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ORIGINAL ARTICLE
Year : 2018 | Volume
: 37
| Issue : 3 | Page : 153-157
Āyurvedic management of Arśas with Apāmārga Kṣāra Taila: A randomized controlled clinical study
SD Laxmikant1, Suketha Kumari2, Manjusha Rajagopal3
1 Department of Shalya Tantra, KLEU's BMK Ayurveda Mahavidhyalaya, Belgaum, Karnataka, India
2 Department of Kaya Chikitsa, KLEU's BMK Ayurveda Mahavidhyalaya, Belgaum, Karnataka, India
3 Department of Shalakya Tantra, AIIA, Delhi, India
Correspondence Address:
Dr. S D Laxmikant
Department of Shalya Tantra, KLEU's BMK Ayurveda Mahavidhyalaya, Shahapur, Belgaum, Karnataka
India
Source of Support: None, Conflict of Interest: None
CheckDOI: 10.4103/asl.ASL_102_17
Backround: Haemorrhoids are the most common problems of the anal canal due to hereditary, anatomical deformities, exciting causes, diet etc. In Ayurveda, disease arśas which is explained by all the classics can be correlated to haemorrhoids. In modern surgery, different surgical methods are advocated to overcome the haemorrhoids. However, modern management has its own limitations and in that it causes various side effects, recurrence, severe pain etc., Ācārya Suśruta advocates different treatment modalities such as auṣadha (medical), śastra (surgical), kṣāra (alkali cauterization) and agni karma (heat cauterization) in the management of arśas. Aims and Objectives: Considering this, the present study has been undertaken to evaluate the comparative efficacy of Apāmārga Kṣāra Sūtra and Apāmārga Kṣāra Taila in the management of arśas. Materials and Methods: A total of 60 patients enrolled for the study, out of which 30 patients were randomly assigned into first group (control group) and were subjected to Apāmārga Kṣāra Sūtra (AKS). 30 patients were randomly assigned into the second group. In second group, i. e trial group, to obtain efficacious and safe results an innovative method was planned by using Apāmārga Kṣāra Taila basti (AKT). AKT involved administration of oil through anal route. Results: After intervention, it was observed that both AKS and AKT group are found to be equally effective to treat the arśas with reduction in clinical parameters such as bleeding per rectum, pain in ano, protrusion of mass and in constipation. In both the groups, results obtained with the above parameters showed statistically highly significant result with P value Conclusion: Hence, Apāmārga Kṣāra Sūtra and Apāmārga Kṣāra Taila are found to be affective in the management of arśas.
Keywords: Apamarga kshara sutra, apamarga kshara taila, arshas, suśruta
In Ayurveda, ācāryas have explained arśas as one of the mahāgada[1] (major disease). Arśas is described as the disease which tortures the person like an enemy.[2]Ācārya Suśruta states that improper diet and regimen leads to vitiation of doṣas. Vitiated doṣa sometimes gets localized in guda vali (anal sphincter), pradhāna dhamani and māṃsadhara kalā. Localized doṣa causes tvak (skin), māṃsa (muscle), medas (adipose tissue) and raktaja (blood) duṣṭi. This in turn causes māṃsāṅkuras (muscular buds) in guda vali. Irritation to guda (anus) by kāṣṭha (stick), upalā (cow dung), vastra (clothes) & śītodaka sparśa (cold exposure) leads to further aggravation of arśas.[3]
Arśas can be correlated to Haemorrhoids in western system of medicine. Haemorrhoids are one of the most common problems of the anal canal due to hereditary, anatomical deformities, exciting causes, diet etc.[4] National Centre for Health Statistics, found that 10 million people in the United States complained of Haemorrhoids with a prevalence rate of 4.4%.[5] Data from IPGT & RA, GAU hospital shows that, per month an average of 600 patients visit Śalya Tantra OPD, among them 500 patients have Ano-rectal disorders and 17% patients get diagnosed for haemorrhoids. Sclerotherapy, Rubber Band ligation, Infrared photocoagulation, Laser therapy, Lord's dilatation, Cryosurgery, Haemorrhoidectomy, Trasand haemorrhoidal deartery ligation and Stapled haemorrhoidectomy are in present practice in western medicine.[6] All these procedures have complications, recurrence etc., Suśruta advocates different treatment modalities such as auṣadha (medical), śastra (surgical), kṣāra (alkali cauterization) and agni karma (heat cauterization) in the management of arśas.[7]Kṣāra cikitsā in arśas is found to be effective in its management as it does not cause any complication and is also helpful in preventing recurrence. The repeated advocacy of Kṣāra Karma in Arśas inspired the present work. This study has undertaken to see the, efficacy of Apāmārga Kṣāra Sūtra and Apāmārga Kṣāra Taila in the management of Arśas. Apāmārga Kṣāra Sūtra ligation is an operative procedure. This should be done under anaesthesia requiring the patient to stay in hospital for a few days. To avoid surgery, the other form of Apāmārga Kṣāra in Taila form was selected as a non-surgical modality of treatment.
