Javaheri 1996.
Study characteristics | ||
Methods | RCT with a cross‐over design | |
Participants |
Number randomised/analysed: 15 Sex (% male): 100% Age: not reported (adults) Inclusion criteria
Exclusion criteria
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Interventions |
Intervention group: theophylline (methylxanthine derivative) 3.3 mg/kg orally twice daily for 5 days Control group: placebo (inactive control) for 5 days Wash‐out period: 1 week Details of intervention: no further details Co‐interventions: optimal therapy, which included angiotensin‐converting‐enzyme inhibitors (in 13 participants), hydralazine (in 2 participants), digoxin (in 11 participants), isosorbide dinitrate (in 7 participants) and furosemide (in all 15 participants) |
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Outcomes |
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Notes |
Study funding source: supported by Merit Review grants from the US Department of Veterans Affairs Conflicts of interest: not reported |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | Quote: "The patients received placebo or theophylline orally twice daily for five days, in a randomised, double‐blind fashion." Comment: no further details; insufficient information to judge selection bias. |
Allocation concealment (selection bias) | Unclear risk | Quote: "The patients received placebo or theophylline orally twice daily for five days, in a randomised, double‐blind fashion." Comment: no further details; insufficient information to judge selection bias. |
Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Quote: "To maintain blinding, the patients were monitored during both the theophylline and the placebo phases of the study." Comment: no further details of how blinding was achieved. |
Blinding of outcome assessment (detection bias) All outcomes | Low risk | Quote: "The polysomnograms were scored blindly." |
Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing data. |
Selective reporting (reporting bias) | Unclear risk | There is insufficient information about the study protocol to judge reporting bias. |
Other bias | Low risk | The study appears to be free of other sources of bias. |