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J Cytology 2004; 21:33-38.
Title : Use of Cervical Cytology, Vaginal pH and Colposcopy as Adjuncts to Clinical
Evaluation of Ayurvedic Vaginal Douche, Panchavalkal, in Leucorrhoea.
Authors: Jayashree Joshi, M D , Ph D , Deputy Director*
Ranjan Bhatt, M Sc , Ph D , Academic Director *
Vanita Rege, M D (Ayur), Head, Dept. of Ob/Gyn #
Rama Vaidya, M D , Ph D , Dean*
Bharati Joshi, B S A M , Panchakarma Director *
Devaki Nadkarni, M D (Ayu), Sr. Res. Officer *
Nancy Pandita, M Sc , Ph D, Phytochemist *
Sudha Sunder, M Sc , Research Officer *
Neerja Rastogi, B Sc, Research Assistant *
Ashok Vaidya, M D, Ph D, Research Director & Director *
Address * Bharatiya Vidya Bhavan’s Swami Prakashananda Ayurveda
Research Centre (SPARC), Juhu, Mumbai
# Ayurvidya Prasarak Mandal’s Sion Ayurveda Mahavidyalaya,
Sion, Mumbai
Corresponding Author : Dr. Jayashree Joshi, M D, Ph D , Bhavan’s SPARC, Vithal
Nagar, 13th N.S. Rd., Juhu, Mumbai 400 049.
Short Title : Panchavalkal Vaginal Douche for Leucorrhoea.
Key words: Leucorrhoea, Ayurveda, Vaginal pH, Panchavalkal douche, Papanicolaou
smear, Colposcopy.
Title: Use of Cervical Cytology, Vaginal pH and Colposcopy as Adjuncts to Clinical
Evaluation of Ayurvedic Vaginal Douche, Panchavalkal in Leucorrhoea.
Abstract
Objective : To use cytology, vaginal pH and colposcopy as adjuncts to clinical
assessment of efficacy of traditional Ayurvedic douche alone in treatment of
uncomplicated leucorrhoea.
Subjects : Forty two cases of uncomplicated leucorrhoea ie. without Pelvic Inflammatory
Disease or associated gynaecological or systemic pathology
Methods : History, clinical examination, Papanicolaou (Pap) smear, Gram smear,
Vaginal pH, and colposcopy were carried out before treatment, at 2 weeks and post
treatment at 1 monthly examination. Daily douches with modified Panchavalkal
(decoction from barks of F. bengalensis, F. religiosa, F. infectoria, F. glomerata and A.
lebbeck, 25gms each), were given for 14 days. Symptoms were evaluated by a
diagrammatic visual grading score.
Results: Thirty six cases (85.7%) had clinical relief or cure (p < 0.001; Chi square test).
The symptom score was reduced from 5.4 ±1.9 to 2.2 ± 2.2 (Mean ± SD) at 2 weeks and
2.3 ± 2.2 (Mean ± SD) at 1 month (p < 0.001; paired ‘t’ test) i.e. at 2 weeks post
treatment . out of 29 cases who had cervical erosion, 20 cases showed reduction in area
of erosion whilst no change was seen in 9 cases. Colposcopy (n=21) confirmed reduced
vascularity, inflammation, discharge and epithelialisation of TZ in 19 cases. Vaginal pH
(n =28) was reduced in 13 and remained normal in 7 and remained same in 4 cases. In 4
cases there was a nonsignificant rise. Pap smears (n=37) showed improvement in severity
of inflammatory changes in 25 cases. Specific infections were seen in 24 cases initially,
and in 15 cases at 1 month.
Conclusions : Apart from symptoms and signs, cervical cytology, colposcopy and
vaginal pH were very useful in evaluation of the traditional Panchavalkal douche
treatment of uncomplicated leucorrhoea. Multiple infections and resistant cases were
identified. Panchavalkal provided symptomatic relief in 85.7% of cases.
Acknowledgements: 1. Bharatiya Vidya Bhavan 2. Research Grant-in-aid from Ministry
of Health, Department of ISM & H, Government of India, New Delhi.
