|Year : 2018 | Volume
| Issue : 1 | Page : 2-8
Comparative clinical study of Guggulu-based Ksharasutra in Bhagandara (fistula-in-ano) with or without partial fistulectomy
Rakesh Kumar Meena1, Tukaram Dudhamal1, Sanjay Kumar Gupta2, Vyasadeva Mahanta2
1 Department of Shalyatantra, I.P.G.T. and R.A., Gujarat Ayurved University, Jamnagar, Gujarat, India
2 Department of Shalyatantra, AIIA, New Delhi, India
|Date of Web Publication||3-Dec-2018|
Dr. Tukaram Dudhamal
Department of Shalyatantra, I.P.G.T. and R.A., Gujarat Ayurved University, Jamnagar - 361 008, Gujarat
Source of Support: None, Conflict of Interest: None
| Abstract|| |
Background: In Ayurveda, Bhagandara is considered as one of the grave disease by Sushruta due to more recurrence rate. Ksharasutra is para-surgical procedure which is found more effective in the management of fistula-in-ano. Ksharasutra is routinely prepared with Snuhi Ksheera (latex), Haridra powder and Apamarga Kshara. In conventional method collection of Snuhi latex is time consuming and laborious. Guggulu was selected as an alternative for preparation of Ksharasutra having similar binding property as Snuhi latex, and has antiseptic, anti-inflammatory and wound-healing properties. That is why, here, in this trial, the Snuhi latex was replaced by Guggulu. Aim: To evaluate the efficacy of Guggulu based Ksharasutra with and without partial fistulectomy in the management of Bhagandara. Materials and Methods: In this research study, 42 patients of Bhagandara (fistula-in-ano) were selected and randomly divided into two groups. In group-A (n = 22), patients were treated only with application of Guggulu-based Ksharasutra and in group-B (n = 20), partial fistulectomy was done and then Guggulu-based Ksharasutra was applied in remaining fistulous tract. After Ksharasutra application, patients were assessed for relief in symptoms such as pain, discharge, itching and swelling as subjective parameters and unit cutting time (UCT) as an objective parameter, on weekly follow-up basis and Ksharasutra was changed by railroad technique up to complete cut through of the tract. Results: In patients of group-A (plain Guggulu-based Ksharasutra), highly significant relief was seen in pain and discharge. The significant result was seen in itching while insignificant relief in swelling. In patients of group-B (partial fistulectomy with Guggulu-based Ksharasutra), relief in symptoms such as pain, discharge, and itching was statistically highly significant. The relief in swelling in this group was found statistically significant. The mean UCT was 8.85 days/cm in group-A, whereas the mean UCT was 8.19 days/cm in group-B. Conclusion: Partial fistulectomy with Guggulu-based Ksharasutra is better as compared to plain Guggulu-based Ksharasutra application in cases of Bhagandara (fistula-in-ano).
Keywords: Bhagandara, fistula-in-ano, Guggulu, Ksharasutra, partial fistulectomy
|How to cite this article:|
Meena RK, Dudhamal T, Gupta SK, Mahanta V. Comparative clinical study of Guggulu-based Ksharasutra in Bhagandara (fistula-in-ano) with or without partial fistulectomy. AYU 2018;39:2-8
|How to cite this URL:|
Meena RK, Dudhamal T, Gupta SK, Mahanta V. Comparative clinical study of Guggulu-based Ksharasutra in Bhagandara (fistula-in-ano) with or without partial fistulectomy. AYU [serial online] 2018 [cited 2019 Feb 22];39:2-8. Available from: http://www.ayujournal.org/text.asp?2018/39/1/2/246783
| Introduction|| |
In Ayurveda, Bhagandara (fistula-in-ano) is considered as one of the grave diseases and is included in list of eight major diseases (Ashta Mahagada). The incidence of fistula-in -ano in rural area was grossly around 8.6 per 1 lakh population and male:female ratio was 11.8:1. In many of the cases of fistula-in-ano, recurrence is seen after being treated by modern surgical conventional methods such as fistulectomy or fistulotomy. In spite of many surgical modalities available, the recurrence rate of fistula is very high, i.e., 20%–30%. The globally famous Bailey and Love's Short practice of Surgery has included Ksharasutra as a treatment method for fistula-in-ano while describing various methods for treatment in its 25th edition. Kshara or Ksharasutra is the best among all surgical and para-surgical measures. Nowadays, Ksharasutra is the first choice for treating the cases of fistula-in-ano. Many of the surgeons are referring patients of fistula-in-ano to Ayurvedic hospitals for Ksharasutra therapy, especially in recurrent and complex fistulae. Ksharasutra therapy requires a minimal setup, minimal equipment and instruments and is a minimal invasive para-surgical measure. Moreover, benefit to the patient is that patient remains ambulatory during the whole course of treatment. The Indian Council of Medical Research has validated this therapy by conducting multicentric research trial and concluded that Ksharasutra is better than conventional surgery in fistula-in-ano.
