Acupuncture With Five Shu Points for Insomnia in Heart-Spleen Deficiency

Official title

Efficacy of Five Shu Point Acupuncture in the Treatment of Insomnia in Patients With Heart-Spleen Deficiency Pattern: A Randomized Controlled Trial

Overview

This study was designed as a randomized controlled trial (RCT) with a multicenter, single-blind methodology. Participants diagnosed with insomnia attributable to the Heart-Spleen Deficiency pattern, receiving treatment at the Ho Chi Minh City Hospital of Traditional Medicine and Hospital 1A, were randomly allocated into two groups.

Detailed description

Background: Insomnia is a prevalent sleep disorder with considerable public health impact. Acupuncture based on Five Shu points, guided by Five Phase theory, represents a promising non-pharmacological approach for Heart-Spleen deficiency pattern insomnia. However, high-quality clinical evidence supporting its efficacy remains scarce, and studies conducted in Vietnamese populations are notably absent. This gap highlights the need for rigorous clinical investigation in this specific context.

Objectives: This trial aims to compare the efficacy of acupuncture at Five Shu points plus Viet Nam Ministry of Health (MOH) standard points versus Viet MOH standard points alone in improving sleep quality (PSQI) and alleviating TCM Heart-Spleen deficiency pattern-specific symptoms after 14 days, 28 days.

Study design: A multicenter, randomized, single-blind (assessor-blinded), active-controlled trial with two parallel arms. A total of 46 participants will be enrolled (23 per arm) based on sample size calculation.

Participants: Adults aged ≥18 years, meeting DSM-V criteria for chronic insomnia and TCM diagnostic criteria for Heart-Spleen deficiency pattern. Exclusion criteria include other sleep disorders, severe psychiatric illness, and use of psychotropic medications.

Interventions:

Experimental arm: Acupuncture at Viet Nam MOH standard points (PC6, SP6, ST36, BL15, SP3, BL17) plus Five Shu points (HT9, HT7, SP2, LR2). Needles retained for 30 minutes using tonifying technique, once daily, 5 consecutive days per week (Monday-Friday, with Saturday and Sunday rest), over a 28-day period, for a total of 20 acupuncture sessions.

Control arm: Same acupuncture at Viet Nam MOH standard points only, same schedule.

Both groups receive standardized sleep hygiene education.

Outcomes: The co-primary outcomes are: (1) change in PSQI global score from baseline to day 28, and (2) change in the TCM Heart-Spleen deficiency symptom scale score from baseline to day 28. The secondary outcome measure is adverse events related to acupuncture, which includes the recording and analysis of any adverse events (such as pain, bleeding, infection, dizziness, or other unexpected reactions) occurring during the 28-day intervention period, from day 1 to day 28 of the treatment

Randomization and blinding: Central computer-generated randomization (1:1). Patients cannot be blinded due to nature of acupuncture, but outcome assessors and data analysts will be blinded to group allocation.

Statistical analysis: Intention-to-treat analysis. Between-group differences will be analyzed using t-test or Mann-Whitney U test as appropriate. A P-value \< 0.05 will be considered statistically significant.

Safety: All adverse events will be documented and managed according to standard operating procedures.

Interventions

• Procedure Acupuncture at Viet Nam MOH standard points plus Five Shu points
  Experimental arm: Acupuncture at Viet Nam MOH standard points (PC6, SP6, ST36, BL15, SP3, BL17) plus Five Shu points (HT9, HT7, SP2, LR2). Needles retained for 30 minutes using tonifying technique, once daily, 5 consecutive days per week (Monday-Friday, with Saturday and Sunday rest), over a 28-day period, for a total of 20 acupuncture sessions. All participants receive identical sleep hygiene psychoeducation.
• Procedure Acupuncture at Viet Nam MOH standard points
  Control arm: Same acupuncture at VIet Nam MOH standard points only, same schedule. All participants receive identical sleep hygiene psychoeducation as Intervention group

Primary outcome measures

• Insomnia Associated with Heart-Spleen Deficiency [Time frame: every 14 days, 28 days post-intervention]
• Insomnia Associated with Heart-Spleen Deficiency [Time frame: Every 14 days, 28 days post-intervention]

Secondary outcome measures (1)

• Adverse events related to acupuncture [Time frame: From day 1 to day 28 of intervention]

Eligibility criteria

Inclusion criteria

• Patients aged 18 years or older who voluntarily consent to participate in the study.
• Patients who have never used or have discontinued insomnia medication within 2 weeks prior to study enrollment.
• Patients meeting the diagnostic criteria for insomnia according to the DSM-V of the American Psychiatric Association, specifically as follows:

A. The patient complains about sleep quantity or quality, including one or more of the following symptoms: difficulty initiating sleep; difficulty maintaining sleep, characterized by frequent awakenings or trouble returning to sleep after awakening; early morning awakening with inability to return to sleep.

