Our Choice: study protocol for a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine

Xiaoying Sun, Xiaoyong Zhou, Yuegang Wei, Wenxin Yang, Ning Huang, Yangfeng Ding, Rongyi Hu, Shun Guo, Chunyan Yang, Huilan Weng, Ying Zhang, Xi Chen, Xiaojie Ding, Liu Liu, Qingfeng Yin, Ruiping Wang, Xin Li, Bin Li, Xiaoying Sun, Xiaoyong Zhou, Yuegang Wei, Wenxin Yang, Ning Huang, Yangfeng Ding, Rongyi Hu, Shun Guo, Chunyan Yang, Huilan Weng, Ying Zhang, Xi Chen, Xiaojie Ding, Liu Liu, Qingfeng Yin, Ruiping Wang, Xin Li, Bin Li

Abstract

Background: Plaque psoriasis is a refractory inflammatory skin disease. The common therapies used to treat plaque psoriasis in traditional Chinese medicine (TCM) and western medicine (WM) have distinct characteristics and advantages. Although a combination of TCM and WM therapies, adjusted to the clinical situation, is widely used, there are no systematic studies on the hierarchical selection of this treatment combination based on the severity of skin lesions. We therefore designed a randomized clinical trial to focus on the sequence of internal and external treatments of TCM in patients with mild-to-moderate plaque psoriasis and to optimize the integration of Chinese and western medicine for the treatment of patients with severe plaque psoriasis, thereby achieving high-level clinical evidence and establish treatment norms for the integrated use of Chinese and western medicines.

Methods: In this proposed multicenter, single-blinded, randomized controlled trial, 108 patients with mild-to-moderate plaque psoriasis will be randomly assigned to two groups in a 1:1 ratio to receive either internal or external TCM treatment, and 270 patients with severe plaque psoriasis will be randomly assigned to three groups in a 1:1:1 ratio to receive treatment with TCM or WM, or TCM + WM. All enrolled patients will receive 8 weeks of treatment. Follow-up assessments will be done 8 weeks after the treatment. The primary outcome of this study is the evaluation of efficacy and relapse rate, based on the Psoriasis Area and Severity Index, and the secondary outcome measures include determination of the affected body surface area, physician's global assessment, pruritus scores (determined using a visual analog scale), TCM symptom score, Dermatology Life Quality Index, patient-reported quality of life score and incidence of serious adverse events.

Discussion: This study will provide high-level clinical evidence for internal and external TCM treatment optimization and will contribute to establishing norms for the integration of Chinese and western Medicines.

Trial registration: ClinicalTrials.gov, NCT03941431. Registered on 8 May 2019.

Keywords: Integrated Chinese and western medicine; Jueyin granules; Moving cupping therapy; NB-UVB; Plaque psoriasis.

Conflict of interest statement

The authors declare that they have no competing interests.

Figures

Fig. 1
Fig. 1
Study flowchart. BSA body surface area, NB-UVB narrow-band ultraviolet B radiation, PASI 75 75% reduction in the Psoriasis Area and Severity Index, TCM traditional Chinese medicine, WM western medicine
Fig. 2
Fig. 2
Cups used in the moving cupping therapy and placebo therapy. a Cups used in the moving cupping therapy. b Cups used for moving cupping placebo therapy

