Objectives: To compare the effects of the Shouzu Ning Decoction (SND) and Halometasone plus Celecoxib (Hal/Cxb) as therapy in patients with grade 2 hand-foot skin reaction (HFSR).Materials and Methods: Fifty patients with grade 2 HFSR participated in a randomized, single-center, open-label study.Patients were randomly assigned in a 1:1 ratio to receive majicontrast red the SND or Hal/Cxb treatment, twice daily for 4 weeks, followed by 4 weeks of post-treatment follow-up.The primary endpoint was clinical remission of HFSR at the end of the fourth week (W4).The secondary endpoints were recurrence rate, quality of life (QoL), pain intensity, and safety.
Results: In this study, 46 patients successfully completed the study, and 4 patients were excluded.There was no statistically significant difference between the 2 groups on demographic and baseline clinical characteristics.In the SND group, 56.52% of patients showed clinical remission at W4, which was significantly superior to that achieved in the Hal/Cxb read more group (26.09%, P =.
036).In addition, the HF-QoL score was statistically lower in the SND group compared to the Hal/Cxb group at W2 ( P =.007), W3 ( P =.005), and W4 ( P =.005), respectively.
In line with this, the inter-group difference in NRS score was statistically significant ( P =.004).Conclusion: In the present study, SND treatment has been observed to be effective and well tolerated for patients with grade 2 HFSR.Thus, SND treatment could be considered a suitable option for HFSR patients.Trial registration: Chinese Clinical Trial Registry, ChiCTR1900027518.
Registered on 17 Nov 2019.