Efficacy and safety of modified Xiao-Feng Powder in the treatment of chronic urticaria: protocol of a randomized double-blind placebo-controlled study.

BACKGROUND: Chronic Urticaria (CU), a common skin disorder known as Yin Zhen in Chinese medicine, is characterized by recurrent, pruritic, pink-to-red edematous lesions and wheals on the skin. Xiao-Feng Powder (XFP, meaning Wind-Dispersing Powder), is reported to be one of the most frequently used Chinese herbal formulae for CU. In this study, we aim to investigate the effectiveness and safety of modified Xiao-Feng Powder (mXFP) for the treatment of CU. METHODS: In this randomised double-blind placebo-controlled clinical trial, 58 subjects identified as having mild to severe urticaria (Urticaria activity score greater than 10) will be recruited and randomised into two groups to receive antihistamine Bilastine with either mXFP or placebo for 12 weeks, followed by post treatment visits at week 16. The primary outcome measure is the change of weekly urticaria activity score (UAS7) at week 12. Secondary outcome measures include the Urticaria Control Test (UCT), Visual Analog Scale of Itch Severity (VAS), Chronic Urticaria Quality of Life Questionnaire (CU-Q2oL), Angioedema Activity Score (AAS), immunoglobulin E (IgE) test, gut microbiota test and use of antihistamines during study period. The trial will be conducted at three Chinese medicine clinics in Hong Kong. EXPECTED OUTCOMES: The results of this study will establish robust clinical evidence about the efficacy and safety of mXFP in the treatment of CU. A specific feature of this trial is that it is a integrative medicine trial with subjects being allowed to take the Western and Chinese medicine together for the treatment. Trial registration This is registered on ClinicalTrials.gov, ID: NCT04967092. Register date: July 19, 2021. https://clinicaltrials.gov/ct2/show/NCT04967092 .

Chinese medicine for residual symptoms of COVID-19 recovered patients (long COVID)-A double-blind, randomized, and placebo-controlled clinical trial protocol.

Introduction: Coronavirus disease 2019 (COVID-19) is the current global pandemic of which residual symptoms exhibited by post-acute, rehabilitating patients include fatigue, dyspnoea, and insomnia. Chinese medicine (CM) has been widely used in China to treat different stages of COVID-19. While there are a significant number of clinical studies suggesting its efficacy and safety in its use during acute stage, there are very few randomized controlled trials focusing on the rehabilitation stage. Liujunzhi Decoction and Shashen Maidong Decoction are frequently recommended by official clinical guidelines in China to treat COVID-19 patients in rehabilitation stage. This double-blind, randomized, placebo controlled study aims to evaluate the efficacy and safety of the combination of the two formulae [named "COVID-19 Rehab Formula (CRF)"] in treating COVID-19 residual symptoms (long COVID). Methods: Eligible subjects will be randomly divided into treatment group and control group in 1:1 ratio. Treatment group will receive CRF along with certain pre-defined CM according to symptoms for 8 weeks, while control group will receive equivalent packs of placebo for 8 weeks. Data in terms of Fatigue Severity Score (FSS), self-reported COVID-19 long term symptom assessment, the modified British Medical Research Council (mMRC) Dyspnoea Scale, EuroQol Five-Dimension Five-Level (EQ-5D-5L) Questionnaire, pulmonary function test and adverse events will be collected and analyzed by SPSS 24. Blood test on liver and renal functions will also be conducted as safety measures. Conclusion: This study will evaluate the efficacy and safety of CRF in the treatment COVID-19 residual symptoms in a scientifically rigorous design. Clinical trial registration: [ClinicalTrials.gov], identifier [NCT04924881].

Efficacy of electroacupuncture plus warm needling therapy for plantar heel pain: a randomised waitlist-controlled trial.

OBJECTIVE: To investigate the therapeutic effects of electroacupuncture plus warm needling (EAWN) therapy on pain and foot function in adults with plantar heel pain (PHP). METHODS: This prospective, randomised, parallel-group, waitlist-controlled trial was conducted at a Chinese medicine centre in Hong Kong between May 2018 and February 2019. Eighty eligible community-dwelling subjects with PHP (mean age 59.7 years; 85% female) were equally randomised to receive EAWN therapy or remain on a waitlist. The treatment group received six 30-min sessions of standardised EAWN therapy over 4 weeks; the control group received no treatment. The outcome measures were the visual analogue scale (VAS) score for first-step pain, foot function index (FFI) scores and global rating of change (GRC) scale scores. Assessments were made at baseline, week 2 and week 4 (primary endpoint). The treatment group underwent additional assessments at week 8. Outcomes were evaluated by intention-to-treat analysis. RESULTS: Patients who received EAWN therapy exhibited greater improvements in the mean first-step pain VAS and all FFI scores than did those in the control group at weeks 2 and 4, with significant between-group differences (all P < 0.001). Compared with baseline, there were significant decreases in mean first-step pain VAS scores at weeks 2 and 4, and FFI scores at week 4, in the treatment group but not in the control group. The improvements in the treatment group continued until week 8. GRC scores at week 4 indicated improvement in all treated patients and only 22.5% of the control group patients (P < 0.001). There were no study-related adverse events. CONCLUSION: EAWN therapy could be an effective treatment for PHP in middle-aged and older adults. TRIAL REGISTRATION NUMBER: ChiCTR1800014906 (Chinese Clinical Trials Registry).

