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Phytomedicine. 2005 Jan;12(1-2):1-9.

A 1-year follow-up after a pilot study with Doloteffin for low back pain.

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Department of Forensic Medicine, University of Freiburg, Albertstr. 9, 79104 Freiburg, Germany.



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.

[Indexed for MEDLINE]

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