• 제목/요약/키워드: Placebo-controlled study

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화병의 한의학적 치료에 대한 연구동향 (Current Trends in Intervention Studies of Hwabyung in Korean Medicine)

  • 서효원;최은지;김상호;김동희;김락형;김종우;이재혁;임재환;최우진;정선용
    • 동의신경정신과학회지
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    • 제27권4호
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    • pp.261-274
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    • 2016
  • Objectives: To determine the general characteristics of clinical studies about Hwabyung and assess their limitations and alternatives. Methods: Clinical studies that examined the effects of traditional Korean medicine intervention on Hwabyung were included in this study. A systematic search of English, Chinese, Japanese, and Korean databases was performed. The characteristics of included articles were described and those articles were assessed by Risk of Bias (RoB) tool or Risk of Bias for Nonrandomized Studies (RoBANS) tool. Results: Sixteen articles were selected from 1,826 articles. Most clinical studies about Hwabyung were published in Korea. The number of conducted trials was insufficient. The prevailing study design was randomized controlled trial. Traditional Korean medicine intervention used in the trials were acupuncture, herbal medicine, counselling, meditation, emotional freedom technique (EFT), music therapy, art therapy, and multi intervention program. Herbal medicine study used placebo as control while non-pharmacological intervention study mostly used no treatment as control. Most of the trials were supported by the government. Therefore, financial conflict of interest might not exist for results. We judged that some studies had a high risk of bias. In general, most of the studies with a high risk of bias were non-pharmacological intervention studies, and the risk of bias was mainly due to lack of blinding. Conclusions: More clinical studies of Hwabyung are needed. There are some issues about a suitable comparison and effective blinding strategy for non-pharmacological study. Improving methodological quality is required.

노인 구강건조증에 대한 음허 진단의 유용성 및 주관적 구강건조감의 영향요인 : 전향적 단면 조사 연구 (Availability of Diagnosis of Yin-deficiency in Elderly People with Xerostomia and Factors Influencing Subjective Oral Dryness: A Prospective Cross-sectional Study)

  • 김주연;김진성;박재우;류봉하
    • 대한한의학회지
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    • 제34권3호
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    • pp.13-24
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    • 2013
  • Objectives: The aims of this study were to investigate the availability of diagnosis of Yin-deficiency in the elderly with xerostomia and factors influencing subjective oral dryness. Methods: We surveyed 50 patients recruited by the clinical trial, 'Efficacy of Yukmijihwang-tang on Xerostomia in the Elderly: A Randomized, Double-blind, Placebo-controlled, Two-center Trial'. The subjects were assessed on their subjective oral dryness using the Dry Mouth Symptom Questionnaire (DMSQ). Their salivary functions were measured by Unstimulated Salivary Flow Rate (USFR) measurements. In addition, the subjects were evaluated on their Qi-stagnation and Yin-deficiency conditions using the Qi-stagnation questionnaire and Yin-deficiency questionnaire. Results: There were statistically significant correlations between three variables (USFR, DMSQ score and Qi-stagnation score) and Yin-deficiency score. In the multiple regression analysis, the regression model was statistically significant (F = 10.273, p < .001). The factor most strongly influencing the subjective oral dryness was USFR (${\beta}$ = -0.386). Yin-deficiency had the next strongest impact on the subjective oral dryness (${\beta}$ = 0.371). Qi-stagnation affected the subjective oral dryness weakly (${\beta}$ = 0.075). In the simple regression analysis, Yin-deficiency had a statistically significant effect on each of six subscales of DMSQ (p < .01). Among the six subscales, DMSQ-1 ('Oral dryness at night or on awakening') was the most strongly influenced by Yin-deficiency. Conclusions: The results of this study show that the diagnosis of Yin-deficiency in the elderly with xerostomia was available and Yin-deficiency was an important factor influencing the subjective oral dryness. Therefore, the consideration of Yin-deficiency is significant for diagnosis and treatment in the elderly with xerostomia.