Introduction
Leucorrhoea is a common symptom and afflicts upto 75% of women at least once in their
lifetime 1. It may be innocuous and physiological as during ovulation or in pregnancy,or
it may be a forerunner of serious complications like pelvic inflammatory disease (PID),
ectopic gestation or cervical cancer. All over the world more than 300 million cases of
sexually transmitted diseases (STDs) in women are reported annually and leucorrhoea is
a common symptom 1-4. As in other developing countries, in India, Reproductive Tract
Infections (RTIs), which include STDs, are common 5-7. Our earlier work has shown that
the prevalence rates are high, not only in the high risk population but also in the relatively
low risk population like Copper-T users and those attending family welfare clinics and
antenatal clinics 6-8. Recent community studies in other parts of India have confirmed
this 9. It becomes extremely important therefore to evaluate all available methods of
treatment and prevention of complications.
In India, traditional systems of medicine, like Ayurveda, are used by large sections of
society. Many current practitioners of Ayurveda use Panchavalkal (PVK) douche for
treatment of leucorrhoea. PVK is a decoction prepared from the mixture of barks of five
medicinal plants and has been described for the treatment of women’s diseases in
Ayurvedic texts10. Laboratory studies over the decades by Bhatt and coworkers have
shown ‘in vitro’ and in vivo antimicrobial activity against several aerobic and anaerobic
organisms, some of which are also known to cause cervico-vaginal infections 11. They
had also shown interesting results in patients with infected burns using modified
Panchavalkal i.e. Parish substituted by Shirisha.
Despite extensive clinical use of PVK for vaginal infections or cervical erosions by
Ayurvedic physicians there is no published data which shows its efficacy or otherwise.
Some thesis work by Ayurvedic postgraduates shows clinical relief only but objective
criteria or laboratory tests have not been used. One clinical study has shown some
beneficial effect of oral PVK capsules in prevention of postoperative complications of
gynecological surgery 12. The present study was undertaken to objectively evaluate the
effect of PVK douche in the treatment of leucorrhoea. The parameters used for
assessment were a semiquantitative assessment of symptom relief, per speculum and per
vaginal examination, cervical cytology (Papanicolaou smear), endocervical gram smear,
vaginal pH and colposcopy done before and after treatment. The project was approved by
the Ethics Committee and was carried out by Bhavan’s SPARC in collaboration with
Sion Ayurved Mahavidyalaya (SAM).
Material & Methods
Subject enrollment : A total of 129 consecutive ambulant cases referred to the joint
leucorrhoea clinic of Bhavan’s SPARC and SAM were evaluated between June 1999 and
September 2001. Out of these 42 cases with uncomplicated leucorrhoea ie. without pelvic
inflammation or associated local or systemic pathology, were admitted to the study group
as per the following criteria:
Inclusion criteria : 1) Willingness to use PVK douches as the only method of treatment
during the study period of 2-4 weeks 2) Willingness to come to the hospital for daily
douches for 14 days 3) History of tubal ligation or condom use for contraception
4) Abstinence from sexual intercourse during study period 5) Age between 20 and 50
years 6) Informed written consent after reading the information about the study.
Exclusion criteria : 1) Pelvic Inflammatory Disease (PID) using standard criteria 2)
Abnormal Papanicolaou smear with intraepithelial or invasive cancer 3) Unexplained
vaginal bleeding 4) Abnormal findings on pelvic sonography 5) Pregnancy 6)
Fibromyoma, polyp, ovarian tumour or cyst, prolapse 7) Systemic disease like
hypertension, diabetes, heart disease, tuberculosis, 8) Severe anaemia i.e.Hemoglobin < 8
gms%, 9) Use of antibiotics or local vaginal formulation within the previous month, 10)
Endocervical smear positive for gonococci 11) Positive VDRL or HIV test.
