| Methods |
Design: five group parallel trial
Purpose: examine the effect of pharmacological treatment in addition to psychotherapy in patients with anxiety and hostility |
| Participants |
Patients: out‐patients with anxiety and hostility admitted to a veteran's Mental Hygiene Clinic for psychotherapy
Baseline comparability: NS |
| Interventions |
Placebo: tablet containing lactose but not chlorpromazine, meprebomate or phenobarbital
Untreated: no tablet (observational group)
Experimental:
‐tablets with chlorpromazine
‐tablet with meprobamate
‐tablet with phenobarbital
(Co‐intervention: sessions of individual psychotherapy) |
| Outcomes |
Anxiety (index)
Hostility
Discomfort |
| Notes |
42% drop‐outs. The standard deviation (SD) of the anxiety score was not reported. The SD was calculated from the reported F‐test statistic. |
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Adequate sequence generation? |
Unclear risk |
NS |
| Allocation concealment? |
Unclear risk |
NS |
| Blinding?
Treatment provider |
Low risk |
'...12‐week double‐blind study' |
| Blinding?
Outcome assessor |
Unclear risk |
Not relevant as patient reported outcome |
| 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? |
Low risk |
N = 80 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out > 15% or NS |
