Spironolactone versus placebo or in combination with steroids for hirsutism and/or acne

Julie Brown; Cindy Farquhar; Olivia Lee; Robyn Toomath; Ruth G Jepson

doi:10.1002/14651858.CD000194

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Analysis 1.1

Comparison 1 100mg spironolactone versus placebo for hirsutism, Outcome 1 Subjective improvement in hair growth.

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Analysis 1.2

Comparison 1 100mg spironolactone versus placebo for hirsutism, Outcome 2 Ferriman‐Galwey score.

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Analysis 1.3

Comparison 1 100mg spironolactone versus placebo for hirsutism, Outcome 3 Hair diameter at 6 months (mean of 6 and 9 months).

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Analysis 1.4

Comparison 1 100mg spironolactone versus placebo for hirsutism, Outcome 4 Free testosterone level at 6 months (mean of 6 and 9 months).

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Analysis 1.5

Comparison 1 100mg spironolactone versus placebo for hirsutism, Outcome 5 Androstenedione level at 6 months (mean of 6 and 9 months).

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Analysis 1.6

Comparison 1 100mg spironolactone versus placebo for hirsutism, Outcome 6 Dehydroepiandrosterone level at 6 months (mean of 6 and 9 months).

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Analysis 2.1

Comparison 2 5% spironolactone versus 3% spironolactone for acne vulgaris, Outcome 1 Sebum secretion rate at 2 months.

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Analysis 3.1

Comparison 3 3%topical spironolactone versus 3% topical carenoate for acne vulgaris, Outcome 1 Sebum excretion at 2 months.

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Analysis 4.1

Comparison 4 Dexamethasone and spironolactone versus spironolactone for hirsutism, Outcome 1 Ferriman and Gallwey score at 6 months.

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Analysis 4.2

Comparison 4 Dexamethasone and spironolactone versus spironolactone for hirsutism, Outcome 2 Androstenedione level at 6 months.

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Analysis 4.3

Comparison 4 Dexamethasone and spironolactone versus spironolactone for hirsutism, Outcome 3 Dehydroepiandrosterone level at 6 months.

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Analysis 4.4

Comparison 4 Dexamethasone and spironolactone versus spironolactone for hirsutism, Outcome 4 Testosterone level at 6 months.

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Analysis 4.5

Comparison 4 Dexamethasone and spironolactone versus spironolactone for hirsutism, Outcome 5 Side effects ‐ Polymenorrhea.

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Analysis 4.6

Comparison 4 Dexamethasone and spironolactone versus spironolactone for hirsutism, Outcome 6 Side effects ‐ induction of cycle regularity.

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Analysis 5.1

Comparison 5 100mg versus 200mg spironolactone dosage trial for hirsutism, Outcome 1 Androstenedione level after 3 months of treatment.

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Analysis 5.2

Comparison 5 100mg versus 200mg spironolactone dosage trial for hirsutism, Outcome 2 Dehydroepiandrosterone level after 3 months of treatment.

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Analysis 6.1

Comparison 6 100 mg spironolactone versus 12.5 mg/d cyproterone acetate, Outcome 1 Ferriman‐Galwey Score.

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Analysis 6.2

Comparison 6 100 mg spironolactone versus 12.5 mg/d cyproterone acetate, Outcome 2 Free Testosterone.

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Analysis 7.1

Comparison 7 100 mg spironolactone versus 5 mg/day of finasteride, Outcome 1 Ferriman‐Galwey score.

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Analysis 7.2

Comparison 7 100 mg spironolactone versus 5 mg/day of finasteride, Outcome 2 Free Testosterone level.

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Study	Spironolactone n=	Hair diameter +/‐%	Finasteride n=	Hair diameter +/‐%
Wong 1995	5	‐10.3 +/‐ 5.5	9	‐9.6+/‐3

Analysis 7.3

Comparison 7 100 mg spironolactone versus 5 mg/day of finasteride, Outcome 3 Anagen hair diameter at 3 months.

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Study	Spironolactone n=	Hair diameter +/‐%	Finasteride n=	Hair diameter +/‐%
Wong 1995	5	‐13.4+/‐3.8	9	‐14+/‐6.7

Analysis 7.4

Comparison 7 100 mg spironolactone versus 5 mg/day of finasteride, Outcome 4 Anagen hair diameter at 6 months.

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Analysis 7.5

Comparison 7 100 mg spironolactone versus 5 mg/day of finasteride, Outcome 5 Self reported improvement in hirsuitism at 3 months.

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Analysis 7.6

Comparison 7 100 mg spironolactone versus 5 mg/day of finasteride, Outcome 6 Self reported improvement in hirsuitsm at 6 months.

