• Title/Summary/Keyword: double-blind/placebo-controlled study

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The Effects of distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on the Heart Rate Variability (녹용 약침과 산조인 약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Kim, Hui-Jun;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Pharmacopuncture
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    • v.12 no.3
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    • pp.31-40
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    • 2009
  • Objective : This study was to investigate the effects of distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture on autonomic nervous system with Heart Rate Variability(HRV). Purpose of the trial was to observe what influence distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture have on the autonomic nervous system. Methods : 60 healthy male volunteers were divided into three groups which consist of two experimental groups such as Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture, and a control group. Study design was a randomized, placebo-controlled, double-blind clinical trial. 20 subjects in experimental group were injected distilled Cervi Pantotrichum Cornu Pharmacopuncture at $GB_{21}$(Kyonjong), 20 subjects in other experimental group were injected distilled Zizyphi Spinosi Semen Pharmacopuncture and 20 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). One volunteer of each groups were excluded from analysis because of error during measuring HRV. At the end of the study 57 volunteers completed HRV analysis. HRV was measured by QECG-3:LXC3203(LAXTHA Inc. Korea) at P0, P1, P2, P3, P4, P5 and P6 and its time-course dependent change in each group was analyzed using paired t-test, and the difference of HRV fluctuation among two experimental group and a control was evaluated by one way ANOVA(p<0.05). Results : A. Time Domain Analysis 1. Analysis of Mean HRV, SDNN and Complexity After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Mean HRV was significantly decreased only at 20 minutes after injection. SDNN was significantly increased from 15 minute after injection. Complexity was significantly decreased only at 15 minute after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Complexity was significantly decreased at 10, 15 and 30 minutes after injection. 2. Analysis of HRV index, pNN50 After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, pNN50 was significantly decreased at 15, 20 and 25 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture showed significant difference on HRV index and pNN50 at 5 minutes after injection. B. Frequency Domain Analysis 1. Analysis of Ln(TP), Ln(VLF) After injection of distilled Cervi Pantotrichum Cornu Pharmacopuncture, Ln(TP) was significantly increased at 15 and 30 minutes after injection. Ln(VLF) was significantly increased at 10, 15 and 30 minutes after injection. After injection of distilled Zizyphi Spinosi Semen Pharmacopuncture, Ln(VLF) was significantly increased only at 30 minutes after injection. Compared with Normal Saline injection, distilled Cervi Pantotrichum Cornu Pharmacopuncture showed significant difference on Ln(TP) after 5 minutes of injection. Conclusions : Our results suggest that Cervi Pantotrichum Cornu Pharmacopuncture and Zizyphi Spinosi Semen Pharmacopuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

Improvement of Skin Moisture Capacity through Dietary Beauty Supplement Containing Ceramides Derived from Rice (쌀 유래 세라마이드를 함유한 미용보조제의 피부미용개선 효과)

  • Kim, Tae-Su;Lee, Sung-Pyo;Park, So-I;Yang, Woong-Suk;Kang, Myung-Hwa;Murai, Hiromichi;Okada, Tadashi;Lee, Jae-Hwan;Park, Il-Bum;Park, Hyun-Jun
    • Korean Journal of Food Science and Technology
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    • v.44 no.4
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    • pp.434-440
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    • 2012
  • A placebo-controlled double-blind ingestion study of a beauty supplement containing rice-derived ceramide was performed. Thirty three subjects who always tended to have rough skin due to dryness participated in the study. Dermatological diagnosis by physicians showed that the supplement significantly improved dryness and itching of the skin. On measurement of water content in the skin, the supplement was shown to significantly increase water content in the skin. On microscopic three-dimensional analysis of the epidermis, the supplement was shown to improve smoothness, exfoliation, and short-term ingestion of the supplement containing rice derived ceramide, which is very effective as skin beautifying food.

