• Journal of Haehwa Medicine
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• v.15 no.1
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• pp.41-45
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• 2006

Aims: This overview summarizes the existing evidence on acupuncture for cancer-related pain. Methods: Literature searches were conducted in 7 databases. All clinical studies of acupuncture, electroacupuncture, ear acupuncture and transcutaneous electrical nerve stimulation (TENS) in cancer patients with the main outcome measure of pain were included. Results: Of the 8 studies included, one high quality randomized clinical trial (RCT) of ear acupuncture showed statistically significant pain relief in comparison with placebo ear acupuncture. All the other studies were either non-blinded (n = 2) or uncontrolled clinical trials (n = 5). Most investigations suffered from methodological flaws such as inadequate study design, poor reporting of results, small sample size and overestimation of the results. Conclusions: The current evidence does not support the use of acupuncture as an adjunctive analgesic method for cancer patients. Only one high quality RCT showed promising results thus warranting further investigation into this under-researched area.

• Korean Journal of Oriental Medicine
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• v.13 no.3
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• pp.97-103
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• 2007

The object of this study is to evaluate confounding effect of sleeping behavior on heart rate variability (HRV) in healthy volunteers during a randomized clinical trial. From 6 healthy volunteer, we acquired circadian electrocardiography(ECG) with a Holter monitoring device(DigiTrak Plus, Philips). The compatible analytical program, Zymed, was used for calculation of RR intervals of 24h ECG signal. Then, we generated HRV signals and calculated 9 HRV parameters in time domain and frequency domain for every 30 minute with Matlab 6.x software. We also encoded participants' activities as follows; stable condition(1), sleeping behavior(2), eating behavior(3), and undefined condition(4). Using SPSS 12.0, we tested if there was any difference between HRV parameters of day-time and night-time and between those of a subject in stable condition and in sleeping behavior. As a result, one of the most important parameter-LF/HF ratio, which indicates the autonomic balance between sympathetic and parasympathetic nervous systems, as same the other parameters, showed large inter-individual variations in circadian profiles. And, the mean LF/HF ratio of each participant was different between in stable condition and in sleeping behavior (p<.05). Consequently, the effect of sleeping behavior must be considered when one or more of HRV parameters, especially LF/HF ratio, are used as assessment index in clinical studies.

• Journal of Periodontal and Implant Science
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• v.44 no.6
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• pp.280-287
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• 2014

Purpose: The purpose of this randomized single-blind controlled trial was to elucidate the clinical and antimicrobial effects of daily phototherapy (PT) as an adjunct to scaling and root planing (SRP) in patients with chronic periodontitis. Methods: The study was conducted from December 2013 to May 2014 at Ewha Womans University Mokdong Hospital, Seoul, Korea. Forty-one patients with mild to moderate chronic periodontitis were randomly divided into two therapeutic groups in a 1:1 ratio: SRP+PT and SRP (control) groups. All participants underwent full-mouth SRP. PT was performed thrice a day for a month by using electric toothbrushes with embedded light-emitting diodes. Plaque index, gingival index, probing pocket depth (PPD), clinical attachment level (CAL), and bleeding on probing were assessed before (baseline) and four weeks after (follow-up) the treatment. Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia, Treponema denticola, Prevotella intermedia, Fusobacterium nucleatum, Parvimonas micra, Campylobacter rectus, Eikenella corrodens, Streptococcus mutans, and Streptococcus sobrinus levels were detected by a real-time polymerase chain reaction at the same points in time. Results: The clinical parameters improved in both the groups. At the follow-up assessment, PPD was significantly decreased in the SRP+PT group (P=0.00). Further, PPD and CAL showed significantly greater changes in the SRP+PT group than in the SRP group (PPD, P=0.03; CAL, P=0.04). P. gingivalis and T. forsythia levels decreased in this group, but no significant intergroup differences were noted. Conclusions: Adjunctive PT seems to have clinical benefits, but evidence of its antimicrobial effects is not sufficient. Long-term studies are necessary to develop the most effective PT protocol and compare the effectiveness of PT with and without exogenous photosensitizers.

