A Randomized Controlled Trial of Auricular Acupressure in Treating Estazolam-dependent Insomnia

A Randomized Controlled Trial of Auricular Acupressure on Reduction of Estazolam in Patients With Insomnia

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.

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%.

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.