Efficacy of V-Gel in Vaginitis

Transcription

1 (Obs. & Gynae. Today (1999): (IV), 2, 111) Efficacy of V-Gel in Vaginitis Bai Narmada, Professor and Vanitha, Lecturer Department of Obstetrics and Gynaecology, Adicunchunagiri Medical College & Research Centre, Hassan, Karnataka, India. ABSTRACT A hospital trial was conducted with V-Gel on 50 obstetrics & gynaecology cases aged between years with vaginitis. An initial microbiological examination was carried out and patients were prescribed V-Gel to be applied twice daily over a period of 2 weeks. Weekly follow up was done in all patients to note the clinical response and side effects if any. Ninety six per cent of the patients showed an excellent response with complete cessation of symptoms and repeat microbiological evaluation showed absence of causative organisms by the end of 2 weeks treatment. All the patients expressed product satisfaction and none of the patients reported any side effects. INTRODUCTION Vaginitis is an umbrella term referring to inflammatory and infectious conditions affecting the vaginal mucosa and vulvitis often accompanies vaginitis due to its close proximity to the vagina. Vulvovaginal pain, itching and burning sensation are a triad of symptoms in vaginitis for which women frequently seek healthcare. Excessive vaginal discharge and dysuria often accompany these symptoms 1. The vaginal ecosystem is a complex system of micro-organisms interacting with host factors to maintain its equilibrium. The endogenous microflora consists of a variety of bacteria, which include aerobic, facultative and obligate anaerobic bacteria. These organisms exist in a commensal, synergistic or antagonistic relationship. The Doderleins bacillus needs special reference among them, as it plays an important role in maintaining the acidity that characterises the normal vaginal secretion 2. The vaginal epithelium in healthy adult women undergoes constant desquamation and the discharges of vaginal origin are characterised chiefly by the presence of epithelial cells. The vaginal secretions ar largely oestrogen dependent and the mount of normal vaginal secretion varies with age and the time of the menstrual cycle, with a physiological increase at ovulation, in the pre-menstrual phase, during pregnancy etc 3. In addition to these physiological variations, the vagina may be infected pathologically by various microbes such as Trichomonas vaginalis, Candida, Gonococcus and other non-specific organisms, which result in increased vaginal secretion. Systemic diseases such as diabetes, cardiovascular diseases and other debilitating illnesses may also predispose to vulvovaginits. At various phases in a woman s life, like during menstruation, after abortion or labour and in endocervicitis, the acidity of the vagina is reduced and it is predisposed to infections. Pessaries, douches and deodorant preparations may also be the causative agents of vaginitis 4. Candidiasis is the most prevalent form of vaginitis, which manifests with vulvar itching, dyspareunia, vulvar and cervical erythema, cervical inflammation and vaginal secretion. The sign consistently observed in bacterial vaginosis is a yellow secretion and women with Trichomonas vaginalis show cervical lesions, friability, microhaemorragic zones and increased vaginal secretion. This organism is common amongst women with other sexually transmitted diseases and coinfection rates with gonococci have been reported to be relatively high in them 5,6.

2 It is well noted that the lower genital tract infections may lead to pelvic inflammatory disease, menstrual irregularity, infertility and other obstetric complications like preterm labour, premature rupture of membranes, intrauterine infection, small for date babies, prematurity and perinatal complications 7,8. Table I: Signs and symptoms Signs and symptoms No. of patients Abnormal vaginal discharge 50 Soreness 13 Itching 28 Vulval inflammation 8 Scratch mark 9 Bad odour 29 Table II: Aetiology Organisms isolated No. of cases % Trichomonas vaginalis Candida albicans 4 08 Gonococcus vaginalis 1 02 Non Specific 5 12 Mixed Optimal management of vaginitis is of considerable importance as it is a cause of considerable discomfort and poses a problem as it is difficult to eradicate, frequently recurrent and can lead to complications 9. Vaginal gels represent a novel and effective formulation for the treatment of common types of vaginitis and it is also of value in the treatment of resistant vaginitis 10. Current treatment protocols advocate the use of nitroimidazoles or synthetic hormone preparations. Though curative, they are not free from side effects. Furthermore, issues of mutagenicity, carcinogenicity and the increasing resistance to these agents are of concern and outline the need for research into alternative therapies 12,12. Bearing in mind the limited utility of modern treatments. The Himalaya Drug Co., Bangalore, after extensive research has formulated a herbal vaginal gel, V-Gel that has proved to be effective in treating vaginitis of varied aetiology, as demonstrated by previous experimental and clinical studies 13. To further evaluate the efficacy of V-Gel in vaginitis a clinical study was conducted at Adicunchunagiri Hospital and Research Centre. MATERIAL AND METHODS Fifty patients in the age group of years with excessive vaginal discharge secondary to vaginitis and/or cervicitis, vaginitis and cervicitis without leucorrhoea, vaginitis predisposed by systemic illnesses, vaginitis in pregnancy and in the postnatal period, were included in the study. Nine pregnant women with vaginitis, cervicitis and abnormal vaginal discharge and one post-natal patient with gaping episiotomy wound also formed the participants in the present study. Patients with mild to severe degree of dysplasia, genetic disorders and other debilitating conditions were excluded from the study. A detailed history with special reference to the characteristics of discharge such as amount, colour, odour, consistency etc., were recorded in each patient. A general systemic and local examination was carried out, noting vaginal lesions, areas of inflammation, irritation or tenderness. The abnormal vaginal secretion was collected on 2 sterile swabs and the samples were sent for microscopy. One swab was used for wet preparation and staining, and the other swab for culture. Wet preparation was used to identify pus cells, epithelial cells, Candida and Trichomonas vaginalis. Trichomonas vaginalis was identified as motile parasites. Under gram stain pus cells, Candida and