• The Journal of Pediatrics of Korean Medicine
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• v.37 no.3
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• pp.75-93
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• 2023

Objectives We aimed to analyze the registration status of interventional clinical trials in children and adolescents with chronic cough. Methods All interventional clinical trials registered up to 3 July, 2023 on the international clinical trial registry platform (ICTRP) of the World Health Organization (WHO) were analyzed. Information was extracted including study design, interventions, inclusion and exclusion criteria, and outcome indicators. Results A total of 18 interventional clinical trials were analyzed. For study design, multicentre trials, randomized allocation, parallel group design and phase 4 trials were the most frequently reported. Blinding was used in 44.4% and informed consents were obtained from 61.1%. For intervention, drugs were used in 61.1%, using placebo control group in 27.8%. Quality of life questionnaires were most frequently reported in 50% as the primary outcome, and adverse events were the most as the secondary outcome. In most cases, the assessment timepoints were after two weeks. Conclusions Based on the characteristics of clinical trial design analyzed in this study, it is necessary to design traditional Korean medicine clinical trials with improved quality and accuracy of information.

• Journal of Periodontal and Implant Science
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• v.48 no.4
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• pp.236-250
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• 2018

Purpose: Resorption of the alveolar bone is an unavoidable consequence of tooth extraction when appropriate alveolar ridge preservation (ARP) measures are not taken. The objective of this trial was to test the hypothesis that dimensional changes in the alveolar bone after tooth extraction would be reduced by inserting an equine collagen membrane and a collagen cone to fill and seal the alveolus (as ARP), in comparison to extraction with untreated alveoli. Methods: In this randomized clinical trial, 31 patients were directly treated with the collagen material after extraction of a tooth from the maxilla (the ARP group). Twenty-nine patients served as the control group. After extraction, no further treatment (i.e., no socket preservation measures) was performed in the control group. Changes in the alveolar process immediately after extraction and after an 8 (${\pm}1$)-week healing period were evaluated 3-dimensionally. Blinded analyses were performed after superimposing the data from the digitalized impressions and surfaces generated by cone-beam computed tomography. Results: Both the ARP and control groups showed a reduction of bone in the alveolar area after tooth extraction. However, significantly less bone resorption was detected in the clinically relevant buccal region in the ARP group. The median bone reduction was 1.18 mm in the ARP group and 5.06 mm in the control group (P=0.03). Conclusions: The proposed hypothesis that inserting a combination material comprising a collagen cone and membrane would lead to a difference in alveolar bone preservation can be accepted for the clinically relevant buccal distance. In this area, implantation of the collagen material led to significantly less alveolar bone resorption. German Clinical Trials Register at www.drks.de, DRKS00004769.

• The Journal of Korean Medicine
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• v.41 no.3
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• pp.205-220
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• 2020

Objectives: The aim of this review is to assess the clinical benefit of chuna for managing symptoms in chronic fatigue syndrome (CFS) Methods: We searched eligible studies from the following 11 databases with no language restriction: Pubmed, CENTRAL, Embase, CNKI, CQVIP, Wanfang, CiNii, OASIS, RISS and Koreamed. We selected randomized controlled trial (RCT), quasi-randomized controlled trial (Quasi-RCT) and controlled clinical trial (CCT) in which patients with chronic fatigue syndrome were treated with chuna. The results of the included studies were synthesized through meta-analysis, and their risk of bias were also assessed. Results: We searched 914 potentially relevant studies, and only 20 studies were selected for this systematic review. Meta-analysis showed that chuna was more effective in improving general symptoms (n=291, RR 0.19 [95% CI 0.11 to 0.32], Z=6.08, p<0.00001, I2=0%), fatigue (n=487, SMD -0.95 [95% CI -1.19 to -0.71], Z=7.76, p<0.00001, I2=37%) and sleep disorder (n=139, SMD -0.58 [95% CI -0.92 to -0.24], Z=3.36, p=0.0008, I2=0%) compared to health supplements or usual care. When chuna was used as an added intervention, it was more effective in improving general symptoms(n=729, RR 0.25 [95% CI 0.15 to 0.42], Z=5.19, p<0.00001, I2=0%) and fatigue severity alone(n=217, SMD -1.21 [95% CI -1.53 to -0.89], Z=7.45, p<0.00001, I2=15%) compared to control. Conclusion: We found that chuna was beneficial for improving severity of general symptoms and fatigue at post treatment in CFS patients.

• Journal of Korean Medicine Rehabilitation
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• v.30 no.1
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• pp.105-113
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• 2020

Objectives Excess weight and obesity are a crucial public health problem worldwide and are considered as the main cause of many chronic diseases. The present study evaluated the effects of Aronia melanocarpa extract (AMEX) supplementation on body compositions in overweight or obese people. Methods This randomized, double-blind, placebo-controlled clinical trial was carried out on 66 healthy overweight or obese peoples. The eligible subjects were divided into AMEX and placebo supplement treatment for 12 weeks. Anthropometrics, body composition (dual-energy X-ray absorptiometry), and blood analysis were performed preand post intervention. Results We observed significant reductions in the body weight and body mass index in both groups; however, the decrease was higher in the AMEX group. Body fat mass and percent body fat showed a tendency to decreases after AMEX supplementation. No clinically significant changes were observed for any safety parameter. Conclusions In conclusion, the data of this trial indicate that AMEX were not effective in reducing body compositions, but as a safe supplement, it may help weight loss in overweight or obese people.

