Asymptomatic Hyperuricemia
Conditions
Keywords
Manual Acupuncture, Asymptomatic Hyperuricemia, Serum Uric Acid, Efficacy, Safety
Brief summary
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
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.
Interventions
DEVICEverum acupuncture
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.
BEHAVIORALhealth education
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.
DEVICEsham acupuncture
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.
Sponsors
Wuhan Integrated Traditional Chinese and Western Medicine Hospital
Xianning Central Hospital
Lingling Yu (103250)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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%.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in the mean level of serum uric acid from baseline. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Effective rate of patients with serum uric acid ≤ 6.0 mg/dL | 4, 8, 12, 16 and 20 weeks after randomization | The ratio of patients with serum uric acid ≤ 6.0 mg/dL at weeks 4, 8, 12, 16 and 20 after randomization |
| Changes in the mean level of serum uric acid from baseline. | At baseline, at 4, 12, 16, and 20 weeks after randomization. | The changes in the mean level of serum uric acid at 4, 12, 16, 20 weeks after randomization compared to baseline |
| Effective rate of patients with serum uric acid ≤ 7.0 mg/dL | 4, 8, 12, 16 and 20 weeks after randomization | The ratio of patients with serum uric acid ≤ 7.0 mg/dL at weeks 4, 8, 12, 16 and 20 after randomization |
| 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. | The proportion of patients with acute gouty arthritis per 4-week cycle after randomization. |
| Changes in body weight of patients | 4, 8, 12, 16 and 20 weeks after randomization | Changes in body weight of patients at 4, 8, 12, 16, and 20 weeks after randomization. |
| 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. | The changes in the dose of intake of acute medication per 4-week cycle after randomization. |
| Arrival of qi assessment | Immediately following each session of acupuncture treatment. | 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) |
| Safety evaluation | Immediately following each session of acupuncture treatment. | Adverse events during the acupuncture process |
Other
| Measure | Time frame |
|---|---|
| 60-item NEO Personality Inventory-Short Form (NEO-FFI) | At baseline only once. |
| Chinese medicine constitution classification | At baseline only once. |
| Acupuncture Expectancy Scale | At baseline only once. |
| Change in Beck Anxiety Inventory(BAI). | At baseline only once. |
| Change in Beck Depression Inventory II(BDI- II). | At baseline only once. |
| Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10). | At baseline only once. |
| Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) . | At baseline only once. |
Countries
China
Contacts
Primary ContactLingling Yu, PhD
Outcome results
None listed