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

Medical University of Vienna

Status: Completed

Conditions: Vulvovaginal Candidiasis

Treatments: Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed); Drug: lactobacillus gasseri; Drug: itraconazole

Study type: Interventional

Funder types: Other

Identifiers

NCT00895453

134/2000

Details and patient eligibility

About

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.

Full 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.

Enrollment: 144 patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 3 patient groups

itraconazole

Active Comparator group

Description:

6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid).

Treatment:

Drug: itraconazole

itraconazole + lactobacilli agent

Active Comparator group

Description:

6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days.

Treatment:

Drug: lactobacillus gasseri

Drug: itraconazole

classic homeopathy (CH)

Active Comparator group

Description:

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.

Treatment:

Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)