The conventional Apamarga Ksharasutra is prepared with Snuhi latex, Haridra powder (Curcuma longa Linn.), and Apamarga Kshara (Achyranthes aspera Linn.). It is a well-proven method to treat fistula-in-ano and has been standardized by CCRAS, New Delhi. Moreover, recent studies have shown that Guggulu-based Ksharasutra is more beneficial than conventional Apamarga Ksharasutra. However, Snuhi latex is difficult to procure as Snuhi latex collection requires a specific season, time and additional labor. Other problem is that Snuhi latex cannot be preserved for a long duration. Shodhit Guggulu (Commiphora mukul Hook ex stocks.) was selected as an alternative to Snuhi latex for preparation of Ksharasutra having binding property. Guggulu is also indicated in Vrana (wound), Apachi (adenitis), Pidika (boils), Granthi (cyst) and Shopha (inflammation), which shows that Guggulu has antiseptic, anti-inflammatory and wound-healing properties and all these properties can increase the therapeutic effect of Guggulu-based Ksharasutra.,, That is why, here, in this trial, Snuhi latex was replaced by Guggulu.
In cases of long fistulous tract, the duration of treatment is more. In total fistulectomy, the sphincter damage may result in incontinence in some cases and may have recurrence. After application of Ksharasutra, the total duration required for cutting and healing of fistulous tract is more. Hence, in this study, partial fistulectomy was done to maintain sphincter integrity and to reduce recurrence rate, Ksharasutra application was done in the remaining tract. Hence, this study was planned with aim to evaluate the efficacy of Guggulu-based Ksharasutra with and without partial fistulectomy in the management of Bhagandara (fistula-in-ano).
| Materials and Methods|| |
Selection of patients
A total of 42 diagnosed cases of Bhagandara (fistula-in-ano) were registered from out-patient and in-patient departments of Shalyatantra of IPGT and RA, Jamnagar, Gujarat, irrespective of age, sex occupation and religion.
Before conducting the clinical trial, approval from the Institutional ethics committee was taken, vide letter No. PGT/7/-A/Ethics/2013-14/1767 dated September 10, 2013. The trial has been registered in CTRI with registration no.: CTRI/2014/08/004807.
The diagnosis was made on the basis of symptoms such as boil at perianal region, pus discharge and perianal pain. Per anal examination findings revealing external opening and per rectal digital examination confirming internal opening of fistula-in-ano.
Patients aged between 20 and 60 years diagnosed with Vataja Bhagandara (Shataponaka), Pittaja Bhagandara (Ushtragreva), Kaphaja Bhagandara (Parisravi), Vata-Pittaja Bhagandara (Parikshepi), Vata-Kaphaja Bhagandara (Riju) and Arsho Bhagandara [(Kapha-Pittaja) (piles fistula)], Bhagandara with Parikartika (fistula-in-ano with fissure-in-ano), all types of low anal fistula (length = 2–10 cm) were included.
