• 한방안이비인후피부과학회지
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• 제21권2호
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• pp.94-101
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• 2008

Objectives : To discuss the types of control groups in randomized controlled trials (RCTs) of herbal medicine, and to provide suggestions for improving the design of control group in future clinical trials. Methods : We reviewed the 8 articles about clinical trial design of Chinese herbal preparation which were published from 2005 through 2008. We selected those articles from CNKI(中國知識基礎施設工程(http://www.cnki.net)). Results : It is necessary to have control group in randomized controlled trials(RCTs) of Korean herbal preparation. But there are problems in the selection of appropriate control group drug. This paper lists several problems about the choice of control drug and puts forward some proposals and countermeasures. There are problems such as ethics and manufacturing matching placebo and positive control herbal drug. Conclusion : To improve the quality of control group design, we introduce standard drug plus placebo drug method and add-on research for placebo control group design, double dummy technique, using negative control drug or composite control drug for active control group design.

• 대한물리치료과학회지
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• 제25권2호
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• pp.15-23
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• 2018

Purpose: The purpose of this study was to investigate the effects of Interferential current stimulation therapy(ICT) on pain, balance, and walking ability of elderly patients with chronic low back pain. Methods: Twenty participants were randomly assigned to ICT group (2 males and 8 females) and placebo ICT group (3 males and 7 females). Participants were ICT and placebo ICT for 20 minutes, and the pre- and post-VAS, TUG and postural balance were measured. Results: The ICT group showed significantly decreased pain scores in the elderly patients with chronic low back pain (p<.05) than the placebo ICT group. The postural fluctuation with eyes opened and closed was significantly lower than the placebo ICT group(p<.05), and the ICT group showed remarkable improvement (p<.05). Conclusion: ICT was expected to improve decrease pain, improve postureal sway and walking ability remarkably. Therefore, It was expected that the application or ICT would be an effective method for elderly patients with Chronic Low Back Pain.

• Nutrition Research and Practice
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• 제11권5호
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• pp.396-401
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• 2017

BACGROUND/OBJECTIVES: In this randomized, placebo-controlled, double-blind study, we evaluated the antihypertensive effects of enzymatic hydrolysate from Styela clava flesh tissue in patients with type 2 diabetes mellitus (T2DM) and hypertension. SUBJECTS/METHODS: S. clava flesh tissue hydrolysate (SFTH) (n = 34) and placebo (n = 22) were randomly allocated to the study subjects. Each subject ingested two test capsules (500 mg) containing powdered SFTH (SFTH group) or placebo capsules (placebo group) during four weeks. RESULTS: In the SFTH group, systolic and diastolic blood pressure decreased significantly 4 weeks after ingestion by 9.9 mmHg (P < 0.01) and 7.8 mmHg (P < 0.01), respectively. In addition, the SFTH group exhibited a significant decrease in hemoglobin $A_{1c}$ with a tendency toward improvement in homeostasis model assessment of insulin resistance, triglyceride, apolipoprotein B and plasma insulin levels after 4 weeks. No adverse effects were observed in other indexes, including biochemical and hematological parameters in both groups. CONCLUSION: The results of our study suggested that SFTH exerts a regulatory, antihypertensive effect in patients with T2DM and hypertension.

• Child Health Nursing Research
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• 제12권2호
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• pp.253-259
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• 2006

Purposes: Venipuncture is one of the most painful and frequently performed invasive procedure for children by nurses. The purpose of this study was to investigate the effect of EMLA cream(eutectic mixture of local anesthetics: 2.5% lidocaine and 2.5% prilocaine) to decrease venipuncture related pain and anxiety in children. Methods: A randomized, double blinded, placebo-controlled study was conducted. Sixty children scheduled venipuncture were recruited, and randomly allocated to receive either EMLA or a placebo cream 1 hour before venipuncture. Venipuncture was carried out by one nurse investigator. Pain and anxiety was measured by parent, nurse investigator, and nurse observer. Results: Pain in the EMLA group was significantly lower than that of placebo group. However, there was no significant difference in anxiety score between the EMLA and placebo groups. Local side effect of EMLA cream were negligible. Conclusions: EMLA cream was found to be an effective local anesthetic for pediatric venipuncture pain. Further studies should continue to evaluate the facilitators and barriers of EMLA cream application in pediatric nursing practice.

• 대한한의학회지
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• 제31권5호
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• pp.146-166
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• 2010

Objective: Few data were available on glycemic control at the early prediabetic stage, though it is the important stage to prevent diabetes mellitus. The purpose of this research was to examine the glycemic control effects of herb medicine treatment (DA-9802) in prediabetic stage patients Methods: In this randomized, single blind, placebo-controlled study, we compared Sanyak extract (DA-9802) with placebo for the treatment of glycemic control effects in prediabetic stage patients. 45 volunteers who satisfied the requirements were enrolled in the study. They took Sanyak extract (DA-9802) or placebo treatment three times a day for 8 weeks. Blood sugar, Total Symptom Score (TSS) and blood serum were measured at weeks 0, 4, and 8. Results: In the DA-9802 group, fasting blood sugar changes between before 8 weeks significantly decreased. Fasting blood sugar, fasting blood sugar gaps between before and after treatment for 8 weeks, insulin changes and C-peptide significantly decreased at 8 weeks compared with those of the placebo group. Conclusion: Herb medicine treatment (DA-9802) is effective in glycemic control on prediabetic stage.

