Besides checking estimates of effectiveness and safety of using the proprietary Harpagophytum extract
Doloteffin, this postmarketing surveillance compared various disease-specific* and generic** measures of effect. We enrolled 250 patients suffering from nonspecific
low back pain (Back group: n = 104) or osteoarthritic
pain in the knee (Knee group: n = 85) or hip (Hip group: n = 61). They took an 8-week course of
Doloteffin at a dose providing 60 mg
harpagoside per day. The measures of effect on
pain and disability included the percentage changes from baseline of established instruments (Arhus
low back pain index*, WOMAC index*, German version of the
HAQ**) and unvalidated measures (total
pain index*, three score index*, the patient's global assessment** of the effectiveness of treatment). Patients also received a diary for the daily recording of their
pain and any additional treatments for it. The three groups differed in age, weight and characteristics of initial
pain. 227 patients completed the study. Multivariate analysis confirmed that several dimensions of effect were recorded by the several outcome measures but, in all groups, both the generic and disease-specific outcome measures improved by week 4 and further by 8. In multivariable analysis, the improvement tended to be more when the initial
pain and disability score was more: older patients tended to improve less than younger, the hip group tended to improve convincingly more than the back group, whereas the improvement in the knee group was less readily differentiated from that in the back group. The subgroup of Back patients who required
NSAIDs during the 8 weeks used significantly more per patient than patients in the other two groups, but that requirement also declined more with time. About 10% of the patients suffered from minor adverse events that could possibly have been attributable to
Doloteffin. Between 50% and 70% of the patients benefitted from
Doloteffin with few adverse effects. Thus,
Doloteffin is well worth considering for osteoarthritic knee and hip
pain and nonspecific
low back pain.