Obstetrics and Gynecology

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ACOG publications are protected by copyright and = all=20 rights are reserved. ACOG publications may not be reproduced in = any form=20 or by any means without written permission from the copyright = owner. This=20 includes the posting of electronic files on the Internet, = transferring=20 electronic files to other persons, distributing printed output, = and=20 photocopying. Requests for authorization to make photocopies = should be=20 directed to: Copyright Clearing Center, 222 Rosewood Drive, = Danvers, MA=20 01923 (978) 750-8400

Original=20 Research

March=20 2002

Volume 99, Number=20 3
Pages 419 -=20 425=20

Over-the-Counter Antifungal = Drug Misuse=20 Associated With Patient-Diagnosed Vulvovaginal Candidiasis=20

Daron G. Ferris, MD,^a=20 Paul Nyirjesy, MD,^c=20 Jack D. Sobel, MD,^d=20 David Soper, MD,^e=20 Adriana Pavletic, MD,^f=20 and Mark S. Litaker, PhD^b=20

Objective: To estimate what proportion of = symptomatic=20 women purchasing over-the-counter antifungal products for = immediate=20 treatment of presumed vulvovaginal candidiasis have = vulvovaginal=20 candidiasis or other genitourinary conditions.=20

Methods: A time-location sample of 95 symptomatic = women=20 who purchased and presented with an over-the-counter = antifungal=20 product for immediate and personal treatment of presumed=20 vulvovaginal candidiasis were evaluated by clinical = examination and=20 pertinent laboratory tests. The percentage of women = diagnosed having=20 vulvovaginal candidiasis or other conditions, proportions of = women=20 with vulvovaginal candidiasis compared between groups with = and=20 without a prior diagnosis of vulvovaginal candidiasis, and = groups=20 that read or did not read the over-the-counter package label = were=20 assessed.=20

Results: The actual diagnoses for women who = self-diagnosed=20 vulvovaginal candidiasis were: vulvovaginal candidiasis = 33.7%,=20 bacterial vaginosis 18.9%, mixed vaginitis 21.1%, normal = 13.7%,=20 other diagnoses 10.5%, and trichomonas vaginitis 2.1%. Women = with a=20 previous clinically based diagnosis of vulvovaginal = candidiasis were=20 not more accurate in diagnosing vulvovaginal candidiasis = than women=20 without a prior clinical diagnosis ( 3Dchi=20 ²=20 =3D 0.27, P =3D .6). Women who read the package label = were no=20 more likely to have vulvovaginal candidiasis than were women = who did=20 not read the label (Fisher exact test, P =3D .39).=20

Conclusion: Many women who self-diagnose and use = an=20 over-the-counter product for treatment of presumed = vulvovaginal=20 candidiasis do not have vulvovaginal candidiasis. A history = of a=20 previous clinically based diagnosis of vulvovaginal = candidiasis and=20 reading the package label do not help women self-diagnose=20 vulvovaginal candidiasis properly. Ready access to these = products is=20 associated with wasted financial expenditures, unfulfilled=20 expectations, and a delay in correct diagnosis for a = substantial=20 number of women.=20

^aDepartments of Family = Medicine=20 and Obstetrics and Gynecology, Medical College of Georgia, = Augusta,=20 Georgia, USA
^bOffice of=20 Biostatistics, Medical College of Georgia, Augusta, Georgia, = USA
^cDepartment = of=20 Obstetrics and Gynecology, Jefferson Medical College, = Philadelphia,=20 Pennsylvania, USA
^dDepartment of Internal Medicine, = Wayne=20 State University, Detroit, Michigan, USA
^eDepartment of Obstetrics and = Gynecology,=20 Medical University of South Carolina, Charleston, South = Carolina,=20 USA
^fDepartment = of Family=20 Medicine, University of Nebraska, Omaha, Nebraska, USA =

This study was supported by an unrestricted grant from = Pfizer,=20 Inc., New York, New York. 3M Pharmaceuticals, St. Paul, = Minnesota,=20 supplied free samples of Metrogel-Vaginal.=20

Special thanks to Betsy Foxman, PhD, for trial design = guidance=20 and manuscript review. Saundra Turner, FNP, PhD, and Lisa = Woodward,=20 RN, provided clinical trial support.=20

(Obstet Gynecol 2002:99:419-425. =C2=A9 2002 by The = American College=20 of Obstetricians and Gynecologists.)

