Clinical use of new oral anticoagulant drugs: dabigatran and rivaroxaban

Orally active small molecules that selectively and specifically inhibit coagulation serine proteases have been developed for clinical use. For some patients these oral direct inhibitors (ODIs) offer substantial benefits over oral vitamin K antagonists (VKA). However, for the majority of patients with good anticoagulant control with VKAs the advantages of the ODIs are primarily convenience and few drug interactions. The drugs are prescribed at fixed dose without the need for monitoring or dose adjustment in the majority of patients and the rapid onset of anticoagulation and short half‐life make initiation and interruption of anticoagulation considerably easier than with VKAs. As yet, specific antidotes to ODIs are not available for clinical use but these are in development as rapid reversal agents. As with all anticoagulants produced so far, there is a correlation between intensity of anticoagulation and bleeding. Consequently, the need to consider the balance of benefit and risk in each individual patient is no less important than with VKA therapy. Dabigatran and rivaroxaban have been chosen for this review as examples of a thrombin inhibitor and an inhibitor of factor Xa respectively. The clinical application of these drugs is the focus of the review.     

The efficacy and safety of Yijinjing exercise in the adjuvant treatment of ankylosing spondylitis: A protocol of randomized controlled trial

Background:Ankylosing spondylitis (AS) is a chronic systemic autoimmune disease with high disability rate. Conventional treatment regimens have long medication cycles and are associated with adverse reactions. Therapeutic exercise is also considered to be an effective treatment for AS. Evidence suggests that Yijinjing as a low-energy exercise has advantages in adjuncting AS, but there is a lack of standard clinical studies to evaluate its efficacy and safety.Methods:This is a prospective randomized controlled trial to investigate the efficacy and safety of Yijinjing in the adjuvant treatment of AS. Approved by the Clinical Research Ethics Association of our hospital, patients were randomly divided into treatment or control groups in a ratio of 1:1. The treatment group received 4-month Yijinjing training on the basis of conventional treatment, while the control group received conventional treatment and maintained their current lifestyle. The outcome indicators included: activity index, functional ability, Bath Ankylosing Spondylitis Metrology Index, adverse reaction, etc. Finally, SPASS 22.0 software was used for statistical analysis of the data.Discussion:This study evaluated the clinical efficacy of Yijinjing exercise in the adjuvant treatment of AS, and the results of our study will provide a reference for the clinical use of Yijinjing exercise as an effective complementary alternative for the treatment of AS.     

Effectiveness and safety of ear acupuncture for allergic rhinitis: A protocol of randomized controlled trial

Background:Allergic rhinitis is a global problem. About 10% to 40% of the global population is affected by allergic rhinitis and is on the rise, which has a significant health and economic impact on society. Ear acupuncture is a non-invasive acupuncture therapy, which has been used in the treatment of allergic rhinitis, and some positive results have been reported, but there is not enough evidence to prove its efficacy and safety.Methods:This is a single-center, randomized, single-blind, sham-controlled trial. With the approval of the ethics committee of our hospital, participants with allergic rhinitis will be randomly assigned to receive either real or sham ear acupuncture once a week for 8 weeks, followed by 12 weeks of follow-up. Evaluate the patient''s nasal symptom score and Standardised Rhinoconjunctivitis Quality of Life Questionnaire score, and monitor adverse events. Finally, the data are analyzed by SPSS 22.0 software.Discussion:The results of this study will determine the efficacy and safety of ear acupuncture in the treatment of allergic rhinitis and provide a basis for promoting the application of ear acupuncture in the treatment of allergic rhinitis.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/MVEF7.     

Efficacy and safety of electroacupuncture in treatment of cervical spondylosis: A protocol of randomized controlled trial

Background:Cervical Spondylotic radiculopathy (CSR) is the most common spinal degenerative disease. Its clinical manifestations are pain and numbness in the neck and arm and limitation of neck movement, which greatly affects the life and work of patients. Acupuncture and electroacupuncture are commonly used in China, the efficacy of acupuncture has been confirmed. Existing evidence shows that electroacupuncture seems to be better than acupuncture, but there is a lack of clinical research to directly compare the two.Methods:This is a prospective randomized controlled trial to compare the efficacy of electroacupuncture and acupuncture in the treatment of CSR and to explore the safety and potential mechanism of electroacupuncture in the treatment of CSR. Approved by the Clinical Research Ethics Committee of our hospital, the patients are randomly divided into an experimental group (electroacupuncture group) or control group (acupuncture group). The patients are followed up for 30 days after 4 weeks of treatment. Observation indexes included VAS score, Neck Disability Index, Yasuhisa Tanaka 20 Score Scale, adverse reactions and so on. Finally, the data will be analyzed by SPSS 18.0 software.Discussion:This study will directly compare the advantages and disadvantages of electroacupuncture and acupuncture in the treatment of CSR. The results of this study will help to guide patients with CSR to choose appropriate treatment.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/9MKPN     

