| Methods |
Design: three group, three period cross‐over trial
Purpose: examine the effect of labetalol on hypertension |
| Participants |
Patients: in‐patients with essential hypertension
Baseline comparability: yes |
| Interventions |
Placebo: tablet without labetalol
Untreated: no tablet
Experimental: tablet with labetalol
(Co‐intervention: No) |
| Outcomes |
Diastolic 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. |
| 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? |
Unclear risk |
No protocol available |
| Free of other bias? |
Unclear risk |
The outcome data from this cross‐over trial was not available from the first period only, and was calculated as deriving from a parallel group trial. |
| No signs of variance inequality or skewness? |
Low risk |
No variance inequality (F‐test not statistically significant) and no skewness (1.64 standard deviations does not exceed the mean) |
| Trial size > 49? |
High risk |
N = 12 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
