| Methods |
Randomized controlled trial with allocation concealment, blinding of all participants and investigators. Analysed by intention to treat. Central computer code held by pharmacy. |
| Participants |
180 participants with clinical DCI (excluding CAGE) from three centres. |
| Interventions |
Control: recompression on physician choice table (88% had USN TT6), placebo medication at first air break and daily for seven days, recompression as clinically indicated to plateau of symptoms or complete resolution plus one further treatment.
Active: as above, but active medication with tenoxicam 20 mg per dose. |
| Outcomes |
Death, outcome functional score (see table 02), number of compression cycles required. |
| Notes |
|
| Risk of bias |
| Bias |
Authors' judgement |
Support for judgement |
| Random sequence generation (selection bias) |
Low risk |
"Allocation was achieved using a computer generated, randomised schedule stratified by admission grade" |
| Allocation concealment (selection bias) |
Low risk |
Figure 1 indicates allocation after entry into study. "Allocation was achieved using a computer generated, randomised schedule stratified by admission grade." |
| Blinding (performance bias and detection bias)
All outcomes |
Low risk |
"Only the trial pharmacist knew the schedule, while the investigators, subjects, treating physicians and outcome assessors were all unaware of group allocation." |
| Blinding of participants and personnel (performance bias)
All outcomes |
Low risk |
As above |
| Blinding of outcome assessment (detection bias)
All outcomes |
Low risk |
As above |
| Incomplete outcome data (attrition bias)
All outcomes |
Low risk |
".. giving a loss at final follow‐up of 16 patients (8.9%)" |
| Selective reporting (reporting bias) |
Low risk |
All indicated outcomes were reported |
| Other bias |
Unclear risk |
Nil other bias detected |