Addressing the efficacy of dihydrocodeine versus methadone as an alternative maintenance treatment for opiate dependence: A randomized controlled trial

AIM: The aim of this study is to define the efficacy of dihydrocodeine as an alternative to methadone in the maintenance treatment of opiate dependence. DESIGN: A pragmatic open-label randomized controlled study of patients recommended for opiate maintenance treatment to test equivalence of the two treatment options with follow-up continuing for up to 42 months after recruitment. SETTING: Assessment at either Edinburgh's Community Drug Problem Service or at two general practitioner practices with specialist drug community psychiatric nurses, then with shared care follow-up. PARTICIPANTS: Two hundred and thirty-five subjects (168 male, 67 female) with opiate dependence syndrome were recruited. Subjects selected were suitable for opiate maintenance treatment. Routine treatment was offered throughout. INTERVENTION: Patients were randomized to receive either methadone mixture 1 mg/ml or dihydrocodeine, 30 mg or 60 mg tablets. MEASUREMENTS: The primary outcome measure was retention in treatment. Eight secondary outcomes included total illicit opiate use, reported crime, physical health, mental health, injecting drug use, overdoses, selling drugs and being in education or work. Measures were compared over 42 months follow-up. FINDINGS: There was no difference in groups for retention in treatment at follow-up and there was improvement in all secondary outcomes from baseline. No significant difference in outcomes was found between randomized groups over time. Compliance with randomized treatment differed by randomized group and was affected by experiences in custody during follow-up. Those randomized to dihydrocodeine were more likely to switch treatments. CONCLUSIONS: These results, combined with existing clinical experience, provide evidence that dihydrocodeine is a viable alternative to methadone as a maintenance treatment for opiate dependence. Indirect comparisons with other studies show dihydrocodeine (and methadone) to be superior to placebo.     

Self-administered acupressure for chronic severe functional constipation: A study protocol for a randomized controlled trial

Background:Functional constipation is a disease with a high incidence, which has a bad effect on general health, mental health, and social functioning. However, current treatment is sometimes unsatisfactory. Acupuncture has been proven effective in some randomized controlled trials. Acupressure is a subtype of acupuncture and can be manipulated by the patients at home. But the evidence is limited now. This study aims to provide some strict evidence for the use of self-administered acupressure in the treatment of functional constipation.Methods:This 2-armed, parallel, nonspecific controlled, randomized trial will be conducted at The Third Affiliated Hospital of Zhejiang Chinese Medical University in Hangzhou. A total of 154 FC patients will be enrolled into the acupoint group and the sham acupoint group with a ratio of 1:1 into this trial and it will consist of a 2-week run-in period, an 8-week intervention period, and an 8-week follow-up period. The treatment will be done by the patients themselves at home twice a day and they should sign in on the WeChat APP every day to make sure they have done the acupressure. The outcome will also be collected in WeChat APP through the diary and questionnaires. For the one who is unable to use the WeChat, the print edition of the diary and questionnaires are provided and the supervision will be done by the short message. The primary outcome will be the proportion of participants whose CSBM≥3 during week 3 to 10. The secondary outcome will be the proportion of participants whose CSBM ≥3 between 2 groups in week 11 to 18, Spontaneous bowel movements, Bristol Stool Form Scale, Straining severity scores, Patient assessment of constipation quality of life, and Medicine use.Discussion:Acupressure is not an invasive method and can be done by the patient itself at home. We hope this trial will provide credible evidence to the application of self-acupressure for the management of severe chronic functional constipation.Trial registration:This trial has been registered at the Chinese Clinical Trial Registry (ChiCTR2000038594).     

