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Effect and safety of acupuncture for Hwa-byung, an anger syndrome: a study protocol of a randomized controlled pilot

Hye-Yoon Lee1, Jung-Eun Kim2, Mikyung Kim3

  • 1Research Institute for Korean Medicine, Pusan National University, 20, Geumo-ro, Mulgeum, Yangsan, Republic of Korea.

Trials
|February 11, 2018
PubMed

Insights

This pilot study explores acupuncture for Hwa-byung (HB), an anger syndrome. Results will inform future trials on this complex condition, assessing feasibility and safety of semi-individualized acupuncture.

Area of Science:

  • Integrative Medicine
  • Psychiatry
  • Traditional Korean Medicine

Background:

  • Hwa-byung (HB) is an anger syndrome with complex, intractable somatic and psychiatric symptoms due to inadequately released anger.
  • It often co-occurs with other psychiatric disorders, necessitating effective and safe treatment options.
  • A pilot study is planned to evaluate semi-individualized acupuncture for HB.

Purpose of the Study:

  • To determine the feasibility of conducting a full-scale randomized controlled trial (RCT) for acupuncture in HB patients.
  • To explore the clinical effects and safety of semi-individualized acupuncture compared to sham acupuncture.
  • To gather preliminary data for optimizing acupuncture treatment protocols for HB.

Main Methods:

  • A randomized, sham-controlled, participant- and assessor-blinded pilot trial involving two groups: real semi-individualized acupuncture and sham acupuncture.
  • Treatment administered over 10 sessions within 4 weeks.
  • Feasibility assessed by recruitment, compliance, and completion rates; clinical effects evaluated using VAS, BDI, SRI-short form, and IOME-HB.

Main Results:

  • This pilot study primarily focuses on assessing trial feasibility, not definitive treatment outcomes.
  • Descriptive analysis will be used to interpret feasibility and preliminary safety data.
  • Cohen's d will be reported to estimate effect size for future RCT power calculations.

Conclusions:

  • The study protocol offers an optimal semi-individualized acupuncture approach for HB.
  • Findings will provide crucial information on the feasibility of this treatment strategy.
  • Data on potential effects and safety will guide future research and clinical application for HB management.
Abstract

Keywords:
AcupunctureAnger syndromeHwa-byungPsychiatric disorderRandomized controlled trial

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