Langemark 1993.
Methods | Multicentre, double‐blind, randomised, response‐conditional cross‐over study: paroxetine vs sulpiride No control for symptomatic/analgesic medications use | |
Participants | Country: Denmark
N = 50; Sex: 20 male, 30 female
Mean age: 42 (range 20 ‐ 70) Diagnosis: Chronic tension‐type headache (not defined) of at least 6 months duration and no more than 14 headache‐free days per months Exclusion criteria: patients suffering migraine more than one day per month; moderate or severe cardiovascular disease or other chronic disease Recruitment: mailed questionnaire among patients from a private neurology clinic and a neurological hospital department |
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Interventions | N = 25 first treated with paroxetine to a maximum of 30 mg/day N = 25 first treated with sulpiride to a maximum of 100 mg/day Active treatment: 16 weeks (8 weeks + 8 weeks, no in‐between washout period if patients crossed over) | |
Outcomes | 1. Severity Index (5 ordinal scale: a. 'no headache'; b. 'slight'; c. 'moderate'; d. 'very troublesome'; e. 'worst possible') 2. Patient's global Evaluation drug performance (5 ordinal scale: a. 'worthless'; b. 'poor'; c. 'fair'; d. 'good'; e. 'excellent') 3. Observer's Global Evaluation drug performance (5 ordinal scale: a. 'worthless'; b. 'poor'; c. 'fair'; d. 'good'; e. 'excellent') 4. Symptomatic/analgesic drug consumption 5. Side effects (4 ordinal scale: a. 'none'; b. 'slight'; c. 'moderate'; d. 'severe = discontinues drug') | |
Notes | First 8 weeks: 10 dropouts (20%):
13 patients crossed over to sulpiride after paroxetine for no response or intolerable side effects, while 10 crossed over to paroxetine after sulpiride Per protocol analyses |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information |
Allocation concealment (selection bias) | Unclear risk | No information |
Blinding (performance bias and detection bias) All outcomes | High risk | Drugs identical in appearance (but the two groups received different numbers of tablets) |
Incomplete outcome data (attrition bias) All outcomes | High risk | Moderate dropout rate, unbalanced, reasons partially reported |
Selective reporting (reporting bias) | Unclear risk | No information |
Other bias | Unclear risk | Financial support not reported |