OBJECTIVE:Lime has a long history as a contraceptive and vaginal hygiene douche, and ongoing use in Africa is documented. We report on the first safety study on diluted lime juice to assess its potential as a candidate microbicide. METHODS:Twenty-five sexually abstinent women were randomly assigned to apply a 10% or 20% concentration of lime juice or 0% (water-only) through a soaked tampon once daily for 14 consecutive days. Tests for genital infections, measurement of inflammatory biomarkers, and a colposcopy were performed before and after treatment. RESULTS: No participant showed severe vaginal irritation. Two women developed a yeast infection after using lime juice. More than 70% of women in all groups reported side effects, most being singular, mild, and transient events. The users of 20% diluted lime juice experienced a significantly higher frequency of burning and dryness. Vaginal inflammatory biomarkers showed no significant change between preexposure and postexposure levels. The naturally low vaginal pH showed little change, and lactobacilli colonization did not decrease. CONCLUSIONS:Lime juice up to 20% concentration has an acceptable safety profile for vaginal use. However, as new in vitro research shows that the effectiveness of lime juice to prevent HIV transmission in concentrations lower than >or=50% is unlikely and concentrations of 50% have been shown to be toxic, women should be discouraged from commencing or continuing the vaginal use of lime juice.
RCT Entities:
OBJECTIVE:Lime has a long history as a contraceptive and vaginal hygiene douche, and ongoing use in Africa is documented. We report on the first safety study on diluted lime juice to assess its potential as a candidate microbicide. METHODS: Twenty-five sexually abstinent women were randomly assigned to apply a 10% or 20% concentration of lime juice or 0% (water-only) through a soaked tampon once daily for 14 consecutive days. Tests for genital infections, measurement of inflammatory biomarkers, and a colposcopy were performed before and after treatment. RESULTS: No participant showed severe vaginal irritation. Two women developed a yeastinfection after using lime juice. More than 70% of women in all groups reported side effects, most being singular, mild, and transient events. The users of 20% diluted lime juice experienced a significantly higher frequency of burning and dryness. Vaginal inflammatory biomarkers showed no significant change between preexposure and postexposure levels. The naturally low vaginal pH showed little change, and lactobacilli colonization did not decrease. CONCLUSIONS:Lime juice up to 20% concentration has an acceptable safety profile for vaginal use. However, as new in vitro research shows that the effectiveness of lime juice to prevent HIV transmission in concentrations lower than >or=50% is unlikely and concentrations of 50% have been shown to be toxic, women should be discouraged from commencing or continuing the vaginal use of lime juice.
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