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Shailesh Kore*, Anahita Pandole**, Sangeeta Kulkarni***, Santosh Puthuraya***, Sheetal Kamat+, V R Ambiye++

Vaginal discharge is one of the most common problems in women coming to the Gynaecological out patient department. Thrichomonal vaginitis, moniliasis, chlamydia, gonorrhoea and bacterial vaginosis are the most common causes of pathological vaginal discharge.
A study was conducted at LTMG Hospital, Sion, to assess the efficacy of one day - oral combination kit therapy containing fluconazole, azithromycin and secnidazole in treating such vaginal discharge. Hundred women coming with complaint of vaginal discharge were treated with such combination kit therapy. The efficacy of such kit was found to be good with an acceptable degree of side effects. Also benefits of such syndromic management were evaluated and discussed.

Vaginal discharge is one of the most common and nagging problems faced by women.About 20-25% of women who attend gynaecology out patient department complain of vaginal discharge and leucorrhoea. Though, in a few cases, discharge may be physiological increase in normal vaginal secretion, in more than 60% of cases, it is because of the infection of the vagina and/or the cervix, caused by bacteria, fungi or parasitic agent.

Many a times, these infections are sexually transmitted. Untreated or under treated sexually transmitted disease is more prone to disease spread and runs a greater risk of contracting HIV.

Vaginal discharge is often polymicrobial and treatment of only one or the most apparent cause may lead to a flare up and clinical manifestations of the other cause. Thus, it is important to treat vaginal discharge as a syndrome rather than a single most clinically apparent cause or disease.

In syndromic management, diagnosis and treatment is not based on specific disease based on testing, but rather on syndromes i.e. group of clinical findings in patient. Treatment is generally given for most of the diseases that could cause that syndrome.

Aim of the present study was to assess the efficacy, acceptability and tolerance of one day combination kit therapy in syndromic management of vaginal discharge.

A prospective study was conducted in a single working unit of the Department of Obstetrics and Gynaecology at LTMG Hospital, Sion over a period of one year.
Hundred women coming to the gynaecology out patient department with chief complaints of vaginal discharge were included in the study.

Their symptoms, menstrual and obstetric history, and relevant past and personal history were documented. Any history suggestive of sexually transmitted disease in the patient and the husband was taken. A detailed gynaecological examination was carried out and the severity and type of discharge was noted. Patients with only severe type of vaginal discharge with or without features of chronic cervicitis were included.

Pregnant and lactating women, patients with history of drug allergy or those who had received any type of medication for vaginal discharge in the last two weeks were excluded.

All the patients were explained about the type and design of the study and due consent was taken. The couple was explained about the sexual route of transmission and the importance of treating both the partners together.

The couple (husband and wife) were given or prescribed one day combination kit, containing -
Fluconazole (150 mg) - 1 tablet
Azithromycin (1 gram) - 1 tablet
Secnidazole (2 grams) - 2 tablet

These patients (husband and wife) were asked to take these tablets after meals on the same day. The couple was advised abstinence for fourteen days. The couple was asked to follow up after seven and fourteen days, with empty packets of the tablets to confirm the compliance of the patient.

On follow up visits, patients (women) were asked about the improvement or relief from the symptoms (in percentage). Also tolerance of tablets in the form of adverse effects observed after the consumption of tablets were noted. Tolerance was graded according to the type, severity and duration of the adverse effects.

Women were examined to assess the decrease in the amount of discharge and other clinical signs. Overall assessment was done regarding the efficacy and tolerance of the combination kit

Patients not following up or not taking the prescribed treatment were excluded form the study.
A total of 100 women coming with the complaint of vaginal discharge were taken for this study.

These patients were between 18 and 59 years of age. All patients were married. Majority of patients were from the lower socio economic class.

Apart from the chief complaints of vaginal discharge. Forty one women complained of urinary symptoms, like burning micturition, dysuria or frequency of micturition.
Forty four women had pruritus vulvae and 6 women had complaints of pain in lower abdomen (Table 1).

All patients had severe degree of mixed type of vaginal discharge. 40% of the patients had features of chronic cervicitis with or without cervical erosion. Five patients also had minimal fornicial tenderness on vaginal examination.