자일로올리고당을 함유한 설탕이 20대 여성의 변비 개선에 미치는 효과: 이중맹검 연구 (Effect of xylooligosaccharide-sugar mixture on defecation frequency and symptoms in young women with constipation: a randomized, double-blind, placebo-controlled trial)

  • 전진호;경명옥;정상원;조성은;장문정
    • Journal of Nutrition and Health
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    • 제48권1호
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    • pp.19-29
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    • 2015
  • 본 연구는 자일로올리고당을 설탕에 혼합하여 변비를 앓고 있는 젊은 여성을 대상으로 변비개선효과를 확인하였다. 평균연령 22.1세인 젊은 여성 56명을 대상으로 실험 1에서는 설탕을 플라시보로 하는 이중맹검 임상연구를 통해 자일로올리고당 0.7 g이 함유된 설탕 10 g (n = 19명) 또는 설탕 10 g (n = 19명)을 블랙커피와 함께 복용하도록 하였고, 실험 2에서는 자일로올리고당 0.4 g 함유한 설탕 5.6 g과 1.6 g의 커피, 4.8 g의 식물성 크림이 함유된 커피믹스를 1일 2회씩 6주간 섭취하도록 하였다 (n = 18명). 섭취결과 XOS군과 XOSmix군의 경우 섭취전 주간 배변횟수가 2.47회에서 섭취 1주째부터 증가하여 섭취 6주째에는 주간 배변횟수가 4.11회와 5.67회로 각각 증가하였다. XOS와 XOS 함유 커피믹스는 통계적으로 유의하게 복부 불쾌감과 잔변감을 개선하였으며, 배변횟수의 증가는 섭취초반 부터 효과가 있는 것으로 나타났다. 따라서 XOS는 0.7 g의 적은양으로도 변비를 개선하는 효과가 있는 것으로 나타나 음료에 기능성을 갖춘 감미료로서의 활용이 기대된다.

Characterization of food allergies in patients with atopic dermatitis

  • Kwon, Jaryoung;Kim, Jungyun;Cho, Sunheui;Noh, Geunwoong;Lee, Sang Sun
    • Nutrition Research and Practice
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    • 제7권2호
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    • pp.115-121
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    • 2013
  • We examined the characteristics of food allergy prevalence and suggested the basis of dietary guidelines for patients with food allergies and atopic dermatitis. A total of 2,417 patients were enrolled in this study. Each subject underwent a skin prick test as well as serum immunoglobulin E (IgE) measurement. A double-blind, placebo-controlled food challenge was conducted using milk, eggs, wheat, and soybeans, and an oral food challenge was performed using beef, pork, and chicken. Food allergy prevalence was found among 50.7% in patients with atopic dermatitis. Among patients with food allergies (n = 1,225), the prevalence of non-IgE-mediated food allergies, IgE-mediated food allergies, and mixed allergies was discovered in 94.9%, 2.2%, and 2.9% of the patients, respectively. Food allergy prevalence, according to food item, was as follows: eggs = 21.6%, milk = 20.9%, wheat = 11.8%, soybeans = 11.7%, chicken = 11.7%, pork = 8.9% and beef = 9.2%. The total number of reactions to different food items in each patient was also variable at 45.1%, 30.6%, 15.3%, 5.8%, 2.2%, and 1.0% for 1 to 6 reactions, respectively. The most commonly seen combination in patients with two food allergies was eggs and milk. The clinical severity of the reactions observed in the challenge test, in the order of most to least severe, were wheat, beef, soybeans, milk, pork, eggs, and chicken. The minimum and maximum onset times of food allergy reactions were 0.2-24 hrs for wheat, 0.5-48 hrs for beef, 1.0-24 hrs for soybeans, 0.7-24 hrs for milk, 3.0-24 hrs for pork, 0.01-72 hrs for eggs, and 3.0-72 hrs for chicken. In our study, we examined the characteristics of seven popular foods. It will be necessary, however, to study a broader range of foods for the establishment of a dietary guideline. Our results suggest that it may be helpful to identify food allergies in order to improve symptoms in patients with atopic dermatitis.

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

  • 김희준;송범용;육태한
    • 대한약침학회지
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    • 제12권3호
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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.

이압요법이 암환자의 불면증에 미치는 효능 : 무작위배정, 단일맹검, 위약대조군 연구 (Effect of Auricular Acupress Therapy on Insomnia of Cancer Patients : Randomized, Single Blinded, Placebo Controlled Trial)

