• Title/Summary/Keyword: randomized clinical controlled trial

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A Clinical Study of Acupuncture with Aromatherapy on Poststroke Depression Patients (중풍후우울증 환자에 대한 향기침요법의 임상적 연구)

  • Chung, Sae-Yun;Hwang, Jae-Woong;Kim, Seok-Min;Jung, Jae-Han;Choi, Chang-Min;Jung, Woo-Sang;Moon, Sang-Kwan;Cho, Ki-Ho;Kim, Young-Suk;Sun, Jong-Joo
    • The Journal of Internal Korean Medicine
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    • v.27 no.2
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    • pp.480-487
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    • 2006
  • Objectives : In this study we investigated BDI(Beck Depression Inventory) improvement of poststroke depression Patients who took the acupuncture with aromatherapy, in order to examine its capacity as a new treatment and to establish a primary data for further studies of developments of diverse Practical acupunctures. Methods : Physicians applied the acupuncture with aromatherapy every day for two weeks. We had evaluated baseline characteristics and BDI of all Patients, and revaluated BDI and examined the side effects two weeks later. The qualified Patients were classified into two groups, depression group (more than 10 points and 10 in BDI) and non-depression group (less than 10 points in BDI) according to the baseline BDI. Results : The study was completed with 27stroke patients. The acupuncture with aroma therapy was applied in 18 post-stroke depression patients and 9 non-depression patients for 2 weeks. And the result showed that the BDI scores in the depression group decreased to $16.5{\pm}11.1$ after the treatment (compared to $24.4{\pm}11.5$ before the treatment). so proved the significant effect on post-stroke depression of the acupuncture. On the other hand. the scores in the non-depression group increased to $9.2{\pm}9.5$ (compared to $3.3{\pm}3.0$). Conclusions : The acupuncture with aromatherapy applied on post-stroke depression patients showed the effect of BDI improvement. Further researches are needed to evaluate the distinct functional mechanism of acupuncture with aromatherapy, and to estimate its effectiveness by well-designed randomized controlled trial.

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Polydeoxyribonucleotide Improves Peripheral Tissue Oxygenation and Accelerates Angiogenesis in Diabetic Foot Ulcers

  • Kim, Seoyoung;Kim, Junhyung;Choi, Jaehoon;Jeong, Woonhyeok;Kwon, Sunyoung
    • Archives of Plastic Surgery
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    • v.44 no.6
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    • pp.482-489
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    • 2017
  • Background Polydeoxyribonucleotide (PDRN) is known to have anti-inflammatory and angiogenic effects and to accelerate wound healing. The aim of this study was to investigate whether PDRN could improve peripheral tissue oxygenation and angiogenesis in diabetic foot ulcers. Methods This was a prospective randomized controlled clinical trial. Twenty patients with a non-healing diabetic foot ulcer were randomly distributed into a control group (n=10) and a PDRN group (n=10). Initial surgical debridement and secondary surgical procedures such as a split-thickness skin graft, primary closure, or local flap were performed. Between the initial surgical debridement and secondary surgical procedures, 0.9% normal saline (3 mL) or PDRN was injected for 2 weeks by the intramuscular (1 ampule, 3 mL, 5.625 mg, 5 days per week) and perilesional routes (1 ampule, 3 mL, 5.625 mg, 2 days per week). Transcutaneous oxygen tension ($TcPO_2$) was evaluated using the Periflux System 5000 with $TcPO_2/CO_2$ unit 5040 before the injections and on days 1, 3, 7, 14, and 28 after the start of the injections. A pathologic review (hematoxylin and eosin stain) of the debrided specimens was conducted by a pathologist, and vessel density (average number of vessels per visual field) was calculated. Results Compared with the control group, the PDRN-treated group showed improvements in peripheral tissue oxygenation on day 7 (P<0.01), day 14 (P<0.001), and day 28 (P<0.001). The pathologic review of the specimens from the PDRN group showed increased angiogenesis and improved inflammation compared with the control group. No statistically significant difference was found between the control group and the PDRN group in terms of vessel density (P=0.094). Complete healing was achieved in every patient. Conclusions In this study, PDRN improved peripheral tissue oxygenation. Moreover, PDRN is thought to be effective in improving inflammation and angiogenesis in diabetic foot ulcers.