An accurate diagnosis of vaginitis is contingent upon = patient=20 information, clinical findings, and interpretation of = vaginal=20 specimen laboratory analyses. However, patient symptoms and = clinical=20 findings alone are often unreliable for determining the = etiology of=20 a woman's complaint.^1-6=20 In particular, vulvovaginal candidiasis is more commonly=20 misdiagnosed than are vaginal trichomoniasis and bacterial=20 vaginosis.^1,6=20 Inaccurate diagnosis of vulvovaginal symptoms may delay = properly=20 diagnosing more serious lower genital tract diseases or = coexisting=20 infections.=20

Until the past decade, treatment of vulvovaginal = candidiasis=20 remained entirely within the domain of qualified health care = providers. However, the reclassification of former = prescription-only=20 vulvovaginal candidiasis drugs to over-the-counter products = provided=20 women easy access to self-treatment. The availability = appeals to=20 women in general, the pharmaceutical industry, health = insurance=20 providers, and many clinicians. This popular approach is = believed to=20 reduce health care expenditures, empower women in addressing = their=20 own wellness, and improve pharmaceutical product convenience = for the=20 public.^7-9=20

Appropriate selection and use of over-the-counter = products for=20 vulvovaginal candidiasis may be problematic, particularly = for some=20 women who have no medical training.¹⁰=20 Universal drug availability does not invariably insure = proper=20 selection, use, or satisfactory outcomes.¹¹=20 The Food and Drug Administration (FDA) assumes that = vulvovaginal=20 candidiasis medical education provided to patients during a = prior=20 visit to a medical provider, or health information written = on the=20 over-the-counter package label enable women to treat = themselves=20 appropriately. Yet, clinicians frequently encounter patients = who=20 have used these drugs to treat vaginal symptoms not caused = by=20 vulvovaginal candidiasis.=20

The magnitude of errant use of over-the-counter = antifungal=20 products remains subject to speculation because of a paucity = of=20 population-based data.^12,13=20 The purpose of this study was to estimate what proportion of = a=20 time-location sample of symptomatic women purchasing=20 over-the-counter antifungal products for immediate treatment = of=20 presumed vulvovaginal candidiasis had vulvovaginal = candidiasis or=20 other genitourinary conditions. In addition, we determined = whether=20 the history of a previous diagnosis of vulvovaginal = candidiasis by a=20 clinician or reading the over-the-counter package label = health=20 education instructions contributed to a more accurate = self-diagnosis=20 of vulvovaginal candidiasis.=20

Materials and = Methods=20

Women 18 years of age and older who purchased an = over-the-counter=20 product for treatment of self-diagnosed vulvovaginal = candidiasis at=20 pharmacies and grocery stores in the metropolitan areas of = Augusta,=20 Georgia, Philadelphia, Pennsylvania, Detroit, Michigan, = Charleston,=20 South Carolina, and Omaha, Nebraska, were referred for = enrollment in=20 the study between September 1997 and December 1999. Subjects = were=20 included if they: 1) had symptoms which prompted them to = purchase an=20 over-the-counter antifungal product, 2) intended to use the = product=20 immediately, 3) and presented to the clinics with an = untampered=20 over-the-counter product purchased recently. Subjects who = had been=20 diagnosed as having vulvovaginal candidiasis by a health = care=20 provider or who had broken the tamper proof seals on the=20 over-the-counter antifungal products were excluded from=20 participation. The study was approved by the respective=20 Institutional Review Boards (Medical College of Georgia, = Temple=20 University, Wayne State University, Medical University of = South=20 Carolina, and University of Nebraska).=20

