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ORIGINAL ARTICLE
Year : 2018 | Volume
: 37
| Issue : 3 | Page : 148-152
Efficacy of an ayurvedic formulation in the management of primitive cervical cell pathology: An open label clinical trial
Amit Veljibhai Rupapara1, Shilpa B Donga2, Dei Laxmipriya2
1 Department of SRPT, Government Ayurved Hospital, Junagadh, Gujarat, India
2 Department of SRPT, IPGT and RA, Gujarat Ayurved University, Jamnagar, Gujarat, India
Correspondence Address:
Dr. Amit Veljibhai Rupapara
Government Ayurved Hospital, Junagadh, Gujarat
India
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/asl.ASL_89_17
Background: Cervical cancer is one of the most common cancers in women worldwide with 122,844 women are diagnosed every year in India. 67,477 die from the disease. High-quality screening with cytology (Pap smear) has markedly reduced mortality from squamous cell cervical cancer. Objective: Efficacy of Kasīsādi Kṣāra Karma followed by Dārvyādi Yonivarti (Vaginal suppository) in cervical cell pathology was evaluated. Materials and Methods: Total 44 patients with cervical erosion diagnosed by Pap smear test were selected from the outpatient department of Prasutitantra and Streeroga, out of which three patients discontinued. The treatment protocol comprised of Kṣāra Karma by Kasīsādi Kṣāra in one sitting followed by Dārvyādi Yoni Varti of 3 gm once at bed time from next day for 21 days. The assessment was done with subjective criteria and Pap-smear after 45 days. Results: The results were observed to be highly significant in clinical features of disease such as yonitaḥ -srāva (77.67%), yoni-kaṇḍu (84.09%), yoni-dāha (87.5%), kaṭi -śūla (73.41%), udara -śūla ( 79.48%), mūtra- dāha (84%), daurbalya ( 72.34%) and area of erosion (85.96%), appearance of erosion (69.32%). Conclusion:Kasīsādi Kṣāra followed by Dārvyādi Yoni Varti was effective in the management of primitive cervical cell pathology.
Keywords: Cervical erosion, cytology, Dārvyādi yoni varti, Kasīsādi kṣāra, pap-smear
Non-healing or recurrent cervical erosion is considered as one among the warning signs of cervical cancer. Cervical cancer is one of the most common cancers in women worldwide with 122,844 women are diagnosed every year in India. 67,477 die from the disease.[1] Indian Council Of Medical Research states that cancer of the cervix is the third most common cancer with estimated 1 lakh new cases in 2016 and projected to be about 1.04 lakh in2020.[2] Almost nine in ten (87%) cervical cancer deaths occur in lesser developed regions.[3] High-quality screening with cytology ( Pap smear More Details) has markedly reduced mortality from squamous cell cervical cancer, which comprises 80% to 90% of cervical cancers. Cytology (Pap test) screening has been very successful in lowering cancer incidence and mortality in countries where good-quality screening is available.[4]
Human Papilloma Virus (HPV) infection is most prevalent among women 20 to 24 years of age, with a gradual decline in prevalence through 59 years of age.[5] Among women who are HPV positive but cytologically negative, about 60 percent become HPV negative within six months. However, even with negative cytology, older women who are HPV positive have a greater risk of developing Cervical Intraepithelial Neoplasia (CIN)-3 within 10 years, compared to younger women.[6]
Cervical erosion is a common condition seen in most women of all the age groups. About 85% of women suffer from the cervical erosion i.e., benign condition of female genital tract during their lifetime.[7]
Ayurvedic literature deals with gynaecological disorders under Yonivyāpat and Strīroga. Direct references regarding the cervical pathology cannot be traced in Ayurvedic Classics. However, considering the pathology and main symptoms of viz. discharge and erosion, it can be correlated with garbhāśaya-mukhagata-vraṇa.
The aim of the treatment is to destroy the over grown columnar epithelium by use of local chemical, electrical or diathermic cauterization, cryosurgery or even excision of the diseased area. After such destruction normal squamous epithelium from basal cell grows and heals the erosion. Kṣāra constitutes of substances, which act as caustic or corrosive agents against any growth when used externally. In Ayurvedic classics Kṣāra Karma is said to be superior to any other surgical or para-surgical measures due to chedana (cutting), bhedana (splitting), lekhana (scraping) and patana karma (incising) even though itis saumya in nature. It can be applied in a narrowest of places.[8]
Substances such as Sphaṭika (alum), Gairika (red ochre), Tuttha (blue vitriol), Kasīsa (green vitriol), Lodhra (Symplocos racemosa Roxb.), Rasāñjana, Dārvī (Berberis aristata DC.) etc. have been mentioned in upadaṃśa-cikitsā.[9] Some of the drugs mentioned in this context such as Kasīsa, Tuttha and Taṅkaṇa (Borax) were selected for the purpose of Kṣāra Karma and some of the drugs such as Dārvī (Berberis aristata DC.), Lodhra (Symplocos racemosa Roxb.), Haridrā (Curcuma longa Linn.), Sphaṭika (alum) and Gairika (red ochre) were selected for yonivarti (vaginal suppository).
