A comparative clinical study of Yashtimadhu Ghrita and lignocaine-nifedipine ointment in the management of Parikartika (acute fissure-in-ano).

BACKGROUND: Parikartika is a common painful condition among anorectal diseases which resembles with fissure-in-ano. In the present era, due to changing lifestyle such as sedentary work pattern, increased stress, improper dietary and sleep habits, various lifestyle disorders are increasing continuously. AIM AND
OBJECTIVE: The aim is to assess the effect of Yashtimadhu Ghrita in comparison with lignocaine-nifedipine ointment in the management of Parikartika (Acute fissure-in-ano).
MATERIALS AND METHODS: A total of 36 patients of acute fissure-in-ano were selected and randomly allocated into two groups (18 in each group). In Group A (n = 18), local application of Yashtimadhu Ghrita in fissure bed (Parikartika) twice a day after sitz bath for 4 weeks was given. In Group B (n = 18), local application of lignocaine-nifedipine ointment in fissure bed (Parikartika) twice a day after sitz bath for 4 weeks was given.
RESULTS: Patients of Group A (Yashtimadhu Ghrita) taken more time than the patients of Group B (lignocaine-nifedipine ointment) to get relief from pain in ano. Ulcer in ano healed earlier in patients of Group A (Yashtimadhu Ghrita) in comparison with patients treated with lignocaine-nifedipine ointment application. Patients of both groups have taken similar time to get relieved from bleeding PR. Complete remission of symptoms of Parikartika was more in patients treated with Yashtimadhu Ghrita than lignocaine-nifedipine ointment.
CONCLUSION: Both the interventions Yashtimadhu Ghrita and lignocaine-nifedipine ointment are equally effective in symptomatic relief in Parikartika (acute fissure-in-ano).

Introduction

In Ayurveda, thorough explanation of Parikartika has been found in scattered manner as a complication of various diseases such as Vatika Jwara,[1] Vatika Pakwa Atisara,[2] Sahaja Arsha,[3] Kaphaja Arsha,[4] Arsha Purvarupa,[5] Udavarta[6] and in Garbhani,[7] unlawful administration of purgatives or enema.[8] As per the classical description of signs and symptoms, the disease Parikartika can be correlated with fissure in ano in modern parlance.

Fissure-in-ano is a most troubling and painful condition that affects a great majority of the population and occurs at any age irrespective of gender having prevalence rate approximately 30% to 40% of total anorectal diseases. In Ayurveda, the vitiated Apana Vayu can be considered as a chief causative factor for the manifestation of Parikartika. It has been proved that constipation is the primary and sole cause of initiation of a fissure. Passage of hard stool, irregularity of diet, consumption of spicy and pungent food, faulty bowel habits and lack of local hygiene can contribute for initiation of this pathology. In females, the ailment is usually triggered during pregnancy and following childbirth. It occurs as a superficial split in the anoderm that may heal by conservative or may progress to a chronic fissure.

All these contribute to increase the incidence of fissure-in-ano. Midline posterior site of occurrence of fissure-in-ano is less common in females than males. The major cause of this can be explained as posterior angulations of the anal canal, relative fixation of anal canal posteriorly, divergence of the fibers of external sphincter muscles posteriorly, and the elliptical shape of the anal canal.

On the basis of the clinical symptoms, the disease has been classified into two varieties, namely, acute fissure-in-ano and chronic fissure-in-ano. No matter either acute or chronic, it makes the patient suffer from excruciating pain and bleeding during and after defecation. The cutting pain and burning pain are the cardinal symptoms of Parikartika. Hence, we can understand that there is an involvement of Vata and Pitta Dosha. The formulations which are having the potency of Vata Pitta Dosha Shamana and Vrana Ropaka can be used locally for better relief.

Keeping in view of etiopathogenesis, this study has been designed to assess the efficacy of Yashtimadhu Ghrita (Ghrita doses form prepared from Glycyrrhiza glabra Linn.) for local application in trial group and lignocaine–nifedipine ointment in control group, which contains lignocaine 1.5% and nifedipine 0.3%. Along with these local application, sitz bath with Panchavalkal Kwatha was advised to improve local hygiene and Erandbhrista Haritaki was given for Anulomana and was administered in both groups.

Anal fissure is one of the most common anorectal problem found in Saurashtra region due to increase intake of spicy, foods such as Ganthia and Bhajia (fried items) producing constipation. In this disease, a fresh cut linear ulcer is developed either at anterior or posterior part of the anal canal and patients demand urgent relief from burning pain so that Parikartika can be considered as Sadhya Vrana. In Sushruta Samhita Sutra Sthana, Yashtimadhu Ghrita has been recommended to subside the immediate pain in fresh wound. Till date, no work has been done on Yashtimadhu Ghrita for the management of Parikartika (acute fissure-in-ano). Hence, in this study, Yashtimadhu Ghrita has been selected to compare its efficacy with conventional medical ointment lignocaine–nifedipine.

