Lee Hye-Yoon, Kim Jung-Eun, Kim Mikyung, Kim Ae-Ran, Park Hyo-Ju, Kwon O-Jin, Cho Jung-Hyo, Chung Sun-Yong, Kim Joo-Hee
Research Institute for Korean Medicine, Pusan National University, 20, Geumo-ro, Mulgeum, Yangsan, Republic of Korea.
Clinical Research Division, Korea Institute of Oriental Medicine, 1672, Yuseong-daero, Yuseong-gu, Daejeon, Republic of Korea.
Trials. 2018 Feb 9;19(1):98. doi: 10.1186/s13063-017-2399-0.
Hwa-byung (HB) is an anger syndrome caused by an inadequate release of accumulated anger that leads to somatic and psychiatric symptoms. As HB results from long-term inadequately treated negative emotions, its symptoms are complex, intractable and concomitant with other psychiatric disorders. Therefore, studies aiming to develop effective and safe treatment options for HB are needed. We plan to conduct a pilot study for a future, full-scale, randomized controlled trial (RCT) of an optimal acupuncture procedure using semi-individualized acupuncture points that consider participants' personal disposition and type of emotional stress.
METHOD/DESIGN: This randomized, sham-controlled, participant- and assessor-blinded pilot trial aims to determine the study feasibility of acupuncture for HB and to explore its clinical effects and safety. This clinical trial will be conducted with two groups: one treated with real acupuncture and the other with sham acupuncture for 10 sessions over 4 weeks. The experimental group (EG) will receive semi-individualized acupuncture, whereas the control group (CG) will receive sham acupuncture, namely minimal acupuncture on non-acupuncture points. The recruitment, compliance, and completion rate and clinical evaluations, including a Visual Analogue Scale (VAS), the Korean version of the Beck Depression Inventory (BDI), the short form of the Stress Response Inventory (SRI-short form) and the Instrument of the Oriental Medical Evaluation for HB (IOME-HB), will be assessed to evaluate feasibility and possible effects and safety. Four weeks after completing treatment, follow-up assessments will be performed.
As this is a pilot study mainly aiming to investigate trial feasibility, the results of this study will be analyzed descriptively and interpreted for the study purposes. Cohen's d will be reported to determine the effect of acupuncture for HB and to enable comparisons with other treatment methods. This protocol is significant in that it provides optimal semi-individualized acupuncture treatment. We expect this study to offer information about the feasibility of this treatment and data about the possible effects and safety.
Clinical Research Information Service (CRIS), Republic of Korea: KCT0001732 . Registered on 14 December 2015.
火病（HB）是一种因累积愤怒未能充分释放而导致躯体和精神症状的愤怒综合征。由于火病源于长期未得到充分治疗的负面情绪，其症状复杂、难以治疗且常伴有其他精神障碍。因此，需要开展旨在开发有效且安全的火病治疗方案的研究。我们计划进行一项初步研究，为未来一项使用考虑参与者个人性格和情绪应激类型的半个体化穴位的最佳针灸程序的全面随机对照试验（RCT）做准备。
方法/设计：这项随机、假针刺对照、参与者和评估者双盲的初步试验旨在确定针灸治疗火病的研究可行性，并探索其临床效果和安全性。该临床试验将分为两组进行：一组接受真针灸治疗，另一组接受假针灸治疗，为期4周，共10次治疗。实验组（EG）将接受半个体化针灸，而对照组（CG）将接受假针灸，即在非穴位上进行最小程度的针刺。将评估招募情况、依从性、完成率以及临床评估，包括视觉模拟量表（VAS）、韩国版贝克抑郁量表（BDI）、应激反应量表简版（SRI简版）和火病东方医学评估工具（IOME - HB），以评估可行性、可能的效果和安全性。治疗结束4周后，将进行随访评估。
由于这是一项主要旨在调查试验可行性的初步研究，本研究结果将进行描述性分析，并根据研究目的进行解读。将报告科恩d值以确定针灸对火病的疗效，并便于与其他治疗方法进行比较。本方案的重要意义在于它提供了最佳的半个体化针灸治疗。我们期望本研究能提供有关这种治疗可行性的信息以及有关可能的效果和安全性的数据。
韩国临床研究信息服务中心（CRIS）：KCT0001732。于2015年12月14日注册。