Patients suffering from Sannipataja Bhagandara (Shambookavarta) and Agantuja Bhagandara (Unmargi), fistula-in-ano associated with conditions such as uncontrolled hypertension, uncontrolled diabetes mellitus, osteomyelitis of hip bones, acute or chronic ulcerative colitis, crohn's disease, anorectal malignancy and tubercular fistula were excluded from the study. Positive cases of venereal diseases, human immunodeficiency virus (HIV) and HBsAg were excluded. Pregnant women were also excluded from the study. Patients having fistula other than anorectal region were also excluded.
Following investigations were done in all patients before Ksharasutra application for fitness purpose.
- Hemogram: Total leukocyte count (TLC), differential leukocyte count (DLC), hemoglobin % (Hb%), erythrocyte sedimentation rate (ESR), bleeding time (BT), clotting time (CT)
- Blood sugar: Fasting blood sugar (FBS), postprandial blood sugar (PPBS)
- Renal function test: Blood urea, serum creatinine
- Liver function test: Serum bilirubin, serum glutamic pyruvic transaminase (SGPT), serum glutamic oxalocetic transaminase (SGOT)
- Venereal disease research laboratory (VDRL), HIV, Australia antigen (HBsAg).
- TRUS (Trans Rectal Ultrasonography)
- X-ray chest posterioanterior view to rule out pulmonary tuberculosis.
Urine and stool routine and microscopic examinations were done in all patients. The biopsy of the tissue of the fistulous tract was done in suspected cases of malignancy.
Ingredients and Preparation of Ksharasutra
- Barbour surgical linen thread No. 20 (purchased from surgical store)
- Apamarga Kshara (Achyranthes aspera Linn.)
- Haridra powder (Curcuma longa Linn.)
- Purified Guggulu (Commiphora mukul Hook ex stocks.).
All above ingredients (except Barbour surgical limen thread) were procured from the Pharmacy of Gujarat Ayurved University, Jamnagar.
Initially, 11 coatings of Guggulu Niryasa (resin) were done on linen Barbour threads, then seven coatings were done with Guggulu resin and Apamarga Kshara and finally three coatings were done with Guggulu resin and turmeric powder. After each coating, the thread was dried in Ksharasutra cabinet and again coatings of above ingredients were done one by one. Total 21 coatings on the Barbour threads were done.
In group-A, 22 patients and in group-B, 20 patients, of Bhagandara (fistula-in-ano) were enrolled and were allotted into two groups by computerized randomization method.
- 22 patients in group-A were treated with application of Guggulu based Ksharasutra under spinal anesthesia
- 20 patients in group-B were treated with application of Guggulu-based Ksharasutra along with partial fistulectomy under spinal anesthesia.
Written informed consent from each patient was taken before performing of surgery. Patients were kept nil orally from midnight. Xylocaine sensitivity test was done and injection tetanus toxoid (TT) intramuscular was given before surgery. Local perianal part preparation was done and proctolysis enema was given as per routine preoperative procedure.
Under low spinal anesthesia (saddle block), Ksharasutra was applied in the fistula tract in patients of group-A. In patients of group-B, first partial fistulectomy was done and then Ksharasutra was applied in remaining part of the fistulous tract. Sterile pad and ‘T’ bandage were applied and the patients were shifted to the ward in conscious condition.
Patients were kept in head low position and nil by mouth for about 6 h after surgery. Appropriate antibiotics and analgesics were given for 3 consecutive postoperative days.
Patients were advised to start warm water sitz bath with Panchavalkala decoction from the next day of operation.
- 10 ml of Jatyadi oil was administered per rectal two times a day, morning and evening after sitz bath
- Triphala Guggulu tablet 1 g/ 2 tab. (500 mg of each tab.) three times a day with warm water after food was also given
- Haritaki (Terminelia chebula Retz.) powder (4 g) and rock salt (1 g) at bedtime was also given in case of constipation.
Method of changing Ksharasutra
Ksharasutra was changed by railroad technique every 7th day at regular interval till the cut through of the entire fistulous tract. In fistulectomy, wound dressing was done after wash with Panchavalkala decoction and 10 ml of Jatyadi oil was administered per rectum.