3 Trichomonas vaginalis were identified. Fontana stain was used to identify Trichomonas vaginalis with flagella. Culture for Candida was done on Sabourand Dextrose Agar with antibiotics. Positive growth of Candida was identified by germ tube and biochemical tests based on its cultural characteristics. Culture for other organisms was done on McConkey s and blood agar and identified by biochemical tests. After initial screening, the patients were advised to apply V-Gel twice daily locally for about 7 to 14 days and were asked to return for follow-up on the 7 th and 14 th day. Cases with persistence of symptoms were followed-up for upto 21 days. Spouses of patients with Trichomonas vaginalis were simultaneously treated with conventional medication to prevent recurrence. During follow-up, improvement in signs and symptoms. Changes in the microbiological picture and side-effects if any were noted. RESULTS In relation to the microbiological tests, Trichomonas vaginalis was found in 18 vaginal swab studies, Candida was found in 4 patients and Gonococcus vaginalis alone was found in one patient. Mixed infections with Trichomonas vaginalis, Candida, and Gonococcus vaginalis organisms were found in 22 cases. Other non-specific organisms were found in 5 patients. Ninety six per cent of the patients showed a good response to V-Gel in vaginitis of varied aetiology. A significant decrease in signs and symptoms was observed by 4 to 5 days of application and a complete relief was obtained after 1 week of application in 7 (14%) patients. Forty two (84%) patients had partial relief in the first week and there was total absence of symptoms by the second week. Persistence of symptoms was seen after 21 days in only one patient (Table V). The microbiological response is shown in Table IV. The product found a good acceptability in all the treated patients, except for a mild local irritation in 2 subjects. There was no withdrawal of patients from the trial. Table III: Associated conditions Conditions No. of cases % Infertility 3 6 Pregnancy 9 18 Postnatal 1 2 PID 9 18 Non-associated Table IV: No. of days required for the eradication of the causative organisms No. of days No. of cases % response % % % Persisting 1 2% DISCUSSION The incidence of genital tract infection was about 40-45% in patients attending the out patient department of Obstetrics and Gynaecology at Sri Adicunchunagiri Hospital and Research Centre. A majority of these patients reside in rural areas under unsatisfactory living conditions with unhygienic practices. Their misconceptions and delay in seeking medical help bring them to a healthcare centre when the infective process has well set in making it difficult for the treating physician to provide complete relief with no adverse reaction, in a cost effective manner. In the present study majority of the patients belonged to the 21 to 30 years age group and the common presenting symptoms were: excessive vaginal discharge, itching and soreness. Nine

4 pregnant women and one postnatal patient were also volunteers in the study. The patients satisfying the inclusion criteria were prescribed V-Gel to be applied locally twice daily for a period of 7-14 days after initial screening. They were followed-up at weekly intervals for subjective, objective and microbiological revaluation. There was a remarkable relief in symptoms with no adverse manifestation even in pregnant and postnatal women. Thus, V-Gel a herbal formulation of The Himalaya Drug Co., has proved to be a safe and effective preparation in the treatment of vaginitis. V-Gel chiefly comprises Berberis aristata, Vitex negundo, Lawsonia inermis, Azadirachta indica, Parmelia perlata, Elettaria cardamomum, Cedrus deodara, Tagetes erect and Nelumbium speciosum. Berberis aristata possesses antimicrobial activity against E. coli, other common microbes and antifungal activity against Candida albicans, its alkaloid berberine possesses antibacterial and anti-inflammatory activity 14. Vitex negundo leaves possess antibacterial properties against Micrococcus pyogenes, E. coli etc., and is prescribed in the treatment of excessive vaginal discharge. It also accelerates the healing process in inflammatory conditions. Lawsonia inermis leaves have effective antibacterial properties and is used to check vaginal discharge. It exhibits a cooling effect and is helpful in inflammatory conditions. Azadirachta indica is widely used in Ayurveda for its beneficial antibacterial, antiviral and fungicidal properties 15. Parmelia perlata acts as a demulcent and is used to promote healing. Elettaria cardamomum is a good anti-inflammatory agent 16. Cedrus deodara oil possesses anti-inflammatory activity and serves as a good fungicidal agent 17. The essential oil of Tagetes erect s leaves exhibits antifungal properties. Nelumbium speciosum possesses bacteriostatic action against gram positive and gram negative bacteria. These herbs acting alone or in combination are beneficial in the treatment of vaginitis. CONCLUSION Based on the results of the present study, it can be concluded that V-Gel is of immense value in the treatment of vaginitis of varied aetiology. It provides symptomatic relief within 4-5 days of application and there is a complete cessation of symptoms by 7-14 days of treatment. V-Gel has proved to be effective against Candida, Trichomonas vaginalis, Gonococcus and the other nonspecific organisms. Table V: Clinical response Response I Week II Week III Week Partial 42 Complete 7 42 Persistent 1 There were no untoward manifestations associated with the use of V-Gel and the product found a good acceptability by all treated patients. It has the added benefit of safety, whereby it can be used in pregnant, postnatal and women with pelvic inflammatory disease. REFERENCES 1. Freeman SB. Common genitourinary infections. Gynaecol Neonatal Nurs 1995: 24 (8): Faro S. Vaginitis: diagnosis and management. Menopausal Study. Int J Fertil 1996: 41(2): Geist SH. Cyclical changes in vaginal mucous membrane. Surg Gynecol Obstet 1930:51: Shaw RW, Soulter WP, Stanton SL. Gynaecology, 2 nd edn. New York: Churchill Livingstone Publication, 1997;

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