The safety and effectiveness of salvianolate in preventing perioperative venous thromboembolism in China: A PRISMA-compliant meta-analysis based on RCTs

Background:Salvianolate, a common drug for stabilizing heart disease and Angina Pectoris, is considered to be off-label for preventing venous thromboembolism (VTE) or anticoagulation at present. However, many clinical studies have showed that salvianolate can effectively inhibit the deep-vein thrombosis (DVT) incidence, and prevent VTE of perioperative patients in the real world in China.Objective:This analysis aimed to evaluate the effectiveness and safety of salvianolate in preventing VTE in perioperative patients.Methods:Databases of PubMed, Cochrane Library, Embase, CNKI, Wanfang and VIP were searched until July 2019. Literature retrieval, data extraction and quality assessment were independently completed by two researchers and checked with each other. Review Manager 5.2 software was applied for meta-analysis.Results:A total of 429 studies were retrieved, including 11 randomized controlled trials (RCTs) with a total of 1149 subjects. Compared with low molecular weight heparin (LMWH) group alone, salvianolate combined LMWH group had lower DVT incidence in preventing perioperative thrombosis (2.75% and 14.23%, OR: 0.21, 95% CI:[0.08,0.53]; P = .0009). The incidence of adverse reactions of experimental group was similar to that of control group (1.79% and 2.31%, OR: 0.65, 95% CI:[0.18,2.35]. P = .51). Compared with the control group, D-dimer level (D-D), platelet count (PLT), fibrinogen (FIB), whole blood high shear viscosity (WBHSV), and whole blood low shear viscosity (WBLSV) were all significantly decreased (P < .01), and prothrombin time (PT) was significantly increased (P < .05).Conclusion:Salvianolate combined LMWH has better effectiveness and the same safety in preventing venous thromboembolism in perioperative patients. However, due to the small number of included literatures, large sample studies are still needed to further verify this conclusion.     

A randomized controlled trial of the efficacy of cosmetic talc compared with iodopovidone for chemical pleurodesis

Background and objective: Talc is an effective and widely used agent for chemical pleurodesis. However, limited availability and high cost hamper the routine use of talc in resource poor countries. In this study, we compared the efficacy and safety of iodopovidone with that of cosmetic talc, for chemical pleurodesis. Methods: Patients with recurrent pleural effusions and/or spontaneous pneumothorax were prospectively randomized to undergo pleurodesis with cosmetic talc (5 g) or iodopovidone (20 mL of a 10% solution) by tube thoracostomy. The cosmetic talc was pretested for impurities (asbestos‐free) and particle size (20–60 µm), using energy dispersive analysis by X‐ray and scanning electron microscopy. The success rate (complete or partial), time to pleurodesis and safety of these two agents was compared. Results: Pleurodesis was performed in 73 patients (39 with iodopovidone, 34 with cosmetic talc; 56 men, 17 women; mean age 51.7 years; 38 pleural effusions, 35 pneumothoraces). A complete response was obtained in all patients with pneumothorax in both the iodopovidone and talc groups. Among patients with pleural effusions, a complete response was observed in 16/19 and 15/19 patients in the iodopovidone and talc groups, respectively. A partial response was observed in two additional patients from each group. The time to pleurodesis was similar in the two groups. Minor side‐effects (fever, chest pain) were observed with similar frequencies in the two groups. None of the patients experienced hypotension or ARDS. Conclusions: Iodopovidone and cosmetic talc are equally efficacious and safe agents for chemical pleurodesis.     

Efficacy and safety of Shenkang injection in the treatment of chronic renal failure: A protocol of a randomized controlled trial

Background:Chronic renal failure (CRF) is the final outcome of the development of multiple kidney diseases, and there is no effective method at home and abroad. Traditional Chinese medicine is found to play a major role in the treatment of the non-replacement stage of CRF. Shenkang injection can not only nourish the kidney, but also promote blood circulation and remove blood stasis, which is suitable for the treatment of CRF. This study aims to explore the efficacy and safety of Shenkang injection for CRF and provide evidence for clinical practice.Methods:This was a prospective randomized controlled trial. One hundred four patients with CRF were randomly divided into treatment groups and control groups according to 1:1, with 52 patients in each group. The control group received basic treatment of western medicine and the treatment group was given Shenkang injection intravenously on the basis of control group. Both groups were given standard treatment for 4 weeks with concurrent follow-up for 1 month. The outcome indicators included: total efficiency, symptom scores, creatinine clearance rate, serum creatinine, blood urea nitrogen, CystatinC, liver function, blood routine, urine routine, incidence of adverse reactions, etc. Data analysis was performed using SPSS 25.0 software.Discussion:This study will evaluate the efficacy and safety of Shenkang injection for CRF, and the results of this trial will provide clinical evidence for the treatment of CRF.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/K9C5T.     

