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