A time-location sample of women with symptoms of presumed = vulvovaginal candidiasis who purchased an over-the-counter=20 antifungal product for their personal and immediate use were = informed about the study and asked to volunteer for the = study by the=20 pharmacists, cashiers, or clerks at the pharmacy/grocery = stores in=20 the respective metropolitan areas. Each woman received a = pamphlet=20 that described the trial, her involvement, and potential = benefits.=20 If the woman agreed to participate, two tamper proof seals = were=20 placed over the ends of the over-the-counter package, and = the woman=20 was asked to take this over-the-counter product to the = clinic site=20 for enrollment. All women were evaluated within 24 hours of=20 presentation or product purchase.=20

At the clinical site, women were informed about the = study, and=20 then read and signed the Institutional Review Board approved = consent=20 form. Demographic information was obtained and a = self-administered=20 survey completed. The survey included questions pertaining = to the=20 subject's symptoms, history of vaginitis, sexual history, = and=20 experience with over-the-counter products. After = visualization of=20 the cervix and vagina by use of a vaginal speculum, cervical = and=20 vaginal specimens were obtained for Neisseria = gonorrhoeae=20 (N. gonorrhoeae) and Chlamydia trachomatis = (C.=20 trachomatis) DNA testing, 10% potassium hydroxide and = saline wet=20 preparation, sniff test, pH determination, Gram stain, and = fungal=20 culture. An abdominal, external genitalia, and pelvic = examination=20 completed the assessment.=20

A vaginal specimen sample for a saline wet preparation = was=20 examined microscopically for the presence of leukocytes, = clue cells,=20 Lactobacillus sp., pseudohyphae and spores, and = motile=20 Trichomonas vaginalis. Another vaginal specimen = sample was=20 examined similarly for pseudohyphae and spores after the = addition of=20 potassium hydroxide. A sniff test of the vaginal discharge = was=20 performed immediately after 10% potassium hydroxide = placement to=20 detect an amine odor. A small amount of the vaginal specimen = was=20 applied to a strip of pH paper, and the resulting = colorimetric=20 reaction was interpreted by comparison with the = corresponding pH=20 reference scale. A small sample of vaginal = secretions/discharge was=20 collected, then inoculated on media, for fungal culture. A = Gram=20 stain was prepared from a small sample of vaginal fluid = smeared on a=20 glass slide. The slide was heat fixed and processed by the = standard=20 Gram stain technique. Gram stains were interpreted at a = central=20 site, and results included Trichomonas vaginalis, = fungal=20 elements, clue cells, inflammatory cells, red blood cells, = sperm,=20 gram-negative diplococci, Lactobacillus sp., = Gardnerella=20 vaginalis, and Mobiluncus sp.=20

A cervical swab specimen was obtained and tested for the = presence=20 of C. trachomatis and N. gonorrhoeae by a = polymerase=20 chain reaction technique. Urine specimens were analyzed by = use of a=20 dipstick test and microscopic examination, when appropriate. = Other=20 than Gram stains, which were evaluated at a central site = (JDS), all=20 specimens were processed and interpreted at the local = clinical=20 center laboratory.=20

A positive diagnosis of vulvovaginal candidiasis in this=20 symptomatic population was defined as gram-positive for = vulvovaginal=20 candidiasis or a positive fungal culture with or without a = positive=20 10% potassium hydroxide preparation (budding yeast, = pseudohyphae, or=20 hyphal forms). A positive diagnosis of Trichomonas = vaginalis=20 was defined as the presence of characteristic motile = trichomonads on=20 a saline wet preparation or nonmotile trichomonads on the = Gram=20 stain. The positive clinical diagnosis of bacterial = vaginosis was=20 defined as the presence of three of four Amsel's criteria = (adherent=20 off-white vaginal discharge, pH greater than 4.5, clue cells = on=20 saline wet preparation, a positive sniff test), or a = positive=20 Nugent's Gram stain score of greater than 7.^14,15=20 A positive diagnosis of C. trachomatis and N.=20 gonorrhoeae infection was defined as a positive = polymerase chain=20 reaction test for C. trachomatis and N. = gonorrhoeae,=20 respectively.=20

