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Randomized Controlled Trial
Efficacy of tramadol-acetaminophen tablets in low back pain patients with depression.
- Tomoko Tetsunaga, Tomonori Tetsunaga, Masato Tanaka, and Toshifumi Ozaki.
- Department of Orthopaedic Surgery, Okayama University Hospital, 2-5-1 Shikata-cho, Kitaku, Okayama, 700-8558, Japan.
- J Orthop Sci. 2015 Mar 1;20(2):281-6.
BackgroundTramadol-acetaminophen tablets are currently used to treat pain, including that of degenerative lumbar disease. Although there are many reports on tramadol-acetaminophen tablets, treatment outcomes in low back pain (LBP) patients with depression remain uncertain. This study investigated the outcomes of LBP patients with depression treated with tramadol-acetaminophen tablets.MethodsOf 95 patients with chronic LBP, 70 (26 men, 44 women; mean age 64 years) who were judged as having depression by the Self-Rating Depression Scale (SDS) were included in this study. In this trial, patients received one of two randomly assigned 8-week treatment regimes: tramadol-acetaminophen (Tramadol group, n = 35) and non-steroidal anti-inflammatory drugs (NSAIDs) (NSAID group, n = 35). In addition to completing self-report questionnaires, patients provided demographic and clinical information. All patients were assessed using a Numerical Rating Scale (NRS), Oswestry Disability Index (ODI), Pain Disability Assessment Scale (PDAS), Hospital Anxiety and Depression Scale (HADS), SDS, and Pain Catastrophizing Scale (PCS).ResultsAfter 8 weeks' treatment, the NRS and SDS scores were lower in the Tramadol group than in the NSAID group (p < 0.05). There were no significant differences in the ODI, PDAS, and PCS scores between the groups (p = 0.47, 0.09, 0.47). Although there was no difference in the anxiety component of the HADS between the groups (p = 0.36), the depression component was lower in the Tramadol group than in the NSAID group (p < 0.05). There was no significant difference between groups in the percentage of patients with treatment-associated adverse events.ConclusionsThis investigation found that tramadol-acetaminophen is effective for reducing LBP and provided a prophylactic antidepressant effect in chronic LBP patients with depression.
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