Duration of therapy
Ksharasutra application is one stage of operation, but the total duration of treatment was different as the length of tract varies from patient to patient. Hence, therapy was continued till the fistulous tract got cut through with the Ksharasutra, and hence, the end point of the study was till complete healing of fistulous tract.
After cut through of the fistulous tract, patients were called for follow-up examination at 7th and 15th days and 1 month.
Criteria for assessment
The assessment was done on the basis of objective/subjective parameters such as relief in symptoms like pain, discharge, itching and swelling in the anal region and objective parameters, i.e., UCT [Table 1], [Table 2], [Table 3], [Table 4].
UCT was calculated by using formula
Overall effect of therapy
91%–100% relief in sign and symptoms and healing of the fistulous tract was considered under complete remission. 76%–90% relief in sign and symptoms and healing of the fistulous tract was considered under marked improvement. 51%–75% relief in sign and symptoms and healing of the fistulous tract was considered under moderate improvement, while <25% relief in sign and symptoms and healing of the fistulous tract were considered under unchanged.
The data obtained in the clinical study was subjected to statistical tests, such as Wilcoxon signed-rank test which was applied to subjective parameters; paired ‘t’-test to assess the result before and after treatment in individual groups; and unpaired ‘t’-test to compare the result between two groups for objective criteria.
In this study, maximum (47.62%) patients were observed in age group of 31–40 years, which suggest that middle age group is more prone to suffer from fistula-in-ano. In surgical classic, it is mentioned that people in the third, fourth and fifth decades of life are commonly affected with fistula-in-ano. In this study, maximum patients were male (88.1%) which go hand in hand with a study conducted by Sainio et al., which concluded that the prevalence rate is double in males as compared to females. Rural patients were slightly move (61.9%) which might be due to their preference for a government hospital. Hindu religion patients were maximum (95.23%) having vegetarian diet (66.66%). Consumption of more spices and junk food might be responsible for Bhagandara. Previous studies also report similar findings. The 42.85% patients were addicted to tobacco chewing, a common habit observed among the people of Saurashtra. It is proved that tobacco consumption affects the wound healing time. Although exact relation between tobacco consumption and Bhagandara is not much clear but it can be said that due to tobacco addiction, gastrointestinal tract disturbance occurs which causes constipation, which may later trigger the favorable conditions for Bhagandara formation.
Majority of the patients belonged to Vata-Kaphaja Prakriti (54.76%) and were affected with Vata-Kaphaja type of Bhagandara (26.19%) The pathogenesis of Bhagandara starts with the vitiation of Vata Dosha in all types of Bhagandara, and it implies that similar Dosha Prakriti individual are prone to suffer from Bhagandara. The maximum number of cases (76.19%) had chronicity of disease for <1 year The blind external type of fistula-in-ano was observed in maximum (88.09%) patients. The fistula-in-ano usually originates from a perianal abscess in the intersphincteric space or infection of anal gland (cryptoglandular infection). Due to the tone of internal sphincter, the duct cannot aptly discharge, so the abscess usually tracks down and opens in the perianal skin externally. The position of external opening at the posterior half was 57% while external opening at the anterior half of anus was 43%. The anal glands are 4–8 in number and most of them are situated at the posterior portion of anal canal. The curved fistulous tracts were noted in 61.90% patients, as external openings at posterior part of anus are curved tract which open midline at 6 O'clock (Goodsall's rule). Previous research work of Cirocco and Reilly also reported the similar finding.
| Results|| |
In group-A (n = 22), where Guggulu-based Ksharasutra was applied in fistula-in-ano without partial fistulectomy, provided highly significant relief in pain and discharge and significant result was found in perianal itching, whereas relief in swelling of the affected area was statistically insignificant [Table 5]. In group-B (n = 20), patients were treated with partial fistulectomy and then Guggulu-based Ksharasutra was applied in the remaining fistulous tract which provided relief in symptoms such as pain, discharge and itching, which was statistically highly significant. The relief in swelling in this group was statistically significant [Table 6].
