Antibiotic treatment for chronic low back pain Study TiTLe: Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy AuThorS: Albert HB, Sorenson JS, Christensen BS, Manniche C puBLiCATion inFormATion: European Spine Journal 2013; 22: 697–707 Bone edema in vertebrae may be referred to as Modic changes (MC), a phrase coined by Dr. Michael Modic, chair of the Neurological Institute at Cleveland Clinic in Ohio, who first described the condition in 1988. Studies have shown Mcs are commonly observed in, and strongly associated with, low back pain. In fact, Modic changes have been reported in 46 per cent of patients with non-specific low back pain (LBP) versus six per cent in the general population. Although three types of Mcs have been described (types 1–3), this study dealt only with type 1. Type 1 Mcs involve vertebral endplate disruption and fissuring with regions of degeneration, regeneration, reactive bone formation, endplate edema and vascular granulation tissue. This study aimed to test the efficacy of Modic antibiotic spine therapy in patients with chronic low back pain and new Modic type 1 changes in the vertebrae adjacent to a previously herniated disc. A further goal was to determine whether a dose–response relationship could be identified. Results • Of 162 study participants, 147 completed the end of treatment questionnaires and 144 fulfilled the one-year follow-up MRI, questionnaire and physical examination. • All primary outcome measures were improved in the antibiotic Group from the 100 days follow-up until one-year follow-up. The antibiotic group’s improvements on all outcome measures were superior to the placebo group at one-year follow- up. These improvements were both statistically significant and clinically important in terms of the relative magnitude of improvement. • For most patients, pain relief and disability improvement began gradually(i. e., six to eight weeks after starting antibiotics). These improvements continued long after the end of the treatment period. Some patients reported continuing improvement at one-year follow-up. • Modic changes were present on the MRIs of 130 out of a possible 134 adjacent endplates in the placebo group, and 142 out of 154 in the antibiotic group. • Ten patients in each group demonstrated no Mcs at one-year follow- up. There was a significant decrease in volume in the antibiotic group, where volume 2–4 Mcs were reduced to volume 1, which was not observed in the placebo group. • Patients receiving double-dose antibiotics appeared to improve more than the single-dose patients, although the difference was not statistically significant – probably because the trial was not powered to test for this comparison. At any rate, the researchers’ hypothesis of A dose-response relationship was not supported. • Sixty-five per cent of participants in the antibiotic group reported adverse events, compared with 23 per cent in the placebo group. Adverse events were mainly low-grade gastroenterological complaints. Middle-grade events were also more common in the antibiotics group (27 per cent versus 11 per cent, respectively), and considerable adverse events in 21 per cent and six per cent, respectively. One serious adverse event, involving severe vomiting with blood, was reported in the placebo group but none in the antibiotic group. Conclusions and practical applications Based on the results of this study and their prior work, the authors suggested a substantial course of antibiotics could be considered as a treatment option for the subgroup of patients with chronic LBP and Modic type 1 changes, but only after all other treatment options have failed. The well-known adverse effects of antibiotic should be considered when referring patients with chronic LBP and Mcs for possible treatment. According to the authors of this study, “High-dose long-term antibiotics should not be prescribed without due consideration.” This is the only randomized controlled trial (RCT) that has been done on this topic thus far. Additional studies involving other populations should be conducted to confirm the results and investigations on the background science should be done.