Most common treatment used according to biomedicine is cauterization which has its own side effects such as secondary infertility, bleeding per vagina, stenosis and so on.[10] There were no previous works done on vaginal suppository. Therefore, there was a need to find out a method of treatment, which could impart a permanent, easy, effective cure with no, or minimal side effects and which also was acceptable to the patients. Keeping all these points in mind, a clinical study was planned to assess the efficacy of Kṣāra Karma followed by Yoni-varti in the management of cervical cell pathology.
Materials and MethodsIt was an open label single arm clinical study conducted at Prasutitantra and Streeroga outpatient department (OPD) of the institute.
Patients
Patients (N = 44) attending the out-patient department of Prasutitantra and Streeroga, fulfilling the criteria for the selection were selected for the study. A detailed history was taken according to the proforma specially prepared for this purpose.
Drugs
The raw drugs of Yoni Varti (Vaginal suppository) and Kasīsādi Kṣāra were collected from the Pharmacy and authenticated in the Pharmacognosy Laboratory. Vaginal suppository was prepared in the department of Rasashashtra and Bhaishajya Kalpana. [Table 1] shows the ingredients of Kasīsādi Kṣāra and [Table 2] shows the ingredients of Yoni Varti.
Ethical clearance
The study was cleared by the Institutional Ethics Committee (PGT/7-A/Ethics/2012-2013/3532) and registered in Clinical Trial Registry of India (CTRI) No. CTRI//2014/01/00623. Prior to initiation of the study, informed written consent was taken from each patient. Patients were asked to withdraw their name from the study at any time without giving any reason if they wished.
Inclusion criteria
Married patients of age between 20 to 60 years with clinical signs and symptoms of cervical cell pathology including white discharge, contact bleeding, backache, erosion, hypertrophy, Acute and Chronic Cervicitis, Cervical intraepithelial neoplasia (CIN) I and II (As per CIN classification) in Pap smear test were enrolled in the study.
Exclusion criteria
Patients with Tuberculosis of reproductive organs, Procidentia, CIN Grade III (As per Bethesda classification), TB, DM, S.T.D., H.I.V., Pregnant and lactating women, women aged <20 and >60 years and Kṣārāyogya were excluded from study.
Posology
The treatment protocol comprised of Kṣāra Karma by Kasīsādi Kṣāra in one sitting followed by Dārvyādi Yoni Varti of 3 gm once at bed time from the following day for 21 days. The assessment was done with subjective criteria and Pap-smear after 45 days.
Criteria for assessment
Assessment was done on the basis of improvement in yonitaḥ-srāva (vaginal discharge), yoni-kaṇḍu (itching vulva), yoni – dāha (burning sensation in vagina), kaṭi-śūla (backache), udara-śūla (lower abdominal pain) and mūtra-dāha (burning micturition), changes in Pap smear report and vaginal pH. A special scoring pattern was adopted for the signs & symptoms.
Statistical analysis
Based on the observations, the data obtained were statistically analysed in terms of mean, Wilcoxon's Signed-Rank test. Paired “t” test was considered at the level of P < 0.001as highly significant, P < 0.05 or P < 0.01 as significant and P > 0.05 as insignificant to assess the result.
Observation and ResultsIn this clinical study, a total of 44 patients were registered, out of which 41 patients completed the treatment, whereas three patients discontinued. Maximum number of patients, i.e., 52.27% belonged to age group of 20-30 years, 44.73% were from lower middle class, 40.91% were multipara, 56.81% were from rural area, 100% had Yoni-srāva (vaginal discharge) and 38.63% had been suffering for 1-2 year.
Pap-smear report shows that 19 patients had chronic cervicitis while 12, 7, 1, 2 patients had acute cervicitis, acute on chronic cervicitis, benign hypertrophy and CIN-1 respectively.
[Table 3] shows the statistically highly significant relief in the yonitaḥ-srāva (Vaginal discharge), yoni - kaṇḍu (Itching vulva), yoni-dāha (Burning sensation in vagina), kaṭi-śūla (Backache), udara-śūla (Lower abdominal pain) and mūtra-dāha (Burning micturition).
