Evidence-Based Clinical Practice Guidelines for Peptic Ulcer Disease 2015
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J Gastroenterol DOI 10.1007/s00535-016-1166-4 SPECIAL ARTICLE Evidence-based clinical practice guidelines for peptic ulcer disease 2015 1,2 2 2 2 Kiichi Satoh • Junji Yoshino • Taiji Akamatsu • Toshiyuki Itoh • 2 2 2 2 Mototsugu Kato • Tomoari Kamada • Atsushi Takagi • Toshimi Chiba • 2 2 2 2 Sachiyo Nomura • Yuji Mizokami • Kazunari Murakami • Choitsu Sakamoto • 2 2 2 2 Hideyuki Hiraishi • Masao Ichinose • Naomi Uemura • Hidemi Goto • 2 2 2 2 Takashi Joh • Hiroto Miwa • Kentaro Sugano • Tooru Shimosegawa Received: 25 December 2015 / Accepted: 6 January 2016 Ó Japanese Society of Gastroenterology 2016 Abstract The Japanese Society of Gastroenterology bleeding is first treated by endoscopic hemostasis. If it (JSGE) revised the evidence-based clinical practice fails, surgery or interventional radiology is chosen. Second, guidelines for peptic ulcer disease in 2014 and has created medical therapy is provided. In cases of NSAID-related an English version. The revised guidelines consist of seven ulcers, use of NSAIDs is stopped, and anti-ulcer therapy is items: bleeding gastric and duodenal ulcers, Helicobacter provided. If NSAID use must continue, the ulcer is treated pylori (H. pylori) eradication therapy, non-eradication with a proton pump inhibitor (PPI) or prostaglandin analog. therapy, drug-induced ulcer, non-H. pylori, non-nons- In cases with no NSAID use, H. pylori-positive patients teroidal anti-inflammatory drug (NSAID) ulcer, surgical receive eradication and anti-ulcer therapy. If first-line treatment, and conservative therapy for perforation and eradication therapy fails, second-line therapy is given. In stenosis. Ninety clinical questions (CQs) were developed, cases of non-H. pylori, non-NSAID ulcers or H. pylori- and a literature search was performed for the CQs using the positive patients with no indication for eradication therapy, Medline, Cochrane, and Igaku Chuo Zasshi databases non-eradication therapy is provided. The first choice is PPI between 1983 and June 2012. The guideline was developed therapy, and the second choice is histamine 2-receptor using the Grading of Recommendations Assessment, antagonist therapy. After initial therapy, maintenance Development and Evaluation (GRADE) system. Therapy is therapy is provided to prevent ulcer relapse. initially provided for ulcer complications. Perforation or stenosis is treated with surgery or conservatively. Ulcer Keywords Peptic ulcer Á Gastric ulcer Á Stomach ulcer Á Duodenal ulcer Á Helicobacter pylori eradication Á Nonsteroidal anti-inflammatory drug Á Cyclooxygenase-2 Á The original version of this article appeared in Japanese as ‘‘Shokasei Low-dose aspirin Kaiyo Sinryo Guideline 2015’’ from the Japanese Society of Gastroenterology (JSGE), published by Nankodo, Tokyo, 2015. Please see the article on the standards, methods, and process of developing the Guidelines (doi:10.1007/s00535-014-1016-1). Introduction The members of the Guidelines Committee are listed in the Appendix In 2009, the Japanese Society of Gastroenterology (JSGE) in the text. developed the evidence-based clinical practice guideline for peptic ulcer disease, and this guideline was revised in 2014. & Kiichi Satoh [email protected] A working committee (chair, Yoshino J., vice-chair, Satoh K., Akamatsu T., Itoh T., Kato M., Kamada T., Takagi A., 1 Department of Gastroenterology, International University of Chiba T., Nomura S., Mizokami Y., and Murakami K.) and Health and Welfare Hospital, 537-3 Iguchi, Nasushiobara-shi, an evaluation committee (chair, Sakamoto C., vice-chair, Tochigi 329-2763, Japan Hiraishi H., Ichinose M., Uemura N., Goto H., and Jo T.) 2 Guidelines Committee for creating and evaluating the collaborated to create the guideline. The revised guideline ‘‘Evidence-based clinical practice guidelines for peptic ulcer’’, the Japanese Society of Gastroenterology (JSGE), K- consists of seven items, newly including non-Helicobacter 18 Building 8F, 8-9-13, Ginza, Chuo, Tokyo 104-0061, Japan pylori (H. pylori), non-nonsteroidal anti-inflammatory drug 123 guide.medlive.cn J Gastroenterol (NSAID) ulcer. For drug-induced ulcers, their epidemiology nonbleeding adherent clots had no difference with that of PPI and pathophysiology were also examined. Ninety clinical alone [6]. We do not recommend endoscopic hemostasis as questions (CQs) were developed, and a literature search was peptic ulcer with adherent clots because treatment of patients performed for the CQs using the Medline, Cochrane, and with adherent clots on ulcer remains controversial. Igaku Chuo Zasshi databases for the period between 1983 and June 2012. The CQs mainly relate to treatment, with no CQ. Is endoscopy for hemostasis confirmation (second CQs about