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Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol.

ABSTRACT: Background:Psoriasis is an incurable, chronic skin disorder with considerable impact on the quality of life. No drugs are available for treating the disease. Clarifying the progression, exploring the risk factors affecting progression, and finding effective treatments with few side-effects and low recurrence rates is critical. This protocol describes a future study that will analyze psoriasis vulgaris progression risk factors and trends, establish a multicenter clinical registration platform, evaluate clinical evidence for Chinese Medicine (CM) intervention for psoriasis, and evaluate therapeutic effectiveness and recurrence rate advantages of CM. Methods:The study is a prospective cohort clinical trial planned for October 2019 to September 2021 involving 20 clinics. The trial will enroll 1,500 participants in a psoriasis vulgaris group, and 500 healthy participants in a control group (no intervention). The psoriasis vulgaris group will be divided into three equal-sized subgroups: blood heat syndrome group (BHS), blood stasis syndrome group (BSS), and non-blood heat nor blood stasis syndrome group (NHS) group. Participants will be grouped according to CM syndrome classification and receive oral CM herbal medication (according to the CM syndrome classification, and tailored to the participant's disease progression). Medication will be administered twice every day during the intervention phase (eight weeks of intervention, and eight weeks of follow-up). Exposure measures include demographic variables, risk factors, and intervention factors. Discussion:The primary outcome measures include improvement in both the psoriasis and severity index scores after eight weeks of intervention. Secondary outcome measures include body surface area affected, Physician Global Assessment scores, Dermatology Life Quality Index, pain-relat ed quality of life, pain on visual analog scale, CM syndromes, and recurrence. Other outcome measures include CM physical scale, personal history, medical expenses, and patient satisfaction. The number, nature, and severity of adverse events will be carefully recorded. Trial registration:The trial has been registered at ClinicalTrials.gov (ID: NCT03942185).

SUBMITTER: Luo Y

PROVIDER: S-EPMC6944550 | biostudies-literature | 2019 Nov

REPOSITORIES: biostudies-literature

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Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol.

Luo Ying Y Ru Yi Y Sun Xiaoying X Zhou Yaqiong Y Yang Yingyao Y Ma Tian T Xu Rong R Chen Jie J Zhou Mi M Ze Kan K Ju Li L Wang Yanjiao Y Yin Qingfeng Q Wang Ruiping R Li Bin B Li Xin X

Annals of translational medicine 20191101 22

<h4>Background</h4>Psoriasis is an incurable, chronic skin disorder with considerable impact on the quality of life. No drugs are available for treating the disease. Clarifying the progression, exploring the risk factors affecting progression, and finding effective treatments with few side-effects and low recurrence rates is critical. This protocol describes a future study that will analyze psoriasis vulgaris progression risk factors and trends, establish a multicenter clinical registration plat ...[more]

PMID: 31930095

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Project description:IntroductionPsoriasis vulgaris was shown to be an independent factor increasing the risk of several comorbidities such as obesity, diabetes and dyslipidaemia with an increased risk of stroke and myocardial infarction. We hypothesise that early endothelial dysfunction, which plays a crucial role in the pathogenesis of atherosclerosis, may be detected by digital video nailfold capillaroscopy (DVNC) at the level of the dermal capillary microvasculature as a surrogate parameter. Nailfolds represent the only body site allowing for a non-invasive assessment of the capillary microvasculature at a horizontal plane. DVNC is a well-established diagnostic tool for in vivo assessment of the peripheral microcirculation by evaluating the morphology of dermal papillary capillaries. To date, reports on morphological changes of the non-lesional nailfold capillaries in patients with psoriasis vulgaris are scarce and the existing data are not conclusive.Methods and analysisThis is a prospective, single-centre, non-randomised, controlled, exploratory study assessing the capillary patterns in 100 subjects affected by psoriasis vulgaris. Non-lesional nailfold capillaries will be imaged by means of DVNC (Optilia Digital Capillaroscopy System, Optilia Instruments AB, Sollentuna, Sweden) in 50 patients affected by psoriasis vulgaris and 50 healthy controls. Assessments will include a qualitative, descriptive analysis of the nailfold capillaries' morphology, as well as a quantitative investigation (frequency, extent) of changes in capillary patterns. Moreover, patients' characteristics associated with the manifestation of nailfold capillaries' pathologies including well-known cardiovascular risk markers will be studied.Ethics and disseminationEthical approval was provided by the ethic committee of the medical faculty of the University of Heidelberg (Ethics approval number S-447/2017). The design and the final results of the study will be published and made available to the public.Trial registration numberDRKS00012856.