The percentage of women in the sample who were diagnosed = with=20 vulvovaginal candidiasis and other gynecologic conditions = was=20 calculated, including conditions coexisting with = vulvovaginal=20 candidiasis. The proportion of women with vulvovaginal = candidiasis=20 was compared between the groups with and without a prior = diagnosis=20 of vulvovaginal candidiasis, using the 3Dchi=20 ²=20 statistic. The odds ratio (OR) was calculated as a measure = of=20 association between prior diagnosis and correct = self-diagnosis. A=20 95% confidence interval (CI) for the true OR was calculated = by the=20 logit method. The sample percentage of women reporting = having read=20 the package label was calculated, along with a 95% CI. The=20 proportion of women who were diagnosed with vulvovaginal = candidiasis=20 among those who reported reading the package label were = compared=20 with the corresponding proportion among those who reported = not=20 reading the label using Fisher exact test. The OR and a 95%=20 confidence limit were calculated as measures of association. = The=20 Wilcoxon rank sum test was used to compare continuous and = Likert=20 scale variables between groups. Mantel-Haenszel 3Dchi=20 ²=20 statistic was used to compare ordinal categoric responses = between=20 groups.=20

Results=20

Of 104 women enrolled in the study, complete data were = available=20 for 95 who presented with a self-diagnosis of vulvovaginal=20 candidiasis and intended to use the product immediately for=20 themselves. The mean age of subjects was 36.6 years, and the = range=20 was 18-67 years. The majority (53.7%) of subjects was black, = 40.0%=20 were white, and 6.3% were Hispanic or Asian. With respect to = marital=20 status, 39.0% of women were married, 36.8% single, 17.9% = divorced,=20 and 6.3% separated or widowed. The majority of subjects = (72.3%) were=20 employed, 88.5% were high school graduates, and 67% had a = household=20 income of greater than or equal to $20,000. Approximately = half=20 (50.5%) of the women used some form of contraception. Of = this group,=20 38.3% used condoms, 27.7% oral birth control pills, 17.0% = were=20 sterilized, 4.3% used DepoProvera, and 12.8% used other = forms of=20 contraception.=20

The final diagnoses for women who intended to treat their = self-diagnosed vulvovaginal candidiasis with an = over-the-counter=20 antifungal product are listed in Table=20 1. Only 32 of 95 (33.7%) women made the correct = diagnosis of=20 vulvovaginal candidiasis. However, an additional 19 (20.0%) = women=20 had vulvovaginal candidiasis plus another type of vaginitis, = primarily coexisting bacterial vaginosis (18.9%). Fifty-one = percent=20 of women had a vaginal pH greater than or equal to 4.7, 30% = had a=20 positive sniff test, 36% had evidence of vulvovaginal = candidiasis by=20 the 10% potassium hydroxide test, 30% had evidence of = vulvovaginal=20 candidiasis by Gram stain, and 45% had a positive fungal = culture.=20 One woman had a positive test for C. trachomatis.=20

Women who made the correct diagnosis of vulvovaginal = candidiasis=20 (pure vulvovaginal candidiasis or mixed infection) were no = more=20 confident of their self-diagnosis (median Likert score =3D = 7, range 1=20 =3D not certain and 10 =3D very certain) than were women who = did not=20 have vulvovaginal candidiasis (median Likert score =3D 8, = P =3D=20 .16, Wilcoxon rank sum test). This was also true if only = women with=20 pure vulvovaginal candidiasis infections were compared with = women=20 who did not have only vulvovaginal candidiasis, medians 7 = and 8,=20 respectively (P =3D .43, Wilcoxon rank sum test).=20

The effect of a prior diagnosis of vulvovaginal = candidiasis on a=20 current correct diagnosis of vulvovaginal candidiasis was = analyzed=20 (Table=20 2). Women with pure vulvovaginal candidiasis were no = more likely=20 to have a previous clinically based diagnosis of = vulvovaginal=20 candidiasis than were women without a current diagnosis of a = pure=20 vulvovaginal candidiasis infection ( 3Dchi=20 ²=20 =3D 0.27, P =3D .6). The odds of having a prior = diagnosis of=20 vulvovaginal candidiasis was equivalent for women with and = without a=20 current pure vulvovaginal candidiasis infection (OR 0.76, = 95% CI=20 0.26, 2.18). These data differed if the current diagnosis = was=20 defined as any vulvovaginal candidiasis instead.=20

