Management of Ano-Rectal disorders by Kṣārasūtra: A clinical report

Abstract

Background:

Ano-rectal complaints are usually benign in origin. Most of the patients suffering with these disorders do not seek medical advice at an early stage due to embarrassment. It results in advancement of the disease and significant disturbance in the quality of life. Among the available treatment modalities of ano-rectal disorders (ARDs), Kṣārasūtra (medicated thread) appears to be the best in terms of relief and nonrecurrence.

Aims and Objectives:

The aim of this study is to provide evidence-based data about the practical application of Kṣārasūtra (medicated thread) in the management of ARDs.

Materials and Methods:

An ano-rectal operation theatre was established in September 2012, in association with the Government Ayurvedic Speciality Clinic at District Hospital, Rajahmundry, Andhra Pradesh, to facilitate the AYUSH services in Allopathic Hospitals. Present report includes the details of ARDs treated by Kṣārasūtra (Medicated thread) method during 2012–2013. A total of 127 ano-rectal cases were operated, which included 44 cases of hemorrhoids, 40 cases of fistula-in-ano, 39 cases of fissure-in-ano and three cases of peri-anal abscess. All the cases were analyzed as per the observations, subjective and objective parameters, and follow-up was carried out for a period of 6 months.

Results:

In the 127 ARDs treated, 45 patients suffering from hemorrhoids, 36 patients got complete relief, marked relief observed in 4 patients, moderate relief observed in 5 patients. In fistula-in-ano, out of 40 patients 29 patients got complete relief, marked relief was seen in 7 patients out of them 4 patients were referred to anti-tubercular treatment center, 4 patients left against medical advice. In fissure-in-ano-out of 39 patients, 32 patients got complete relief, 5 patients got marked relief, moderate relief observed in 2 patients. These results authenticate the effectiveness of Kṣārasūtra, no adverse effects or recurrence observed in any case.

Conclusions:

ARDs are efficiently treated by Kṣārasūtra technique with prompt symptomatic resolution and prevention of recurrence and complications.

INTRODUCTION

Ayurveda emphasizes the preventive and curative aspects of disease.[1] Common disorders of ano-rectal area treated with Kṣārasūtra (medicated thread) are Arṣa (hemorrhoids), Bhagandara (fistula-in-ano), and Parikartikā (fissure-in-ano). Arṣa and Bhagandara, are categorized under Aṣṭamahāgada[2] (eight major diseases) keeping in view their prognostic significance. These disorders occur in peri-anal and perineal region, the seat of sadyaḥ prāṇahara marma[3] (vital area) and require proper examination and proficient management.

A detailed description of Arṣa and its treatment has been available in classics like Suśruta Saṃhitā[4] and Caraka Saṃhitā.[5] Hemorrhoid cushions are part of normal anatomy but become pathological when swollen or inflamed.[6] Treatment of hemorrhoids includes variety of methods such as medical therapy, sclerotherapy (injection of sclerosant agent in sub-mucous spaces of hemorrhoids), rubber band ligation, infra-red coagulation, cryo-surgery (using nitrous oxide gas) and excisional hemorrhoidectomy,[7] etc., according to the nature and degree of pile mass, but these procedures have their own limitations.[8]

Ācārya Suśruta has elaborately described about Bhagandara (fistula-in-ano), its pathogenesis two stages of disease formation as Bhagandara pīḍaka[9] (peri-anal abscess) and Bhagandara (fistula-in-ano), along with remedial surgical procedures. Fistula-in-ano implies a chronic granulating track connecting two epithelial lined surfaces. This may be cutaneous or mucosal.[10] Current surgical treatment methodologies for this disease include: Fistulectomy, fistulotomy with secondary healing,[11] fistulectomy, followed by immediate skin grafting, fistulectomy and primary suturing, destruction of fistula track by carbon dioxide laser beam. This is one condition for which maximum number of surgical and para-surgical applications have been described. Major problems faced during the fistula-in-ano treatment are, extensive mutilation of ano-rectal and ischio-rectal area, prolonged hospitalization, high rate of recurrence (21–36%) and division of sphincter muscles leads to incontinence (3–7%) of feces.[12] Complications like sphincter incontinence, stricture, continuous pus discharge etc., following the treatment are sometimes more severe than the disease.

