Gupta 1995.
Methods | Randomised controlled cross‐over trial. The method of randomisation is not described in the report. The trial consisted of two phases, at the start of the second phase participants crossed over to receive the treatment they had not received in the first phase. The testing therapist was not aware of the treatment status of participant. Participants were examined by a physician at each visit for monitoring of side effects and compliance. All participants signed to give informed consent indicating their understanding of the risks and benefits of the study. | |
Participants | As far as can be determined from the report, the study took place in a single centre in the USA. Participants were 20 adult men, from 43 screened, all with cerebral infarction incurred during the previous year, which had resulted in aphasia. All had to be able to understand and sign to give the informed consent. The average age of the participants was 62 years, with a median 61. Two were left handed. Seventeen had a right hemi‐paresis. The mean phrase length of the participants' utterances was one to five words, with a score greater than 5 on the Auditory Comprehension subscore of the Western Aphasia Battery (WAB, Kertesz 1982). Exclusion criteria: Significant dysarthria Language other than English as first language Education level less than eighth‐grade or unable to read and write before the stroke Already receiving language therapy Uncontrolled hypertension Sensitivity to ergot alkaloids Significant renal or hepatic disease Receiving concurrent therapy with phenothiazines or butyrophenones. | |
Interventions | During first phase of study (weeks 1‐8) people received either bromocriptine or placebo. The drug or placebo was given as one capsule (5 mg) daily, increasing to 3 capsules (15 mg) by the third week.
During the second phase the participants crossed over to the alternative arm of the trial. A washover period of six weeks elapsed between the two stages, with the dose gradually reduced over 2 weeks, followed by 4 drug free weeks. Bromocriptine is a semi‐synthetic ergot alkaloid, which acts as a dopamine D2 agonist. |
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Outcomes | Each participant's speech and language and nonverbal cognitive abilities were evaluated at the beginning and end of each phase of the study, and also 6 weeks after the completion of the second phase (cross over period). Five evaluation sessions were performed in all. Language tests used were the Western Aphaaia Battery (WAB, Kertesz 1982), and the Boston Naming Test (Kaplan 1983). Non verbal skills were tested with selected subtests of the Wechsler Memory Scale‐ Revised, including Figure Memory, Visual Paired Associates, Visual Reproduction 1, and Visual Memory subtests (Wechsler 1987), Raven's Progressive Matrices (Raven 1962), and the Rey‐Osterrieth Figure (Rey‐Osterrieth 1944). All measures were taken by a speech and language pathologist who was blinded to the treatment status of the person being assessed. Participants were also blinded to their own treatment status. | |
Notes | It is not made explicit in the report whether the placebo and the bromocriptine tablets tasted or smelled the same. | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Allocation concealment? | Unclear risk | B ‐ Unclear |