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Analysis 8.1

Comparison 8 Spironolactone 50 mg versus metformin 1000mg for hirsuitsm, Outcome 1 Ferriman‐ Gallwey score.

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Analysis 8.2

Comparison 8 Spironolactone 50 mg versus metformin 1000mg for hirsuitsm, Outcome 2 Serum testosterone.

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Analysis 8.3

Comparison 8 Spironolactone 50 mg versus metformin 1000mg for hirsuitsm, Outcome 3 DHEAS.

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Analysis 8.4

Comparison 8 Spironolactone 50 mg versus metformin 1000mg for hirsuitsm, Outcome 4 Side effects.

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Comparison 1. 100mg spironolactone versus placebo for hirsutism

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Subjective improvement in hair growth Show forest plot	2	42	Peto Odds Ratio (Peto, Fixed, 95% CI)	7.18 [1.96, 26.28]

2 Ferriman‐Galwey score Show forest plot	1	20	Mean Difference (IV, Fixed, 95% CI)	‐7.20 [‐10.98, ‐3.42]

3 Hair diameter at 6 months (mean of 6 and 9 months) Show forest plot	2	42	Mean Difference (IV, Fixed, 95% CI)	‐9.94 [‐22.48, 2.60]

4 Free testosterone level at 6 months (mean of 6 and 9 months) Show forest plot	2	42	Mean Difference (IV, Fixed, 95% CI)	0.02 [‐0.50, 0.54]

5 Androstenedione level at 6 months (mean of 6 and 9 months) Show forest plot	2	42	Mean Difference (IV, Fixed, 95% CI)	0.55 [‐0.93, 2.04]

6 Dehydroepiandrosterone level at 6 months (mean of 6 and 9 months) Show forest plot	1	22	Mean Difference (IV, Fixed, 95% CI)	0.30 [‐2.19, 2.79]

Comparison 1. 100mg spironolactone versus placebo for hirsutism

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Comparison 2. 5% spironolactone versus 3% spironolactone for acne vulgaris

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sebum secretion rate at 2 months Show forest plot	1	8	Mean Difference (IV, Fixed, 95% CI)	0.10 [‐0.12, 0.32]

Comparison 2. 5% spironolactone versus 3% spironolactone for acne vulgaris

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Comparison 3. 3%topical spironolactone versus 3% topical carenoate for acne vulgaris

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Sebum excretion at 2 months Show forest plot	1	11	Mean Difference (IV, Fixed, 95% CI)	0.20 [0.08, 0.32]

Comparison 3. 3%topical spironolactone versus 3% topical carenoate for acne vulgaris

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Comparison 4. Dexamethasone and spironolactone versus spironolactone for hirsutism

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ferriman and Gallwey score at 6 months Show forest plot	1	23	Mean Difference (IV, Fixed, 95% CI)	1.20 [‐2.20, 4.60]

2 Androstenedione level at 6 months Show forest plot	1	23	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐2.26, 2.26]

3 Dehydroepiandrosterone level at 6 months Show forest plot	1	23	Mean Difference (IV, Fixed, 95% CI)	‐3.8 [‐6.78, ‐0.82]

4 Testosterone level at 6 months Show forest plot	1	23	Mean Difference (IV, Fixed, 95% CI)	‐0.30 [1.00, 0.40]

5 Side effects ‐ Polymenorrhea Show forest plot	1	23	Peto Odds Ratio (Peto, Fixed, 95% CI)	0.86 [0.17, 4.33]

6 Side effects ‐ induction of cycle regularity Show forest plot	1	23	Peto Odds Ratio (Peto, Fixed, 95% CI)	1.16 [0.23, 5.82]

Comparison 4. Dexamethasone and spironolactone versus spironolactone for hirsutism

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Comparison 5. 100mg versus 200mg spironolactone dosage trial for hirsutism

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Androstenedione level after 3 months of treatment Show forest plot	1	30	Mean Difference (IV, Fixed, 95% CI)	0.7 [‐0.00, 1.40]

2 Dehydroepiandrosterone level after 3 months of treatment Show forest plot	1	30	Mean Difference (IV, Fixed, 95% CI)	0.24 [‐0.46, 0.94]

Comparison 5. 100mg versus 200mg spironolactone dosage trial for hirsutism

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Comparison 6. 100 mg spironolactone versus 12.5 mg/d cyproterone acetate

