Department of Obstetrics & Gynecology, Zuyderland Medical Centre Heerlen, Heerlen, The Netherlands.
Department of Gynecology and Obstetrics, Maastricht University Medical Centre+, Maastricht, The Netherlands.
BMJ Open. 2023 Aug 28;13(8):e070466. doi: 10.1136/bmjopen-2022-070466.
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.
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.
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.
NCT05367089.
复发性外阴阴道念珠菌病（RVVC）影响全球多达 9%的女性。由于生活方式的改变、真菌耐药性的增加和生物膜的形成，这一数字预计将会增加。治疗选择有限，在开始氟康唑治疗（金标准）后 12 个月内，57%的病例会复发。RVVC 的发病机制是多因素的，包括真菌生物学、阴道微环境和免疫系统。氟康唑具有抗菌作用，能有效诱导短期缓解，但很难实现长期治愈。医用级蜂蜜（MGH）具有抗菌、保护、抗氧化和免疫调节作用，因此可能是一种很好的替代治疗方法。本研究旨在比较 MGH 与氟康唑治疗 RVVC 患者的临床治愈率和长期疗效。
这是一项多中心、随机对照试验（马斯特里赫特大学医学中心+和祖伊德兰医疗中心）。共有 252 名符合条件的女性将被随机分配到氟康唑组（对照组）或 MGH 组（L-Mesitran，治疗组）。主要目的是通过阴道培养评估 1 个月后的真菌学治愈率。次要目标是症状的临床治愈率、6 个月维持治疗后的预防活性以及 12 个月内的复发次数。此外，还将通过问卷调查收集有关副作用、不适和生活质量的信息。
已获得马斯特里赫特大学医学中心/马斯特里赫特大学医学伦理审查委员会的伦理批准（NL 73974.068.21，V.7 于 2022 年 2 月 8 日）。祖伊德兰医疗中心赫伦伦理委员会（Z2021141 于 2022 年 3 月 4 日）也批准了额外的批准。2022 年 8 月 22 日，首例患者被随机分配。结果将通过会议、会议和同行评议的国际出版物提供给研究人员和医疗保健专业人员。
NCT05367089。
