#362 Facing the Evidence in Acne, Part I: Oral contraceptives and spironolactone in females
CLINICAL QUESTION
How effective are combined oral contraceptives (COC) and spironolactone for treating acne of at least mild-moderate severity in females?
BOTTOM LINE
At ~24 weeks, ~80-90% of females report improvement in their acne with COCs, compared to 50-80% placebo, and 30-50% will have clear-almost clear skin versus 10-40% on placebo. Efficacy appears similar between individual COCs. Spironolactone, typically added to topical agents, has similar outcomes. Discontinuations due to adverse events appear comparable to placebo.
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EVIDENCE
- COC: Two systematic reviews1,2 (19-31 randomized controlled trials [RCTs]; 6199-12,579 patients, 11 different COC combinations) in females aged 14-49 with at least mild to moderate acne. At ~24 weeks:
- Versus placebo:
- Patient-assessed improvement: ~80-90% versus 50-80% (placebo).1 Number needed to treat (NNT)=4-7.
- Clinician assessed clear-almost clear skin: 30-50% versus 10-40% (placebo), NNT=6-9.
- Adverse event discontinuations:1 Usually similar to placebo. When different, number needed to harm (NNH)=25-50
- Versus COC:1
- No consistent statistical differences in 17 comparisons.
- Adverse event discontinuations: Usually not different.
- Versus placebo:
- Spironolactone: One double-blind RCT (410 females, mean age 29),3 spironolactone 100mg daily versus placebo (~70% using topicals concurrently) for 24 weeks:
- Patient-assessed improvement: 82% versus 63% (placebo) (NNT=6).
- Patient-assessed clear-almost clear skin: 32% versus 11% (placebo) (NNT=5).
- Quality of life (30-point scale, higher=better, baseline=13): Increased 8.0 versus 4.5 points (placebo), difference likely clinically meaningful.4
- Any adverse events: 64% versus 51% (placebo); example: headache 20% versus 12% (placebo).
- Adverse event discontinuations: No difference.
- Other RCT added spironolactone to topical benzoyl peroxide found slightly greater benefit, but benefits possibly exaggerated as smaller, shorter RCT (63 patients, 12 weeks).5
- Limitations: Most COC RCTs unblinded, many COC RCTs prohibited concurrent topical agents, no RCTs comparing COCs to topical agents, many industry-funded.
CONTEXT
- Guidelines support adding COC if hormonal contraception desired, or when standard treatments (example: topical benzoyl peroxide or retinoid) inadequate. No clear recommendations for spironolactone (all published prior to recent RCT).6-8
- Two small RCTs (170 patients) found no statistical difference between COC and oral antibiotics.1,2
- Potassium monitoring with spironolactone generally unnecessary unless patient otherwise at risk (example: on angiotensin-converting enzyme inhibitors).6
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#362 Facing the Evidence in Acne, Part I: Oral contraceptives and spironolactone in females
How effective are combined oral contraceptives (COC) and spironolactone for treating acne of at least mild-moderate severity in females?
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