Parikartikā (fissure-in-ano), is a disease whose description available in Caraka Saṃhitā, listed in the complications of Pañcakarma.[13] Fissure-in-ano is a tear in the pectin (below the dentate line of the anal canal) caused by trauma from the passage of hard stool. This tear results due to the angulation caused by, bulging of posterior perineum during defaecation. Excision of sub-cutaneous external sphincter muscles and internal sphinctorectomy are the choice of treatments, in both conditions incontinence develops in 30% cases.[14]

To combat aforementioned complications, Kṣārasūtra (medicated thread) is the W.H.O. accepted best alternative, surgical procedure,[15] which is successfully practiced in Ayurvedic colleges and other medical centers throughout India.

Kṣārasūtra[16] first described in Suśruta Saṃhitā, later by Cakrapāṇidatta (11CE).[17] In 1964, the conceptual basis for revival of Kṣārasūtra preparation was laid down by Dr. Shankaran and Dr. Pathak under the guidance of Prof. Deshpande at Department of Shalya-Shalakya, PGIIM, BHU, Varanasi. Kṣārasūtra prepared with surgical linen (Barbour) 20 thread coated with latex of Snuhi (Euphorbia neriifolia), Haridrā (Curcuma longa) powder and kṣāra made from the whole plant of Apāmārga (Achyranthes aspera Linn., Amaranthaceae).

MATERIALS AND METHODS

In this report, patients operated for ano-rectal disorders (ARDs) at ano-rectal O.T. Rajahmundry during the period of September 2012 to August 2013 were selected for the study.

Patients were reviewed once weekly.

Written informed consent was taken from all patients prior to the surgical procedure and were examined and investigated as per the protocol. Findings in each case were recorded over a period of 6 months.

Inclusion criteria

All the patients operated for ARDs, that is, a total of 127 cases (20–70 years of age) of either sex were selected for the study.

Exclusion criteria

Patients suffering from chronic systemic disorders, severe uncontrolled hypertension and diabetes, hepatitis B surface antigen (HBsAg), HIV.

Laboratory investigations

Following investigations were carried out before the surgical procedure.

• Hematological investigations: Hemoglobin %, total leukocyte count, differential leucocyte count, erythrocyte sedimentation rate

• Coagulation profile: Bleeding time, clotting time

• Biochemical investigations: Blood sugar, blood urea, serum creatinine and lipid profile

• Urine examination: Routine and microscopy for albumin, sugar and casts, crystals and micro-organisms

• Viral screening: HBsAg, HIV

• Electrocardiogram.

Special investigations for fistula-in-ano

Radiological examination (if required)

• X-ray chest, spine, hip joint

• Barium enema

• Fistulography, colonoscopy, perianal and intra luminal ultrasonography, magnetic resonance imaging, computed tomography scan, Montoux test, biopsy (for tuberculosis and carcinoma).

Disease criteria used for assessment

Criteria used for hemorrhoids

• Bleeding per rectum

• Pain related to defecation

• Constipation

• Protrusion of pile mass

• Mucus discharge

• Itching of anus

• Anemia.

Criteria used for fistula-in-ano

• Discharge

• Pain

• Bowel habit

• Associated diseases, that is, tuberculosis, diabetes, ulcerative colitis, Crohn's disease

• Previous surgery

• Number of openings and position

• Type of fistula.

Criteria used for Fissure-in-ano

• Pain related to defecation

• Constipation (bowel habits)

• Discharge and pruritis

• Infected sentinel tag.

Confirmatory tests like digital rectal examination per rectal (P/R) and proctoscopy were performed in each case.

Preparation of Kṣārasūtra (medicated thread)

Standard Kṣārasūtra (medicated thread)[18] prepared with 21 coatings, that is, 11 coatings of Snuhi latex, 7 coatings of Apāmārga kṣāra mixed with Snuhi latex, 3 coatings of Haridrā powder mixed with Snuhi latex.

