Efficacy of miphil ®, an acidic vaginal gel, on Ph and IL-6 levels in pregnant women: a double blind, placebo-controlled trial

Giriş

Elevated vaginal Interleukin 6 levels (IL-6) and a vaginal pH >4,7 are assoeiated with obstetric complieations such as pre-tem delivery and low birth weight. IL-6, an inflammatory cytokine, is a major mediator of the host response to inflammation and infection. High vaginal levels of IL-6 are detected during vaginal infections.

Amaç

In a randomised, double blind, placebo-controlled trial, we evaluated the effects of Miphil®(Mipharm, Milan. Italy), an acidic vaginal gel with high mucosal bioadesivity, applied 2,5 g every three days. on vaginal pH and IL-6 levels in 70 "low-risk" pregnant (I1 trimester) women.

Yöntem

Vaginal pH and vaginal IL-6 were measured at baseline and after 12 weeks of treatment. Vaginal pH was measured in the lateral vaginal fornix using strip indicator papers. 11-6 was measured with a chemiluminescent immunometric assay. Vaginal pH at baseline was 4,6 and 4,4 in Miphil and placebo group, respectively.

Bulgular

At week 12 vaginal pH was 4,3 in Miphil group and 4,3 in placebo group (p=n.s). Treatment with Miphil normalized vaginal pH (i.e. pH<4,5) in three women in comparison with only one patient in placebo group. İn comparison with placebo and baseline values, Miphil induced a significant (p<0,02 Wilcoxon test) reduction of vaginal IL-6 levels (-61%).

Sonuç

The use of Miphil in "low-risk" pregnant women is able to maintain a "physiological" vaginal ecosystem and prevents the increases of vaginal IL-6. Prospective, large, and controlled trials are warranted to evaluate if this treatment can reduce obstetric complications linked to vaginal inflammatory and infective conditions.