| Methods |
Design: four period, four group, cross‐over trial
Purpose: examine the effect of hospitalisation (habituation to the medical environment and rest in hospital bed) and placebo on arterial hypertension |
| Participants |
Patients: patients with untreated essential hypertension |
| Interventions |
Placebo: oval pink tablet
Untreated: no tablet
Experimental: hospitalisation
(Co‐intervention: NS) |
| Outcomes |
Diastolic arterial blood pressure (mm Hg)
Systolic arterial blood pressure (mm Hg)
Heart rate
Plasma renin activity
Plasma norepinephrine activity
Anxiety scores
Urinary catecholamines |
| Notes |
|
| 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 |
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 = 24 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Trial size < 49 |