Preparation of douche
The barks of 5 medicinal plants ( Vata or Ficus bengalensis, Udumbar or Ficus
glomerata, Plaksha or Ficus infectoria, Ashwatta or Ficus religiosa and Shirisha or
Albizzia lebbeck) were purchased from a standard Ayurved pharmacy (Arya Vaidya
Rasashala, Mumbai). Packets of 25 gms of mixture with equal proportions of each type of
bark by weight (5 gms each) were prepared and stored at room temperature, away from
sunlight, with silica gel bags to avoid absorbance of moisture. Fresh decoction (Kwath)
was prepared for daily use by boiling 25 gms of PVK in 2 litres of water in an open
vessel till it was reduced to 500 ml 10,13. The mixture was filtered and when tepid warm,
was used for douching under hygienic conditions with disposable plastic nozzles used
separately for each patient.
Dose : PVK douche was given daily in the gynecological ward between 10.00 am and
12.30 am for 14 days by Ayurvedic physicians.
Follow up: All cases were advised to come for daily douching and were assessed initially
and at 1 week (symptom score only), 2 weeks and 4 weeks ie. 2 weeks post treatment.
They were advised abstinence from sexual intercourse for 2 to 4 weeks . The initial and 1
monthly examinations were carried out in the same phase of the menstrual cycle to avoid
the confounding effect of cyclic changes in pH , and colposcopic findings 14. Women
with persistent specific infections at the end of 4 weeks, or those who worsened earlier
were given appropriate modern drugs 15-17. Their male partners were prescribed modern
drugs whenever indicated. All anemic women were prescribed oral iron therapy at the
end of 2 weeks of treatment.
Pretherapy investigations
Symptom score: A specially designed case record form with symptom scoring was used
at each visit. The amount of discharge was scored by the patient on demonstration of a
schematic diagram ie. Visual grading (Fig 1). The criteria used for overall assessment are
given in Table I.
Gram stain smear : Endocervical smear was Gram-stained and examined for pus cells,
bacteria, clue cells, candidiasis and intracellular gram negative diplococci.
Papanicolaou smears : Two smears (ectocervical and endocervical) were collected at
each examination using a presterilised (gamma radiated) disposable wooden spatula and
endocervical brush (Contech devices). The severity of inflammation was assessed by
cytoplasmic and nuclear changes, polymorphonuclear leucocytes, lymphocytes,
histiocytes, transformed lymphocytes and cocci or bacteria in the background.
Inflammatory changes like abnormal eosinophilia, cytoplasmic granules, vacuoles,
phagocytosis, perinuclear halo, cytolysis, coarse chromatin, nuclear haziness, crenation,
karyorrhexis and karyolysis were noted in all smears.
Specific cytological changes typical of Bacterial Vaginitis (clue cells, cocci, bacilli),
Chlamydia trachomatis (intracytoplasmic vacuoles with eosinophilic granules and
presence of transformed lymphocytes), Trichomonas vaginalis (pear shaped or
pleomorphic bluish grey bodies, 8-15 µ in diameter, if well preserved with eccentric
nuclei and flagella), Candida (budding yeast or branching hyphae or spores), Herpes
Simplex Virus infection (ground glass appearance of nuclei, multinucleation, intranuclear
inclusions, megalocytes), or Human Papilloma Virus infection (koilocytes, megalocytes,
multinucleation, dyskaryosis, hyperkeratosis, parakeratosis) were recorded as per
literature criteria and as reported by us earlier 18,19.
Vaginal pH : Vaginal pH was measured in 28 cases by a separate sterile swab placed in
anterior vaginal fornix and using laboratory grade pH paper (Qualigens) before the
application of acetic acid and after ascertaining abstinence.
Colposcopy : The ASCON colposcope was available after November 1999. the amount
of discharge, vascularity, acetowhite areas and extent of transitional zone (TZ) were
noted in 21 cases before and after application of 5% acetic acid.
Results
The overall clinical response was good and thirty six cases (85.7%) showed clinical cure
or improvement (Table II). However investigations revealed a worsening of Pap smears
(increased severity of inflammatory changes in epithelial cells, increased cocci and short
rods, and increased leucocytes and histiocytes) in 7 cases and lack of improvement or no
change in another 5 cases.
