title: [Systemic enzyme therapy in the treatment of recurrent vulvovaginal candidiasis].
abstract: 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.
  
  
  METHODS
  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).
  
  
  CONCLUSIONS
  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.
authors.affiliation: Centrum AMbulantní Gynekologie a Primáámí Péce, Brno. vit@unzeitig.info
authors.forename: V
authors.initials: V
authors.lastname: Unzeitig
authors.forename: V
authors.initials: V
authors.lastname: Dvořák
authors.forename: O
authors.initials: O
authors.lastname: Hlaváčková
authors.forename: T
authors.initials: T
authors.lastname: Malík
authors.forename: J
authors.initials: J
authors.lastname: Nový
authors.forename: A
authors.initials: A
authors.lastname: Stará
authors.forename: A
authors.initials: A
authors.lastname: Skřivánek
authors.forename: J
authors.initials: J
authors.lastname: Stěpán
mesh_terms: D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy* / Q000453:epidemiology*; D057487:Enzyme Therapy; D005260:Female; D006801:Humans; D010447:Peptide Hydrolases / Q000627:therapeutic use*; D011247:Pregnancy; D011446:Prospective Studies; D012008:Recurrence; D012189:Retrospective Studies
chemical_list: D010447:Peptide Hydrolases