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. 2016 Oct 15;2016(10):CD012382. doi: 10.1002/14651858.CD012382

Goldie 1968a.

Methods RCT; double‐blind, placebo‐controlled trial
Participants 50 inpatients and 5 outpatients with true sciatica, low back pain with irradiation down either leg were included. Duration of symptoms did not exceed 3 weeks
Interventions Treatment duration 16 days, follow‐up duration 7 and 14 days
(i) NSAID group: indomethacin 25 mg 3 times daily (n = 25)
(ii) Control group: placebo 3 times daily in identical capsules (n = 25)
No other drugs and no physical therapy allowed during the treatment duration
Outcomes Pain: Daily registration of pain, results not reported.
Disability: Not assessed. Clinical tests including straight leg raise test were performed daily. No difference between the groups at 7 and 15 days.
Global improvement: Relief in pain intensity using a scoring system: no recovery from initial pain (3 points), lessened pain (= fair relief, 2 points), no pain (= complete pain relief, 1 point). At day 7, 15 out of 25 participants in the NSAID group and 18 out of 25 in the placebo group reported a fair or complete relief of pain. After 14 days, 15 in the NSAID group and 18 in the placebo group reported fair or complete relief.
Additional drug use: No additional drug use allowed.
Other outcomes: None.
Adverse effects: Adverse effects were reported in 13/50 participants: headache (NSAID group n = 4, placebo n = 2), nausea (NSAID group n = 4, placebo n = 2), dizziness (NSAID group n = 0, placebo n = 1)
Notes Did not report on funding
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk No information given on how the random sequence was generated
Allocation concealment (selection bias) Low risk Only the manufacturer of the indomethacin and the identical placebo capsules knew the code
Blinding of participants and personnel (performance bias) 
 All outcomes Low risk Doctors, nurses, and participants were unaware of the treatment
Blinding of outcome assessment (detection bias) 
 All outcomes Low risk Doctors, nurses, and participants were unaware of the treatment
Incomplete outcome data (attrition bias) 
 All outcomes Unclear risk No reporting on missing data and ITT analysis
Selective reporting (reporting bias) Low risk The outcomes defined in the methods section were reported in the results. No protocol published
Group similarity at baseline Unclear risk Only limited information on baseline characteristics reported
Influence of co‐interventions Low risk No additional treatment during the intervention
Compliance with interventions Unclear risk Not addressed
Funding Unclear risk Not reported
Other bias High risk Small trial. The scale used for the outcome only allowed answers for the following responses: lessened pain, no pain, pain relief, therefore no deterioration could be reported