S Chrubasik1, O Künzel, J Thanner, C Conradt, A Black. 1. Department of Forensic Medicine, University of Freiburg, Albertstr. 9, 79104 Freiburg, Germany. sigrun.chrubasik@klinikum.uni-freiburg.de
Abstract
OBJECTIVE: To complete a year's follow-up on patients from a 6-week double-blind pilot comparison between 44 Doloteffin patients and 44 rofecoxib patients being treated for acute exacerbations of chronic low back pain. METHODS:38 "ex-Doloteffin" (ex-D) and 35 "ex-rofecoxib" (ex-R) received Doloteffin containing 60 mg harpagoside per day for up to 54 weeks. Pain, additional analgesics, mobility, general health and adverse events were assessed from diary records and at 6-week visits. RESULTS: 53 patients remained in the follow-up at 24 weeks and 43 at 54 weeks. There was never any convincing difference between ex-D and ex-R patients in the number of patients remaining in follow-up, diary pain scores, additional analgesics, Arhus Index and health assessment questionnaire scores (HAQ). Individual fluctuations notwithstanding, the follow-up showed a slight overall improvement on the improvements in Arhus and HAQ scores achieved in the pilot study (MANOVA p = 0.016). Of the 21761 patient-days, the respective percentages with no, mild, moderate, severe and excruciating pain were 28%, 39%, 22%, 8.5% and 1.5%, respectively. Few patients requested additional treatments for their pain. Three patients suffered from minor adverse drug reactions. CONCLUSION: Long-term treatment with Doloteffin was well tolerated. Ex-R and ex-D patients behaved similarly during the follow-up.
RCT Entities:
OBJECTIVE: To complete a year's follow-up on patients from a 6-week double-blind pilot comparison between 44 Doloteffin patients and 44 rofecoxibpatients being treated for acute exacerbations of chronic low back pain. METHODS: 38 "ex-Doloteffin" (ex-D) and 35 "ex-rofecoxib" (ex-R) received Doloteffin containing 60 mg harpagoside per day for up to 54 weeks. Pain, additional analgesics, mobility, general health and adverse events were assessed from diary records and at 6-week visits. RESULTS: 53 patients remained in the follow-up at 24 weeks and 43 at 54 weeks. There was never any convincing difference between ex-D and ex-R patients in the number of patients remaining in follow-up, diary pain scores, additional analgesics, Arhus Index and health assessment questionnaire scores (HAQ). Individual fluctuations notwithstanding, the follow-up showed a slight overall improvement on the improvements in Arhus and HAQ scores achieved in the pilot study (MANOVA p = 0.016). Of the 21761 patient-days, the respective percentages with no, mild, moderate, severe and excruciating pain were 28%, 39%, 22%, 8.5% and 1.5%, respectively. Few patients requested additional treatments for their pain. Three patients suffered from minor adverse drug reactions. CONCLUSION: Long-term treatment with Doloteffin was well tolerated. Ex-R and ex-D patients behaved similarly during the follow-up.
Authors: Hanna Oltean; Chris Robbins; Maurits W van Tulder; Brian M Berman; Claire Bombardier; Joel J Gagnier Journal: Cochrane Database Syst Rev Date: 2014-12-23