were then randomised to one of 3 intervention groups (medroxyprogesterone acetate (MPA), danazol or placebo) post laparoscopy group: MPA group: n = 16, age = 32.5 +/‐ 5.9 SD years danazol group: n = 17, age = 31.1 +/‐ 5.6 SD years placebo group: n = 14, age= 31.9 +/‐ 6.0 SD years Post laparotomy group: MPA group: n = 13, age = 29.5 +/‐ 5.8 SD years danazol group: n = 15, age = 32.1 +/‐ 6.7 SD years placebo group: n = 12, age= 28.2 +/‐ 5.6 SD years Inclusion criteria: endometriosis confirmed at laparoscopy or laparotomy AFS scores: 72 of 87 women had stage I and II Exclusion criteria: none
Interventions	Treatments: MPA 100 mg x 1/day + placebo x 2/day; danazol 200 mg x 3/day Control: placebo x 3/day Duration: 6 months
Outcomes	AFS scores Levels of CA‐125
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Telimaa 1987a

Methods	Randomised, placebo‐controlled double blind trial Method of randomisation: not specified Exclusions post randomisation: x 4 MPA (x 1 hot flushes, x 1 nervousness, x 1 psychological, x 1 conception); x 2 danazol (x 1 skin rash, x 1 conception); x 3 placebo (x 3 conceptions) Losses to follow up: none
Participants	Country: Finland 59 patients randomised to one of 3 intervention groups (MPA, danazol or placebo) MPA group: n = 20, age = 32.2 +/‐ 5.4 SD years danazol group: n = 20, age = 31.4+/‐ 5.2 SD years placebo group: n = 19, age = 32.4 +/‐ 5.7 SD years Inclusion criteria: laparoscopically confirmed endometriosis, no previous surgical and/or medical treatment for endometriosis AFS scores: all women had stage I or II disease Exclusion criteria: none stated
Interventions	Treatments: MPA 100 mg/day; danazol 200 mg 3 x/day Control: placebo Duration: 6 months
Outcomes	AFS scores (peritoneal implants component) Symptoms Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Telimaa 1987b

Methods	Randomised, placebo‐controlled double blind trial Method of randomisation: not specified Exclusions post randomisation: x 3 MPA (x 3 conceptions), x 2 danazol (x 2 conceptions), x 4 placebo (x 3 conceptions, x 1 insomnia/nervousness/depression) Losses to follow up: none
Participants	Country: Finland 60 patients randomised to one of 3 intervention groups (MPA, danazol or placebo) MPA group: n = 20, age = 29.4 +/‐ 5.4 SD years danazol group: n = 20, age = 31.5 +/‐ 6.0 SD years placebo group: n = 20 age = 29.1 +/‐ 5.9 SD years Inclusion criteria: recent conservative surgery for endometriosis, no previous surgical and/or medical treatment for endometriosis AFS scores: 11 of 33 women had stage I or II disease Exclusion criteria: not stated
Interventions	Treatments: MPA 100 mg/day; danazol 200 mg 3 x/day Control: placebo Duration: 6 months
Outcomes	AFS scores (peritoneal implants component) Symptoms Adverse effects
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Telimaa 1990

Methods	Randomised, placebo‐controlled trial Blinding: unclear Method of randomisation: not specified Exclusions post randomisation: none Losses to follow‐up: none
Participants	Country: Finland 87 patients divided into two groups of 33 and 54 evaluated for hormonal parameters and biochemical parameters respectively. Each group of patients was randomised to one of 3 intervention groups (MPA, danazol or placebo) Hormonal group: MPA: n = 11, age = 31.1 +/‐ 6.3 SD years danazol: n = 11, age = 30.7 +/‐ 4.6 SD years placebo: n = 11, age = 32.8 +/‐ 5.7 SD years Biochemical group: MPA: n = 18, age = 29.8 +/‐ 5.7 SD years danazol: n = 18, age = 31.5 +/‐ 6.0 SD years placebo: n = 18, age = 29.6 +/‐ 6.0 SD years Inclusion criteria: endometriosis confirmed by laparoscopy or laparotomy AFS scores: all women had stage I or II disease Exclusion criteria: none
Interventions	Treatments: MPA 100 mg/day; danazol 200 mg 3 x/day Control: placebo Duration: 6 months
Outcomes	Levels of hormonal parameters ‐LH ‐FSH ‐prolactin ‐progesterone ‐oestradiol ‐testosterone/free androgen index ‐sex‐hormone binding globulin Levels of biochemical parameters ‐albumin ‐ALT ‐AST ‐ALP ‐GGT ‐bilirubin (total and conjugated) ‐creatinine ‐sodium ‐potassium ‐white cell count ‐platelets Haemoglobin
Notes
*Risk of bias*
Bias	Authors' judgement	Support for judgement
Allocation concealment?	Unclear risk	B ‐ Unclear

