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Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine
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Associate Professor; Residency Director, Department of Family Medicine, University of California, Irvine
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CME Released: 12/21/2004; Reviewed and Renewed: 12/21/2005
Valid for credit through: 12/21/2006
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Dec. 21, 2004 — Several prescription antibiotic regimens for facial acne vulgaris were not better than over-the-counter benzoyl peroxide, according to the results of a randomized study published in the December 18/25 issue of The Lancet.
"Antibiotic therapy has been an important part of acne management worldwide for the past 40 years, but acne is not an infection in the classic sense: direct antiinflammatory activity could be as important as inhibition of propionibacterial growth, or even more important," write Mara Ozolins, MD, from Queens Medical Centre in Nottingham, U.K. and colleagues. "One consequence of the heavy reliance on antibiotics has been a large increase in the prevalence of propionibacteria resistant to commonly used agents."
In this 18-week, observer-masked trial, 649 community participants with mild-to-moderate inflammatory facial acne were randomized to one of five antibacterial regimens. The primary outcomes, analyzed by intent-to-treat, were patients' self-assessed improvement and reduction in inflamed lesions.
At 18 weeks, there was at least moderate or greater improvement in 72 (55%) of 131 participants assigned oral oxytetracycline plus topical placebo, 70 (54%) of 130 assigned oral minocycline plus topical placebo, 78 (60%) of 130 assigned topical benzoyl peroxide plus oral placebo, 84 (66%) of 127 assigned topical erythromycin and benzoyl peroxide in a combined formulation plus oral placebo, and 82 (63%) of 131 assigned topical erythromycin and benzoyl peroxide separately plus oral placebo. Most improvement occurred in the first six weeks.
Treatment differences for the proportion of people with at least moderate improvement were -1.2% for minocycline vs oxytetracycline (unadjusted 95% confidence interval [CI], -13.3 to 10.9); 11.1% for combined erythromycin and benzoyl peroxide vs oxytetracycline (95% CI, -0.7 to 22.9) and 12.3% for combined erythromycin and benzoyl peroxide vs minocycline (95% CI, 0.4-24.2); -3.5% for erythromycin and benzoyl peroxide separately vs combined formulation (95% CI, -15·2 to 8·2); and 5.0% for benzoyl peroxide vs oxytetracycline (95% CI, -7.0 to 17.0), 6.2% for benzoyl peroxide vs minocycline (95% CI, -5.8 to 18.2), and -6.1% for benzoyl peroxide vs combined formulation (95% CI, -17.9 to 5.7).
Preexisting tetracycline resistance reduced the efficacy of both tetracyclines. The most cost-effective treatment was benzoyl peroxide.
Study limitations include low rate of recruitment, focus on facial acne, differences in compliance related to enrollment in a clinical trial, and absence of participant masking.
"Differences in cost-effectiveness between regimens were large; the cheapest treatment (benzoyl peroxide) was 12 times more cost-effective than minocycline," senior author Hywel C. Williams, MD, also from Queens Medical Centre, says in a news release. "We found that clinical efficacy of oral tetracyclines is compromised by pre-existing propionibacterial resistance. By contrast, topical regimens that included erythromycin and benzoyl peroxide were unaffected by resistance but were not superior to benzoyl peroxide alone."
The National Health System Health Technology Assessment Programme provided financial support. Stiefel Laboratories, maker of benzoyl peroxide, supplied the control vehicle gel. Some of the authors report various financial arrangements with Stiefel, Dermik Laboratories (Aventis), maker of erythromycin, Lederle, and/or Adams Healthcare.
Lancet. 2004;364:2188-2195
