DOI: http://dx.doi.org/10.18203/2349-3259.ijct20180127

Assessment of quality of reporting of Helicobacter pylori related randomized controlled trials: a focus on highly ranked gastroenterology journals

Mahmood E. Elrggal, Morooj Al-Muwallad, Areej Al-Otaibi, Jomanah Alsiddik, Alaa Shahbar, Ejaz Cheema

Abstract


Background: Randomized controlled trials are often considered as the gold standard for measuring the effectiveness of an intervention. However, inappropriate or poor reporting in randomized controlled trials can produce biased estimates of treatment effects. Clinical trials that do not use the CONSORT statement for reporting their findings will have limited value to the clinicians and researchers due to the risk of bias in their results. This review aims to assess the quality of reporting of randomized controlled trials in Helicobacter pylori associated infections by using the CONSORT 2010 checklist.

Methods: All issues of 20 highly ranked gastroenterology journals published from Jan 2011 up to November 2017 were searched. Searches were conducted in November 2017. Randomized controlled trials reporting on Helicobacter pylori associated infections were included in the review.

Results: 21 randomized controlled trials published in gastroenterology journals were included in the study. All included studies adequately reported (100%) on items including description of interventions, outcomes assessed, total number of participants analysed, baseline characteristics and results of outcome assessed. However, items including blinding and mechanism of allocation concealment were reported in only 12 randomized controlled trials (50%). The maximum and minimum scores and percentage of compliance of included randomised controlled trials were 24 (100%) and 15 (62.5%) respectively.

Conclusions: The finding of this review suggests that the overall quality of reporting in the included randomized controlled trials was adequate. However, items including trial design, trial registration and protocol and sample size calculations should be reported adequately in the future randomized controlled trials to improve the quality of reporting and replicability of clinical trials.


Keywords


Randomized controlled trials, Helicobacter pylori, CONSORT

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References


Dunn BE, Cohen H, Blaser MJ. Helicobacter pylori. Clin Microbiol Rev 1997;10:720-41.

Megraud F. H. pylori antibiotic resistance: prevalence, importance, and advances in testing. Gut. 2004;53:1374-84.

Blaser MJ. Epidemiology and pathophysiology of Campylobacter pylori infections. Rev Infect Dis 1990; 12:99-106.

Megraud F. Epidemiology and mechanism of antibiotic resistance in Helicobacter pylori. Gastroenterology 1998;115:1278-82.

Concato J, Shah N, Horwitz RI. Randomized, controlled trials, observational studies, and the hierarchy of research designs. N Engl J Med 2000;342:1887-92.

Juni P, Altman DG, Egger M. Systematic reviews in health care: Assessing the quality of controlled clinical trials. BMJ. 2001;323:42-6.

Moher D, Schulz KF, Altman; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. Ann Intern Med. 2001;134:657-62.

The EQUATOR Network. EQUATOR: enhancing the quality and transparency of health research, 2012. Available at: http://www.equator-network. org. Accessed on 11 November 2017.

Schulz KF, Altman DG, Moher D, Group C. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. PLoS Med. 2010;7(3):e1000251.

Moher D, Hopewell S, Schulz KF, Montori V, Gotzsche P, Devereaux PJ. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c869.

The CONSORT Group. The CONSORT statement. Available at http://www.consort-statement.org. Accessed on 6 November 2017.

Wang JL, Sun TT, Lin YW, Lu R, Fang JU. Methodological reporting of randomized controlled trials in major hepato-gastroenterology journals in 2008 and 1998: a comparative study. BMC Med Res Methodol. 2011;11:110.

Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman G, et al. CONSORT for reporting randomized controlled trials in journal and conference abstracts: explanation and elaboration. PLoS Med. 2008;5:e20.

Nojomi M, Ramezani M, Ghafari-Anvar A. Quality of reports on randomized controlled trials published in Iranian journals: application of the new version of consolidated standards of reporting trials (CONSORT). Arch Iran Med. 2013;16:20-2.

Wang P, Xu Q, Sun Q, Fan FF, Guo XR, Guo F. Assessment of the reporting quality of randomized controlled trials on the treatment of diabetes mellitus with traditional Chinese medicine: a systematic review. PLoS One 2013;8:e70586.

Liu KS, Hung IF, Seto WK, Tong T, Hsu AS, Lam FY, et al. Ten day sequential versus 10 day modified bismuth quadruple therapy as empirical first line and second line treatment for Helicobacter pylori in Chinese patients: an open label, randomised, crossover trial. Gut 2014;63(9):1410-5.

McNicholl AG, Marin AC, Molina-Infante J, Castro M, Barrio J, Ducons J, et al. Randomised clinical trial comparing sequential and concomitant therapies for Helicobacter pylori eradication in routine clinical practice. Gut. 2014;63(2):244-9.

Wong BC, Zhang L, Ma JL, Pan KF, Li JY, Shen L, et al. Effects of selective COX-2 inhibitor and Helicobacter pylori eradication on precancerous gastric lesions. Gut. 2012;61(6):812-8.

Park CS, Lee SM, Park CH, Koh HR, Jun CH, Park SY, et al. Pre-treatment antimicrobial susceptibility-guided vs. clarithromycin-based triple therapy for Helicobacter pylori eradication in a region with high rates of multiple drug resistance. Am J Gastroenterol. 2014;109(10):1595-602.

Zhou L, Zhang J, Chen M, Hou X, Li Z, Song Z, et al. A comparative study of sequential therapy and standard triple therapy for Helicobacter pylori infection:a randomized multicenter trial. Am J Gastroenterol. 2014;109(4):535-41.

