• Korean Journal of Acupuncture
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• v.35 no.2
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• pp.47-55
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• 2018

Objectives: Clinical improvements can be observed following placebo administrations in clinical trials. Randomized controlled trials have been conducted to disentangle the specific effects of therapeutic interventions over the past decade. In acupuncture trials, non-penetrating placebo needles offer the opportunity to determine the specific effects of needling. Methods: The present review provides an overview of the concept of the placebo effect and the characteristics of the placebo needles. Results: Placebo control can contribute to minimize for bias and the contextual and psychological components of therapeutic interventions. Placebo control should meet two criteria: blinding efficacy (indistinguishable from active treatment) and physiological inertness. In the case of acupuncture, however, it is difficult to meet both criteria simultaneously. The dilemma of placebo needles suggests that placebo needles do not constitute proper control in acupuncture research. Considering the characteristics of placebo needles, patients are more likely to perceive placebo needles as active treatment in acupuncture trials compared to placebo pills in pharmaceutical trials. Placebo response might be observed more frequently to placebo needles than to placebo pills. When acupuncture treatments are utilized in clinical use, placebo effects can be enhanced by exploiting patients' expectations in the contextual or environmental cues that surround medical intervention. Conclusions: We have to consider these unique characteristics of placebo needles in order to avoid drawing premature conclusions that acupuncture itself is just a placebo.

• Korean Journal of Biological Psychiatry
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• v.19 no.4
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• pp.164-171
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• 2012

The placebo effect, a response observed during the placebo arm of a clinical trial, is produced by the psychobiological action of the placebo as well as by other potential contributors to symptom amelioration such as spontaneous improvement, regression to the mean, biases, concurrent treatments, and study design. From a psychological viewpoint, there are many mechanisms that contribute to placebo effects, including expectations, conditioning, learning, and anxiety reduction. Placebo responses are also mediated by opioid and non-opioid mechanisms including dopamine, serotonin, cholecystokinin, and immune mediators. During recent years, a trend towards increased placebo effects in clinical trials of neuropsychiatric drugs has been noted. Indeed, the placebo effects observed in clinical trials constitute an increasing problem and interfere with signal-detection analyses of potential treatments. Several potential factors including protocol/study design and conduct related factors may account for the placebo effect observed in clinical trials. This paper reviews key issues related to this problem and aims to identify potential solutions.

• Culinary science and hospitality research
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• v.21 no.6
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• pp.158-166
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• 2015

The purpose of this study is to verify whether education on the placebo effect has significant impacts on the knowledge of the placebo effect, as well as the intention of healing food intake. For this purpose, 37 experimental group students and 29 control group students participated in the experiment. The results were as follows. First, education on the placebo effect did not appear to have significant impact on the functional value although it did have significant impact on emotional value and nutritional value. Second, knowledge of the placebo effect gained from the education had significant influence on intention of healing food intake. Third, only nutritional value showed a statistically positive (+) impact on intention of healing food intake.

• Journal of Ginseng Research
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• v.20 no.2
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• pp.125-132
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• 1996

To investigate the effect of Korean red ginseng (KRG) on male sexual function and serum lipid level, the results of KRG treatments were compared to placebo group. A total of 35 patients with psychogenic impotence were assigned to medication group with KRG (n=28) and placebo (n=7). KRG and placebo were given to each group for 2 months. Changes in symptoms such as frequency of coitus, morning erection, penile rigidity and tumescence were significantly higher in the group receiving KRG than placebo group. The overall therapeutic efficacies on erectile function were 67% for KRG group and 28% for placebo group (p <0.05). In the group treated with 9 tablets of KRG, there was tendency of better efficacy as compared to the group treated with 6 tablets of KRG. The level of serum high density lipid- cholesterol (HDL-cholesterol) was significantly elevated (p < 0.05) while the other serum lipid such as total cholesterol, tiglyceride and low density lipid-cholesterol (LDL-cholesterol) , were not changed after administration of KRG. This effect was observed significantly in the group in which KRG exerted its effect on sexual function(p < 0.05). From the above results, the administration of Korean red ginseng has shown to have superior of facts as compared to the placebo. The tendency of good effect was increased when a large amount of KRG was administered. The mechanism of KRG in improving sexual function would be the result of elevating the level of geum HDL-cholesterol in impotent patients. The effect of KRG was produced when the level of cholesterol was high before starting KRG medication. Therefore, the effect of KRG could be observed more intensively when the patients have high serum cholesterol level.

