• Title/Summary/Keyword: randomized clinical

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The Effects of distilled Astragali Radix Herbal Acupuncture on the Heart Rate Variability(HRV) (황인 약침이 정산인의 심박변이도(HRV)에 미치는 영향)

  • Lim, Sung-Taek;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.107-124
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    • 2008
  • We investigated the effects of distilled Astragali Radix Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Astragali Radix Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 61 healthy volunteers consisted of 31 subjects in experiment(distilled Astragali Radix Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 31 subjects in experiment group were injected distilled Astragali Radix Herbal Acupuncture at GB21(Kyonjong) and 30 subjects in control group were injected Normal Saline at GB21(Kyonjong). except of 2 subjects(in control group) who can't be measured and 10 subjects(6 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 25 subject in experiment group and 24 subject in control group are studied. We measured HRV by PolyG-I on 7 times : before and after injection per 5 minutes during 30 minutes. The SPSS 10.0 for windows was used to analyze the data and the paired t test(in group) and Student t test(between two groups) were used to verify the result. Results : I. After distilled Astragali Radix Herbal Acupuncture injection, SDNN is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute, Complexity is significantly low from 20 minute to 30minute. HRV index is significantly mgb for first 20 minute and from 25 minute to 30 minute, RMSSD is significantly high only from 15 minute to 20 minute. 2. HRV index of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, pNN50 of distilled Astragali Radix Herbal Acupuncture Group significantly decreased from 25 minute to 30 minute and RMSSD of distilled Astragali Radix Herbal Acupuncture Group significantly increased from 25 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Astragali Radix Herbal Acupuncture injection, Ln(TP) is significantly high from 5 minute to 10 minute and from 15 minute to 30 minute. Ln(VLF) is significantly high after 5 minute, Ln(LF) is significantly high after 15 minute and Ln(HF) is significantly high from 5 minute to 10 minute and 25 minute to 30 minute, but significantly low for first 5 minute and from 10 minute to 20 minute. Normalized LF is significantly high after 20 minute and Normalized LF is significantly low after 20 minute. Conclusions : The results suggest that distilled Astragali Radix Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system within normal range. This result is derived from that parasympathetic nervous system was continuously activated and sympathetic nervous system was activated a little later.

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Effects of Sweet Bee Venom Pharmacopuncture Combined with Korean Medicine Treatment for Acute Low Back Pain Syndrome Patient: A Case Report (급성 요통 증후군 환자에 대해 봉독약침요법을 병행한 한의학적 치료 효과: 증례보고)

  • Bong, Sung Min;Jang, Woo Seok;Kim, Kyung Ho
    • Korean Journal of Acupuncture
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    • v.37 no.1
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    • pp.54-62
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    • 2020
  • Objectives : Acute low back pain syndrome causes pain and poor quality of life. There are various studies of SBV (Sweet bee venom) pharmacopuncture, but few have identified the therapeutic effects for patients unable to walk due to acute back pain. This case series report three cases of acute low back pain syndrome treated with SBV pharmacopuncture combined with Korean Medicine (KM) treatments. Methods : Three acute low back pain syndrome patients with no other acute abnormalities in the imaging were treated by KM treatments including SBV pharmacopuncture, acupuncture, cupping, herbal medicine and physical therapy. The improvement of symptoms was evaluated using Numerical rating scale (NRS), Oswestry disability Index (ODI), EuroQol-5 dimension index (EQ-5D) and EuroQol-visual analogue scale (EQ-VAS). Results : Patients who were unable to walk due to acute back pain were able to walk. There were significant improvements of NRS, ODI, EQ-5D and EQ-VAS after treatment. The patients experienced an average 90% decrease in low back pain after inpatient KM treatment for about 8 days. NRS decreased by an average of 78.9%, ODI decreased by an average of 49.4%, and EQ-VAS increased by an average of 92.6%. In the case 1, EQ-5D decreased in all categories, but in the case 2, it decreased in all categories except for pain/discomfort and anxiety/depression, but in the case 3, it decreased in all categories except anxiety/depression. There was no serious side effect after treatment of SBV pharmacopuncture. Conclusions : KM treatments including SBV pharmacopuncture may be effective for acute low back pain syndrome patients. However, randomized controlled trials are needed in the future to confirm the clinical effects of these interventions.

