[Clinical controlled study of Zhongyi Ointment() in the treatment of Kellgren-Lawrence gradeⅡknee osteoarthritis with moderate-to-severe pain].

OBJECTIVE

To evaluate the clinical efficacy and safety of Zhongyi Ointment() in the treatment of Kellgren-Lawrence grade (K-L)Ⅱknee osteoarthritis with moderate-to-severe pain.

METHODS

This study adopted a prospective, randomized, double-blind, placebo-controlled design. Patients were recruited from November 2022 to October 2023. A total of 80 participants meeting the diagnostic criteria for K-L gradeⅡknee osteoarthritis at the acute exacerbation stage were enrolled and randomly assigned to the Zhongyi Ointment() group or the placebo group, with a uniform treatment course of 6 days. Two patients were lost to follow-up in the Zhongyi Ointment() group and three in the placebo group, resulting in a final sample of 75 patients included in the statistical analysis. The Zhongyi Ointment() group comprised 38 patients (15 males, 23 females) aged from 55 to 80 years (70.97±5.05)years. The placebo group included 37 patients (12 males, 25 females) aged from 52 to 79 years (68.70±6.11)years. The primary outcome measures were the Western Ontario and McMaster Universities osteoarthritis index (WOMAC) scores, knee joint range of motion, and the occurrence of adverse events before and after treatment.

RESULTS

On day 6 of treatment, the total WOMAC score in the Zhongyi Ointment() group decreased from (109.79±11.32) scores at baseline to( 44.92±14.84) scores (P<0.001), which was significantly lower than (56.78±9.33) scores in the placebo group (P<0.001). Improvements in all WOMAC subscales (pain, stiffness, physical function) in the Zhongyi Ointment() group were superior to those in the placebo group (all P<0.05), with more rapid symptom relief in the first 3 days. The knee joint range of motion in the Zhongyi Ointment() group was (127.21±15.87)° which was significantly higher than (117.11±13.44)° in the placebo group (P=0.028). No serious adverse events occurred in either group.

CONCLUSION

Zhongyi Ointment() can rapidly and significantly improve symptoms in patients with K-L gradeⅡknee osteoarthritis with moderate-to-severe pain during the acute exacerbation stage, with definite short-term efficacy and favorable safety. Continuous treatment helps to consolidate the therapeutic effect and warrants further validation through multicenter studies with large sample sizes, as well as investigations into the underlying mechanisms.