Of the 60 women who consulted with a clinician for their = last=20 diagnosis of vulvovaginal candidiasis, 72.3% received the = diagnosis=20 after a clinical examination, 17.3% were diagnosed by = telephone, and=20 11.4% had both a telephone and then clinically based = diagnosis. A=20 prior telephone diagnosis of vulvovaginal candidiasis did = not=20 improve women's self-diagnosis ability ( 3Dchi=20 ²=20 =3D 0.88, P =3D .3).=20

Of women who diagnosed themselves correctly, more read = the=20 over-the-counter package label (63.3%) than women who did = not read=20 the label (36.7%) (Table=20 3). However, women who read the label were no more = likely to=20 have vulvovaginal candidiasis than were women who did not = read the=20 label (P =3D .39, Fisher exact test). The odds of = reading the=20 label was equivalent for women with and without vulvovaginal = candidiasis (OR 1.1, 95% CI 0.4, 2.7, P =3D .8).=20

Next, we examined various factors, which might affect a = correct=20 self-diagnosis of vulvovaginal candidiasis (Table=20 4). Women who did not correctly self-diagnose pure or = mixed=20 vulvovaginal candidiasis had a significantly greater mean = and median=20 number of lifetime vulvovaginal candidiasis infections (17.8 = and=20 7.5, respectively) compared with women who made a correct=20 self-diagnosis of vulvovaginal candidiasis (6.5 and 4.0,=20 respectively, P =3D .01, Wilcoxon rank sum test). = Women who=20 incorrectly self-diagnosed vulvovaginal candidiasis also had = a=20 significantly greater mean and median number of prior = clinically=20 diagnosed vulvovaginal candidiasis infections (9.9 and 4.0,=20 respectively) compared with women who diagnosed vulvovaginal = candidiasis correctly (4.0 and 3.0, respectively, P = =3D .02,=20 Wilcoxon rank sum test). However, there were no significant=20 differences noted between median group scores for the other=20 variables. Because a large number of women (38.9%) also had=20 bacterial vaginosis, we assessed the role of a prior = clinical=20 diagnosis of bacterial vaginosis on establishing a correct = current=20 diagnosis of vulvovaginal candidiasis. A prior diagnosis of=20 bacterial vaginosis did not improve women's ability to = diagnose a=20 pure and mixed vulvovaginal candidiasis infection correctly = (²=20 =3D 0.009, P =3D .9), nor a pure vulvovaginal = candidiasis=20 infection ( 3Dchi=20 ²=20 =3D 3.1, P =3D .8).=20

Finally, there were 44 (46.3%) patients whose correct = diagnoses=20 were considered delayed by initial intent to use the=20 over-the-counter antifungal product. The consequence of this = delay=20 was determined by the investigators to be minor for 61%, = moderate=20 for 19%, severe for 4%, and of no consequence for the = remaining 16%=20 of patients. Acute salpingitis requiring hospitalization is = an=20 example of a severe delay.=20

Discussion=20

We determined that approximately one-third of women who=20 self-diagnosed a vulvovaginal candidiasis infection and = purchased an=20 over-the-counter product to treat their condition actually = had=20 vulvovaginal candidiasis confirmed by a nearly immediate = clinical=20 and laboratory examination. An additional 20% of women had=20 vulvovaginal candidiasis, but also with another type of = vaginitis.=20 Self-treatment with an over-the-counter antifungal product = will=20 generally cure vulvovaginal candidiasis in women with mixed=20 infections, but these women may likely continue to have = other=20 vaginal symptoms because of a second coexisting infection = that=20 requires clinical and laboratory evaluation. These women, = and an=20 additional 32% (or 51% total), needed a clinician-prescribed = pharmaceutical product for adequate therapy. Therefore, half = of the=20 women who use over-the-counter products for self-diagnosed=20 vulvovaginal candidiasis may eventually need to visit a = clinician to=20 receive proper therapy. The remaining 14% of women also = require a=20 clinical examination and pertinent laboratory tests to = reassure them=20 that they are normal and no treatment is necessary. The = implications=20 of these findings are unnecessarily wasted financial = expenditures,=20 unfulfilled expectations, potential precipitation of lower = genital=20 tract allergic and contact dermatitis, and a delay in = diagnosis and=20 cure for the majority of women.^11,16=20