A Systematic Review on the Reporting Quality of Acupuncture Treatment for Carpal Tunnel Syndrome (손목터널증후군에 사용된 침 치료 보고의 질 평가)

  • Hyun, Ji-Yoon;Shin, Joo-eun;Im, Chae-Jeong;Park, Ji-Yeun
    • Korean Journal of Acupuncture
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    • v.37 no.3
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    • pp.131-144
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    • 2020
  • Objectives : The aim of this study is to analyze the details of acupuncture treatment methods and the reporting quality of acupuncture on Carpal Tunnel Syndrome (CTS). Methods : Search was conducted in Pubmed, EMBASE, and Cochrane Library for acupuncture studies on CTS. The reporting quality of acupuncture treatment was assessed using the following guidelines: Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA) for analyzing the method of acupuncture treatment, Consolidated Standards of Reporting Trials (CONSORT) for analyzing study design and study process, and Risk of Bias (ROB) for analyzing bias. The number of reported items was calculated and evaluated as a proportion. The reported proportion of each study was classified into three grades: Grade A (% score ≥75), Grade B (50≤ % score <75), and Grade C (% score <50). Results : A total of 9 Randomized Controlled Trials (RCTs) were included in this study. All trials reported 12 items (66.67%) on average in STRICTA guidelines. Five studies were conducted with manual acupuncture and 3 studies were conducted with electroacupuncture. PC7 (Daereung) was most frequently used to treat CTS. In STRICTA guideline evaluation, 3 studies were classified as Grade A, 5 studies were classified as Grade B, and 1 study was classified as Grade C. In the CONSORT statement assessment, all trials reported an average of 20.56 items. Of the 9 RCTs, 6 studies were classified as Grade B and 3 studies were classified as Grade C. In ROB assessment, most studies showed a low (63.49%) or unclear (26.98%) risk of bias. The selective reporting bias and the incomplete outcome data bias were found to have the lowest risk of bias, and the allocation concealment of selection bias was found to have the most unclear risk of bias. Conclusions : Recent acupuncture studies on CTS showed moderate reporting quality. However, more detailed reports on acupuncture are still needed to establish more solid evidence of acupuncture treatment.

Comparison of Dental Biofilm Reduction between Rolling Method and Modified Stillman Method (회전법과 변형스틸맨법의 치면세균막 감소 효과 비교)

  • Han, Ye-Seul;Lim, Soon-Ryun;Cho, Young-Sik
    • Journal of dental hygiene science
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    • v.12 no.6
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    • pp.660-665
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    • 2012
  • The purpose of this study was to use basic data of dental hygiene curriculum by comparing the rolling method and modified stillman method. Plaque measurement method, Q-ray examination of the clinical utilization value shall review. True experimental design is randomized controlled trial to the intervention group and the control group. Measurements are plaque control record (PCR; O'Leary index) measurements and Quantitative Light induced fluorescnece Digital (QLFD) shooting as a pre-test was conducted. Intervention group is modified stillman method, control group is rolling method. Intervention after 5 weeks, PCR measurement and QLFD shooting was carried out as a post-test. Rolling method and modified stillman method plaque reduction did not differ. Intervention before and after the results of the comparison showed reduced plaque score after brushing law education. Also, Plaque reduction differences were more pronounced modified stillman method than rolling method. PCR and QLFD values of the correlation was not confirmed but SPS Score and the lower value of the ${\Delta}R$ value of the correlation. Plaque of maturity tooth that are not observed visually.

