RESUMO
OBJECTIVES: Bee venom contains a potent antiinflammatory peptide 401 as well as mellitin. The purpose of this study was to see the efficacy and safety of purified bee venom injection therapy for knee or spinal osteoarthritis patients. METHODS: One hundred and one osteoarthritis patients were randomly assigned to bee venom injection therapy or oral nabumetone medication group. Bee venom injection group was subdivided into 3 groups according to different dosing schedule(group A: gradual increase up to 0.7mg, group B: up to 1.5mg and group C: up to 2.0mg). Control group patients(group D) were given 1000mg nabumetone daily for 6 weeks. There were 25, 26, 25, and 26 patients assigned to A, B, C, or D group. The efficacy of treatment was evaluated by measuring instruments developed by authors, and the safety of bee venom injection was evaluated by hematology and chemistry laboratory examination. RESULTS: Among 101 patients, eighty-one patients completed the study, but twenty patients were dropped out and two of these patients were dropped out due to adverse drug reaction. The efficacy in bee venom group showed better improvement than nabumetone group(p<0.01). Within bee venom group, group B and C showed better improvement than group A(p<0.01). Itching around injection site occurred in most patients, and bodyache occurred in 49 patients (81.7%). Hemoglobin was decreased(0.3g/dl) in group C, but no significant changes were observed in other laboratory values. CONCLUSION: The efficacy of bee venom injection in the control of knee or back pain in osteoarthritis patients was better than nabumetone medication. No severe allergic or adverse reaction was observed in bee venom treatment patients, but problems related with bee venom injection, such as pruritis, bodyache, and the possibility of anaphylaxis, should be considered for the use of bee venom injection.