• Title/Summary/Keyword: Placebo-controlled Study

Search Result 350, Processing Time 0.028 seconds

The Effect of Sa-am Acupuncture Treatment for Major Symptom of Hwa-byung : A Preliminary Study (화병의 핵심증상에 대한 사암침 치료의 효과 : 예비연구)

  • Lee, Sang-Ryong;Park, Yang-Chun;Hong, Kwon-Eui;Koo, Young-Sun;Jo, Jeong-Hyo;An, Joung-Jo;Kang, Wee-Chang;Kim, Jong-Woo;Choi, Sun-Mi;Jung, In-Chul
    • Journal of Oriental Neuropsychiatry
    • /
    • v.18 no.1
    • /
    • pp.79-94
    • /
    • 2007
  • Objective : The Purpose of this research is to examine the effect of Sa-am acupuncture treatment(Sim-seungkyuk) for major symptoms of Hwa-byung. Method : In this randomized, single blind, placebo-controlled study, we compared active acupuncture with sham acupuncture in the treatment for major symptoms of Hwa-byung. likert scale(5 score) 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 : 26 volunteers participated in this study by dividing two groups, each 13 persons in trial group and control group at random. In comparison of likert scale for major symptoms, after treatment the total score of likert scale for major symptoms decreased significantly in both group than before treatment. And after treatment, the total score of trial group decreased less than those of control group in comparison between two groups. especially after 2 weeks from all treatment, there was significant difference between two groups. Conclusion : We considered that Shim-seungkyuk of Sa-am acupuncture treatment will be not recommended to treatment of Hwa-byung because this study could not prove effect of Shim-seungkyuk treatment for Hwa-hyung in spite of preliminary study. This study will be used to provide a fundamental data for development of clinical research as preliminary study of Hwa-byung.

  • PDF

Evaluation of Therapeutic Effect of the Extract from Rhubarb (Rheum officinalis) in Dogs with Chronic Renal Failure (개의 만성 신부전에서 대황 추출물의 치료학적 효과의 평가)

  • Kim, Ye-Won;Hyun, Changbaig
    • Journal of Veterinary Clinics
    • /
    • v.29 no.6
    • /
    • pp.435-440
    • /
    • 2012
  • This study was designed to evaluate the clinical efficacy and safety of Rhubarb extracts ($Rubenal^{(R)}$) in dogs with chronic renal failure (CRF). Client-owned 40 dogs with CRF graded International renal interest Society (IRIS) II-III were enrolled in this study. The dogs were equally allocated and blindly administered with $Rubenal^{(R)}$ or placebo. The following items were evaluated at day 0, 30, 90 and 180: body condition score (BCS), clinical score (appetite, polydipsia/polyuria, quality of life score), hemogram (WBC, RBC, PCV), serum biochemistry (ALT/AST, ALP, Creatinine/BUN, total protein, albumin), serum electrolyte (Na, K, Cl, Ca, P), systolic blood pressure, urinalysis (UPC, USG) and IRIS stage. In this study, we found that the $Rubenal^{(R)}$ preparation was well tolerated by dogs and induced no adverse effects. Statistically significant improvements were observed in clinical score (quality of life score by vet and clients), serum BUN and creatinine levels, serum phosphorus concentration, level of proteinuria, and the IRIS score of CRF in dogs after 6 month of treatment of $Rubenal^{(R)}$. Those findings suggested that the Rhubarb extracts can improve the clinical signs of CRF (i.e. azotemia, hypertension, proteinuria, hyperphosphoremia) and the quality of life (i.e. BCS, clinical score) and can retard the progression of CRF in dogs. Therefore the Rhubarb extracts can be a good supplementary drug for treating dogs with subclinical and clinical renal diseases. However, care should be taken for interpreting our result, because this study is not double-blinded controlled study but pilot study.

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

  • Suh, Hyo-Weon;Choi, Eun-Ji;Kim, Sang-Ho;Kim, Dong Hee;Kim, Lak-Hyung;Kim, Jong-Woo;Lee, Jae-Hyok;Lim, Jae-Hwan;Choi, Woo-Jin;Chung, Sun-Yong
    • Journal of Oriental Neuropsychiatry
    • /
    • v.27 no.4
    • /
    • pp.261-274
    • /
    • 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.

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

  • Kim, Juyeon;Kim, Jinsung;Park, Jaewoo;Ryu, Bongha
    • The Journal of Korean Medicine
    • /
    • v.34 no.3
    • /
    • pp.13-24
    • /
    • 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.

