• 제목/요약/키워드: Placebo-controlled study

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STRICTA 권장안에 기초한 침 연구방법론의 적절성 평가;새로운 평가지수를 이용한 5편 Systematic Review와 그 대상인 58편 무작위대조시험의 고찰 (The Assessment of Appropriateness of Acupuncture Methodology Based on STRICTA Recommendations;The Discussion of 5 Systematic Reviews and Their Objects 58 Randomized Controlled Trials Using the New Tool)

  • 김우영;이승덕;임병묵;김갑성
    • Journal of Acupuncture Research
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    • 제24권5호
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    • pp.151-170
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    • 2007
  • Backgraounds : Recent studies provide the evidences that the efficacy of acupuncture may be no better than placebo or inconclusive. These results are very different from those of the actual clinical situations in many acupuncture medical institutions. Objectives : The present study was designed to evaluate the influencing factors which affect the efficacy of acupuncture scale(FEAS) as the methodological assessment tool of acupuncture for examining acupuncture interventions and to demonstrate the importance of it in randomized controlled trials of acupuncture. Data sources : Electronic data were retrieved from NDSL, Pubmed, sciencedirect, LWW, OVID, Black-Well Synergy, Wiley Interscience, EBSCO HOST, springer, PML, and Kluwer. No electronic data were collected from MEDLIS and MEDLAS. Study selection : The inclusion criteria were five systematic reviews included in Alberta study and all randomized controlled trials obtained from their references. Study analysis : The acupuncture rationale, methods of stimulation, treatment regimen, and the practitioner's background were rated by FEAS, and the scores were compared with those by other methodological assessment tools. Results : The number of positive conclusions of high-rank RCTs by FEAS was the same as or higher than that of high-rank RCTs by other methodological assessment tools. Conclusions : We have analysed 5 systematic reviews and their objectives 58 RCTs using FEAS. Practitioner's background has been described slightly in some reviews and studies. It may directly influence the effectiveness of acupuncture negatively in the systematic reviews.

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골반염의 침치료에 대한 최신 연구 동향 (Research Trends of the Acupuncture Treatment for Pelvic Inflammatory Disease)

  • 강누리;황덕상;이진무;이창훈;장준복
    • 대한한방부인과학회지
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    • 제33권1호
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    • pp.76-85
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    • 2020
  • Objectives: The purpose of this review is to overview the studies of acupuncture treatment for pelvic inflammatory disease. Methods: In order to investigate the effect of acupuncture treatment for pelvic inflammatory disease, we searched relevant studies in Pubmed, Cochrane, Oasis, Korean studies Information Service System up to March 2019. After searching studies, we analyzed selected studies. Results: Five studies were included in this review. There were 1 randomized controlled studies and 4 before and after studies. The outcome measurement of pelvic inflammatory disease was divided into effective rate, physical examination, response, hematological parameter, pain. The acupuncture treatment was effective in improving pelvic inflammatory disease. Conclusions: This study shows that acupuncture treatment is one of effective treatment methods for pelvic inflammatory disease. Further large randomized placebo controlled trials will be needed.

외음부 통증(陰痛)의 침치료에 대한 최신 연구 동향 (Research Trends of the Acupuncture Treatment for Vulvodynia)

  • 임지영;황덕상;이진무;이창훈;장준복
    • 대한한방부인과학회지
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    • 제32권1호
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    • pp.26-36
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    • 2019
  • Objectives: The purpose of this review is to overview the studies of acupuncture treatment for vulvodynia. Methods: In order to investigate the effect of acupuncture treatment for vulvodynia, we searched relevant studies in Pubmed, Cochrane, Oasis, KISS up to October 2018. After searching studies, we analyzed selected studies. Results: Six studies were included in this review. There were 3 randomized controlled studies and 3 before and after studies. The outcome measurement of vulvodynia was divided into pain, sexual function, and quality of life. The acupuncture treatment was effective in relieving vulvar pain, dyspareunia and improving quality of life. Conclusions: This study shows that acupuncture treatment is one of effective treatment methods for vulvodynia. Further large randomized placebo controlled trials will be needed.

