Xi-Feng-Hua-Shi granules for diarrhea-predominant irritable bowel syndrome:protocol for a randomized,double-blind,placebo-controlled multi-center clinical trial

Background:Irritable bowel syndrome(IBS)is a common functional bowel disorder that can severely affect the quality of life of patients.Limited drugs have been reported for modern medical IBS treatment.The advantages of traditional Chinese medicine(TCM)treatment are gradually becoming prominent.Xi-Feng-Hua-Shi granules have been clinically used for diarrhea-predominant IBS(IBS-D)treatment for many years in TCM practice.Thus,this study aimed to further verify the effectiveness and safety of Xi-Feng-Hua-Shi(XFHS)granules in IBS-D treatment through a randomized,double-blind,placebo-controlled multi-center clinical trial and provide high-quality evidence for its effectiveness and safety in treatment,as well as provide a basis for clinical rational drug use and explore new clinical IBS-D treatment plans.Methods:A randomized,double-blind,placebo-controlled multi-center clinical trial will be performed in 23 hospitals.A total of 300 participants will be randomly divided into the experimental group(prescribed with XFHS granules)and the control group(prescribed with the placebo granules),with 150 participants in each group.The appearance,shape,color,and taste of the placebo granules are the same as those of XFHS granules.All participants will receive a 4-week treatment and a 6-month follow-up.The primary outcome is the overall clinical efficacy;the secondary outcomes are the IBS-Symptom Severity Score(IBS-SSS),TCM Syndrome Evaluation,and the IBS-Quality of Life(IBS-QoL)score,mental state assessment,and recurrence rate.Outcome measures(including primary and secondary outcome measures)are collected at baseline,as well as 2,4,16,and 28 weeks post-intervention.Discussion:This randomized,placebo-controlled,multi-center trial may provide high-quality evidence for the clinical XFHS granule efficacy in IBS-D treatment.Additionally,this study will conduct safety evaluations to provide a basis for clinical rational drug use.

Shexian Bupleurum Alleviates Insomnia and Improves Symptoms of Anxiety and Depression:A Randomized Double-Blind Placebo-Controlled Clinical Trial

Objective:To observe the clinical efficacy of Shexian bupleurum on insomnia based on evaluation scales and polysomnogram(PSG).Methods:A total of 260 patients suffering from insomnia admitted to the outpatient department of Handan Central Hospital were included in a randomized,double blind,placebo-controlled trial.The patients were randomly divided into two groups:a control group(receiving placebo,n=150),and an intervention group(receiving Shexian bupleurum treatment,n=110).The clinical trial lasted for 4 weeks.The Pittsburgh Sleep Quality Index(PSQI),Insomnia Severity Index(ISI),Patient Health Questionnaire(PHQ)-9,Generalized Anxiety Disorder(GAD)-7,17 items of Hamilton Depression Scale(HAMD-17),and Hamilton Anxiety Scale(HAMA)were used to evaluate the patients at baseline as well as two weeks and four weeks after treatment;the Treatment Emergent Symptom Scale(TESS)was used to evaluate adverse reactions;polysomnography(PSG)was used to monitor and analyze their sleep characteristics at baseline and four weeks after treatment.Results:The PSQI,ISI,PHQ-9,HAMD-17,and HAMA scores of the intervention group significantly decreased compared to the control group,while the total sleep time,rapid eye movement sleep latency,stage 2 sleep,deep sleep,rapid eye movement sleep,and sleep efficiency of the intervention group significantly increased compared to the control group.The PHQ-9 score of the control group only decreased two weeks after treatment(p<0.05)compared to the intervention group.In addition,there were no obvious adverse events in both the intervention group and the control group.Conclusion:Shexian bupleurum not only improves sleep quality,but also relieves depression and anxiety in patients who suffer from insomnia.

Evaluation of the effect of acupuncture on hand pain,functional deficits and health-related quality of life in patients with rheumatoid arthritis--A study protocol for a multicenter,double-blind,randomized clinical trial

BACKGROUND： Rheumatoid arthritis（RA） is a systemic inflammatory disease characterized by functional disability and pain. Although acupuncture is widely used, until now Western acupuncture studies on RA have not shown conclusive positive results. Acupuncture is regarded as a reflex therapy that has effects on the human autonomic nervous system. By establishing a traditional Chinese medicine（TCM） diagnosis first, the practitioner is able to choose acupoints according to the state of each individual patient.METHODS/DESIGN： We are interested if acupuncture, using a classical diagnostic procedure to allocate acupoints to the patient according to the Shang Han Lun theory, can be effective in relieving pain, improving hand function and increasing health-related quality of life in RA.The authors intend to harmonize TCM diagnosis according to clinical and genetic profiles. Patients with the TCM diagnosis of a so-called Turning Point syndrome will be followed up in a randomized, prospective, double-blind, placebo-controlled, multicenter and three-armed parallel-group study with a standardized treatment in order to optimize potential therapeutic effects of acupuncture on pain, strength and muscle function of patients with RA as well as the influence on inflammation and quality of life.DISCUSSION： The findings of this study will provide important clinical information about the feasibility and efficacy of acupuncture treatment for RA patients. In addition, it will explore the feasibility of further acupuncture research.TRIAL REGISTRATION NUMBER： Clinical Trials.gov Identifier NCT02553005.

Chinese herbal medicine Xinfeng Capsule in treatment of rheumatoid arthritis:study protocol of a multicenter randomized controlled trial

BACKGROUND： Rheumatoid arthritis （RA）, as a common systemic inflammatory autoimmune disease, affects approximately 1 in 100 individuals. Effective treatment for RA is not yet available because current research does not have a clear understanding of the etiology and pathogenesis of RA. Xinfeng Capsule, a patent Chinese herbal medicine, has been used in the treatment of RA in recent years. Despite its reported clinical efficacy, there are no large-sample, multicenter, randomized trials that support the use of Xinfeng Capsule for RA. Therefore, we designed a randomized, double-blind, multicenter, placebo-controlled trial to assess the efficacy and safety of Xinfeng Capsule in the treatment of RA. METHODS AND DESIGN： This is a 12-week, randomized, placebo-controlled, double-blind, multicenter trial on the treatment of RA. The participants will be randomly assigned to the experimental group and the control group at a ratio of 1：1. Participants in the experimental group will receive Xinfeng Capsule and a pharmaceutical placebo （imitation leflunomide）. The control group will receive leflunomide and an herbal placebo （imitation Xinfeng Capsule）. The American College of Rheumatology （ACR） Criteria for RA will be used to measure the efficacy of the Xinfeng Capsule. The primary outcome measure will be the percentage of study participants who achieve an ACR 20% response rate （ACR20）, which will be measured every 4 weeks after randomization. Secondary outcomes will include the ACR50 and ACR70 responses, the side effects of the medications, the Disease Activity Score 28, RA biomarkers, quality of life, and X-rays of the hands and wrists. The first four of the secondary outcomes will be measured every 4 weeks and the others will be measured at baseline and after 12 weeks of treatment. DISCUSSION： The result of this trial will help to evaluate whether Xinfeng Capsule is effective and safe in the treatment of RA. TRIAL REGISTRATION： This trial has been registered in ClinicalTrials.gov. The identifier is N CT01774877.