Further there is no reference available in any of the texts regarding the different application form of Apāmārga Kṣāra to be used in the treatment of specific varieties of arśas. Moreover, the innovative modes of preparations are to be applied to evaluate their efficacy in the light of scientific aspects. Considering the efficacy of local application, its advantage in uniform drug delivery, ease in performance and avoidance surgery, Apāmārga Kṣāra Taila has been administered in a trial group.
Materials and MethodsMaterials
Selection of patients
Registered patients visiting the OPD and IPD of the Śalya Tantra Department, I.P.G.T. and R.A. Hospital Jamnagar were selected for the study.
Trial drugs
Apāmārga Kṣāra Sūtra was prepared in the Apāmārga Kṣāra Taila was prepared in the pharmacy of Rasa Śastra and Bhaiṣajya Kalpanā Department, Gujarat Ayurved University, Jamnagar.Methods
Inclusion criteria
Patients with either sex of age group between 16 to 70 years were included.Exclusion criteria
Patients of haemorrhoids with fistula in ano, ano-rectal carcinoma, HIV, VDRL and hepatitis B positive were excluded.Diagnostic criteria
Diagnosis of Arśas was done based on the signs and symptoms and clinical examination.They are,
Bleeding per rectumPile massConstipationPer digital examinationProctoscopic examination.Assessment criteria
Subjective criteria
Physical assessment
Consists of per digital and proctoscopic examination. The degree of pile mass was assessed on the basis of protrusion of mass.
Investigations
Hb%TCDCESRFBSSerum cholesterol.These investigations are carried out to assess the general condition of the patient and to exclude the other pathological conditions that may interfere with the course of intervention.
Study design
Patients diagnosed to have arśas were selected from the OPD, IPD of Shalya Tantra department, I.P.G.T and R. A Hospital, Jamnagar.
It was a controlled clinical study for a duration of 7 days, where random sampling method was employed. The study was carried out as per ethical guidelines with ethical clearance number PGT/7/Ethics/2009-2010/3494.
The CTRI number is - REF/2011/10/002832.
Intervention
Total 61 numbers of patients were registered, out of which 60 patients completed the course of treatment. They were randomly divided into two groups.Group AKS: Apāmārga Kṣāra Sūtra was used[8]Group AKT: Apāmārga Kṣāra Taila was used.[9]Preparation of Apāmārga Kṣāra Sūtra
For the preparation of Apāmārga Kṣāra Sūtra, Barbour Linen Thread No. 20 was used. The surgical Barbour linen thread no. 20 was autoclaved and mounted on hangers. A piece of folded gauze was taken, dipped in the fresh Snuhi Kṣīra and the thread was smeared with the Snuhi Kṣīra. After first coat was dried the second smearing was done. The thread was smeared 11 times in this manner. The threads were placed in the Kṣāra Sūtra cabinet for drying after each smearing. The temperature inside the chamber was increased till 400 C by passing hot dry air with the help of a blower to facilitate drying of the threads.
