title: Mucosal healing effect of mesalazine granules in naproxen-induced small bowel enteropathy.
abstract: OBJECTIVE
  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).
  
  
  CONCLUSIONS
  According to the small bowel CE evaluation mesalazine granules significantly attenuated mucosal injuries in patients with moderate-to-severe enteropathies induced by naproxen.
authors: Department of Gastroenterology, Petz Aladár County and Teaching Hospital, 9024 Győr, Hungary. raczi@petz.gyor.hu
authors: István
authors: I
authors: Rácz
authors: Milán
authors: M
authors: Szalai
authors: Valéria
authors: V
authors: Kovács
authors: Henriett
authors: H
authors: Regőczi
authors: Gyöngyi
authors: G
authors: Kiss
authors: Zoltán
authors: Z
authors: Horváth
mesh_terms: D000368:Aged; D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000009:adverse effects*; D053704:Capsule Endoscopy; D005260:Female; D006801:Humans; D006814:Hungary; D007410:Intestinal Diseases / Q000139:chemically induced / Q000473:pathology / Q000517:prevention & control*; D007413:Intestinal Mucosa / Q000187:drug effects* / Q000473:pathology; D007421:Intestine, Small / Q000187:drug effects* / Q000473:pathology; D008297:Male; D019804:Mesalamine / Q000627:therapeutic use*; D008875:Middle Aged; D009288:Naproxen / Q000009:adverse effects*; D010865:Pilot Projects; D012720:Severity of Illness Index; D013997:Time Factors; D016896:Treatment Outcome; D014945:Wound Healing / Q000187:drug effects*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D019804:Mesalamine; D009288:Naproxen
keywords: Capsule endoscopy; Mesalazine granules; Mucosal healing; Nonsteroidal anti-inflammatory drug; Small bowel enteropathy