Paper
Over-the-counter antifungal drug misuse associated with patient-diagnosed vulvovaginal candidiasis 1 1 Special thanks to Betsy Foxman, PhD, for trial design guidance and manuscript review. Saundra Turner, FNP, PhD, and Lisa Woodward, RN, provided clinical trial support.
Published Jun 1, 2002 · A. Pavletic, J. Sobel, M. Litaker
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Abstract
Patients with symptoms suggestive of vulvovaginal candidiasis now have the option of treating themselves with over-the-counter antifungal products. This investigation was undertaken to determine whether women using these products actually have a yeast infection or whether their symptoms are due to another vulvovaginal condition. From September 1997 to December 1998, women who purchased an over-the-counter antifungal product at pharmacies and grocery stores in five metropolitan areas in the United States were given the opportunity to participate in the study. They were recruited by pharmacists, cashiers, and clerks at the stores where they bought the products. If they agreed to participate, the product package was taped with two tamper-proof seals, and the women were asked to bring the package with them to the appropriate clinic site within 24 hours of purchase for clinical examination and laboratory studies. Sufficient data for analysis were available from 95 of the 104 women who initially agreed to take part in the study. The average age of the women was 36.6 years. More than 50% of participants were black, and 40% were white; almost 90% were high school graduates. Half of the women regularly used contraception. At the clinic visit, 32 of the 95 subjects were diagnosed with vulvovaginal candidiasis alone. Eighteen women had a diagnosis of both vulvovaginal candidiasis and bacterial vaginosis. Four women were had trichomonas vaginitis, two with trichomonas vaginitis only and one each with bacterial vaginosis and vulvovaginal candidiasis. No abnormalities were seen in 13 participants. The women with vulvovaginal candidiasis were no more confident than those who did not have candidiasis. A previous clinical diagnosis of vulvovaginal candidiasis did not improve a woman's ability to diagnose a repeat infection. Forty of the 44 subjects who were negative for vulvovaginal candidiasis had previously had this condition diagnosed clinically. Of the 51 women who did have vulvovaginal candidiasis, 37 had a previous diagnosis and 14 were experiencing their first infection. Reading the information on the over-the-counter antifungal medicine package did not improve a women's chances of correct self-diagnosis. A woman was more likely to be incorrect in her diagnosis of vulvovaginal candidiasis if she had a history of multiple clinically diagnosed fungal infections. The 42 subjects with a positive history who diagnosed themselves incorrectly had a lifetime mean of 18 prior infections. Compared with a lifetime mean of 6.5 for the 47 women who were correct in their diagnosis, this difference is statistically significant (P = .01). Forty-four women were identified who intended to use an over-the-counter antifungal treatment for vaginal symptoms but who delayed purchasing the product. The investigators estimated that this delay caused severe consequences (e.g., acute salpingitis requiring hospitalization) for 4% of the women.
Observational StudyWomen using over-the-counter antifungal products for vulvovaginal candidiasis may not accurately diagnose their condition, and reading the package information does not improve their chances of correct self-diagnosis.
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