None listed
Conditions
Brief summary
Background: Many clinical trials have been performed to study the efficacy of acupuncture for insomnia. The results have shown that the acupuncture might be overall a promising treatment modality for insomnia. However, majority of the studies were of low methodological quality. In clinical practice, acupuncture treatments are individualized according to the Traditional Chinese Medicine (TCM) pattern diagnosis. It is believed from the theoretical view of Chinese medicine that pattern-based TCM treatment will provide better efficacy. However, most clinical trials of acupuncture have been based on a standardized formula of points for every patient without properly accounting for individual differences, and as a result, have not been reflective of the true efficacy of clinical practice. Previous clinical studies regarding the efficacy of syndrome differentiation-based acupuncture treatment is rare. Objective: To compare the effectiveness of individualized acupuncture based on TCM syndrome differentiation with standardized acupuncture in patients with insomnia. Design: Pilot, parallel, double blinded, randomized controlled trial Setting: Subjects will be recruited from the Christian Family Service Centre - The CUHK Chinsese Medicine Centre for Training & Research (Ngau Tau Kok) via referrals from Chinese Medicine Practitioners and advertisement or poster at the clinic and electronic media. Participants: 40 subjects aged 18 or above who report having insomnia 3 or more nights per week for a minimum of three months. Inclusion criteria: Chinese adult aged 18 or above who report having insomnia 3 or more nights per week for a minimum of three months, whose symptoms meet the criteria of the revised Hong Kong Chinese version of Brief Insomnia Questionnaire (HK-BIQ) which covers the diagnostic criteria of insomnia disorders according to the Diagnostic and Statistical Manual, Fifth Edition (DSM-5). Interventions: All eligible subjects will be randomly allocated into individualized acupuncture group or standardized acupuncture group in a ratio 1:1. All patients receive CM diagnosis before the first treatment. Each patient will be evaluated by two licensed Chinese medicine practitioners (CMPs) independently on the same day. The individualized acupuncture or standardized acupuncture treatment will be administered 2 times per week for 4 weeks. Outcome measures: The primary outcome is Insomnia Severity Index (ISI), and the secondary outcomes include Hospital Anxiety and Depression Scale (HADS), and One-week Expanded Consensus Sleep Diary for Morning (CSD-M). Assessments will be made at baseline, 1-week post-treatment (week5) and 4-week post treatment (week 8).
Interventions
In clinical practice, acupuncture treatments are individualized according to the TCM pattern diagnosis, also called syndrome differentiation. TCM pattern, in terms of TCM theory, is defined as a diagnostic conclusion of the pathological changes of a disease mainly based on an individual’s symptoms and signs, including pulse form and tongue appearance. The pattern identified determines the appropriate treatment principle, based on which the specific treatment modalities and acupoints stimulated a
In clinical practice, acupuncture treatments are individualized according to the TCM pattern diagnosis, also called syndrome differentiation. TCM pattern, in terms of TCM theory, is defined as a diagnostic conclusion of the pathological changes of a disease mainly based on an individual’s symptoms and signs, including pulse form and tongue appearance. The pattern identified determines the appropriate treatment principle, based on which the specific treatment modalities and acupoints stimulated are defined. It is believed from the theoretical view of Chinese medicine that pattern-based TCM treatment will provide better efficacy. For individualized acupuncture treatment, two types of acupoints including basic acupoints and acupoints based on the syndrome differentiation will be selected. Each patient will be evaluated by two licensed Chinese medicine practitioners (CMPs) independently on the same day. The five basic TCM syndrome patterns of insomnia are Fire syndrome caused by stagnation of liver-Qi, Internal disturbance of phlegm-heat, Hyperactivity of fire due to yin deficiency, Deficiency of both the heart and spleen and Deficiency of both heart and gallbladder. Each patient will be classified and assigned to one or two combined patterns from the five TCM patterns. If there is no agreement between the two CMPs on the diagnosis, a senior Chinese medicine practitioner will examine the patient with respect to the dispute. The basic acupoints are Sishencong (Ex-HN1), Shenmen (HT7), Sanyinjiao (SP6) and Fengchi (GB20). For fire syndrome caused by stagnation of liver-Qi , Taichong (LR3), Xingjian (LR2) and Ganshu (BL 18) may be added. For internal disturbance of phlegm-heat, Zhongwan (CV12), Zusanli (ST36), Fenglong (ST 40) and Neiting (ST 44) may be added. Fro hyperactivity of fire due to Yin deficiency, Xinshu (BL 15), Shenshu (BL 23), Taixi (KI 3) and Ximen (PC 4) may be added. For deficiency of both heart and spleen, Xinshu (BL 15), Pishu (BL20) and Jueyinshu (BL 14) may be added. For deficiency of both heart and gallbladder, Xinshu (BL 15), Danshu (BL 19) and Qiuxu (GB 40) may be added. For subjects assigned to one TCM pattern, two to four acupoints with regard to the corresponding pattern will be selected. For subjects assigned to two combined TCM patterns, two to four acupoints of the two corresponding patterns will be selected. The subjects will be treated 2 times per week for 4 weeks. Each treatment will last 30 minutes. Acupuncture interventions are carried out by licensed Chinese medicine practitioners with at least 2 years’ clinical experience. The same patient is treated by the same Chinese medicine practitioner throughout the study. Both groups will use the same kinds of disposable, sterile steel needles (MOCM, 0.25 X 25mm and 0.25 X 40mm) and same skin disinfection process with alcohol pads in the treatment. All researchers, practitioners and assessors will undergo training before participating in this study to ensure consistent practices and strict adherence to the study protocol. The training will include diagnoses, inclusion and exclusion criteria, screening and outcome measuring. Acupuncturists will be trained in the location of acupoints and acupuncture manipulation techniques. And the work manual will be provided for different parties. The treatment will be administered in the Christian Family Service Centre - The CUHK Chinsese Medicine Centre for Training & Research (Ngau Tau Kok). Dropouts and withdrawals from the study will be documented. Periodic monitoring will guarantee accuracy and quality throughout the study.
Sponsors
School of Chinese Medicine, The Chinese University of Hong KOng
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
All eligible subjects should be Chinese adult aged 18 or above who report having insomnia 3 or more nights per week for a minimum of three months, whose symptoms meet the criteria of the revised Hong Kong Chinese version of Brief Insomnia Questionnaire (HK-BIQ). HK-BIQ is a lay-administered, structured interview covering the diagnostic criteria of insomnia disorders according to the Diagnostic and Statistical Manual, Fifth Edition (DSM-5).
Exclusion criteria
a. Has a severe neural or psychiatric disorder; b. Substance use insomnia disorder besides caffeine or nicotine use; c. Has taken western and/or herbal medicine in the past 2 weeks for insomnia; d. Has taken anti-coagulant or anti-platelet drugs in the past one month; e. Has received acupuncture for insomnia treatment in the past one month; f. Has participated in any other clinical trial within a month of the screening date; g. Has contradictions of acupuncture, e.g. hemorrhagic disease, infection or inflammation at the acupoints, pregnancy or being a woman of childbearing age not on a proper method of birth control, cancer patients etc.
Outcome results
None listed