diagnosis. The guideline was developed using the look) necessary? Grading of Recommendations Assessment, Development • Second-look endoscopy is recommended to confirm and Evaluation (GRADE) system [1]. The quality of evi- recurrent bleeding of high-risk patients. Recommenda- dence was graded as A (high), B (moderate), C (low), and D tion 1, 100 % agreed, evidence level A. (very low). The strength of a recommendation was indicated as either ‘‘1’’ (strong recommendation) or ‘‘2’’ (weak rec- Comment: In meta-analysis of Tsoi et al. [7], second-look ommendation) [1]. Consensus was previously defined as endoscopy with thermal coagulation reduced re-bleeding, 70 % or more votes in agreement. but second-look with injection provided no significant improvement in re-bleeding. The author suggested that 1. Bleeding gastric and duodenal ulcers routine second-look endoscopy was not useful. With Endoscopic therapy respect to medical economic benefit, routine second-look endoscopy could not recommend for all patients with CQ. Is endoscopic therapy effective in treating peptic endoscopic therapy. ulcer bleeding? Systematic review of Elmunzer et al. [8] indicated the independent pre-endoscopic predictors of re-bleeding were • Endoscopic therapy for peptic ulcer bleeding is superior hemodynamic instability and comorbid illness. In their to pharmacotherapy alone with regard to initial review, the independent endoscopic predictors of re- hemostasis and re-bleeding. Endoscopic therapy bleeding were active bleeding at endoscopy, large ulcer decreases the need for surgery and mortality versus size, posterior duodenal ulcer, and lesser gastric curvature pharmacotherapy alone. Recommendation 1, 100 % ulcer. Second-look is useful to patients with pre-endo- agreed, evidence level A. scopic or endoscopic predictors. Comment: Sachs et al. [2] reported in their meta-analysis Non-endoscopic therapy that endoscopic therapy at peptic ulcer bleeding signifi- cantly decreased continued bleeding, re-bleeding, and CQ. Is medication with antacid agents required after transfer to emergency surgery vs. standard therapy. In endoscopic treatment for hemorrhagic peptic ulcers? meta-analysis of Barkun et al. [3], endoscopic therapy • Medication with antacid agents is strongly recom- decreased re-bleeding, the need for surgery, and mortality mended after endoscopic treatment for hemorrhagic versus pharmacotherapy alone. Meta-analysis of Barkun peptic ulcers. Recommendation 1, 100 % agreed, et al. was different from Sachs’s report with respect to evidence level A. significant improvement in mortality. Result of Barkun’s meta-analysis reflects to our statement. Comment: Compared with placebo, intravenous PPI ther- apy after endoscopic treatment for hemorrhagic peptic CQ. What type of peptic ulcer bleeding is indication for ulcers has been proven to reduce the rate of re-bleeding, the endoscopic hemostasis? volume of blood transfusion, the period of admission, and the rate of converting to surgery in two meta-analyses [9, • Active bleeding and ulcer with non-bleeding visible 10] and some randomized controlled trials (RCTs). High- vessel is a good indication for endoscopic hemostasis. dose PPI therapy was more effective in reducing the vol- Recommendation 1, 100 % agreed, evidence level A. ume of blood transfusion compared with ordinary-dose of Comment: In meta-analysis of Sachs et al. [2], they defined PPI therapy [11]. There was no significant difference cases of peptic ulcer with active bleeding and non-bleeding between intravenous and oral PPI therapy. visible vessels were indication for endoscopic hemostasis. The effectiveness of an intravenous medication of his- Two non-randomized control studies [4, 5] reported tamine 2-receptor antagonist (H2RA) therapy after endo- endoscopic therapy of nonbleeding adherent clots signifi- scopic treatment for hemorrhagic peptic ulcers is cantly reduced ulcer re-bleeding rates in high-risk patients controversial. Selby et al. [10] reported that H2RA therapy compared with medical therapy alone. On the other hand, significantly reduced the rate of converting to surgery randomized study reported effect of combination therapy compared with placebo, while Carr-Loche et al. [12] [endoscopic hemostasis ?proton pump inhibitor (PPI)] with reported that H2RA therapy did not reduce it. 123 guide.medlive.cn J Gastroenterol PPI therapy has been considered more effective than peptic ulcers cured by conservative treatment. Recom- H2RA therapy with respect to the rate of re-bleeding [13], mendation 1, 100 % agreed, evidence level A. volume of blood transfusion [9], period of admission [9], Comment: The effectiveness of H. pylori eradication rate of conversion to surgery, suppression of gastric acid, therapy after healing of a hemorrhagic peptic ulcer to arterial bleeding, and gastric ulcer after endoscopic treat-