Vulvovaginal Candidiasis
Conditions
Keywords
recurrent vulvovaginal candidiasis, itraconazole, classic homeopathy
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.
Interventions
DRUGitraconazole
6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid)
DRUGlactobacillus gasseri
Lactobacillus vaginal tablets monthly given through 6 days
DRUGclassic 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.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 60 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Candida Culture Free After Maintenance Therapy | 12 months | candida culture free (monthly vaginal cultures were obtained) |
Countries
Austria
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Itraconazole itraconazole alone | 48 |
| Itraconazole + Lactobacillus Gasseri itraconazole + local lactobacillus gasseri | 50 |
| Classic Homeopathy | 46 |
| Total | 144 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 25 | 25 | 23 |
Baseline characteristics
| Characteristic | Itraconazole + Lactobacillus Gasseri | Classic Homeopathy | Itraconazole | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 50 Participants | 46 Participants | 48 Participants | 144 Participants |
| Age, Continuous | 30.4 years STANDARD_DEVIATION 7.4 | 30.3 years STANDARD_DEVIATION 8 | 30.5 years STANDARD_DEVIATION 7.8 | 30.4 years STANDARD_DEVIATION 7.4 |
| Region of Enrollment Austria | 50 participants | 46 participants | 48 participants | 144 participants |
| Sex: Female, Male Female | 50 Participants | 46 Participants | 48 Participants | 144 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 48 | 0 / 50 | 0 / 46 |
| serious Total, serious adverse events | 0 / 48 | 0 / 50 | 0 / 46 |
Outcome results
Primary
Candida Culture Free After Maintenance Therapy
candida culture free (monthly vaginal cultures were obtained)
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Itraconazole | Candida Culture Free After Maintenance Therapy | 18 participants |
| Itraconazole + Lactobacillus Gasseri | Candida Culture Free After Maintenance Therapy | 19 participants |
| Classic Homeopathy | Candida Culture Free After Maintenance Therapy | 9 participants |