Chinese herbal medicine treatment based on subgroup differentiation as adjunct therapy for Parkinson's disease: study protocol of a pilot add-on, randomised, controlled, pragmatic clinical trial.

BACKGROUND: Parkinson's disease (PD) is a prevalent and debilitating condition. Conventional medications cannot control all symptoms and may inflict adverse effects. A survey reported that Chinese herbal medicine (CHM) is frequently sought. Existing CHM trials were contradictory and often of poor quality due to lack of methodological rigor. A national clinical guideline was drafted in China with diagnostic criteria and treatment strategy of Chinese medicine (CM) patterns subgroups of PD. The suggested CHM were found to exhibit neuroprotective effect in in vitro and in vivo studies. This trial aims to preliminarily assess the effect of CHM prescribed based on pattern differentiation on PD symptoms and patients' quality of life, and evaluate the feasibility of the trial design for a future large-scale trial. METHODS: This trial will be a pilot assessor- and data analyst blind, add-on, randomised, controlled, pragmatic clinical trial. 160 PD patients will be recruited and randomised into treatment or control groups in a 1:1 ratio. The trial will be conducted over 32 weeks. PD patients in the treatment group will be stratified into subgroups based on CM pattern and receive CHM accordingly in addition to conventional medication (ConM). The control group will receive ConM only. The primary outcome will be part II of the Movement Disorder Society Sponsored Revision of Unified Parkinson's Disease Rating Scale (MDS-UPDRS). Secondary outcomes will include part and total scores of MDS-UPDRS, domain and total scores of Non-motor symptom scale (NMSS). Adverse events will be monitored by monthly follow-ups and questionnaires. Mixed models will be used to analyse data by Jamovi and R. EXPECTED OUTCOMES: The success of our trial will show that the pragmatic design with subgroup differentiation is feasible and can produce reliable results. It will also provide preliminary data of the effect of CHM on improving clinical outcomes and quality of PD patients. Data collected will be used to optimize study design of the future large-scale clinical study. ETHICAL CLEARANCE: Ethical clearance of this study was given by the Research Ethics Committee of Hong Kong Baptist University (REC/20-21/0206). Trial registration This trial is registered on ClinicalTrials.gov (NCT05001217, Date: 8/10/2021, https://clinicaltrials.gov/ct2/show/NCT05001217 ). Type of manuscript: clinical trial protocol (date: 3rd November, 2021, version 1).

Massage therapy in infants and children under 5 years of age: protocol for an overview of systematic reviews.

INTRODUCTION: Massage is a popularly used complementary and alternative therapy. Previous randomised controlled trials have examined the effects of massage on children, and several systematic reviews have been conducted to synthesise these data. This study aims to assess and summarise the current evidence from published systematic reviews of controlled clinical trials on the practice of paediatric massage, specifically in infants and children aged < 5 years. METHODS: The online databases MEDLINE, Embase, Health Technology Assessment Database, Cochrane Database of Systematic Reviews, Database of Abstracts of Reviews of Effects, Allied and Complementary Medicine, China National Knowledge Infrastructure and Wanfang Data will be searched from the inception onwards for evidence of the treatment effects. We will include systematic reviews of randomised control trials evaluating the effects and safety of massage therapy in infants and children aged < 5 years. The primary outcomes will be any physical or psychological outcome, and adverse effects on children. Secondary outcomes will include any physical or psychological outcome on caregivers. Two reviewers will independently screen the articles for inclusion as per the eligibility criteria. They will extract information from the included studies and assess the methodological quality of the included studies. A table will be used to summarise of information of the included studies, which includes the basic information, method and findings. The methodological quality of the included systematic reviews will be assessed by A Measurement Tool to Assess Systematic Reviews version 2 (AMSTAR 2). Extracted data from the included studies will be collected and presented using narrative approach. The pooled effect estimates for meta-analysed outcomes will be extracted when possible. If there is a discrepancy in results of two or more reviews on the same topic, then the causes of such discrepancy will be further explored. DISCUSSION: This overview of systematic reviews will summarise the current evidence on massage, specifically for infants and children aged < 5 years. We will comprehensively present the positive effects and adverse effects of this intervention. Findings from this overview will be published in a peer-reviewed journal. SYSTEMATIC REVIEW REGISTRATION: CRD42020186003 .

Prevalence of sleep disturbances during COVID-19 outbreak in an urban Chinese population: a cross-sectional study.

OBJECTIVE: The COVID-19 pandemic is a large-scale public health emergency that likely precipitated sleep disturbances in the community. This study aimed to investigate the prevalence and correlates of sleep disturbances during the early phase of COVID-19 pandemic. METHODS: This web-based cross-sectional study recruited 1138 Hong Kong adults using convenience sampling over a two-week period from 6th April 2020. The survey collected data on sleep disturbances, mood, stress, stock of infection control supplies, perceived risk of being infected by COVID-19, and sources for acquiring COVID-19 information. The participants were asked to compare their recent sleep and sleep before the outbreak. The Insomnia Severity Index (ISI) was used to assess their current insomnia severity. Prevalence was weighted according to 2016 population census. RESULTS: The weighted prevalence of worsened sleep quality, difficulty in sleep initiation, and shortened sleep duration since the outbreak were 38.3%, 29.8%, and 29.1%, respectively. The prevalence of current insomnia (ISI score of ≥10) was 29.9%. Insufficient stock of masks was significantly associated with worsened sleep quality, impaired sleep initiation, shortened sleep duration, and current insomnia in multivariate logistic regression (adjusted OR = 1.57, 1.72, 1.99, and 1.96 respectively, all p < 0.05). CONCLUSION: A high proportion of people in Hong Kong felt that their sleep had worsened since the COVID-19 outbreak. Insufficient stock of masks was one of the risk factors that were associated with sleep disturbances. Adequate and stable supply of masks may play an important role to maintain the sleep health in the Hong Kong general population during a pandemic outbreak.