Gotshall 2000.
Methods | Randomised placebo‐controlled cross‐over study. | |
Participants | 8 (1 male and 7 female) participants with objectively diagnosed exercise‐induced asthma (> 10% drop in FEV1 after exercise). Mean age 23 years. All subjects used short‐acting rescue medications and none were on maintenance medications. Control group were 8 (4 male and 4 female) non‐asthmatics. Exclusion criteria: no participants had atopic asthma. |
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Interventions | All participants entered the study on their normal sodium diet for 1 week. Participants then consumed a low sodium diet (65 mmol of sodium a day by means of a meal plan) and randomly assigned to either high sodium limb or low sodium limb for 2 weeks. Thereafter, a 1‐week wash‐out period on a normal sodium diet followed, then all patients followed alternative diet for 2 weeks (crossover). In the low sodium limb participants consumed a low sodium diet and placebo tablets and participants in the high sodium limb consumed a low sodium diet (174 mmol of sodium/day). | |
Outcomes | FEV1, FVC, FEV1/FVC and PEFR pre‐exercise test and 1,5,10,15 minutes post‐exercise tests. | |
Notes | Author reply received (03/02/01) further information provided on allocation (drawing lots) | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Low risk | Allocation of treatment was done by drawing lots. |
Allocation concealment (selection bias) | Low risk | Treatments were drawn by lots so both participants and investigators blinded to the randomisation sequence. |
Blinding (performance bias and detection bias) All outcomes | Unclear risk | Described as blinded; no other information available. |
Incomplete outcome data (attrition bias) All outcomes | Low risk | |
Selective reporting (reporting bias) | Unclear risk | Not clear from information presented. |
Other bias | Unclear risk | Population recruited from an university population only. No calculation of power described. |