The FDA suggests that only women who have had a prior = diagnosis=20 of vulvovaginal candidiasis or have read the = over-the-counter=20 package label should use these products. However, our data = clearly=20 indicate that a prior clinician-based diagnosis of = vulvovaginal=20 candidiasis and reading the label do not improve women's = ability to=20 properly diagnose vulvovaginal candidiasis. Furthermore, the = type of=20 prior diagnostic assistance, whether by telephone or even by = clinical examination, did not increase women's = self-diagnosis=20 capability. Although telephone diagnosis is becoming = increasingly=20 popular in capitated health care settings, the approach is = fraught=20 with inaccurate diagnoses. The number of prior clinically = diagnosed=20 vulvovaginal candidiasis infections, frequency of = over-the-counter=20 vulvovaginal candidiasis product use, and prior clinician=20 recommendation to use over-the-counter products did not = influence=20 accurate decision making by these women. The latter finding = is=20 particularly troubling because many clinicians tell their = patients=20 to use an over-the-counter product in the future if the same = present=20 symptoms return. The educational benefit appears to be = overestimated=20 for many women and may be explained by either a failure of=20 clinicians to successfully impart the characteristics of=20 vulvovaginal candidiasis to their patients or some patients' = general=20 inability to learn how to self-diagnose future vulvovaginal=20 candidiasis based on the current clinician- and = laboratory-derived=20 diagnosis. Amazingly, the majority of women reported reading = the=20 label, even though it did not increase the probability of=20 appropriate product selection and proper use. Did women=20 miscomprehend the instructions or are the instructions of no = value=20 for helping women discriminate whether they have = vulvovaginal=20 candidiasis? Eye-tracking studies of people reading product = labels=20 have shown that individuals rarely read them.¹⁷=20 Among those who do read them, abbreviated duration of = observation=20 and haphazard eye pattern suggest poor comprehension.=20

The total number of lifetime vulvovaginal candidiasis = infections=20 was associated with women's ability to self-diagnose = vulvovaginal=20 candidiasis, but not as might be expected. Women who = diagnosed=20 vulvovaginal candidiasis incorrectly reported a = significantly=20 greater number of lifetime vulvovaginal candidiasis = infections=20 compared with women who made the correct self-diagnosis. It = is=20 possible that many of these presumed vulvovaginal = candidiasis=20 infections were in fact not vulvovaginal candidiasis. = Repetitive=20 treatment with an over-the-counter product for a = nonvulvovaginal=20 candidiasis infection would mistakenly convey the impression = of=20 recurrent and numerous vulvovaginal candidiasis infections. = Perhaps=20 the women who incorrectly self-diagnosed vulvovaginal = candidiasis=20 also tended to overestimate the frequency because of their=20 frustrations in dealing with the matter.=20

A potential for delay in proper diagnosis was noted for = half of=20 these women. Although the consequences of the diagnostic = delays were=20 primarily minor, several were believed to be potentially = severe. A=20 patient who presented with vaginal discharge determined to = be caused=20 by acute salpingitis, requiring hospital admission and = treatment, is=20 one example from our study of a potentially serious = diagnostic=20 delay. Had this woman instead used the over-the-counter = product for=20 self-diagnosed vulvovaginal candidiasis, more serious = complications=20 could have occurred. New data indicating women with = bacterial=20 vaginosis are at increased risk for acquiring human = immunodeficiency=20 virus underscores the importance of what was previously = believed to=20 represent a minor patient inconvenience.¹⁸=20 An unhealthy vaginal ecosystem places women at risk for = human=20 immunodeficiency virus and other serious medical conditions, = including post-operative infections and pregnancy-related=20 complications.^19-24=20