Tolerability : Panchavalkal douches were tolerated very well. There were no major side
effects of the treatment in 41 cases. Only one case complained of increased discharge .
One case had mild transient local itching for 2 days and another case had mild tolerable
dryness of vagina for 2 days.
Three cases reported significant relief of backache following douche
treatment.
Symptom score : Thirty six cases (85.7%) had clinical partial or total relief of symptom
of leucorrhoea (p < 0.001, Chi square test). The mean symptom score for the amount of
discharge was 5.4 ± 1.9 (Mean ± SD) before treatment. This was reduced to 2.2 ± 2.2 at
2 weeks and 2.3 ± 2.2 at 1 month. The reduction in amount of discharge was statistically
highly significant (p < 0.001, Student’s paired ‘t’ test).
Vaginal pH : Vaginal pH before and after treatment was measured in 28 cases (Fig 2).
The mean vaginal pH before treatment was 5.3 ± 1.2 (mean ± S.D). This was reduced to
4.8 ± 0.7 (mean ± S.D) at 1 month (p<0.001 ; Student’s paired ‘t’ test). In 13 cases the
pH was reduced and in another 7 it remained normal (≤ 4.5). In 4 cases the pH which was
higher than normal, remained same, and in 4 cases there was a nonsignificant rise in pH.
Cytology :
Papanicolaou smears : The results of analysis of Pap smears are given in Table III. In 5
cases Pap smears and Gram smears could not be done at 2 weekly, and in another 5 cases
at 1 monthly check up either because they were in periods, or because of nonmedical
reasons. Cytological manifestations specific to Bacterial vaginitis, Chlamydiasis,
Trichomoniasis, Candidiasis and HSV or HPV infections as mentioned in methodology
section were observed in 24/42 (57%) cases initially, in 7 (19%) cases at 2 weekly
examination and in 15 (40%) cases at 1 monthly examination. Multiple infections were
seen in 8 cases. Smears from 6 cases showed marked inflammatory changes but no
specific organisms or cytopathology could be identified.
Gram smears : These did not give any additional information in the study cases as none
of the smears showed Gram-negative intracellular diplococci. Clue cells and yeast were
seen in the smears as in Pap smears also. However one case excluded from study for PID
did show Gram negative diplococci.
Colposcopy : Colposcopy was carried out in 21 cases before and after treatment (Table
IV). Except for 1 case (No 20) all showed reduced vascularity at follow up. In 1 case
(No.4) cervicitis (congestion and discharge) reduced after treatment whilst in two cases
(No. 16,17) only congestion and redness were seen which were reduced.
In 13/21 cases there was a significant reduction in the area of TZ after application of
acetic acid. In 6 cases (No. 2,3,5,8,13,14) there was almost complete healing of erosion
and corresponded with reduction in size of TZ. One case (No.20) showed increased
vascularity, edema and discharge discontinued douches on 8th day.
Non responders
Though 86% of cases were relieved symptomatically an analysis of cases according to
laboratory parameters revealed that those with specific infections on cytological
examination, specially Chlamydia trachomatis or HPV infection, and those with
moderate or large erosions responded less or poorly to PVK douche treatment.
Discussion
Panchavalkal douche is routinely prescribed by Ayurvedic physicians for a subset
leucorrhoea with vitiation of pitta dosha 10, 20 . However there is no published clinical and
laboratory data on the use of the PVK vaginal douche. Apart from the antimicrobial
effect of alcoholic extracts ‘in vitro’11, 12 there is evidence that the barks of Panchavalkal
and many other medicinal plants of the genus ficus have constituents like anthrocyanins,
terpenoids, bioflavonoids which may be responsible for antimicrobial and anti
inflammatory activity 11, 21.
