| Objective To evaluate the clinical efficacy and safety of six-ingredient dispelling wind and activating channel ointment in the treatment of periarthritis of shoulder. Methods A multicenter, open, and observational clinical design method was used. A total of 2400 patients with periarthritis of shoulder were included. Twenty-one Chinese and western medicine hospitals of different regions and different levels were selected. The efficacy and safety of six-ingredient dispelling wind and activating channel ointment (pain score of the shoulder, movement of the shoulder joint, total score of single symptoms) were studied. Results There were 2111 patients with periarthritis of shoulder in this study, including 2111 cases (100%) in full analysis set (FAS), 2020 cases (95.68%) in per protocol set (PPS), and 2111 cases (100%) in the safety set (SS). The change of main outcome indexes before and after treatment FAS (PPS) was 4.54±2.00 (4.61±1.95), and the difference was statistically significant (P< 0.05). There were significant differences in the curative effect of shoulder function and the total score of single symptoms before and after the treatment (P<0.05). In terms of safety, there were 32 cases with mild adverse events in the trial group of 2111 selected cases, who were not treated during the trial and the symptoms were alleviated or disappeared. Blood, urine, and stool routine, and heart, liver and kidney function were not abnormal before and after the test. Conclusion Six-ingredient dispelling wind and activating channel ointment is effective and safe in the treatment of periarthritis of shoulder. |