The Effects of distilled Rehmannia glutinosa Herbal Acupuncture on the Heart Rate Variability(HRV) (생지황 약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Shin, Jin-Cheol;Kim, Lak-Hyung;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Pharmacopuncture
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    • v.11 no.1
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    • pp.83-97
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    • 2008
  • Objectives : We investigated the effects of distilled Rehmannia glutinosa Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Rehmannia glutinosa Herbal Acupuncture on the balance of the autonomic nervous system. Methods : We investigated on 58 healthy volunteers consisted of 28 subjects in experiment(distilled Rehmannia glutinosa Herbal Acupuncture) group and 30 subjects in control(Normal Saline) group. Study form was a randomized, placebo-controlled, double-blind clinical trial. 28 subjects in experiment group were injected distilled Rehmannia glutinosa Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $G_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 6 subjects(2 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 26 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 : 1. After distilled Rehmannia glutinosa Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low only from 20 minute to 25 minute. HRV index is significantly high for first 5minute and from 10 minute to after 10 minute. 2. HRV index of distilled Rehmannia glutinosa Herbal Acupuncture Group significantly increased from 25 minute to 30 minute, and pNN50 of Rehmannia glutinosa Herbal Acupuncture Group significantly decreased from 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Rehmannia glutinosa Herbal Acupuncture injection, Ln(TP) and Ln(VLF) are significantly high after injection. Normalized LF is significantly high from 5 minute to 20 minute and from 25 minute and 30 minute. Normalized HF is significantly low from 5minute to 20 minute and from 25 minute and 30 minute. 4. Ln(TP) and Ln(VLF) of distilled Rehmannia glutinosa Herbal Acupuncture Group significantly increased from 20 minute to 25 minute compared with those of Normal Saline group. Conclusions : The results suggest that Rehmannia glutinosa Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and parasympathetic nervous system compared to Normal Saline within normal range.

Effect of Ephedra Sinica and Evodia Rutaecarpa on Resting Metabolic Rate in Obese Premenopausal Women during Low-calorie Diet: A Randomized Controlled Clinical Trial (저열량 식이요법을 한 폐경 전 비만 여성의 휴식 대사량에 대한 마황과 오수유의 효과)

  • Kim, Su-Jin;Ko, Byung-Pyo;Kim, Hyung-Do;Kim, Jin-Ah;Park, Jeong-Mi;Choi, Seung-Ki;Jeon, Uoo-Hyun;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.4 no.1
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    • pp.45-54
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    • 2004
  • Objective: To evaluate the effect of Ephedra Sinica and Evodia Rutaecarpa on resting metabolic rate(RMR), weight and body composition in obese women during low-calorie diet. Methods: We recruited 90 healthy premenopausal women$(body\;mass\;index{\geq}25kg/m^2)$ and randomly assigned to three groups(ephedra group, evodia group and placebo group). Subjects were administered Ephedra Sinica(6g twice a day) or Evodia Rutaecarpa(6g twice a day) or placebo in a double-blind fashion and participated in low-calorie diet for 8 weeks. Resting metabolic rate and body composition were measured at baseline, 4 and 8 weeks. Results: RMR change for 4 weeks was significantly higher in the ephedra group compared with the placebo group(p<.05). But the change for 8 weeks was not significant and the Evodia group showed no significant RMR change. Weight and percent body fat changes for 4 weeks and 8 weeks were significantly higher than the placebo group in the ephedra group(p<.05), but the Evodia group didn't show significant level. Conclusions: This study supports and emphasizes the benefits of herbal medicine in maintaining or increasing RMR during low-calorie diet. Especially Ephedra treatment was effective on significant maintainment of RMR, loss of weight and percent body fat(P<.05).

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The Effect of Sa-am Acupuncture Simjeongkyeok Treatment for Major Symptom of Hwa-byung (화병의 핵심증상에 대한 사암침 심정격 치료의 효과)

  • Jeong, In-Chul;Lee, Sang-Ryong;Park, Yang-Chun;Hong, Kwon-Eui;Lee, Young-Koo;Kang, Wee-Chang;Choi, Sun-Mi;Choi, Kang-Wook;Oh, Dal-Seok;Park, Ji-Eun
    • Journal of Oriental Neuropsychiatry
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    • v.19 no.1
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    • pp.1-18
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    • 2008
  • The purpose of this research is to examine the effect of Simjeongkyeok Sa-am acupuncture treatment for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared Simjeongkyeok acupuncture with Sham acupuncture in the treatment for major symptoms of Hwa-byung. Likert scale 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 : In comparison of Likert scale for major symptoms, total score of after treatment decreased significantly at each point on both groups, but there was no significant difference between both groups. In comparison of STAXI-K, STAI-K, BDI-K, there was no significant difference in variation of score between both groups. But Simjeongkyeok group showed higher ratio variation of STAXI expression than that of Sham group, Also on subjects whose main complaint symptom were burning sensation and whose pattern identification were Qizhi, Simjeongkyeok group showed higher variation of Likert scale score and BDI-K than that of Sham group. The significance was border line around. Conclusion : We considered that Shimjeongkeok treatment will he likely to he recommended for treating Hwa-byung, especially on subjects in each group whose main complaint symptom were burning sensation or whose pattern identification were Qizhi. Also it may also be effective on the management of anger expression.

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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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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.

