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

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.

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.

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Interventions

Eligibility

Locations (3)

Outcomes

Central Contacts