Feuerstein 1986.
Study characteristics | ||
Methods | Randomised, double‐blind, placebo‐controlled trial Study type: single‐centre study Location: Germany (Freiburg) Study design: parallel Randomisation: not described Allocation concealment: not described Blinding: blinding of participants and evaluation personnel Follow‐up period: until healing of the headache |
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Participants | Randomised: 16 (not described the number of participants initially allocated to each group) Excluded (post‐randomisation): 5 (not described how many from each group). Analysed: 11 (intervention group: 6; control group: 5) Gender (women): 6 (54%) Age (years); n (%): 4 (36.4%) 10 to 30 years old (intervention group 3; control group 1); 4 (36.4%) 31 to 50 years old (intervention group 1; control group 3); 3 (27.3%) > 50 years old (intervention group 2; control group 1) Baseline VAS score: not evaluated Inclusion criteria: patients with a diagnostic lumbar puncture performed, with no headache during the last week before the lumbar puncture and a severe headache Exclusion criteria: not described |
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Interventions |
Intervention group: oral theophylline 281.7 mg tablets (verum Euphyllin retard tablets) 3 times a day Control group: oral placebo tablets 3 times a day Co‐interventions: analgesics and hypotonic saline solution as needed |
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Outcomes |
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Notes | Post‐dural puncture headache (PDPH): Quote "Subjective severe headache occurring only after arising and ceasing within a few minutes after lying down.". (Page 217) Sum of pain: 1 = slight headache; 2 = intermediate headache and 3 = severe headache. 3 values per day Sample size calculation: not described |
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Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | Unclear risk | No information provided. Reported as randomised |
Allocation concealment (selection bias) | Unclear risk | No information provided |
Blinding (performance bias and detection bias) All outcomes | Low risk | Quote: "The placebo tablets, indistinguishable from the verum Euphyllin retard tablets (281.7 mg theophylline), were kindly provided by Byk Gulden Pharmazeutika, Konstanz, FRG." (Page 217) Quote: "Verum and placebo tablets were randomised so that neither the patient nor the examining medical staff knew the real content of the administered tablets." (Page 217) |
Incomplete outcome data (attrition bias) All outcomes | High risk | 5 of 16 participants randomised dropped out, with insufficient information provided Quote: "Five patients of 16 dropped out (transferal to other clinical departments, dismissal before the end of the study or insufficient compliance)." (Page 217) |
Selective reporting (reporting bias) | High risk | The study report fails to include results for a key outcome (PDPH persistence of any severity at follow‐up) that would be expected to have been reported for such a study |
Size of study | High risk | Total 11 (intervention group: 6; control group: 5) |