• Korean Journal of Acupuncture
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• v.28 no.3
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• pp.151-163
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• 2011

Objectives : Our aim is to evaluate feasibility for massive clinical research and to make basic analysis of efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue. Methods : This study is a protocol for a pilot randomized controlled trial. It was developed through literature searches and discussions among researchers. Results : Forty participants allocated to acupuncture group and wait-list group. Participants allocated to acupuncture group will be treated three times per week for a total of 12 sessions over four weeks. Eight points (GV20; bilatral GB20, BL11, BL13, BL15, BL18, BL20, BL23) have been selected for the acupuncture group. Participants in the wait-list group will not receive acupuncture treatment during study period and follow-up will be made in the 5th and 9th weeks after random allocation. Then the same acupuncture treatment as that performed to the acupuncture group will be made to the wait-list group. Fatigue Severity Scale, a short form of Stress Response Inventory, Beck Depression Inventory, and Insomnia Severity Index will be used as outcome variables to evaluate the efficacy of acupuncture. Safety will be assessed at every visit. Conclusions : The trial based on this study will be performed. The results of the trial will provide basis for the efficacy and safety of acupuncture treatment for chronic fatigue syndrome and idiopathic chronic fatigue.

• Journal of Oriental Neuropsychiatry
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• v.18 no.1
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• pp.79-94
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• 2007

Objective : The Purpose of this research is to examine the effect of Sa-am acupuncture treatment(Sim-seungkyuk) for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture in the treatment for major symptoms of Hwa-byung. likert scale(5 score) for major symptom of Hwa-byung was measured as the 1st evaluative instrument, and STAXI-K, STAI-K, BDI-K and HRV were also measured as the 2nd evaluative instrument at the before treatment and after treatment. Results : 26 volunteers participated in this study by dividing two groups, each 13 persons in trial group and control group at random. In comparison of likert scale for major symptoms, after treatment the total score of likert scale for major symptoms decreased significantly in both group than before treatment. And after treatment, the total score of trial group decreased less than those of control group in comparison between two groups. especially after 2 weeks from all treatment, there was significant difference between two groups. Conclusion : We considered that Shim-seungkyuk of Sa-am acupuncture treatment will be not recommended to treatment of Hwa-byung because this study could not prove effect of Shim-seungkyuk treatment for Hwa-hyung in spite of preliminary study. This study will be used to provide a fundamental data for development of clinical research as preliminary study of Hwa-byung.

• Journal of Korean Medicine Rehabilitation
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• v.24 no.4
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• pp.49-60
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• 2014

Objectives The purpose of this study is to research current trends of acupuncture treatment of lumbar herniated intervertebral disc using the PubMed database. Methods We set up the search strategy and investigated clinical trials on acupuncture treatment of lumbar herniated intervertebral disc through PubMed search. This study analyzed previous researched papers published from January 1st, 2000 to April 30th, 2014, and classified them by publication year, journal names, types of literature, treatment methods and evaluation scales. To assess the quality of the reviewed literature, randomized controlled trial (RCT) studies were assessed by Cochrane's risk of bias (ROB) tool and non-RCT studies were assessed by risk of bias for non-randomized studies (RoBANS). Results We found 35 studies on the acupuncture treatment of lumbar herniated intervertebral disc. Papers on this topic have been published, on average, three to four times annually in 9 journals since the mid-2000's. The journal with the largest number of publications was Chinese Acupuncture & Moxibustion, and most of articles were classified as RCT. Acupuncture treatment was performed individually or together with other treatments. The most frequently used pain evaluation index was visual analogue scale (VAS). The index of effective rate was used frequently but there was a lack of objectivity. In regards to the quality of the studies, outcome assessment in RCT showed that random sequence generation, allocation concealment, and the blinding of participants and personnel increase potential of risk of bias. For non-RCT assessment, outcome showed that confounding variable, measurement of intervention were at high risk of bias. Conclusions In order to obtain objective clinical evidence of acupuncture treatment of lumbar herniated intervertebral disc, further clinical studies should be designed to minimize the risk of bias, using STRICTA with larger sample sizes.