Material and Methods

Selection of patients

Patients of Parikartika (acute fissure-in-ano) having signs and symptoms, that is, pain, bleeding, linear ulcer at either anterior or posterior part of anus and constipation, were selected from OPD or IPD of Shalya Tantra, irrespective of gender, occupation, religion etc. The registered patients were randomly allocated into two groups. The study was approved by Institutional Ethics committee (IEC), vide letter no: PGT/7/-A/Ethics/2015-16/1490 dated 25.08.2015 before starting the clinical trial. the study was also registered in clinical trial register of India vide, registration number: CTRI/2016/11/007496.

Inclusion criteria

Patients having acute fissure-in-ano with less than 12 weeks duration.

Patients with age group between 17 to 60 years were included in the study. Patients of fissure with controlled cases of diabetes mellitus or hypertension were also included in the study.

Exclusion criteria

Patients of acute fissure-in-ano having duration more than 12 weeks were excluded.

Patients below 17 years and above 60 years were excluded from the study.

Patients suffering from malignancy of any organ or ano-rectum were excluded.

Positive cases of HIV, VDRL, Hepatitis-B, and Tuberculosis were excluded.

Fissure-in-ano associated with piles and fistula and patients having multiple fissures were excluded. Uncontrolled cases of diabetes mellitus and hypertension were also excluded from this study.

Diagnostic criteria

The diagnosis was made on the basis of external findings such as position of fissure and external sentinel tag along with the presence of external piles/and external opening of the fistula were noted to diagnose the presence of associated diseases.

Laboratory investigations

Routine hemogram, fasting blood sugar, postprandial blood sugar, renal function test – Blood urea and serum creatinine. Liver function test- Serum bilirubin (T), serum glutamic oxaloacetic transaminase, serum glutamic pyruvic transaminase. HIV (Human Immunodeficiency Virus), VDRL (Veneral Disease Research Laboratory test), HBsAg (Hepatitis B surface Antigen). Urine analysis - Albumin, sugar, and microscopic.

Materials

Among 36 registered patients in Group A (n = 18), patients of Parikartika were treated with Yashtimadhu Ghrita, and in Group B (n = 18), patients of Parikarika were treated with local application of lignocaine–nifedipine ointment.

Methodology

Group A: Local application of Yashtimadhu Ghrita in fissure bed (Parikartika) twice a day after sitz bath for 4 weeks

Group B: Local application of lignocaine–nifedipine ointment in fissure bed (Parikartika) twice a day after sitz bath for 4 weeks.

Trial Drug: Yashtimadhu Ghrita has been prepared in the Pharmacy of Gujarat Ayurved University, Jamnagar, as per classical Ghrita Kalpana. The pharmaceutical analysis was done as shown in Table 1.

Table 1

Pharmaceutical details of Yashtimadhu Ghrita

Common treatment in both groups:

Adjuvant drugs such as Panchvalkala Kwatha (decoction) were used for Avagaha Swedana (Sitz bath) for 1 month in both groups. Prepared Kwatha (decoction) was mixed with warm water in the plastic tub and the patient was asked to sit for 10-15 min daily for two times as external use. Erandbhrushta Haritaki 5 g at bedtime with lukewarm water daily was prescribed in the patients who reported constipation in both groups.

Assessment criteria

The gradation adopted for the assessment of symptoms is depicted in Table 2 and overall assessment in Table 3.

Table 2

Gradation for symptoms

Table 3

Criteria for overall assessment

Duration of treatment

Patients were assessed on weekly interval up to 4 weeks.

Follow up period

One month after completion of the treatment proper to observe reoccurrence and any untoward effects of the treatment.

Statistical tests

Wilcoxon Signed-Rank test was used for intragroup statistical analysis of result. The Mann–Whitney Rank Sum Test was used for intergroup comparison.

Observations

The maximum patients belonged to 31–45 years of age (47.22%) and female 55.56% patients were more. The symptoms of Parikartika observed among 36 patients of both groups were Gudagata Vedana (Pain in ano) 100% (Severe 75%), Vibandha 100% (Regular 52.77%) and Gudagata Raktasrava in 80.56% (Dropping type 58.33%, Moderate 55.56%, after defecation 58.06% and occasional pain in 64.52%) patients. On per rectal examination, maximum patients 68.75% were having fissure tear at 6 o’ clock position without sentinel tag in any patient. Maximum patients were observed with healthy perianal skin (80.56%) with 16.67% patients having discharge from anus. Sphincter spasm was noted in 66.67% of patients.

Results

The assessment was made on the basis of relief in pain, oozing of blood, discharge from ano and days required for complete healing of ulcer. In this study, assessment was done on 7th day, 14th day, 21st day and on 30th day. Although individual results in both groups were found statistically significant (P < 0.0001) in pain in ano, but while comparing between both groups, there was no significant difference (0.4818). It was observed that all patients of both groups had got complete relief in bleeding P/R within 14 days. In Group A as well as in Group B, complete relief in bleeding P/R was found on 14 days. There was no statistically significant difference in number of days required for relief in bleeding P/R. Any discharge from ano in the form of serous showed 100% relief after 7 days. Statistical analysis showed non-significant result in Group A and B [Tables 4–7].

Table 4

Assessment of pain in ano in Group A and B

Table 7

Assessment of any discharge per ano in Group A and B

In comparison, in Group A, 18.06 days were required for relief in pain in ano, while in Group B, 16.88 days required. Clinically, pain relief in both group was found almost similar. Patients of Group A required average 8.50 days, while in Group B, average 8.08 days required for relief in bleeding P/R which was almost same between both groups (P = 0.8002). There was no statistically significant difference in number of days required for healing in ulcer in ano, but average 24.60 days were required in Group A, while in Group B, average 22.13 days were required for wound healing [Table 8]. Thirty-two patients of Parikartika treated in this study clearly shows that 75% patients were cured and 9.37% patients were having marked improvement, 6.25% patients were found moderately improved while 9.37% patients showed mild improvement [Table 9].

Table 8

Average days required for relieve in symptoms

Table 9

Overall effect of both therapies

The complications such as perianal itching (4 patients) and headache (1 patient) were noted in only 5 patients of Group B (lignocaine–nifedipine ointment). None of the patients reported complication in Group A (Yashtimadhu Ghrita application). All patients have reported recurrence of Parikartika in both groups after one month with mild pain. Hence, it can be said that both formulations are effective for short duration. In other word, it can be said that Parikartika has nature of recurrence.

Discussion

Maximum patients (47.22%) were from age group between 31 and 45 years. In this age, the person is more active and usually, they have altered Ahara and Vihara which leads to Agni Dushti, resulting in constipation which is prime responsible factor for Parikartika. The male-to-female ratio is 14:16 and John Goligher reported that the fissure-in-ano can occur equally, but this difference might be due to the less number of patients.[9] Hence, this observed finding was correlated to the classical description.[10]

All patients were observed with burning pain in ano. Among them, 75% patients were having severe burning pain which is a cardinal symptom of Parikartika. Sushruta has mentioned its name as Parikartika, which means cutting type of pain.[11] Constipation is a main causative factor of Parikartika and it was reported in all patients.[12] About 80.56% of patients were noted bleeding per ano. In this study, 70% of male patients and 68.75% female patients were having fissure-in-ano at 6 o’ clock position. During defecation, direct pressure of stool at posterior wall of anal canal and less muscular support results in ulceration at 6 o’ clock position.[13] Spasmodic anal sphincter was observed in maximum 66.67% patients which is due to the increased intrarectal pressure.[14]

Anal pain was relieved early in Group B (lignocaine–nifedipine ointment) as compared to Group A (Yashtimadhu Ghrita) as lignocaine is one of the topical anesthetic.[15] There is no statistically significant difference in number of days required for healing of ulcer in ano (P value > 0.9999). In Group A, anal fissure healed earlier than Group B due to the trial drug (Yashtimadhu Ghrita) had potential to heal the ulcer. In the classics, it is clearly mentioned about the healing property (Ropana) of Yashtimadhu Ghrita.[16] Some previous research studies also reported the mucosal ulcer healing effect of Yashtimadhu Ghrita.[17] In Group A complete relief was found on 14 days, while in Group B also 14 days required for 100% relief in oozing of blood P/R. In symptomatic relief, all symptoms relieved and there was no significant difference in both the groups when data analyzed statistically.

Mode of action of Yashtimadhu Ghrita

Yashtimadhu has Madhura Rasa, Sheeta Virya, Madhura Vipaka and is Vata-Pitta Shamaka property.[18] Yashtimadhu also has Vrana Shodhana and Vrana Ropana properties that helped for the healing of anal fissure. Go-Ghrita has a soothing property and form a thin-film layer over them and that allows early epithelization of wound. Yashtimadhu has proven healing, anti-ulcerogenic, anti-inflammatory and skin regeneration activity.[19] Sodium glycyrrhizate possessed anti-ulcer activity and stimulation of regeneration of skin.

Mode of action of lignocaine–nifedipine ointment

In anal fissure, high anal pressures can hamper the blood supply to the anoderm. Nifedipine works to dilate blood vessels, increasing blood flow to injured tissues. It also works to reduce pressure in the internal anal sphincter, which decreases pain and further facilitates healing. In many clinical trials, the dual effect that is reduced anal pressure and improved anodermal blood flow results in fissure healing in more than 80% of patients.[20] Nifedipine is one of the calcium-channel blockers and found to relax the internal anal sphincter by blocking calcium influx into its smooth muscle cell cytoplasm.[21] Lignocaine, creates the anesthetic effect so that immediate relief from anal pain is formulated.

Conclusion

Yashtimadhu Ghrita as well as lignocaine–nifedipine ointment both are equally effective in symptomatic relief in the management of Parikartika (acute fissure in ano). In lignocaine-nifedipine ointment minor complications were noted.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.

Table 5

Assessment of ulcer in ano in Group A and B

Table 6

Assessment of oozing (bleeding PR) in Group A and B