• Journal of Ginseng Research
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• v.47 no.6
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• pp.766-772
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• 2023

Background: Korean Red Ginseng (KRG) is an effective anti-stress treatment. In this study, we investigated the therapeutic potential effects of KRG on relieving stress in a general population using transcriptome analysis. Methods: We conducted an 8-week clinical pilot study on 90 healthy men who reported stress. The study was completed by 43 participants in the KRG group and 44 participants in the placebo group. Participants were randomized 1:1 to the KRG and placebo groups. We evaluated the stress by stress response inventory (SRI) at baseline and 8 weeks. The main outcomes were changes in the levels of neurotransmitters (NTs) and NT-related gene expression. NTs were analyzed using automated (GC) content, and levels of gene expression were measured by reads per kilobase of transcript per million mapped reads (RPKM). Results: The KRG group showed significantly preserved epinephrine decrease compared with placebo group at 8 weeks (changes in epinephrine, KRG vs. placebo; -1623.2 ± 46101.5 vs. -35116.3 ± 86288.2, p = 0012). Among subjects who higher SRI score, meaning stress increased compared to baseline, the KRG group showed a smaller decrease in serotonin than the placebo group (changes in serotonin, KRG vs. placebo; -2627.5 ± 5859.1 vs, -8087.4 ± 7162.4, p = 0.005) and a smaller increase in cortisol than the placebo group (changes in cortisol, KRG vs. placebo; 1912.7 ± 10097.75 vs. 8046.2 ± 8050.6 , p = 0.019) in subgroup analysis. Transcriptome findings indicated that KRG intake affects gene expression related with metabolism of choline, adrenalin, and monoamine. Conclusion: These findings suggest that KRG has beneficial effects on the amelioration of stress response in NTs, and this effect is more prominent in stressful situations. Further clinical studies are required to confirm the anti-stress effect of KRG.

• The Journal of Korean Physical Therapy
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• v.26 no.5
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• pp.331-343
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• 2014

Purpose: The purpose of this study is to assess the effectiveness of short-wave therapy (SWT) for treatment of knee osteoarthritis (OA) as compared to placebo and control, and to assess the question of whether the effects are related to the mode, dosage, and application method. Methods: We searched randomized, placebo-controlled trials using electronic databases. We also manually reviewed sources in order to identify additional relevant studies. Results: Eight studies (597 participants) with OA were included in the meta-analysis. Pulse SWT had a significant effect on pain relief compared with control treatment, while did not favour compared with the placebo group. Pulse SWT had a significant effect on functional improvement compared with control and placebo treatment. Continuous SWT had no effect on pain relief and functional improvement. Capacitive SWT a significant effect on pain relief, functional improvement, and muscle strength. Continuous and capacitive SWT had increased muscle strength significantly. We found no clinical significance of all outcomes except pain and functional improvement in pulsed SWT with low dose. There was no difference in adverse events. None of the participants experienced any serious adverse events. Conclusion: Low dose pulsed SWT provided a short-term clinical benefit for pain relief and functional improvement. Pulsed SWD with low and high dose had effects on pain and function. There seems to be a placebo effect. We found significant effects on pain and function in capacitive SWT. Despite some positive findings, this analysis lacked data on how effectiveness is affected by mode, dosage, and application method of SWT. Further well-designed clinical studies are required in order to confirm the effectiveness of SWT.

• Nutrition Research and Practice
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• v.9 no.6
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• pp.673-676
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• 2015