Characteristics of excluded studies [ordered by study ID]

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estudios incluidos

Study	Reason for exclusion
Bayer 1988	Outcomes published relate to infertility only
Mahmood 1990	No outcomes of interest, unclear randomisation process.
Mahmood 1991	Did not include outcomes of interest to this review
Morgante 1999	Treatment period was post opertative and included surgery
Nezhat 1996	Women had oviarian cysts and endometriosis was not confirmed
Seibel 1982	Outcomes published relate to infertility only
Telimaa 1988	Outcomes published relate to infertility only

Data and analyses

Open in table viewer

Comparison 1. Danazol versus placebo ‐ no surgery

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.1 Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 1 Total pain.
1.1 Three months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐4.95 [‐6.61, ‐3.29]
1.2 Six months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐5.7 [‐7.51, ‐3.89]
1.3 Six months after stopping treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐7.50 [‐9.38, ‐5.62]
2 Pelvic pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.2 Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 2 Pelvic pain.
2.1 Three months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐0.65 [‐0.90, ‐0.40]
2.2 Six months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐1.40 [‐1.68, ‐1.12]
2.3 Six months after stopping treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐1.05 [‐1.33, ‐0.77]
3 Low back pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.3 Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 3 Low back pain.
3.1 Six months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐1.25, ‐0.55]
3.2 Six months after stopping treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐1.2 [‐1.55, ‐0.85]
4 Defaecation pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.4 Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 4 Defaecation pain.
4.1 6 months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐0.77 [‐1.10, ‐0.44]
4.2 6 months after stopping treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐0.68 [‐0.99, ‐0.37]
5 Adverse events Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 1.5 Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 5 Adverse events.
5.1 Oedema at six months	1	35	Odds Ratio (M‐H, Fixed, 95% CI)	12.8 [1.38, 118.32]
5.2 Acne at six months	1	35	Odds Ratio (M‐H, Fixed, 95% CI)	25.14 [2.70, 234.17]
5.3 Vaginal spotting at six months	1	35	Odds Ratio (M‐H, Fixed, 95% CI)	1.79 [0.36, 9.05]
5.4 Muscle cramps at six months	1	35	Odds Ratio (M‐H, Fixed, 95% CI)	18.2 [0.94, 353.55]
6 AFS scores, total ‐ 12 months (six months after stopping treatment) Show forest plot	1	31	Mean Difference (IV, Fixed, 95% CI)	‐0.40 [‐1.58, 0.78]
Open in figure viewer Analysis 1.6 Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 6 AFS scores, total ‐ 12 months (six months after stopping treatment).
7 AFS scores, total ‐ change in Show forest plot	1	31	Mean Difference (IV, Fixed, 95% CI)	‐1.9 [‐4.16, 0.36]
Open in figure viewer Analysis 1.7 Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 7 AFS scores, total ‐ change in.
8 Total or partial resoultion of peritoneal endometriotic implants Show forest plot	1	32	Odds Ratio (M‐H, Fixed, 95% CI)	5.0 [0.83, 30.28]
Open in figure viewer Analysis 1.8 Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 8 Total or partial resoultion of peritoneal endometriotic implants.