Our study was limited by a somewhat small sample size. = However,=20 recruitment was extremely difficult for our experienced = research=20 group because most women who use these over-the-counter = products do=20 so to avoid being seen by a health care provider. Even = though we=20 were available to see women immediately and provided = transportation=20 money, the vast majority chose to ignore our offer. = Therefore, some=20 may infer that we may have attracted women who were unsure = of their=20 self-diagnosis. Yet, it was noteworthy to find a high = confidence=20 level for correct self-diagnosis of vulvovaginal candidiasis = in both=20 groups. This high level of confidence has been noted by=20 others.²⁵=20 Such a finding would argue against the contention of an=20 unintentional selective recruitment. Black women were also=20 represented at a greater percentage than found in the = general US=20 population. However, this percentage reflects the normal = population=20 expected at the major enrollment site in the southern United = States.=20 Whether this increased percentage also represents an actual = barrier=20 to health care is unknown.=20

Finally, the overall economic impact of these = misdiagnoses may be=20 less than reverting back to a prescription-only era. Much of = the=20 costs to the health care industry have been clearly reduced = and=20 assumed by consumers. In fact, the health care industry is = now=20 pushing for other prescription-only products to become = classified as=20 over the counter. Our intent was not to determine the=20 cost-effectiveness of the self-diagnosis, self-treatment=20 scenario.^7,8=20 However, it is also obvious that the pharmaceutical industry = has=20 benefited economically by empowering women. The FDA has = allowed the=20 use of over-the-counter antifungal drugs for treatment of=20 self-diagnosed vulvovaginal candidiasis, although our study = found=20 the FDA's proper use stipulations ineffective. In the = current era of=20 self-diagnosis and treatment for vulvovaginal candidiasis, = American=20 women have been led to believe that they are able to fully = handle=20 this condition on their own. Our data strongly dispute this=20 assumption and suggest that further analysis should address = whether=20 women truly benefit from the current approach towards = treating=20 vulvovaginal candidiasis.=20

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19. Hillier SL. The vaginal microbial = ecosystem=20 and resistance to HIV. AIDS Res Hum Retrovir = 1998;14:S17-S21.=20

20. Soper DE, Bump R, Hurt WG. Bacterial = vaginosis=20 and trichomoniasis vaginitis are risk factors for cuff = cellulitis=20 after abdominal hysterectomy. Am J Obstet Gynecol = 1990;163:1016-23.=20

21. Lin L, Song J, Kimber N, Shott S, = Tangora J,=20 Aroutcheva A, et al. The role of bacterial vaginosis in = infection=20 after major gynecologic surgery. Infect Dis Obstet Gynecol=20 1999;7:169-74.=20

22. Watts DW, Krohn M, Hillier SL, = Eschenbach DA.=20 Bacterial vaginosis as a risk factor for post cesarean = endometritis.=20 Obstet Gynecol 1990;75:52-8.=20

23. Gravett MG, Nelson PH, DeRoven T, = Critchlow C,=20 Eschenbach DA, Holmes KK. Independent associations of = bacterial=20 vaginosis and Chlamydia trachomatis infection with = adverse=20 pregnancy outcome. JAMA 1986;256:1899-903.=20

24. Hillier SL, Martins J, Krohn M, = Kiviat N,=20 Holmes KK, Eschenbach DA. A case-controlled study of = chorioamniotic=20 infection and histologic chorioamniotis in prematurity. N = Engl J Med=20 1988;319:972-8.=20

25. Lipsky MS, Taylor CA. The use of=20 over-the-counter antifungal vaginitis preparations by = college=20 students. Fam Med 1996;29:493-5.

Address reprint requests to: Daron G. Ferris, MD, Medical = College=20 of Georgia, Departments of Family Medicine and Obstetrics = and=20 Gynecology, 1423 Harper Street, HH-100, Augusta, GA 30912; = E-mail:=20 dferris@mail.mcg.edu

Received August 30, 2001.
Received in = revised=20 form November 13, 2001.
Accepted = November 19,=20 2001.

Copyright =C2=A9 2002 by = The American=20 College of Obstetricians and Gynecologists
Published by = Elsevier=20 Science Inc.
Visit Obstetrics & Gynecology online at = http://www.greenjournal.org/ =

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