  • 정인숙;김정선;유화승
    • 대한약침학회지
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    • 제13권2호
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    • pp.93-100
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    • 2010
  • Background: Auricular acupressure is one of the traditional health care treatments in oriental medicine. Approximately, 30~40% of the cancer patients have said to be suffering from insomnia and half of them having chronic and severe insomnia at the same time. Insomnia caused cancer patients feel more pain, fatigue, depression and anxiety and it sometimes let the power to have the best of cancer pull down. Objective: To investigate how effective the auricular acupressure treatment to cancer patients suffering from insomnia. Methods: We recruited participants from East-West Cancer Center of Daejeon University. Finally, of the people whose age range from 20 to 75, 12 patients who got less than 40 points from the score of Oh's sleeping score (OSS) were recruited. Single-blind, randomized pilot study was performed. The treatment group received auricular acupressure treatment (AAT) on active points and the control group had received sham acupressure treatment (SAT) for five times. Sleep parameters were checked by using OSS and numeric rating scale (NRS). We checked the scale everytime, both before and after treatment. We analyzed the data statistically by using independent T-test, paired T-test and analysis of variance (ANOVA) test. (p<0.05) Results: Twelve cancer patients participated in this pilot study and there was no significant difference between control and treatment group. Only 7 of them had completed the whole treatment process, 4 patients of AAT group and 3 participants of SAT. The OSS of AAT group had increased from $34.0{\pm}4.3$ to $39.5{\pm}3.1$ and that of SAT group had increased from $38.3{\pm}3.5$ to $40.0{\pm}0.0$. There was no significant difference between them. The NRS of AAT group had increased from $6.3{\pm}2.9$, $04.8{\pm}2.1$ and that of SAT group had increased from $7.0{\pm}1.0$ to $5.0{\pm}2.6$. No significant difference was observed between them. Conclusion: Although both groups did not show significant differences, most of the experimental participants showed increasing OSS and NRS after treatments. Significant participants' number will be needed in the next study.

고려인삼의 식품 안전성에 관한 임상 연구 (Clinical Study on Food Safety evaluation of Panax ginseng)

  • 김동휘;허영화;김영창;방경환;김장욱;차선우;하충매;양학;장인복;장연학
    • 한국약용작물학회지
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    • 제23권3호
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    • pp.185-189
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    • 2015
  • In this study, the clinical safety and toxicology of oral ingestion of supplement capsules containing ginseng radix was investigated in healthy young volunteers. This study was a pilot randomized, double blinded, placebo controlled trial. The healthy volunteers were divided into 6 groups of 20 each (10 males and 10 females). They took the ginseng powder for 35 days (3g/day) for safety evaluation. There were measured general healthy levels such as hematological, biochemical and electrocardiographic parameters. After the first week, besides Korean white ginseng the other treatments led to an significant increase of white blood cells. Korean red ginseng increased UREA (blood urea nitrogen) in healthy volunteers, but it didn't exceed the range of normal values, and in the subsequent process of treatment there is no effect of elevating UREA. After the three weeks, Korean white ginseng showed relatively low the content of blood glucose and low-density lipoprotein cholesterol. After the five weeks, compared with the other treatments, Korean red ginseng increased white blood cells, platelet distribution width and average volume of platelet. Korean white ginseng decreased low-density lipoprotein cholesterol. American ginseng decreased blood creatinine in healthy volunteers. In conclusion, through test the blood routine, urine routine, liver function, renal function, blood glucose, blood lipid and electrocardiogram, the healthy volunteers continuous taking ginseng for 35 days (3 g/day) is safe and reliable, and have no obvious adverse reactions and side effects.

흰쥐에서 양파 농축액의 고지혈 개선 작용 (A Concentrated Onion Extract Lowers Serum Lipid Levels in Rats Fed a High-Fat Diet)

  • 김주연;서윤정;노상규;차용준
    • 한국식품저장유통학회지
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    • 제17권3호
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    • pp.398-404
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    • 2010
  • 양파 농축액이 흰쥐 동물모델에서 고지방식이로 유도된 고지혈증에 어떤 영향을 미치는지를 조사하였다. 고지방식이가 혼합된 식이만 공급된 동물군을 대조군, 고지방 식이와 함께 양파 농축액 중 양파만 제거된 농축액만 공급된 동물군을 위약군, 그리고 고지방 식이와 양파 농축액을 함께 공급된 동물군을 농도에 따라 저농도군, 중농도군, 고농도군으로 8마리씩 5그룹으로 나누어 6주간 사육하였다. 시작전, 3주째 그리고 6주째에 혈액을 채취하였고 간은 6 주 혈액 채취 직후 적출되었다. 대조군과 실험군 모두 연구 시작부터 종료 시까지 지속적으로 체중이 증가하였으나 그룹 간에 유의적인 차이를 보이지 않았다. 양파 농축액을 공급받은 동물군들의 혈액의 중성지방, 총콜레스테롤 non-HDL콜레스테롤 수치는 고지방 식이를 지속적으로 동시에 공급받았음에도 불구하고 6주째에는 대조군에 비해서 유의적으로 감소되는 경향을 보였다. 간의 총지방 함량이나 총지방산의 농도는 대조군과 비교해서 양파농축액 고농도 급여군에서만 유의적으로 감소되는 경향을 보였다. 이상의 실험 결과들을 종합해 볼 때, 6주 동안 고지방 식이로 유도된 실험동물의 고지혈은 양파 농축액에 의해서 유의적으로 개선되는 경향을 보였다. 이 실험 결과는 양파 농축액이 혈액의 중성지방과 총콜레스테롤을 감소시킴으로서 고지혈증 개선에 효과가 있어 고지혈증을 완화하는데 효과적인 식이적인 수단이 될 것으로 판단된다.