Impact of Transcranial Direct Current Stimulation Combined With Constraint-Induced Movement Therapy on Upper Limb Function in Chronic Stroke: A Systematic Review (뇌졸중 환자의 상지기능 향상을 위한 경두개 직류 자극과 강제 유도 운동 치료의 결합 중재 효과에 대한 체계적 고찰)

  • Kim, Sun-Ho
    • Therapeutic Science for Rehabilitation
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    • v.8 no.4
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    • pp.7-18
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    • 2019
  • Objective : This systematic review aimed to investigate the impact of transcranial direct current stimulation combined with constraint-induced movement therapy (CIMT) in patients with stroke Methods : PubMed and NDSL databases were employed to review literature published between January 2009 and December 2018. The main search terms were "Transcranial direct current stimulation" or "tDCS," "Constraint-induced movement therapy" or "CIMT," "Upper extremity function," "Upper limb," and "Stroke." Based on the inclusion and exclusion criteria, 6 articles were selected. Furthermore, intervention effects on upper extremity function, activities of daily living, and cortical activity were assessed. Results : The current intensity, application time, and protocol of the CIMT varied the between studies. However, the intervention procedures to perform CIMT immediately after transcranial direct current stimulation was the same. Transcranial direct current stimulation combined with CIMT was effective in improving upper limb function and activities of daily living in patients with stoke and had a significant effect on cerebral cortex activation. Conclusions : This study provides information on transcranial direct current stimulation combined with CIMT for use by clinical therapists. Further studies are needed to standardize the stimulation time, current intensity, and electrode attachment position. Furthermore, randomized controlled trials, including long-term follow up, are needed for larger populations using the most appropriate CIMT protocol.

A study on the minimal acupuncture using a modified guide tube for Korean female participants familiar with acupuncture therapy (침치료에 익숙한 한국의 여자 임상시험 피험자를 대상으로 한 침관 변형을 통한 Minimal acupuncture 경험)

  • Roh, Jin-Ju;Jung, Su-Kyoung;Choi, Min-Sun;Choi, Sun-Mi;Kim, Dong-Il
    • The Journal of Korean Obstetrics and Gynecology
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    • v.20 no.3
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    • pp.200-212
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    • 2007
  • Purpose: To find objective validity of minimal acupuncture using a modified guide tube as a method to verify the effect of acupuncture. Methods: Subjects of this study were participants of a randomized clinical trial which was practiced to verify the effect of acupuncture on postmenopausal hot flash. There were 2 arms of treatment, one's for active acupuncture group(AG) with manipulation and De qi, the other's for minimal acupuncture group(MG) using a modified guide tube which was designed to give minimal stimulation to the patient. After 8 weeks' treatment followed by 4 weeks' observation, participants were asked to fill in self-report forms on their education, previous experiences of acupuncture, original idea on the efficacy of acupuncture and recognition of blinding. Results: 19 participants of 26 in AG and 19 of 26 in MG completed the self-report form. There was no difference between AG and MG in their education(p=0.5976, Fisher exact test) and previous experiences of acupuncture(p=0.9999, Fisher exact test). In their original ideas on the efficacy of acupuncture, most of AG and MG respondents have been thought that acupuncture is very effective or quite effective, and there was no difference between 2 groups(p=0.5065). 16 of 19 in AG and 14 of 19 in MG believed that they underwent more effective way, there was no statistical difference between 2 groups(p=0.6928, Fisher exact test). Participants believed in undergoing more effective way not because they recognized treatment method, but they were satisfied with the effectiveness of treatment retrospectively. Conclusion: As the result of this study, these authors suggest that minimal acupuncture using a modified guide tube is acceptable as a method to verify the effect of acupuncture in acupuncture-familiar Korean culture. Also further studies on the stimulation-specific effect of minimal acupuncture are demanded.