The efficacy of ultrasound-guided erector spinae plane block after mastectomy and immediate breast reconstruction with a tissue expander: a randomized clinical trial

  • Park, Sukhee;Park, Joohyun;Choi, Ji Won;Bang, Yu Jeong;Oh, Eun Jung;Park, Jiyeon;Hong, Kwan Young;Sim, Woo Seog
    • The Korean Journal of Pain
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    • v.34 no.1
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    • pp.106-113
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    • 2021
  • Background: We aimed to investigate the analgesic efficacy of an erector spinae plane block (ESPB) in immediate breast reconstruction (IBR) with a tissue expander. Methods: Adult women undergoing IBR with a tissue expander after mastectomy were randomly assigned to either intravenous patient-controlled analgesia (IV-PCA) alone (group P) or IV-PCA plus ESPB (group E). The primary outcome was the total amount of opioid consumption during 24 hours postoperatively between the two groups. Secondary outcomes were patient satisfaction, pain score at rest and on shoulder movement using numerical rating scale, incidences of postoperative nausea and vomiting (PONV), and a short form of the brief pain inventory (BPI-SF) at 3 and 6 months after surgery between the groups. Results: Fifty eight patients completed the study. At 24 hours postoperatively, total opioid consumption was significantly less in group E than in group P (285.0 ± 92.0, 95% confidence interval [CI]: 250.1 to 320.0 vs. 223.2 ± 83.4, 95% CI: 191.5 to 254.9, P = 0.005). Intraoperative and cumulative PCA fentanyl consumption at 3, 6, 9, and 24 hours were also less in group E than in group P (P = 0.004, P = 0.048, P = 0.020, P = 0.036, and P < 0.001, respectively). Patient satisfaction was higher in group E (6.9 ± 1.8 vs. 7.8 ± 1.4, P = 0.042). The incidences of PONV was similar. Conclusions: The ESPB decreased postoperative opioid consumption and increased patient satisfaction without significant complications after IBR with a tissue expander after mastectomy.

Case Report of the Pityriasis Rosea Patient with Pruritus Treated by Korean Medicine Treatment alone (소양감이 동반된 장미색 비강진 환자의 한방단독치료 보고)

  • Lee, Kyoungeun;Kim, Jungpil;Jeong, Seonhyung;Ahn, Joon;Jeong, Hyein;Kim, Kyounghan;Jang, Insoo;Choi, Yoomin;Oh, Yongtaek
    • Herbal Formula Science
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    • v.30 no.1
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    • pp.27-36
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    • 2022
  • Objective : The purpose of this study is to present a case report with the adult patient who needed active treatment of pityriasis rosea with severe pruritus, and did not respond to steroid treatment in the preceding month. Methods : The subject is an adult patient with pityriasis rosea over the age of 40 without any other diseases. We administered Korean medicine treatment with Bangpungtongseong-san (防⾵通聖散) and acupuncture. The effects of the treatment were evaluated via scales including Pruritus score, Pityriasis Rosea Severity Score (PRSS), and picture. Results : After the treatment Pruritus score/PRSS index of the case changed from 8/20 to 0/0. No other severe adverse reactions were reported. No more recurrence or pruritus was confirmed in follow-up. Conclusions : Korean medicine treatment with Bangpungtongseong-san showed marked improvement in pruritus and skin symptoms of pityriasis rosea in need of active care. With the lack of existing clinical reports of pityriasis rosea, we found that Korean medicine treatment could be an effective way, and it is expected that Bangpungtongseong-san could be administered to pityriasis rosea patients. Randomized-controlled trial for further evaluation will be needed in the future.

Efficacy and Safety of Combination Treatment of Traditional Korean Medicine after Gastric Cancer Surgery: A Systematic Review and Meta-analysis Protocol (위암 수술 후 항암치료를 병행한 한의치료의 유효성 및 안전성: 체계적 문헌고찰 및 메타분석 프로토콜)

  • Jong-hee Kim;Eunbin Kwag;So-jung Park;Donghyun Kim;Soodam Kim;Jihye Park;Hwa-seung Yoo
    • Herbal Formula Science
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    • v.31 no.4
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    • pp.361-371
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    • 2023
  • Objectives : Gastric cancer is a malignant tumor of the digestive tract that not only has a high mortality rate, but also affects quality of life. In Traditional Korean Medicine, acupuncture and herbal medicines can increase the survival rate for Gastric cancer and improve the quality of life. Traditional Korean Medicine treatment played an important role when used alone or in combination with chemotherapy. However, there is still insufficient evidence to support the efficacy and safety of Traditional Korean Medicine in patients undergoing chemotherapy after surgery. Therefore, the purpose of this study is to systematically evaluate the effect of oriental medicine treatment on patients as a complementary therapy for Gastric cancer. Methods : 2 researchers will search using EMBASE, Pubmed, CNKI, Cochrane Library, CiNii, KMBASE, KISS, OASIS, RISS, ScienceON. The search period of the database is from inception until June 2022. This study will include a randomized controlled trial of GC for acupuncture and herbal treatment. Primary outcomes include anti-cancer effects. Secondary outcomes evaluate survival rates and improvements in quality of life. The data uses Review Manager Software 5.4. Results : This study will provide a systematic evaluation by synthesizing the anti-cancer effect, survival rate and quality of life of Gastric cancer when Traditional Korean Medicine is combined with chemotherapy. Conclusion : The conclusion of this study will provide a basis for determining whether Traditional Korean Medicine treatment for Gastric cancer treatment is an effective and safe treatment method in clinical practice.