Methods |
Randomised blind cross over controlled trial. |
Participants |
6 men, 9 women, mean age 44 yrs. |
Interventions |
Isosorbide dinitrate 5mg v. nifedipine 20mg sublingually. |
Outcomes |
LOS pressure; radiolabelled test meal of oesophageal retention. |
Notes |
|
Risk of bias |
Bias |
Authors' judgement |
Support for judgement |
Adequate sequence generation? |
Low risk |
Quote: "each received at random either ID or Nif sublingually". |
Allocation concealment? |
High risk |
Quote: "Because of the different routes of drug administration, the participants were not blinded as to whether they received ID or Nif". |
Blinding?
clinical response |
Low risk |
Quote: "the clinical response was assessed by the physician without knowing or asking which medication was given". |
Blinding?
Manometric examinations |
Low risk |
Quote:"Analysis of the manometric examinations was made without knowing which drug was administered.". |
Incomplete outcome data addressed?
All outcomes |
Low risk |
No incomplete outcome data. |
Free of selective reporting? |
Low risk |
Yes |
Free of other bias? |
Low risk |
Yes |