Evaluation of Three Different Types Kshara Sutra Ligation in Arsha roga (Hemorrhoids)

Background: Anorectal disorders are a group of medical disorders that occur at perianal and the junction of the anal canal and the rectum. Arsha is enumerated under the heading of Ashtomahagada and occurs in Guda pradesh , the seat of Sadyapranahar marma . Out of available treatments of Arsha roga , the Kshara sutra ligation is the best one. In the present research work, three different types of Kshara Sutras , Snuhi ( Euphorbia neriifolia ), Guggulu ( Commiphora mukul ) and Udumber ( Ficus racemosa ) were used in Arsha roga (Hemorrhoids). Material and Methods: Total 33 patients of both genders of Arsha ( Hemorrhoids ) has been selected randomly after taking written consent and treated with three different types of Kshara Sutra followed in the "Anorectal clinic" of S.S. Hospital, IMS, BHU. Result : It reveals that lowest pain during the entire trial period was experienced by Group C - Udumber Kshara sutra with 81.8% and maximum pain was experienced by Group A - S nuhi Kshara sutra with 54.5%. Lowest discharge was experienced by Group C- Udumber Kshara sutra with 72.7% and average healing time was minimum for group C - Udumber Kshara sutra (6.55 ± 1.12) followed by group B - Guggulu Kshara sutra (7.18 ± 1.16). Maximum average healing time was seen in group A - Snuhi Kshara sutra (7.27 ± 1.10). Discussion : All types of Kshara sutra have good results in wound healing and prevent infection due to its alkaline pH (pH -10.3) that works as antibacterial at site of ligation. Patients of hemorrhoids feel lowest pain during the entire trial period, minimum average healing time, fewer irritants and good tolerance by the patients by Group C - Udumber Kshara sutra and another study also favor this result.


Introduction
Hemorrhoid is a common disorder, affecting 4% of the world population which is very specific to human race due to its erect posture. Classification of a hemorrhoid corresponds to its position relative to the dentate line. Internal hemorrhoids lie above the dentate line and are derived from endoderm whereas external hemorrhoid lies below the dentate line and derived from ectoderm 1 . Hemorrhoids are dealt rationally under the concept of Arsha roga. Acharya Charaka as well as Madhava mentioned that the Dushyas of Arsha are Twak, Mamsa and Medas 2 . According to Ayurveda the disease comes under the heading of Maharogas 3 . Arsha occurs in Gudabhaga, which is undoubtedly a Marma, and it is well known for its chronicity and difficult to treat. If neglected or not cured properly, it may turn into complications such as hemorrhage, thrombosis, portal pyaemia, fibrosis, strangulation, suppuration. Acharya Sushruta has mentioned four lines of management such as: Bhaisaja, Kshara, Agni, Shastra 4 . According to Acharya Vagbhatta, Arsha is a muscular projection (Mans-kila) which troubles the patient like an enemy 5 and Acharya Madhava also followed it 6 . Internal hemorrhoids are classified by the degree of prolapse of the anal canal. External may be classified as acute (hemorrhoidal thrombosis) or chronic (anal skin tags). In modern surgery for treatment of hemorrhoids sclerotherapy, infrared, photocoagulation, rubber band ligation laser therapy, Lord's dilatation, hemorrhoidectomy, and stapled hemorrhoidectomy are in practice but these are costly and chance or recurrence is more. Conventional kshara sutra therapy yield better long-term results and chance of recurrence is very less. This clinical research work explores effect of three different type Kshara sutras ligation in Arsha roga (hemorrhoids).

Kshara Sutra in Arsha Roga
The ancient writing of Indian medical practitioners like Sushruta, Charaka and Vagbhatta provide an elaborate description of Arsha Roga and various modalities of treatment along with brief description of Kshara sutra therapy. Complete and detail descriptions of Kshara sutra are not available in Sushruta Samhita. Acharya Sushruta (800 BC) has described four folded line of treatment as Bhaishaja chikitsa, Kshara karma, Agni karma and Shastra Karma in management of anorectal disorders 7 . Among all these therapies Kshara karma has become very useful and recently modified method of treatment for selected anorectal diseases. Kshara sutra has been described in most of the ancient books of Ayurveda as medicated thread. Kshara sutra has extensive uses in a number of surgical disorders which often pose problems for the patients and also for the surgeons. This has specific role to play in the common anorectal conditions like hemorrhoids, fistula and fissures etc. Recent modern surgical texts are also accepting the role of Kshara sutra in the management of Anorectal disorders. The present form of Kshara Sutra therapy was initiated by Dr. P. S. Shankaran and subsequently established by Prof. P. J. Deshpandey through many researches and development in department of Shalya Tantra at Banaras Hindu University. The process of development was supported in last few decades by eminent scholars like Prof. K. R. Sharma, Prof. G. C. Prasad, Prof. S. N. Pathak and others from same department 8 . Now Kshara Sutra therapy has been accepted globally and has emerged as a gold standard treatment for Anorectal diseases 9 . The Indian Council of Medical Research (ICMR) has validated this unique and effective approach 10 .