• Journal of Acupuncture Research
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• v.35 no.2
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• pp.95-100
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• 2018

Background: The aim of this study is to assess the feasibility of acupuncture treatment for the management of subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures. Methods: A total of 30 participants who have undergone thoracotomy after traumatic multiple rib fractures will be recruited. Participants will be invited and equally randomised into acupuncture plus usual care and usual care alone groups. A computer-generated random number sequence will be used and concealed using opaque, sealed, sequentially numbered envelopes. Twelve sessions of manual and electrical acupuncture performed by Korean medicine doctors will be provided over a span of 3 months to participants allocated to the acupuncture group. Participants in the usual care group will continue pain medication, exercise and physical therapy as required. Study feasibility will be measured based on the proportion of patients who complete the measurement of pain at 12 or 24 weeks after baseline. The clinical outcomes will include; the average pain intensity over the recent week at rest, movement and cough, quality of life, patient's global assessment of recovery, respiratory function measured by the pulmonary function test and use of pain medication at 4, 8, 12 and 24 weeks after enrolment. Adverse events will be recorded for all participants. Written informed consent will be obtained from all participants. The local ethics committee has approved the study. This pilot trial will inform further studies investigating the potential role of acupuncture for subacute and chronic post-thoracotomy pain in patients with traumatic multiple rib fractures.

• Korean Journal of Acupuncture
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• v.34 no.4
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• pp.251-264
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• 2017

Objectives : To identify the prevalence and types of spin in randomised controlled trials(RCTs) of obesity with statistically non-significant results for primary outcomes to provide adequate reporting directions. Methods : Spin is specific reporting strategy that could lead the readers to misinterpret the results of RCTs. RCTs on obesity with statistically non-significant primary outcomes published from July 2015 to June 2016 were retrieved from PubMed. All included RCTs were classified into 3 intervention categories. The identification and classification of spin in the included articles was performed by two independent researchers. Results : Among 46 RCTs with statistically non-significant primary outcomes, 32 studies were assessed as having at least one spin in title, abstract or main text. Of these, 9 articles were on complementary and alternative medicine, 7 on western medicine and 16 on dietary supplement and exercise. The frequency of spin among the types of interventions was similar. The most common type of spin was 'focusing on statistical significance within-group comparison' in results section of abstract and main text, and 'focusing only on treatment effectiveness with no consideration of statistical significance' in conclusion section of abstract and main text. Studies where random sequence generation was appropriately done was less likely to have spin. Conclusions : As a majority of obesity RCTs have spin, researchers should pay more attention to adequately interpreting and reporting statistically non-significant results.

• Journal of Korean Medicine Rehabilitation
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• v.31 no.1
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• pp.137-147
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• 2021

Objectives Domestic acupuncture research is being actively conducted in various fields. The aim of this study is to systematically analyze the current acupuncture randomized controlled trials (RCTs) conducted on healthy volunteers. Methods We searched RCTs by the search terms of (acupuncture & random & healthy) in 10 electronic databases and related journals. Then, we analyzed the characteristics and assessed the risk of bias by Cochrane tool. Results Finally, 49 acupuncture RCTs on health volunteers were included in our analysis. The purpose of research could be classified into five major categories: (1) checking the effects on physiological function, (2) comparing the effects of different acupuncture/acupuncture methods, (3) a study confirming improvement after inducing a specific condition, (4) a sham acupuncture study, and (5) a comparison of acupuncture sense. The Cochrane risk of bias was generally high, especially only 1 trial adopted allocation concealment (1/49, 2.0%) and 9 ones with assessor blinding (9/49, 18.4%). Conclusions Acupuncture RCTs in healthy subjects have confirmed various effects in various age/sex groups. However the research quality should be updated for future clinical research and to draw clear conclusion within rigorous methodology.

• Journal of The Korean Society of Integrative Medicine
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• v.10 no.2
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• pp.73-83
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• 2022

Purpose : Low back pain (LBP) is reported as a risk of experiencing musculoskeletal disorders due to muscle stiffness and hypokinetics. The lumbar spine in an unstable state causes imbalance and lumbar instability. Therefore, This study examined the effects of lumbar stabilization exercise and self-complex exercise program on pain, function, psychosocial level, static balance ability, and transverse abdominal muscle (TrA) thickness and contraction ratio in patients with lumbar instability. Methods : The design of this is a randomized controlled trial (RCT). Twenty-six LBP patients participated in this study. Screening tests were performed and assigned to the experimental group (n=13) and control group (n=13) using a random allocation program. Both groups underwent a lumbar stabilization exercise program. In addition, the experimental group implemented the self-complex exercise program. All interventions were applied three times per week for four weeks. The quadruple visual analog (QVAS), the Korean version of the Oswestry disability index (K-ODI), Korean version of fear-avoidance belief questionnaire (FABQ), static balance ability, TrA thickness, and contraction ratio were compared to evaluate the effect on intervention. Statistical significance was set at 𝛼=.05. Results : Both groups showed significant differences before and after the intervention in QVAS, K-ODI, FABQ, static balance ability, and TrA thickness in contraction (p<.05). In addition, significant differences in K-ODI and FABQ were observed between the experimental group and control group (p<.05). Conclusion : A lumbar stabilization exercise and self-complex exercise program resulted in reduced dysfunctions, psychosocial stability in patients with lumbar instability. Therefore, Lumbar stabilization exercise and self-complex exercise program for patients with lumbar instability are effective method with clinical significance in improving the function and psychosocial stability.

