The PAV trial: does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277].

BACKGROUND: Complementary and alternative medicines are used by many consumers, and increasingly are being incorporated into the general practitioner's armamentarium. Despite widespread usage, the evidence base for most complementary therapies is weak or non-existent. Post-antibiotic vulvovaginitis is a common problem in general practice, for which complementary therapies are often used. A recent study in Melbourne, Australia, found that 40% of women with a past history of vulvovaginitis had used probiotic Lactobacillus species to prevent or treat post-antibiotic vulvovaginitis. There is no evidence that this therapy is effective. This study aims to test whether oral or vaginal lactobacillus is effective in the prevention of post-antibiotic vulvovaginitis. METHODS/DESIGN: A randomised placebo-controlled blinded 2 x 2 factorial design is being used. General practitioners or pharmacists approach non-pregnant women, aged 18-50 years, who present with a non-genital infection requiring a short course of oral antibiotics, to participate in the study. Participants are randomised in a four group factorial design either to oral lactobacillus powder or placebo and either vaginal lactobacillus pessaries or placebo. These interventions are taken while on antibiotics and for four days afterwards or until symptoms of vaginitis develop. Women self collect a vaginal swab for culture of Candida species and complete a survey at baseline and again four days after completing their study medications. The sample size (a total of 496--124 in each factorial group) is calculated to identify a reduction of half in post-antibiotic vulvovaginitis from 23%, while allowing for a 25% drop-out. An independent Data Monitoring Committee is supervising the trial. Analysis will be intention-to-treat, with two pre-specified main comparisons: (i) oral lactobacillus versus placebo and (ii) vaginal lactobacillus versus placebo.

"Not thrush again!" Women's experience of post-antibiotic vulvovaginitis.

OBJECTIVES: To examine the frequency of post-antibiotic vulvovaginitis (PAV); describe how women prevent and treat PAV; and determine whether concern about PAV affects their decisions about taking antibiotics. DESIGN: Cross-sectional survey using a written questionnaire. SETTING AND PARTICIPANTS: Five general practice waiting rooms in north-western Melbourne, in February 2000. 1298 women aged 18-70 years were surveyed. MAIN OUTCOME MEASURES: Self-reported symptoms and management of vulvovaginitis and PAV. RESULTS: The response rate was 86%. Thirty-five per cent of women reported ever having PAV and 73% reported ever having symptoms suggestive of vulvovaginal candidiasis. Antifungal medications and lactobacillus products or yoghurt were most popular for both prevention (49%, 40%) and treatment (63%, 43%) of PAV. Other home remedies such as tea tree oil, vinegar, and dietary and clothing modification were infrequently used by the women surveyed. Twenty-three per cent of women who had taken antibiotics in the previous month had experienced symptoms of vulvovaginitis. Of women who had ever had vulvovaginitis, 35% were moderately to very concerned about developing PAV when prescribed antibiotics. Because of this concern, around a fifth of these women would not take prescribed antibiotics. CONCLUSIONS: Concern about PAV affects women's decision-making regarding antibiotic use. Many women use unproven complementary therapies to prevent or treat PAV. When prescribing antibiotics, doctors should discuss the risks of PAV and its management with patients.

Tratamiento de la candidiasis vulvovaginal recidivante: estudio prospectivo comparativo de tres preparados antimicóticos con dosis única durante 6 meses / Treatment of recurring vulvo-vaginal candidiasis: a comparative prospective study during six months of three anti-mycotic preparations of a single dosis

Un total de 45 mujeres con candidiasis vulvovaginal recidivante (CVVR), tras ser distribuidas al azar, se trataron con dosis única de fluconazol en comprimido de 150 mg, oral (19 casos), o un comprimido vaginal de clotrimazol de 500 mg (12 casos) o 2 cápsulas de 100 mg, oral, de itrazonazol (14 casos), el sexto día del ciclo. Se practicó cultivo para hongos antes y a los 6 meses del tratamiento. Se evaluaron a los 6 meses, tras finalizar la pauta, y al año. Los resultados de curación clínica a los 6 meses fueron del 52,63 por ciento para fluconazol, del 91,66 por ciento para clotrimazol y del 85,71 por ciento para itraconazol. Hubo diferencias significativas al compararlos entre sí, p < 0,05 para itraconazol y para cotrimazol frente a fluconazol. Al año, los resultados fueron curación clínica en un 42,10 por ciento para fluconazol, en un 58,33 por ciento para clotrimazol, y en un 64,28 por ciento para itraconazol (mejor resultado). Las recidivas fueron del 57,89 por ciento para fluconazol, del 41,66 por ciento para clotrimazol y del 35,71 por ciento para itraconazol, sin diferencias significativas entre ellos. La curación microbiológica no es completa, y oscila entre 33,3 por ciento para clotrimazol e itraconazol y el 50 por ciento para fluconazol. No se refieren efectos secundarios del tratamiento. Como conclusiones cabe señalar que la eficacia clínica global del tratamiento es del 73,33 por ciento. Con CVVR hay que hacer profilaxis precozmente con una pauta y mantenerla al menos un año para el beneficio de la paciente (AU)

Treatment of recurrent vulvovaginal candidiasis.

Vulvovaginal candidiasis is considered recurrent when at least four specific episodes occur in one year or at least three episodes unrelated to antibiotic therapy occur within one year. Although greater than 50 percent of women more than 25 years of age develop vulvovaginal candidiasis at some time, fewer than 5 percent of these women experience recurrences. Clinical evaluation of recurrent episodes is essential. Patients who self-diagnose may miss other causes or concurrent infections. Known etiologies of recurrent vulvovaginal candidiasis include treatment-resistant Candida species other than Candida albicans, frequent antibiotic therapy, contraceptive use, compromise of the immune system, sexual activity and hyperglycemia. If microscopic examination of vaginal secretions in a potassium hydroxide preparation is negative but clinical suspicion is high, fungal cultures should be obtained. After the acute episode has been treated, subsequent prophylaxis (maintenance therapy) is important. Because many patients experience recurrences once prophylaxis is discontinued, long-term therapy may be warranted. Patients are more likely to comply when antifungal therapy is administered orally, but oral treatment carries a greater potential for systemic toxicity and drug interactions.