Mesopotamia research document report received from ADPPharmaceuticals 13

Copy of a research document report received from ADP Pharmaceuticals 13.11.2000

DEER ANTLER CARTILAGE IN THE TREATMENT OF ARTHRITIS

Results of a 6 months Placebo-controlled Double-blind Study with CERVUSEN in 54 Patients with Osteoarthritis conducted by Jack Edelman, Paddy Hanrahan and Peter Ghosh at the GOATCHER RESEARCH UNIT, SIR CHARLES GARDNER HOSPITAL, PERTH, WESTERN AUSTRALIA AND THE INSTITUTE OF BONE AND JOINT RESEARCH, ROYAL NORTH SHORE HOSPITAL, SYDNEY NSW.

Although osteoarthritis (OA) is the major cause of pain and disability worldwide conventional medical treatments have had limited success. Indeed, mainstream therapies such as the non-steroidal anti- inflammatory drugs (NSAIDs), while providing relief of OA symptoms have been found to be often associated with deleterious side-effects, particularly from the gastrointestinal tract. Earlier research from our laboratories had shown that a deer antler cartilage formulation (Cervusen) was orally active in animal models of arthritis as shown by a dose-dependent reduction of joint swelling, cartilage erosions and decrease in levels of pro-inflammatory mediators in pouch fluids. These positive findings encouraged us to undertake the present placebo-controlled study with human OA patients to determine if Cervusen was active in resolving clinical symptoms when administered daily over a 6 month period.

54 patients were examined at baseline for x-ray grade of OA, pain and functionality using visual analogue scales (VAS) and the WOMAC questionnaire (version 3). They were randomly assigned under double-blinded conditions to either active Cervusen (2 x 350mg capsules/day) or placebo (2 x 350 mg lactose capsules/day) treatment arms and clinically assessed at 1, 3 and 6 months post-baseline. Groups were found to be demographically matched, apart from duration of disease (active 6.1+-0.8 yrs, placebeo = 9.4+-0.8 yrs; p<0.004). No adverse side-effects or dropouts were reported for the duration of the study. Active and placebo groups were analysed statistically for change from baseline for each parameter using analyses of variance. Cervusen treated patient scores for pain improvement (VAS) and global assessment of improvement (Llkert scale) relative to baseline were significant at 3 months (p<0.03); (p<0.02) and 6 months (p<0.04); (p<0.01) respectively. Physician global assessment of improvement were also significant for the drug, but not placebo treated group at 3 months (p<0.05) and 6 months (p<0.01). WOMAC scores were almost significant at 3 months (p<0.053) and 6 months (p<0.063) for the Cervusen treated group. No significant improvement in change from baseline was observed for the placebo treated group for any of the parameters examined. This is the first report of a double-blinded, placebo-controlled GCP study which has demonstrated the clinical efficacy of a deer antler preparation for symptomatic relief in OA. The pre-clinical studies with Cervusen and lead time required to reach clinical efficacy is strongly indicative that the drug achieves symptomatic relief in OA by disease modification, rather than simply by providing analgesia.

KEY WORDS – Osteoarthritis, double-blind-study, Cervusen, deer cartilage

Compliments of:        Neil and Margaret Burke,
                               Mesopotamia Lodge Deer Park,
                               192 Spooners Ave.,
                               KEMPSEY. NSW   2440