- In patients with chronic low back pain and Modic changes at the level of a previous disc herniation, 3 months amoxicillin treatment did not provide a clinically important benefit compared with placebo.
Why this matters
- Findings do not support the use of antibiotics treatment for chronic low back pain and Modic changes.
- 180 patients with chronic low back pain, previous disc herniation and type 1 or 2 Modic changes were randomly assigned to receive 3 months of oral amoxicillin 750 mg (n=89) or placebo (n=91) 3 times daily.
- Primary outcome: Roland-Morris Disability Questionnaire (RMDQ) score (range, 0-24) at 1-year follow-up.
- Funding: Governmental organisations Helse Sør-Øst and Helse Vest.
- In the primary analysis, the adjusted mean difference (MD) in the RMDQ score between the amoxicillin and the placebo group was −1.6 (95% CI, −3.1 to 0.0) points; P=.04.
- In the secondary analysis, the adjusted MD in the RMDQ score between the groups was −2.3 (95% CI, −4.2 to −0.4) points (P=.02) for patients with type 1 Modic changes and −0.1 (95% CI, −2.7 to 2.6) points (P=.95) for patients with type 2 Modic changes.
- Overall, 50 (56%) patients in the amoxicillin group experienced ≥1 drug-related adverse event compared with 31 (34%) in the placebo group.
- Initiation of antibiotic treatment without first documenting infection in tissue samples taken from individual patients.
- Heterogeneity of the treated sample.