Abstract Background This systematic review and meta‐analysis aimed to summarize evidence regarding the effectiveness and safety of oral antibiotic intervention for chronic low back pain (CLBP) patients with/without type‐1 Modic changes (MC1). Methods AMED, CINAHL, Cochrane Library, Embase, and Medline were searched from inception to March 3, 2023. Randomized controlled trials (RCTs) or non‐RCTs that investigated the effectiveness or safety of oral antibiotics in treating CLBP patients were eligible for inclusion. Two independent reviewers screened abstracts, full‐text articles, and extracted data. The methodological quality of each included article were evaluated by RoB2 and NIH quality assessment tools. The quality of evidence was appraised by GRADE. Meta‐analyses were performed, where applicable. A subgroup analysis was conducted to evaluate the RCTs and case series separately, and to evaluate the effect of removing a low‐quality RCT. Results Three RCTs and four case series were included. All Amoxicillin‐clavulanate/Amoxicillin treatments lasted for approximately 3 months. Moderate‐ and low‐quality evidence suggested that antibiotic was significantly better than placebo in improving disability and quality of life in CLBP patients with MC1 at 12‐month follow‐up, respectively. Low‐quality evidence from meta‐analyses of RCTs showed that oral antibiotic was significantly better than placebo in improving pain and disability in CLBP patients with MC1 immediately post‐treatment. Very low‐quality evidence from the case series suggested that oral Amoxicillin‐clavulanate significantly improved LBP/leg pain, and LBP‐related disability. Conversely, low‐quality evidence found that oral Amoxicillin alone was not significantly better than placebo in improving global perceived health in patients with CLBP at the 12‐month follow‐up. Additionally, oral antibiotic users had significantly more adverse effects than placebo users. Conclusions Although oral antibiotics were statistically superior to placebo in reducing LBP‐related disability in patients with CLBP and concomitant MC1, its clinical significance remains uncertain. Future large‐scale high‐quality RCTs are warranted to validate the effectiveness of antibiotics in individuals with CLBP.
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