B. Sleep difficulty occurs for at least 3 months. C. Sleep disturbance causes significant distress or impairment in social, occupational, educational, academic, behavioral, or other important areas of functioning.

D. Sleep difficulty occurs at least 3 nights per week. E. Sleep difficulty occurs despite adequate opportunity for sleep. F. Insomnia is not better explained by another sleep disorder (e.g., narcolepsy, breathing-related sleep disorder, circadian rhythm sleep disorder).

G. Co-existing mental disorders or medical conditions do not adequately explain the predominant complaint of insomnia.

H. Insomnia is not attributable to the physiological effects of a substance.

• Patients who are able to understand Vietnamese.
• Patients meeting the diagnostic criteria for Heart-Spleen dual deficiency syndrome according to Jing Lv, requiring the presence of mandatory symptoms + 2 primary symptoms + 2 secondary symptoms + tongue and pulse findings, specifically:

Mandatory symptoms

• Sleeplessness throughout the night, or light sleep with frequent awakening; fragmented sleep.
• Frequent nightmares.
• Early morning awakening with inability to fall back asleep.

Primary symptoms

Palpitations, forgetfulness. Mental fatigue, poor appetite. Pale, unhealthy complexion. Secondary symptoms

Dizziness, blurred vision. Weakness of limbs. Abdominal distension, loose stools. Tongue and pulse findings

Pale tongue with thin white coating. Thin, weak, forceless pulse.

Exclusion criteria

• Patients diagnosed with other sleep disorders such as sleep apnea syndrome or narcolepsy.
• Patients previously diagnosed with neurological or psychiatric disorders (e.g., anxiety disorder, autism spectrum disorder, depression, obsessive-compulsive disorder, rapid eye movement sleep behavior disorder) prior to study enrollment.
• Patients currently using antidepressants or psychiatric medications.
• Patients participating in other clinical trials involving behavioral, psychological, or complementary medical interventions during the study period.
• The patient no longer agrees to continue participation.
• Occurrence of uncomfortable symptoms during the study, such as needle syncope, nausea, headache, dizziness, sweating, etc.
• Significant worsening of the condition or development of new complications.
• Non-adherence to the treatment protocol, making continuation impossible.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Vietnam · 3 centers

• Ho Chi Minh City Hospital of Traditional Medicine (179-187 Nam Ky Khoi Nghia Street, Xuan — Ho Chi Minh City
• Hospital 1A (1A Ly Thuong Kiet Street, Tan Son Nhat Ward, Ho Chi Minh City) — Ho Chi Minh City
• University of Medicine and Pharmacy at Ho Chi Minh City — Ho Chi Minh City

Publications

• Zhang KQ, Zhao ZH, et al. Analysis of the connotation and clinical application rules of "Shu" (俞)-named acupoints on the whole body. Journal of Traditional Chinese Medicine and Pharmacy. 2023;29(10):103-106.
• Yuan CX. Clinical study of abdominal acupuncture for the treatment of insomnia of heart-spleen deficiency type [PhD thesis]. [Beijing]; 2020.
• Liu C. Acupuncture at five-shu acupoints for insomnia due to heart-kidney disharmony: a clinical analysis of 50 cases. Chronic Pathematology J. 2020;21(12):1788-1791.
• Shu RJ. Theoretical discussion and preliminary clinical application of Five-element acupuncture in the treatment of skin diseases from the perspective of "Shen" [PhD thesis]. 2018.
• Wang W. Five-element acupuncture: a mind-body therapy originating from China. Science & Technology Review. 2019;37(15):91-97.
• Zhang J, Lu L, Li Y, et al. A randomized controlled study of water-acupoint embedding therapy combined with herb-separated moxibustion for the treatment of obesity complicated with hyperlipidemia due to spleen deficiency and dampness stagnation. Sichuan Traditional Chinese Medicine. 2017;35(5):189-192.
• Lv J. A preliminary study on the distribution of Traditional Chinese Medicine (TCM) syndrome types and the differences in sleep status between syndrome types in short-term insomnia [Master's thesis]. 2016.

Identifiers

NCT: NCT07544082 · 606/DHYD - HDDD

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