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Placebo cure rates in the treatment of onychomycosis

Aditya K Gupta, Maryse Paquet

    Journal of the American Podiatric Medical Association
    |June 6, 2014
    PubMed

    Insights

    Placebo cure rates in onychomycosis trials are low, averaging below 9% for mycological cure. These rates, across clinical and complete cures, did not significantly correlate with study design or participant factors.

    Area of Science:

    • Dermatology
    • Clinical Trials
    • Mycology

    Background:

    • Placebo cure rates in onychomycosis randomized clinical trials (RCTs) exhibit variability.
    • Factors influencing these placebo cure rates remain under-investigated.

    Purpose of the Study:

    • To systematically investigate factors influencing placebo cure rates in RCTs for dermatophyte toenail onychomycosis.

    Main Methods:

    • A systematic literature search of PubMed and reference sections was conducted.
    • Included RCTs of dermatophyte toenail onychomycosis with placebo controls assessing cure rates.
    • Pooled analysis of cure rates from 21 identified studies.

    Main Results:

    • Pooled mean placebo cure rates: 8.7% (mycological), 3.4% (clinical), and 1.2% (complete).
    • No significant difference observed between oral and topical treatments.
    • No analyzed participant or study design characteristics correlated with cure rates.

    Conclusions:

    • Placebo cure rates in toenail onychomycosis RCTs are generally low.
    • These low rates appear independent of study characteristics and participant factors analyzed.

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