Clinical trial NCT05406830: Efficacy Study of Acupuncture on Asymptomatic Hyperuricemia
Official title: Evaluating the Efficacy of Acupuncture for Patients With Asymptomatic Hyperuricemia (HUA): A Multicenter Randomized Controlled Clinical Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asymptomatic Hyperuricemia
Keywords: Manual Acupuncture
Asymptomatic Hyperuricemia
Serum Uric Acid
Efficacy
Safety
Lead sponsor: Tongji Hospital
Sponsor class: OTHER
Collaborators: name: Wuhan Integrated Traditional Chinese and Western Medicine Hospital
name: Xianning Central Hospital
First posted: 2022-06-07
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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%.

Primary outcomes:
measure: Changes in the mean level of serum uric acid from baseline.
timeFrame: At baseline, and at 8 weeks after randomization.
Secondary outcomes:
measure: Changes in the mean level of serum uric acid from baseline.
timeFrame: At baseline, at 4, 12, 16, and 20 weeks after randomization.
measure: Effective rate of patients with serum uric acid ≤ 6.0 mg/dL
timeFrame: 4, 8, 12, 16 and 20 weeks after randomization
measure: Effective rate of patients with serum uric acid ≤ 7.0 mg/dL
timeFrame: 4, 8, 12, 16 and 20 weeks after randomization
measure: The proportion of patients with acute gouty arthritis
timeFrame: 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.
measure: Changes in body weight of patients
timeFrame: 4, 8, 12, 16 and 20 weeks after randomization
measure: Changes in the dose of intake of acute medication.
timeFrame: 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.
measure: Arrival of qi assessment
timeFrame: Immediately following each session of acupuncture treatment.
measure: Safety evaluation
timeFrame: Immediately following each session of acupuncture treatment.
Other outcomes:
measure: 60-item NEO Personality Inventory-Short Form (NEO-FFI)
timeFrame: At baseline only once.
measure: Chinese medicine constitution classification
timeFrame: At baseline only once.
measure: Acupuncture Expectancy Scale
timeFrame: At baseline only once.
measure: Change in Beck Anxiety Inventory(BAI).
timeFrame: At baseline only once.
measure: Change in Beck Depression Inventory II(BDI- II).
timeFrame: At baseline only once.
measure: Change in Patient-Doctor Relationship Questionnaire(PDRQ-9) .
timeFrame: At baseline only once.
measure: Change in Difficult Doctor-Patient Relationship Questionnaire(DDPRQ-10).
timeFrame: At baseline only once.
Locations:
city: Wuhan
country: China
facility: Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
state: Hubei
Study officials:
affiliation: Institute of Integrated Traditional Chinese and Western Medicine, Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan,430030, China
name: Shenghao Tu, PhD
role: PRINCIPAL_INVESTIGATOR
References: