Kanayama 2005.
| Methods | Single‐centre RCT | |
| Participants | 40 outpatients (50% men), mean age 32.7 years Inclusion criteria: patients with LBP and sciatic symptoms, associated with an L4L5 or L5S1 herniated disc, seeking treatment at the orthopaedic department of a hospital. Pain duration: 14 patients < 1 months, 18 patients 1 to 3 months, and 8 patients > 3 months. Exclusion criteria: patients referred for surgical treatment with indicators as presence of cauda equina syndrome or drop foot |
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| Interventions | Treatment duration 14 days, follow‐up duration 14 days (i) Control group: sarpogrelate, a 5‐HT2A inhibitor; orally 300 mg OD (ii) NSAID group: diclofenac orally 75 mg OD |
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| Outcomes | Pain: In both groups significant decrease of pain (VAS 0 to 100) from baseline to day 14. No significant difference between the groups. No significant difference between the groups regarding back pain, leg pain, or leg numbness. Disability: Not assessed. Global improvement: Improvement rate (%) = (baseline VAS score ‐ postintervention VAS score)/baseline VAS score x 100%: 33% (i) and 46% (ii) for low back pain, 32% (i) and 32% (ii) for leg pain, and 35% (i) and 32% (ii) for leg numbness, respectively. Additional drug use: Supplemental NSAID needed (i) n = 11, (ii) n = 6. Other outcomes: No Adverse effects: The trial did not report information on side effects. The pharmaceutical company reported the following information from unpublished sources: overall side effects: 2% in 5‐HT2A inhibitor group (out of 4807 participants) and 8% in NSAID group (out of 35,653 participants). Gastrointestinal side effects: 7% in 5‐HT2A inhibitor group and 1% in NSAID group). |
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| Notes | No withdrawals. 4 participants (20%) who received 5‐HT2A inhibitor treatment and 6 participants (30%) who received NSAIDs eventually underwent surgery for unremitting sciatic symptoms or muscle weakness. Funding: Mitsubishi Pharma Corp is mentioned in the trial |
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| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Low risk | 40 envelopes, 20 for each treatment group |
| Allocation concealment (selection bias) | Low risk | Sealed envelopes used, but whether or not they are opaque is not mentioned |
| Blinding of participants and personnel (performance bias) All outcomes | Unclear risk | Not addressed for the personnel; for the participants randomisation was used by creating 40 envelopes |
| Blinding of outcome assessment (detection bias) All outcomes | Unclear risk | Not addressed |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No drop‐out |
| Selective reporting (reporting bias) | Low risk | Prespecified outcomes reported, no study protocol |
| Group similarity at baseline | Unclear risk | Limited baseline characteristics presented (age, gender, level of herniation) |
| Influence of co‐interventions | Low risk | Only allocated medication for 14 days, after that participants were free to choose |
| Compliance with interventions | Unclear risk | Not addressed |
| Funding | Unclear risk | Mitsubishi Pharma Corp mentioned |
| Other bias | Unclear risk | Small trial |