Clinical Studies

Metronidazole with Lactic Acid vaginal gel in bacterial vaginosis:

Abstract

Aim: To assess the efficacy and tolerability of lactic acid vaginal gel; (LVG) when given as an adjunct to metronidazole in the treatment of bacterial vaginosis (BV) among Filipino patients.

Methods: A multicenter, open-labeled, controlled, randomized, three-arm comparative study on 90 women aged 18 years or over with clinically and microbiologically proven BV.

Results: The lactobacilli colony count significantly increased over time in all three arms. At day 14, growth of lactobacilli was significantly higher among patients in the lactic acid gel and combination treatment arms. Significant reduction of malodorous vaginal discharge (whiff test) and lowest recurrence of BV were noted in the metronidazole plus lactic acid gel arm. Regarding disappearance of signs of BV, there was significant decrease in the pH level and frequency of clue cell positive patients across time but was not significantly different across treatment groups. Only one patient (3%, 1/60) among those who received lactic acid gel complained of increased curd-like discharge. Six patients (10%, 6/60) who received metronidazole complained of epigastric

pain/discomfort, dizziness and dyspnea.

Conclusions: Lactic acid gel (LVG) is safe and as efficacious as metronidazole in the treatment of BV. There is evidence that LVG when combined with metronidazole is superior to metronidazole alone in promoting lactobacilli colonization. LVG as an adjunct to metronidazole, having the least number of recurrent BV, appears to result in better long-term treatment effect on bacterial vaginosis. Key words: bacterial vaginosis, lactic acid vaginal gel, metronidazole.

Results:

Figure:1 Change in Lactobacillus colony count. *Repeated measures ANOVA: P < 0.001 across visits; P = 0.0045 at day 8 between lactic acid gel group and metronidazole. group; P = 0.0002 at day 14 between combination arm and metronidazole arm and between lactic acid gel arm and metronidazole arm.

Evaluation of the Efficacy and Safety of Hyaluronic Acid Vaginal Gel to Ease Vaginal Dryness:

Abstract 1

Introduction. Atrophic vaginitis is a common occurrence, particularly among postmenopausal women; however, few seek or receive treatment. One therapeutic solution is topically applied products. Estrogen-based treatments have been shown to be effective; however, many patients are reluctant to use such formulations due to health concerns, hence the need to assess the efficacy of acceptable alternatives.

Aim. This multicenter, randomized, controlled, open-label, parallel-group clinical trial set out to evaluate the efficacy and safety of hyaluronic acid vaginal gel to treat vaginal dryness compared with estriol cream in postmenopausal women.

Methods. One hundred forty-four subjects were randomized, 72 to the test group treated with hyaluronic acid vaginal gel , and 72 to the control group treated with estriol cream (Ovestin). Treatment in both groups was applied by means of a device once every 3 days for a total of 10 applications over 30 days. Main Outcome Measures. Efficacy was measured by grading vaginal dryness and three other vaginal symptoms on a visual analog scale. Safety assessments included vital signs, laboratory examinations of the vaginal micro-ecosystem, vaginal pH value, vaginal B ultrasound, and incidence of adverse events. Assessments were performed at baseline, by telephone after the third application, and at the final visit.

Results. Both hyaluronic acid vaginal gel and estriol cream can significantly improve the clinical symptoms of vaginal dryness in postmenopausal women, with improvement rate of 84.44% and 89.42%, respectively, after 10 applications, without statistically significant difference between them.

Conclusion. Both hyaluronic acid vaginal gel and estriol cream are effective in the treatment of vaginal dryness. Hyaluronic acid vaginal gel may be considered as a valid alternative to estrogen-based treatments in relieving the symptoms of vaginal dryness

The comparison of hyaluronic acid vaginal tablets with estradiol vaginal tablets in the treatment of atrophic vaginitis:

a randomized controlled trial​

Abstract 2

Objective: To compare the effectiveness of the vaginal tablets of hyaluronic acid and estrodiol for the treatment of atrophic vaginitis.

Materials and methods: Forty-two postmenopausal women with symptoms of atrophic vaginitis were randomized totake vaginal tablets of 25 micro-g estradiol (n = 21) (group I) or 5 mg hyaluronic acid sodium salt (n = 21) (group II) for 8 weeks. The symptoms of atrophic vaginitis were evaluated by a self-assessed 4-point scale of composite score and the degree of epithelial atrophy was determined as, none, mild, moderate and severe. Vaginal pH and maturation index were measured and compared in both the groups.

Results: The symptoms were relieved significantly in both the groups (P < 0.001). The relief of symptoms was significantly superior in group I compared with group II (P < 0.05). A significant decrease in epithelial atrophy and vaginal pH were detected in both the groups (P  < 0.01) after treatment. The vaginal maturation values were also significantly improved at both study groups (P  < 0.001).The mean maturation value was significantly higher in group I when compared with group II (P  < 0.001).

Conclusion: Both treatments provided relief of vaginal symptoms, improved epithelial atrophy, decreased vaginal pH, and increased maturation of the vaginal epithelium. Hyaluronic acid vaginal tablets can be used in patients with atrophic vaginitis who do not want to or can not take local estrogen treatment

Results:

Figure 1: Secondary efficacy end points—improvement in vaginal itching, dyspareunia, and burning sensation