Evaluation of the effects of Hangover-releasing agent containing freeze-dried mature silkworm larval powder (SMSP) on alcohol metabolism and hangover improvement (숙잠 함유 복합물의 알코올 대사 및 숙취개선 효능평가)

  • Woo, Miseon;Cha, Ji Hyeon;Kim, Yonghwan;Kang, Hee-Taik;Kim, Hyeondok;Cho, Kyong Won;Park, Sung Sun;Lee, Jong Hun
    • Korean Journal of Food Science and Technology
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    • v.53 no.1
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    • pp.72-77
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    • 2021
  • Silkworms have traditionally been used to produce silk and textiles. However, steamed and freeze-dried mature silkworm larval powder (SMSP) contain large amounts of amino acids, vitamins, and essential minerals. In this study, we investigated the potential of SMSP as a hangover-relieving agent. Thirty individuals who met the selection criteria and exclusion criteria were included in the study and subsequently underwent a double-blind, randomized, placebo-controlled, cross-design human application test. Importantly, the test product containing SMSP (CKDHC) was proven to alleviate hangovers through a significant reduction in the plasma concentration of acetaldehyde in the context of an alcohol-induced hangover model. In particular, from 0.5 h after SMSP intake, the blood acetaldehyde concentration (mg/L), area under the time curve (AUC; indicating the degree of bioabsorption of blood acetaldehyde), and the highest blood acetaldehyde concentration (Cmax) were reduced. Altogether, these results suggest that the test product (CKDHC) exhibits an accelerated hangover-relieving effect.

Effect of Beraprost Sodium in Patients with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Beraprost sodium의 효과에 대한 연구: 이중 맹검 무작위 임상시험)

  • Lee, Sang-Do;Seo, Kwang Won;Lee, Jung Yeon;Huh, Jin Won;Choi, Ik Su;Park, Jae Sun;Shim, Tae Sun;Oh, Yeon-Mok;Park, In Won;Ryu, Wang-Seong;Choi, Byoung Whui
    • Tuberculosis and Respiratory Diseases
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    • v.57 no.4
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    • pp.320-328
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    • 2004
  • Background : Pulmonary vascular changes which occur early in the course of chronic obstructive pulmonary disease (COPD) are prevalent manifestation and later cause pulmonary hypertension, which is a bad prognostic factor in COPD. Beraprost sodium (BPS), an orally active prostacyclin analogue, has been shown to improve survival in patients with primary pulmonary hypertension. This study investigated the effect of BPS in the patients with COPD. Methods : This is a double-blind randomized placebo-controlled, two center clinical trial. Twenty one consecutive patients with COPD were enrolled from June 2003 to June 2004 (patients treated with BPS for 3 months, BPS group, n=11; those with placebo, placebo group, n=10). The baseline demographic, pulmonary function and hemodynamic data were not significantly different between two groups. Results : On echocardiographic examination, trans tricuspid valve pressure gradient has decreased significantly after 3 months with beraprost in the BPS group [17.7(${\pm}11.4$) to 8.2(${\pm}8.9$) mm Hg, p-value<0.05], while there was no significant change in the control group. Six-minute walking distance has decreased in the control group and increased in the BPS group, but there was no statistical significance. Conclusion : In patients with COPD oral administration of BPS reduced the pulmonary arterial pressure. The clinical significance of this finding, that is improving symptoms and natural course of the disease, needs further study.

The Effects of distilled Wild Ginseng Herbal Acupuncture on the Heart Rate Variability(HRV) (산삼 약침이 정상인의 심박변이도(HRV)에 미치는 영향)

  • Roh, Jeong-Du;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.55-69
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    • 2008
  • Objective : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. Method : We investigated the effects of distilled Wild Ginseng Herbal Acupuncture on autonomic nervous system with the Heart Rate Variability(HRV) in adult man. as well as we tried to observe how distilled Wild Ginseng Herbal Acupuncture on the balance of the autonomic nervous system. 1 healthy volunteers consisted of 31 subjects in experiment(distilled Wild Ginseng 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 Wild Ginseng Herbal Acupuncture at $GB_{21}$(Kyonjong) and 30 subjects in control group were injected Normal Saline at $GB_{21}$(Kyonjong). except of 2 subjects(in control group) who can't be measured and 11 subjects(7 in experiment group and 4 in control group) who move or make unforceable error during measuring. Finally 24 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. Result : 1. After distilled Wild Ginseng Herbal Acupuncture injection, Mean HRV is significantly low only for first 5 minute, SDNN is significantly high after 5 minute, Complexity is significantly low after 5 minute, HRV index is significantly high after 10 minute and pNN50 is significantly low after 5 minute. 2. SDNN of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25minute, and pNN50 of distilled Wild Ginseng Herbal Acupuncture Group significantly decreased from 10minute to 15minute and 20 minute to 30 minute compared with those of Normal Saline group. 3. After distilled Wild Ginseng Herbal Acupuncture injection, Ln(TP), Ln(VLF) and Ln(LF) are significantly high after 5 minute, normalized LF is significantly high after 5 minute and normalized HF is significantly low after 5 minute. 4. Ln(TP) and Ln(VLF) of distilled Wild Ginseng Herbal Acupuncture Group significantly increased from 20minute to 25 minute compared with those of Normal Saline group. Conclusion : The results suggest that distilled Wild Ginseng Herbal Acupuncture in healthy adult man tend to activate the autonomic nervous system and sympathetic nervous system compared to Normal Saline within normal range.