References

    1. Parisi R, Symmons DP, Griffiths CE, et al. Global epidemiology of psoriasis: a systematic review of incidence and prevalence. J Invest Dermatol. 2013;133(2):377–385. doi: 10.1038/jid.2012.339.
    1. Adriana CL, Tinara LS, Jorge RS, et al. Parvovirus B19 and in situ immune response in eczema and psoriasis skin lesions of patients from the Brazilian Amazon region. Microb Pathog. 2018;117:27–31. doi: 10.1016/j.micpath.2018.02.013.
    1. Ryo KK, Akifumi HW, Yasuko NJ, et al. Computed tomography imaging findings in erythrodermic psoriasis treated with infliximab: a case report. Radiol Case Rep. 2018;13(2):460–463. doi: 10.1016/j.radcr.2018.02.005.
    1. Parker S, Zhang CS, Yu JJ, et al. Oral Chinese herbal medicine versus placebo for psoriasis vulgaris: a systematic review. J Dermatolog Treat. 2017;28(1):21–31. doi: 10.1080/09546634.2016.1178377.
    1. Zhang CS, Yang L, Zhang AL, et al. Is oral Chinese herbal medicine beneficial for psoriasis vulgaris? A meta-analysis of comparisons with acitretin. J Altern Complement Med. 2016;22(3):174–188. doi: 10.1089/acm.2014.0212.
    1. Yang L, Zhang CS, May B, et al. Efficacy of combining oral Chinese herbal medicine and NB-UVB in treating psoriasis vulgaris: a systematic review and meta-analysis. Chin Med. 2015;10(1):27. doi: 10.1186/s13020-015-0060-y.
    1. Zhang CS, Yu JJ, Parker S, et al. Oral Chinese herbal medicine combined with pharmacotherapy for psoriasis vulgaris: a systematic review. Int J Dermatol. 2014;53(11):1305–1318. doi: 10.1111/ijd.12607.
    1. Deng S, May BH, Zhang AL, et al. Topical herbal formulae in the management of psoriasis: systematic review with meta-analysis of clinical studies and investigation of the pharmacological actions of the main herbs. Phytother Res. 2014;28(4):480–497. doi: 10.1002/ptr.5028.
    1. Yu JJ, Zhang CS, Zhang AL, et al. Add-on effect of Chinese herbal medicine bath to phototherapy for psoriasis vulgaris: a systematic review. Evid Based Complement Alternat Med. 2013;2013(4):673078.
    1. Deng S, May BH, Zhang AL, et al. Plant extracts for the topical management of psoriasis: a systematic review and meta-analysis. Br J Dermatol. 2013;169(4):769–782. doi: 10.1111/bjd.12557.
    1. Wu M, Deng Y, Li S, et al. The immunoregulatory effects of traditional Chinese medicine on psoriasis via its action on interleukin: advances and considerations. Am J Chin Med. 2018;46(4):739–750. doi: 10.1142/S0192415X18500386.
    1. Chen J, Wang Y, Xu R, et al. The efficacy of Jueyin prescription in the treatment of mild to moderate psoriasis vulgaris. Chin J Dermato Venerol Integ Trad W Med. 2013;12(2):108–109.
    1. Ma T, Jiang W, Li X, et al. Effects of Chinese formula Jueyin granules on psoriasis in an animal model. Evid Based Complement Alternat Med. 2014;2014:1–8.
    1. Miao X, Zhang Y, Jiang H, et al. Effects of Jueyin prescription on proliferation and cell cycle of HaCaT cells. Chin J Derm Venereol. 2016;30(1):10–2,55.
    1. Xiang Y, Wu X, Lu C, et al. An overview of acupuncture for psoriasis vulgaris, 2009-2014. J Dermatol Treat. 2017;28(3):221–228. doi: 10.1080/09546634.2016.1224801.
    1. Ya X. Research progress and preliminary evaluation of acupuncture and moxibustion in the treatment of psoriasis vulgaris based on the point of view of blood [dissertation]. Beijing: Beijing University of Traditional Chinese Medicine; 2014.
    1. Han H. Clinical observation of cupping therapy in the treatment of plaque psoriasis [dissertation].Wulumuqi: Xinjiang Medical University; 2013.
    1. Ibbotson SH, Bilsland D, Cox NH, et al. An update and guidance on narrowband ultraviolet B phototherapy: a British Photodermatology Group Workshop report. Br J Dermatol. 2004;151(2):283–297. doi: 10.1111/j.1365-2133.2004.06128.x.
    1. Patrizi A, Raone B, Ravaioli GM. Management of atopic dermatitis: safety and efficacy of phototherapy. Clin Cosmet Investig Dermatol. 2015;8:511–520. doi: 10.2147/CCID.S87987.
    1. Gottlieb AB, Dann F. Comorbidities in patients with psoriasis. Am J Med. 2009;122(12):0-2147483647. doi: 10.1016/j.amjmed.2009.06.021.
    1. Grozdev I, Korman N, Tsankov N. Psoriasis as a systemic disease. Clin Dermatol. 2014;32(3):343–350. doi: 10.1016/j.clindermatol.2013.11.001.
    1. Najarian DJ, Gottlieb AB. Connections between psoriasis and Crohn’s disease. J Am Acad Dermatol. 2003;48(6):805–821. doi: 10.1067/mjd.2003.540.
    1. Saleky S, Bulur I, Saraçoğlu ZN. Narrowband UVB treatment increases serum 25-hydroxyvitamin D levels in patients with chronic plaque psoriasis. Cutis. 2017;99(6):431–435.
    1. Assarsson M, Duvetorp A, Dienus O, et al. Significant changes in the skin microbiome in patients with chronic plaque psoriasis after treatment with narrowband ultraviolet B. Acta Derm Venereol. 2018;98(4):428–436. doi: 10.2340/00015555-2859.
