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PATIENT REPORTED OUTCOMES OF HORMONAL TREATMENTS FOR ACNE
Jerry Tan1, Karen Y. Fung2
Background
There are no comparative clinical trials on the comparative efficacy of the three hormonal preparations currently indicated in Canada for treatment of acne; namely Tri-Cyclen® (Ortho-McNeil), Alesse® (Wyeth), and Diane-35® (Berlex).
Objective
Comparative effectiveness in acne for these 3 hormonal agents was sought from the Canadian acne epidemiological survey.
Methods
Relative effectiveness was evaluated in 2 ways:
• retrospective patient responses to questions on effectiveness of previous hormonal therapy, and
• prospective evaluation of outcomes (IGA, Leeds score, Acne-QoL) for patients prescribed these hormones for a minimum of 4 to maximum of 6 months.
Results
Mean effectiveness scores based on retrospective patient responses were: 1.36 for Tricyclen®, 1.73 for Alesse® and 2.0 for Diane 35®. Proportions of patients rating these treatments as moderate-extremely effective were 22% for Tricyclen®, 19% for Alesse® and 42% for Diane 35® (P = 0.044). Prospective evaluation was performed only for the Diane-35® cohort (N= 17) as insufficient sample sizes were obtained for Tricyclen® and Alesse® cohorts (N=1 each). Objective improvement in acne was observed in 12/17 (70.6%) patients. Overall improvement in Acne-QoL total score was 19% (P = 0.017) with significant subscale improvement in 3 of 4 domains (self-perception, symptoms, role-emotional). Seventy-one percent of patients (12 out of 17) rated Diane 35® as moderately-extremely effective in treatment of acne after 4-6 months of treatment.
Summary
Female acne patients previously treated with one of the 3 hormonal preparations indicated in Canada for treatment of
acne ranked Diane-35® more highly for effectiveness than Tricyclen® or Alesse®. Patients were more likely to rate previous treatment with Diane-35® as moderately-extremely effective compared to these other hormonal preparations. After up to 6 months treatment with Diane-35®, objective improvement in at least one acne-affected region was observed in 71% of patients. The majority of these patients (71%) rated Diane-35® as moderately-extremely effective in treatment of acne. Diane-35® was also associated with improvement in acne-specific quality of life (Acne-QoL).
Limitations
• Retrospective recall for rating effectiveness – however, comparator cohorts should minimize confounding.
• The lack of a cohort comparator group in the prospective analysis increases the risk for potential bias.
• The combination with topical acne agents and oral antibiotics may confound effectiveness outcome determination of Diane-35® alone but is consistent with usual clinical practice and combination therapy.
Acknowledgements
The Canadian Acne Epidemiological Survey is partially funded by educational grants from Berlex, Roche, Dermik and Stiefel.
1 Dept. of Medicine, University of Western Ontario, Windsor, Ont.
2 Dept. of Mathematics & Statistics, University of Windsor, Windsor, Ont.
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