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Integrated Traditional Chinese and Western Medicine for Chronic Spontaneous Urticaria: Protocol for a Trials Within
Linhao Li1,2,3, Sihan Wang1,2,3, Jiale Chen1,2
1Department of Dermatology, Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine, 110 Ganhe Road, Hongkou District, Shanghai, China, 86 18817773736.
Background:
Chronic spontaneous urticaria (CSU) is a common inflammatory skin disease characterized by severe itching and wheals, affecting approximately 1.4% of the global population. Both second-generation H1-antihistamines and omalizumab have limited efficacy in some patients. Previous studies suggest that combining traditional Chinese medicine with biological agents may improve efficacy and reduce adverse effects in inflammatory skin diseases.
Objective:
This study uses a trials within cohorts (TwiCs) design to evaluate the efficacy and safety of the shenqi formula (SQF) combined with omalizumab for the treatment of CSU.
Methods:
This TwiCs study is built upon an existing urticaria cohort established in November 2019 at Yueyang Hospital of Integrated Traditional Chinese and Western Medicine, Shanghai University of Traditional Chinese Medicine. Overall, 92 eligible patients with type 1 autoallergic CSU and qi and blood deficiency syndrome will be randomly allocated in a 1:1 ratio to receive either omalizumab alone or omalizumab combined with the SQF. The treatment period is 24 weeks, followed by 16 weeks of follow-up. The primary outcome is the 7-day Urticaria Activity Score. Data will be managed using Microsoft Excel (version 2016), analyzed with SPSS (version 27.0; IBM Corp), and visualized with GraphPad Prism (version 9.0). A complier average causal effect analysis will be applied to estimate causal effects using generalized linear latent mixed models.
Results:
As of the manuscript submission (November 2025), the trial has been funded (December 2024) and registered with the International Traditional Medicine Clinical Trial Registry (registered January 28, 2025). Patient enrollment commenced in April 2025 and is projected to conclude by December 2027. Data analysis is expected to be completed by June 2028, with final results anticipated for publication in the fourth quarter of 2028.
Conclusions:
This study is the first to apply a TwiCs design to compare the efficacy and safety of SQF combined with omalizumab versus omalizumab alone in patients with CSU. The findings are expected to provide high-quality real-world evidence for the integration of traditional Chinese medicine with biological therapy in the management of CSU and to serve as a methodological reference for future TwiCs applications in dermatology research.