Efficacy Study of Acupuncture on Asymptomatic Hyperuricemia

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Evaluating the Efficacy of Acupuncture for Patients With Asymptomatic Hyperuricemia (HUA): A Multicenter Randomized Controlled Clinical Trial

Conditions
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Asymptomatic Hyperuricemia

Intervention / Treatment
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* Device: verum acupuncture
* Behavioral: health education
* Device: sham acupuncture


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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%.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Verum acupuncture (VA)<br>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. | Device: verum acupuncture<br>* The special type of acupuncture needles will be inserted into the skin of standard acupuncture points and manipulated manually by using the techniques such as lifting, thrusting, and twirling, until the internal compound sensation known as deqi.<br>Behavioral: health education<br>* According to the Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia related Diseases in China and the 2012 Guidelines of the American College of Rheumatology, health education should be given as basic prevention. These include weight control, regular exercise, limiting alcohol and high-purine and high-fructose diets, encouraging dairy and fresh vegetables and drinking moderate amounts of water, and not recommending or limiting soy products.<br>|
| Sham Comparator: Sham acupuncture (SA)<br>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. | Behavioral: health education<br>* According to the Multidisciplinary Expert Consensus on the Diagnosis and Treatment of Hyperuricemia related Diseases in China and the 2012 Guidelines of the American College of Rheumatology, health education should be given as basic prevention. These include weight control, regular exercise, limiting alcohol and high-purine and high-fructose diets, encouraging dairy and fresh vegetables and drinking moderate amounts of water, and not recommending or limiting soy products.<br>Device: sham acupuncture<br>* We will use a non-insertive sham control. Sham points are located at 5 cun lateral to the seventh, eighth, ninth, tenth, eleven and twelve thoracic spine. Cun is a distance measure unit used in locating acupoints in traditional Chinese medicine (TCM) acupuncture, and the width of patient's thumb interphalangeal joint is regarded as one cun.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the mean level of serum uric acid from baseline. | The changes in the mean level of serum uric acid at 8 weeks after randomization compared to baseline | At baseline, and at 8 weeks after randomization. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the mean level of serum uric acid from baseline. | The changes in the mean level of serum uric acid at 4, 12, 16, 20 weeks after randomization compared to baseline | At baseline, at 4, 12, 16, and 20 weeks after randomization. | 
| Effective rate of patients with serum uric acid ≤ 6.0 mg/dL | The ratio of patients with serum uric acid ≤ 6.0 mg/dL at weeks 4, 8, 12, 16 and 20 after randomization | 4, 8, 12, 16 and 20 weeks after randomization | 
| Effective rate of patients with serum uric acid ≤ 7.0 mg/dL | The ratio of patients with serum uric acid ≤ 7.0 mg/dL at weeks 4, 8, 12, 16 and 20 after randomization | 4, 8, 12, 16 and 20 weeks after randomization | 
| The proportion of patients with acute gouty arthritis | The proportion of patients with acute gouty arthritis per 4-week cycle after randomization. | 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 | Changes in body weight of patients at 4, 8, 12, 16, and 20 weeks after randomization. | 4, 8, 12, 16 and 20 weeks after randomization | 
| Changes in the dose of intake of acute medication. | The changes in the dose of intake of acute medication per 4-week cycle after randomization. | 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. | 
| Arrival of qi assessment | The Chinese Version of the Massachusetts General Hospital Acupuncture Sensation Scale Acupuncture sensations will be measured by the Massachusetts General Hospital (MGH) Acupuncture Sensation Scale (MASS) | Immediately following each session of acupuncture treatment. | 
| Safety evaluation | Adverse events during the acupuncture process | Immediately following each session of acupuncture treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Manual Acupuncture, Asymptomatic Hyperuricemia, Serum Uric Acid, Efficacy, Safety