Career outcomes of PhD holders in Africa: Protocol for a scoping review.

Urticaria is an immune-mediated skin disease characterized by the development of wheals, angioedema, or both []. It is predominantly categorized into acute urticaria and chronic urticaria based on the duration of the disease manifestation. Chronic spontaneous urticaria (CSU) refers to a form of chronic urticaria that persists or recurs for more than 6 weeks, arising from known or unknown causes without an identifiable external trigger []. The etiology of CSU is heterogeneous. On the basis of distinct pathogenic mechanisms, CSU can be classified into allergic (type 1) and autoimmune subtypes (type 2b) [,]. The lifetime prevalence of chronic urticaria worldwide is 1.4%. In the Asia-Pacific region, the prevalence is 1.5%, with over 90% of cases being CSU []. Second-generation H1-receptor antagonist antihistamines are recommended as the first-line treatment for CSU [,,]. Although second-generation H1-antihistamines are effective in many patients, the response can be poor and the improvement unsatisfactory, restricting clinical applications. Moreover, immunoglobulin E (IgE)–mediated inflammatory responses are pivotal in the development and progression of CSU []. Therefore, IgE-targeting therapy can be more effective when H1-antihistamines are not sufficient to control CSU. Omalizumab, a recombinant humanized anti-IgE monoclonal antibody, is currently one of the most mature and widely used IgE-targeting therapies []. Multiple clinical studies have confirmed that omalizumab can significantly reduce the 7-day Urticaria Activity Score (UAS7) and decrease the number of wheals []. However, some studies found that the efficacy of omalizumab alone in treating CSU remains between 55% and 73% [-]. After treatment with omalizumab, patients still experience issues such as easy relapse and adverse reactions. Hence, it is urgent to continue to seek treatment options for patients with CSU. The earliest documented treatment of urticaria in traditional Chinese medicine (TCM) can be traced back to the , with a history of more than 1300 years. TCM has been applied for urticaria clinically in China for a long period. Clinical studies have confirmed that TCM has advantages in alleviating symptoms of urticaria [-]. The formula (SQF) is an empirical prescription from Xia’s family in TCM surgery, which is composed of 12 TCM ingredients (). Our research team has found that the SQF is safe and effective in treating CSU through long-term clinical practice. Several studies indicate that combining TCM with targeted therapies can enhance efficacy and reduce relapse rates in dermatological conditions [,]. However, there is a lack of clinical research confirming the efficacy and safety of SQF combined with omalizumab for CSU. Therefore, we adopted a trials within cohorts (TwiCs) study design, a derivative of a randomized controlled trial (RCT) design [], to evaluate the efficacy and safety of the combination therapy.