| Methods |
Design: six group parallel trial
Purpose: to examine the effect of psycho‐ and pharmacotherapy on psychiatric out‐patients |
| Participants |
Patients: out‐patients with neuroses, borderline schizophrenia or personality disorders
Baseline comparability: yes (rating scales) |
| Interventions |
Placebo: capsule without meprobamate, phenobarbital or
prochlorperazine
Untreated: no capsule (waiting list group)
Experimental: capsule with ‐meprobamate
‐phenobarbital
‐prochlorperazine
(Co‐intervention: NS) |
| Outcomes |
Patient's rating (anxiety, tension, irritability, concentration, alertness, mood, sleep, appetite, general feeling)
Rating by relative and patient (getting along, nervousness, happiness, ability to handle personal problems, energy, physical health, presenting symptoms or problems, ability to work, ability to enjoy life, overall condition)
MMPI (Minnesota Multi phasic Personality Inventory)
Social Worker Interview Evaluation |
| Notes |
Number of patients assigned to untreated group was 34 contrasting the number in the other groups which had 50 to 54 patients. Relevant outcome data not accessible |
| 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 |
'Used a double‐blind method of administration of drugs' |
| 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? |
High risk |
Relevant outcome data not accessible |
| Free of other bias? |
Low risk |
|
| Trial size > 49? |
Low risk |
N = 89 |
| Clearly concealed allocation + trial size > 49 + drop‐out max 15% |
High risk |
Drop‐out >15% or NS |
