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


CONCLUSIONS
Long-term treatment with Doloteffin was well tolerated. Ex-R and ex-D patients behaved similarly during the follow-up.
Chrubasik
S
S
Department of Forensic Medicine, University of Freiburg, Albertstr. 9, 79104 Freiburg, Germany. sigrun.chrubasik@klinikum.uni-freiburg.de
Künzel
O
O
Thanner
J
J
Conradt
C
C
Black
A
A
D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006027:Glycosides / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D031684:Harpagophytum; D006801:Humans; D007783:Lactones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D017116:Low Back Pain / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D011714:Pyrans / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D013450:Sulfones / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
D000894:Anti-Inflammatory Agents, Non-Steroidal; C469611:Doloteffin; D006027:Glycosides; D007783:Lactones; D010936:Plant Extracts; D011714:Pyrans; D013450:Sulfones; C116926:rofecoxib; C033249:harpagoside