The influence of obesity on the effects of spirulina supplementation in the human metabolic response of Korean elderly

  • Park, Hee-Jung;Lee, Hyun-Sook
    • Nutrition Research and Practice
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    • 제10권4호
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    • pp.418-423
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    • 2016
  • BACKGROUND/OBJECTIVES: Spirulina, a blue-green alga, is widely produced and commercialized as a dietary supplement with bio- and immune-modulatory functions. We have previously shown that spirulina had favorable effects on lipid profiles, immune functions, and antioxidant capacity in healthy Korean elderly. Despite favorable effect of spirulina supplementation, some sub-populations have shown a poor response to supplementation. Obesity is a factor related to poor-response. Therefore, the purpose of this study was to determine the immuno-modulation, antioxidant capacity, and lipid-lowering effect of spirulina in obese and non-obese Korean elderly. SUBJECTS/METHODS: The subjects were 78 elderly aged 60-87 years. In a randomized double blind, placebo-controlled study, subjects were fed either placebo or spirulina daily, at 8 g for 12 weeks. Subjects were divided into the non-obese group and the obese group based on body mass index (BMI) criteria for Asians suggested by the International Obesity Task Force: $BMI<25kg/m^2$ (non-obese) and $BMI{\geq}25kg/m^2$ (obese). RESULTS: In the non-obese group, spirulina supplementation showed a significant lowering effect on plasma concentration of total cholesterol and LDL-cholesterol, a significant increase in interleukin (IL)-2 concentration (P < 0.01) and a significant increment (P < 0.05) in IL-2/IL-6 ratio, and a significant increase in total antioxidant status level and a significant decrease in thiobarbituric acid reactive substances level. However, these effects were not observed in the obese group. CONCLUSION: These results demonstrated that blood lipid lowering and immune and antioxidant improving response for spirulina supplement was affected by obesity in Korean elderly.

만성 어깨 통증의 한약 추출 외용 젤 치료에 대한 임상연구 (A Randomized Controlled Clinical Trial of Topical Herbal Gel Treatment for Chronic Shoulder Pain)

  • 조수정;최영두;장진택;김갑성;이승덕
    • Journal of Acupuncture Research
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    • 제31권4호
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    • pp.1-9
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    • 2014
  • Objectives : The aim of this study is to evaluate the efficacy of a topical herbal gel application for the treatment of chronic shoulder pain. Methods : We compared the effects of Dapureo gel, which contains several herbal medicines known to improve shoulder pain, with those of placebo gel by double-blind method. 30 participants were randomized - 15 were assigned to treatment group and the other 15 were assigned to control group. Either Dapureo gel(treatment group) or placebo gel(control group) was applied topically by themselves, once a day for 2 weeks. Primary outcome was daily visual analogue scale(VAS) changes for shoulder pain which was self-reported for 2 weeks. Secondary outcome was the difference in the total shoulder pain and disability index(SPADI) which was measured at a baseline and 2 weeks after the treatment. Results : Primary outcome: Subjects of treatment group showed statistically significant improvement in VAS compared to control subjects continuously from the second day(p <0.05) to the fifteenth day(p <0.001). The treatment group showed 31% of pain reduction on the fifteenth day, while the control group showed only 7%. Secondary outcome: In terms of SPADI changes, the treatment group showed improvement compared to the control group(p <0.01). Conclusions : These results suggest that the topical herbal gel treatment used in this study is effective in improving chronic shoulder pain.

The antiplaque and bleeding control effects of a cetylpyridinium chloride and tranexamic acid mouth rinse in patients with gingivitis