The UCT was considered as the objective parameter to assess the result of the groups. After change of Ksharasutra, the length of the thread was measured and recorded in a research proforma. Individual patients UCT was calculated and the comparison was made with the mean UCT of both groups. In group-A, mean UCT was 8.85 days/cm where plain Guggulu-based Ksharasutra was applied. In group-B, mean UCT was 8.19 days/cm in which partial fistulectomy was done followed by Guggulu-based Ksharasutra [Table 7].
In this study, out of total 42 patients, 22 patients in Group-A and 20 in group-B had completed the treatment and had complete remission. There was no adverse drug reaction (ADR) during the study and follow-up period. No recurrence was observed in any patient during follow-up. Overall, both the groups provided significant results on Bhagandara in the regard of chief complaints and in reducing UCT, group-B was better than group-A.
| Discussion|| |
Conventional Apamarga Ksharasutra is a known medicine to treat Bhagandara (fistula-in-ano). Its efficacy has been established and standardized by Ayurvedic Pharmacopeia of India. In this study, Guggulu-based Ksharasutra was used for the management of Bhagandara in both groups. The main objective of this study was to compare the results of Guggulu-based Ksharasutra with and without partial fistulectomy.
In group-A, only Ksharasutra was applied which aids in cutting of the tract and pus drainage and hence, in most of the patients due to continuous drainage of pus, perianal itching persisted, so statistically significant relief was observed. In case of swelling of the tract or periphery, as Ksharasutra has Chedhana (excision), Bhedana (incision) and Lekhana (scrapping) properties, there may be continuous tissue inflammation. Hence, till complete cut through of the fistulous tract, the inflammation was noticed and hence, statistically, the result was insignificant on this parameter. However, inflammation was of mild in nature or grade-1 and it did not hampered the daily routine of the patients. Hence, in this group, although the result was insignificant, patients could do their daily routine activity without any complaints. In patients of group-B, partial fistulectomy was done; hence, from the remaining tract, the discharge and perianal itching were minimized due to open wound which facilitates complete drainage of pus. Hence, Guggulu-based Ksharasutra along with partial fistulectomy was more effective than only Guggulu-based Ksharasutra application in reducing symptoms such as pain, discharge, itching and swelling.
The shortest UCT was found in group-A which was 1.5 days/cm, where the length of the tract was 2.0 cm. The longest UCT was also found in group A which was 17.5 days/cm and the length of the tract was 7 cm. Although the length of the tract was small, even then it took more time to heal which shows the callous nature of healing of the fistulous tract. The mean difference between UCT was lilttle, i.e., 0.66 days/cm; however, further, it was found that in group-A, in 10 patients, UCT was >10 days/cm, while in group-B, only in 2 patients, UCT was >10 days/cm. This shows the additional effect of partial fistulectomy as it reduces UCT. It can be said that due to partial fistulectomy, particularly in long fistulas tract, the total duration was minimized due to early healing of fistulectomy wound and cutting of the remaining small tract. Hence, the patients of group-B showed better results as compared to patients of group-A.
Overall, both the groups showed good results in treatment of Bhagandara with complete remission. Ksharasutra is a para-surgical procedure having high success rate. Hence, in this study also, all patients were cured completely without any complications. However, on the prospects of relief in complaints and reducing the UCT, group-B (Ksharasutra application with partial fistulectomy) is better than group-A (Ksharasutra application only).
Probable mode of Ksharasutra action
In this clinical trial, Guggulu-based Ksharasutra was used in all patients of both the groups. The ingredients are Guggulu resin, Apamarga Kshara and Haridra powder. Apamarga Kshara has Chedana (excision), Bhedana (incision), Lekhana (scrapping) and Tridoshaghna (alleviating all Dosha) properties. Haridra powder has the properties such as Rakta Shodhaka (blood purifier), Shothahara (anti-inflammatory), Vatahara (alleviate Vata) and Vishaghna (antimicrobial) and it is useful in Vrana Ropana (wound healing). Guggulu has the properties such as anti-inflammatory, antimicrobial and healing thus helps in healing of fistula-in ano.