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

  • Jeon, Jin Ho;Kyung, Myungok;Jung, Sangwon;Jo, SungEun;Chang, Moon-Jeong
    • Journal of Nutrition and Health
    • /
    • v.48 no.1
    • /
    • pp.19-29
    • /
    • 2015
  • Purpose: To investigate the effects of the intake of xylooligosaccharide-sugar mixture (XOS) on defecation frequency and symptoms in 56 young women (mean age of 22.1 years old) with constipation. Methods: Two experiments were conducted. In experiment 1, a randomized double-blind study was performed to evaluate the effect of 6 weeks' intake of 10 g sucrose containing 7% xylooligosaccharide or 10 g sucrose on constipation. In experiment 2, 24 g coffee mixture containing 12.8 g plant cream and 11.2 g xylooligosaccharide-sugar mixture was consumed by the subjects. During the study, the clinical efficacy was assessed by using a daily diary. The subjects indicated the number of frequencies they defecated in a day and the clinical symptom scores. Results: In experiment 1, the mean frequency of defecations was 2.07 in the pretreatment week and increased significantly to 4.05, 4.42, 4.84, 4.84, and 4.05 in weeks 2 to 6 of XOS intake, in comparison with the 3-3.67 with sucrose intake (sucrose, SUC). In experiment 2, the mean frequency of defecations significantly increased from 2.47 in the pretreatment week to 4.11-5.67 in weeks 1-6 of XOS intake. The occurrence of very loose or loose stools in the XOS group was significantly increased in weeks 5 and 6, compared with the pretreatment week and SUC group. XOS intake significantly alleviated the abdominal displeasure and feeling of residual stool leftness in weeks 2, 3, 5, and 6, while SUC did so in weeks 4 and 6 (p < 0.05). The coffee mixture containing xylooligosaccharide-sugar mixture reduced the abdominal displeasure and feeling of residual stool leftness from week 3 until the end of the experiment (p < 0.05). Conclusion: Our results suggest that xylooligosaccharide-sugar mixture intake was effective, without adverse effects, for the alleviation of constipation in the young women in this study.

Characterization of food allergies in patients with atopic dermatitis

  • Kwon, Jaryoung;Kim, Jungyun;Cho, Sunheui;Noh, Geunwoong;Lee, Sang Sun
    • Nutrition Research and Practice
    • /
    • v.7 no.2
    • /
    • pp.115-121
    • /
    • 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.

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
    • /
    • v.12 no.3
    • /
    • pp.31-40
    • /
    • 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.

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

  • Jung, In-Sook;Kim, Jung-Sun;Yoo, Hwa-Seung
    • Journal of Pharmacopuncture
    • /
    • v.13 no.2
    • /
    • pp.93-100
    • /
    • 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.

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

  • Kim, Dong Hwi;Xu, Yong Hua;Kim, Young Chang;Bang, Kyong Hwan;Kim, Jang Uk;Cha, Seon Woo;He, Zhong Mei;Yang, He;Jang, In Bok;Zhang, Lian Xue
    • Korean Journal of Medicinal Crop Science
    • /
    • v.23 no.3
    • /
    • pp.185-189
    • /
    • 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.

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

  • Kim, Ju-Youn;Seo, Yun-Jung;Noh, Sang-K.;Cha, Yong-Jun
    • Food Science and Preservation
    • /
    • v.17 no.3
    • /
    • pp.398-404
    • /
    • 2010
  • It is known that onions, or bioactive compounds therein, providehealth benefits. The present study was designed to investigate whether a concentrated onion extract lowered blood lipid levels in rats fed a high-fat diet. Initially, male Sprague-Dawley rats were housed singly in an environment in which temperature and light duration were controlled, and had free access to a nutritionally adequate AIN-93G diet and deionized water. After an acclimatization period, rats were weight-matched and assigned to one of the following five groups: 1) a control group, fed the AIN-93G diet mixed with 10% (w/v) lard and 0.7% (w/v) cholesterol to induce hyperlipidemia (control); 2) three experimental groups, fed the AIN-93G diet mixed with a high-fat source plus concentrated onion extract at three different levels (termed the low-dose, medium-dose, and high-dose groups); and, 3) a placebo group, fed the AIN-93G diet with fats plus the same concentrated extract but devoid of onion-derived material. All five groups freely ingested their respective diets over 6 weeks. At 0, 3, and 6 weeks, blood samples were collected from the orbital sinus following overnight food deprivation. At 6 weeks, livers were collected. Both control and experimental groups continually gained body weight throughout the study. No significant differencein body weight gain was observed among groups. However, the serum concentrations of triglycerides, total cholesterol, and non HDL-cholesterol were significantly reduced by ingestion of concentrated onion extract. Also, the hepatic levels of total lipids and total fatty acids, especially C18:1 (oleic acid), were significantly decreased in rats fed a high level of concentrated onion extract, compared with the control and placebo groups. These results provide clear evidence that ingestion of a concentrated onion extract has a profound inhibitory effect on serum lipid levels in rats fed a high-fat diet. Our findings indicate that a concentrated onion extract may be used to alleviate hyperlipidemia by lowering serum cholesterol and triglyceride levels.