  • Lee, Ji-Eun;Lee, Jae-Mok;Lee, Youngkyun;Park, Jin-Woo;Suh, Jo-Young;Um, Heung-Sik;Kim, Yong-Gun
    • Journal of Periodontal and Implant Science
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    • 제47권3호
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    • pp.134-142
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    • 2017
  • Purpose: This study aimed to evaluate the effects of a cetylpyridinium chloride (CPC) and tranexamic acid (TXA) mouth rinse on patients with gingivitis. Methods: This randomized, placebo-controlled, double-blind, parallel-group, clinical trial included 45 healthy adults with gingivitis, who were randomized into 2 groups. The experimental group used a 0.05% CPC and 0.05% TXA mouth rinse, and the control group used a placebo mouth rinse. The following clinical indices were assessed at baseline, at 3 weeks, and at 6 weeks: the Turesky-Quigley-Hein plaque index (QHI), the $L{\ddot{o}}e-Silness$ gingival index (GI), and bleeding on marginal probing (BOMP). The subjects used the mouth rinse during the experimental period for 20 seconds, 4-5 times daily (10 mL each time). Results: There were no significant differences in the clinical indices between the groups at baseline. In the experimental group (CPC+TXA), a statistically significant improvement was evident in the QHI, GI, and BOMP at 3 and 6 weeks. These results were similar to those observed in the control group at 3 and 6 weeks, although the change in BOMP was not statistically significant in that group. At 6 weeks, the experimental group had a significantly lower mean score for the QHI than the control group. Conclusions: This study demonstrated that a CPC and TXA mouth rinse exhibited significant antiplaque and anti-gingivitis efficacy, and had a positive effect on bleeding control when used daily for 6 weeks.

Effects of γ-aminobutyric acid-enriched fermented sea tangle (Laminaria japonica) on brain derived neurotrophic factor-related muscle growth and lipolysis in middle aged women

  • Choi, Wook-chul;Reid, Storm N.S.;Ryu, Je-kwang;Kim, Yunsook;Jo, Young-Hong;Jeon, Byeong Hwan
    • ALGAE
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    • 제31권2호
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    • pp.175-187
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    • 2016
  • This study evaluated the effects of γ-aminobutyric acid (GABA)-enriched fermented sea tangle (GFST), as a functional food, on brain derived neurotrophic factor (BDNF)-related muscle growth and lipolysis, in a sarcopenic obesity high-risk group. Twenty-one middle-aged women (53-63 y) participated in this randomized, double-blind, placebo controlled study. Participants ingested either 1,000 mg of GFST (n = 10) or a sucrose placebo (CON) (n = 11) everyday, for 8 weeks. Subjects were asked to abstain from any regular exercise. Fasting venous blood samples, body composition and muscular strength were measured before and after supplementation period. Collectively, we demonstrated that GFST significantly decreased total fat mass and triglyceride in body composition, as well as significantly increasing serum BDNF (p < 0.001), angiotensin converting enzyme (p < 0.001), human growth hormone and insulin-like growth factor-1 levels (p < 0.05 and p < 0.05, respectively) accompanied by increased total lean mass (p < 0.01). Furthermore, the reported improvements in total work, knee extension and flexion at 60° s−1 (p < 0.05), and peak torque normalized to body weight of knee flexion at 60° s−1 (p < 0.05), support an ergogenic effect of GABA associated with increased growth factor levels. The use of GFST, as a functional food ingredient, to elicit anti-obesity effects and stimulate the release of muscle-related growth factors with increasing serum BDNF levels may provide a protective intervention for age-related degeneration such as sarcopenic obesity.

성요한초제제 임상시험 고찰을 통한 한약기원 항우울제 임상시험 방법론 연구 (A Study on the Methodology for a Clinical Trial of an Antidepressive Korean Herb by Comparison with St. John's Wort Trials)

  • 정희;이지형;장보형;고성규
    • 대한한방내과학회지
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    • 제28권2호
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    • pp.363-376
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    • 2007
  • Objectives : This study was undertaken to learn what should be considered in a good clinical trial investigating a herbal medicine as an antidepressant. Methods : Five well-designed clinical trials published from 2000 to 2006 investigating SJWE in depressive disorder were selected. The trials were reviewed and compared in terms of methodology such as trial design, patient selection, efficacy & safety evaluation, and so on. On the basis of this review of the trials and the regulations and guidelines of KFDA, we suggest some points to be considered for a good clinical trial of a herb for depression. Results : Although every trial had its own unique design, procedure, objectives and so on, all trials used randomizing and double blinding methods. If there is no ethical problem, a placebo-controlled design should be considered in a herbal antidepressant clinical trial for depression. Conclusions : Some points to be considered in an optimal & good clinical trial for an antidepressive herbal medicine were suggested as follows: 1) randomizing and double blinding manner is essential, 2) if there is no ethical problem, placebo control design should be considered, 3) the trial period should be 6 weeks, 4) out-patients will be recruited as subjects, 5) investigators will be well-trained psychiatrists or medical doctors, 6) the number of subjects should be calculated by statistical methods, 7) subjects should be diagnosed by DSM-IV criteria, 8) subjects who have current risk of committing suicide should be excluded, etc.

