Short-term treatment with proton pump inhibitors, H2-receptor antagonists and prokinetics for gastro-oesophageal reflux disease-like symptoms and endoscopy negative reflux disease

 

Abstract

Background

Approximately 25% of adults regularly experience heartburn, a symptom of gastro-oesophageal reflux disease (GORD). Most patients are treated empirically (without specific diagnostic evaluation e.g. endoscopy. Among patients who have an upper endoscopy, findings range from a normal appearance, mild erythema to severe oesophagitis with stricture formation. Patients without visible damage to the oesophagus have endoscopy negative reflux disease (ENRD). The pathogenesis of ENRD, and its response to treatment may differ from GORD with oesophagitis.

Objectives

Summarise, quantify and compare the efficacy of short-term use of proton pump inhibitors (PPI), H2-receptor antagonists (H2RA) and prokinetics in adults with GORD, treated empirically and in those with endoscopy negative reflux disease (ENRD).

Search methods

We searched MEDLINE (January 1966 to November 2008), EMBASE (January 1988 to November 2008), and EBMR in November 2008.

Selection criteria

Randomised controlled trials reporting symptomatic outcome after short-term treatment for GORD using proton pump inhibitors, H2-receptor antagonists or prokinetic agents. Participants had to be either from an empirical treatment group (no endoscopy used in treatment allocation) or from an endoscopy negative reflux disease group (no signs of erosive oesophagitis).

Data collection and analysis

Two authors independently assessed trial quality and extracted data.

Main results

Thirty-two trials (9738 participants) were included: fifteen in the empirical treatment group, thirteen in the ENRD group and four in both. In empirical treatment of GORD the relative risk (RR) for heartburn remission (the primary efficacy variable) in placebo-controlled trials for PPI was 0.37 (two trials, 95% confidence interval (CI) 0.32 to 0.44), for H2RAs 0.77 (two trials, 95% CI 0.60 to 0.99) and for prokinetics 0.86 (one trial, 95% CI 0.73 to 1.01). In a direct comparison PPIs were more effective than H2RAs (seven trials, RR 0.66, 95% CI 0.60 to 0.73) and prokinetics (two trials, RR 0.53, 95% CI 0.32 to 0.87).
In treatment of ENRD, the RR for heartburn remission for PPI versus placebo was 0.73 (eight trials, 95% CI 0.67 to 0.78) and for H2RA versus placebo was 0.84 (two trials, 95% CI 0.74 to 0.95). The RR for PPI versus H2RA was 0.78 (three trials, 95% CI 0.62 to 0.97) and for PPI versus prokinetic 0.72 (one trial, 95% CI 0.56 to 0.92).

Authors' conclusions

PPIs are more effective than H2RAs in relieving heartburn in patients with GORD who are treated empirically and in those with ENRD, although the magnitude of benefit is greater for those treated empirically.

 

Plain language summary

Short-term treatment with medications for heartburn symptoms.

Patients with only mild or intermittent heartburn may have adequate relief with lifestyle modifications and antacids, although other options are available. The two most commonly used drugs for treatment of heartburn are H2-receptor antagonists (H2RAs) and proton pump inhibitors (PPIs). These drugs act by suppressing the discharge of acid from the stomach. This review found that in the short term PPIs relieve heartburn better than H2RAs in patients who are treated without specific diagnostic testing and, although the difference is smaller, in patients with GORD who have a normal upper endoscopy too. In summary, proton pump inhibitor drugs appear to be more effective than H2-receptor antagonists for relieving heartburn, the cardinal feature of "gastro-oesophageal reflux disease" (GORD).

 

摘要

背景

對於內視鏡陰性卻有胃食道逆流症狀的病患，使用質子幫浦抑制劑、H2受體拮抗劑和促進腸胃蠕動藥物之短期治療

大約25%的成人經歷過每月至少一次心灼熱的經驗，此症狀為胃食道逆流的基本特徵。胃食道逆流的評估和治療通常會有重大的經濟負擔。大多數患者都是接受經驗性治療(無特定的診斷評估)。它們包括範圍廣泛的潛在食道損傷。食道損傷的嚴重程度需由內視鏡確定。內視鏡發現無明顯食道損傷稱之為內視鏡陰性胃食道逆流。內視鏡陰性胃食道逆流的病理機轉以及治療反應，與具有食道炎的胃食道逆流截然不同。

目標

對於成人內視鏡陰性胃食道逆流的治療，使用質子幫浦抑制劑、H2受體拮抗劑和促進腸胃蠕動藥物之短期治療，總結，量化和比較其功效。

搜尋策略

作者搜查了Cochrane Central Register of Controlled Trials(Cochrane圖書館第4期，2005年)、MEDLINE(1966年1月至2005年12月)、EMBASE(1988年1月至2005年12月)。

選擇標準

對於胃食道逆流的治療,使用質子幫浦抑制劑, H2受體拮抗劑和促進腸胃蠕動藥物之短期治療,隨機對照試驗的重點放在治療後的症狀結果。被納入的研究中，參與者可歸為二類,一類是在經驗治療組(治療分配沒有內視鏡確定),另一類為內視鏡陰性胃食道逆流(內視鏡發現沒有食道炎糜爛跡象)。

資料收集與分析

兩位作者獨立評估試驗品質和提取數據。

主要結論

共有31個試驗(9457位參與者)被納入：15個試驗為經驗治療組，12個為內視鏡陰性胃食道逆流組，4個試驗為合併二者。胃食道逆流經驗性治療與安慰劑對照試驗比較，胃灼熱緩解的相對風險率為0.37 (2個試驗，95%信賴區間為0.32至0.44)，與H2RAs試驗比較，胃灼熱緩解的相對風險率為0.77 (2個試驗，95%信賴區間為0.60至0.99)與prokinetics試驗比較，胃灼熱緩解的相對風險率為0.86 (1個試驗，95%信賴區間為0.73至1.01)。質子幫浦抑制劑比H2受體拮抗劑更有效(7個試驗，其相對風險率為0.66，95%信賴區間為0.60至0.73)，亦比prokinetics有效(2個試驗，其相對風險率為0.53 ，95%信賴區間為0.32至0.87)。治療內視鏡陰性胃食道逆流，質子幫浦抑制劑與安慰劑相比較，其心灼熱緩解的相對風險率是0.69 (7個試驗中，95%信賴區間為0.62至0.78)，H2RA與安慰劑相比較的相對風險率為0.84 (2個試驗，95%信賴區間為0.74至0.95)。質子幫浦抑制劑與H2RA相比較，其心灼熱緩解的相對風險率為0.78 (3個試驗，95%信賴區間為0.62至0.97)，質子幫浦抑制劑與促進腸胃蠕動藥物相比較，其心灼熱緩解的相對風險率為0.72 (1個試驗，95%信賴區間為0.56至0.92)。

作者結論

胃食道逆流接受經驗治療或是內視鏡陰性胃食道逆流接受治療，質子幫浦抑制劑比H2RAs更有效緩解心灼熱，但經驗治療得到規模更大的好處。

翻譯人

本摘要由臺中榮民總醫院周佳滿翻譯。

此翻譯計畫由臺灣國家衛生研究院(National Health Research Institutes, Taiwan)統籌。

總結

質子幫浦抑制劑比H2RAs更有效緩解胃灼熱，此症狀為胃食道逆流的基本特徵。患者只有輕微或間歇性胃灼熱可能只需要適當的生活方式改變和制酸劑，但仍有其他方法可用。這兩個最常用的藥物治療心灼熱為質子幫浦抑制劑和H2受體拮抗劑(H2RAs)。這些藥物作用透過抑制胃酸分泌。本篇回顧發現，在短期治療胃食道逆流，包括無內視鏡證實或是內視鏡陰性之胃食道逆流，質子幫浦抑制劑緩解心灼熱的效果比H2受體拮抗劑好。