Nitroglycerin 0.4% ointment vs placebo in the treatment of pain resulting from chronic anal fissure: a randomized, double-blind, placebo-controlled study

BMC Gastroenterology

Research Article

Dennis S Riff¹  Scott M Berry²  Gregory V Collins³  Michael Safdi⁴  Raj Bhandari⁵  John E Pappas⁶  Julian Howell⁷  Gemma Clark⁷  Ann Yellowlees⁸  Charles F Barish⁹ 

[1] Advanced Clinical Research Institute, 1211 West La Palma Ave. Suite 303, 92801, Anaheim, CA, USA;CRC of Jackson, 501 Marshall Street #500, 39202, Jackson, MS, USA;Charlotte Clinical Research, 330 Billingsley Road, 28211, Charlotte, NC, USA;Consultants for Clinical Research/GCGA Physicians, 2925 Vernon Place, Suite 200, Cincinnati, OH, USA;Delta Research Partners, LLC, 608 Grammant Street, 71201, Monroe, LA, USA;Kentucky Medical Research Center, 354 Waller Avenue, Suite 110, 40504, Lexington, KY, USA;ProStrakan Pharmaceuticals Ltd, Galabank Business Park, TD1 1QH, Galashiels, UK;Quantics Consulting, Roslin BioCentre, Edinburgh, Scotland, UK;Wake Research Associates, LLC, 3100 Blue Ridge Road, Suite 300, 27612, Raleigh, NC, USA;

关键词: Clinical Trial;    Fissure In Ano;    Nitroglycerin;    Pain;   

DOI  :  10.1186/1471-230X-13-106

 received in 2012-07-25, accepted in 2013-06-05,  发布年份 2013

来源: Springer

【 摘 要 】

BackgroundComplications of chronic anal fissure (CAF) treatments are prompting interest in lower-risk therapies. This study was conducted to compare nitroglycerin (NTG) 0.4% ointment with placebo for pain associated with CAF.MethodsIn this randomized, double-blind, placebo-controlled trial, patients with one CAF and moderate-to-severe pain (≥50 mm on a 100 mm visual analog scale [VAS]) received 375 mg NTG 0.4% (1.5 mg active ingredient) or 375 mg placebo ointment applied anally every 12 hours for 21 days. The primary end point was change from baseline VAS score in 24-hour pain averaged over days 14–18. Review of data from patients who withdrew early was blinded to treatment. To control for the confounding effects of analgesics, all patients received 650 mg acetaminophen for headache prophylaxis before each application.ResultsA total of 247 patients were enrolled (NTG, n = 123; placebo, n = 124). The prespecified baseline observation carried forward (BOCF) analysis found no significant difference between groups; however, a last observation carried forward (LOCF) analysis showed a significant advantage for NTG. A post hoc analysis (LOCF/BOCF hybrid) demonstrated a significant adjusted mean difference of −7.0 mm in favor of NTG 0.4% (95% CI −13.6, –0.4; P = .038). Headache was the most common adverse event in the NTG (69.9%) and placebo (47.6%) groups.ConclusionsThis was the first placebo-controlled study that also controlled for the confounding effects of analgesics used to treat NTG-induced headache. In patients with moderate-to-severe CAF pain, NTG 0.4% ointment effectively reduced CAF pain compared with placebo.Trial registrationClinicalTrials.gov, NCT00522041

【 授权许可】

CC BY   
© Berry et al.; licensee BioMed Central Ltd. 2013