Basu PP, Rayapudi K, Pacana T, Shah NJ, Krishnaswamy N, Flynn M. A randomized study comparing levofloxacin, omeprazole, nitazoxanide, and doxycycline versus triple therapy for the eradication of Helicobacter pylori. Am J Gastroenterol. 2011;106:1970-5.

Liang X, Xu X, Zheng Q, Zhang W, Sun Q, Liu W, et al. Efficacy of bismuth-containing quadruple therapies for clarithromycin-, metronidazole-, and fluoroquinolone-resistant Helicobacter pylori infections in a prospective study. Clin Gastroenterol Hepatol. 2013;11(7):802-7.

Cho SJ, Choi IJ, Kook MC, Yoon H, Park S, Kim C, et al G. Randomised clinical trial:the effects of Helicobacter pylori eradication on glandular atrophy and intestinal metaplasia after subtotal gastrectomy for gastric cancer. Aliment Pharmacol Ther. 2013;38:477–89.

Huang J, Zhou L, Geng L, Yang M, Xu XW, Ding ZL, et al. Randomised controlled trial:sequential vs. standard triple therapy for Helicobacter pylori infection in Chinese children–a multicentre, open-labelled study. Aliment Pharmacol Ther. 2013;38:1230–5.

Lane JA, Murray LJ, Harvey IM, Donovan JL, Nair P, Harvey RF. Randomised clinical trial: Helicobacter pylori eradication is associated with a significantly increased body mass index in a placebo-controlled study. Alimentary Pharmacol Therap 2011;33:922–9.

Kim YS, Kim SJ, Yoon JH, Suk KT, Kim JB, Kim DJ, et al. Randomised clinical trial:the efficacy of a 10-day sequential therapy vs. a 14-day standard proton pump inhibitor-based triple therapy for Helicobacter pylori in Korea. Alimentary Pharmacol Therap. 2011;34:1098–105.

Park HG, Jung MK, Jung JT, Kwon JG, Kim EY, et al. Randomised clinical trial:comparative study of 10-day sequential therapy with 7-day standard triple therapy for Helicobacter pylori infection in naïve patients. Alimentary Pharmacol Therap. 2012;35:56–65.

Nseir W, Diab H, Mahamid M, Abu-Elheja O, Samara M, Abid A, et al. Randomised clinical trial:simvastatin as adjuvant therapy improves significantly the Helicobacter pylori eradication rate - a placebo-controlled study. Aliment Pharmacol Ther. 2012;36:231–8.

Murakami K, Furuta T, Ando T, Nakajima T, Inui Y, Oshima T, et al. Multi-centre randomized controlled study to establish the standard third-line regimen for Helicobacter pylori eradication in Japan. J Gastroenterol. 2013;48(10):1128-35.

Sugano K, Kontani T, Katsuo S, Takei Y, Sakaki N, Ashida K, et al. Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term non-steroidal anti-inflammatory drug (NSAID) therapy:results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled J Gastroenterol. 2012;47(5):540-52.

Sanuki T, Fujita T, Kutsumi H, Hayakumo T, Yoshida S, Inokuchi H, et al. Rabeprazole reduces the recurrence risk of peptic ulcers associated with low-dose aspirin in patients with cardiovascular or cerebrovascular disease:a prospective randomized active-controlled trial. J Gastroenterol 2012;47(11):1186-97.

Sugano K, Kontani T, Katsuo S, Takei Y, Sakaki N, Ashida K, et al. Lansoprazole for secondary prevention of gastric or duodenal ulcers associated with long-term low-dose aspirin therapy:results of a prospective, multicenter, double-blind, randomized, double-dummy, active-controlled trial. J Gastroenterol. 2011;46:724.

Fujiwara S, Morita Y, Toyonaga T, Kawakami F, Itoh T, Yoshida M, et al. A randomized controlled trial of rebamipide plus rabeprazole for the healing of artificial ulcers after endoscopic submucosal dissection. J Gastroenterol. 2011;46(5):595-602.

Tominaga K, Kato M, Takeda H,Takeda H, Simoyama Y, Umegaki E, et al. A randomized, placebo-controlled, double-blind clinical trial of rikkunshito for patients with non-erosive reflux disease refractory to proton-pump inhibitor:the G-PRIDE study. J Gastroenterol. 2014;49(10):1392-405.

Tan VP, Wong WM, Cheung TK, Lai K, Hung I, Chan P, et al. Treatment of non-erosive reflux disease with a proton pump inhibitor in Chinese patients:a randomized controlled trial. J Gastroenterol. 2011;46(7):906-12.

Nagahara A, Suzuki T, Nagata N, Sugai N, Takeuchi Y, Sakuri K, et al. A multicentre randomised trial to compare the efficacy of omeprazole versus rabeprazole in early symptom relief in patients with reflux esophagitis. J Gastroenterol. 2014;49(12):1536-47.

Kjaergard LL, Frederiksen SL, Gluud C. Validity of randomized clinical trials in gastroenterology from 1964-2000. Gastroenterology. 2002;122:1157-60.

Godwin OP, Dyson B, Lee PS, Lee E. Compliance with the CONSORT Statement on Participant Flow Diagrams in Infectious Disease Randomized Clinical Trials. J Pharma Care Health Sys. 2015;2:129.

Ziogas DC, Zintzaras E. Analysis of the quality of reporting of randomized controlled trials in acute and chronic myeloid leukemia, and myelodysplastic syndromes as governed by the CONSORT statement. Ann Epidemiol. 2009;19:494-500.

Halpern SH, Darani R, Douglas MJ, Wight W, Yee J. Compliance with the CONSORT checklist in obstetric anaesthesia randomised controlled trials. Int J Obstet Anesth. 2004;13:207-14.