• Korean Journal of Acupuncture
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• v.28 no.4
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• pp.1-15
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• 2011

Objectives : The purpose of this study is to evaluate the feasibility of massive clinical research and to make a basic analysis on the effectiveness and safety of moxibustion treatment on knee osteoarthritis compared to usual care. Methods and Results : This study is a protocol for a pilot randomized controlled trial. Forty participants are assigned to the moxibustion group (n=20) and usual care group (n=20). Participants assigned to the moxibustion group receive moxibustion treatment on the affected knee(s) at six standard acupuncture points (ST36, ST35, ST34, SP9, Ex-LE04 and SP10) three times per week for four weeks (total of 12 sessions). Participants in the usual care group don't receive moxibustion treatment during the study period and follow-up are made on the 5th, 9th and 13th weeks after random allocation. Both groups are allowed to use any kind of treatment, including surgery, conventional medication, physical treatment, acupuncture, herbal medicine, over-the-counter drugs and other active treatments. Education material that explains knee osteoarthritis and current management options and self-exercise is provided for each group. The pain scale of the Korean Western Ontario and McMaster Universities Questionnaire (K-WOMAC) is the primary outcome measurement used in this study. Other subscales of the K-WOMAC, the Short-Form 36 Health Survey (SF-36), Beck Depression Inventory (BDI), Physical Function test, Patient Global Assessment, and Pain Numeric Rating Scale (NRS) are used as outcome variables to evaluate the effectiveness of acupuncture. Safety is assessed at every visit. Conclusions : The result of this trial will provide a basis for the effectiveness and safety of acupuncture treatment for knee osteoarthritis.

• The Korean Journal of Physiology and Pharmacology
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• v.16 no.4
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• pp.273-279
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• 2012

Busulfan is an antineoplastic agent with a narrow therapeutic window. A post-hoc population pharmacokinetic analysis of a prospective randomized trial for comparison of four-times daily versus once-daily intravenous busulfan was carried out to search for predictive factors of intravenous busulfan (iBu) pharmacokinetics (PK). In this study the population PK of iBu was characterized to provide suitable dosing recommendations. Patients were randomized to receive iBu, either as 0.8 mg/kg every 6 h or 3.2 mg/kg daily over 4 days prior to hematopoietic stem cell transplantation. In total, 295 busulfan concentrations were analyzed with NONMEM. Actual body weight and sex were significant covariates affecting the PK of iBu. Sixty patients were included in the study (all Korean; 23 women, 37 men; mean [SD] age, 36.5 [10.9] years; weight, 66.5 [11.3] kg). Population estimates for a typical patient weighing 65 kg were: clearance (CL) 7.6 l/h and volume of distribution (Vd) 32.2 l for men and 29.1 L for women. Inter-individual random variabilities of CL and $V_d$ were 16% and 9%. Based on a CL estimate from the final PK model, a simple dosage scheme to achieve the target $AUC_{0-inf}$ (defined as median AUC0-inf with a once-daily dosage) of 26.18 $mg/l{\cdot}hr$, was proposed: $24.79{\cdot}ABW^{0.5}mg$ q24h, where ABW represents the actual body weight in kilograms. The dosing scheme reduced the unexplained interindividual variabilities of CL and Vd of iBu with ABW being a significant covariate affecting clearance of iBU. We propose a new simple dosing scheme for iBu based only on ABW.

• Therapeutic Science for Rehabilitation
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• v.4 no.2
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• pp.63-71
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• 2015

Objective : The purpose of this study was to investigate the effects of vibratory stimulation applied to the left forearm on unilateral neglect in patients with stroke. Methods : The subjects were 11 unilateral neglect patients with stroke. They were divided into 2 groups; 6 experimental subjects and 5 control subjects. Both groups received standardized rehabilitation program and occupational therapy for the intervention of unilateral neglect in a day. In random order, line bisection test (LBT), Albert test, and star cancellation test (SCT) were conducted at baseline, the next day. During the process of all assessments of the next day, vibration stimulation was provided for the 6 subjects in the experimental group (EG), while the 5 subjects in CG carried out all assessments without vibration stimulation. Result : No significant differences were found between groups on any demographic variable or baseline assessments scores. In the next day, there was significant improvement in the EG for the LBT(p<0.05), Albert's test(p<0.05), and SCT(p<0.05). However, there was no significant improvement in the CG for the LBT(p<0.05), Albert's test(p<0.05), and SCT(p<0.05). Conclusion : These result indicate that vibratory stimulation has a positive effect on the unilateral neglect, and may be considered as alternative choice in clinical occupational therapy for reducing unilateral neglect.