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

  • 김태수;이성표;박소이;양웅석;강명화;무라이 히로미치;오카다 타다시;이재환;박일범;박현준
    • 한국식품과학회지
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    • 제44권4호
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    • pp.434-440
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    • 2012
  • 쌀 유래 세라마이드를 함유한 미용보조제의 섭취에 관한 위약 대조, 이중 맹검 연구가 건조함으로 인해 항상 피부가 거친 경향이 있었던 33명의 피험자들에게 실시되어 다음과 같은 결과가 얻어졌다. 섭취 6주 후 피부과적 진단에 따르면 건조함, 홍조, 화장 유지력, 가려움 등의 관찰항목에서 플라시보 군 및 세라마이드군 모두에서 개선효과가 있었으나 플라시보 군 에서는 개선율이 43.8%인 반면, 세라마이드 군의 개선율은 64.7%로 높았다. 수분량, 유분량, pH 측정결과를 보면, 플라시보 군과 세라마이드 군 모두에서 유분량 및 pH 관련하여 유의한 변화는 없었다. 그러나 수분량에서는 플라시보 군에서 유의한 변화가 없었던 반면, 세라마이드 군에서는 6주 후 유의한 수분량 증가가 있었다. 3차원 현미경 경피분석시스템에 의한 분석결과에 따르면, 세라마이드 군에서는 Kurtosis, 유연성지수(SEsm), 거�s지수(SEr), 각질 및 인설 지수(SEsc), 주름지수(SEw)가 유의하게 개선되었으나 플라시보 군에서는 어떠한 유의한 변화도 관찰되지 않았다. 이는 이중맹검법으로 실시된 이번 연구에서 피부과적 진단이 명백한 플라시보 효과를 보인 점과 대비된다. 이로써 의사들에 의한 관찰과 더불어 과학적이고 객관적인 측정에 의해 세라마이드는 피부건조함과 거�s을 개선하는 데 효과가 있음이 입증되었고 경구섭취로 그 효과가 나타났다. 상기 결과는 쌀 유래 세라마이드 보조제의 장기간에 걸친 섭취가 보습, 피부의 유연성 유지에 효과적이고 따라서 효과적인 피부미용식품임을 보여준다.

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

  • 우미선;차지현;김용환;강희택;김현덕;조경원;박성선;이종훈
    • 한국식품과학회지
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    • 제53권1호
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    • pp.72-77
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    • 2021
  • 숙취를 해결하기 위해서는 숙취를 직접적으로 유발하는 물질인 아세트알데하이드의 조절이 가장 중요한 인자로 작용한다. 숙잠을 함유하는 복합물인 시험식품(CKDHC)의 섭취로 혈중 아세트알데하이드 농도가 대조식품 대비 통계적으로 유의하게 감소하여 숙취개선 효능을 확인하였다. 특히, 30분부터 각 시간별(mg/L), 혈중 아세트알데하이드 농도-시간곡선하 면적(AUC), 최고 혈중 아세트알데하이드 농도(Cmax)의 감소를 통해 30분부터 빠른 숙취개선 효능을 확인하였다. 본 연구의 주원료로 사용된 숙잠은 Ji 등(2016a)에 따르면 18종의 아미노산 및 무기질을 모두 함유하며, 고단백 식용곤충으로 간에 좋은 주요 아미노산인 Alanine, Arginine 등을 많이 함유하여 간의 효소활성에 긍정적인 영향을 줄 수 있음을 알수있다. 본 연구결과를 통해 숙잠을 함유하는 시험식품이 숙취해소제로 작용할 수 있으며, 특히 음주 전 섭취시 아세트알데하이드를 빠르게 분해하여 30분부터 숙취 개선에 효과가 있음을 입증하였다.