Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY)
Introduction Recurrent vulvovaginal candidiasis (RVVC) affects up to 9% of women worldwide. This amount is expected to increase due to lifestyle changes, increased fungal resistance and biofilm formation. Treatment options are limited and in 57% of the cases, relapses occur within 12 months after st...
| Main Authors: | , , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-08-01
|
| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/8/e070466.full |
| _version_ | 1826980152043634688 |
|---|---|
| author | Sander M J van Kuijk Martine M L H Wassen Senna J J M van Riel Céline M J G Lardenoije Niels A J Cremers |
| author_facet | Sander M J van Kuijk Martine M L H Wassen Senna J J M van Riel Céline M J G Lardenoije Niels A J Cremers |
| author_sort | Sander M J van Kuijk |
| collection | DOAJ |
| description | Introduction Recurrent vulvovaginal candidiasis (RVVC) affects up to 9% of women worldwide. This amount is expected to increase due to lifestyle changes, increased fungal resistance and biofilm formation. Treatment options are limited and in 57% of the cases, relapses occur within 12 months after starting fluconazole therapy (golden standard). The pathogenesis of RVVC is multifactorial and includes fungal biology, the vaginal microenvironment and the immune system. Fluconazole is antimicrobial and effective in inducing short-term remission but a long-term cure is hard to achieve. Medical grade honey (MGH) has antimicrobial, protective, antioxidative and immunomodulatory activity and may therefore be a good alternative treatment. This study aims to investigate the clinical cure rate and long-term efficacy of MGH compared with fluconazole in patients with RVVC.Methods and analysis This study is a multicentre, randomised controlled trial (Maastricht University Medical Centre+ and Zuyderland Medical Centre). A total of 252 eligible women will be randomly assigned to the fluconazole group (control) or the MGH group (L-Mesitran, treatment). The primary objective is to investigate the mycological cure rate after 1 month assessed through a vaginal culture. Secondary objectives are the clinical cure rate regarding symptoms, the prophylactic activity after 6 months of maintenance therapy and the number of relapses within 12 months. Moreover, information about side effects, discomfort and quality of life will be collected with the use of questionnaires.Ethics and dissemination Ethical approval from the Medical Ethics Review Committee of the academic hospital Maastricht/University Maastricht has been obtained (NL 73974.068.21, V.7 on 8 February 2022). Additional approval was obtained from the Ethics Committee of the Zuyderland Medical Centre Heerlen (Z2021141 on 4 March 2022). The first patient was randomised on 22 August 2022. Results will be made available to researchers and healthcare professionals via conferences, meetings and peer-reviewed international publications.Trial registration number NCT05367089. |
| first_indexed | 2024-03-12T11:48:44Z |
| format | Article |
| id | doaj.art-7d524227dbeb4ef6b2da7f7e3580614c |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2025-02-18T05:41:40Z |
| publishDate | 2023-08-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-7d524227dbeb4ef6b2da7f7e3580614c2024-11-14T09:40:09ZengBMJ Publishing GroupBMJ Open2044-60552023-08-0113810.1136/bmjopen-2022-070466Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY)Sander M J van Kuijk0Martine M L H Wassen1Senna J J M van Riel2Céline M J G Lardenoije3Niels A J Cremers4Department of Clinical Epidemiology and Medical Technology Assessments, Maastricht University Medical Centre, Maastricht, The NetherlandsDepartment of Obstetrics & Gynecology, Zuyderland Medical Centre Heerlen, Heerlen, The NetherlandsDepartment of Obstetrics & Gynecology, Zuyderland Medical Centre Heerlen, Heerlen, The NetherlandsDepartment of Gynecology and Obstetrics, Maastricht University Medical Centre+, Maastricht, The NetherlandsDepartment of Gynecology and Obstetrics, Maastricht University Medical Centre+, Maastricht, The NetherlandsIntroduction Recurrent