Patient Preferences in the Treatment of Vaginal Candidiasis

Vulvovaginal candidiasis (VVC) is one of the most frequent problems facing women and their healthcare professionals (HCP). It is difficult for providers to understand the prevalence of VVC because effective over the counter treatments (OTC), are available. It is expected that there are a great many more episodes of VVC in our patient population, as the frequency of self-treatment, success and satisfaction for those that use OTC products prior to seeing a women’s health care provider is unknown. In this study; healthcare providers were given OTC miconazole/tioconazole units for free distri-bution to patients for whom they diagnosed VVC by exam in their offices. Surveys for both HCP and patients were also distributed to determine the ini-tial or recurrent nature of their symptoms and their satisfaction with their treatments. 1265 OBGYNs and 1821 NP/CNM/PAs reported on over 19,000 patients receiving a single complete treatment. Among HCPs, treatment efficacy was the primary reason for recommending miconazole/tioconazole. How-ever, rapid onset of symptom relief, safety vs. fluconazole, patient preference for the less messy ovule, avoidance with drugs metabolized by the liver, and resistance to, or failure on, fluconazole were additional reasons noted for topical preference. Overall, patient satisfaction (n = 317) was high at 95%, with 97% of patients reporting that they would use miconazole again. Impor-tantly, 100% of first time sufferers (n = 95) would use miconazole again. The few patients dissatisfied presenting to a healthcare office.


Introduction
The most common cause of vulvovaginal candidiasis (VVC) is Candida albicans but other candidal species or yeasts may be responsible for causing the clinical syndrome [1].
Typical symptoms of VVC [2] include pruritus, vaginal soreness, dyspareunia, dysuria, and abnormal vaginal discharge. Approximately 75% of women will have at least one episode of VVC during their lifetime, and between 40% and 45% will have two or more episodes. Based on clinical presentation, microbiology, host factors, and response to therapy, VVC can be classified as either uncomplicated or complicated. Up to 20% of women will have complicated VVC, requiring special consideration regarding diagnosis and treatment [3].
For many patients, a short-course of a topical formulation, either as a single dose or a 3-day regimen, can be used to treat uncomplicated VVC effectively.
According to the CDC, the topically applied azole drugs are more effective than nystatin. Treatment with azoles results in relief of symptoms and negative cultures in 80% -90% of patients who complete therapy.
Topical agents usually cause no systemic side effects, although local burning or irritation might occur. Healthcare professionals should keep in mind that clinically important interactions can occur when oral azoles agents are administered with other drugs [4] [5] [6].
One of the topical azoles, miconazole, has been shown to be just as effective at curing VVC as fluconazole, the leading prescription pill. In a clinical study that compared 7-day topical miconazole to prescription fluconazole, there was no statistically significant difference in clinical cure rates at 14 days post-treatment.
Topical agents, such as miconazole begin to work on contact, curing VVC just as effectively as fluconazole while relieving symptoms much sooner, is effective for both albicans and non-albicans species of yeast, and treats a broader spectrum of VVC than prescription fluconazole [7] [8] [9] [10].
For non-albicans VVC, a non-fluconazole azole is recommended by CDC, for a duration of 7 -14 days. Practically, if patients use a 1-day, 3-day or 7-day course of a topical azole and they are still symptomatic after a week, following up with a second course of intra-vaginal therapy for 7 days is advised.
In 2016, the International Society for the Study of Vulvovaginal Disease (ISSVD), developed treatment recommendations by species of yeast. Interestingly, the only non-compounded azole that covers the top 5 most prevalent species of yeast (C. albicans, C. glabrata, C. parapsilosis, C. krusei and S. cerevisiae), Open Journal of Obstetrics and Gynecology is miconazole. Thus, miconazole is the society's only recommended antifungal azole treatment for C. glabrata, the most prevalent non-albicans yeast species.
Because of the different methods by which patients can receive VVC treatment, (oral by prescription following contact with HCP or by phone; or OTC with/without interaction or notification with a HCP), providers miss feedback from patients on the success and satisfaction of their treatment as this interaction is bypassed by direct OTC purchase or by telephone prescribing/recommendation.
Although miconazole has been shown to be highly effective in clinical and laboratory studies, it is just as important to understand the patient perspective and a level of satisfaction with over-the-counter products, as they may have been used prior to patients visit or recommended by the HCP.

