• Korean Journal of Acupuncture
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• v.25 no.2
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• pp.57-69
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• 2008

Objectives : To review the controlling methods used in RCTs (randomized controlled trials) of auricular acupuncture. Methods : To investigate the controlling methods used in clinical trials of auricular acupuncture, 46 articles were retrieved from PUBMED (from August 1976 to August 2007, with limits: english, clinical trial) using the key words of "ear acupuncture", "auricular acupuncture", "auriculo-medicine", and sorted out according to the types of control treatments. Among them, 10 articles were selected based on STRICTA (Standards for Reporting Intervention in Controlled Trials of Acupuncture), and the controlling methods used in those articles were reviewed. Results : In clinical trials of auricular acupuncture, 'sham acupoints (non-acupoints and non-treatment acupoints included)', 'minimal acupuncture', 'pseudo-intervention', and 'placebo devices' have been used as controlling methods, but their 'inactivity' have been in question. To compensate the disadvantages of 'minimal acupuncture', and 'pseudo-intervention' control, placebo auricular acupuncture needles have been developed, although these needles didn't satisfy the conditions of 'blinding' and 'physical inactivity' simultaneously. Conclusions : Further researches on 'sham acupoints' and new development of 'placebo auricular acupuncture needles' are needed.

• The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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• v.21 no.2
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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.

• Journal of Korean Physical Therapy Science
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• v.25 no.2
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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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• v.11 no.5
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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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• v.12 no.2
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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.

• The Journal of Korean Medicine
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• v.31 no.5
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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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• v.23 no.4
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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.

• The Korean Journal of Applied Statistics
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• v.21 no.6
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• pp.947-957
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• 2008

Two-arm non-inferiority trials is often applied to parametric procedure suggested by Hauschke et al. (1999). Since this design does not allow a direct comparison of a new treatment group with placebo group, parametric procedure in a three-arm non-inferiority trial with a placebo group was suggested by Pigeot et al. (2003). But, procedures in these designs are necessary for distribution assumptions. Therefore we propose, in this paper, non parametric procedures employing Wilcoxon rank sum test in a two-arm design and linear contrast test suggested by Scheirer et al. (1976) in a three-arm design. The proposed nonparametric procedures and parametric procedures are compared by Monte Carlo simulation study.

• Korean Journal of Acupuncture
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• v.23 no.1
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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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• v.7 no.2
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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.