• Journal of Korean Medicine Rehabilitation
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• v.29 no.1
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• pp.63-73
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• 2019

Objectives The purpose of this study is to evaluate the safety of Ojeok-san extract powder and soft extract in healthy male volunteers. Methods Randomized controlled, cross over study was carried out in healthy male volunteers. Total 27 of 31 subjects meeting the inclusion criteria were enrolled and three subjects for waiting were included. To each group 12 subjects were randomly allocated by random number table. Group A took the extract powder in the first period and then took the soft extract in the second period. Group B took the medicine in the opposite order. Trial was conducted through two times of hospitalizations and all subjects had a seven-days of wash out period. Vital sign and laboratory test were checked before and after the medication. The mean difference of safety evaluation variables were analyzed by paired t-test (p<0.001) or wilcoxon signed rank test (p<0.05). The mean difference between two groups were analyzed by independent t-test (p<0.05) or Mann whitney test (p<0.05). Results As a result of all data related to vital sign and laboratory test in both group, There were no significant differences associated with the clinical trial drug between before and after the medication. And there was no adverse event associated with the clinical trial drug. Conclusions Both Ojeok-san extract powder and soft extract were found to be safe for healthy male volunteers.

• Journal of Acupuncture Research
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• v.39 no.3
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• pp.202-212
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• 2022

Background: The aim of this study was to evaluate the effectiveness and safety of Cheong-A-Won Gagambang (JCE003) treatment for degenerative knee osteoarthritis. Methods: This was a single-center, randomized, double-blind, placebo-controlled pilot clinical trial. There were 36 adults with degenerative knee osteoarthritis who were randomly allocated into JCE003 1,000 mg, JCE003 2,000 mg, or the placebo group (in a 1:1:1 ratio). The participants received 12 weeks of treatment and had scheduled tests every 6 weeks. The primary outcomes were measured using the Korean Western Ontario and McMaster Universities scale, and the secondary outcomes were measured using the visual analog scale, European quality of life-5-dimensions, patient global impression of change, C-reactive protein, and erythrocyte sedimentation rate. Changes between baseline scores and scores following study completion were analyzed. Results: There were 29 participants whose data were analyzed in this study. The change of Korean Western Ontario and McMaster Universities, visual analog scale, European quality of life-5-dimensions scores showed significant improvement in the JCE003 1,000 mg group. The change of patient global impression of change was significantly improved in the placebo group. There were 14 adverse events, but there was no clinically significant relationship with the intake of JCE003 compared with the placebo. Conclusion: Taking JCE003 may be effective at improving knee pain in patients with degenerative knee osteoarthritis and appears to be safe. Based on this study, the concentration and feasibility of the test group may be used when conducting a large-scale clinical trial of degenerative knee osteoarthritis in the future.

• Journal of the Korean Association of Oral and Maxillofacial Surgeons
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• v.48 no.6
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• pp.356-362
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• 2022

Objectives: A single-blinded randomized controlled trial was designed to compare and evaluate the effectiveness of the periotome and piezotome as aids for atraumatic extraction and its sequalae. Materials and Methods: The study sample comprised 48 teeth, equally allotted to the piezotome or periotome groups by random allocation, in participants aged 19-62 years. All samples in both groups had either complete tooth structure or intact roots without crowns and had mobility ≤grade II. Clinical parameters of operative duration, presence or absence of gingival laceration, reported operative and postoperative pain, and intake of analgesics following extraction were recorded. IBM SPSS software package version 22 was used for data entry and analysis. Results: The mean operation time was significantly (P≤0.05) longer in the piezotome group than in the periotome group. However, fewer gingival lacerations were observed with use of a piezotome than with a periotome, although no significant difference was observed. The piezotome group reported significantly (P≤0.05) higher visual analog scale (VAS) pain scores during the procedure and non-significantly higher scores thereafter until the third postoperative day. In the piezotome group, the dosage of analgesic was higher, although the periotome group had a higher percentage of participants who used analgesics postoperatively; however, these differences were not statistically significant. Conclusion: The present clinical trial favors the use of periotome over piezotome for atraumatic extraction due to shorter operating time, lower postoperative VAS pain scores, and lower dosage of analgesics despite the superior ability of the piezotome to prevent gingival laceration.