Background
Methods
Design
Eligibility criteria
Participants
Interventions
Comparators
Outcomes
Search strategies to identify studies
Study selection and screening
Data extraction and risk of bias assessment
Data synthesis
Results
Characteristics of included studies
Study author, year, country, study design | Participants, condition or symptom, setting, age | Intervention | Comparison | Co-interventions | Outcomes assessed in this review |
---|---|---|---|---|---|
Morales et al., 2020, Columbia cross-over RCT [29] | 65 participants with GORD-associated sleep disturbance recruited from a hospital outpatient unit with mean age of 56 years | Bed blocks + PPIs and/or sodium alginate Head-of-bed elevation for 6 weeks at home using 20 cm wooden blocks under bed | Lying flat No Head-of-bed elevation as clinically indicated. | PPIs and/or sodium alginate | Gastroesophageal reflux symptoms Patient preferences Adverse Events |
Huang et al., 2019, Taiwan, cross-over RCT [28] | 14 participants with oesophageal cancer and nocturnal reflux symptoms or reflux esophagitis, recruited from hospital database, with mean age of 62 years | Sleeping on a Wedge + PPIs Using a 20 cm high wedge-shaped pillow at home (with an elevation angle of 20 degree) for 2 weeks + PPIs | PPIs only Not using the pillow for 2 weeks | One pillow of ≤8 cm high | Gastroesophageal reflux symptoms |
Hamilton et al., 1988, United States, cross-over RCT [27] | 15 participants with chronic reflux symptoms and endoscopic evidence of erosive esophagitis, recruited from hospital outpatients, aged between 51 and 74 years | Sleeping on a Wedge Using a 25 cm high foam wedge (with an elevation angle of 22 degree) for one night. Bed blocks Head-of-bed elevated using 20 cm high metal cones under the bed legs for one night. | Lying flat One pillow on a standard hospital bed for one night. b | All anti-reflux medications stopped. Other chronic medications allowed. | Intra-oesophageal pH measurement (Acid exposure/reflux episodes/acid clearance time) Patient preferences |
Harvey et al., 1987, United Kingdom, factorial RCTa [26] | 71 participants with severe gastro-oesophageal reflux, recruited from a hospital, with a median age of 59 years | Bed blocks Head-of-bed raised on 20 cm blocks (with 10% elevation slope) for 6 weeks at home. | Lying flat No bed elevation | Antacid tablets as needed | Gastroesophageal reflux symptoms Adverse Events |
Stanciu et al., 1977, United Kingdom, cross-over trial [25] | 63 participants with typical symptoms of Gastroesophageal reflux, recruited within a hospital, with mean age of 49 years | Bed blocks Head-of-bed elevated with 28 cm blocks during part of the night Sleeping on a Wedge Sitting propped up during part of the night | Lying flat One or two pillows during part of the night | None | Gastroesophageal reflux symptoms Intra-oesophageal pH measurement (Acid exposure/reflux episodes/acid clearance time) |
Risk of bias assessment
Main findings
Studies | Patient-reported gastroesophageal reflux symptoms | Intra-oesophageal pH measurement | Preferences | Adverse events |
---|---|---|---|---|
Morales, 2020, Columbia cross-over RCT [29] | Outcome measures (validated) Reflux Disease Questionnaire Score, a 6-point score, with a higher score meaning a worse outcome and a change of ≥0.6 points considered clinically meaningful Findings (improved) Mean difference (MD) in change scores at 6 weeks of 1.327, 95% CI 0.626 to 2.027. 27 of 39 [69.2%] participants in the head-of-bed elevation group were more likely to report a clinically meaningful change of ≥10% in their symptom scores at 6 weeks compared to 13 [33.3%] in the control group. Risk ratio (RR) of 2.08; 95% CI 1.19 to 3.61). | NR | 63.2% (95% CI 50.6 to 75.7%) of the 57 participants preferred the head of bed elevation to control. | 39 of 63 participants in head-of-bed elevation group reported adverse events at 14 weeks compared to none on the control group (of 54): 20 bed slipping; 4 bed unsteadiness; 10 varicose vain pain; 7 musculoskeletal pain; and 1 sexual activity interference and headache each. |
Huang, 2019, Taiwan, cross-over RCT [28] | Outcome measures (validated) Modified Dysfunction after Upper Gastrointestinal Surgery, a 30-point score, with higher scores means better outcomes. Findings (improved) MD in change scores at 2 weeks − 5.1, 95% CI − 7.6 to − 2.6 | NR | NR | NR |
Hamilton, 1988, United States, cross-over RCT [27] | NR | Outcome measures Acid exposure, defined as percent of total time intra-oesophageal pH remained ≤4; Reflux episodes, defined as drop of intra-oesophageal pH to < 4; Acid clearance time, defined as the total time that intra-oesophageal pH < 4 by the number of reflux episodes. Findings (improved) A reduction in acid exposure in both sleeping on a wedge (mean% 14.8, 95% CI 12.2 to 17.5 vs control: 21.2, 95% CI 18.4 to 23.7) and head-of-bed elevation groups (mean% 15.3, 95% CI 11.7 to 18.8 vs control: 21.2, 95% CI 18.4 to 23.7) compared to the control. A non-statistically significant reduction in the number of reflux episodes and acid clearance time in any of the two groups compared to the control. | 60% (9 of 15) preferred head-of-bed elevation, 33.3% (5 of 15) preferred sleeping on wedge, and 6.7% (1 of 15) preferred neither. | NR |
Harvey, 1987, United Kingdom, factorial RCT [26] | Outcome measures An overall improvement in symptoms and a 4-point-sclae of gastroesophageal reflux, retrosternal pain, epigastric pain, and dysphagia. Findings (improved) 23 of 32 [71.9%] participants in the head-of-bed elevation group are more likely to report an overall improvement in symptoms at 6 weeks compared to 17 of 31 [54.8%] - unadjusted OR 2.1, 95% CI 0.74 to 5.99; adjusted OR 3.1, X2 = 4, p < 0.005. A statistically significant reduction in symptom scores of gastroesophageal reflux and retrosternal pain but not epigastric pain and dysphagia. | NR | NR | 2 of 32 participants in the head-of-bed elevation group reported adverse events both resolved and neither discontinued: 1 bed slipping and 1 sexual activity interference. |
Stanciu, 1977, United Kingdom, cross-over trial [25] | Outcome measures Number of reflux symptoms (i.e. heartburn or acid regurgitation) Findings (improved) Compared to control group, a statistically significant reduction in the number of reflux symptoms during the intervention (6 h) in the head-of-bed elevation group (2.0 ± 1.2 vs. 3.0 ± 2.4) and sleeping on a wedge groups (2.4 ± 1.4 vs. 3.4 ± 2.2). | Outcome measures Acid exposure, defined as percent of total time that intra-esophageal pH remained < 4; Reflux episodes, defined as a drop in intra-esophageal pH by 2; Acid clearance time, defined as the total duration of reflux by the number of reflux episodes. Findings (improved) A statistically significant reductions in acid exposure and reflux episodes in the head-of-bed elevation group (acid exposure: 6.7 ± 7.6; reflux episodes per participant: 3.7 ± 1.9) compared to control group (acid exposure: 14.0 ± 15.3; reflux episodes per participant: 6.2 ± 3.9) but no significant difference in sleeping on a wedge group compared to control group in terms of acid exposure (7.7 ± 11.7 vs 8.9 ± 9.7) and reflux episodes (5.4 ± 3.8 vs. 4.8 ± 3.2). | NR | NR |