Main Article Content
Objective: To evaluate the efficacy and safety of poly-herbal formula Sahatsatara (SHT) in pain reduction in acute low back pain (LBP) patients.
Methods: Twenty-nine patients aged 18-65 years with a history of moderate to severe acute LBP ≤3-day (score ≥4 on a 0-10 numeric rating scale [NRS]) were enrolled and randomized to receive an ibuprofen (400 mg after meals three times daily) or SHT (1,350 mg before meals three times daily) for 7 days. The non-inferiority trial margin was set at ±10 percentage points. The outcomes were measured on pain intensity on the 0-10 NRS, disability on the Thai version of the Oswestry disability index [ODI], total analgesic consumption, patient satisfaction, and safety.
Results: Fourteen patients and 15 patients were randomly allocated to ibuprofen and SHT groups, respectively. The mean difference in pain intensity and disability between the two groups at day 7 adjusted according to baseline was within ±1 for pain (-0.3; 95% CI, -1.48 to 0.96) and ±10% (-4.9%; 95% CI, -14.86% to 5.02%) for the NRS and ODI scores, respectively. One patient in the SHT group and 5 in the ibuprofen group had gastrointestinal irritation, but the difference was not statistically significant.
Conclusion: SHT was not inferior to ibuprofen in pain relieving and disability in patients with acute LBP. The result suggests a role for SHT as an alternative analgesic in acute LBP. (Thai Clinical Trials Registry number 20141027001)
Keywords: Acute low back pain, poly-herbal formula Sahatsatara, ibuprofen
All articles published in the Siriraj Medical Journal (SMJ) are protected by copyright. No material in this journal may be reproduced on any platform including electronic or in print or transmitted by any means, in whole or in part, without the prior written permission of the Editor of the SMJ. Written permission must also be obtained before any part of the SMJ is stored in any retrieval system of any nature.