Efficacy and safety of Biqi capsule in the treatment of knee osteoarthritis: A protocol of a randomized controlled trial

Background:Knee osteoarthritis (KOA) is a chronic and degenerative bone and joint disease, with KOA, cartilage degeneration, destruction and subchondral bone remodeling as the main pathological features. Its clinical symptoms are knee pain, swelling, limited activity, and long course of disease can cause joint deformities. At present, the early treatment of Western medicine is mainly the use of nonsteroidal drugs for anti-inflammation and removing pain, but because the efficacy of these drugs is unstable, the disease is easy to repeat after treatment, and the clinical effect is not good. Although Biqi capsule has advantages in the treatment of KOA, there is a lack of standard clinical studies to verify it, so the purpose of this randomized controlled study is to evaluate the efficacy and safety of Biqi capsule in the treatment of KOA.Methods:This is a prospective randomized controlled trial to study the efficacy and safety of Biqi capsule in the treatment of KOA. The patients were randomly divided into a treatment group and a control group according to 1:1. Among them, treatment group: Biqi capsule combined with diclofenac sodium sustained release tablets; Control group: Diclofenac sodium sustained-release tablets alone. Both groups were treated with standard treatment for 2 weeks and were followed up for 30 days to pay attention to the efficacy and safety indexes. Observation indicators included: the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Hospital for Special Surgery Knee Score (HSS), liver and kidney function, adverse reactions, and so on. SPSS 25.0 software is used for data analysis.Discussion:This study will evaluate the efficacy and safety of Biqi capsule in the treatment of KOA, and the results of this experiment will provide a clinical basis for Biqi capsule in the treatment of KOA.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/6HB9D     

The efficacy of niacin supplementation in type 2 diabetes patients: Study protocol of a randomized controlled trial

Background:Dyslipidemia is a main risk factor of cardiovascular disease in the diabetic patients. Niacin was found acutely to decrease the plasma concentration of free fatty acids by inhibiting their mobilization from adipose tissue. This present study is a double blinded, randomized, and prospective trial to determine the effect of niacin during dyslipidemia in type 2 diabetic patients.Methods:This randomized controlled, double-blinded, single center trial is carried out according to the principles of Declaration of Helsinki. This present study was approved in institutional review committee of the Second Affiliated Hospital of Dalian Medical University. All the patients received the informed consent. Diabetic patients were randomized (1:1) to receive 3-month treatment with extended-release niacin or matching placebo. The major outcome of our present study was the change in the level of HbA1c from the baseline to week 12. Secondary outcome measures contained the levels of fasting blood glucose, the concentrations of serum transaminase, the other laboratory variables, and self-reported adverse events. The P < .05 was regarded as statistically significant.Results:We assumed that adding the niacin to the medication in patients with type 2 diabetes would reduce dyslipidemia and achieve target lipid levels.Trial registration:This study protocol was registered in Research Registry (researchregistry5925).     

Efficacy of warming needle moxibustion in the treatment of ankylosing spondylitis: A protocol of a randomized controlled trial

Background:Ankylosing spondylitis is a recurrent autoimmune disease, which has a high disability rate and seriously affects patients’ daily life. Conventional treatment cannot effectively solve the clinical problems of patients, and long-term medication is accompanied by adverse reactions. The evidence shows that warming needle moxibustion has advantages in the treatment of ankylosing spondylitis, but there is still a lack of clinical studies on warm acupuncture alone and long-term follow-up.Methods:This is a prospective randomized controlled trial to study the efficacy and safety of needle warming through moxibustion in the treatment of ankylosing spondylitis. It was approved by the Ethics Committee of Clinical Research of our hospital. Patients were randomly assigned to an observation group or a control group. The patients were followed up for 6 months after 30 days of treatment. Observation indicators include; activity index, functional ability, Bath Ankylosing Spondylitis Metrology Index, inflammatory indicators, adverse reactions, and so on. Finally, SPASS 22.0 software is used for statistical analysis of the data.Discussion:This study will evaluate the clinical efficacy of warming needle moxibustion in the treatment of ankylosing spondylitis. The results of this study will provide a reference basis for the clinical use of warm needle moxibustion in the treatment of ankylosing spondylitis.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/GWPX3     

Use of rivaroxaban in sickle cell disease and venous thromboembolism: A case report

Introduction:Sickle cell disease (SCD) is a hematological disorder characterized by sickling of red blood cells. Patients are at increased risk of venous thromboembolism. There are no guidelines for the management of venous thromboembolism in sickle cell disease specifically in terms of the anticoagulant of choice.Patient concerns:Here, we report a case of a 30-year-old lady with past medical history of sickle cell disease who came with chest pain and shortness of breath.Diagnosis:We found that she has bilateral pulmonary embolism (PE).Intervention:She was started on rivaroxaban.Outcome:The patient was followed for 18 months, she did not suffer from recurrence of PE, and she did not develop any complications related to rivaroxaban.Conclusion:We concluded that rivaroxaban is effective in treating PE in sicklers and also it is safe.     