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.

Effects of Polycan on bone Metabolism in healthy Perimenopausal Women: a 12-week Randomized, Double-blind, Placebo-controlled study (폴리칸이 중년 여성의 골대사에 미치는 영향: 12주간의 무작위배정, 이중눈가림, 플라세보 대조 연구)

  • Kim, Min-Gul;Ha, Ki-Chan;Back, Hyang-Im;Kim, Sun-Young;Kim, Joo-Wan;Kim, Ki-Young;Cho, Hyung-Rae;Chae, Han-Jung;Chae, Soo-Wan;Kim, Dal-Sik
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.297-304
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    • 2011
  • 배경: 골다공증은 골대사의 불균형으로 인해 골 흡수가 골 형성보다 많아져 골밀도가 감소함으로서 발생한다. 골다공증의 이상적인 치료목표는 골형성을 증가시키거나 골소실을 방지하여 골량을 현 상태로 유지하는 것이다. 따라서 향후 발생되는 골소실을 에방하는 것이 골다공증의 원칙적이고 효과적인 치료방법이 될 것이다. 본 연구에서는 흑효모 중 $Aureobasidium$ $pullulans$으로부터 유래한 폴리칸(베타-글루칸)이 중년여성의 골대사에 미치는 영향을 규명하고자 하였다. 연구방법: 골대사에 대한 폴리칸의 효과를 규명하기 위해 12주간의 무작위배정, 이중눈가림, 플라세보 대조 임상연구를 수행하였다. 총 60명(폴리칸 투여군30명, 플라세보 투여군 30명)의 중년 여성 피험자가 등록되어 이 중 총 58명의 피험자가 최종적으로 12주간의 임상연구를 종료하였다. 결 과: 폴리칸(150 mg/d) 투여 12주 후, 폴리칸 투여군은 요 중 Deoxypyridinoline (DPD) 농도가 유의적인 감소를 보였다($P$=0.014). 혈청 중 Osteocalcin(OSC) 농도는 두 군 모두에서 유의적으로 증가하였으며, bone-specific alkaline posphatase (bALP) 와 collagen type 1 cross-linked C-telopeptide (CTx)는 유의적 변화가 보이지 않았다. 폴리칸은 골밀도(BMD)와 혈청 부갑상선 호르몬(iPTH)에 대해 유의적인 변화를 보이지 않았으나, 24시간 요 중 Ca 배설량은 폴리칸 투여군에서 유의하게 감소되었다($P$=0.028). 또한 폴리칸 투여군에서 고밀도지단백 콜레스테롤(HDL-cholesterol) 농도의 증가 경향 및 중성지방(triglyceride)의 유의적인 감소가 보였다. 임상연구 기간 중에 발생한 이상반응은 두 군간에 유의적인 차이를 보이지 않았다. 결 론: 본 연구에서는 폴리칸이 골대사 및 지질에 대해 일부 개선효과가 있음을 보여주었다. 그러나, 골다공증 예방 측면에서 보다 장기적인 임상연구와 피험자 수를 확대하여 골대사 및 지질대사에 대한 폴리칸의 예방적 효과를 규명할 필요가 있을것으로 사료된다.