BACKGROUND/OBJECTIVES: Lactobacillus brevis G101 suppresses the absorption of monosodium glutamate (MSG) from the intestine into the blood in mice. Therefore, the attenuating effect of orally administered G101 on monosodium glutamate (MSG) symptom complex was investigated in humans MATERIALS/METHODS: Capsules (300 mg) containing Lactobacillus brevis G101 ($1{\times}10^{10}CFU/individual$) or maltodextrin (placebo) was orally administered in 30 respondents with self-recognized monosodium glutamate (MSG) symptom complex for 5 days and the rice with black soybean sauce containing 6 g MSG (RBSM) was ingested 30 min after the final administration. Thereafter, the MSG symptom complex (rated on a 5-point scale: 1, none; 5, strong) was investigated in a double blind placebo controlled study. The intensity of the MSG symptom complex was significantly reduced in respondents of the G101 intake group ($2.87{\pm}0.73$) compared to that in those treated with the placebo ($3.63{\pm}1.03$) (P = 0.0016). Respondents in the placebo group exhibited more of the various major conditions of the MSG symptom complex than in the G101 intake group. Although there was no significant difference in the appearance time of the MSG symptom complex between subjects orally administered G101 and those administered the placebo, its disappearance in < 3 h was observed in 69.9% of subjects in the G101 treatment group and in 38.0% of subjects in the placebo group (P = 0.0841). CONCLUSIONS: Oral administration of Lactobacillus brevis G101 may be able to reduce the intensity of the MSG symptom complex.

• Journal of Oriental Neuropsychiatry
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• v.31 no.3
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• pp.135-147
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• 2020

Objectives: Hwa-byung is a mental illness. It is also known as a Korean culture-related syndrome. In traditional Korean medicine, Sihogayonggolmoryeo-tang is used to treat Hwa-byung related neuropsychiatric symptoms. The purpose of this research was to examine the effect of Sihogayonggolmoryeo-tang on Hwa-byung. Methods: A multicenter, randomized, double-blinded, placebo-controlled study was performed for 160 patients with Hwa-byung. Patients were divided into a Sihogayonggolmoryeo-tang group and a placebo group. Treatment period was 8 weeks. Hamilton Rating Scale for Anxiety (HAM-A), Likert scale for major symptoms of Hwa-byung, Hwa-byung Scale (HBS), Korean Beck Depression Inventory (K-BDI), Korean State-Trait Anxiety Inventory (K-STAI), Korean State-Trait Anger Expression Inventory (K-STAXI), and Korean WHO Quality of Life Scale Abbreviated Version (WHOQOL-BREF) were used to evaluate the effect of Sihogayonggolmoryeo-tang on Hwa-byung. We also used an Instrument of Pattern Identification for Hwa-Byung to evaluate different responses for six patterns of patients. Results: Scores of all the measurements improved significantly for each group, showing no significant differences between the two groups. In the case of deficiency of both Qi and blood pattern, the Sihogayonggolmoryeo-tang group showed a significant decrease in the HAM-A score compared to the placebo group. Conclusions: The effect of Sihogayonggolmoryeo-tang on Hwa-byung did not exceed that of the placebo. Further studies involving more elaborate pattern identification are needed.

• Journal of Oriental Medical Thermology
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• v.7 no.1
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• pp.44-54
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• 2009

Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.

• The Journal of Korean Obstetrics and Gynecology
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• v.22 no.3
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• pp.223-235
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• 2009

Purpose: To evaluate thermal effect and medication compliance of red ginseng extract. Methods: Randomized, double-blind, placebo-controlled, cross-over clinical study was performed. Twenty four healthy, married women aged 30-45 years with FSFI score below 25 were randomly divided into two groups; red ginseng group(N=12) and placebo group(N=12). During the first 6-week period (Study1), each group was dosed with red ginseng or placebo twice a day. Before starting the second 6-week period(Study2), a crossover design was chosen with a 2-week break(Washout period). Interchanging two groups after Washout period, red ginseng and placebo were dosed to each group. The efficacy of thermal effect was measured with subjective warm sensation scale and lower abdomen temperature by Digital Infrared Thermographic imaging(DITI) before and after each 6-week period. A medication compliance was assessed after each 6-week period and the correlation medication compliance between Sasang Constitution and subjective warm sensation was analyzed. Results: Overall 23 participants completed the study. In subjective warm sensation scale, after taking placebo, all participants exhibited an improving trend, but there was no significant difference. In lower abdomen temperature by DITI, statistically significant objective thermal effect of red ginseng was also not shown. A medication compliance was higher in Yin constitution(Taeumin, Soeumin), and showed an upward trend with decreasing subjective warm sensation. But no statistically significant difference was exhibited. Conclusion: Statistically significant thermal effect of red ginseng was not shown in this study. We anticipate if a long-term clinical trial is practiced, significant thermal effect of red ginseng will be shown.