Nonspecific vaginitis. Evaluation of the effectiveness and tolerability of the API‑NORM® suppositories

Department of Endocrine Gynecology, State University "Institute of Pediatrics, Obstetrics and Gynecology, National Academy of Medical Sciences of Ukraine"

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Report on conducting a clinical trial

"Evaluation of the effectiveness and tolerability of the API‑NORM® drug produced by UOVL LLC in the treatment of nonspecific vaginitis"

1. The purpose and tasks of the research

The purpose of this study was to evaluate the effectiveness and tolerability of the API‑NORM® drug, suppositories produced by UOVL LLC in the treatment of cylindrical epithelial ectopy (ECE) against the background of nonspecific vaginitis.

Objectives of the study:

-study of the effect of the researched drug on the course of the disease.

-studying the tolerability and possible side effects of the drug under study.

2. Introduction and rationale

Along with traditional methods of treatment, recently, old and new non-traditional methods, which include the use of natural preparations based on api-phyto components, are gaining more and more popularity among doctors. A representative of this group is API-NORM suppositories, which include propolis extract, beeswax, St. John's wort extract, calendula oil, and sea buckthorn oil. The drug exhibits anti-inflammatory, antiviral, antispasmodic, and reparative effects.

3. Research design

The study included 28 women of reproductive age in whom ECE was detected against the background of non-specific vulvovaginitis, ECE was established colposcopically, non-specific colpitis based on complaints, clinical picture, and confirmed by bacterioscopy of urogenital secretions.

• during a gynecological examination, the localization and prevalence of inflammation, the presence of edema, hyperemia on the mucous membrane, and the amount, smell, and nature of secretions were taken into account.

• subjective complaints were evaluated according to the following criteria: - itching, burning in the vagina; - discomfort during sexual life; - the presence of discharge from the vagina.

• bacterioscopy took into account: - type and number of microorganisms; - the number of leukocytes.

• colposcopy data: - normal colposcopic picture; - inflammatory process; - ectopy of the cylindrical epithelium; - leukoplakia; - cervical dysplasia.

All patients included in the study were prescribed API-NORM one suppository vaginally once in the evening for 10 days. Examinations were carried out before treatment and 2 weeks after its end.

4. Assessment of efficacy and tolerability

4.1 Performance criteria:

• dynamics of decreasing severity of clinical manifestations of the disease (itching, heartburn, discharge);

• positive dynamics according to a bacterioscopic examination of vaginal swabs;

• positive dynamics according to the data of colposcopy (reduction of the phenomena of the inflammatory process, reduction of ECE).

4.2 Evaluation of the tolerability of the studied drug

Tolerability of the drug was assessed on the basis of subjective symptoms and sensations reported by the patient and objective data obtained by the researcher during treatment. The dynamics of laboratory indicators, as well as the frequency and nature of adverse reactions were taken into account.

The tolerability of the drug was assessed by the researcher in points according to the following scale:

1. unsatisfactorily

2. satisfactorily

3. fine

5. Processing of clinical research data and report

All women before the start of treatment complained about the presence of abundant secretions from the genital tract, which met the criteria for inclusion in the study. In most patients, the onset of the disease was accompanied by the appearance of itching, heartburn in the genital area of varying degrees of severity, and discomfort during sexual life (Table 1). The complaints listed above were evaluated as 1 point - for a light degree of their severity, 2 - for medium, and 3 - for severe.

In the first stage, all women underwent clinical examinations (inspection of the vagina and cervix in mirrors, bimanual gynecological examination, colposcopy), laboratory examinations (bacterioscopic examination of vaginal smears, evaluation of the degree of vaginal cleanliness).

A gynecological examination showed edema, hyperemia of the mucous membrane of the vagina and cervix in combination with ECE detected colposcopically.

During the study, 23 (82.14%) women noted the complete disappearance of clinical symptoms of vulvovaginitis. After the end of the course of treatment, patients noted isolated cases of secretions, heartburn, and itching in a minor degree of severity.

Tab 1

Microscopy of the urogenital smear showed an increased number of leukocytes, abundant or moderate coccal, and rod-shaped flora, specific microflora was not detected, and Dederlein's rods were absent or present in small quantities. Thus, before the start of treatment, 18 (64.3%) patients were diagnosed with stage III. vaginal cleanliness, in 10 (35.7%) - IV century. vaginal cleanliness. After treatment, 2 (7.1%) patients were diagnosed with stage I. vaginal cleanliness, in 23 (82.1%) patients - the II stage, in 3 (10.7%) - the III stage. vaginal cleanliness. (Tab 2)

Tab 2

During colposcopy, the patients showed signs of an inflammatory process of varying severity, as well as ECE in the first zone

After treatment, there was a decrease in the ECE zone, as well as an incomplete zone of benign transformation (ZNT) in 12 (42.9%) patients, as well as a complete zone of benign transformation (ZNT) and a normal colposcopic picture in 7 (25%) patients, which indicates stimulation of epithelialization processes (Tab 3).

Tab 3

The tolerability of the treatment was assessed by the researcher as good at 93%, and by the patient at 89%. This indicates a good tolerability of the API-NORM suppositories, it practically does not affect the general condition of patients (Table 4). Among the side effects, itching was observed in one patient, and heartburn in the vagina in another. At the same time, hyperemia of the vaginal mucosa was noted by the researcher in one case.

Conclusion

Clinical tests of API-NORM suppositories produced by UOVL LLC testify to its high clinical effectiveness in the treatment of non-specific vaginitis, as well as the improvement of the process of epithelialization of the ectopy of the cylindrical epithelium, the absence of adverse reactions and good tolerability, which makes it possible to recommend it for use in the complex therapy of non-specific vaginitis. as well as in the treatment of ectopy of the cylindrical epithelium against the background of non-specific vaginitis.