• Journal of Acupuncture Research
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• v.41 no.2
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• pp.107-114
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• 2024

Background: Low back pain (LBP) is a common musculoskeletal disorder worldwide, with a lifetime prevalence of up to 80%. Among nonsurgical treatments for chronic LBP, Korean medicine treatments are highly preferred, and pharmacopuncture therapy combining acupuncture and herbal medicine is widely used. However, no evidence-based study has focused on the use of various types of pharmacopuncture. Methods: The pragmatic randomized controlled clinical trial will include 44 participants; recruitment will start in July 2023. All participants will receive integrated Korean medicine treatment including acupuncture, cupping, and infrared therapy, and the intervention group will also receive pharmacopuncture. After 16 treatment sessions, twice a week for 8 weeks, follow-up assessments will be performed at week 9. As a pragmatic randomized controlled clinical protocol, the type, dose, and acupoints of acupuncture and pharmacopuncture are not determined in advance but are selected and recorded according to the clinical judgment of the Korean medicine doctor. Results: The primary outcome will be measured using a visual analog scale score, and the secondary outcomes include the Oswestry disability index, patient global impression of change, no worse than mild pain, and range of motion. Safety will be assessed by examining participants' self-reported adverse events and vital signs and conducting blood tests before and after the test. Conclusion: This study aims to provide clinical evidence of the effectiveness and safety of pharmacopuncture for chronic LBP.

• Clinical Nutrition Research
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• v.13 no.1
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• pp.22-32
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• 2024

Rheumatoid arthritis (RA) is a systemic inflammatory autoimmune disorder with widespread synovitis. Isoflavones, the main active component of soy, have been reported to have potent anti-inflammatory effects; the previous RA animal models showed the promising effect of soy supplementation. We aimed to evaluate the effect of soy bread on inflammatory markers and lipid profiles in RA patients. The present study was designed as a randomized controlled trial. RA patients were randomly allocated to obtain soy bread (n = 22) or placebo bread (n = 22) for 8 weeks. Fasting serum levels of lipid profile, total antioxidant capacity (TAC), tumor necrosis factor-α (TNF-α), C-reactive protein (CRP), and DAS28 were checked. Findings showed that there were no significant differences between the two groups in physical activity and dietary intake at the beginning of the study and the end of the study. There were no significant differences between the two groups in measured lipid profile markers, including high-density lipoprotein, low-density lipoprotein, total cholesterol, triglyceride, and very low-density lipoprotein, at the end of the trial. In addition, TAC and CRP also were not significant at the end of the trial between the 2 groups (0.66 and 0.12, respectively). However, the serum levels of TNF-α reduced significantly in the soy bread group at the end of the intervention (p < 0.000) and compared with the control group (p < 0.019). Soy bread consumption only decreased circulating TNF-α serum concentration. Other outcome measures were not changed following supplementation. Future long-term, well-designed studies are needed to confirm these findings.

• Korean Journal of Acupuncture
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• v.24 no.3
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• pp.33-45
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• 2007

Background : Hot flushes are general postmenopausal symptoms which about 75% of climacteric women undergo. They affect hotness, perspirations, systemic weakness, panic disorders, insomnia. Acupuncture is effective in alleviating hot flushes in practice. Assessment effectiveness and safety of acupuncture in hot flushes would be needed through multi-center trial. Objectives : Purpose of this study is to develope the protocol of effects of acupuncture on hot flushes, a postmenopausal symptom in climacteric women. Methods & Results : It will be a multi-centered, randomized, sham controlled, comparative trial. It will be performed by Good Clinical Practice after approval of Institutional Review Board. Selection criteria will be set according those of FDA above moderate degree. There will be a notice on concomitant medication, other herbs, dietary supplements. Superficial needling on sham points will be used for control group. Treatment period will be 8 weeks with 12 weeks' follow up. Some questionnaire scale will be used as the primary and secondary outcome. Conclusions : The clinical trials based on this protocol will be performed.

• Journal of Physiology & Pathology in Korean Medicine
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• v.34 no.3
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• pp.117-125
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• 2020

The purpose of this review is to confirm whether Soyo-san (Xiaoyao-san) and its modifications is effective on alleviating clinical symptoms in chronic fatigue syndrome (CFS) patients. We collected clinical trials (randomized controlled trial, quasi-randomized controlled trial, controlled clinical trial) to investigate the effects of Soyo-san and its modifications on general symptoms, fatigue, depression and anxiety in CFS patients. The databases used for data retrieval were Pubmed, Central Cochrane, Embase, CNKI, CQVIP, Wanfang, CiNii, OASIS, RISS, and Koreamed. We performed selection/exclusion process from the found studies to conform with prespecified criteria, and assessed the final included trials according to the Cochrane risk of bias tool. The included studies were classified based on the interventions in experimental and control group. Eight randomized controlled trials and one controlled clinical trial (total 921 participants) were eligible and their results were synthesized in the meta analysis. The synthesis showed a considerable effect of Soyo-san and its modifications on improvement of general symptoms (relative risk 0.27 [95% CI 0.19 to 0.39], Z=7.03, P<0.00001; I2=0%) and fatigue severity (SMD -1.20 [95% CI -1.46 to -0.93], Z=8.78, P<0.00001; I2=52%) in CFS patients, while Effect on depression and anxiety were inconclusive. We found that Soyo-san and its modifications were effective for improvement of general symptoms and fatigue severity in CFS post-treatment.

