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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| itraconazole | Active Comparator | 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). |
|
| itraconazole + lactobacilli agent | Active Comparator | 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) | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| itraconazole | Drug | 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Candida Culture Free After Maintenance Therapy | candida culture free (monthly vaginal cultures were obtained) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Armin Witt, MD | Vienna Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vienna Medical School | Vienna | 1090 | Austria |
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| ID | Title | Description |
|---|---|---|
| FG000 | Itraconazole | itraconazole alone |
| FG001 | Itraconazole + Lactobacillus Gasseri | itraconazole + local lactobacillus gasseri |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| lactobacillus gasseri | Drug | Lactobacillus vaginal tablets monthly given through 6 days |
|
| classic homeopathy (carcinosin M, nux vomica, pulsatilla M, ferrum metallicum, sepia M, etc. as prescribed) | Drug | 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. |
|
| FG002 | Classic Homeopathy |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Itraconazole | itraconazole alone |
| BG001 | Itraconazole + Lactobacillus Gasseri | itraconazole + local lactobacillus gasseri |
| BG002 | Classic Homeopathy | |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Candida Culture Free After Maintenance Therapy | candida culture free (monthly vaginal cultures were obtained) | Posted | Feb 2006 | Number | participants | 12 months |
|
|
|
12 months
Systematik Assessment by using a questionnaire
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Itraconazole | 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid) | 0 | 48 | 0 | 48 | ||
| EG001 | Itraconazole + Lactobacilli Agent | 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid). Additionally, Lactobacillus vaginal tablets monthly given through 6 days. itraconazole: 6-months maintenance regimen with monthly single-day itraconazole 200mg twice daily (bid) lactobacillus gasseri: Lactobacillus vaginal tablets monthly given through 6 days | 0 | 50 | 0 | 50 | ||
| EG002 | Classic Homeopathy (CH) | 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. 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. | 0 | 46 | 0 | 46 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Armin Witt MD | Vienna Medical School | +43140400 | 2821 | armin.witt@meduniwien.ac.at |
| ID | Term |
|---|---|
| D002181 | Candidiasis, Vulvovaginal |
| ID | Term |
|---|---|
| D002177 | Candidiasis |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014848 | Vulvovaginitis |
| D014627 | Vaginitis |
| D014623 | Vaginal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D014847 | Vulvitis |
| D014845 | Vulvar Diseases |
| D000091662 | Genital Diseases |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| C022361 | 6-phospho-beta-galactosidase |
| D019266 | Iron, Dietary |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D058085 | Iron Compounds |
| D007287 | Inorganic Chemicals |
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| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|