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

1.1 6 months of treatment	1	28	Mean Difference (IV, Fixed, 95% CI)	0.72 [‐0.12, 1.56]
1.2 12 months of treatment	1	28	Mean Difference (IV, Fixed, 95% CI)	‐0.06 [‐1.04, 0.92]
1.3 12 months after treatment	1	28	Mean Difference (IV, Fixed, 95% CI)	‐1.18 [‐2.10, ‐0.26]
2 Free Testosterone Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 12 months of treatment	1	28	Mean Difference (IV, Fixed, 95% CI)	‐1.5 [‐4.74, 1.74]
2.2 12 months after end of treatment	1	2	Mean Difference (IV, Fixed, 95% CI)	0.0 [0.0, 0.0]

Comparison 6. 100 mg spironolactone versus 12.5 mg/d cyproterone acetate

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Comparison 7. 100 mg spironolactone versus 5 mg/day of finasteride

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Ferriman‐Galwey score Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

1.1 6 months of treatment	1	28	Mean Difference (IV, Fixed, 95% CI)	‐0.19 [‐0.94, 0.56]
1.2 12 months of treatment	1	28	Mean Difference (IV, Fixed, 95% CI)	‐0.53 [‐1.61, 0.55]
1.3 12 months after the end of treatment	1	28	Mean Difference (IV, Fixed, 95% CI)	‐2.34 [‐3.23, ‐1.45]
1.4 Decrease in score after 3 months treatment	1	14	Mean Difference (IV, Fixed, 95% CI)	0.0 [‐0.37, 0.37]
1.5 Decrease in score after 6 months treatment	1	14	Mean Difference (IV, Fixed, 95% CI)	‐0.40 [‐1.07, 0.27]
2 Free Testosterone level Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 12 months of treatment	1	28	Mean Difference (IV, Fixed, 95% CI)	‐2.0 [‐4.62, 0.62]
3 Anagen hair diameter at 3 months Show forest plot			Other data	No numeric data

4 Anagen hair diameter at 6 months Show forest plot			Other data	No numeric data

5 Self reported improvement in hirsuitism at 3 months Show forest plot	1	14	Odds Ratio (M‐H, Fixed, 95% CI)	0.31 [0.02, 4.02]

6 Self reported improvement in hirsuitsm at 6 months Show forest plot	1	14	Odds Ratio (M‐H, Fixed, 95% CI)	0.19 [0.02, 2.06]

Comparison 7. 100 mg spironolactone versus 5 mg/day of finasteride

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Comparison 8. Spironolactone 50 mg versus metformin 1000mg for hirsuitsm

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

1.1 Score at 3 months	1	69	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐3.01, 0.41]
1.2 Score at 6 months	1	69	Mean Difference (IV, Fixed, 95% CI)	‐1.30 [‐2.57, ‐0.03]
2 Serum testosterone Show forest plot	2		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

2.1 3 months	1	69	Mean Difference (IV, Fixed, 95% CI)	‐0.59 [‐1.30, 0.12]
2.2 6 months	1	69	Mean Difference (IV, Fixed, 95% CI)	0.24 [‐0.20, 0.68]
3 DHEAS Show forest plot	1		Mean Difference (IV, Fixed, 95% CI)	Subtotals only

3.1 3 months	1	69	Mean Difference (IV, Fixed, 95% CI)	0.31 [‐1.31, 1.93]
3.2 6 months	1	69	Mean Difference (IV, Fixed, 95% CI)	0.13 [‐0.99, 1.25]
4 Side effects Show forest plot	1		Odds Ratio (M‐H, Fixed, 95% CI)	Subtotals only

4.1 Polyuria	1	69	Odds Ratio (M‐H, Fixed, 95% CI)	10.48 [0.54, 202.47]
4.2 Abdominal pain	1	69	Odds Ratio (M‐H, Fixed, 95% CI)	3.18 [0.13, 80.79]
4.3 Menstrual irregularity	1	69	Odds Ratio (M‐H, Fixed, 95% CI)	26.45 [1.47, 475.45]
4.4 hyperuricemia	1	69	Odds Ratio (M‐H, Fixed, 95% CI)	3.18 [0.13, 80.79]
4.5 Nausea and vomiting	1	69	Odds Ratio (M‐H, Fixed, 95% CI)	0.10 [0.01, 1.96]
4.6 Diarrhoea	1	69	Odds Ratio (M‐H, Fixed, 95% CI)	0.05 [0.00, 0.85]
4.7 Hyperadrenergic symptoms (not hypoglycaema)	1	69	Odds Ratio (M‐H, Fixed, 95% CI)	0.19 [0.01, 4.20]
4.8 Drug withdrawal	1	69	Odds Ratio (M‐H, Fixed, 95% CI)	0.48 [0.08, 2.84]

Comparison 8. Spironolactone 50 mg versus metformin 1000mg for hirsuitsm

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