Efficacy Study of Acupuncture on Asymptomatic Hyperuricemia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Asymptomatic Hyperuricemia
• Intervention / Treatment: Device: verum acupuncture; Behavioral: health education; Device: sham acupuncture

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.

• Study Type: Interventional
• Enrollment (Estimated): 180
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lingling Yu, PhD; Phone Number: 86-13545862185; Email: 527679774@qq.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430030
      • Recruiting
      • Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
      • Contact: 玲玲 余; Phone Number: +8613545862185; Email: 527679774@qq.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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%.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: verum 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.; Behavioral: health 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.
Sham Comparator: 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.	Behavioral: health 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.; Device: sham 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.

What is the study measuring?

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.

Other Outcome Measures

Outcome 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 Patient-Doctor Relationship Questionnaire(PDRQ-9) .	At baseline only once.
Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10).	At baseline only once.

Collaborators and Investigators

• Sponsor: Lingling Yu (103250)
• Collaborators: Wuhan Integrated Traditional Chinese and Western Medicine Hospital; Xianning Central Hospital
• Investigators: Principal Investigator: Shenghao Tu, PhD, Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan,430030, China

Study record dates

Study Major Dates

• Study Start (Actual): July 13, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: June 1, 2022
• First Submitted That Met QC Criteria: June 1, 2022
• First Posted (Actual): June 7, 2022

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Safety; Efficacy; Manual Acupuncture; Asymptomatic Hyperuricemia; Serum Uric Acid
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperuricemia
• Other Study ID Numbers: 2021HUATJ01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No