Patient-perceived benefit during one year of treatment with Doloteffin®

Abstract

We recruited 114 patients (56 with chronic nonspecific low back pain, 37 with osteoarthritic knee and 21 with osteoarthritic hip pain) into a surveillance of the effects of taking Doloteffin at a dose providing 60 mg harpagoside per day for up to 54 weeks. Their symptoms and well-being were monitored at 4-6 week intervals by disease-specific and generic outcome measures, and the patients also kept a diary of their pain and requirement for rescue medication. The principal analyses were on the basis of Intention to Treat (ITT) with Last Value Carried Forward (LOCF). A Multivariate Analysis of Variance (MANOVA) indicated an appreciable overall improvement during the surveillance, similar in the Back, Knee and Hip groups. In separate ANOVAs, most of the individual outcome scores decreased significantly over time. Multiple regression analyses indicated that changes from baseline were independent of patients' characteristics. Additional analgesic requirements (which were very modest) declined during the year of surveillance. "Response during treatment", assessed according to criteria adapted from joint proposals of the Outcome Measures in Rheumatoid Arthritis Clinical Trials group and the Osteoarthritis Research Society International group, was achieved in 75% of patients, and was reflected in the percentages who rated the treatment as "good" or "very good". Adverse events were few and none were serious.