Am Fam Physician. 2002;65(11):2349-2354
Many medications for vulvovaginal candidiasis are now available without a prescription. The reclassification of these medications to over-the-counter status was based on the belief that women can accurately identify such infections and begin treatment promptly, thus reducing morbidity and saving health care costs. Ferris and colleagues studied the accuracy of self-diagnosis of vulvovaginitis in women who purchased nonprescription medications for this condition.
Women were invited to participate in the study by grocery store or pharmacy clerks at the time they purchased the medication. The medication of those who agreed to participate in the study was taped with two tamper-proof seals, and the women were enrolled within 24 hours at a participating clinic. To be included in the study, women had to have active symptoms that they interpreted as fungal vulvovaginitis and show the unopened purchased product. Baseline data included demographic information, sexual and gynecologic history, and details of current and previous vaginal symptoms. Patients were also asked to score their level of confidence in their self-diagnosis of vulvovaginal candidiasis. All patients underwent pelvic examination, including visualization of the cervix and vagina, collection of specimens for Neisseria gonorrhoeae, Chlamydia trachomatis, potassium hydroxide and saline wet preparations, sniff test, pH measurement, Gram stain, and fungal culture. Positive diagnosis of vulvovaginal candidiasis was based on a positive Gram stain or fungal culture.
The age range of the 95 patients was 18 to 67 years (mean, 36.6 years), and nearly 89 percent were high school graduates. More than 70 percent were employed, and 67 percent reported a household income of $20,000 or more per year. Condom use was reported by 38 percent, and birth control pills by 28 percent.
As shown in the accompanying table, only 32 (34 percent) of the women made an accurate diagnosis of vulvovaginal candidiasis. An additional 19 women (20 percent) had vulvovaginitis plus another type of vaginitis. Women who did not have vulvovaginal candidiasis were just as confident of their self-diagnosis as those who correctly identified the condition. Women reporting previous episodes of vulvovaginal candidiasis and those who reported reading the product information were no more accurate in self-diagnosis than other women.
The choice to initially use nonprescription medication was estimated to have delayed the correct diagnosis in 44 (46 percent) patients. The consequences of delay were judged to be minor in 61 percent of them, moderate in 19 percent, severe in 4 percent, and of no consequence in 16 percent of patients.
The authors conclude that the majority of women who purchase nonprescription medications for vulvovaginal candidiasis do not have that disease, even if they have previous experience of the condition and have read the medication information. The availability of these medications without prescription results in overuse, wasted resources, and inappropriate treatment of gynecologic symptoms in many women. In a small number of women, the delay in accurate diagnosis and correct treatment of gynecologic conditions can have serious consequences.
editor's note: The results of this study are particularly worrisome in light of the growing practice of telephone triage of patients. For many reasons, including the time pressures on working women, we frequently advise patients who are confident that they have vulvovaginal candidiasis to use a nonprescription medication. If the results of this study can be generalized, only one half of such patients will be appropriately treated with these medications, and nearly 14 percent have no detectable pathology. The implications for patients who directly seek nonprescription or even alternative treatments are unknown. The concern goes beyond relieving vaginal symptoms. Diagnoses made in these “candidiasis” patients included acute salpingitis, which requires hospitalization.—a.d.w.