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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Monthly Itraconazole Versus Classic Homeopathy for the Treatment of Recurrent Vulvovaginal Candidiasis: a Randomised Trial

Conditions
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Vulvovaginal Candidiasis

Intervention / Treatment
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* Drug: itraconazole
* Drug: lactobacillus gasseri
* Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: itraconazole<br>6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). | Drug: itraconazole<br>* 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)<br>|
| Active Comparator: itraconazole + lactobacilli agent<br>6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days. | Drug: itraconazole<br>* 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)<br>Drug: lactobacillus gasseri<br>* Lactobacillus vaginal tablets monthly given through 6 days<br>|
| Active Comparator: classic homeopathy (CH)<br>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. | Drug: classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Candida Culture Free After Maintenance Therapy | candida culture free (monthly vaginal cultures were obtained) | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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recurrent vulvovaginal candidiasis, itraconazole, classic homeopathy