Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia

Combined Electroacupuncture and Auricular Acupuncture for Persistent Insomnia: A Randomized Controlled Trial of Dose-Response Effect

This is a randomized controlled trial to evaluate the clinical efficacy of combined electro-acupuncture and auricular acupuncture for persistent Iinsomnia in the adult population in Hong Kong.

Combined electro-acupuncture and auricular acupuncture is potential to be an alternative treatment for primary insomnia. The purpose of this study is to evaluate the clinical effectiveness of combined electroacupuncture and auricular acupuncture on persistent insomnia. This is a randomized double-blinded controlled trial. Patients will be randomly assigned to the electro-acupuncture group, the electro-acupuncture plus auricular acupuncture group or the waitlist controlled group. Patients will be put into groups and then compared.The chance of getting into each group is 3:3:1.

Inclusion Criteria:

• Aged 18 years or above
• Hong Kong residents
• Ethnic Chinese
• Meet the diagnosis criteria of presistent insomnia for at least 3 months according to Current Diagnostic and Statistical Manual of Mental Disorders (the proposed Fifth Edition)
• Insomnia more than 3 nights per week for at least 3 months
• Willing to give informed consent
• Able to comply with trial protocol

Exclusion Criteria:

• Have a Hamilton Depression Rating Scale scores above 18
• Have sleep apnea or periodic limbs movement disorder detected by overnight polysomnography
• Have suicidal risk as assessed by the Hamilton Depression Rating Scale suicidal risk item
• Have current major depressive disorder, generalized anxiety disorders or panic disorder, manic or hypomanic episode, substance use disorders except caffeine and nicotine, organic mental disorder, schizophrenia or any other psychotic disorder
• Receiving psychotropic drugs with dosage changes in the last 4 weeks prior to screening, baseline or during the study
• Have valvular heart defects or bleeding disorders or were taking anticoagulant drugs
• Are pregnant, breast-feeding, or woman of childbearing potential not using adequate contraception
• Have any unstable psychiatric conditions or serious physical illnesses which are judged by the investigator to render unsuitable or unsafe
• Have infection or abscess close to the site of selected acupoints and in the investigator's opinion inclusion is unsafe
• Taking Chinese herbal medicine or over-the-counter drugs which are intending for insomnia within the last 2 weeks prior to baseline or during the study
• Any acupuncture or auricular acupuncture treatment during the previous 6 months prior to baseline