| Methods |
Study Design: Parallel Randomised Controlled Trial
Randomisation: Random stated: Method ‐ alternation
Concealment of Allocation: Alternation ‐ inadequate
Double‐Blinding: Not stated or described
Withdrawals/Dropouts: Not described
Adverse Events: Not described
Statistical Analysis: Described |
| Participants |
Number randomised: 62
Number completed: not reported
Mean age (range): 52 (36‐65)
Diagnostic Criteria for Asthma: as per ATS
Diagnostic Criteria for GOR: Manometry, Acid perfusion test. Symptomatic GOR was not required for entry nor reported.
Association between GOR & Asthma tested? No ‐ not required for entry
H‐Pylori Tested?: No
Other diseases included: Not specified
Major exclusions: Not specified
Baseline severity of asthma: stated "more severe" p 191. Mean FEV1 pre bronchodilator 2.16 l/min
Baseline Severity of GOR: Not stated
Baseline Complications of GOR: hiatal hernia 55%; dysmotility 58%, positive acid perfusion test 35% and decreased lower esophageal sphincter pressure 40%. |
| Interventions |
Conservative treatment of GOR including: elevation of head of bed; warm water after meals; avoid food 3 hours before bed time; refrain from aspirin &/or anticholinergic drugs; avoid procedures which raise intra‐abdominal pressure.
Control group were informed there was a suspicion of esophageal dysfunction but that results had to be checked in two months time. Both groups kept diaries of asthma drugs.
Duration of intervention: 8 weeks
Asthma medications were considered optimal at the time of entry into the study. |
| Outcomes |
Duration over which outcomes were measured: a comparison between the first and the third month was made for asthma medications. Patient reported improvement in symptoms was noted at the 2 month follow‐up.
Asthma symptoms (number who self‐reported an improvement) dyspnoea, wheeze, cough, expectoration; FEV1; beta‐agonist use;GOR symptoms (number who self‐reported an improvement). |
| Notes |
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| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Allocation concealment? |
High risk |
Investigators aware as to order of treatment group assignment (Cochrane Grade C) |