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효모추출복합물과 헛개나무 열매추출 복합물이 알코올 대사에 미치는 영향 - 무작위, 이중맹검, 위약 대조군, 교차 인체적용시험 - (Effects of Improving Alcohol Metabolism of Yeast Extract Mixtures and Hovenia dulcis Mixtures in Healthy Men - A Double-Blind, Randomized Crossover, Placebo-Controlled Trial -)

  • 조보람;남충우;정세영;정인경;문민선
    • 한국식품영양학회지
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    • 제30권4호
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    • pp.735-741
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    • 2017
  • This study was conducted to investigate if the supplement formula may improve alcohol metabolism in healthy adult men. In a double-blinded, randomized, crossover study, subjects were administrated yeast extract mixtures (YEM, n=15), Hovenia dulcis mixtures (HDM, n=15), placebo (PLA, n=15), and control (CON, n=15) in an oral dose followed by one week washout periods. At each visit (0, 1, 2, 3, 4 week), subjects drank 450 mL, 20.1 percent alcohol after administered mixtures. Blood was drawn periodically (0, 0.25, 0.5, 1, 2, 4, 6, 15 hours). Fifteen subjects completed the protocol and were included in the analysis. Plasma ethanol concentration was lower in YEM (10 percent) and the HDM (5 percent) groups. The area under the curves (AUC) and $C_{max}$ for plasma ethanol were significantly decreased only in the YEM group, when compared with the CON group. The AUC and $C_{max}$ for plasma acetaldehyde concentration were significantly decreased in the YEM (45 and 54 percent) and the HDM (35 and 53 percent) groups respectively, when compared with PLA (p<0.01). Together, these findings validate that YEM or HDM improved alcohol metabolism and hangover syndromes, leading to reduce alcohol concentration and acetaldehyde concentration without adverse effects.

파킨슨병의 침 치료 효과에 대한 최신 연구 동향 고찰 - 최근 5년간의 임상 연구를 중심으로 - (Review on the effect of acupuncture on Parkinson's disease over the last 5 years)

  • 김서영;임영우;김은주;박성욱
    • 대한한의학회지
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    • 제43권1호
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    • pp.112-135
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    • 2022
  • Objectives: The objective of this study was to summarize clinical studies conducted over the last five years that investigated the effect of acupuncture on Parkinson's disease and to propose a better process of study. Methods: Research Information Sharing Service (RISS), Korea Studies Information Service (KISS), Cochrane Central Register of Controlled Trials (CENTRAL), PubMed, Embase, and China National Knowledge Infrastructure (CNKI) were systemically searched for clinical trials that had investigated the effect of acupuncture on the course of Parkinson's disease from May 2016 to April 2021. Results: A total of 23 studies met all the inclusion criteria. In most reports, acupuncture had significant positive effects on the course of Parkinson's disease. Furthermore, there were no serious adverse events associated with acupuncture in any of the studies. In addition to the acupuncture methods that showed effectiveness in previous studies, various types of acupuncture have been used to treat sub-symptoms of Parkinson's disease. The outcome measures were subdivided through individual symptom evaluation and mechanical analysis. Follow-up assessments were also performed to analyze the continuous effect. Conclusion: In the clinical studies conducted over the last five years, many studies investigated the various types of acupuncture used to treat Parkinson's disease and the segmentation and diversification of outcome measures focusing on individual symptoms, and a new approach for excluding placebo effects through follow-up studies has been made. Further attempts like these are needed to overcome methodological flaws in studies on the effects of acupuncture on Parkinson's disease.