Clinical efficacy enhancement of a Chinese herbal injection in the treatment of mycoplasma pneumonia in children: A protocol of randomized controlled trial

Background:Mycoplasma pneumonia is a common disease in pediatrics, and macrolides is the first choice for the treatment. However, the increase of antibiotic resistance of macrolides makes it more and more complicated for clinical treatment. Due to the long term treatment of macrolides, it may increase the incidence of nausea, vomiting, abdominal pain, diarrhea, and other gastrointestinal symptoms, vascular phlebitis, liver and kidney function damage. Tanreqing injection, a Chinese herbal extraction injection, has advantages in the treatment of mycoplasma pneumonia in children, and it could improve the curative effect, shortening the course of disease, and reducing the side effects. Yet there is a lack of standard clinical studies to verify it, so this randomized controlled trial (RCT) will evaluate the efficacy and safety of Tanreqing injection combined with azithromycin in the treatment of mycoplasma pneumonia in children.Methods:This is a prospective RCT to study the efficacy and safety of Tanreqing injection combined with azithromycin in the treatment of mycoplasma pneumonia in children. It is approved by the Clinical Research Society of our hospital. According to the 1:1 ratio, the patients will be randomly divided into Tanreqing injection combined with azithromycin group (observation group) and azithromycin group (control group). Duration of hospitalization, clinical improvement 7 days after admission, changing laboratory tests, pulmonary function, immunoglobulin level, and adverse reactions will be compared between the 2 groups. The data will be analyzed by SPSS 16.0 software.Discussion:This study will evaluate the efficacy and safety of Tanreqing injection combined with azithromycin in the treatment of mycoplasma pneumonia in children. The results of this experiment will provide clinical basis for the treatment of mycoplasma pneumonia in children with Tanreqing injection combined with azithromycin.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/X6VFS.     

A randomized controlled trial of adding the nicotine patch to rimonabant for smoking cessation: efficacy, safety and weight gain

Aims Because smoking cessation rates might be improved by combining drugs and by reducing post‐cessation weight gain, we tested the smoking cessation efficacy, safety and effect on body weight of adding the nicotine patch to rimonabant, a cannabanoid type‐1 receptor antagonist that reduces body weight. Design Randomized double‐blind placebo‐controlled trial. Setting Fifteen US research centers. Participants A total of 755 smokers (≥15 cigarettes/day). Intervention Rimonabant (20 mg daily) was given open‐label for 9 weeks. The 735 participants completing week 1 were randomized at day 8 (target quit day) to add a nicotine patch (n = 369) or placebo patch (n = 366) for 10 weeks (21 mg daily for 8 weeks plus a 2‐week taper). Participants received weekly smoking counseling and were followed for 24 weeks. Measurements Biochemically validated 4‐week continuous abstinence at end‐of‐treatment (weeks 6–9; primary end‐point); 7‐day point prevalence abstinence at weeks 9 and 24; sustained abstinence (weeks 6–24); change in body weight; and adverse events. Findings Rimonabant plus nicotine patch was superior to rimonabant plus placebo in validated continuous abstinence at weeks 6–9 (39.0% versus 21.3%; odds ratio 2.36, 95% confidence interval: 1.71–2.37; P < 0.01) and in all other efficacy measures. Mean end‐of‐treatment weight gain among quitters did not differ between groups (0.04 kg for combination versus 0.49 kg for rimonabant only, P = 0.15) and was similar in weight‐concerned smokers. Serious adverse event rates did not differ between groups. Depression‐ and anxiety‐related adverse events occurred in 32 (4.2%) and 44 (5.8%) subjects, respectively; eight (1.1%) and nine (1.2%) subjects stopped the drug due to depression and anxiety, respectively. Conclusions Adding a nicotine patch to rimonabant was well tolerated and increased smoking cessation rates over rimonabant alone. There was little post‐cessation weight gain in either group, even among weight‐concerned smokers, during drug treatment.     

