Monthly Itraconazole Versus Classic Homeopathy for Treatment of Recurrent Vulvovaginal Candidiasis (RVVC)

Not Applicable

Completed

• Conditions: Vulvovaginal Candidiasis
• Interventions: Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed); Drug: itraconazole; Drug: lactobacillus gasseri

• Registration Number: NCT00895453
• Lead Sponsor: Medical University of Vienna

Brief Summary

A prospective study to evaluate the efficacy of classic homeopathic therapy compared to maintenance itraconazole therapy with and without additional exogenous lactobacillus for treatment of recurrent Candida vaginitis.

Detailed Description

Objective:

Antimycotics effectively treat sporadic and recurrent vulvovaginal candidiasis (RVVC). Classic homeopathy (CH) is also used to treat this condition. We compared the efficacy of CH and itraconazole in reducing the frequency of RVVC episodes.

Design:

Single-centre, prospective, randomized.

Sample:

One-hundred-and-fifty patients with a history of RVVC and an acute episode of VVC.

Methods:

Women were randomised into 3 groups: itraconazole with lactobacilli (group 1), itraconazole without lactobacilli (group 2) and CH (group 3). Itraconazole treatment of acute infection was followed by a 6-months maintenance regimen with monthly single-day itraconazole (200 mg bid). Thereafter, patients were followed without treatment for 6 months. Women in group 1 were given additional vaginal lactobacilli for six days per month. CH treatment was performed for 12 months.

Study Timeline

• Study Start: 2000-05
• Primary Completion: 2006-02
• Study Completion: 2006-02
• Study First Submitted: 2009-01-16
• Results First Submitted: 2009-01-16
• Status Verified: 2009-05
• Study First Submitted QC: 2009-05-07
• Results First Submitted QC: 2009-05-07
• Study First Posted: 2009-05-08
• Results First Posted: 2009-05-08
• Last Update Submitted: 2016-09-26
• Last Update Posted: 2016-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 144

Inclusion Criteria

• Patients over 18 years, premenopausal
• Negative pregnancy test
• Signed informed consent
• At least 4 Episodes of Candidiasis within the last year
• Candida detectable by culture
• Negative Hepatitis- and HIV-Serology
• No Allergy to Itraconazole

Exclusion Criteria

• Under 18 years

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
itraconazole + lactobacilli agent	lactobacillus gasseri	6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.
classic homeopathy (CH)	classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)	CH treatment was provided by a licensed CH practitioner. Specifically, a personal history was taken and an individualised treatment scheme was prescribed. The most often used homeopathic remedies were carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, and sepia M. Potencies of homeopathic remedies ranged from C 30 to C 1000.
itraconazole + lactobacilli agent	itraconazole	6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.
itraconazole	itraconazole	6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).

Primary Outcome Measures

Name	Time	Method
Candida Culture Free After Maintenance Therapy	12 months	candida culture free (monthly vaginal cultures were obtained)

Trial Locations

Locations (1)

Vienna Medical School; 🇦🇹 Vienna, Austria