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. |
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. |
