Treatment of chronic low back pain and disc herniation with amoxicillin-clavulanate (Augmentin) may not be effective for pain control

1. In adult patients with chronic low back pain (LBP) and disc herniation on magnetic resonance imaging (MRI), treatment with amoxicillin-clavulanate did not significantly reduce pain compared to placebo.

Evidence Rating Level: 1 (Excellent)

Study Rundown: LBP is the greatest cause of disability burden worldwide. An increasing number of pharmacologic treatments have been recommended for LBP. Recent studies have identified that the spinal discs of individuals with LBP are colonized with low-virulent bacteria. Subsequently, clinical trials found equivocal evidence of benefit from antibiotic therapy in these patients. The authors sought to examine whether amoxicillin-clavulanate is effective at reducing pain in patients with LBP and disc herniation.

This study was a double-blind, placebo-controlled randomized clinical trial with a 2-arm, parallel group, superiority design conducted in Australia from January 2016 to July 2022. Participants included adults aged 18 to 60 years with chronic LBP (pain between the lower borders of the rib cage and the gluteal folds persisting for more than 3 months) and disc herniation on MRI. These patients were randomized 1:1 to receive amoxicillin-clavulanate 500 mg/125 mg twice daily for 90 days (intervention arm) or placebo (control arm). Outcome data were collected from the beginning of randomization to the end of the 12-month follow-up period. Pain was measured using the Low Back Pain Rating Scale (LBPRS) and 100-mm visual analog scale (VAS), and disability was measured using the Roland Morris Disability Questionnaire (RMDQ).

Overall, this study found no significant difference in pain reduction between the treatment and control groups. There were also no significant differences in RMDQ outcomes, work absence, general health status, depression, or fear of movement or reinjury.

Click here to read this study in JAMA Network Open

Relevant reading: Chronic low back pain, bacterial infection and treatment with antibiotics

In-Depth [randomized clinical trial]: Some individuals with LBP, the greatest cause of disability worldwide, have been identified to have low-virulent bacteria in their spinal discs. Although recent trials have shown antibiotics to improve symptoms in these patients, their efficacy remains unclear. This randomized controlled trial compared pain and overall health outcomes in adults with chronic low back pain and the presence of a disc herniation on MRI receiving either amoxicillin-clavulanate or placebo. The primary outcome was pain intensity measured using the LBPRS at 12 months.

This trial included 170 patients (mean [SD] age, 44.4 [10.8] years; 40.6% female) who were randomized 1:1 to receive amoxicillin-clavulanate (intervention arm; n = 85; mean [SD] age, 43.1 [11.2] years; 41.2% female) or placebo (control arm; n = 85; mean [SD] age, 45.6 [10.3] years; 40.0% female). 152 participants completed 12-month outcomes. Based on pill count, 24 of 29 participants (82.8%) in the amoxicillin-clavulanate group and 39 of 49 participants (79.6%) in the placebo group were more than 80% adherent. Based on self-report, 21 of 23 participants (91.3%) in the amoxicillin-clavulanate group and 17 of 18 participants (94.4%) from the placebo group were adherent. There were no significant differences in pain reduction as measured with the LBPRS between the intervention and control arms at either 3 months (adjusted difference, 0.34; 95% CI, −0.18 to 0.86) or 12 months (adjusted difference, 0.06; 95% CI, −0.58 to 0.70). There were also no significant differences in RMDQ at 3 months (adjusted difference, 1.15; 95% CI, −0.03 to 2.34) or 12 months (adjusted difference, −0.54; 95% CI, −1.79 to 0.72), work absence (OR, 0.72; 95% CI, 0.34-1.54) or hindrance (OR, 0.74; 95% CI, 0.37-1.51) at 12 months, or in general health status, depression, and fear of movement or reinjury as measured using the EuroQoL 5-dimension 5-level instrument, Beck Depression Inventory, and Tampa scale, respectively. Adverse events were reported in 34 participants (40.0%) in the amoxicillin-clavulanate group and 20 (23.5%) in the placebo group. 1 patient in the intervention group experienced an allergic reaction, 8 experienced diarrhea, 6 reported thrush, and 6 reported other infections. In the control arm, 1 experienced diarrhea, 0 reported thrush, and 3 reported other infections.

Image: PD

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