All the 100 women and their husbands took the prescribed treatment. Patients followed up seven days and fourteen days after the treatment. Patients were asked about the reduction or relief from various symptoms.

Though only 55% women had excellent - good response (i.e. 75% - 100% relief from vaginal discharge) by day seven, the number increased to 88% by day fourteen.
Only one woman had no relief (< 25% decrease) from the vaginal discharge by day fourteen (Table 2).

Of the 41 patients who had urinary symptoms majority had complete relief form the symptoms by day fourteen of treatment (Table 3).

However the over-all response to pruritus vulvae was modest and slow.

This comparative low response was probably due to scratch cycle or secondary local fungal infection in a few patients (Table 4).

Table 5 shows the percentage reduction in the symptomatic patients. The patient with significant degree of improvement i.e. excellent to good response to drugs, were deducted to get this number. The overall evaluation was mainly based on the efficacy of drugs in reducing vaginal discharge - (both objective and subjective symptoms). As per overall evaluation 93% of patients showed clinical cure, 4% had improvement, 2% had minimal response while one had failure.

Adverse effects observed after consumption of kit tablets are summarized in Table 6. Majority of the patients tolerated these drugs well. Only two patients had severe type of adverse effects. Patients who had no or mild type of adverse effects were categorized as excellent or good tolerance, while woman who had severe type of side effects were categorized as bad tolerance.

Ninety one women were satisfied with the treatment and had an opinion that they would prefer a similar treatment in future if required, while 2 patients totally disapproved it. Remaining 7 patients had an equivocal reaction about this treatment. Approximately 45% of the patients felt that the cost of the treatment was on the higher side.

The commonest presentation of sexually transmitted disease is vaginal discharge. Amongst women, the common causes of vaginal discharge are trichomonal vaginitis, candidial vaginitis and bacterial vaginosis. However, cervicitis caused by Gonorrhoea and Chlamydia trachomatis also cause vaginal discharge. Although cervicitis causing vaginal discharge is less common, it is a more serious cause as it may lead to infection ascending in the uterine cavity, fallopian tubes and peritoneal cavity causing pelvic inflammatory disease and related complication. Majority of times, vaginal infection is polymicrobial in nature.1

Untreated sexually transmitted disease is more prone to disease spread and runs a higher risk of contracting HIV. Chlamydia increases replication of HIV, gonorrhoea helps excretion of HIV in semen, while trichomoniasis and bacterial vaginosis facilitate HIV transmission and acquisition. Thus, sexually transmitted diseases increase the risk of HIV by 10 fold.2

The diagnosis and subsequent treatment often depends on clinical or laboratory diagnosis. In case of vaginal discharge, clinical diagnosis is often inaccurate and has limited value in final diagnosis and treatment. Laboratory diagnosis is time consuming, expensive and many a times unavailable.

Thus it becomes necessary to treat vaginal discharge as a ‘Syndrome’ rather than an individual disease.

In 1988, World Health Organization introduced the concept of ‘Syndromic management’.

In syndromic management, diagnosis and treatment is not based on specific diseases identified by testing but rather on syndromes, which is a group of clinical findings. Treatment is generally given for all or at least most commonly seen diseases that could cause that syndrome.3

To be effective, syndromic approach must consider data on prevalence of sexually transmitted disease in a given area, antibiotic resistance and drug availability.

Also it is important to assess risk, which is helpful to decide whether to treat cervictis which is likely to be associated with vaginitis.
It is also important to treat asymptomatic patients, which greatly reduces spread of sexually transmitted diseases and HIV. As most of the aetiological causes of vaginal discharge are sexually transmitted, it is logical to treat both partners and not only the women. Treating only women with vaginal discharge leads to inadequate treatment and relapse. In this study we gave therapy to both the partners.

Drugs selected for syndromic management should have high efficacy, less adverse effects and should be cost effective. Also these drugs should be orally administrable and preferably be given as a single dose to increase the acceptance and compliance.
Syndromic management has many advantages over conventional methods. It greatly decreases dependence on laboratory tests. In resource limited countries like India, laboratory testing may be too expensive and are often unavailable. Even where laboratory diagnosis is available, it is time consuming and often does not correlate with clinical findings. Thus its use is meaningless in clinical practice.