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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Neuroimaging Assessment of the Therapeutic Mechanism of Acupuncture and Bee Venom Acupuncture in Patients with Idiopathic Parkinson's Disease: A Double-blind Randomized Controlled Trial

  • Young-Eun Lee;Seung-Yeon Cho;Han-Gyul Lee;Seungwon Kwon;Woo-Sang Jung;Sang-Kwan Moon;Jung-Mi Park;Chang-Nam Ko;Seong-Uk Park
    • The Journal of Korean Medicine
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    • v.44 no.4
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    • pp.104-120
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    • 2023
  • Objectives: The purpose of this study was to explore the therapeutic mechanism of acupuncture and bee venom acupuncture (BVA) in patients with idiopathic Parkinson's disease (IPD) using positron emission tomography (PET) and arterial spin labeling (ASL). Methods: Patients with IPD who received a stable dose of anti-parkinsonian medication for at least 4 weeks were recruited and randomly divided into one of two groups: treatment and control. The treatment group (11 subjects) received acupuncture and BVA at acupoints, and the control group (9 subjects) received sham acupuncture and normal saline injections at non-acupoints, twice per week for 12 weeks. The patients were examined using PET and ASL at baseline and after the 12-week treatment. In addition, age- and sex-matched healthy subjects without neurological symptoms and history were recruited to compare ASL data of patients with IPD. Results: PET results revealed that striatal dopamine transporter binding increased in each group after 12 weeks. Although the change was larger in the treatment group, the difference was not statistically significant. In ASL results, the treatment group exhibited hyperperfusion in specific regions compared with the healthy control group. After 12 weeks' intervention, hyperperfusion regions were recovered only in the treatment group. In contrast, significant changes were not found in hyperperfusion regions in the control group after 12 weeks. Conclusions: Our findings suggest that the therapeutic mechanisms of acupuncture and BVA in IPD are different from placebo and operate by altering dopamine availability and recovering hyperactivity in cerebral blood flow.

Effect of Glucose Control, SDSCA and Quality of Life of D-chiro-inositol(DCI) in patients with type 2 diabetes: A Path Analysis (제2형 당뇨병 환자의 D-chiro-inositol의 혈당강하 효과와 당뇨 자가관리 및 삶의 질: 경로분석)

  • Kang, Young Mi;Kim, Hyun Jin;Lee, Tae-Yong;Ku, Bon-Jeong
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.19 no.10
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    • pp.243-253
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    • 2018
  • This study aimed to investigate the effects of DCI on glucose control, quality of life(SF-36 Version 2.0, Korean) and SDSCA(Summary of Diabetes Self-Care Activities) in patients with type 2 diabetes mellitus. A randomized, double-blind, placebo-controlled study was performed on 46 patients with HbA1c 7.0% taking triple anti-diabetic drug regimen who visited the department of Endocrinology and Metabolism in Chungnam National University Hospital between March 2015 and May 2016. As a result, DCI treatment in the intervention group resulted in significantly reduced HbA1c levels $8.75{\pm}0.79%$(baseline), $8.36{\pm}1.03%$(after 12weeks), and $8.65{\pm}0.81%$(after 24weeks). However, patients in the control group did not show any significant change. Interestingly, both DCI treatment group and the control group significantly showed improvements in SDSCA. Participants in the intervention group showed a small yet significant improvement in their only fasting blood glucose test in SDSCA and revealed significant increase in the quantitative levels of quality of life, from $73.05{\pm}16.85$ to $82.74{\pm}10.68$. By using pathway analysis, improvement of SDSCA scores(${\beta}=-0.505$, t=-2.743) was the most influential factor to the fasting blood glucose. The quality of life of patients with type 2 diabetes mellitus was affected by changes of SDSCA scores(${\beta}=0.411$, t=2.024) and fasting c-peptide(${\beta}=-0.445$, t=-2.668) in DCI treatment group. In conclusion, treatment of DCI effectively improved glucose control in patients with type 2 DM(HbA1c level>7.0%) after 12 weeks of treatment, although it had no impact on glucose control after 24 weeks of treatment. Improved glucose control may encourage diabetic patients to conduct self-care activities and improve the quality of life. Based on the present study, we suggest that diabetes self-management, as well as consideration of comprehensive laboratory findings, may be important factor in regulating the quality of life in type 2 DM patients.