Effect of Tai Chi on cardiac function in patients with myocardial infarction: A protocol for a randomized controlled trial

Background:Myocardial infarction is 1 of the most serious cardiovascular diseases. Early interventional therapy preserves the cardiac function of patients with myocardial infarction to the greatest extent, but it is far from meeting people''s need only limited to cardiac revascularization. It is also necessary to help patients improve their quality of life, exercise tolerance, and reduce the incidence of acute cardiac recurrence as much as possible. All these depend on cardiac rehabilitation (CR) are based on exercise. Early and correct CR helps to improve the patient''s heart function and improve living standards. Traditional Chinese exercise Tai Chi as an alternative form of CR has gradually become popular, but it lacks large samples and high-quality clinical studies to verify it. This study aims to explore the effect of Tai Chi on the cardiac function of patients with myocardial infarction, and to provide a strong basis for patients to choose which CR exercise.Methods:This is a prospective randomized controlled trial. 272 patients with myocardial infarction will be randomly divided into an experimental group and a control group according to 1:1, with 136 cases in each group. The control group: conventional treatment; the experimental group: increase Tai Chi exercise on the basis of the control group. Both groups will receive standard treatment for 24 weeks and will be followed up for 3 months. Observation indicators include: total effective rate, 6 minutes walking test, brain natriuretic peptide, left ventricular ejection fraction, the adverse reaction rate, etc. The data will be analyzed by using SPSS 25.0 software.Discussion:This study will evaluate the effect of Tai Chi on the cardiac function of patients with myocardial infarction. The results of this test will provide clinical evidence for patients to choose which CR exercise.Trial registration:OSF Registration number: DOI 10.17605/OSF.IO/QKWDP.     

Efficacy evaluation of acupuncture combined with Liujunzi Decoction in the treatment of functional dyspepsia: A protocol of randomized controlled trial

Background:Functional dyspepsia (FD) is a common and frequently-occurring disease in internal medicine. It is known that Liujunzi decoction and acupuncture are widely used in the treatment of FD, but there are few studies on the combination of Liujunzi decoction and acupuncture in the treatment of FD, and its safety and efficacy are still controversial. Therefore, the purpose of this study is to evaluate the efficacy and safety of acupuncture combined with Liujunzi decoction in the treatment of FD.Methods:We designed a prospective randomized controlled trial. The study protocol was approved by the Clinical Research Ethics Committee of our hospital. Patients with FD were randomly assigned to the treatment group of acupuncture combined with Liujunzi Decoction (the experimental group) and the treatment group of Liujunzi Decoction (the control group) in a ratio of 1:1. Outcome indicators were Nepean Dyspepsia Index, the MOS item short from health survey, and adverse reactions. Finally, SPSS 18.0 software would be used for statistical analysis of the data.Discussion:This study will evaluate the efficacy and safety of acupuncture combined with Liujunzi Decoction in the treatment of FD and provide clinical basis for the use of acupuncture combined with Liujunzi Decoction in the treatment of FD.OSF Registration number:DOI 10.17605/OSF.IO/67GKN     

Evaluation of the therapeutic effect of acoustic therapy combined with acupuncture on idiopathic tinnitus: A randomized controlled trial protocol

Background:There is no effective treatment for idiopathic tinnitus. Both acoustic therapy and acupuncture have been used in the treatment of idiopathic tinnitus, but the clinical efficacy is quite different. For there is no clinical study combining the 2, the purpose of this randomized controlled trial is to evaluate the effectiveness and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus.Methods:This is a prospective randomized controlled trial to study the effectiveness and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus, and is approved by the clinical research ethics committee of our hospital. The patients are randomly divided into one of 2 treatment options: (A) acoustic therapy combined with acupuncture group and (B) simple acupuncture group. Patients, doctors, nurses, and data collection assistants are blinded to group allocation. Observation indicators include:

• 1.Tinnitus Disability Scale;
• 2.Loudness visual analog scale;
• 3.Adverse reactions.

Data is analyzed using the statistical software package SPSS version 25.0 (Chicago, IL).Discussion:This protocol will evaluate the efficacy and safety of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus. The results of this experiment will provide clinical evidence for the use of acoustic therapy combined with acupuncture in the treatment of idiopathic tinnitus.Trial registration:This study protocol is registered inEthics and dissemination:Private information from individuals will not be published. This systematic review also does not involve endangering participant rights. Ethical approval was not required.OSF Registration number:DOI 10.17605/OSF.IO/87VFB.