Open in table viewer

Comparison 2. Danazol versus placebo ‐ post surgery

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.1 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 1 Total pain.
1.1 3 months of treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐2.2 [‐3.59, ‐0.81]
1.2 6 months of treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐4.2 [‐5.71, ‐2.69]
1.3 6 months or more after treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐1.80 [‐3.18, ‐0.42]
2 Pelvic pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.2 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 2 Pelvic pain.
2.1 3 months of treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐0.52 [‐0.80, ‐0.24]
2.2 6 months of treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐1.1 [‐1.38, ‐0.82]
2.3 6 months after treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐0.47 [‐0.75, ‐0.19]
3 Moderate or severe pain 6 months or more after followup Show forest plot	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	0.65 [0.20, 2.05]
Open in figure viewer Analysis 2.3 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 3 Moderate or severe pain 6 months or more after followup.
4 Adverse events Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only
Open in figure viewer Analysis 2.4 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 4 Adverse events.
4.1 vaginal spotting	1	34	Odds Ratio (M‐H, Fixed, 95% CI)	18.75 [2.02, 173.94]
4.2 acne	1	34	Odds Ratio (M‐H, Fixed, 95% CI)	18.75 [2.02, 173.94]
5 Satisfaction with treatment Show forest plot	1	34	Peto Odds Ratio (Peto, Fixed, 95% CI)	9.94 [2.61, 37.81]
Open in figure viewer Analysis 2.5 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 5 Satisfaction with treatment.
6 Weight gain Show forest plot	1	34	Mean Difference (IV, Fixed, 95% CI)	3.0 [1.34, 4.66]
Open in figure viewer Analysis 2.6 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 6 Weight gain.
7 AFS scores, total ‐ 12 months (six months after stopping treatment) Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐3.50 [‐5.27, ‐1.73]
Open in figure viewer Analysis 2.7 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 7 AFS scores, total ‐ 12 months (six months after stopping treatment).
8 AFS scores, total ‐ change in Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐3.02, 1.22]
Open in figure viewer Analysis 2.8 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 8 AFS scores, total ‐ change in.
9 AFS scores, peritoneal and ovarian ‐ 12 months (six months after stopping treatment) Show forest plot	1	34	Mean Difference (IV, Fixed, 95% CI)	‐2.1 [‐3.90, ‐0.30]
Open in figure viewer Analysis 2.9 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 9 AFS scores, peritoneal and ovarian ‐ 12 months (six months after stopping treatment).
10 Resolution of endometriotic implants at laparoscopy Show forest plot	1	34	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.72 [0.44, 6.74]
Open in figure viewer Analysis 2.10 Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 10 Resolution of endometriotic implants at laparoscopy.

Analysis 1.1

Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 1 Total pain.

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Analysis 1.2

Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 2 Pelvic pain.

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Analysis 1.3

Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 3 Low back pain.

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Analysis 1.4

Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 4 Defaecation pain.

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Analysis 1.5

Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 5 Adverse events.

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Analysis 1.6

Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 6 AFS scores, total ‐ 12 months (six months after stopping treatment).

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Analysis 1.7

Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 7 AFS scores, total ‐ change in.

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Analysis 1.8

Comparison 1 Danazol versus placebo ‐ no surgery, Outcome 8 Total or partial resoultion of peritoneal endometriotic implants.

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Analysis 2.1

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 1 Total pain.

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Analysis 2.2

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 2 Pelvic pain.

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Analysis 2.3

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 3 Moderate or severe pain 6 months or more after followup.

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Analysis 2.4

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 4 Adverse events.

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Analysis 2.5

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 5 Satisfaction with treatment.

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Analysis 2.6

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 6 Weight gain.

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Analysis 2.7

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 7 AFS scores, total ‐ 12 months (six months after stopping treatment).

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Analysis 2.8

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 8 AFS scores, total ‐ change in.

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Analysis 2.9

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 9 AFS scores, peritoneal and ovarian ‐ 12 months (six months after stopping treatment).

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Analysis 2.10

Comparison 2 Danazol versus placebo ‐ post surgery, Outcome 10 Resolution of endometriotic implants at laparoscopy.

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Table 1. Table of included studies risk of bias

Study ID	Concealed allocation	Method of randomisat	Losses to followup	Post random exclus	Intention to treat	Blinding
Bianci 1999	Not stated	Computer generated list	None	None	yes	Open study
Kaupilla 1988	Not stated	Not stated	None	None	yes	Double blind
Telimaa 1987a	Not stated	Not stated	None	9 ‐ 4 in the MPA group and 2 in the danazol group and 3 in the placebo group (5 for pregnancies)	no	Double blind
Telimaa 1987b	Not stated	Not stated	None	9 ‐ 3 in the MPA group, 2 in the danazol group and 4 in the placebo group, 8 for pregnancies	no	Double blind
Telimaa 1990	Not stated	Not stated	None	None	yes	Unclear

Table 1. Table of included studies risk of bias

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Comparison 1. Danazol versus placebo ‐ no surgery