• The Journal of Korean Physical Therapy
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• 제23권4호
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• pp.23-28
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• 2011

Purpose: To investigate the effects of hyperbaric oxygen therapy (HBOT) on chronic low back pain in elderly patients with impaired functioning in daily life. Methods: 35 subjects with chronic low back pain were randomly allocated into two groups, HBOT group and Placebo group. We applied TENS and mechanical massage to the lower back in both groups. Then 35% oxygen at 1.4 ATA was given to the HBOT group and atmospheric oxygen at 1 ATA to the placebo group. Results: Comparing the HBOT group with the placebo group after performing interventions six times in 2 weeks, a statistically significant difference in the Visual Analogue Scale (VAS) and Oswestry Disability Index (ODI) scores was observed between the two groups. There was a statistically significant difference in VAS and ODI scores (56% and 34.97% respectively) between the HBOT group and the placebo group. A statistically significant difference was ascertained in the degree of variables VAS and ODI in the HBOT group. Conclusion: Application of HBOT in chronic low back pain could be beneficial for reducing pain and could help in functional recovery.

• 응용통계연구
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• 제21권6호
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• pp.947-957
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• 2008

비열등성 시험시에 치료군(treatment group)과 활성대조군(active control group)을 이용한 모형으로 Hauschke 등 (1999)이 제안한 모수적 검정법이 있다. 이 방법은 위약군(placebo group)과 직접적인 비교가 불가능하므로 Pigeot 등 (2003)이 세 군으로 확장한 검정법을 제안하였다. 그러나 이와 같은 두 검정법은 구체적인 분포가정이 필요하다. 이런 단점을 보완하기 위하여 본 논문에서는 비모수적 방법으로서 두 군 설계에 Wilcoxon 순위합 검정(Wilcoxon, 1945)을 이용한 방법을, 세 군 설계에 Scheirer 등 (1976)이 제안한 선형대비검정을 확장한 새로운 방법을 제안한다. 또한 모의실험을 통하여 모수적 방법과 비모수적 방법간의 검정력을 비교하였다.

• Korean Journal of Acupuncture
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• 제23권1호
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• pp.95-109
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• 2006

Objectives : There has been a considerable debate about how to best control for placebo effects in clinical trials of acupuncture. Recently several sham needles were developed and validated. This study aimed at summarising the validation studies of these needles and evaluating the outcomes of the randomised controlled trials (RCTs) using them. Methods : Computerised literature searches were performed using 'acupuncture' AND 'placebo OR sham' with a limitation of the results to RCTs in Medline via PubMed and the Cochrane Library. Only formally validated sham needle controlled studies were included. Data were extracted regarding study design, condition, sample size, credibility testing, intervention and outcomes. Methodological quality was assessed using a modified Jadad scale. Results : Three validated sham needles by Streitberger, Park, and Fink, were identified. Acupuncture's effectiveness for various conditions was tested using these needles in 12 RCTs. Real acupuncture was superior to sham acupuncture for rotator cuff tendonitis and hypertension. No significant differences between real acupuncture and sham acupuncture emerged for chemotherapy-related nausea and vomiting, postoperative nausea and vomiting, menstrually related migraine, acute stroke rehabilitation, chronic/episodic tension-type headache, neutrophil respiratory burst in healthy volunteers, alcohol withdrawal symptoms and chronic poststroke leg spasticity. Conclusions : The new sham devices have been adequately validated and may be useful tools for investigating specific research question. In spite of the sham needle's limits, the results of RCTs using such devices tend to suggest that the clinical effects of acupuncture are largely due to a placebo response.

• International Journal of Contents
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• 제7권2호
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• pp.59-63
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• 2011

The aim of our study was to evaluate the immediate effects of an 830-nm Aluminium gallium arsenide (GaAlAs) laser, by examining the changes, in pressure-pain threshold (PPT) and tenderness at 3 kg of the myofascial trigger point (MTrP) of the upper trapezius muscle in visual display terminal (VDT) workers in comparison with placebo treatment. Thirty VDT workers (13 males, 17 females) with complaints of upper trapezius muscle were recruited. All participants were given either active GaAlAs laser (830 nm wavelength, 450 mW, 9 J at point) or placebo GaAlAs laser, according to the double-blinded and placebo-controlled trial. Both active and placebo low-level laser therapy (LLLT) treatments showed no significant effect on PPT and tenderness at 3 kg. These results suggest that a higher dosage may be necessary to produce immediate effects when applying LLLT to the MTrP of relatively large muscles such as the upper trapezius muscle.

• 한국임상약학회지
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• 제29권4호
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• pp.247-253
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• 2019

Background: Glutamate is implicated in the pathophysiology of migraine, a common neurological disorder. Therefore, glutamate receptor antagonists (GluRAs) have been suggested as a novel migraine treatment that are able to overcome the limitations of triptans. Objective: The aim of this study was to perform a meta-analysis to assess the efficacy of GluRAs for patients with migraine. Method: The PubMed, Cochrane Library, CINAHL, and Clinical Trial.gov databases were searched for randomized placebo-controlled trials of the efficacy of GluRAs for patients with migraine conducted up to August 2019. Two independent reviewers screened the literature according to inclusion and exclusion criteria and performed quality assessment and data extraction. Review Manager 5.3 software was used for the meta-analysis. Results: Three studies involving a total of 206 patients were included in the final analysis. Compared with placebo, GluRAs significantly improved the pain-free response at 2 hours (odds ratio [OR]=3.85, 95% confidence intervals [CIs]=1.63-9.09) and the 24-hour sustained pain freedom (OR=7.40; 95% CIs=2.36-23.20). The use of rescue medications with GluRAs was lower compared to that with placebo, but the difference was not significant (OR=0.39, 95% CI=0.10-1.47). Conclusion: Our meta-analysis showed that GluRAs were more effective than placebo for patients with migraine.