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. 2015 Jul 15;2015(7):CD007887. doi: 10.1002/14651858.CD007887.pub3

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
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
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
Outcomes
  1. Number of participants with a conservative supplementary therapeutic option offered

  2. Change in pain severity ("sum of pain") during the treatment period

  3. Number of any possible adverse events

  4. Missing data (withdrawals, drop‐outs and participants lost to follow‐up)

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
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)