Preparation of patient

Preoperative preparation

• Administration of laxative, Dulcolax 2 tablets bed time for bowel preparation on the previous night and soap water enema at 6 am on the day of surgical procedure

• Part preparation of the patient

• Administration of injection tetanus toxoid 0.5 ml, I/M

• Injection xylocaine sensitivity test

• Written informed consent from the patient for surgery (photographs if needed)

• Preparation of operation theatre and sterilization of instruments.

Operative procedure

Hemorrhoids

Patient was kept in lithotomy position. Perianal region was cleaned with savlon, spirit, betadine consecutively and draping was done after administration of spinal anesthesia. In maximum cases, local anesthetic drug 1% lignocaine with adrenaline was used. Proctoscopy was performed with care to assess the position of hemorrhoids. Hemorrhoids were grasped one by one with the help of the pile holding forceps and transfixed by passing a curved cutting needle with plain thread. Kṣārasūtra passed with curved cutting needle through transfixed area. Excess hemorrhoids were excised leaving stumps. Jātyādi ghṛta[19] soaked pack inserted in the anal canal and tight T-bandage application done.

Fistula-in-ano

Patient was kept in lithotomy position. Perianal region was cleaned with savlon, spirit, betadine consecutively, and draping was done after giving spinal anesthesia. In maximum cases, local anesthetic 1% lignocaine with adrenaline was used. Gloved index finger was gently introduced into the rectum, and a suitable metallic probe was passed through the external opening of the fistula. The probe was forwarded along the path of least resistance to reach into the lumen of the anal canal through the internal opening, guided by the index finger of the other hand inserted in to the rectum. Now tip of the probe was finally directed to come out from the anal orifice. Then a suitable length of Kṣārasūtra was taken and threaded into the eye of the probe. Thereafter, the probe was pulled out through the anal orifice, to leave the Kṣārasūtra in situ, that is, in the fistulous tract. Two ends of Kṣārasūtra were tied together keeping a gap of index finger thickness outside the anal canal. This procedure is termed as “primary threading.” After this, a gauze piece soaked with Jātyādi ghṛta was placed, and T-bandage applied.

Fissure-in-ano

Patient was kept in lithotomy position, perianal region was cleaned with savlon, spirit, betadine consecutively and draping was done. Local anesthetic 2% lignocaine with adrenaline diluted with distilled water to 1% dilution was infiltrated. Curved cutting needle with Kṣārasūtra was passed into the muscle fibers of the sphincter so that the floor of the fissure cleared off gradually. Sentinel tag(s) present were excised. Kṣārasūtra divides the sphincter muscle smoothly leaving a soft wound, which will heal gradually with the help of Jātyādi ghṛta.

Peri-anal abscess

Patient was kept in lithotomy position, perianal region was cleaned with savlon, spirit, betadine consecutively and draping was done. Local anesthetic 2% lignocaine with adrenaline diluted with distilled water to 1% dilution was infiltrated. With the help of blade number 15 abscess was incised and drained, after 1-week, the cavity was probed, and primary threading was done and treated like fistula-in-ano.

Postoperative measures

Patient was kept nothing by mouth till complete waving off of the anesthetic effect, that is, 2 h for local anesthesia, 6 h for spinal anesthesia. Patients under local anesthesia were discharged after 2 h rest. Hemorrhoid patients were admitted in the ward for three to 5 days based on number of pile masses and anesthesia. Fistula-in-ano patients under spinal anesthesia were admitted for 2 days, remaining patients discharged after 2 h rest. All of the fissure-in-ano patients discharged after 2 h rest.

• Intravenous fluids were given as per the requirement

• Suitable antibiotics and analgesic were administered as per the requirement

• General management - Recording of pulse, blood pressure and vital functions were done

• After 1-day Uṣṇodaka avagāha[20] (sitz bath) with Triphalā kvātha[21] twice daily was prescribed

• Local application of Jātyādi ghṛta for wound healing was advised.