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A Review on Domestic Study Trends on Hot Flush in Menopausal Women with Traditional Korean Medicine (갱년기 여성의 안면홍조 증상에 대한 국내 한의학 연구 동향 분석)

  • Hong, Noo-Ri;Jang, Yeong-Suk;Yang, Su-Hyeon;Choi, Yun-Young;Oh, Da-Yoon;Lee, Soo-Jin;Namgoong, Jin;Kim, Jin-Hwan
    • The Journal of Korean Obstetrics and Gynecology
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    • v.33 no.1
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    • pp.86-103
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    • 2020
  • Objectives: The purpose of this study is to analyse the domestic trends of Traditional Korean Medicine on Hot flush in menopausal women. Methods: We searched six databases and selected relevant papers according to the criteria. Results: 12 papers included case report, literature review, randomized controlled clinical trials (RCTs), Non-RCTs, and retrospective chart analysis study design. 1. The daily diary, Kupperman's Index, Menopause Rating Scale, Menopause-specific Quality of Life Questionnaire, Digital Infrared Thermographic Imaging were used as a measure of the symptoms of hot flush. 2. There were significant correlations between Thermographic images, Pulse energy, Lifestyle Habits, Low frequency power/High frequency power (LF/HF) ratio and certain items of Menopausal Symptoms Measurement. 3. The case report using Er-Xian decoction and Hwangryunhaedoktang-Gamibang showed significant effect. 4. Domestic RCT studies using herbal or acupuncture treatments showed a significant value of 3.4 on average in the quality assessment conducted in the study. However, the number of domestic studies included was five, which is not enough compared to foreign countries. Conclusions: This study examined domestic research trends on hot flushes of menopausal women and found that various evaluation tools and diagnostic methods were applied. It is necessary to conduct various RCT studies in Korea, where the number of studies is insufficient compared to overseas.

The effects of hard and soft tissue grafting and individualization of healing abutments at immediate implants: an experimental study in dogs

  • Thoma, Daniel S.;Jung, Ui-Won;Gil, Alfonso;Kim, Myong Ji;Paeng, Kyeong-Won;Jung, Ronald E.;Fickl, Stefan
    • Journal of Periodontal and Implant Science
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    • v.49 no.3
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    • pp.171-184
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    • 2019
  • Purpose: To evaluate the effects of intra-alveolar socket grafting, subepithelial connective tissue grafts, and individualized abutments on peri-implant hard and soft tissue outcomes following immediate implant placement. Methods: This randomized experimental study employed 5 mongrel dogs, with 4 sites per dog (total of 20 sites). The mesial roots of P3 and P4 were extracted in each hemimandible and immediate dental implants were placed. Each site was randomly assigned to 1 of 4 different treatment groups: standardized healing abutment (control group), alloplastic bone substitute material (BSS) + standardized healing abutment (SA group), BSS + individualized healing abutment (IA group), and BSS + individualized healing abutment + a subepithelial connective tissue graft (IAG group). Clinical, histological, and profilometric analyses were performed. The intergroup differences were calculated using the Bonferroni test, setting statistical significance at P<0.05. Results: Clinically, the control and SA groups demonstrated a coronal shift in the buccal height of the mucosa ($0.88{\pm}0.48mm$ and $0.37{\pm}1.1mm$, respectively). The IA and IAG groups exhibited an apical shift of the mucosa ($-0.7{\pm}1.15mm$ and $-1.1{\pm}0.96mm$, respectively). Histologically, the SA and control groups demonstrated marginal mucosa heights of $4.1{\pm}0.28mm$ and $4.0{\pm}0.53mm$ relative to the implant shoulder, respectively. The IA and IAG groups, in contrast, only showed a height of 2.6mm. In addition, the height of the mucosa in relation to the most coronal buccal bone crest or bone substitute particles was not significantly different among the groups. Volumetrically, the IA group ($-0.73{\pm}0.46mm$) lost less volume on the buccal side than the control ($-0.93{\pm}0.44mm$), SA ($-0.97{\pm}0.73mm$), and IAG ($-0.88{\pm}0.45mm$) groups. Conclusions: The control group demonstrated the most favorable change of height of the margo mucosae and the largest dimensions of the peri-implant soft tissues. However, the addition of a bone substitute material and an individualized healing abutment resulted in slightly better preservation of the peri-implant soft tissue contour.

