Possible effect of blonanserin on gambling disorder:A clinical study protocol and a case report

BACKGROUND Gambling disorder is characterized by excessive and recurrent gambling and can have serious negative social consequences.Although several psychotherapeutic and pharmacological approaches have been used to treat gambling disorder,new treatment strategies are needed.Growing evidence suggests that dopamine D3 receptor plays a specific role in the brain reward system.AIM To investigate if blonanserin,a dopamine D3 receptor antagonist,would be effective in reducing gambling impulses in patients with gambling disorder.METHODS We developed a study protocol to measure the efficacy and safety of blonanserin as a potential drug for gambling disorder,in which up to 12 mg/d of blonanserin was prescribed for 8 wk.RESULTS A 37-year-old female patient with gambling disorder,intellectual disability,and other physical diseases participated in the pilot study.The case showed improvement of gambling symptoms without any psychotherapy.However,blonanserin was discontinued owing to excessive saliva production.CONCLUSION This case suggests that blonanserin is potentially an effective treatment for patients with gambling disorder who resist standard therapies,but it also carries a risk of adverse effects. Further studies are needed to confirm the findings.

Contralateral needling at the foot of unaffected side combining with rehabilitation treatment for motor dysfunction of hand after ischemic stroke:study protocol for a randomized controlled pilot trial

This pilot study is to assess the feasibility and the effect of a combination therapy of rehabilitation treatment and contralateral needling,which is manipulated at the foot of the unaffected side,for the recovery of the paretic hand post-stroke.This prospective pilot clinical trial will recruit 72 stroke patients with paretic hands and a disease course of 14 to 90 d.Patients will be randomized into two groups:the control group will receive conventional Xingnao Kaiqiao acupuncture and basic treatment for the stroke;based on the control group,the observation group will receive the contralateral needling at the foot of the unaffected side combined with the rehabilitation movement of the paretic hand.12 sessions will be administrated for 2 weeks.The primary outcome,FuglMeyer Assessment,and the secondary outcomes,the handgrip strength,the range of motion,the modified Barthel index,and the Brunnstrom recovery stages,will be measured the recovery of the hand motor function during the 2 weeks'intervention.This study aims to investigate the instant effect of contralateral needling at the foot of the unaffected side combined with the rehabilitation treatment movement for patients with the paretic hand of Poststroke motor dysfunction and provide the previous evidence for the future large sample studies.

Analysis of Interventional Clinical Research Protocols Related to Coronavirus Disease 2019 and Future Expectations

Coronavirus disease 2019(COVID-19)is a newly emerging infectious disease.After its outbreak,researchers started a large number of clinical interventional studies,using a variety of interventions to study the different types of COVID-19 cases.In this article,we searched the websites of Chinese Clinical Trial Registry,Clinical Trials.gov,etc.,to study the publicly registered research information.Through the classification and summary of interventional methods,evaluation indicators,research design,etc.,this article provided readers with the outline of clinical research about COVID-19,and looked forward to the scientificity,feasibility,and future evidence of the clinical researches.

Zhengyuan capsule(正元胶囊)for the treatment of cancer-related fatigue in lung cancer patients undergoing operation:a study protocol for a randomized controlled trial

OBJECTIVE: To evaluate the efficacy and safety of Zhengyuan capsule(正元胶囊) when treating Cancer-related fatigue(CRF) in lung cancer patients undergoing surgical operation.METHODS/DESIGN: This is a single-center, double-blinded, prospective, and randomized controlled trial in the Department of Integrated Chinese and Western Medicine, Shanghai Chest Hospital Shanghai Jiao Tong University, Shanghai. Eligible participants will be randomly allocated into two groups: a treatment group receiving an 8-week Zhengyuan capsule regimen therapy and a control group receiving an 8-week placebo capsule regimen therapy. Evaluation will be carried out at four timelines: the participants' screening period, baseline period, the middle of the intervention period,and the end of the intervention period. The primary outcome assessment is fatigue scoring using the Cancer Fatigue Scale(CFS) measurement system.Secondary measurements include fatigue severity assessment using the Multidimensional Fatigue Symptom Inventory-Short Form(MFSI-SF) measurement system, Traditional Chinese Medicine syndrome pattern differentiation, levels of immunologic indicators(TNF-α, IL-6, IL-1, T lymphocytes subsets and B lymphocyte subsets), patient's pulmonary function, performance status scale(PS),self-rating scale of sleep(SRSS), and adverse events(AEs).DISCUSSION: The trial results can provide efficacy and safety data of Zhengyuan capsule when treating CRF in clinic. The data can also be imported into the management and treatment guidelines for CRF in lung cancer patients undergoing operation throughout China.

Protocol to study the effects of Traditional Chinese Medicine on patients with coronary heart disease showing phlegm-heat-stasis symptom pattern

OBJECTIVE:To describe a protocol to assess the effects of Traditional Chinese Medicine(TCM)on patients with coronary heart disease(CHD)showing symptoms of phlegm-heat-stasis symptom pattern.METHODS:This is a single-blind randomized controlled trial that will be conducted in the First Teaching Hospital of Tianjin University of TCM and 60 patients with CHD showing phlegm-heat-stasis symptom pattern will be included.Patients will be randomly divided into either a treatment group(Qingre Huatan formulae+Western Medicine)or to acontrol group(conventional Western Medicine only)for 7-14 d.Primary patient outcomes will be vascular endothelial function and quality of life.Measurement data will be expressed as mean±standard deviation using t-test analysis or repeated-measure variance analysis.Enumeration data will be expressed by cases and percentages,usingχ^(2) analysis,and rank sum test will be used for ranked data.RESULTS:This study further verified the effectiveness and safety of Qingre Huatan formulae for the phlegm-heat-stasis syndrome pattern of CHD on the basis of previous studies on the characteristics of syndromes and medication rules.DISCUSSION:Phlegm-heat-stasis symptom pattern has become a common manifestation in CHD.Standardized Western medications together with TCM have been extensively used in China and have developed into a comprehensive treatment model.Our trial will help formulate recommendations for symptom maintenance and provide clinical evidence for the application of TCM for patients with CHD showing phlegm-heat-stasis symptom pattern.