A protocol for the integration of multi-omics bioinformatics: Mechanism of acupuncture as an adjunctive therapy for alcohol use disorder.

Background: Alcohol use disorder (AUD) has become a significant global factor in various diseases. As a non-pharmacological therapy, certain therapeutic potential has been found in acupuncture; however, in-depth mechanistic studies related to acupuncture for patients with AUD are still insufficient. Methods: Based on a randomized control design and a multi-omics analysis plan, this protocol details the recruitment (42 AUD patients), group allocation (21 in acupuncture group vs. 21 in sham acupuncture group), intervention and follow-up (replacement drugs as a normal treatment, 2 weeks acupuncture duration, and 3 month follow-up), and data collection and analytical processes. For the clinical outcomes, in addition to the time required for alcohol withdrawal symptoms to subside as the primary outcome, changes in the alcohol withdrawal symptoms, alcohol craving, mood dysfunction, sleep disorder, fatigue, self-efficacy, gastrointestinal symptoms, the quality of life, and the relapse outcomes will be compared between the groups to confirm the acupuncture clinical effectiveness on alcohol withdraw. The gut microbiome and the fecal metabolomics will also be assessed to explore the association of the structure and the function of gut microflora and the mediation of acupuncture effect on AUD fully utilizing gut microflora multi-modal data and clinical information, via the combination of multi-omics methods, feature screening algorithms and appropriate models. Discussion: The results of this study may help to strengthen clinical evidence of the mechanism of acupuncture intervention in patients with AUD, through understanding of the regulatory mechanism of acupuncture in the gut microbiome and its metabolism as well as AUD-related clinical manifestations. Trial registration: Chinese Clinical Trial Registry ChiCTR2200058120. Registered on 24 Mar 2022.

Effect of acupuncture for methadone maintenance treatment patients: study protocol of a randomized clinical trial.

BACKGROUND: Opioid dependence is an increasing public health problem all over the world. Patients with opioid dependence have to receive methadone maintenance therapy (MMT) as replacement therapy for years or even for their entire life. Acupuncture as a kind of therapy has been used to treat substance dependence for many years. Jin's three-needle acupuncture (JTN), a type of acupuncture technique, has been applied to treat various diseases for several decades. However, JTN as an acupuncture technique has not been used to treat patients receiving MMT. Therefore, we designed a randomized controlled trial to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. METHODS/DESIGN: This study is a parallel-arm, randomized controlled trial that aims to evaluate the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. A total of 140 eligible participants who range in age from 18 to 60 years and fulfil the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-V), for opiate dependence will be enrolled into this study. All eligible participants will be randomly assigned to the acupuncture group or routine group in a 1:1 allocation ratio. Participants who are enrolled in the acupuncture group will receive MMT and JTN treatment for 30 min per session. Meanwhile, those who are assigned to the routine arm will receive MMT only. All 18 sessions of JTN treatment will be delivered over 6 weeks (3 per week) and followed by a 4-week follow-up period. The primary outcome measure will be the visual analogue scale (VAS) for drug craving and the daily consumption of methadone (DCOM). Secondary outcome measures will include the urine test for opioid use, the 36-item Short Form Survey (SF-36), the Beck Anxiety Inventory (BAI), the Beck Depression Inventory II (BDI-II) and Pittsburgh sleep quality index (PSQI). VAS, DCOM, BAI, BDI-II and the urine test for opioid use will be evaluated at baseline, the second week, the fourth week, the sixth week and the tenth week. SF-36 and PSQI will be assessed at baseline, the fourth week, the sixth week and the tenth week. DISCUSSION: The results of this trial will provide evidence on the efficacy and safety of acupuncture as adjunctive therapy for patients receiving MMT. TRIAL REGISTRATION: Chinese Clinical Trial Registry ChiCTR1900026357 . Registered on 2 October 2019.

Jin's three-needle acupuncture technique for chronic fatigue syndrome: a study protocol for a multicentre, randomized, controlled trial.

BACKGROUND: With an unclear pathomechanism, no confirmed treatment regimen has been established for chronic fatigue syndrome (CFS). Acupuncture is applied as an alternative therapy for CFS. As a kind of acupuncture therapy, Jin's three-needle acupuncture (JTN) has been applied to treat CFS. However, few large-sample randomised controlled trials on JTN treatment for CFS have been reported. We designed this study to evaluate the efficacy and safety of JTN treatment for CFS. METHOD/DESIGN: This study is a multicentre, single-blind, randomised controlled trial. Patients who meet the inclusion criteria will be recruited and randomly assigned to either the JTN treatment group or the basic acupuncture group. Both interventions will be conducted for five consecutive days per week and last for 2 weeks. The primary outcome is the effective rate based on the 14-item Fatigue Scale (FS-14) score. Other outcome measures include the Fatigue Assessment Scale (FAI), the Depression Status Inventory (DSI), and the Self-rating Anxiety Scale (SAS). Plasma adrenocorticotropic hormone (ACTH), plasma cortisol, and serum levels of IL-2 and IFN-γ will also be measured in this study. Adverse events will be observed and recorded for the safety evaluation. DISCUSSION: This study may help to identify the efficacy and safety of JTN acupuncture treatment for CFS. TRIAL REGISTRATION: Chinese Clinical Trial Registry, ID: ChiCTR-IOR-17011009 . Registered on 29 March 2017.

[Discussion on the principle and treatment pathway of Jin's three-needle technique for mind regulation and treatment from the "adjusting qi to regulate mind, adjusting blood to regulate mind"].

The Jin's three-needle technique is famous for mind regulation and treatment. From the perspective of qi and blood, the special principle and treatment pathway of Jin's three-needle technique for mind regulation and treatment were summarized and analyzed. Moreover, themethods of invigorating brain and regulating mind, calming heart and tranquilizing mind, strengthening spleen and stomach, dredging the meridian and channel were applied to guide the qi into the brain to regulate the mind. The mind is regulated by adjusting heart and blood, nourishing the yang with yin, adjusting the source of blood and qi and dredging the channel of qi and blood. With "adjusting qi to regulate mind, adjusting blood to regulate mind", a comprehensive treatment is achieved to increase the efficacy of mind regulation and treatment.

Discussion on the principle and treatment pathway of 's three-needle technique for mind regulation and treatment from the "adjusting to regulate mind, adjusting blood to regulate mind" / 中国针灸

The 's three-needle technique is famous for mind regulation and treatment. From the perspective of and blood, the special principle and treatment pathway of 's three-needle technique for mind regulation and treatment were summarized and analyzed. Moreover, themethods of invigorating brain and regulating mind, calming heart and tranquilizing mind, strengthening spleen and stomach, dredging the meridian and channel were applied to guide the into the brain to regulate the mind. The mind is regulated by adjusting heart and blood, nourishing the with , adjusting the source of blood and and dredging the channel of and blood. With "adjusting to regulate mind, adjusting blood to regulate mind", a comprehensive treatment is achieved to increase the efficacy of mind regulation and treatment.