Due to all above properties, Guggulu-based Ksharasutra have the properties such as Chedana, Bhedana, Lekhana, Krimighna (anti-anthelmintic), Vrana Shodhaka and Vrana Ropaka. The effect of Ksharasutra has combined effect of all ingredients and was found effective in cutting and healing of the fistulous tract. Ksharasutra cuts unhealthy portion of the tract and provides simultaneous healing due to above properties. Hence, it advances tract outward day by day and the length of the tract is cut by Ksharasutra which was measured as the UCT. Healing from the base of the fistulous tract runs parallel to the cutting of tract. Ultimately, 1 day, Ksharasutra comes out by cutting through the entire fistulous tract with simultaneous healing from its base. At last, a small linear scar remains at the site of fistula. Guggulu-based Ksharasutra has properties of excision of fistulous track, cleaning of the track and simultaneously healing of the tract due to its Shodhana and Ropana activity.
Probable mode of action of adjuvant drugs
Panchavalkala Kwatha (decoction)
All patients of both the groups were advised for Avagaha Swedana (warm water sitz bath) with 100 ml of Panchavalkala decoction two times a day. It helped to clean the pus discharge and associated debris from the tract and also reduced local congestion and inflammation at perianal area. The ingredients of Panchavalkala decoction like Vaṭa (Ficus benghalensis Linn.), Udumbara (Ficus glomerata Roxb.), Plakṣha (Ficus lacor Buch Ham.), Parisha (Thespesia populenoides L.) and Ashvattha (Ficus religiosa Linn.) have predominant of Kashaya Rasa (astringent taste). Hence, when the decoction was used for sitz bath, it exhibited Vrana Shodhana and Vrana Ropana properties. It also helped to maintain local hygiene of the anus and surrounding area and control the local infection.
Per rectal administration of 10 ml of Jatyadi oil two times daily after Ksharasutra was beneficial as it produced soothing effect at anal canal and lower part of rectum. In classic, Jatyadi oil is indicated in Bhagandara (fistula-in ano), Upadansha Vrana (syphilitic ulcer) and Dushta Vrana (infected wound) due to its Shodhana (cleaning) and Ropana (healing) properties. So, local inflammation was reduced and the feces passed without much friction thus minimized the chances of infection.
Triphala Guggulu was prescribed in tablet form 1 g three times a day up to completion of the treatment in both groups. The ingredients of Triphala Guggulu are Bibhitaki, Haritaki, Amalaki, Pippali and Shuddha Guggulu. Triphala Guggulu has anti-inflammatory activity, so it helped in the postoperative pain management.
Haritaki and Saindhava
This combination of drug was prescribed in all patients after Ksharasutra for initial 15 days regularly once daily with lukewarm water. Haritaki (Terminalia chebula Retz.) has properties such as Tridoshaghna (especially Vata pacification), anti-inflammatory, wound cleaning, wound healing, digestive, laxative, mild purgative and anthelminthic. Saindhava (rock salt) has properties such as Snigdha, Ushna (hot in potency), Tikshna (penetrating), Agni Deepaka (digestive stimulant) and Anulomaka (laxative). Hence, due to these properties, patients had relief in indigestion and constipation.
| Conclusion|| |
Overall, in both the groups, Guggulu-based Ksharasutra was effective in Bhagandara with cure; however, on the prospects of relief in complaints and reducing the UCT, group-B (Ksharasutra application with partial fistulectomy) was better than group-A (Ksharasutra application only). The adjuvant drugs prescribed during the treatment that is sitz bath with Panchavalkala decoction, Jatyadi oil, Triphala Guggulu, Haritaki and Saindhav also play role in symptomatic relief. No recurrence was observed in any patient during follow-up of 1 month after complete cut through of fistulous tract however follow up for one year is needed.
We would like to acknowledge Prof. M.S. Baghel, Ex-Director, IPGT and RA, Gujarat Ayurved University, Jamnagar, and Prof. K.S. Dhiman, Director, IPGT and RA, Gujarat Ayurved University, Jamnagar.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5], [Table 6], [Table 7]