COMPARATIVE EFFICACY AND SAFETY OF TAPENTADOL AND TRAMADOL IN PATIENTS WITH MODERATE TO SEVERE CHRONIC LOW BACK PAIN: A PROSPECTIVE, RANDOMIZED, OPEN-LABELTRIAL AT TERTIARY CARE TEACHING HOSPITAL IN NORTH INDIA
Journal Title: Journal of Evidence Based Medicine and Healthcare - Year 2018, Vol 5, Issue 6
Abstract
BACKGROUND Chronic Low back pain is one of the leading causes of disability and has a major socioeconomic impact. Despite the availability of numerous treatment options, pain continues to be under-treated, indicating a need for a potent analgesic with a low sideeffect profile. The use of opioids has been strongly recommended in chronic low back pain but are underutilised due to potential risk of adverse effects. The present study was conducted to compare the efficacy and safety of atypical opioids tapentadol and tramadol in patients with moderate to severe chronic low back pain. MATERIALS AND METHODS It was randomized, prospective, open label, comparative and parallel group study. 96 patients suffering from moderate to severe chronic low backache were included in the study. They were randomised to receive either tapentadol ER (50 -250 mg twice a day orally) or tramadol ER (100-300 mg, twice a day, orally.) for 6 weeks. Patients in both the groups were followed up for a period of 6 weeks. Two patients were lost to follow-up with one patient in each group. Henceforth, 48 patients in Group I and 46 patients in Group II completed the study. Efficacy and safety of tapentadol and tramadol was assessed by visual analogue scale, finger to floor distance test and straight leg raising test and by noticing ADRs in both the groups. The data was analyzed with the help of computer software MS Excel and SPSS version 17.0 for Windows. Statistical significance was assessed by paired and unpaired Student ‘t’ test. RESULTS The mean baseline VAS score was 9.66 ± 0.69 in Group I patients, which decreased to 8 ± 0.54, 6.39 ± 0.64 and 4.45 ± 0.58 respectively and the mean baseline VAS score was 9.65 ± 0.70 in Group II patients, which decreased to 8.15 ± 0.36, 6.45 ± 0.69 and 4.47 ± 0.54 respectively at follow up visits in chronic low backache patients. Both the groups showed statistically highly significant reduction in pain at all levels on VAS scale and finger to floor distance parameter at all levels but the results of straight leg raising test were not statistically significant. Patients on tapentadol reported less adverse drug reactions with better gastrointestinal tolerability as compared to tramadol. CONCLUSION Both the drugs tapentadol ER and tramadol ER provided significant analgesic efficacy for management of moderate to severe chronic low backache. However tapentadol ER with better gastrointestinal tolerability profile, may represent a better alternative to other strong opioids for such patients.
Authors and Affiliations
Seema Gupta, Nusrat Kreem Bhat, Shivani Rani, Farid Hussain, Rajesh Kumar
Keywords
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- EP ID EP454142
- DOI 10.18410/jebmh/2018/110
- Views 79
- Downloads 0
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