Follow-up

Patients were advised to come for clinical assessment once every 7 days till the completion of treatment.

Patients with fistula-in-ano were asked to come once every week and the Kṣārasūtra was replaced by rail road technique.

Do's and don’ts in ano-rectal disorders advised to the patient

Dietary regimen

Do's:[22] Patients were encouraged to take regular and proper fibrous diet with adequate quantity of water, milk, buttermilk and green leafy vegetables.

Don’ts:[23] Spicy foods, green chilies, alcohol and red meat were discouraged.

Life style

Do's: Patients were advised regular exercise, to sit on soft surface, and to wear loose, comfortable clothes.

Don’ts: They were advised to avoid spending more time on toilet, riding vehicles for long hours.

Review of the patients

In fistula-in ano – Once the tract was completely excised or cut through, patient was advised to visit the clinic once in every month for 3 months to get the excised area re-examined. Consequently, patient was advised to visit once in 3 months twice or thrice for a period of 1-year to observe the recurrence or any other adverse effects.

Hemorrhoids and fissure-in-ano cases were reviewed till completion of healing.

Adjuvant treatment advised for ano-rectal disorders

Stool softening measures are essential in ARDs as soft and formed stools negotiate the rectum and anal canal in nontraumatic physiologic maneuver.

Laxatives

To promote easy evacuation of stools: Vaiśvānara cūrṇa[24] or Pañcasakara cūrṇa[25] or Svādiṣṭavirecana cūrṇa[25] 1-3 g bedtimes, considering the patient's bowel habit.

Avagāha svedana (sitz bath)

With Triphalā kvātha twice daily to maintain local hygiene and reduce pain and inflammation.

Local application

Jātyādi ghṛta or Vraṇa śodhana taila[26] over the wound to enhance early healing.

To reduce pain and inflammation

Triphalā guggulu[27] two tablets twice daily.

Antibiotic

A course of suitable antibiotic oral/injection (ciprofloxacin 500 mg or ampicillin or ofloxacin 200 mg) is prescribed for 5 days after surgery.

Analgesics

Oral/injection analgesics, that is, diclofenac sodium or tramadol prescribed to alleviate pain for 5 days.

Patients advised to attend their normal routine work after 3 days.

RESULTS

Clinical assessment - 127 cases

Clinical assessment of 127 cases is shown in the Tables 1-8.

Table 1.

Age incidence

Table 8.

Prakṛti

Observations

In this study highest incidence of ARDs were observed in the age group of 20–50 years that is, 103 patients (82%) shown in Table 1, with slightly higher incidence in females patients (65 patients) [Table 2]. It was observed that house-wives 40 patients (31%) [Table 3] and people engaged in strenuous work (laborers) 36 patients (28%) were suffering from ARDs. It was found that the prevalence of ARDs were more among nonvegetarians 87 patients (69%) [Table 4]. In the disease-wise distribution in Table 5 hemorrhoids 45 patients (35%), fistula-in-ano 40 patients (31%), fissure-in-ano 39 patients (31%) and perianal abscess 3 patients (2%) were recorded. Table 6. represent type of anesthesia used and it signify that maximum cases are performed under local anesthesia. Of 127, patients from outpatient department were were 94 (74%) and in-patients were 33 (26%) shown in Table 7. Patients belong to vāta pittaja prakṛti were 49 (39%), pitta kaphaja prakṛti 42 (33%), kapha vātaja prakṛti 36 (28%) [Table 8].

Table 2.

Gender incidence

Table 3.

Occupation

Table 4.

Dietary habits

Table 5.

Disease wise distribution

Table 6.

Anesthesia

Table 7.

O.P/I.P

According to the bio-chemistry, parameters 12 patients were anemic state, 4 patients were borderline diabetic and 15 patients with controlled diabetes using oral hypo-glycemic drugs.

Result-wise distribution of the patients

Parameters for relief shown in Table 9 and contextual results are shown in Tables 10-13.

Table 9.

Extent of relief

Table 10.

