A Randomized Controlled Trial of Auricular Acupressure on Reduction of Estazolam in Patients With Insomnia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 主要终点
- Estazolam Dosing and Reduction Rates
研究概览
简要总结
Insomnia is a disorder characterized by difficulties in falling asleep, maintaining sleep or waking up too early, and impairment of daytime functioning. Drug-dependent insomnia refers to insomnia patients taking sedatives and sleeping pills regularly for a long period of time, and becoming psychologically and physiologically dependent on them. In many countries, auricular acupressure (AA) has attracted growing attention as a complementary or alternative treatment for insomnia; however, there is a lack of rigorous randomized, controlled studies evaluating AA specifically for estazolam-dependent insomnia. Our proposed trial aims to assess the therapeutic effect of AA on estazolam-dependent insomnia.
详细描述
This study is a randomized, single-blinded, three-arm controlled trial. No less than 120 participants will be randomized into one of three groups: AA group, sham auricular acupressure (SAA) group, and conventional dosage reduction group. All treatments will be administered for 4 weeks, with a follow-up period of 1 month. The primary clinical outcomes will be estazolam dosing and reduction rates, serum gamma-aminobutyric acid (GABA) and cortisol (CORT) levels. Secondary outcomes will concern the Pittsburgh sleep quality index (PSQI) and Benzodiazepine Withdrawal Symptom Questionnaire (BWSQ). Both intention-to-treat and per-protocol analyses will be performed, with significance level determined as 5%.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for insomnia;
- •Meet the diagnostic criteria for hypnotic drug-dependent insomnia;
- •Regularly taking estazolam tablets for more than 2 months, and need to stop the medication;
- •The dependent dosage of estazolam is 1mg, and withdrawal reaction occurs when the dosage is less than 1mg;
- •PSQI score ≥ 7 (defined as "poor sleep quality", PSQI ≥ 7 is used as the reference threshold for judging sleep quality problems);
- •Sign the informed consent.
排除标准
- •Patients with cognitive disorders caused by cerebrovascular diseases, psychiatric disorders, and so on;
- •Patients with serious heart, liver, kidney and blood system diseases;
- •Patients with psychiatric illness/drug abuse (including alcohol);
- •Patients who cannot cooperate with treatment, observation and evaluation.
研究组 & 干预措施
Conventional dosage reduction group
The drug reduction method of estazolam tablets (Shanghai Xinyi Pharmaceutical Co., Ltd., Shanghai, China, State Drugs Administration License No.: H31020644, 1 mg) will be given, with a starting dose of 1 mg, that is, the dosage of estazolam will be reduced by 25% (0.25mg) every week until the dosage will be stopped completely on the premise of no aggravation of insomnia symptoms.
干预措施: Conventional dosage reduction (Drug)
Auricular acupressure group
Auricular acupressure therapy will be added based on the estazolam reduction method in the control group. The specific auricular points to be treated are Shenmen (TF4), Sympathetic (AH6), Endocrine (CO18), Heart (CO15), Liver (CO12) and Kidney (CO10). During the treatment, the acupuncturist will use a metal probe to identify the auricular points and ask the patients if they experience "deqi" sensations such as heat, numbness, distension, or pain. Once the auricular points have been confirmed, the ear will be disinfected using a 75% ethanol solution and dried using a sterile dry cotton ball. The acupuncturist will then hold the ear in place with their left hand while using their right hand to manipulate a tweezer and apply tape (0.5 x 0.5 cm) with vaccaria (Suzhou Konakang Medical Instrument Co., LTD., Suzhou, China) to the selected auricular point.
干预措施: Auricular acupressure (Procedure)
Sham auricular acupressure group
Based on the estazolam reduction method in the control group, the acupuncturist will place the same skin-colored adhesive tapes without vaccaria on the auricular points, but these tapes will not be pressed during treatment.
干预措施: Sham auricular acupressure (Procedure)
结局指标
主要结局
Estazolam Dosing and Reduction Rates
时间窗: Estazolam dosing will be assessed before treatment，1, 2, 3, and 4 weeks after treatment，1 month after follow-up visiting. The rate of dosage reduction will be observed 4weeks after treatment，1 month after follow-up visiting
The amount of drug taken by patients will be assessed.The rate of dosage reduction will be observed. Estazolam reduction rate = (pre-treatment Estazolam dose - post-treatment Estazolam dose)/pre-treatment Estazolam dose x 100%.
Serum Gamma-aminobutyric acid and Cortisol Levels
时间窗: Venous blood samples will be drawn twice from each patient at 8:00-9:00 in the morning 1 day before treatment and 1 day after the end of treatment.
The method of enzyme-linked immunosorbent assay (ELISA) will be used. 4 ml of venous blood will be extracted from the subjects, and will be added anticoagulant. After that, the samples will be centrifuged at 3000 r/min to separate upper serum and preserved in a refrigerator at -80℃, according to the kit instructions.
次要结局
- Pittsburgh Sleep Quality Index(Baseline, 4 weeks after treatment commencement, and the 1-month follow-up)
- Benzodiazepine Withdrawal Symptom Questionnaire(Baseline, 4 weeks after treatment commencement, and the 1-month follow-up)
研究者
Qiqi Wu
Resident physician of TCM
Wenzhou Central Hospital