Comparing the Efficacy of 2% Diltiazem Gel with 0.2% Glyceryl Trinitrate in Anal Fissure

Objective: To compare the efficacy of 2% diltiazem gel with 0.2% glyceryl trinitrate in patients presenting with chronic anal fissure at Tertiary Care Hospital, Larkana. Methodology: This prospective comparative Study was conducted at department of Surgery wardII Chandka Medical Hospital, Larkana from 14-01-19 to 14-07-19. A total of 130 patients who were treated as OPD cases were included in this study. Each patient detailed history & clinical examination, details of symptomatology was recorded in a epically diagnosed proforma. These patients were randomly divided in two equal groups i-e group A 65 patients and group B 65 patients. Group A patients were treated with 02% glyceryl trinitrate and group B patients were treated with diltiazem gel 02%. All the patients of group A & B were followed up to 02 months after start of leadema as a OPD cases. Original Research Article Malik et al.; JPRI, 33(42B): 397-401, 2021; Article no.JPRI.73299 398 Results: A total of 130 patients (65 each in 2% diltiazem gel with 0.2% glyceryl trinitrate group) were included. Mean age in both groups was 42.56±3.91 and 41.71±4.01. 46 (70.8%) and 19 (29.2%) were male and female in Group A and 39 (60%) and 26 (40%) were male and female in Group B. Efficacy of 2% diltiazem gel with 0.2% glyceryl trinitrate in patients presenting with chronic anal fissure was 76.9% and 50.8% respectively. Conclusion: DTZ (2%) and GTN (0.2%) are equally effective in healing anal fissures. DTZ is better than GTN as it causes less side effects, low recurrence rate, healing rate and therefore better compliance.


INTRODUCTION
Anal fissure affects particularly young peoples and it is most common disease which affects every age group [1]. It is caused due to persistent hypertonia which causes linear tea especially at the distal anal canal and also due to the internal sphincter spans which leads to mucosal ischemia [2]. Chronic fissures are categorized by an anal spasm, sentinel tag, fibrosis, anal papillae and hypertrophic [3]. Most of the acute fissures can be treated conservatively with bulking agents, stool softeners, local anesthesia creams, and sits bath.
GTN (Glyceryl Tri Nitrate) is being used for many years; the nitrious oxide cause increase in the blood flow and causes decrease in the resting tone [4]. NO (Nitric oxide) is the principle noncholinergic, non-adrenergic neurotransmitter responsible for contraction of internal anal sphincter and when released locally causes relaxation of internal anal sphincter.
On the other hand benzothiozapine derived drug Diltiazem causes increase in tissue perfusion and dilation of blood vessels [5]. In also reduce the muscle tone and act as CCB (calcium channel pump blocker) [6]. Due to complication though prolong healing of the wounds the surgeries are been avoided and hence medical treatments for out patients are been given which are also cost effective [7].

METHODOLOGY
This prospective comparative Study was conducted at department of Surgery ward-II Chandka Medical Hospital, Larkana from 14-01-19 to 14-07-19. A total of 130 patients who were treated as OPD cases. Each patients detailed history was taken & clinical examination was done, details of symptomatology were recorded in an epically diagnosed proforma. These patients were randomly divided in two equal groups i-e group A 65 patients and group B 65 patients. Group A patients were treated with 02% glyceryl trinitrate and group B patients were treated with diltiazem gel 02%. All the patients of group A & B were followed up to 02 months after start of leadema as an OPD cases.

RESULTS
A total of 130 patients (65 each in each group were treated 02% diltiazem gel and with 02% glyceryl trinitrate were included. Mean  Duration of symptomatology showed that out of 65 patients in group A, 35 (53.8%) and 30 (46.2%) had duration of symptoms < 12 and > 12 weeks respectively. Similarly, out of 65 patients in group B, 30 (46.2%) and 35 (53.8%) had duration of symptoms < 12 and > 12 weeks respectively. As presented in Table 3.
Stratification for duration of symptoms with respect to efficacy in group A and B showed that 25 (71.4%) and 10 (28.6%) achieved and did not achieve efficacy and 12 (40%) and 18 (60%) achieved and did not achieve efficacy in duration of symptoms group < 12 weeks respectively. Whereas duration of symptoms with respect to efficacy in group A and B showed that 25 (83.3%) and 05 (16.7%) achieved and did not achieve efficacy and 21 (60%) and 14 (40%) achieved and did not achieve efficacy in duration of symptoms group > 12 weeks respectively. Pvalue was 0.03. As presented in Table 4.

DISCUSSION
Fissure of anus is the painful and most common disease. Its treatment is under discussion and several treatments have been proposed. In the last decade the understating regarding it pathophysiology has resulted in reduction of invasive and treatments in favor of treatments which cause relaxation of anal sphincter muscle. Success of Medical treatment with diltiazem, calcium channel blockers, glyceryl trinitrite and nifedipine is about 50% to 90%.
Out of a total of 130 patients (65 each in 2% diltiazem gel with 0.2% glyceryl trinitrate group) were included. Mean age in both groups was 42.56±3.91 and 41.71±4.01. 46 (70.8%) and 19 (29.2%) were male and female in Group A and 39 (60%) and 26 (40%) were male and female in Group B. Efficacy of 2% diltiazem gel with 0.2% glyceryl trinitrate in patients presenting with chronic anal fissure was 76.9% and 50.8% respectively.
In a study the healing with Diltiazem was found to be about eighty percentage and sixty two percentage with GTN and overall percentage of about seventy one. The total relief from pain was found to be 67.9%, mild pain complaints were about 26.1% and moderate pain complaints were 5.4%. a solitary patient with GTN complained about severe pain with no healing after 1 month of followup [8].
A polish study included 43 outpatients with chronic anal fissure, 22 patients were randomized to topical diltiazem (2%) ointment and 21 patients to glyceryltrinitrate (GTN) (0.5%) ointment twice daily for 8 weeks. Those who were treated with nitroglycerin ointment developed headache and dizziness developed after GTN in 33.3% of cases while no patient had any side-effects after diltiazem [9].    [11].
Chemical sphincterotomy with topical Diltiazem gel is an effective first-line treatment for early symptomatic relief of anal fissures, owing to negligible side effects.
In our study efficacy in group A patients who achieved efficacy was 50 (76.9%) and 15 (23.1) patients did not achieved efficacy, in group B in 33 (50.8%) and 32 (49.2%) patients achieved and did not achieve efficacy respectively. As presented in Table 5.

CONCLUSION
Diltiazem (2%) and Glycerinetrinitrate (0.2%) are equally effective in healing anal fissures. DTZ is better than GTN as it causes less side effects, low recurrence rate, healing rate and therefore better compliance. We conclude that both provide rapid pain relief and healing of fissure, and it offers an effective treatment choice. This evidence would also enable us in setting standards and clinical guidelines in order to provide good care to our patients. This study can serve as preliminary study to be followed by other large scale studies which can provide the required data to health care authorities for planning appropriate strategies.

CONSENT
Consent was taken from the patients.

ETHICAL APPROVAL
As per international standard or university standard written ethical approval has been collected and preserved by the author(s).