Objective  To investigate the clinical effect of modified Qingliang Huohua powder for external application in the treatment of patients with knee osteoarthritis (KOA) of damp-heat accumulation type.

Methods Patients with KOA who were admitted to Hangzhou Hospital of Traditional Chinese Medicine between January 2023 and January 2024 were selected and randomly divided into three groups: a hypothermia group (treated with modified Qingliang Huoxing powder application at low-temperature of 10-20°C), a normothermia group (treated with modified Qingliang Huoxing powder application at normal-temperature of 20-30°C) and a hyperthermia group (treated with heating modified Qingliang Huoxing powder application at the temperature of 37-45°C). The total treatment course was two weeks. The three groups were compared for clinical efficacy, TCM syndrome scores, knee pain [visual analogue scale (VAS) score], blood inflammatory markers [C-reactive protein (CRP), interleukin-6 (IL- 6)], safety, and long-term efficacy (WOMAC score).

Results  A total of 102 patients with KOA were enrolled, with 34 in each of the three groups. After treatment, the total clinical efficacy rate in the hyperthermia group was significantly higher than that in the normothermia and hypothermia groups [97.06% (33/34) vs. 82.35% (28/34) and 73.53% (25/34), respectively, both P<0.05]. TCM syndrome scores and VAS scores decreased in all three groups compared with pre-treatment levels (P<0.05), with those in the hyperthermia group lower than those in the normothermia and hypothermia groups, and those in the normothermia group lower than those in the hypothermia group (P<0.05). CRP and IL-6 levels decreased in all three groups compared with pre-treatment levels (P<0.05), with those in the hypothermia group lower than those in the normothermia and hyperthermia groups, and those in the normothermia lower than those in the hyperthermia group (P<0.05). No adverse reactions were observed in any of the three groups. At 12-month follow-up, WOMAC scores of the three groups decreased after 2 weeks of treatment, and the score in the hyperthermia group was lower than that in the normothermia group and the hypothermia group, and the score in the normothermia group was lower than that in the hypothermia group (P<0.05). WOMAC scores of the three groups decreased after 6 and 12 months of treatment, but there was no statistically significant difference among the groups (P>0.05).

Conclusion  The short-term efficacy of external application of modified Qingliang Huoxing Powder at different temperatures on KOA patients varies to a certain extent. Treatment at high temperature shows certain advantages in improving efficacy, relieving clinical symptoms, alleviating pain, and improving knee joint function, while the long-term efficacy is comparable.

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