Study Design
In the present study three types of Kshara sutra: Snuhi kshara sutra, Guggulu Kshara sutra and Udumber Kshara sutra have been prepared and evaluated clinically on the patients of Arsha roga (Hemorrhoids).

Selection of the Patient
33 patients of both genders suffering from Arsha (Hemorrhoids) has been selected randomly after taking written consent. All selected cases were suffering from internal hemorrhoids.

Ethical Clearance
The study was approved by the ethical committee of IMS, BHU vide letter no. Dean/2011-2012/EC/296, dated 01.11.2011.

Inclusion Criteria
Patients diagnosed to have Prolapsed rectum and those unwilling for surgery are randomly included in the study irrespective of age, sex, chronicity, Prakriti and type of disease.

Grouping and Design
11 patients of Arsha roga (Hemorrhoids) were taken in each groups of Kshara sutra (Table 1).

Preparation of Three Different
Types of Kshara Sutra

Snuhi Kshara Sutra
The Barbour thread no. 20 has been spread throughout the length and breadth of the hanger which is then mounted over a hanger stand. Each hanger is then smeared with Snuhi Ksheer or latex with the help of clean gauze piece soaked in latex. The hanger was then replaced into the cabinet in order to dry the threads. The same process was repeated the next day. Eleven such coatings with Snuhi Kshara alone were accomplished. The 12 th coating was done by first smearing the thread with latex and then passing the wet thread through a heap of finely powdered Kshara. When all the threads were smeared with Kshara, the hanger was gently shaken so that all the excess particles of Kshara fall down. It was again placed into the cabinet for drying. This process was repeated till seven coatings of Snuhi Ksheer and Kshara were achieved, thus the total number of coatings being 18. The remaining three coatings were finally completed with the latex of Snuhi and the fine powder of turmeric in the same way. Thus, twenty one coatings over the thread were completed. When all the 21 coatings were completed, each thread measuring about 30-31 cm was cut away from the hanger and sealed in a glass tube. The orders of 21 coatings are as:
• Udumber Kshara = 11 When dried the last coating, each thread removed from the hanger, kept in a sterile tube which is gently sealed and stored in an incubator at 37°C. By doing so, Kshara sutra did not get contaminated inspite of passage of time, indicating that the ingredients do not allow the growth of bacteria even over longer periods of time.

Preoperative Procedure
• Well written inform consent of patient was taken.
• Cleaning of bowel was done at prior night.
• Part preparation of the perianal area was done.
• Xylocaine sensitivity to be done.

Operative Procedure
Patient was kept in lithotomy position on operation table. The part is cleaned with aseptic solutions and then after local anesthesia is given with 1% xylocaine injection under the advice of anesthetics and draping was done. Later on position of various pile masses were assessed. The pile mass was hold with the help of pile holding forceps. Then the slight pull is exerted over the pile mass, so that its base is clearly demarcated along with the blood vessels.

Transfixation
Pile mass has been transfixed by passing the curved round body needle with Kshara sutra at its base. The transfixation was made horizontally or vertically according to the suitable position of hemorrhoid mass, preferably horizontal then stab cut is made on the budge of transfixed hemorrhoid mass to prevent strangulation. Then warm water irrigation was done following to T bandaging ( Figure 1).

Post Kshara sutra Regime
The patient was advised to have sitz bath (Luke warm water) twice a day. Ambulation of the patients was made as a routine to encourage all the patients to remain as active as possible and to lead a normal life. The patients were advised to take easily digestible diet along with adjuvant therapies if required.

Follow-up of the Patient
The patients of hemorrhoids were asked to attend the OPD on days 1, 3, 7, 15, 30 after Kshara Sutra ligation, then every fortnightly for 3 months then monthly till six month.

Assessment Criteria
The patients of Arsha roga (Hemorrhoids) were assessed on the basis of subjective and objective parameters such as Pain, Discharge, Bleeding and Sphincter tone. The total information of subjective or objective assessment pre-operatively or post-operatively has been done in a systemic and scientific manner on regular weekly information. The treatment effect has assessed on the basis of the relief of signs and symptoms of the major symptoms of the disease (Table 2-6).

Subjective Parameter
The patients were assessed on the basis of following parameters before and after treatment as follows:

Pain on VAS (Visual Analogue Scale)
Pain was recorded on Visual Analog Scale on days 1, 3, 7, 15 and 30 after operation.

Grading of Discharge
Grading of discharge amount was based on this table.

Grading of Sphincter Tone
Grading of sphincter Tone was based on this table

Complete Healing Time
Complete healing time is the total time taken for the entire treatment. This is recorded in the patients who are on the follow up regimen. The patients of hemorrhoids were asked to attend the OPD on days 1,3,7,15,30 after Kshara Sutra ligation, then every fortnightly for 3 months then monthly till six month.

Pain Relief Day (P.R.D.)
This is the day when the patient is totally relieves or free from post-operative pain. Due to irritation effect of Kshara on the local tissue there will be burning and scalding type of pain often encountered. However the pain is relieved after dissolving of the Kshara generally after 3 rd or 4 th day in different conditions. The pH value of Kshara sutra and type of tissue probably effect the reaction. Therefore in this study it is recorded as the pain relief day i.e. (P.R.D.).