• Journal of Acupuncture Research
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• v.30 no.5
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• pp.117-123
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• 2013

Objectives : The purpose is to review large-scale clinical researches, the acupuncture randomized trials(ART) and the acupuncture in routine care(ARC), concerning efficacy and effectiveness of acupuncture performed in Germany. Methods and Results : We have reviewed the studies that were searched by keyword 'acupuncture' as the title and'Witt CM' as one of the main authors in PubMed. Sixteen clinical reports focused on the ART and ARC studies were analyzed among all thirty six were searched. Six studies were related with the ART and eight were focused on the ARC, and other two were on both. Finally, across all researches except osteoarthritis of knee trials in the ART, compared the acupuncture group with the control were significantly improved. On the other hand, ARC showed that additional acupuncture plus routine care was more effective than routine care alone and the response to treatment of the non-randomized group did not differ the one of the randomized acupuncture group. Conclusions : The results may suggest that acupuncture treatment has obvious clinical effectiveness. These results are expected to inspire domestic research and clinical applications in Korea, and more rigorous research on the efficacy of acupuncture should be guaranteed.

• Asian Pacific Journal of Cancer Prevention
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• v.13 no.12
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• pp.6337-6342
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• 2012

Background: Clinical trials on cancer subjects have one of the highest dropout rates. Barriers to recruitment range from patient-related, through institutional-related to staff-related factors. This paper highlights the low response rate and the recruitment barriers faced in our Qigong exercises trial. Materials and Method: The Qigong trial is a three-arm trial with a priori power size of 114 patients for 80% power. The University Malaya Medical Centre database showed a total of 1,933 patients from 2006-2010 and 751 patients met our inclusion criteria. These patients were approached via telephone interview. 131 out of 197 patients attended the trial and the final response rate was 48% (n=95/197). Results: Multiple barriers were identified, and were regrouped as patient-related, clinician-related and/or institutional related. A major consistent barrier was logistic difficulty related to transportation and car parking at the Medical Centre. Conclusions: All clinical trials must pay considerable attention to the recruitment process and it should even be piloted to identify potential barriers and facilitators to reduce attrition rate in trials.

• 대한위암학회:학술대회논문집
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• 2005.04a
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• pp.19-19
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• 2005

• Journal of the Korean Data and Information Science Society
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• v.22 no.3
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• pp.605-612
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• 2011

In multi-center randomized clinical trial the treatment eect may be changed over centers. It is thus important to investigate the heterogeneity in treatment eect between centers. For this, uncorrelated random-eect models assuming independence between random-eect terms have been often used, which may be a strong assumption. In this paper we propose a correlated frailty modelling approach of investigating such heterogeneity using the hierarchical-likelihood method when the outcome is time-to-event. In particular, we show how to construct a proper prediction interval for frailty, which explores graphically the potential heterogeneity for a treatment-by-center interaction term. The proposed method is illustrated via numerical studies based on data from the design of a multi-center clinical trial.

• Journal of Oriental Neuropsychiatry
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• v.20 no.4
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• pp.79-89
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• 2009

Objectives : To address suitable method for designing clinical trial intervening Traditional Korean Herbal Medicine on General anxiety disorder through the recent clinical research in Chinese Herbal Medicine. Methods : Randomized, controlled trials(RCTs) of treatment of general anxiety disorder intervening herbal medicine were searched through CNKI databases. We examined several item of studies and evaluated using Jadad scale. We searched articles in CNKI with the key word "General anxiety disorder or 廣範性焦慮症", among them we selected the clinical trial studies related with herbal medicine except for case reports, studies of acupuncture therapy or west medicines. Results : 11 RCT studies of herbal medicine met inclusion criteria. The Studies used CCMD-3, HAMA as inclusion tool and mainly HAMA as a evaluation tool. Studies were progressed for 2-8 weeks, mostly used various positive control. Experiment medicine were mainly 理氣劑, 安神劑. In most studies, experiment group made similar or higher efficacy in comparison with control group. Mean Jadad score of studies was $1.3{\pm}0.67$, and only one study was double-blinded among 11 studies. Conclusions : RCT studies on general anxiety disorder of chinese herbal medicine tend to focus on investigating effect of herbal medicine through setting positive control group with CCMD-3 and HAMA. But, most studies had low quality of trial, for lack of pattern identification, evaluation and inclusion tool of chinese medicine. Clinical trials of general anxiety disorder should provide good quality by randomization, double-blinding, and multi-site trial.

• Journal of Periodontal and Implant Science
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• v.51 no.3
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• pp.199-212
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• 2021

Purpose: This randomized clinical placebo-controlled trial was conducted to evaluate the effectiveness of Lactobacillus reuteri as a probiotic in guided pocket recolonization (GPR) for the treatment of chronic periodontitis (CP) adjunctive to scaling and root planing (SRP). Methods: Forty-eight CP patients were randomly assigned to 3 treatment groups: group 1 (SRP+placebo), group 2 (SRP+single application of probiotic), and group 3 (SRP+incremental application of probiotic). Clinical parameters were evaluated at baseline and at 8, 12, and 24 weeks, whereas biochemical parameters were measured at baseline and 12 weeks. Results: At 24 weeks, the probing pocket depth and clinical attachment level improved in all 3 groups from baseline with no significant intergroup differences; however, a statistically significant difference was observed in localized plaque and gingival scores between groups 1 and 3 (P<0.05). At 12 weeks, matrix metalloproteinase-8 (MMP-8), nitric oxide (NO), and gingipains-R (Rgps) levels improved in all 3 groups, with statistically significant differences between groups 1 and 3 for MMP-8 and NO (P<0.05), but no difference for Rgps levels. Conclusions: Within its limitations, the results of this study show that incremental 3-time application of L. reuteri as a probiotic led to improvements in clinical and biochemical parameters. This protocol can be a useful adjunct to SRP in the non-surgical management of CP.