Efficacy of a traditional herbal formula based on Colchicum autumnale L. (Rhazes tablet) in low back pain: A randomized controlled clinical trial

摘要

Background: Low back pain (LBP) is one of the most common and costly chronic diseases in the world today. The use of herbal medicines based on Colchicum autumnal is one of the solutions recommended by Persian medicine for treatment of LBP. One of these products is Rhazes tablet. This study aimed to determine effect of the Rhazes tablet on LBP pain relief and symptoms. Methods: Fifty patients with chronic LBP, aged 19-59 years old, who had LBP for more than 12 weeks, were enrolled in the study. Patients were randomly divided in to intervention group (n=26) and control group (n=24). The patients in the intervention and control groups were treated with Rhazes tablet + Ibuprofen pearl (400mg) PRN and placebo tablet + Ibuprofen pearl (400mg) PRN, respectively. All patients received one tablet in the first week, 2 tablets in week 2-4 and 3 tablets in week 5-8. Pain severity was measured and recorded using VAS and Roland-Morris Disability Questionnaire for all patients at weeks 0, 4 and 8. Results: The results indicated that Rhazes tablet as a traditional Persian medicine caused a significant reduction in LBP in the intervention group compared to control group (P0.039). Using the Rhazes tablet for 8 weeks reduced pain severity in the group suffering from severe pain from 50% in the first visit to 15.4% in the third visit; while the pain severity was increased from 20% to 25% in the control group. In the intervention group, a woman in the fifth week of study got severe diarrhea, and the severity was decreased by reducing the number of Rhazes tablet. In the intervention group, a man experienced increased libido in the fourth week of study. Conclusion: Rhazes tablet can be used as a pharmacological intervention to reduce pain in patients with LBP. Results showed promising effects of Rhazes tablet on pain relief and LBP symptoms.