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1 Three months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐4.95 [‐6.61, ‐3.29]
1.2 Six months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐5.7 [‐7.51, ‐3.89]
1.3 Six months after stopping treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐7.50 [‐9.38, ‐5.62]
2 Pelvic pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 Three months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐0.65 [‐0.90, ‐0.40]
2.2 Six months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐1.40 [‐1.68, ‐1.12]
2.3 Six months after stopping treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐1.05 [‐1.33, ‐0.77]
3 Low back pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 Six months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐1.25, ‐0.55]
3.2 Six months after stopping treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐1.2 [‐1.55, ‐0.85]
4 Defaecation pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

4.1 6 months of treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐0.77 [‐1.10, ‐0.44]
4.2 6 months after stopping treatment	1	35	Mean Difference (IV, Fixed, 95% CI)	‐0.68 [‐0.99, ‐0.37]
5 Adverse events Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

5.1 Oedema at six months	1	35	Odds Ratio (M‐H, Fixed, 95% CI)	12.8 [1.38, 118.32]
5.2 Acne at six months	1	35	Odds Ratio (M‐H, Fixed, 95% CI)	25.14 [2.70, 234.17]
5.3 Vaginal spotting at six months	1	35	Odds Ratio (M‐H, Fixed, 95% CI)	1.79 [0.36, 9.05]
5.4 Muscle cramps at six months	1	35	Odds Ratio (M‐H, Fixed, 95% CI)	18.2 [0.94, 353.55]
6 AFS scores, total ‐ 12 months (six months after stopping treatment) Show forest plot	1	31	Mean Difference (IV, Fixed, 95% CI)	‐0.40 [‐1.58, 0.78]

7 AFS scores, total ‐ change in Show forest plot	1	31	Mean Difference (IV, Fixed, 95% CI)	‐1.9 [‐4.16, 0.36]

8 Total or partial resoultion of peritoneal endometriotic implants Show forest plot	1	32	Odds Ratio (M‐H, Fixed, 95% CI)	5.0 [0.83, 30.28]

Comparison 1. Danazol versus placebo ‐ no surgery

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Comparison 2. Danazol versus placebo ‐ post surgery

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Total pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1 3 months of treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐2.2 [‐3.59, ‐0.81]
1.2 6 months of treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐4.2 [‐5.71, ‐2.69]
1.3 6 months or more after treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐1.80 [‐3.18, ‐0.42]
2 Pelvic pain Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 3 months of treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐0.52 [‐0.80, ‐0.24]
2.2 6 months of treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐1.1 [‐1.38, ‐0.82]
2.3 6 months after treatment	1	34	Mean Difference (IV, Fixed, 95% CI)	‐0.47 [‐0.75, ‐0.19]
3 Moderate or severe pain 6 months or more after followup Show forest plot	1	60	Odds Ratio (M‐H, Fixed, 95% CI)	0.65 [0.20, 2.05]

4 Adverse events Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 vaginal spotting	1	34	Odds Ratio (M‐H, Fixed, 95% CI)	18.75 [2.02, 173.94]
4.2 acne	1	34	Odds Ratio (M‐H, Fixed, 95% CI)	18.75 [2.02, 173.94]
5 Satisfaction with treatment Show forest plot	1	34	Peto Odds Ratio (Peto, Fixed, 95% CI)	9.94 [2.61, 37.81]

6 Weight gain Show forest plot	1	34	Mean Difference (IV, Fixed, 95% CI)	3.0 [1.34, 4.66]

7 AFS scores, total ‐ 12 months (six months after stopping treatment) Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐3.50 [‐5.27, ‐1.73]

8 AFS scores, total ‐ change in Show forest plot	1	27	Mean Difference (IV, Fixed, 95% CI)	‐0.90 [‐3.02, 1.22]

9 AFS scores, peritoneal and ovarian ‐ 12 months (six months after stopping treatment) Show forest plot	1	34	Mean Difference (IV, Fixed, 95% CI)	‐2.1 [‐3.90, ‐0.30]

10 Resolution of endometriotic implants at laparoscopy Show forest plot	1	34	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.72 [0.44, 6.74]

Comparison 2. Danazol versus placebo ‐ post surgery

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Danazol para el dolor pélvico asociado con endometriosis

Referencias

Referencias de los estudios incluidos en esta revisión

Bianchi 1999 {published data only}

Kauppila 1988 {published data only}

Telimaa 1987a {published data only}

Telimaa 1987b {published data only}

Telimaa 1990 {published data only}