RESUMO
OBJECTIVE: Phase I: A prospective evaluation of long-term systemic enzyme therapy (Wobenzym; WE) effects on the frequency of recurrent vulvovaginal candidiasis (RVVC) episodes. Phase II: A retrospective analysis of possible positive effects remaining in the next 3 years. TRIAL DESIGN: Original work - pilot project consisting of prospective phase I and retrospective phase II trials. METHODS: Composition of animal and plant proteo-lytic enzymes (WE) is a common component in the treatment of chronic or recurrent inflammatory diseases and has been also shown to have immunomodulatory effects. Project involving 7 gynecology practices has been started in 2005 - 2007 to evaluate the effectiveness of WE in the complex treatment of RVVC. The trial involved 62 women with at least 4 microscopically confirmed episodes of RVVC in the last 12 months (year 1; 4-9 episodes, mean 4.4 episodes per patient-year). From the beginning of the trial, participants took WE in the dose of 2× 8 tbl/day for 10 weeks and were monitored for 12 months (year +1). All infections of RVVC were treated according to usual practice of the particular gynecologist. The number of RVVC episodes during the year -1 was compared to the number of RVVC during the year +1. To evaluate possible long-term effects of the WE treatment, retrospective analysis of the data from 3 years following the phase I (year +2, +3, +4) was performed. Complete data for 54 women were collected (87.1% of the former group of patients). All data were processed with regular statistics methods. RESULTS: Mean number of RVVC in the year +1 has decreased from 4.4 to 0.5 per patient-year (i.e. by 88.5%; p < 0.001). All women experienced an improvement, 63% of them experienced no recurrence. The lower incidence of RVVC remained also for the phase II (year +2: 0.91; year +3: 0.57; year +4: 0.52 episodes of RVVC per patient-year). The difference, as compared to the mean incidence of RVVC before the treatment (year -1), remains significant (p < 0.001) although women, who became pregnant during the trial, were not excluded from the observed population. If only non-pregnant women were analyzed (41 women), the mean incidence of RVVC was even lower (year +2: 0.69; year +3: 0.39; year +4: 0.44 episodes of RVVC per patient-year). CONCLUSION: 10 weeks of systemic enzyme therapy (WE) in women with RVVC significantly reduced recurrence of this disease not only for the first year following the treatment, but also for the next 3 years. An explanation of the basis for this effect needs further research.