After completing the first 11 smearing of Snuhi Kṣīra, coating of the thread by Apāmārga Kṣāra with Snuhi Kṣīra was done. The thread was smeared with fresh Snuhi Kṣīra in the way described above. Apāmārga Kṣāra was coated on it immediately (i.e. when the thread was still wet) so that it sticks to the thread well. This was done by sliding the wet thread over the heap of Apāmārga Kṣāra in such a way that the thread passes through the heap of Apāmārga Kṣāra and the Apāmārga Kṣāra sticks on the wet thread. The thread was coated seven times in this way, only when the previous coating got completely dried.
The last 3 coatings were given with Snuhi Kṣīra and Haridrā. This wasdone in the same way as the previous coating substituting Haridrā powder in theplace of Kṣāra.
While applying every coating, care was taken to see that the drugspreads evenly along the length of the thread and does not become thick at spots and thereby bring about knotted appearance. The thread was smooth and evenly coated, havingthe same thickness throughout the length. Precaution was taken to carry out theprocedure in a dry atmosphere. After finishing the coating on the threads (total 21 times), the sūtras were dried well in the Kṣāra Sūtra cabinet and were cut into assorted sizes of10-12 inches and then packed in polythene bags.
Preparation method of Apāmārga Kṣāra taila
The alkali obtained from the Apāmārga, Sarja, Yava, five salts (sea-salt, rock-salt, black-salt, sambhar-salt and sedimented-salt), Hiṅgu, Śigru, dry ginger, Devadāru, Vacā, Kuṣṭha, Śatapuṣpā, Dāruharidrā, Pippalī-mūla, Mustā (1 part each) were made into paste, mixed with Tila Taila, Kadalīkanda Svarasa, Nimbu Svarasa and Madhuśukta (64 parts each) boiled to oil consistency and used for the intervention.
Drug schedule
Group –Apāmārga Kṣāra SūtraSpinal anaesthesiaIn lithotomy positionThe base of Pile mass was transfixed and ligated with Apāmārga Kṣāra Sūtra.Group – Apāmārga Kṣāra Taila basti
In lithotomy position10ml of Apāmārga Kṣāra Taila Basti was given every morning for 7 – days.Postoperative
Dressing done with 10 ml JātyādiTaila mātrā basti daily in the morningWarm water sitz bath by SphaṭikādiYoga thrice dailyLaxative – PañcasakāraCūrṇa – 5gm at bed time with luke warm waterFor relieving pain – VātagajāṅkuśaVaṭi 250mg – BD or Injectable analgesic – SOS.Criteria for the assessment of overall effect of therapy
* Complete cure : 100%
* Marked improvement : >75 – 99%
* Moderate improvement : >50 – 75%
* Mild improvement : >25 – 50%
* No cure : 00 – 25%.
ResultsIn the AKS group (containing 30 patients), before intervention 22 patients had history bleeding per rectum, 28 patients had pain in ano, 30 patients had protruded mass, 26 patients had constipation. After intervention, results obtained with the above parameters (bleeding per rectum, pain in ano, protrusion of mass) showed statistically highly significant result with P value < 0.001. Constipation showed complete relief (100%) after intervention.
In group AKT (containing 30 patients), before intervention, 18 patients had history of bleeding per rectum, 25 patients had pain in ano, all 30 patients had protruded mass, and 26 patients had constipation. After intervention, results obtained with the above parameters (bleeding per rectum, pain in ano, protrusion of mass and constipation) showed statistically highly significant results with P value < 0.001. Constipation showed compete relief (100%) after intervention.
On analyzing the bleeding per rectum between the groups the result is not significant at P > 0.05 level. Hence, both the groups are equally effective.
On analysing the pain in ano between the groups the result is highly significant at P < 0.001 level. Though statistically Group AKS is more effective than Group AKT, but clinically both groups showed significant improvement.
On analyzing the protrusion of mass between the groups the result is highly significant at P < 0.01 level. Group AKT is more effective than Group AKS. Though statistically Group AKT is more effective than Group AKS, but clinically both groups showed significant improvement [Table 4], [Table 5], [Table 6], [Table 7], [Table 8], [Table 9].