Also syndromic approach greatly simplifies complex diagnostic process for health workers without advanced medical skills or experience. In developing countries like ours, this significantly expands the pool of health care providers thus greatly reducing the prevalence of such diseases.
The most important benefit of syndromic management is that treatment begins immediately. Patient acceptance and compliance is good. Immediate treatment dramatically increases the chance of successful care and reduces the time interval during which the infection can spread.2,3

Since most commonly encountered aetiologies of vaginal discharge are trichomoniasis, moniliasis, bacterial vaginosis, chlamydial infection and gonorrhoea, according to the principles of syndromic management, treatment should be directed against all these diseases.

Appropriate drugs should be chosen, which effectively cover all the organisms causing vaginal discharge, preferably in a single dose to ensure patient compliance.

Both trichomoniasis, and bacterial vaginosis can be treated with nitroimidazoles. In the past, five day therapy of metronidazole was the first line of treatment. There is an increased resistance found to metronidazole in trichomonal vaginitis. Secnidazole, a new nitroimidazole can be given in single stat dose of 2 grams, has better tolerability and patient compliance. It has a larger half life and a longer duration of action. It is more cost effective with less adverse effects.4

Vaginal candidiasis is usually managed locally with creams or vaginal tablets/suppositories containing clotrimazole or miconazole. This topical treatment is often inconvenient and unacceptable due to various cultural, religious and social factors. Among the oral options, flucanozole has increased acceptance and is the only oral drug recommended by center for disease control (CDC) USA in a single stat dose of 150 milligrams. It is very well tolerated and cost effective. Recurrence rate is low due to elimination of rectal fungal infection.
Chlamydia and gonorrhoea are routinely treated with tetracycline or penicillin group of antibiotics, which have to be given in multiple doses. This causes poor patient compliance and missed doses leading to relapse. However with the advent of Azithromycin, a new microlide, single stat dose of 1 gram has excellent cure rates of 90 - 100%.5 It is important to treat these two diseases in vaginal discharge, as 70% of chlamydial and 30% of gonococcal infections are asymptomatic and remain undetected in women.

The vaginal discharge is often polymicrobial in nature. When any of these three drugs is used individually, the desired effect may or may not be achieved due to diversity of pathogenic agents observed.2 In a study of Patani KV (1994), where one of these drugs was used individually for vaginal discharge, the clinical cure rate was less than 40%.6 As compared to this, in our study, clinical cure rate was much higher due to use of combination treatment. This stresses the importance of taking these drugs together on the same day. If these drugs are prescribed separately, patient may not purchase or take them together. Thus it is important to have these drugs available in a combination kit.

Combination kits are cheaper, effective, given in single dose orally with efficacy of 95 - 98%. The single dose combination kit allows good compliance, complete treatment at the first visit thus preventing the spread of sexually transmitted disease and HIV. This can allow supervised or directly observed therapy for both partners leading to almost 100% cure rate and low relapse rate. Immediate complete treatment prevents secondary complications and development of resistant organisms thus proving to be cost effective in the long run.
The combination kit therapy in syndromic management of vaginal discharge allows simple, fast and assured therapy with a high cure rate. Though at present, cost of the drugs in this kit is higher, if weighed against cost of inadequate treatment causing complications, relapse and further transmission, development of resistance and increased transmission of HIV, its use turns out to be cost effective and is highly recommended.
1. Pandit DV, Bhat RR, Karnad DM, Deodhar LP. Journal of Obstetrics and Gynaecology India. 1993; 43 : 244.
2. Sharma N. Obstetrics and Gynaecology Today 2000; V-2 : 4, 125.
3. Latif AS. Syndromic management of STD Part 2. The management of genital discharge. Central African Journal of medicine 1998; 44 : 236.
4. Bagnoli VR. An overview of the clinical experiences of secnidazole in bacterial vaginosis and trichomoniasis. Drug invest 8 (supplement). 1994; 53 : 60.
5. Gupta V. Acute PID, an overview. Indian Journal of Obstetrics and Gynaecology 2000; 3 : 35.
6. Patani KV, Sheriar NK, Walvekar VR. Journal of Obstetrics and Gynaecology India 1994; 44 : 122.

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