{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,8]],"date-time":"2026-10-08T15:14:15Z","timestamp":1791472455943,"version":"4.3.4"},"reference-count":32,"publisher":"Springer Science and Business Media LLC","issue":"1","license":[{"start":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T00:00:00Z","timestamp":1663113600000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"},{"start":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T00:00:00Z","timestamp":1663113600000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["BMC Pharmacol Toxicol"],"abstract":"<jats:title>Abstract<\/jats:title><jats:sec>\n                <jats:title>Background<\/jats:title>\n                <jats:p>Although various pharmacological and nonpharmacological treatments are available for the chronic low back pain (CLBP), there is no consensus on the best optimal treatment for this condition. This study aimed to investigate the efficacy of co-administration of pregabalin and agomelatine versus pregabalin with placebo to treat CLBP.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Methods<\/jats:title>\n                <jats:p>Forty-six CLBP patients without the surgical indication referred to the outpatient orthopedic clinic of Rasoul-e-Akram Hospital, Tehran, Iran, were randomly divided into two study groups: Group A [pregabalin (75\u00a0mg twice per day)\u2009+\u2009placebo] and Group B [pregabalin (75\u00a0mg twice per day)\u2009+\u2009agomelatine (25\u00a0mg per night)]. Patients were evaluated at weeks 0, 4, and 8. Outcome measures were the Persian versions of the Brief Pain Inventory (BPI) interference scale, Roland-Morris Disability Questionnaire (RMDQ), The Hospital Anxiety and Depression Scale (HADS), 36-Item Short Form Survey (SF-36), and General Health Questionnaire-28 (GHQ-28) were used.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Results<\/jats:title>\n                <jats:p>At weeks 4 and 8 after the intervention, all evaluated measures showed significant improvement in both study groups (P\u2009&lt;\u20090.01). The mean improvement of GHQ-28 was 3.7\u2009\u00b1\u20091.22 in group A and 13.1\u2009\u00b1\u20094.71 in group B. This difference was statistically significant (P\u2009=\u20090.003). Other outcomes did not vary substantially between the two research groups. Agomelatine treatment was well tolerated, with no significant adverse effects seen in patients. Liver tests of all patients were routine during the study period. Major adverse effect was not seen in any patient. The prevalence of Minor side effects was not significantly different between two study groups.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Conclusion<\/jats:title>\n                <jats:p>Compared with the pregabalin and placebo, co-administration of pregabalin and agomelatine had no added effect on improving pain scores in CLBP patients. However, the patients\u2019 general health was significantly improved after the combined administration of pregabalin and agomelatine.<\/jats:p>\n              <\/jats:sec><jats:sec>\n                <jats:title>Trial registration<\/jats:title>\n                <jats:p>The study protocol was registered in the Iranian Registry of Clinical Trials before starting the study (NO.IRCT20200620047852N1, Registration date: 23\/06\/2020).<\/jats:p>\n              <\/jats:sec>","DOI":"10.1186\/s40360-022-00612-3","type":"journal-article","created":{"date-parts":[[2022,9,14]],"date-time":"2022-09-14T16:03:00Z","timestamp":1663171380000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":5,"title":["The effectiveness of pregabalin with or without agomelatine in the treatment of chronic low back pain: a double-blind, placebo-controlled, randomized clinical trial"],"prefix":"10.1186","volume":"23","author":[{"given":"Seyed Mani","family":"Mahdavi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Behnam","family":"Shariati","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Mohammadreza","family":"Shalbafan","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Vahid","family":"Rashedi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Masoomeh","family":"Yarahmadi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Alireza","family":"Ghaznavi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Shayan","family":"Amiri","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2022,9,14]]},"reference":[{"key":"612_CR1","doi-asserted-by":"publisher","unstructured":"Allegri M, Montella S, Salici F, Valente A, Marchesini M, Compagnone C, et al. 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Written informed consent was taken from the patients before participating in the study. All methods were conducted in accordance with the principles of the Declaration of Helsinki.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare that they have no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"70"}}