Table 4: Effect of therapy on chief complaints in group Apāmārga Kṣāra Sūtra
Table 5: Effect of therapy on chief complaints in group Apāmārga Kṣāra Taila basti Discussion Discussion on observation
In this study it was observed that in both the groups (AKS and AKT), maximum number of patients had chronicity of less than 1 year i.e. 73% and 70% respectively. 60% of patients had normal sphincter tone and 40% had spasmodic sphincter tone in group AKS, where as in group AKT 80% had normal sphincter tone and 20% had spasmodic sphincter tone.
In group AKS, secondary pile mass was seen in 50% of patients and 40% had primary pile mass. In group AKT, 60% had secondary pile mass and 20% had primary pile mass. Intero-external pile mass was seen in 83% of patients in group AKS and 63% of patients in group AKT. In both the groups 60% of patients had 2nd degree pile mass and 30% patients had 3rd degree pile mass.
Discussion on results
After intervention, there was marked improvement in signs and symptoms of Arśas. In bleeding per rectum 100% and 99.65% of improvement was seen in group AKS and AKT respectively. In Pain in Ano, Group AKS showed 100% relief and Group AKT shows 95% relief. In Protrusion of mass, Group AKS showed 100% relief and Group AKT shows 85.88% relief. In constipation (difficulty in defecation) both the groups showed 100% relief.
In few parameters, there was minute percentage of difference between the groups, however it can be said that both the groups had showed encouraging results. Hence, results in both Group AKS and Group AKT are comparable. After analysing statistically it was also observed that in Group AKS, results obtained with the parameters bleeding per rectum, pain in ano, protrusion of mass showed statistically highly significant results with P value < 0.001. Same observations found in Group AKT showed statistically highly significant results with P value < 0.001 in parameters such as in bleeding per rectum, pain in ano and protrusion of mass.
Due to the kṣāraṇa (scraping) action of Apāmārga Kṣāra the pile mass will get slough out. Haridrā cūrṇa has antiseptic and healing actions.[10] Therefore Apāmārga Kṣāra Sūtra has given good result. Although the Kṣāra Sūtra is very useful in all types of arśas, it is very difficult to manage in OPD without anaesthesia because of the pain, shock and need of assistance to perform it. Apāmārga Kṣāra Sūtra ligation is an operative procedure. Patient has to stay in hospital minimum for afew days. In the patients who are not willing or not suitable for surgery there is a need to treat with other local methods of drug administration. Therefore an innovative administration method was established in the form of Apāmārga Kṣāra Taila basti i.e. local administration of the drug into anal canal. It gives the advantage of uniform drug delivery, easy to perform without assistance and reduced chances of contamination. In a condition such as Arśas, local administration of drugs may be required to achieve the lekhana karma (scraping action) and to reduce the pile mass. The rectum has rich blood and lymph supply and the drugs can cross the rectal mucosa like other lipid membranes. Thus, un-ionized and lipid soluble substances are readily absorbed from the rectal mucosa. Small quantities of short chain fatty acids, such as those from butter-fat are absorbed directly into blood rather than being converted into triglycerides. This is because short chain fatty acids are more water-soluble and allow direct diffusion from the epithelial cells into the capillary blood of the villi.[11]
After observing the results Apāmārga Kṣāra Taila basti also showed encouraging results in different clinical parameters of Arśas.
ConclusionsApāmārga Kṣāra Sūtra and Apāmārga Kṣāra Taila are found to be equally effective to treat the Arśas with respect to the parameters such as bleeding per rectum, pain in ano, protrusion of mass and in constipationIn both the groups, results were statistically highly significant at P value < 0.001No marked difference was seen in the overall effect of therapy in between Group AKS and Group AKTApāmārga Kṣāra Sūtra and Apāmārga Kṣāra Taila can give subjective and objective relief and can prevent the recurrence in the management of arśas.Financial support and sponsorship
Nil.
Conflicts of interest
There are no conflicts of interest.
References
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