The study aims to evaluate the additive effect of intra-vaginal gentian violet (GV) on a single dose oral 200 mg fluconazole for acute vaginal candidiasis (VC). Women aged ≥18 years who had VC were randomly allocated to receive either fluconazole 200 mg (group 1, FLU, N = 90); or the fluconazole with GV (group 2, FLU + GV, N = 93). Outcome measures were 2-week clinical cure rate, conversion of positive fungal culture, time-to-cure, side effects, satisfaction and symptomatic recurrence within 2 months. No significant difference of participants' characteristics was observed. They were 32.4 ± 8.7 year-old and non-obese. Participants receiving FLU + GV had higher clinical cure rates (81.7% vs. 74.4%, p=.236); lower recurrence rate (19.4% vs. 30.0%, p=.097); shorter time-to-cure (3.1 vs. 4.0 days, p=.013); but lower culture conversion rate (74.2% vs. 80.0%, p=.351). Participants in both groups reported high satisfaction and none had severe adverse events. In conclusion, the addition of GV results in a shorter time-to-cure but not cure rate. Clinical trial registration: TCTR20180917003 (http://thaiclinicaltrials.org/show/TCTR20180917003).Impact StatementWhat is already known on this subject? The efficacy of fluconazole for acute vaginal candidiasis is limited to 75-90% due to drug resistance and non-albicans Candida. Gentian violet (GV) has long been used for mucosal candidiasis; and is recommended as the second line treatment for women with recurrent vulvovaginal candidiasis (RVVC).What do the results of this study add? Adding GV to a single oral 200 mg fluconazole results in a quicker resolution of symptoms of acute VC but not cure rate. The participants' satisfaction and acceptance are high. Lifestyle modification, particularly reduction of sugar-rich diet, associates with the higher culture-based cure rate.What are the implications of these findings for clinical practice and/or further research? As GV is widely and easily accessible, and speculum examination with or without microscopy is the main diagnostic tool of VC; the single application of GV seems doable in real-life practice. This simple anti-septic solution can accelerate symptom resolution. However, the proper frequency of GV application should be further explored. As importantly, lifestyle modification should always be included in counselling session to optimise treatment outcome.
Keywords: Acute; culture; fluconazole; gentian violet; vaginal candidiasis.