Efficacy and safety of electroacupuncture plus warm needling therapy for heel pain: study protocol for a randomized controlled trial.

BACKGROUND: Heel pain is a common foot disorder that causes pain and functional limitations. The prevalence of disabling foot pain will increase as the population ages. Previous studies have reported the positive therapeutic effects of electroacupuncture, warm needling, or the combination of both for heel pain but with limitations in the study methodologies. The current study is a rigorously designed randomized controlled trial that aims to evaluate the clinical efficacy and safety of electroacupuncture plus warm needling therapy in patients with heel pain. METHODS/DESIGN: The study protocol describes a prospective, open-label, parallel-group, randomized controlled trial to be conducted in Hong Kong. Eighty patients aged 50-80 years who have reported heel pain and first-step pain equal to or exceeding 50 mm on the 100-mm visual analog scale (VAS) will be recruited. They will be randomly assigned (1:1 ratio) to the electroacupuncture plus warm needling therapy (i.e., treatment) group or the waitlist (i.e., control) group. The treatment group will undergo six treatment sessions in 4 weeks. The control group will receive no treatment during the study period. The primary outcome measure is a mean change in the first-step pain VAS score from the baseline to week 4. Secondary outcome measures include a mean change in first-step pain VAS score from the baseline to week 2, a mean change in Foot Function Index (FFI) subscale scores and the total score from the baseline to week 2 and week 4, and patients' self-reported level of improvement at week 4. Additional week 8 follow-up assessments with first-step pain VAS and FFI measurements will be arranged for the treatment group. Any adverse events will be recorded throughout the study to evaluate safety. An intention-to-treat approach will be used to analyze the study results. DISCUSSION: This study will provide evidence on the efficacy and safety of electroacupuncture plus warm needling therapy as an alternative treatment method for heel pain. The findings will determine whether the treatment protocol is efficacious in relieving pain and improving foot function among older adults with heel pain. The study will also provide information for subsequent large-scale randomized controlled trials in the future. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ChiCTR1800014906 . Registered on 12 February 2018.

Effects of Acupuncture on the Recovery Outcomes of Stroke Survivors with Shoulder Pain: A Systematic Review.

BACKGROUND: Poststroke shoulder pain limits stroke survivors' physical functioning, impairs their ability to perform daily activities, and compromises their quality of life. The use of acupuncture to manage shoulder pain after a stroke is believed to free the blockage of energy flow and produce analgesic effects, but the evidence is unclear. We therefore conducted a systematic review to summarize the current evidence on the effects of acupuncture on the recovery outcomes of stroke survivors with shoulder pain. METHODS: Fourteen English and Chinese databases were searched for data from January 2009 to August 2017. The review included adult participants with a clinical diagnosis of ischemic or hemorrhagic stroke who had developed shoulder pain and had undergone conventional acupuncture, electroacupuncture, fire needle acupuncture, or warm needle acupuncture. The participants in the comparison group received the usual stroke care only. RESULTS: Twenty-nine randomized controlled trials were included. Most studies were assessed as having a substantial risk of bias. Moreover, due to the high heterogeneity of the acupuncture therapies examined, pooling the results in a meta-analysis was not appropriate. A narrative summary of the results is thus presented. The review showed that conventional acupuncture can be associated with benefits in reducing pain and edema and improving upper extremity function and physical function. The effects of conventional acupuncture on improving shoulder range of motion (ROM) are in doubt because this outcome was only examined in two trials. Electroacupuncture might be effective in reducing shoulder pain and improving upper extremity function, and conclusions on the effects of electroacupuncture on edema, shoulder ROM, and physical function cannot be drawn due to the limited number of eligible trials. The evidence to support the use of fire needle or warm needle acupuncture in stroke survivors with shoulder pain is also inconclusive due to the limited number of studies. CONCLUSION: Although most studies reviewed concluded that conventional and electroacupuncture could be effective for management of shoulder pain after stroke, the very high potential for bias should be considered. Further work in this area is needed that employs standardized acupuncture treatment modalities, endpoint assessments, and blinding of treatments.