Brief Article
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World J Gastroenterol. Feb 14, 2013; 19(6): 889-896
Published online Feb 14, 2013. doi: 10.3748/wjg.v19.i6.889
Mucosal healing effect of mesalazine granules in naproxen-induced small bowel enteropathy
István Rácz, Milán Szalai, Valéria Kovács, Henriett Regőczi, Gyöngyi Kiss, Zoltán Horváth
István Rácz, Milán Szalai, Valéria Kovács, Henriett Regőczi, Gyöngyi Kiss, Department of Gastroenterology, Petz Aladár County and Teaching Hospital, 9024 Győr, Hungary
Zoltán Horváth, Department of Mathematics and Computational Sciences, Széchenyi István University, 9026 Győr, Hungary
Author contributions: Rácz I designed the research; Szalai M, Kovács V, Regőczi H and Kiss Gy performed the research; Horváth Z analyzed the data; and Rácz I wrote the paper.
Supported by Dr. Falk Pharma GmbH, in part, study code: SAG-43/SBE
Correspondence to: István Rácz, MD, PhD, Department of Gastroenterology, Petz Aladár County and Teaching Hospital, 9024 Győr, Hungary. raczi@petz.gyor.hu
Telephone: +36-96-418244 Fax: +36-96-418486
Received: August 29, 2012
Revised: November 1, 2012
Accepted: November 14, 2012
Published online: February 14, 2013
Abstract

AIM: To investigate the effect of mesalazine granules on small intestinal injury induced by naproxen using capsule endoscopy (CE).

METHODS: This was a single center, non-randomized, open-label, uncontrolled pilot study, using the PillCam SB CE system with RAPID 5 software. The Lewis Index Score (LIS) for small bowel injury was investigated to evaluate the severity of mucosal injury. Arthropathy patients with at least one month history of daily naproxen use of 1000 mg and proton pump inhibitor co-therapy were screened. Patients with a minimum LIS of 135 were eligible to enter the 4-wk treatment phase of the study. During this treatment period, 3 × 1000 mg/d mesalazine granules were added to ongoing therapies of 1000 mg/d naproxen and 20 mg/d omeprazole. At the end of the 4-wk combined treatment period, a second small bowel CE was performed to re-evaluate the enteropathy according to the LIS results. The primary objective of this study was to assess the mucosal changes after 4 wk of mesalazine treatment.

RESULTS: A total of 18 patients (16 females), ranging in age from 46 to 78 years (mean age 60.3 years) were screened, all had been taking 1000 mg/d naproxen for at least one month. Eight patients were excluded from the mesalazine therapeutic phase of the study for the following reasons: the screening CE showed normal small bowel mucosa or only insignificant damages (LIS < 135) in five patients, the screening esophagogastroduodenoscopy revealed gastric ulcer in one patient, capsule technical failure and incomplete CE due to poor small bowel cleanliness in two patients. Ten patients (9 female, mean age 56.2 years) whose initial LIS reached mild and moderate-to-severe enteropathy grades (between 135 and 790 and ≥ 790) entered the 4-wk therapeutic phase and a repeat CE was performed. When comparing the change in LIS from baseline to end of treatment in all patients, a marked decrease was seen (mean LIS: 1236.4 ± 821.9 vs 925.2 ± 543.4, P = 0.271). Moreover, a significant difference between pre- and post-treatment mean total LIS was detected in 7 patients who had moderate-to-severe enteropathy gradings at the inclusion CE (mean LIS: 1615 ± 672 vs 1064 ± 424, P = 0.033).

CONCLUSION: According to the small bowel CE evaluation mesalazine granules significantly attenuated mucosal injuries in patients with moderate-to-severe enteropathies induced by naproxen.

Keywords: Nonsteroidal anti-inflammatory drug; Small bowel enteropathy; Mesalazine granules; Mucosal healing; Capsule endoscopy