Andreani (1990) |
Random sequence generation (selection bias) | Low risk | Quote: “the patients in each center were randomly assigned” |
Allocation concealment (selection bias) | Unclear risk | Not described |
Blinding of participants and personnel (performance bias) | High risk | Quote: “these treatments were not administered blindly” |
Blinding of outcome assessment (detection bias) | Unclear risk | Not described |
Incomplete outcome data addressed (attrition bias) | High risk | Quote: “Fourteen patients were lost to follow-up after a period of 4.9 ± 1.9 mo (propranolol=six, sclerosis=six, placebo=two)” |
Selective reporting (reporting bias) | Low risk | Both potential efficacy and complications were reported. Review authors do not believe that bias will be introduced. |
Conn (1991) |
Random sequence generation (selection bias) | Low risk | Quote: “the patients were randomly selected” |
Allocation concealment (selection bias) | Low risk | Quote: “using a sealed envelope technique and computer-generated randomization” |
Blinding of participants and personnel (performance bias) | Low risk | Quote: “double-blinded”, “The placebo and the propranolol tablets were identical in appearance” |
Blinding of outcome assessment (detection bias) | Low risk | Quote: “double-blinded”, “the patients were examined on each visit by a nurse and the postdoctoral fellow assigned to the study” |
Incomplete outcome data addressed (attrition bias) | Unclear risk | Not described |
Selective reporting (reporting bias) | Low risk | Both potential efficacy and complications were reported. Review authors do not believe that bias will be introduced |
Cales (1999) |
Random sequence generation (selection bias) | Low risk | Quote: “patients were randomized” |
Allocation concealment (selection bias) | Low risk | Quote: “by the opaque sealed envelope method” |
Blinding of participants and personnel (performance bias) | Low risk | Quote: “double-blinded”, “Patients and physicians were unaware of the treatment” |
Blinding of outcome assessment (detection bias) | Low risk | Quote: “double-blinded”, “Patients and physicians were unaware of the treatment” |
Incomplete outcome data addressed (attrition bias) | High risk | Quote: “In the propranolol group, 41 patients were lost to follow-up, compared with 32 in the placebo group” |
Selective reporting (reporting bias) | Low risk | Both potential efficacy and complications were reported. Review authors do not believe that bias will be introduced |
Merkel (2004) |
Random sequence generation (selection bias) | Low risk | Quote: “A total of 83 patients were randomized to” |
Allocation concealment (selection bias) | Low risk | Quote: “Randomization was generated by tables of random numbers, stratified by participating centers, prepared at the University of Padua, and administered by opaque sealed and consecutively numbered envelopes containing randomization” |
Blinding of participants and personnel (performance bias) | Low risk | Quote: “The single-blind study design was chosen” |
Blinding of outcome assessment (detection bias) | High risk | Quote: “The single-blind study design was chosen” |
Incomplete outcome data addressed (attrition bias) | High risk | Quote: “11 patients randomized to nadolol and 10 patients randomized to placebo were lost to follow-up” |
Selective reporting (reporting bias) | Low risk | Both potential efficacy and complications were reported. Review authors do not believe that bias will be introduced |
Groszmann (2005) |
Random sequence generation (selection bias) | Low risk | Quote: “patients were randomly assigned” |
Allocation concealment (selection bias) | Low risk | Quote: “The randomization code was generated by computer for each participating center” |
Blinding of participants and personnel (performance bias) | Low risk | Quote: “The study was an investigator-initiated, randomized, double-blind, placebo-controlled, clinical trial conducted at four sites” |
Blinding of outcome assessment (detection bias) | Low risk | Quote: “double-blinded”, “To maintain study blinding, the patient’s heart rate was measured by the study nurse and not by the investigators” |
Incomplete outcome data addressed (attrition bias) | Low risk | Quote: “The remaining 277 were excluded for the following reasons: …6 were lost to follow-up…” Patients who were lost to follow-up were excluded from the final analysis |
Selective reporting (reporting bias) | Low risk | Both potential efficacy and complications were reported. Review authors do not believe that bias will be introduced |
Sarin (2012) |
Random sequence generation (selection bias) | Low risk | Quote: “Patients were randomly assigned” |
Allocation concealment (selection bias) | Low risk | Quote: “All randomizations were done by computer-generated random numbers” |
Blinding of participants and personnel (performance bias) | Low risk | Quote: “single-blind” |
Blinding of outcome assessment (detection bias) | High risk | Quote: “single-blind” |
Incomplete outcome data addressed (attrition bias) | Low risk | Quote: “Another 14 patients were excluded because they dropped out before the completion of 6 months of study” Patients who were lost to follow-up were excluded from the final analysis |
Selective reporting (reporting bias) | Low risk | Both potential efficacy and complications were reported. Review authors do not believe that bias will be introduced |