harpagoside and rofecoxib

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.. 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.. 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.. Long-term treatment with Doloteffin was well tolerated. Ex-R and ex-D patients behaved similarly during the follow-up.

Topics: Anti-Inflammatory Agents, Non-Steroidal; Double-Blind Method; Female; Follow-Up Studies; Glycosides; Harpagophytum; Humans; Lactones; Low Back Pain; Male; Middle Aged; Pain Measurement; Phytotherapy; Pilot Projects; Plant Extracts; Pyrans; Sulfones; Surveys and Questionnaires; Treatment Outcome