[Table 4] shows the statistically highly significant reduction in the % area of cervical erosion and appearance in per speculum finding.
Effect of therapy on cytology reports shows that after treatment, normal cytology was observed in 8 patients of chronic cervicitis, two patients of acute cervicitis, and two patients of acute on chronic cervicitis. Decrease in infection with repair changes was observed in eight patients of chronic cervicitis, 5 patients of acute cervicitis, and four patients of acute on chronic cervicitis and one patient of CIN-1. No change was observed in one patient each of acute cervicitis, chronic cervicitis, acute on chronic cervicitis, CIN-1 and benign hypertrophy. Infection increased in four patients of acute cervicitis and two patients of chronic cervicitis [Table 5]. Restoration of abnormal vaginal pH was observed in 5.50% of patients, which was statistically highly significant.
The total effect of therapy shows that 4.87% of the patients got complete remission, 51.23%patients got marked improvement and 43.90% patients got moderate improvement [Figure 1].
DiscussionIn the present study, majority of patients i.e., 52.27% belonged to age group of 20-30 years. It is similar to Neelam et al.[7] 44.73% of the patients were from lower middle class. The increased risk with low socioeconomic status is attributed to a lack of screening, failure to treat precancerous conditions, and lack of knowledge about prevention of human papilloma virus (HPV) infection.[11] 47.12% of the patients were multiparous, while 43.68% were found parous. 21.84% patients had history of two or more abortions. 92.41% patients had Full Term Normal Delivery. It could be attributed to cervical trauma, which may occur due to multiple pregnancies at short intervals. Previous studies[12],[13] have documented multiparity as a risk factor. 56.81% were from rural area and therefore suggests that they were not conscious enough to seek early medical help. 38.63% had been suffering for one to two years year. Chronicity of a disease provides knowledge of its severity and is helpful to decide the prognosis of the disease. Patients do not consult the physician until it creates major vaginal discomfort or other associated problems such as severe backache, body ache, burning micturition, infertility etc. Therefore, negligence converts the disease into achronic one. Results observed were highly statistically significant in most of the symptoms. Properties of Kṣāra suchas chedana ( cutting), bhedana (splitting) and lekhana (scraping) normalized the kapha-pitta doṣa by kleda-śoṣaṇa thus relief in discharge, itching and burning sensation were observed. It also normalized garbhāśaya sthāna and relief in kaṭiśūla and udaraśūla was observed. Abnormal vaginal discharge, pruritus vulvae are mainly due to trichomonas, monilial and bacterial infections that were reduced due to antipyretic, anti-protozoal, antimicrobial, anti-inflammatory and antifungal action of the selected drugs.
Infection was increased in 4 patients of acute cervicitis and 2 patients of chronic cervicitis. It may be due to chronicity of disease and greater eroded area which may have needed longer duration of treatment.
Probable mode of action of Kasīsādi Kṣāra
Probable local mode of action of Kasīsādi Kṣāra can be understood as:
Yoni Śodhana
Cleaning the eroded cervix by lekhana (scraping) and vraṇaśodhana property.
Restrain Srāva
Due to kaṣāya (astringent) and kaṭu (pungent) rasa; laghu and rūkṣa guṇa that restrain srāva (discharge).
Kill causative microorganisms
Kṛmighna, antimicrobial, antibacterial, anti-fungal, antiviral properties[14],[15] of Kasīsādi Kṣāra thatkill microorganisms.
Rejuvenate the epithelium
Vraṇanāśana (wound healing) and antioxidant and madhura (sweet) rasa properties such as prīṇana (gratifying), jīvana (vivifying) etc. help to rejuvenate the cervical epithelium.
Probable mode of action of Dārvyādi Yoni Varti[16],[17]
The approach of management of the present study may lead to better treatment of Primitive cervical cell pathology. Itis concluded that the Kasīsādi Kṣāra Karma along with Dārvyādi Yoni Varti is highly significant and effective in term of P values. 77.67% relief in yonitaḥ- srāva, 84.09%relief in yoni kaṇḍu, 85.96% relief in % area of cervical erosion and 69.32% relief in appearance of garbhāśaya-mukhagata-vraṇa (Primitive cervical cell pathology) were found. No Adverse Drug Reaction (ADR) or side effects were reported in the present study.
Acknowledgement
The authors are very much thankful to Director of Institute for Post Graduate Teaching and Research in Ayurved, Department of Rasa Shastra for providing facilities.
Financial support and sponsorship
Institute for post graduate teaching and research in Ayurved, Jamnagar, Gujarat, India.
Conflicts of interest
There are no conflicts of interest.
References
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