In the present study objective methods for clinical and laboratory assessment were used
to determine the effectiveness of PVK douche when it is used as the only method of
treatment of uncomplicated leucorrhoea. Symptom scoring, pH measurement and
assessment of inflammatory changes in Pap smears and colposcopy were used in addition
to the clinical assessment of symptoms and per speculum and bimanual gynecological
examination. The Pap smear is now increasingly used in the diagnosis of some
cervicovaginal infections and the Bethesda system of reporting now makes it mandatory
to report associated infections 22. In addition to screening for precancerous and cancerous
conditions of the cervix we have made use of Pap smear for cytological diagnosis of
seven reproductive tract infections since 1985. We have compared it with other
diagnostic tests like anaerobic culture, immunofluorescence and peroxidase
antiperoxidase test and have reported on its usefulness 6-8, 18,19. Recently we have reported
a sensitivity of 58% and specificity of 90% for Pap smear diagnosis of Chlamydia
trachomatis by comparing 4 non-culture diagnostic methods 23,24. This has also been the
observation of Panuco et al in a recent report and they reported higher sensitivity and
specificity 25. Confounding variables which may change the outcome of treatment were
taken care of in the present study. Cases with PID, HIV seropositivity, Diabetes mellitus,
severe anemia and systemic diseases were excluded. Care was taken to ensure abstinence
during the study period. Partner treatment, health education and further management of
the couple were included in this study.
The results show good symptomatic relief (p < 0.001) in 85.7% of cases. The persistence
of symptom relief and improved laboratory parameters at 1 monthly examination ie 2
weeks after completion of the treatment rules out a placebo effect due to mere douching.
In spite of symptomatic relief as many as 11 cases showed persistent (n =5) or severe (n
= 7) inflammatory smears. These were mainly in those cases who had specific infections
in Pap smears or large or moderate erosion of the cervix at initial examination confirmed
by colposcopy. Only 1 case had worsening of symptoms and discontinued treatment. She
also failed to respond to conventional antibiotics given subsequently. The healing effect
seen in 13 cases of erosion, and significant in 6 cases, indicates the usefulness of PVK for
local treatment. Modification of formulation and dose searching may improve the
response to PVK douche treatment. Adjuvant therapy with systemic drugs (Ayurvedic or
Modern) may be necessary for cure.
Although the Papanicoloaou smear is well established as method, for diagnosis of
leucorrhoea it is not commonly used for assessing efficacy of treatment of leucorrhoea. It
has been used more often to determine the efficacy of treatment of HPV related lesions or
intraepithelial neoplasias. Wet smears, cultures, PCR or cytochemistry, fluorescence
based methods have been used more often for follow up of infections. In this group of
low risk behavior they incidence of gonorrhoea was low. Only 1 case had gram negative
diplococci and she was excluded from the study as she had PID. In our earlier study
where we had used endocervical cultures as well as swabs from a similar group of
women the incidence of gonorrhoea was 1.7 % 7.
The analysis of response of specific infections to PVK douche indicated that those with
Chlamydiasis or viral infections had persistent inflammatory or worsened smears. Those
with Trichomoniasis or Candidiasis or Bacterial vaginitis responded better, however the
numbers are too small in each group to generalize. The use of multiple plants with several
active principles may be an in built mechanism in Ayurvedic methods of treatment
whereby bacterial resistance is prevented. Thus this may be an added advantage in the
modern era when resistance to several organisms causing STDs is an increasing cause of
concern 26, 27.
Conclusions
Daily panchavalkal douches for 14 days provided symptomatic relief in 85.7% of cases
of uncomplicated leucorrhoea (p < 0.001). Cervical cytology, vaginal pH and colposcopy
were utilized in confirming its antimicrobial and anti-inflammatory effects. Cytology was
very useful in assessing the severity of infection and in identifying some specific
infections.
Acknowledgements: We are grateful for a research grant-in-aid from the Ministry of
Health, ISM & H, Govt. of India, for partial funding of this project, and we thank Shri R.
Venkatraman, President, Bharatiya Vidya Bhavan, for providing the facilities for this
study.
Legend to Figure 3
Figure 3 a,b,c, Papanicolaou smear (x 400) a of patient a) before starting PVK douche
treatment b) at 2 weeks c) at 1 month
Legend to Figure 1.
