Comparative Examination of the Therapeutic Deficiency of Oral Metronidazole Plus Prangos ferulacea Vaginal Cream Versus Oral Metronidazole Plus Placebo Vaginal Cream in Accelerating Trichomonas Vaginalis Infection Recovery: A Triple-Blind Clinical Trial

Abstract

Objectives: Trichomonas infection is prevalent in the United States and a metronidazole oral tablet is the medication of choice for treating this infection. Based on various side-effects of oral or vaginal metronidazole and the increase in microbial resistance against chemical antibiotics, the use of herbal medicine with fewer side-effects seems to be essential. Laboratory experiments indicate the strong anti-microbial effects of Prangos ferulacea (PF) medicinal herb. However, no clinical trial has focused on its anti-microbial effects in humans. Thus, the present study aimed to determine the effects of PF vaginal cream on accelerating Trichomonas vaginalis infection (TVI) recovery. Materials and Methods: The present randomized clinical trial was conducted on 80 non-pregnant women visiting the healthcare centers affiliated with Lorestan University of Medical Sciences, Iran, in 2018. Trichomonas infection was diagnosed based on patient complaints, clinical observations, as well as wet mount and stained microscopic tests. The women were randomly divided into two groups of 40 each. One group received oral metronidazole plus PF vaginal cream while the other received oral metronidazole plus placebo vaginal cream for 7 days. Clinical observations, along with wet mount and stained microscopic tests were performed during 7 days following the treatment. Finally, data were analyzed using independent-samples t test, as well as chi-square, Fisher exact, Mann-Whitney U, and McNemar tests at the significance level of P<0.05. Results: Based on the results, the response to treatment with oral metronidazole plus PF vaginal cream was 92.50 based on patient complaints. More precisely, 86.25% was based on clinical criteria (i.e., strawberry cervix, foamy greenish-yellow vaginal discharge, pH ≥4.5, and positive amine test) and 85% was related to the microscopic criteria of wet mount (x40) and polymorphonuclear leukocytes (x100). In addition, the response to treatment with oral metronidazole and placebo vaginal cream was 91.25%, 83.12%, and 80% based on the patient complaint, clinical criteria, and microscopic criteria, respectively. Eventually, the analysis of the patient complaint, clinical criteria, and microscopic criteria in each group revealed a significant difference before and after the treatment (P<0.001) Conclusions: The results of this study showed that the PF herbal vaginal cream can be used for the treatment of TVI as an effective treatment along with oral metronidazole.