Postoperative Pain
It reveals that in the patients of hemorrhoids, the lowest pain during the entire trial period was experienced by Group C -Udumber Kshara sutra with 81.8% were experienced no pain on 5 th Postoperative day followed by Group B -Guggulu Kshara sutra with 63.6% were experienced no pain on 5 th Postoperative day, Whereas   Severe Patient requires change more than two pad of 4x4 cm gauze.  maximum pain was experienced by Group A -Snuhi Kshara sutra with only 54.5% were experienced no pain on 5 th Postoperative Day. Pain was seen maximum immediately after Kshara sutra ligation (Table 7).

Postoperative Discharge
It reveals that in the patients of hemorrhoids, the lowest Discharge during the entire trial period was experienced by Group C -Udumber Kshara sutra with 72.7% and Group B -Guggulu Kshara sutra with 72.7% patients reported complete relief from any type of discharge on 5 th Postoperative day, Whereas higher Discharge was experienced by Group A -Snuhi Kshara sutra with 63.6 % patients reported complete relief from any type of discharge on 5 th Postoperative Day. It was observed that sloughing and serous discharge was present in all type of Kshara sutra ligation varing from 2 nd to 7 th Postoperative day but in group A -Snuhi Kshara sutra, it was found that the discharge from anus was more number which may lead anal infection and wound contamination due to fecal matter. However there was 45.5% patients experienced purulent discharge in group A, while only 27.3% patients experienced purulent discharge in group B and group C. The purulent discharge found in less number of cases in group C & group B proving its advantages over the group A (Table 7).

Postoperative Hemorrhage
It reveals that in the patients of hemorrhoids, the lowest Bleeding during the entire trial period was experienced by Group C -Udumber Kshara sutra with 90.0% patients reported complete relief from bleeding on 5 th Postoperative day, followed by Group A -Snuhi Kshara sutra with 81.8% and Group B -Guggulu Kshara sutra with 81.8% patients reported complete relief from bleeding on 5 th Postoperative Day (Table 7). It was seen that average sloughing off was minimum for group A (3.27 ± 0.10) followed by group B (4.39 ± 0.3 0). Maximum average sloughing off was seen in group C (5.07 ± 0.16). But it was seen that average healing time was minimum for group C -Udumber Kshara sutra (6.55 ± 1.12) followed by group B -Guggulu Kshara sutra (7.18 ± 1.16). Maximum average healing time was seen in group A-Snuhi Kshara sutra (7.27 ± 1.10). According to One way ANOVA test applied for comparison between the groups A, B, C, result is non-significant with p>0.05 (Table 8; Figure 2).

Discussion
Anorectal disorders are very common among all ages. Hemorrhoids (Arsha) are one of the most common ano rectal diseases in which varicosity of haemorrhoidal vein occurs, may be internal or external. It is manifested due to improper diet, prolonged standing and faulty habits of defecation causing derangement of tridosha, mainly Vata dosha. Hemorrhoids have many distressing symptom such as pain, bleeding, prolapsed piles, discharge per anum, its treatment is targeted at elimination of symptoms, improvement of quality of life and patient satisfaction. Many studies prove that Kshara sutra ligation show better result on many parameters as compared other treatment modalities as rubber band ligation etc. in the parameter of patient satisfaction, Time taken for sloughing off of hemorrhoidal masses, Return to day to day activities; Postoperative pain and hospital stay Kshara sutra ligation is better than any modern therapy for hemorrhoid such as rubber band ligation etc 14 . All type of Kshara sutra have good result in wound healing and prevent infection due to its alkaline pH (pH-10.3) that works as antibacterial at site of ligation 15 . In this research work patients of hemorrhoids feel lowest pain during the entire trial period, minimum average healing time, fewer irritants and good tolerance by the patients by Group C -Udumber Kshara sutra and another study also favor this result 16 . Kshara sutra ligation creates pressure effect that cause mechanical strangulation of the blood vessels and tissue and, ultimately, forces falling out of the pile mass during defecation 17 . The Guggulu Kshara sutras have minimum post-operative discharge and minimum average healing time due to its antiinflammatory, antibacterial property which helped in wound healing 18,19 .

Conclusion
Kshara sutra therapy is a radical cure in the treatment of Hemorrhoids (Arsha) without complications and recurrence. Post-operative pain was lowest experienced by Udumber Kshara sutra after that Guggulu Kshara sutra and maximum pain was experienced by Snuhi Kshara sutra. Post-operative discharge was lowest experienced by Udumber Kshara sutra after that Guggulu Kshara sutra whereas higher discharge was experienced by Snuhi Kshara sutra. Post-operative hemorrhage was lowest experienced by Udumber Kshara sutra followed by Snuhi Kshara sutra and Guggulu Kshara sutra. Average healing time was minimum for Udumber Kshara sutra followed by Guggulu Kshara sutra and maximum average healing time was seen Snuhi Kshara sutra. There was no adverse effect of any of the drugs observed during the course of study.