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

ABSTRACT: 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.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.

SUBMITTER: Lee HY

PROVIDER: S-EPMC5807845 | biostudies-other | 2018 Feb

REPOSITORIES: biostudies-other

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

Lee Hye-Yoon HY Kim Jung-Eun JE Kim Mikyung M Kim Ae-Ran AR Park Hyo-Ju HJ Kwon O-Jin OJ Cho Jung-Hyo JH Chung Sun-Yong SY Kim Joo-Hee JH

Trials 20180209 1

<h4>Background</h4>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) o ...[more]

PMID: 29426348

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Project description:BackgroundChronic urticaria (CU) is a refractory skin disease with long duration and a high recurrence rate. Acupuncture has been widely used for the treatment of CU in clinical practice in China. However, until now, there has been no appropriately designed randomized controlled trial (RCT) to provide explicit evidence about the effectiveness of acupuncture for the treatment of CU worldwide. Therefore, we plan to conduct a pilot study to explore its effectiveness and safety and determine the feasibility of studying acupuncture in a future, full-scale, RCT of CU.Methods/designThis randomized, sham-controlled, participant-blinded and assessor-blinded pilot trial is underway in China. A total of 60 participants with CU will be randomly assigned to two groups in a 1:1 ratio: one treated with real acupuncture and the other with sham acupuncture, for 10 sessions over 2 weeks. The experimental group will receive acupuncture on a fixed prescription of acupoints, whereas the control group will receive sham acupuncture, namely minimal acupuncture on non-acupuncture points. The primary outcome will be the urticaria activity score (UAS). The secondary outcomes will include a visual analogue scale (VAS) score for itching intensity, the Dermatology Life Quality Index (DLQI), the Hamilton Depression Scale (HAMD), the Hamilton Anxiety Scale (HAMA), the humoral immunity index, serum total IgE, and adverse events. The UAS, VAS for itching and the DLQI will be conducted at baseline and at 1, 2, 3, and 4 weeks after randomization. The HAMD, HAMA, humoral immunity index, and serum total IgE will be assessed at baseline and at 2 weeks after randomization. Adverse events will be summarized at 1 week and 2 weeks after randomization.DiscussionThe pilot study mainly aims to investigate trial feasibility, and confirm basic information about its effects and safety. Results of this trial will help clarify whether the acupuncture treatment is beneficial for symptom improvement in patients with CU. The finding of this study will provide preliminary evidence on the effectiveness and safety of acupuncture for CU.Trial registrationAcupuncture-Moxibustion Clinical Trial Registry, AMCTR-ICR-18000190 . Registered on 19 June 2018.

Project description:Whether acupuncture is effective for relieving perimenopausal syndrome has been controversial recently. In this article, we report the protocol of a randomized controlled trial using acupuncture to treat perimenopausal syndrome, aiming to answer this controversy.A multicenter randomized controlled trial with two parallel arms is underway in China. Two hundred and six women with perimenopausal syndrome will be randomly assigned to a treatment group using acupuncture plus auricular acupressure (AA group) and a control group using Climen (Bayer Healthcare Company Limited, Guangzhou, China), a 28-day sequential hormone replacement therapy, in a 1:1 ratio. Participants in the AA group will receive three acupuncture sessions per week in the first 4 weeks and two sessions per week in the following 8 weeks, for a total of 28 sessions over 12 weeks. Auricular points will be plastered by Semen Vaccariae twice per week for a consecutive 12 weeks, with both ears used alternately. The Climen control group is prescribed a tablet containing estradiol valerate 2 mg/day for the first 11 days, and a tablet containing estradiol valerate 2 mg/day plus cyroterone acetate 1 mg/day for the following 10 days. The total treatment period of the control group is three cycles. The post-treatment follow-up period will last 24 weeks. The primary outcome is the Menopause Rating Scale (MRS) assessed at baseline and 4, 12, 16, 24 and 36 weeks after randomization. The secondary outcomes are Menopause-Specific Quality of Life, average hot flash score during 24 hours, serum estradiol, follicle-stimulating hormone and luteinizing hormone level. The first two secondary outcomes are measured at the same point as the MRS. Other secondary outcomes are measured at baseline and 12, 24 weeks after randomization.The results of this trial, which will be available in 2015, will clarify whether acupuncture is effective to relieve perimenopausal syndrome.ClinicalTrials.gov NCT01933204 (registered 9 August 2013).

Project description:BackgroundIrritable bowel syndrome (IBS) is a chronic gastrointestinal disorder characterized by abdominal pain and change of bowel habit without organic disease. A global perspective given by the World Gastroenterology Organization (WGO) points out that IBS can impact the quality of an individual's daily life, cause socioeconomic problems and potentially impair the patient-physician relationship. It remains a problem to treat IBS due to the complicated pathophysiology. Acupuncture is an alternative therapy recommended for IBS. The aim of this study is to investigate the efficacy and safety of acupuncture therapy for patients with IBS. We also want to explore the correlation between IBS-gene subtypes and acupuncture effect.Methods/designA multicenter randomized controlled trial will be performed in seven hospitals. Six hundred participants will be stratified into two strata (IBS-C or IBS-D). Then, patients within each stratum will be divided into an experimental group and a control group randomly. The experimental group is treated with acupuncture while the control group is treated with Western medicine. All the patients will receive a 6-week treatment and a 3-month follow-up. The primary outcome is the IBS-Symptom Severity Score (IBS-SSS), the secondary outcome is the score of the IBS-Quality of Life (IBS-QoL).The correlation between IBS-gene subtypes and acupuncture effect will be detected based on polymerase chain reaction-restriction fragment length polymorphism (PCR-RFLP). Outcome measures (including primary and secondary outcome measures) are collected at baseline,1 week, 2 weeks, 4 weeks, and 6 weeks of the intervention, and 12 weeks after the intervention.DiscussionThis is a multicenter randomized controlled trial for IBS in China. It may clarify the efficacy of acupuncture as an alternative therapy for IBS. This is the first time ever that the potential mechanism of IBS based on genomics has been investigated.Trial registrationChinese Clinical Trials Register, ID: ChiCTR-IOR-15006259 . First registered on 14 April 2015.

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

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

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