Interventions for Hirsutism Other Than Light-Based Therapies

Table 1. Summary of Findings for ethinyl oestradiol 35 μg + cyproterone acetate 2 mg compared with ethinyl oestradiol 30 μg + desogestrel 0·15 mg for hirsutism
Patient or population: women with hirsutism
Intervention: ethinyl oestradiol 35 μg + cyproterone acetate 2 mg
Comparison: ethinyl oestradiol 30 μg + desogestrel 0·15 mg
Outcomes	Illustrative comparative risks^a (95% CI)		Relative effect (95% CI)	Number of participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Ethinyl oestradiol 30 μg + desogestrel 0·15 mg	Ethinyl oestradiol 35 μg + cyproterone acetate 2 mg
Participant-reported improvement of hirsutism (not measured)	See comment	See comment	Not estimable		See comment	No study addressed this outcome
Change in health-related quality of life (not measured)	See comment	See comment	Not estimable		See comment	No study addressed this outcome
Proportion of participants who reported an adverse event	Study population		RR: 0·41 (0·08–2·05)	100 (1 study)^b	⊕⊕⊕⊖ moderate^c
	100 per 1000	41 per 1000 (8–205)
	Low
	40 per 1000	16 per 1000 (3–82)
Clinician's assessment of improvement of hirsutism: Ferriman–Gallwey score (scale 0–36)	The mean clinician's assessment of improvement of hirsutism ranged across control groups from −1·69 to −9·51	The mean clinician's assessment of improvement of hirsutism in the intervention groups was 1·84 lower (3·86 lower to 0·18 higher)		164 (3 studies)^d	⊕⊕⊖⊖ low^e,f	Both treatments demonstrated a clinically important reduction in Ferriman–Gallwey score, but MD between the groups was not statistically significant
Change in serum androgen levels	See comment	See comment	Not estimable	184 (4 studies)^g	⊕⊕⊕⊕ high	There were no clinically important differences in serum androgen levels between the two groups
Change in BMI kg m⁻²	See comment	See comment	Not estimable	136 (2 studies)^h	⊕⊕⊕⊖ moderate^j	MD: −0·14 kg m⁻², 95% CI −2·44–2·16; P = 0·90 (Bhattacharya^[38]) and 0·10 kg m⁻², 95% CI −2·85–3·05; P = 0·95 (Mastorakos^[96])
Improvement of other clinical signs of hyperandrogenism; acne score: grade 1–4 (higher is worse)	The mean improvement of other clinical signs of hyperandrogenism in the control groups was −1·41	The mean improvement of other clinical signs of hyperandrogenism in the intervention groups was 0·11 lower (0·61 lower to 0·39 higher)		100 (1 study)^b	⊕⊕⊕⊖ moderate^j

BMI, body mass index; CI, confidence interval; MD, mean difference; RR, risk 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. ^aThe basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ^bBhattacharya.³⁸ ^cDowngraded one level owing to serious imprecision (95% CI around the pooled or best estimate of effect includes both no effect and appreciable harm). ^dBhattacharya,³⁸ Mastorakos,⁹⁵ Mastorakos.⁹⁶ ^eDowngraded one level owing to serious risk of performance and detection bias as in two of the three studies participants, investigators, and outcome assessors were not blinded. ^fDowngraded one level due to serious imprecision (95% CI around the pooled or best estimate of effect includes both no effect and appreciable benefit). ^gBhattacharya,³⁸ Mastorakos,⁹⁵ Mastorakos,⁹⁶ Porcile.¹⁰⁸ ^hBhattacharya,³⁸ Mastorakos.⁹⁶ ⁱDowngraded one level owing to serious imprecision (wide CI for both studies). ^jDowngraded one level owing to serious imprecision (wide CI).

Table 2. Summary of findings flutamide 250 mg twice daily compared with placebo for hirsutism
Patient or population: women with hirsutism
Intervention: flutamide 250 mg twice daily
Comparison: placebo
Outcomes	Illustrative comparative risks^a (95% CI)		Relative effect (95% CI)	Number of Participants (studies)	Quality of the evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Flutamide 250 mg twice daily
Participant-reported improvement of hirsutism 4-point Likert scale	Study population		RR: 17 (1·11–259·87)	20 (1 study)^b	⊕⊕⊖⊖ low^c	Improvement as assessed on a Likert scale was good to excellent but based on a small sample size
	Low		RR: 17 (1·11–259·87)	20 (1 study)^b	⊕⊕⊖⊖ low^c
Change in health-related quality of life (not measured)	See comment	See comment	Not estimable	–	See comment	No study addressed this outcome
Proportion of participants who reported an adverse event	See comment	See comment	Not estimable	60 (2 studies)^d	⊕⊖⊖⊖ very low^c,e	RR: 9·00, 95% CI 0·52–156·91; P = 0·13 (Gambineri⁶⁸) and RR: 1·00, 95% CI 0·07–13·87; P = 1·00 (Moghetti⁹⁷)
Clinician's assessment of improvement of hirsutism: Ferriman–Gallwey score (scale 0–36)	See comment	See comment	Not estimable	60 (2 studies)^d	⊕⊖⊖⊖ very low^c,e	MD: −7·60, 95% CI −10·53 to −4·67; P < 0·001 (Gambineri⁶⁸) and MD: −7·20, 95% CI −10·15 to −4·27; P < 0·001 (Moghetti⁹⁷) Both studies demonstrated a statistically significant and clinically important difference in mean Ferriman–Gallwey score in favour of the flutamide group
Change in serum androgen levels	See comment	See comment	Not estimable	60 (2 studies)^d	⊕⊕⊖⊖ low^c	There were in both studies statistically significant differences in androstenedione levels in favour of the flutamide group
Change in BMI kg m⁻²	The mean change in BMI in the control groups was −2 kg m⁻²	The mean change in BMI in the intervention groups was 2·00 kg m⁻² lower (3·83 to 0·17 lower)		40 (1 study)^f	⊕⊖⊖⊖ very low^c,e	All participants were on a calorie-restricted diet
Improvement of other clinical signs of hyperandrogenism. Mean number of menses in the previous 6 months (scale 0–6)	The mean number of menses in the previous 6 months in the control groups was 0·50	The mean number of menses in the previous 6 months in the intervention groups was 0·8 higher (0·18–1·42 higher)		40 (1 study)^f	⊕⊖⊖⊖ very low^c,e