Hemorrhoids number of cases 45

Table 13.

Perianal abscess number of cases 3

Table 12.

Fissure-in-ano number of cases 39

DISCUSSION

Ācārya Suśruta has recommended kṣāra and Agni karma as the most effective treatment for ARDs.[28]

In this study highest incidence of ARDs were seen in the age group of 20–50 years that is,103 patients (82%).

In the gender incidence 65 female patients (51%) were affected, among them house-wives were 40 (31%). This may be due to availability of a female surgeon at the ano-rectal clinic. It was observed that most of the female patients seek medical advice at an advanced or complicated disease condition. Ano-rectal diseases in initial stage presents only with mild aching pain accompanied by some discharge and if neglected, they may turn into high anal fistula with multiple tracts, thrombosed and prolapsed hemorrhoids and multiple fissures.

It was found that the prevalence of ARDs was more among nonvegetarians, 87 patients (69%). Nonvegetarian diet[29] with high amount of spicy food disturbs digestive system leading to chronic constipation and anal complaints.

In the result wise distribution of ARDs, out of 45 patients with hemorrhoids, [Table 10]. Depicts, 36 patients got complete relief (80%). Marked relief observed in 4 patients (9%), moderate relief observed in 5 patients (11%). It indicates that the method of treatment chosen, that is, Kṣārasūtra is exhibiting good results. Kṣārasūtra[30] applied to the stump of hemorrhoid causes chemical cauterization and strangulation of blood vessel with sloughing of tissue within 5–7 days. P/R application of Jātyādi ghṛta and Vraṇa śodhana taila ensure complete healing of wound surface.

Fistula-in-ano, Table 11 shows out of 40 patients, 29 patients got complete relief (72%). Marked improvement was seen in 7 patients out of them 4 patients with multiple tracks and sputum tested positive for acid-fast bacillus and were hence referred to anti-tubercular treatment[31] center. Four patients left against medical advice.

Table 11.

Fistula-in-ano number of cases 40

Fissure-in-ano-out [Table 11] of 39 patients, 32 patients got complete relief (82%), 5 patients got marked improvement (13%), moderate relief observed in 2 patients (5%). In fissure-in-ano, to acquire complete relaxation of the internal sphincter is the object of treatment. In this condition meticulously applied kṣārasūtra on fissure bed relaxes sphincter muscles to the desired levels and application of Jātyādi ghṛta heals the wound.

Perianal abscess [Table 13] - In 3 patients, initially incision and drainage was performed, after 1-week these were treated like fistula-in-ano, and all of them got complete relief.

Adjuvant treatments were prescribed to achieve a better outcome of the management in all patients. Avagāha sveda (sitz bath) using Triphalā kvātha helped in maintaining the hygiene of perineal and peri-anal area and reduced the inflammation, pain and relaxed the spasm of sphincter muscles.

Mode of action-Kṣārasūtra

Anti-bacterial theory

Kṣārasūtra is attributed with anti-bacterial effect[32] as one of its ingredient is turmeric.[33] Turmeric is universally known for its anti-bacterial, anti-fungal and anti-inflammatory properties.

Chemical cauterization

Necrosis of unhealthy granulation and proliferation of new connective tissue takes place under the influence of Kṣāra present in the thread prepared with Achyranthes and corrosive nature of latex of Euphorbia.

Local drug delivery system

Drugs incorporated in the thread are delivered layer by layer to the local pathological tissue planes and debrides the unhealthy granulation, this enhances the healing process.

Mechanical action

Kṣārasūtra exerts mechanical pressure on the tissue as it is tightly applied on the fistulous tract. It cuts the tissue and augments healing.

Kṣāra[35] acts as a powerful debridement agent and selectively acts on unhealthy granulation, pus pockets, etc. This process of debridement and healing starts from deeper tissues and travels toward periphery.

CONCLUSIONS

It can be concluded that ARDs are efficiently treated by Kṣārasūtra technique. Proper understanding of patho-physiology related to ano-rectal diseases and meticulous surgical skill are required for the success of the treatment.