Topical interventions for genital lichen sclerosus

Ching‐Chi Chi; Gudula Kirtschig; Maha Baldo; Fabia Brackenbury; Fiona Lewis; Fenella Wojnarowska

doi:10.1002/14651858.CD008240.pub2

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Figure 1

Methodological quality summary: review authors' judgements about each methodological quality item for each included study.

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Figure 2

Methodological quality graph: review authors' judgements about each methodological quality item presented as percentages across all included studies.

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Analysis 1.1

Comparison 1 Clobetasol vs placebo, Outcome 1 Participant‐rated improvement or remission of symptoms.

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Analysis 1.2

Comparison 1 Clobetasol vs placebo, Outcome 2 Investigator‐rated global degree of improvement.

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Analysis 2.1

Comparison 2 Mometasone vs placebo, Outcome 1 Investigator‐rated change in clinical score of phimosis from baseline.

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Analysis 3.1

Comparison 3 Testosterone vs placebo, Outcome 1 Participant‐rated improvement or remission of symptoms.

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Analysis 3.2

Comparison 3 Testosterone vs placebo, Outcome 2 Investigator‐rated improvement of gross appearance.

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Analysis 3.3

Comparison 3 Testosterone vs placebo, Outcome 3 Adverse drug reactions that were severe enough to require withdrawal of treatment.

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Analysis 4.1

Comparison 4 Dihydrotestosterone vs placebo, Outcome 1 Investigator‐rated gross improvement.

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Analysis 5.1

Comparison 5 Testosterone vs clobetasol, Outcome 1 Participant‐rated improvement or remission of symptoms.

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Analysis 5.2

Comparison 5 Testosterone vs clobetasol, Outcome 2 Investigator‐rated global degree of improvement.

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Analysis 5.3

Comparison 5 Testosterone vs clobetasol, Outcome 3 Adverse drug reactions that were severe enough to require withdrawal of treatment.

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Analysis 5.4

Comparison 5 Testosterone vs clobetasol, Outcome 4 Adverse drug reactions that were not severe enough to require cessation of treatment.

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Analysis 6.1

Comparison 6 Testosterone vs dihydrotestosterone, Outcome 1 Participant‐rated remission of itching.

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Analysis 6.2

Comparison 6 Testosterone vs dihydrotestosterone, Outcome 2 Investigator‐rated gross improvement.

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Study	Testosterone	Placebo
Cattaneo 1996	The symptom score significantly worsened from 6 to 23 (p < 0.05).	No significant change in the symptom score.

Analysis 7.1

Comparison 7 Testosterone vs placebo as maintenance therapy, Outcome 1 Participant‐rated global degree of improvement.

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Study	Testosterone	Placebo
Cattaneo 1996	No significant change in the score of gross appearance.	No significant change in the score of gross appearance.

Analysis 7.2

Comparison 7 Testosterone vs placebo as maintenance therapy, Outcome 2 Investigator‐rated global degree of improvement.

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Analysis 7.3

Comparison 7 Testosterone vs placebo as maintenance therapy, Outcome 3 Adverse drug reactions that were severe enough to require cessation of treatment.

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Analysis 8.1

Comparison 8 Progesterone vs placebo, Outcome 1 Participant‐rated improvement or remission of symptoms.

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Analysis 8.2

Comparison 8 Progesterone vs placebo, Outcome 2 Investigator‐rated global degree of improvement.

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Analysis 9.1

Comparison 9 Pimecrolimus vs clobetasol, Outcome 1 Change in pruritus (VAS‐PR).

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Analysis 9.2

Comparison 9 Pimecrolimus vs clobetasol, Outcome 2 Change in burning/pain (VAS‐BP).

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Analysis 9.3

Comparison 9 Pimecrolimus vs clobetasol, Outcome 3 Investigator‐rated global degree of improvement.

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Table 1. Potency of topical corticosteroids (as defined by the British National Formulary)

Potency	Topical corticosteroids
Mild	Hydrocortisone 0.1% to 2.5% Fluocinolone acetonide 0.00625%
Moderate	Alclometasone dipropionate 0.05% Betamethasone valerate 0.025% Clobetasone butyrate 0.05% Fludroxycortide (flurandrenolone) 0.0125% Fluocortolone 0.25%
Potent	Betamethasone dipropionate 0.05% to 0.064% Betamethasone valerate 0.1% to 0.12% Diflucortolone valerate 0.1% Fluocinolone acetonide 0.025% Fluocinonide 0.05% Fluticasone propionate 0.005% to 0.05% Hydrocortisone butyrate 0.1% Mometasone furoate 0.1% Triamcinolone acetonide 0.1%
Very potent	Clobetasol propionate 0.05% Diflucortolone valerate 0.3%

Table 1. Potency of topical corticosteroids (as defined by the British National Formulary)

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Comparison 1. Clobetasol vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participant‐rated improvement or remission of symptoms Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Investigator‐rated global degree of improvement Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 1. Clobetasol vs placebo

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Comparison 2. Mometasone vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Investigator‐rated change in clinical score of phimosis from baseline Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 2. Mometasone vs placebo

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Comparison 3. Testosterone vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participant‐rated improvement or remission of symptoms Show forest plot	2	97	Risk Ratio (M‐H, Random, 95% CI)	1.21 [0.56, 2.64]

2 Investigator‐rated improvement of gross appearance Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

3 Adverse drug reactions that were severe enough to require withdrawal of treatment Show forest plot	2	97	Risk Ratio (M‐H, Random, 95% CI)	5.19 [0.62, 43.19]

Comparison 3. Testosterone vs placebo

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Comparison 4. Dihydrotestosterone vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Investigator‐rated gross improvement Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 4. Dihydrotestosterone vs placebo

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Comparison 5. Testosterone vs clobetasol

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participant‐rated improvement or remission of symptoms Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Investigator‐rated global degree of improvement Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

3 Adverse drug reactions that were severe enough to require withdrawal of treatment Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

4 Adverse drug reactions that were not severe enough to require cessation of treatment Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 5. Testosterone vs clobetasol

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Comparison 6. Testosterone vs dihydrotestosterone

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participant‐rated remission of itching Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Investigator‐rated gross improvement Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 6. Testosterone vs dihydrotestosterone

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Comparison 7. Testosterone vs placebo as maintenance therapy

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participant‐rated global degree of improvement Show forest plot			Other data	No numeric data

2 Investigator‐rated global degree of improvement Show forest plot			Other data	No numeric data

3 Adverse drug reactions that were severe enough to require cessation of treatment Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

Comparison 7. Testosterone vs placebo as maintenance therapy

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Comparison 8. Progesterone vs placebo

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Participant‐rated improvement or remission of symptoms Show forest plot	1		Risk Ratio (M‐H, Random, 95% CI)	Totals not selected

2 Investigator‐rated global degree of improvement Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 8. Progesterone vs placebo

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Comparison 9. Pimecrolimus vs clobetasol

Outcome or subgroup title	No. of studies	No. of participants	Statistical method	Effect size
1 Change in pruritus (VAS‐PR) Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

2 Change in burning/pain (VAS‐BP) Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

3 Investigator‐rated global degree of improvement Show forest plot	1		Std. Mean Difference (IV, Random, 95% CI)	Totals not selected

Comparison 9. Pimecrolimus vs clobetasol

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