BMI, body mass index; CI, confidence interval; MD, mean difference; RR, risk 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. ^aThe basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ^bMoghetti.⁹⁷ ^cDowngraded two levels due to very serious imprecision (very wide CI owing to small sample size). ^dGambineri,⁶⁸ Moghetti.⁹⁷ ^eDowngraded one level owing to serious risk of selection bias (allocation concealment was assessed as 'high risk of bias' for Gambineri).⁶⁸ ^fGambineri.⁶⁸

Table 3. Summary of findings for finasteride 5–7·5 mg compared with placebo for hirsutism
Patient or population: women with hirsutism
Intervention: finasteride 5–7·5 mg
Comparison: placebo
Outcomes	Illustrative comparative risks^a (95% CI)		Relative effect (95% CI)	Number of participants (studies)	Quality of evidence (GRADE)	Comments
	Assumed risk	Corresponding risk
	Placebo	Finasteride 5–7·5 mg
Participant-reported improvement of hirsutism 3-point (Lakryc⁸⁷) and 4-point (Moghetti⁹⁷) Likert scale	See comment	See comment	Not estimable	54 (2 studies)^b	⊕⊖⊖⊖ very low^c,d	RR: 2·06, 95% CI: 0·99–4·29; P = 0·05 (Lakryc⁸⁷) and RR: 11·00, 95% CI: 0·69–175·86; P = 0·09 (Moghetti⁹⁷)
Change in health-related quality of life (not measured)	See comment	See comment	Not estimable	–	See comment	No study addressed this outcome
Proportion of participants who reported an adverse event	Study population		RR: 1·13 (0·48–2·67)	67 (3 studies)^e	⊕⊖⊖⊖ very low^c,d
	243 per 1000	275 per 1000 (117–649)
	Moderate
	200 per 1000	226 per 1000 (96–534)
Clinician's assessment of improvement of hirsutism; Ferriman–Gallwey score (scale 0–36)	The mean clinician's assessment of improvement of hirsutism in the control groups was 0·8	The mean clinician's assessment of improvement of hirsutism in the intervention groups was 5·73 lower (6·87–4·58 lower)		62 (3 studies)^e	⊕⊖⊖⊖ very low^c,d	MD is statistically significant, however, the difference is unlikely to be clinically important
Change in serum androgen levels	See comment	See comment	Not estimable	52 (3 studies)^e	⊕⊕⊖⊖ low^d	Finasteride reduces the conversion of testosterone into dihydrotestosterone (DHT), there was a statistically significant MD in reduction of DHT levels
Change in BMI kg m⁻²	The mean change in BMI in the control groups was 0·8 kg m⁻²	The mean change in BMI in the intervention groups was 1·30 kg m⁻² lower (2·96 lower to 0·36 higher)		24 (1 study)^f	⊕⊖⊖⊖ very low^d,g
Improvement of other clinical signs of hyperandrogenism (not measured)	See comment	See comment	Not estimable	–	See comment

BMI, body mass index; CI, confidence interval; MD, mean difference; RR, risk 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. ^aThe basis for the assumed risk (e.g. the median control group risk across studies) is provided in footnotes. The corresponding risk (and its 95% CI) is based on the assumed risk in the comparison group and the relative effect of the intervention (and its 95% CI). ^bLakryc,⁸⁷ Moghetti.⁹⁷ ^cSeveral domains have been judged as at unclear risk of bias (Ciotta⁴⁷). ^dWide CI owing to low sample size. ^eCiotta,⁴⁷ Lakryc,⁸⁷ Moghetti.⁹⁷ ^fLakryc.⁸⁷ ^gHigh dropout rate (29%) and per-protocol analysis.

Interventions for Hirsutism Excluding Laser and Photoepilation Therapy Alone

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Interventions for Hirsutism Excluding Laser and Photoepilation Therapy Alone

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