机构:[1]Psoriasis Clinical and Basic Research Team, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.广东省中医院[2]Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou 510120, China.广东省中医院[3]Guangdong Provincial Key Laboratory of Clinical Research on Traditional Chinese Medicine Syndrome, Guangzhou 510120, China.[4]Key Unit of Methodology in Clinical Research, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.广东省中医院[5]School of Medical Information Engineering, Guangdong Pharmaceutical University, Guangzhou 510006, China
IntroductionPsoriasis vulgaris is a common skin disease characterized by persistent localized erythematous scaly plaques, typically on the elbows, knees, and scalp. It is an immune-abnormal disease that progresses slowly over a long period with frequent symptom recurrence. Current studies have shown that acupuncture is an effective therapy for psoriasis. However, the scientific evidence of the efficacy of auricular acupressure treatment for patients with psoriasis is still insufficient. Therefore, we designed a randomized controlled clinical trial to investigate the effect, safety, and cost-effectiveness of auricular acupressure in addition to medication in patients with psoriasis.Methods and analysisThis on-going study is a two-arm parallel, assessor-blinded, randomized controlled trial in which 180 participants with psoriasis will be recruited and then randomly allocated into two groups in a 1:1 ratio. Equal randomization will be conducted using a computer-generated random allocation sequence. Participants in the intervention group will receive auricular acupressure treatment once per week for 4weeks, and calcipotriol betamethasone ointment for topical use once daily for 4weeks. Participants in the control group will receive only calcipotriol betamethasone ointment treatment once daily for 4weeks. All patients will be followed up for 12weeks. The primary outcome is relapse rate. The secondary outcomes include time to relapse, rebound rate, time to new onset, Psoriasis Area and Severity Index score improvement rate, body surface area affected, a visual analogue scale, and Dermatology Life Quality Index. Cost-effectiveness analysis will be carried out from a health and community care provider perspective.DiscussionThis multicenter randomized controlled trial will provide important clinical evidence for the effect and safety of auricular acupressure as a complementary therapy in patients with psoriasis.Trial registrationChinese Clinical Trial Registry, ChiCTR-TRC-14004916. Registered on 20 May 2014. This protocol is version 3.0 which was updated on 24 September 2016.
基金:
National Key Technology R&D Program for the 12th Five-year Plan of Ministry of Science and Technology, ChinaNational Key Technology R&D Program [2013BAI02B03]; Traditional Chinese Medicine Bureau Foundation of Guangdong Province [20161111, 20183005]
第一作者机构:[1]Psoriasis Clinical and Basic Research Team, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.[2]Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou 510120, China.
通讯作者:
通讯机构:[1]Psoriasis Clinical and Basic Research Team, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou 510120, China.[2]Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou 510120, China.
推荐引用方式(GB/T 7714):
Deng Jingwen,Lu Chuanjian,Xiang Yu,et al.Auricular acupressure as a complementary therapy for psoriasis vulgaris: study protocol for a multicenter randomized controlled trial[J].TRIALS.2019,20:doi:10.1186/s13063-019-3475-4.
APA:
Deng, Jingwen,Lu, Chuanjian,Xiang, Yu,Deng, Hao,Wen, Zehuai...&Yan, Yuhong.(2019).Auricular acupressure as a complementary therapy for psoriasis vulgaris: study protocol for a multicenter randomized controlled trial.TRIALS,20,
MLA:
Deng, Jingwen,et al."Auricular acupressure as a complementary therapy for psoriasis vulgaris: study protocol for a multicenter randomized controlled trial".TRIALS 20.(2019)