Suppository naproxen reduces incidence and severity of post-endoscopic retrograde cholangiopancreatography pancreatitis: Randomized controlled trial

AIM: To determine the efficacy of rectally administered naproxen for the prevention of post-endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP).METHODS: This double-blind randomized control trial conducted from January 2013 to April 2014 at the Gastrointestinal and Liver Diseases Research Center in Rasht, Iran. A total of 324 patients were selected from candidates for diagnostic or therapeutic ERCP by using the simple sampling method. Patients received a single dose of Naproxen (500 mg; n = 162) or a placebo (n = 162) per rectum immediately before ERCP. The overall incidence of PEP, incidence of mild to severe PEP, serum amylase levels and adverse effects were measured. The primary outcome measure was the development of pancreatitis onset of pain in the upper abdomen and elevation of the serum amylase level to > 3 × the upper normal limit (60-100 IU/L) within 24 h after ERCP. The severity of PEP was classified according to the duration of therapeutic intervention for PEP: mild, 2-3 d; moderate 4-10 d; and severe, > 10 d and/or necessitated surgical or intensive treatment, or contributed to death.RESULTS: PEP occurred in 12% (40/324) of participants, and was significantly more frequent in the placebo group compared to the naproxen group (P < 0.01). Of the participants, 25.9% (84/324) developed hyperamylasemia within 2 h of procedure completion, among whom only 35 cases belonged to the naproxen group (P < 0.01). The incidence of PEP was significantly higher in female sex, in patients receiving pancreatic duct injection, more than 3 times pancreatic duct cannulations, and ERCP duration more than 40 min (Ps < 0.01). There were no statistically significant differences between the groups regarding the procedures or factors that might increase the risk of PEP, sphincterotomy, precut requirement, biliary duct injection and number of pancreatic duct cannulations. In the subgroup of patients with pancreatic duct injection, the rate of pancreatitis in the naproxen group was significantly lower than that in the placebo (6 patients vs 23 patients, P < 0.01, RRR = 12%, AR = 0.3, 95%CI: 0.2-0.6). Naproxen reduced the PEP in patients with ≥ 3 pancreatic cannulations (P < 0.01, RRR = 25%, AR = 0.1, 95%CI: 0.1-0.4) and an ERCP duration > 40 min (P < 0.01, RRR = 20%, AR = 0.9, 95%CI: 0.4-1.2).CONCLUSION: Single dose of suppository naproxen administered immediately before ERCP reduces the incidence of PEP.

Seven-day quintuple regimen as a rescue therapy for Helicobacter pylori eradication

AIM: To determine the efficacy of two quintupleregimens for eradication of Helicobacter pylori(H. pylori) in patients who failed previous therapies.METHODS: This prospective, open-label, randomized controlled trial was a phase Ⅱ study conducted from April 2011 to March 2012 at the Gastrointestinal and Liver Diseases Research Center in Rasht, Iran. A total of 208 patients with dyspepsia who failed previous H. pylori eradication with a ten-day quadruple therapy were enrolled. A random block method was used to assign patients to one of two treatment groups. Patients in the first group were treated with 240 mg bismuth subcitrate, 20 mg omeprazole, 1000 mg amoxicillin, 500 mg clarithromycin and 500 mg tinidazole(BOACT group). Patients in the second group received a regimen containing 240 mg bismuth subcitrate, 20 mg omeprazole, 500 mg tetracycline, 500 mg metronidazole and 200 mg ofloxacin(BOTMO group). Both regimens were given twice daily for a duration of seven days. The eradication was confirmed by a 14 C urea breath test 12 wk after completion of therapy. Patient compliance and drug side effects were evaluated at the end of the treatment period. The success rates were calculated by intention-to-treat and per-protocol analyses.RESULTS: A total of 205 patients completed the course of treatment, with three patients excluded due to drug intolerance. The mean age of patients did not differ between the BOACT and BOTMO groups(41.6 ± 12.2 years vs 39.6 ± 11.8 years), and no significant differences were found between the two groups in terms of age, sex, smoking habits or the initial eradication regimen. The intention-to-treat and perprotocol eradication rates were significantly higher in the BOTMO group(86.5%, 95%CI: 0.85-0.87 and 86.7%, 95%CI: 0.80-0.89, respectively) compared with the BOACT group(75.5%, 95%CI: 0.73-0.76 and 76%, 95%CI: 0.69-0.80, respectively)(P < 0.05). Univariate analyses for both groups did not show any association of sex, smoking and initial therapeutic regimen witheradiation rate(P > 0.05 for all). Significantly more patients experienced side effects in the BOACT group compared to the BOTMO group(77.4% vs 36.6%, P < 0.01). This difference was exemplified by increases in headache and taste disturbance(P < 0.05).CONCLUSION: Quintuple therapy with a BOTMO regimen is an alternative second-line rescue therapy for Iranian patients with failed first-line eradication treatment of H. pylori.

Knowledge levels and attitudes of health care professionals toward patients with hepatitis C infection

AIM:To study knowledge levels and attitudes of health care providers toward patients with hepatitis C virus infection in Guilan,a northern province of Iran.METHODS:This cross-sectional study was performed on 239 health care professionals from the Razi Hospital,including doctors,nurses,and operating room technicians.The questionnaires consisted of questions on demographic characteristics,knowledge levels,and attitudes toward hepatitis C patients.The questionnaire was tested in a pilot study and validated by Cronbach' s alpha coefficient.Data were analyzed using SPSS16 software.RESULTS:The mean ± SD knowledge score was 17.43 ± 2.65(from a total of 22).51.9% of the participants achieved scores higher than the mean.There was a significant relationship between knowledge score and age(P = 0.001),gender(P = 0.0001),occupational history(P = 0.0001),and educational history(P = 0.027).There was also a significant relationship between attitude level and age(P = 0.002),gender(P = 0.0001),occupational history(P = 0.0001),and educational history(P = 0.035).Physicians were significantly more knowledgeable and showed more positive attitudes.There was a positive correlation between knowledge and attitude scores(P = 0.02).CONCLUSION:Discriminatory attitudes are common among health care providers toward hepatitis C patients.It is therefore necessary to improve their knowledge level and attitude toward this disease.