A Randomized Controlled Trial of Auricular Acupressure on Reduction of Estazolam in Patients With Insomnia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Enrollment
- 108
- Primary Endpoint
- Estazolam Dosing and Reduction Rates
Study Overview
Brief Summary
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.
Detailed Description
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%.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •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.
Arms & Interventions
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.
Intervention: 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.
Intervention: 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.
Intervention: Sham auricular acupressure (Procedure)
Outcomes
Primary Outcomes
Estazolam Dosing and Reduction Rates
Time Frame: 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
Time Frame: 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.
Secondary Outcomes
- 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)
Investigators
Qiqi Wu
Resident physician of TCM
Wenzhou Central Hospital