Meta AnalysisID 2742
组胺H2受体拮抗剂治疗功能性消化不良：系统评价和Meta分析
CRD42019127924
How effective are Histamine H2 antagonists for the treatment of functional dyspepsia in adults compared to placebo or prokinetics?
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Record Fields
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- Meta Analysis Id
- 2742
- Evidence Id
- 11300
- Core Evidence Id
- 11300
- Source Meta Analysis Id
- 2692
- Herb2 Meta Analysis Id
- HBMA002692
- Crd Id
- CRD42019127924
- Title
- Histamine H2 antagonists for functional dyspepsia: a systematic review and meta-analysis
- Review Question
- How effective are Histamine H2 antagonists for the treatment of functional dyspepsia in adults compared to placebo or prokinetics?
- Study Type Included
- Only randomized controlled trials (RCTs) reporting the efficacy of H2RAs in people with FD defined by the Rome Criteria will be included. Quasi‐RCTs, cross‐over trials, cluster‐randomized trials, and other study designs will be excluded.
- Condition Being Studied
- Functional dyspepsia (FD) is a common gastrointestinal disorder, defined as continuous or frequently recurring epigastric pain or discomfort not explained by structural or biochemical abnormalities. The current Rome IV criteria divide FD into two subtypes: postprandial distress syndrome (PDS) and epigastric pain syndrome (EPS). The prevalence of FD has been reported to vary widely from 5% to 40%, and the disorder follows a relapsing and remitting course. FD has not only negative impact on quality of life, but also induces enormous direct and indirect costs due to absenteeism and work output. In the USA costs for FD have been calculated as high as $18.4 billion per year. The clinical management of FD is therefore important. Unfortunately, as the etiology and pathophysiology of FD are not yet well understood, there is no definitive and effective therapy applied to all individuals. The main therapeutic strategies for FD include histamine H2 antagonists (H2RA), prokinetic agents, proton pump inhibitors (PPIs), antidepressants, and H. pylori eradication therapy. Acid suppression drugs such as PPIs and H2RA are commonly used to treat FD. Even in EPS, acid suppression therapy is a first line therapy; however, the efficacy and safety of these drugs remain controversial.
- Participant
- We will include studies involving adult patients aged over 18 years with FD defined by the Rome Criteria (I to IV), who presented with dyspepsia symptoms including epigastric pain/discomfort and who had a normal or insignificant findings on upper endoscopy as well as no other organic and metabolic disorders. Studies involving participants with other gastrointestinal conditions, such as peptic ulcer, organic dyspepsia and reflux disease with primarily reflux or heartburn symptoms will be excluded.
- Animal
- Human Disease Modelled
- Intervention
- H2RAs are one of the most widely used acid-suppressive agents. H2RAs act by competitive inhibition of histamine at H2 receptors located on the parietal cells, so that gastric acid secretion is reduced. Evidence from randomized controlled trials (RCTs) suggests that H2RAs are superior to placebo in FD. Further, closer study of the meta-analysis data reveals H2RAs may be more efficacious than PPI although the H2RAs data are admittedly more heterogeneous. In practice, this prescription is not recommended as a first‐line therapy but as an alternative to PPIs, and some patients find them helpful even if PPIs have failed. Some trials reported that H2RAs had minor adverse effects such as headache, dizziness, fatigue, constipation and diarrhea, etc. Up to now, It is still difficult to establish whether H2RA therapy has efficacy in FD.
- Comparator Control
- We will include trials comparing oral administration of any dose of any H2RAs available (cimetidine, ranitidine, famotidine, nizatidine) with placebo or prokinetics. A combination of treatments in either intervention or control groups will be included only if the combination of treatment was present in both groups.
- Main Outcome
- Improvement in global symptoms of dyspepsia, Preferably patient-reported outcomes at study end, but if that is not available then as assessed by a physician/ researcher. Moreover, We will use the most stringent definition of overall symptom improvement if more than one definition of symptom improvement is given. Measures of effect Outcomes may be measured as continuous (mean score pre- and post-treatment) and dichotomous (improved or not improved).
- Outcome Measure
- Additional Outcome
- Quality of life (QoL) and adverse events. Measures of effect Quality of life (QoL), measured using the 36‐Item Short Form Health Survey (SF‐36). The number of events in each group for adverse events will be measured.
- Study Method
- Meta-analysis, Systematic review
- Keyword
- Dyspepsia; Gastritis; Histamine H2 Antagonists; Humans
- Contact
- Juanjuan Li [email protected]
- Organisational Affiliation
- Xiyuan Hospital Affiliated to China Academy of Traditional Chinese Sciences http://www.xyhospital.com/
- Funding Source
- National Science Foundation of China（81673853）
- Other Selection Criteria
- Final Publication
- Same Topic Review
- Published Protocol
- Review Type
- Language
- English
- Country
- China
- Review Stage
- Review Ongoing
- First Submission Date
- 2019-03-19
- Registration Date
- 2019-06-07
- Anticipated Start Date
- 2019-03-26
- Anticipated Completion Date
- 2019-06-28
- Title Cn
- 组胺H2受体拮抗剂治疗功能性消化不良：系统评价和Meta分析
- Title En
- Histamine H2 antagonists for functional dyspepsia: a systematic review and meta-analysis
- Bilingual Status
- complete