Kashin-Beck Disease in Sichuan, China Report of a Pilot Open Therapeutic Trial

Objective: The objective of the study was to identify adults with symptomatic Kashin-Beck disease (KBD) and observe the efficacy and safety of diclofenac sodium, naproxen, and glucosamine hydrochloride in these adult patients in Rang-tang (Sichuan Province), China. Subjects and Methods: One hundred eighty-three adult patients with KBD were enrolled into this open study. Patients were randomized to receive diclofenac sodium 50 mg twice a day (BID), naproxen 300 mg BID, or glucosamine hydrochloride 750 mg BID for 6 weeks. The primary efficacy parameters evaluated were the visual analog pain scale, Western Ontario and McMaster Universities Osteoarthritis Index, and physical function subscores. Assessment of daily self-care activities and physician and patient global overall efficacy were also recorded. Results: Diclofenac sodium, naproxen, and glucosamine hydrochloride all reduced the joint pain and improved physical function and daily self-care activities in adult patients with KBD. Visual analog pain scale scores, Western Ontario and McMaster Universities Osteoarthritis Index pain scores, physical function scores, and daily self-care activities subscore differences were statistically significant compared with baselines (P < 0.05). Comparison studies among the 3 agents showed no statistically significant difference in efficacy. The incidences of gastrointestinal adverse reactions were 18% and 14% in the diclofenac sodium group and the glucosamine hydrochloride group, respectively, which tended to be lower than the naproxen group (29%). However, the differences were not statistically significant. Conclusions: This report documents characteristic findings in these patients. Diclofenac sodium, naproxen, and glucosamine hydrochloride produced substantial improvements over baseline in pain relief, physical function, and daily self-care activities in these open observations of adult patients with KBD.