Objectives
A Trial Program was initiated among patients, nurses and physicians to assess patients' experience and satisfaction with topical miconazole and HCP reasons for dispensing topical miconazole or tioconazole. The objectives of the study were to: 1) Provide hands on experience with dosages and forms.
2) Give HCP's experience with selecting the best topical OTC product for the specific history or symptoms.

3) Record data from patients and gain insights and feedback about the success
and safety of topical miconazole/tioconazole in patients with first time or recurrent VVC.

Methods
Physicians and advanced practice professionals were given 3 samples of each of the following miconazole treatment options to dispense to their gynecologic patients at least age 18 or greater for the treatment of yeast infections: 1) tioconazole ointment 6.5% (Monistat  1 Simple Therapy TM ) 2) miconazole ovule 1200 mg. (Monistat  1 Complete Therapy) 3) miconazole ovule 200 mg × 3 (Monistat  3 Complete Therapy) 4) miconazole cream 100 mg × 7 (Monistat  7 Complete Therapy) 5) In addition to the intra-vaginal treatment, Monistat "complete" products include a tube of miconazole cream for external use and cleansing wipes (Coolwipes  ).
Vulvovaginal candidiasis was diagnosed clinically if signs of vulvar or vaginal erythema with thick white discharge were noted and symptoms of vulvar or vaginal itching and/or irritation were noted. Microbiologic confirmation was often performed but not required and not reported.
Both HCPs and patients were asked to fill out a form. HCPs, including physicians (OBGYN), nurse practitioners (NP), certified nurse midwifes (CNM) and physician assistants (PA) were asked to provide, the name of the dispensed product and the reasons for dispensing the specific product. Open Journal of Obstetrics and Gynecology Only one course of treatment was provided, and the duration matched the specific product given of 1, 3, or 7 consecutive days.
Patients were asked to report on their overall experience and satisfaction with the topical products by responding to the following questions and statements, as shown in the Table 1 below.
As no identifying information was collected, the study was deemed exempt from the Institutional Research Review Board.

3) Patient Findings
An analysis of the responses revealed that almost all patients reported fast symptom relief with any topical miconazole/tioconazole treatment ( Figure 3).    When evaluating the individual treatment options, the perception of benefit was associated with specific treatment options ( Table 2).
As mentioned previously, almost all patients reported that topical miconazole/tioconazole cured their infection within seven days ( Figure 4).
As all agents were topical, side effects were minimal (less than 1%) and local, with vulvar burning the predominant symptom. For the 3% of patient respondents who would not use or were not sure they would use topical miconazole again, the primary reasons were that they did not feel quick symptom relief, did not have had their infection cured within 7 days, or experienced "allergic reaction" and burning sensation after use.
Healthcare professionals recommended the various miconazole/tioconazole products for a variety of reasons that are listed in Table 2. Open Journal of Obstetrics and Gynecology

Discussion
Vulvovaginal candidiasis is one of the most common gynecologic disorders in women today. While in the past, most treatments required a prescription, effective over-the-counter agents have been available for more than a generation.

Conclusions
The Patient Trial program provided feedback from thousands of prescribers and Open Journal of Obstetrics and Gynecology many patients including attitudinal information about the symptom relief and rationale for choosing specific products based on dosages and forms.
Some of the key findings from this study are listed below: 1) Nearly all patients were satisfied with miconazole (95%) and would use miconazole again (97%), showing that patients will accept a recommendation of an over-the-counter drug from health professionals.
2) 100% of first time sufferers would use miconazole again.

5)
Patients were also satisfied with the external cream (93%) and cleansing wipes (96%) which provided additional soothing and symptom relief.
Therefore, assumptions that topical over the counter antifungal are ineffective in patients with either primary or recurrent infections are incorrect. Care must be taken not to assume that oral agents are necessary, with the excellent results and satisfaction with the topical agents, our recommendation is that prescription of oral agents should be used with caution until studies are completed proving equal efficiency and safety.