    1. Cui BN, Sun YX, Liu WL. Clinical efficacy of narrow band ultraviolet B combined with Yuyin recipe in treating psoriasis vulgaris. Chin J Integr Tradit West Med. 2008;28(4):355–357.
    1. Psoriasis Professional Committee of Dermatology and venereology Branch of Chinese Medical Association Guidelines for the diagnosis and treatment of psoriasis in China (2018 simplified edition) Chin J Dermatol. 2019;52(4):223–230.
    1. European Medicines Agency. Guideline on clinical investigation of medicinal products indicated for the treatment of psoriasis. Committee for Medicinal Products for Human Use CHMP/EWP/2454/02. 2004.
    1. Yang X, Liu X, Yan L, et al. Clinical observation on the treatment of plaque psoriasis with moving cupping therapy combined with NB-UVB. Guangxi Tradit Chin Med. 2014;37(4):53–54.
    1. Gupta MA, Gupta AK, Watteel GN. Perceived deprivation of social touch in psoriasis is associated with greater psychologic morbidity: an index of the stigma experience in dermatologic disorders. Cutis. 1998;61(6):339–342.
    1. Richards HL, Fortune DG, Main CJ, et al. Stigmatization and psoriasis. Br J Dermatol. 2003;149(1):209–211. doi: 10.1046/j.1365-2133.2003.05391.x.
    1. Kimball AB, Jacobson C, Weiss S, et al. The psychosocial burden of psoriasis. Am J Clin Dermatol. 2005;6(6):383–392. doi: 10.2165/00128071-200506060-00005.
    1. Kimball AB, Wu EQ, Guérin A, et al. Risks of developing psychiatric disorders in pediatric patients with psoriasis. J Am Acad Dermatol. 2012;67(4):651–657. doi: 10.1016/j.jaad.2011.11.948.
    1. Russo PA, Ilchef R, Cooper AJ. Psychiatric morbidity in psoriasis: a review. Australas J Dermatol. 2004;45(3):155–161. doi: 10.1111/j.1440-0960.2004.00078.x.
    1. Farley E, Menter A. Psoriasis: comorbidities and associations. G Ital Dermatol Venereol. 2011;146(1):9–15.
    1. Finlay AY. Psoriasis from the patient’s point of view. Arch Dermatol. 2001;137(3):352–353.
    1. Finlay AY, Coles EC. The effect of severe psoriasis on the quality of life of 369 patients. Br J Dermatol. 1995;132(2):236–244. doi: 10.1111/j.1365-2133.1995.tb05019.x.
    1. Lu C, Deng J, Li L, et al. Application of metabolomics on diagnosis and treatment of patients with psoriasis in traditional Chinese medicine. Biochim Biophys Acta. 2014;1844(1):280–288. doi: 10.1016/j.bbapap.2013.05.019.
    1. Chen X, Hong S, Sun X, et al. Efficacy of fish oil and its components in the management of psoriasis: a systematic review of 18 randomized controlled trials. Nutr Rev. 2020. .
    1. Voiculescu VM, Lupu M, Papagheorghe L, et al. Psoriasis and metabolic syndrome—scientific evidence and therapeutic implications. J Med Life. 2014;7(4):468–471.
    1. Zheng Q, Jiang WC, Sun XY, et al. Total glucosides of paeony for the treatment of psoriasis: a systematic review and meta-analysis of randomized controlled trials. Phytomedicine. 2019;62:152940. doi: 10.1016/j.phymed.2019.152940.
    1. Chen Y, Guo D-j, Deng H, et al. Acute and chronic toxicity of a polyherbal preparation—Jueyin granules. BMC Complement Altern Med. 2018;18(1):148. doi: 10.1186/s12906-018-2211-z.
    1. Li X, Xiao QQ, Li FL, Xu R, et al. Immune signatures in patients with psoriasis vulgaris of blood-heat syndrome: a systematic review and meta-analysis. Evid Based Complement Alternat Med. 2016;2016:9503652.
    1. Tiejun W, Lingling X, Bin L, et al. Determination of chlorogenic acid and paeonol in the silver particles. Med J West China. 2014;26(9):1225–1231.
    1. Sun S. Clinical study on the treatment of plaque psoriasis with moving cupping with Lithospermum erythrorhizon Sieb oil as a medium based on the existence theory of meridian symmetry [dissertation]. Beijing: Beijing University of Traditional Chinese Medicine; 2016.
    1. Hallaji Z, Barzegari M, Balighi K, et al. A comparison of three times vs. five times weekly narrowband ultraviolet B phototherapy for the treatment of chronic plaque psoriasis. Photodermatol Photoimmunol Photomed. 2010;26(1):10–15. doi: 10.1111/j.1600-0781.2009.00473.x.
    1. Dawe RS, Wainwright NJ, Cameron H, et al. Narrow-band (TL-01) ultraviolet B phototherapy for chronic plaque psoriasis: three times or five times weekly treatment? Br J Dermatol. 1998;138(5):833–839. doi: 10.1046/j.1365-2133.1998.02221.x.
    1. Liu M, Li X, Chen XY, et al. Topical application of a linoleic acid-ceramide containing moisturizer exhibit therapeutic and preventive benefits for psoriasis vulgaris: a randomized controlled trial. Dermatol Ther. 2015;28(6):373–382. doi: 10.1111/dth.12259.
    1. Luo Y, Ru Y, Sun X, et al. Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol. Ann Transl Med. 2019;7(22):10.21037. doi: 10.21037/atm.2019.10.46.

Source: PubMed

Sponsors and Collaborators

Medical Conditions

Drug Interventions

3
Subscribe