Figure 1. Visual grading of symptom of leucorrhoea for amount of discharge.
Legend to Figure 2.
Fig 2. Vaginal pH in leucorrhoea cases before and after PVK douche treatment.
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___________________
Table I
Assessment Criteria
Parameter Cured Improved No Change Worse
Symptom Decreased Decreased No change Increased
Score* to ≤ 2 by 2 by 2
Signs Cervix Mild No change Worse
clean infection
pH ≤4.5 Decreased No change Increased
Pap smear ** Negative Inflammation No change Increased
or mild less, inflammation,
inflammation normal cytolysis
few wbc morphology karyorrhexis
Doderlein’s wbc less karyopyknosis
bacilli, No bacteria less perinuclear
specific halos
infection. phagocytosis
* Refer Visual Grade Figure 1.
** Details given in methodology
Table II
Overall Response To PVK Douche Treatment For 14 Days
(N = 42)*
Response Cured Improved No Change Worse
Symptoms 17 19 3 3
(N=42)
Signs 21 9 6 6
(N=42)
Cytology 3 22 5 7
(N=37)
Colposcopy 8 9 3 1
(N=21)
pH 5 8 11 # 4
(N=28)
* As per criteria in Table I and details in methodology section
# 7 reemained within normal rangem; 4 remained high
Table III
Cytological Manifestations Of Genital Infections In Papanicolaou Smears Of
Women Treated With PVK Douche.
(N=42)*
Pap smear report Before PVK 2 weeks after Post
treatment treatment treatment
(N=42) (N=37) (N=37)
Bacterial vaginitis 10 6 5
Candidiasis 6 1 6
Chlamydiasis 13 5 9
Trichomonas vaginitis 6 1 2
HPV infection 5 1 4
HSV infection 3 7 1
Specific infections 24 7 15
Non specific infection 18 30 22
* 5 cases did not come for 2 weeks follow up; another 5 cases did not come for post
treatment follow up.
Table IV
Colposcopic Findings Before And After PVK Douche Treatment
S.No. TZ Initial TZ 2 weeks TZ 1 month Inflammation*
1. >75% 50% 50% Decreased
2. >75% ND <25% Decreased
3. 75% 50% <25% Decreased
4. Cervicitis Mild Mild Decreased
5. 75% <25% <25% Decreased
6. 25% 20% 25% Decreased
7. >75% 75% 50% Decreased
8. <25% <25% Healed Decreased
9. <25% ND <25% Decreased
10. 50% <25% ND Decreased
11. 50% 30% ND Decreased
12. 75% 50% 60% No change
13. 70% Healed Healed Decreased
14. 70% 30% 30% Decreased
15. 50% 25% ND Decreased
16. Absent Absent Absent Decreased
17. Absent Absent Absent Decreased
18. 50% ND 30% Decreased
19. 10% Absent Absent Decreased
20. 90% 100% ND Increased
21. 30% ND 25% Decreased
* cerivicitis, vaginitis, vascularity, edema, discharge.
TZ=Transformation zone as % area of ectocervix (Reduction due to
epithelialisation)
ND = Not Done
Fig. 2. Vaginal pH in leucorrhoea cases before & after PVK treatment(N=28)
0
1
2
3
4
5
6
7
8
9
0 5 10 15 20 25 30
Serial No of Case
Vaginal pH
Initial 1 month
Table 5. Cytological Manifestations Of Genital Infections In Papanicolaou Smears
of Women Treated With PVK Douche (N=42)*
Pap smear report Before PVK 2 weeks after Post
treatment treatment treatment
(N=42) (N=37) (N=37)
Bacterial vaginitis 10 6 5
Candidiasis 6 1 3#
Chlamydiasis 13 5 9
Trichomonas vaginitis 6 1 2
HPV infection (Koilocytosis) 5 1 4
HSV infection(nuclear changes) 3 7 1
Specific infections 24 7 15
Non specific infection 18 30 22
• 5 cases did not come for 2 weeks follow up; another 5 cases did not come for
post treatment 4 weeks follow up.
• However 6 were positive with culture
