Co-administration of Agomelatine and Pregabalin exhibited superior efficacy than Pregabalin + placebo in treating the symptoms of chronic low back pain (CLBP) in a double-blind, placebo-controlled, randomized clinical study. Seyed Mani Mahdavi et al. compared the effectiveness of Pregabalin plus Agomelatine with Pregabalin plus a placebo for CLBP management.

Overall, 46 CLBP patients without a surgical indication were randomized into Group A (Pregabalin [75 mg two times a day] + placebo) and Group B (Pregabalin [75 mg two times a day] + Agomelatine [25 mg per night]). At weeks 0, 4, and 8, the volunteers were examined. The Persian versions of the Brief Pain Inventory (BPI) interference scale, the General Health Questionnaire-28 (GHQ-28), the 36-Item Short Form Survey (SF-36), the Hospital Anxiety and Depression Scale (HADS), the Roland-Morris Disability Questionnaire (RMDQ) were the outcome measures ascertained.

All analyzed parameters revealed a substantial improvement in both study groups at weeks 4 and 8 following the treatment. In group A, the mean GHQ-28 improvement was 3.7 ± 1.22, whereas, in group B, it was 13.1 ± 4.71. This variation was clinically meaningful. The other results did not considerably vary between the study groups. No notable side effects were seen in patients after receiving Agomelatine therapy, which was well-tolerated. All participants underwent regular liver exams throughout the research.

No patient had a major adverse event. Between both the research groups, there were no discernible differences in the occurrence of minor side effects. Co-administration of Pregabalin and Agomelatine showed no additional impact in reducing pain scores in CLBP patients when compared to Pregabalin and a placebo. However, after receiving the combination of Pregabalin and Agomelatine, the patient's overall health substantially improved.