| Methods |
Design: three group parallel trial
Purpose: examine the effect of behavioural treatment on hypertension |
| Participants |
Patients: out‐patients with primary hypertension
Baseline comparability: yes (blood pressure) |
| Interventions |
Placebo: stressful life events were recorded and participants instructed to relax at home some time every day without any formal relaxation training
Untreated: waiting list
Experimental: 'Behavioural program' (deep muscle relaxation technique and anxiety management training)
(Co‐intervention: no) |
| Outcomes |
Diastolic blood pressure (mm Hg)
Urinary catecholamine concentration
Anxiety |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
High risk |
Not described as double‐blind (placebo/behavioural program) |
| Blinding?
Outcome assessor |
Low risk |
Automatic blood pressure measurement |
| Incomplete outcome data addressed?
All outcomes |
High risk |
Drop‐out > 15% or NS |
| Free of selective reporting? |
Unclear risk |
No protocol available |
| Free of other bias? |
Low risk |
|
| 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 = 13 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