Project description:Background Offering living kidney donation raised the concern that donors are exposed to unknown risks. All Swiss transplant centres therefore decided to start a prospective cohort study of living kidney donors in Switzerland. This paper describes the rationale for and implementation of this cohort study. Methods/design All kidney donors in Switzerland are registered and examined before donation and biennially after donation starting in the first year after nephrectomy. Before each follow-up visit, the study centre sends a package to the kidney donor containing the health questionnaire, blood and urine tubes and a prepaid envelope for sending the samples to the central laboratory. The donor makes an appointment with their family physician, who examines the donor and reports findings such as pain and other complaints, blood pressure, creatinine, albumin, all major health events and the state of mental and social well-being to the study centre. The family doctor draws the blood sample and mails it with the urine sample in the prepaid envelope. All data are centrally managed. All abnormal findings in the follow-up of individual donors are regularly discussed with the principal investigator, and necessary clinical changes made and recorded in the database. The health insurance of the recipient covers all costs of the donor follow-up. The main outcomes are the occurrence of albuminuria, hypertension and renal insufficiency. The secondary outcomes are major somatic and social events such as death, cardiovascular disease, stroke and depression. Discussion This prospective cohort offers unique opportunities to assess the risks of living kidney donation and will allow us to examine the risks associated with the methods used for nephrectomy in Switzerland (various forms of open surgery and laparoscopic nephrectomy). The prospective collection of all clinically relevant data and the regular monitoring of donors will allow timely interventions at early stages before serious kidney and general health problems occur.

Project description:Introduction: To develop appropriate strategies for early diagnosis and intervention of cognitive impairment, the identification of minimally invasive and cost-effective biomarkers for the early diagnosis of cognitive impairment is crucial and desirable. Therefore, the CHina registry study on cOgnitive imPairment in the Elderly (HOPE) study is designed to investigate the natural course of cognitive decline and explore the clinical, imaging, and biochemical markers for the detection and diagnosis of cognitive impairment on its earliest stage. Methods: Approximately 5,000 Chinese elderly aged more than 50 years were recruited from Sun Yat-sen Memorial Hospital, Sun Yat-sen University in Guangzhou, China by the year 2024. All subjects were invited to complete the clinical assessment, neuropsychological assessment, the biological samples collection (blood and cerebrospinal fluid (CSF)], magnetic resonance imaging (MRI) examination, and optional amyloid and tau PET. The follow-up survey was conducted every 1 year to repeat these assessments for 20 years. To better clarify the relationship between potential risk factors and endpoint events [changes in cognitive score or incidence of mild cognitive impairment (MCI) and/or dementia], appropriate statistical methods were used to analyze the data, including but not limited to, such as linear mixed-effect model, competing risk model, or the least absolute shrinkage and selection operator model. Significance: The CHina registry study on cOgnitive imPairment in the Elderly study is designed to explore the longitudinal changes in characteristics of participants with cognitive decline and to identify potential plasma and imaging biomarkers with cost-benefit and scalability advantages. The results will enable broader clinical access and efficient population screening and then improve the development of treatment and the quality of life for cognitive impairment at the early stage. Trial registration number: NCT04360200.

Project description:INTRODUCTION:Psoriasis 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 ANALYSIS:This 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 4 weeks, and calcipotriol betamethasone ointment for topical use once daily for 4 weeks. Participants in the control group will receive only calcipotriol betamethasone ointment treatment once daily for 4 weeks. All patients will be followed up for 12 weeks. 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. DISCUSSION:This 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 REGISTRATION:Chinese Clinical Trial Registry, ChiCTR-TRC-14004916 . Registered on 20 May 2014. This protocol is version 3.0 which was updated on 24 September 2016.

Project description:BACKGROUND:Psoriasis vulgaris (PV) is a chronic, immune-mediated dermatological disease that significantly affects the patient's health and quality of life. At present, cupping has been widely used in the treatment of psoriasis. However, the effectiveness and safety of cupping in patients with PV are still controversial. Therefore, this review aims to evaluate the efficacy and safety of cupping therapy on PV. METHODS:The following databases will be searched from their inceptions to April 2020 with a language limitation of English and Chinese: Pubmed, Medline, Embase, Cochrane Central Register of Controlled Trials, Chinese Biomedical Literature Databas, China National Knowledge Infrastructure Database, Wanfang database and Chinese Scientific Journal Database. The reference lists of eligible studies and other resources will also be searched. Two researchers will independently perform the selection of studies, data extraction, and data analysis. A fixed or random-effect model will be applied to synthesize data depend on the heterogeneity test. The primary outcome is the proportion of patients achieving at least a 60% improvement in psoriasis area and severity index (PASI) score from baseline (PASI 60). Secondary outcomes include the proportion of patients achieving at least a 90% improvement in PASI score from baseline (PASI 90), the mean change of PASI and dermatology life quality index score, the itching index, adverse events, and recurrence rate. RevMan V.5.3 software will be used for meta-analysis. RESULTS:The study will provide a high-quality evidence-based review of cupping for PV. CONCLUSIONS:The study will be conducted to evaluate the efficacy and safety of cupping in the treatment of PV and supposed to provide clear evidence for the clinical application of cupping therapy. ETHICS AND DISSEMINATION:As the study is a protocol of systematic review and meta-analysis that does not involve individual data, ethical approval will not be required. The results will be published in a peer-reviewed journal. OSF REGISTRATION NUMBER:DOI 10.17605/OSF.IO/KV4CJ.

Dataset Information

Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol.

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Characteristics of psoriasis vulgaris in China: a prospective cohort study protocol.

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