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#362 Facing the Evidence in Acne, Part I: Oral contraceptives and spironolactone in females


CLINICAL QUESTION
QUESTION CLINIQUE
How effective are combined oral contraceptives (COC) and spironolactone for treating acne of at least mild-moderate severity in females?


BOTTOM LINE
RÉSULTAT FINAL
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
DONNÉES PROBANTES
  • 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.
  • 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
CONTEXTE
  • 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


johannes malan April 3, 2024

helpfull

gregory Stroh April 7, 2024

Informative

Elionora sofronova April 19, 2024

informative


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Author(s)
Auteur(s)
  • Sasha Katwaroo PharmD candidate
  • Brianne Desrochers PharmD candidate
  • Allison Paige MD CCFP
  • Jamie Falk PharmD

1. Williams Arowojolu AO, Gallo MF, Lopez LM, et al. Cochrane Database Syst Rev. 2012; 2012(7):CD004425.

2. Huang CY, Chant IJ, Bolick N, et al. Ann Fam Med. 2023; 21(4):358–69.

3. Santer M, Lawrence M, Renz S, et al. BMJ. 2023; 381:e074349.

4. McLeod LD, Fehnel SE, Brandman J, Symonds T. Pharmacoeconomics. 2003; 21(15):1069-79.

5. Patiyasikunt M, Chancheewa B, Asawanonda P, et al. J Derm. 2020; 47:1411–1416.

6. Zaenglein AL, Pathy AL, Schlosser BJ, et al. J Am Acad Dermatol. 2016; 74:945-73.

7. Asai Y, Baibergenova A, Dutil M, et al. CMAJ. 2016; 188(2):118-126.

8. National Institute for Health and Care Excellence (NICE). Acne vulgaris: management. Available at: https://www.nice.org.uk/guidance/ng198/resources/acne-vulgaris-management-pdf-66142088866501; Updated Dec 2023. Accessed December 12, 2023.

Authors do not have any conflicts of interest to declare.