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Efficacy of a Combination of Herbal Gel Versus Topical Diltiazem (2%) in Chronic Anal Fissure Healing: A Randomized Double-Blind Clinical Trial Publisher



Tavakolidastjerdi S1, 2, 3 ; Motavasselian M1, 3 ; Emami SA4 ; Mansourian M5 ; Sahebkar A6, 7, 8 ; Teimouri A9
Authors
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Authors Affiliations
  1. 1. Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
  2. 2. Student Research Committee, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
  3. 3. Department of Persian Medicine, School of Persian and Complementary Medicine, Mashhad University of Medical Sciences, Mashhad, Iran
  4. 4. Department of Pharmacognosy, School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
  5. 5. Department of Biostatistics and Epidemiology, School of Health, Isfahan University of Medical Sciences, Isfahan, Iran
  6. 6. Biotechnology Research Center, Pharmaceutical Technology Institute, Mashhad University of Medical Sciences, Mashhad, Iran
  7. 7. Neurogenic Inflammation Research Center, Mashhad University of Medical Sciences, Mashhad, Iran
  8. 8. School of Pharmacy, Mashhad University of Medical Sciences, Mashhad, Iran
  9. 9. Gastroenterology Department, Isfahan University of Medical Sciences, Isfahan, Iran

Source: Journal of HerbMed Pharmacology Published:2019


Abstract

Introduction: Chronic anal fissure (CAF) is a common painful ailment that adversely affects quality of life. Nonsurgical treatments such as topical diltiazem are routinely administered to patients with CAF. However, diltiazem is associated with side effects such as headache and allergic reactions, which often lead to discontinuation of the treatment. The aim of this study was to determine the efficacy and safety of a topical Persian herbal remedy with analgesic, anti-inflammatory and antiseptic properties versus topical diltiazem (2%) in CAF healing. Methods: In this randomized double-blind clinical trial, 70 patients with CAF were randomly divided into an intervention group receiving topical herbal medicine and control group receiving topical diltiazem (2%) for 6 weeks. Both groups were given lifestyle and dietary advice including adherence to a high-fiber diet, avoidance of spicy foods, use of a laxative (psyllium powder) in case of constipation, and taking sitz baths. Severity of pain, bleeding, and itching were measured at the firstvisitaswellasthefirst,third,andsixthweeksoftreatment.Woundhealingandepithelialization were evaluated by anal examination. The treatment and follow-up period was 12 weeks; 6 weeks for assessing the effect of treatment and 6 weeks for examining treatment maintenance and evaluating the percentage of recurrence. Results: The herbal medicine caused significant reduction in pain compared with diltiazem (P<0.001). The herbal medicine had a significant effect in terms of wound healing at the end of the period (P<0.001). Recurrence rate was lower in the intervention group (32%) than the control group (56%), though this difference was not significant (P=0.323) Conclusion: Findings of this clinical trial suggest a higher efficacy of the combination herbal remedy versus topical diltiazem 2% in the management of pain and wound associated with CAF. © 2019 Nickan Research Institute. All rights reserved.
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