vulvovaginal candidiasis (RVVC) affects up to 9% of women worldwide. This amount is expected to increase due to lifestyle changes, increased fungal resistance and biofilm formation. Treatment options are limited and in 57% of the cases, relapses occur within 12 months after starting fluconazole therapy (golden standard). The pathogenesis of RVVC is multifactorial and includes fungal biology, the vaginal microenvironment and the immune system. Fluconazole is antimicrobial and effective in inducing short-term remission but a long-term cure is hard to achieve. Medical grade honey (MGH) has antimicrobial, protective, antioxidative and immunomodulatory activity and may therefore be a good alternative treatment. This study aims to investigate the clinical cure rate and long-term efficacy of MGH compared with fluconazole in patients with RVVC.Methods and analysis This study is a multicentre, randomised controlled trial (Maastricht University Medical Centre+ and Zuyderland Medical Centre). A total of 252 eligible women will be randomly assigned to the fluconazole group (control) or the MGH group (L-Mesitran, treatment). The primary objective is to investigate the mycological cure rate after 1 month assessed through a vaginal culture. Secondary objectives are the clinical cure rate regarding symptoms, the prophylactic activity after 6 months of maintenance therapy and the number of relapses within 12 months. Moreover, information about side effects, discomfort and quality of life will be collected with the use of questionnaires.Ethics and dissemination Ethical approval from the Medical Ethics Review Committee of the academic hospital Maastricht/University Maastricht has been obtained (NL 73974.068.21, V.7 on 8 February 2022). Additional approval was obtained from the Ethics Committee of the Zuyderland Medical Centre Heerlen (Z2021141 on 4 March 2022). The first patient was randomised on 22 August 2022. Results will be made available to researchers and healthcare professionals via conferences, meetings and peer-reviewed international publications.Trial registration number NCT05367089.https://bmjopen.bmj.com/content/13/8/e070466.full |
| spellingShingle | Sander M J van Kuijk Martine M L H Wassen Senna J J M van Riel Céline M J G Lardenoije Niels A J Cremers Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY) BMJ Open |
| title | Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY) |
| title_full | Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY) |
| title_fullStr | Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY) |
| title_full_unstemmed | Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY) |
| title_short | Efficacy of a medical grade honey formulation (L-Mesitran) in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis: protocol for a randomised controlled trial (HONEY STUDY) |
| title_sort | efficacy of a medical grade honey formulation l mesitran in comparison with fluconazole in the treatment of women with recurrent vulvovaginal candidiasis protocol for a randomised controlled trial honey study |
| url | https://bmjopen.bmj.com/content/13/8/e070466.full |
| work_keys_str_mv | AT sandermjvankuijk efficacyofamedicalgradehoneyformulationlmesitranincomparisonwithfluconazoleinthetreatmentofwomenwithrecurrentvulvovaginalcandidiasisprotocolforarandomisedcontrolledtrialhoneystudy AT martinemlhwassen efficacyofamedicalgradehoneyformulationlmesitranincomparisonwithfluconazoleinthetreatmentofwomenwithrecurrentvulvovaginalcandidiasisprotocolforarandomisedcontrolledtrialhoneystudy AT sennajjmvanriel efficacyofamedicalgradehoneyformulationlmesitranincomparisonwithfluconazoleinthetreatmentofwomenwithrecurrentvulvovaginalcandidiasisprotocolforarandomisedcontrolledtrialhoneystudy AT celinemjglardenoije efficacyofamedicalgradehoneyformulationlmesitranincomparisonwithfluconazoleinthetreatmentofwomenwithrecurrentvulvovaginalcandidiasisprotocolforarandomisedcontrolledtrialhoneystudy AT nielsajcremers efficacyofamedicalgradehoneyformulationlmesitranincomparisonwithfluconazoleinthetreatmentofwomenwithrecurrentvulvovaginalcandidiasisprotocolforarandomisedcontrolledtrialhoneystudy |