Effects of Transcranial Direct-Current Stimulation Therapy on Primary Chronic Insomnia: A Proof-of Concept Clinical Trial (일차성 만성불면증 환자에서 경두개 직류전기자극법 치료 효과: 개념 증명 연구)

  • Jun, Jin-Sun;Kim, Tae-Joon;Koo, Sun A;Park, Ji-Sook;Kim, Keun Tae;Yang, Tae-Won;Lim, Jung-Ah;Byun, Jung-Ick;Sunwoo, Jun-Sang;Jung, Ki-Young
    • Journal of Sleep Medicine
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    • v.15 no.2
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    • pp.37-42
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    • 2018
  • Objectives: To assess the effect and safety of transcranial direct-current stimulation (tDCS) in primary chronic insomnia. Methods: A one-month, double-blind, randomized, sham-controlled trial was performed. A total of 7 patients with primary chronic insomnia received tDCS using anodal (n=3), cathodal (n=2), or sham stimulation (n=2). They were followed up at 1 week and 1 month after treatment. The primary outcome measures included improvement in total sleep time (TST), sleep latency (SL), and sleep efficiency (SE) at 1 month follow-up. Results: TST and SE were improved with tDCS at 1 month follow-up in all patients (100%) of the anodal group, one (50%) of the cathodal group, and one (50%) of the sham group. tDCS improved SL at 1 month follow-up in two patients (67%) of the anodal group, one (50%) of the cathodal group, and none (0%) of the sham group. With respect to adverse events, transient itching sensation occurred in one patient of the anodal group. None of the other groups reported adverse events. Conclusions: Our results suggest that tDCS may be effective and safe for treatment of primary chronic insomnia. A larger controlled study needs to be further investigated.

Analysis of the Numeric Rating Scale (NRS) Used in Clinical Studies Based on Randomized Controlled Studies (임상연구에서 사용되고 있는 NRS에 대한 분석 : 무작위대조군연구를 중심으로)

  • Lee, Chan;Cho, Im-hak;Heo, Gi-yoon;Kang, Hee-kyung;Kim, Min-hwa;Han, Chang-woo;Kim, So-yeon;Choi, Jun-yong;Park, Seong-ha;Yun, Young-ju;Hong, Jin-woo;Kwon, Jung-nam;Lee, In
    • The Journal of Internal Korean Medicine
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    • v.42 no.4
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    • pp.510-531
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    • 2021
  • Objectives: The purpose of this study was to review the status of numeric rating scale (NRS) usage and suggest the potential for use in multicenter retrospective studies of various diseases. Methods: Articles published from 2011 to 2021 that used the keywords "NRS", "Multi-center", and "RCT" were identified in foreign databases, including EMBASE, PubMed, CENTRAL. The articles were analyzed according to their use of "NRS" by symptoms and by disease group using the major classifications of the Korean Standard Classification of Diseases (KCD-7). Results: Classification by symptom in a total of 288 articles illustrates that the NRS was not only commonly used in pain evaluation but also for non-pain symptoms. In usage with non-pain symptoms, chief complaint of patients was the most common at 79%, and other factors included treatment satisfaction, evaluation of daily life, and sleep quality. In disease classification according to the KCD-7, the NRS was commonly used in connection with musculoskeletal and connective tissue diseases but was also utilized in various other disease groups. Conclusions: This study confirms usage of the NRS in multi-center RCTs, as the NRS was widely used in all types of diseases and symptoms. Considering the result and the advantages of the NRS, it is recommended for use as a daily evaluation tool for the collection of common data in multicenter retrospective studies.