| Methods |
Design: two period, two group, cross‐over trial
Purpose: examine the effect of placebo on arterial hypertension |
| Participants |
Patients: out‐patients with untreated mild‐to‐moderate hypertension |
| Interventions |
Placebo: NS
Untreated: no placebo
(Co‐intervention: NS) |
| Outcomes |
Diastolic blood pressure (mm Hg)
Systolic blood pressure (mm Hg) |
| Notes |
The outcome data was not available from the first period only, and was calculated as deriving from a parallel group trial. The results from the trial were reported in two publications (without cross reference). In the original report there were 36 included patients, but in the subsequent report there appears only 26. The reported effect of placebo on diastolic blood pressure was higher in the second trial report. We decided to include the results from the original publication. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Unclear risk |
NS |
| Blinding?
Outcome assessor |
Unclear risk |
NS |
| Incomplete outcome data addressed?
All outcomes |
Low risk |
Drop out < 15% |
| Free of selective reporting? |
High risk |
No protocol available. Authors were contacted. They shared data after request from the involved journal. |
| Free of other bias? |
Low risk |
|
| No signs of variance inequality or skewness? |
Unclear risk |
Not relevant (not naturally positive continuous outcomes e.g. change) |
| Trial size > 49? |
Low risk |
N = 68 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Not clearly concealed allocation |
