Multi-center study for acupuncture combined with Chinese medicine in the treatment of chronic spontaneous urticaria based on the theory of taking shu-stream points when the disease is aggravated

Abstract Chronic spontaneous urticaria (CSU) is a common dermatologic disease that seriously affects patient quality of life. The choice of therapy to control the disease and prevent its recurrence has always presented a difficult clinical issue. Previous studies have shown that traditional Chinese medicine is a safe and effective treatment for CSU. Recently, the temporal rhythms of CSU, a disease characterized by intermittent flares of active disease and periods of little or no disease, have attracted the attention of traditional Chinese medicine researchers. We designed a multicenter, randomized, controlled study to evaluate the efficacy and safety of combining a Chinese herbal formulation with acupuncture using shu-stream acupoints applied on the corresponding time meridians during disease exacerbations. We plan to recruit 111 outpatients with CSU aged 18 to 65 years. Participants will be randomized to 1 of the 3 groups: group A, which will be given basic acupuncture and the herbal formulation dangui yinzi; group B, which will be given danggui yinzi and shu-stream acupuncture; and a control group, which will be given danggui yinzi alone. Patients will be treated for 4 weeks and followed for 8 additional weeks. Investigators will evaluate the following parameters: the symptoms and side effects of treatment, quality of life (using the chronic urticaria quality of life questionnaire), and overall patient condition. Each week, patients will also complete the measurement of 7-day urticarial activity score. This is the first use of a combination of shu-stream acupoints and Chinese herbal medicine in the treatment of CSU. If successful, it will prove to be a simple, inexpensive, treatment strategy for solving a difficult clinical problem.

[1]  Y. Liu,et al.  Acupoint injection of Bacillus Calmette–Guerin polysaccharide nucleic acid for patients with chronic urticaria , 2020, Medicine.

[2]  G. Pellacani,et al.  Chronic Spontaneous Urticaria: A Review of Pathological Mechanisms, Diagnosis, Clinical Management, and Treatment , 2020, European Medical Journal.

[3]  M. Rafique,et al.  Frequency of depression and anxiety among patients with chronic spontaneous urticaria visiting a tertiary care hospital in Karachi, Pakistan. , 2020, JPMA. The Journal of the Pakistan Medical Association.

[4]  Ying Liu,et al.  Cupping for patients with chronic urticaria , 2019, Medicine.

[5]  Y. Liu,et al.  Efficacy and safety of acupuncture for patients with chronic urticaria: study protocol of a randomized, sham-controlled pilot trial , 2019, Trials.

[6]  Hui Zheng,et al.  Autologous whole-blood or autologous serum acupoint injection therapy for chronic urticaria , 2019, Medicine.

[7]  A. Leung,et al.  Chronic Urticaria: An Overview of Treatment and Recent Patents , 2019, Recent patents on inflammation & allergy drug discovery.

[8]  M. Hew,et al.  Strongyloides infection as a reversible cause of chronic urticaria , 2019, Journal of asthma and allergy.

[9]  S. Eun,et al.  Natural course of new-onset urticaria: Results of a 10-year follow-up, nationwide, population-based study. , 2019, Allergology international : official journal of the Japanese Society of Allergology.

[10]  T. Zuberbier,et al.  The EAACI/GA²LEN/EDF/WAO guideline for the definition, classification, diagnosis and management of urticaria , 2018, Allergy.

[11]  M. Sánchez-Borges,et al.  Chronic Urticaria: Comparisons of US, European, and Asian Guidelines , 2018, Current Allergy and Asthma Reports.

[12]  Soichiro Matsushima,et al.  Efficacy and safety of omalizumab in Japanese and Korean patients with refractory chronic spontaneous urticaria. , 2017, Journal of dermatological science.

[13]  Jason K. Lee,et al.  Chronic spontaneous urticaria , 2017, Canadian Medical Association Journal.

[14]  Ji-Hye Kim,et al.  Serum Clusterin as a Prognostic Marker of Chronic Spontaneous Urticaria , 2016, Medicine.

[15]  Fang Wang,et al.  Activation of the Blood Coagulation System in Patients with Chronic Spontaneous Urticaria. , 2015, Clinical Laboratory.

[16]  S. Shibata,et al.  Disruption of the Suprachiasmatic Nucleus Blunts a Time of Day-Dependent Variation in Systemic Anaphylactic Reaction in Mice , 2014, Journal of immunology research.

[17]  T. Hiragun,et al.  Prognosis of chronic spontaneous urticaria in 117 patients not controlled by a standard dose of antihistamine , 2013, Allergy.

[18]  M. Leshno,et al.  Chronic urticaria and autoimmunity: associations found in a large population study. , 2012, The Journal of allergy and clinical immunology.

[19]  J. Bousquet,et al.  Unmet clinical needs in chronic spontaneous urticaria. A GA2LEN task force report 1 , 2011, Allergy.

[20]  Todor A Popov,et al.  The effectiveness of levocetirizine and desloratadine in up to 4 times conventional doses in difficult-to-treat urticaria. , 2010, The Journal of allergy and clinical immunology.

[21]  G. Canonica,et al.  A new tool to evaluate the impact of chronic urticaria on quality of life: chronic urticaria quality of life questionnaire (CU‐Q2oL) , 2005, Allergy.