Evaluating the Efficacy of Acupuncture for Patients With Asymptomatic Hyperuricemia (HUA): A Multicenter Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Changes in the mean level of serum uric acid from baseline.
研究概览
简要总结
hyperuricemia (HUA) is an important risk factor for various chronic diseases, such as gout, and the current treatment programs for HUA are not ideal. It is urgent to find new methods to prevent and treat HUA and to carry out early clinical intervention. Acupuncture is commonly used for the treatment of HUA, while the evidence for its efficacy is still uncertain. This clinical trial aimed to evaluate the efficacy and safety of manual acupuncture for asymptomatic HUA.
详细描述
This is a multicentre, stratified, randomized, sham-controlled clinical trial. 180 eligible participants will be randomly allocated into verum acupuncture group or sham acupuncture group, in a 1:1 ratio. The verum acupuncture group will receive 16 sessions of manual acupuncture treatments over an eight-week period, while the sham acupuncture group will receive sham acupuncture treatments with non-penetrating needling. Health education will be provided to participants in the two groups. The primary outcomes will be the changes in the mean levels of serum uric acid 8 weeks after randomization. The secondary outcomes will be the changes in the mean levels of serum uric acid 4, 12, 16, and 20 weeks after randomization. Other secondary outcomes included effective rates, the proportion of patients with acute gouty arthritis, changes in body weight and BMI, safety evaluation and deqi evaluation. The central randomization and data collection will be conducted by an electronic data management system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed as hyperuricemia; and
- •Fasting blood uric acid level ≥ 7-11.0 mg/dL after 1 month of low-purine diet; and
- •Without history of gouty arthritis; and
- •Without drug treatment for hyperuricemia or stop uric acid-lowering drug treatment ≥12 weeks; and
- •18.5kg/m2≤BMI≤30.0kg/ m2; and
- •Able to signing a informed consent.
排除标准
- •Those who are using or have used one of the following drugs for the treatment of hyperuricemia 12 weeks before eligibility evaluation, such as: allopurinol, benzbromarone, probesulfan, bugelone, toppirosteine, Busotan; and
- •Patients are using or used other drugs that affect uric acid metabolism in the past 12 weeks, such as: thiazide diuretics, angiotensin-converting enzyme inhibitors, angiotensin receptor blockers, compound reserpine, pyrazinamide, nitrates fendipine, propranolol, and benzbromarone; and
- •Patients have history of gouty arthritis; and
- •Combined with secondary hyperurmicema, such as bone marrow and lymphoproliferative diseases, tumor radiotherapy and chemotherapy, liver cirrhosis and drug-induced hyperurmicema; and
- •Combined with one of the following comorbidities: hypertension, diabetes, stroke, coronary heart disease, severe liver and kidney damage (≥CKD stage 2, or high creatinine, urea, glutamate, glutamate ≥ 2 times of the limit of clinical normal values); and
- •Combined with severe neuropsychological diseases, such as severe anxiety, depression, and intellectual disability; and
- •Pregnant women; and
- •Unwilling to accept acupuncture treatment; and
- •Illiterate, or patients unable to sign informed consent; and
- •The completion rate of baseline screening data is ≤80%.
研究组 & 干预措施
Sham acupuncture (SA)
Participants will be treated by non-penetrating sham acupuncture and usual care. They will be treated twice a week for 8 weeks, to fulfill a 16-session treatment course. Each acupuncture treatment session for patients will be 30 minutes in duration.
干预措施: health education (Behavioral)
Sham acupuncture (SA)
Participants will be treated by non-penetrating sham acupuncture and usual care. They will be treated twice a week for 8 weeks, to fulfill a 16-session treatment course. Each acupuncture treatment session for patients will be 30 minutes in duration.
干预措施: sham acupuncture (Device)
Verum acupuncture (VA)
Participants will be treated by real manual acupuncture and usual care. They will be treated twice a week for 8 weeks, to fulfill a 16-session treatment course. Each acupuncture treatment session for patients will be 30 minutes in duration.
干预措施: health education (Behavioral)
Verum acupuncture (VA)
Participants will be treated by real manual acupuncture and usual care. They will be treated twice a week for 8 weeks, to fulfill a 16-session treatment course. Each acupuncture treatment session for patients will be 30 minutes in duration.
干预措施: verum acupuncture (Device)
结局指标
主要结局
Changes in the mean level of serum uric acid from baseline.
时间窗: At baseline, and at 8 weeks after randomization.
The changes in the mean level of serum uric acid at 8 weeks after randomization compared to baseline
次要结局
- Changes in the dose of intake of acute medication.(Weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.)
- Safety evaluation(Immediately following each session of acupuncture treatment.)
- The proportion of patients with acute gouty arthritis(Weeks 1-4 after randomization, weeks 5-8 after randomization, weeks 9-12 after randomization, weeks 13-16 after randomization, and weeks 17-20 after randomization.)
- Changes in body weight of patients(4, 8, 12, 16 and 20 weeks after randomization)
- Effective rate of patients with serum uric acid ≤ 6.0 mg/dL(4, 8, 12, 16 and 20 weeks after randomization)
- Changes in the mean level of serum uric acid from baseline.(At baseline, at 4, 12, 16, and 20 weeks after randomization.)
- Effective rate of patients with serum uric acid ≤ 7.0 mg/dL(4, 8, 12, 16 and 20 weeks after randomization)
- Arrival of qi assessment(Immediately following each session of acupuncture treatment.)
研究者
Lingling Yu (103250)
Professor
Tongji Hospital