• Title/Summary/Keyword: placebo effect

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Effects of Caffeine on Auditory- and Vestibular-Evoked Potentials in Healthy Individuals: A Double-Blind Placebo-Controlled Study

  • Tavanai, Elham;Farahani, Saeid;Ghahraman, Mansoureh Adel;Soleimanian, Saleheh;Jalaie, Shohreh
    • Korean Journal of Audiology
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    • v.24 no.1
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    • pp.10-16
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    • 2020
  • Background and Objectives:The blockage of adenosine receptors by caffeine changes the levels of neurotransmitters. These receptors are present in all parts of the body, including the auditory and vestibular systems. This study aimed to evaluate the effect of caffeine on evoked potentials using auditory brainstem responses (ABRs) and cervical vestibular-evoked myogenic potentials (cVEMPs) in a double-blind placebo-controlled study. Subjects and Methods: Forty individuals (20 females and 20 males; aged 18-25 years) were randomly assigned to two groups: the test group (consuming 3 mg/kg pure caffeine powder with little sugar and dry milk in 100 mL of water), and the placebo group (consuming only sugar and dry milk in 100 mL water as placebo). The cVEMPs and ABRs were recorded before and after caffeine or placebo intake. Results: A significant difference was observed in the absolute latencies of I and III (p<0.010), and V (p<0.001) and in the inter-peak latencies of III-V and I-V (p<0.001) of ABRs wave. In contrast, no significant difference was found in cVEMP parameters (P13 and N23 latency, threshold, P13-N23 amplitude, and amplitude ratio). The mean amplitudes of P13-N23 showed an increase after caffeine ingestion. However, this was not significant compared with the placebo group (p>0.050). Conclusions: It seems that the extent of caffeine's effects varies for differently evoked potentials. Latency reduction in ABRs indicates that caffeine improves transmission in the central brain auditory pathways. However, different effects of caffeine on auditory- and vestibular-evoked potentials could be attributed to the differences in sensitivities of the ABR and cVEMP tests.

Cognitive function improvement effects of gintonin-enriched fraction in subjective memory impairment: An assessor- and participant-blinded placebo-controlled study

  • Rami Lee ;Han Sang Lee ;Won-Woo Kim ;Manho Kim ;Seung-Yeol Nah
    • Journal of Ginseng Research
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    • v.47 no.6
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    • pp.735-742
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    • 2023
  • Background: Gintonin is a new material of ginseng that acts through the ginseng-derived lysophosphatidic acid (LPA) receptor ligand. The gintonin-enriched fraction (GEF) inhibits amyloid plaque accumulation in the cortex and hippocampus, improves cognitive dysfunction by increasing acetylcholine levels, and promoted hippocampal neurogenesis in an animal model of Alzheimer's disease. We evaluated the effect of the GEF on the cognitive performance of subjects with subjective memory impairment (SMI). Methods: In this eight-week, randomized, assessor- and participant-blinded, placebo-controlled study, participants with SMI were assigned to three groups receiving placebo, GEF 300 mg/day or GEF 600 mg/day. The Korean versions of the Alzheimer's Disease Assessment Scale (K-ADAS), Mini-Mental State Examination (K-MMSE), and Stroop color-word test (K-SCWT) were also evaluated along with the safety profiles. Results: One hundred thirty-six participants completed the study. After eight weeks, we analyzed intergroup differences in primary or secondary outcome score changes. When we compared the GEF group with the placebo group, we observed significant improvements in the K-ADAS and K-SCWT scores. The GEF group did not show a significant improvement in K-MMSE and BDI scores compared to the placebo group. No adverse events were observed in the gintonin and placebo groups for eight weeks. Conclusion: The GEF is safe and effective in improving subjective cognitive impairment related to both the K-ADAS and K-SCWT in this study. However, further large-scale and randomized controlled studies are warranted to secure other cognitive function tests besides the K-ADAS and K-SCWT, and to confirm the findings of the current study.

Effect of high-dose ginsenoside complex (UG0712) supplementation on physical performance of healthy adults during a 12-week supervised exercise program: A randomized placebo-controlled clinical trial

  • Lee, Eon Sook;Yang, Yun Jun;Lee, Jun Hyung;Yoon, Yeong Sook
    • Journal of Ginseng Research
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    • v.42 no.2
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    • pp.192-198
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    • 2018
  • Background: Ginseng has been used as an ergogenic agent, although evidence for its effectiveness is weak. A randomized, double-blind, placebo-controlled clinical trial was conducted to evaluate the effect of a ginsenoside complex (UG0712) on changes in exercise performance. Methods: Sedentary individuals (n = 117) were randomly assigned into one of three groups: low-dose ginsenoside supplementation (100 mg/d, n = 39), high-dose ginsenoside supplementation (500 mg/d, n = 39), or a placebo group (500 mg/d, n = 39). All participants underwent a supervised 12-wk aerobic and resistance exercise training course. To assess the effects of supplementation on physical performance, maximal oxygen consumption ($VO_2max$), anaerobic threshold (AT), lactic acid, and muscle strength of the dominant knee were measured at baseline, every visit, and after the training program. Results: Both ginsenoside groups showed significant increases in $VO_2max$ and muscular strength during exercise training. There were no definite changes in AT and lactic acid levels over time. After exercise training, there were definite differences in the $VO_2max$ (28.64.9 to $33.7{\pm}4.9ml/kg/min$ in high-dose group vs. $30.4{\pm}6.7$ to $32.8{\pm}6.6ml/kg/min$ in placebo, p = 0.029) and AT ($19.3{\pm}4.2$ to $20.9{\pm}3.5ml/kg/min$ in high-dose group vs. $20.0{\pm}5.1$ to $20.0{\pm}4.9ml/kg/min$ in placebo, p = 0.038) between the high-dose ginsenoside and placebo groups. However, there was no difference in $VO_2max$ between the low-dose ginsenoside and placebo groups (p = 0.254). There were no differences in muscular strength during exercise training among the three groups. Conclusion: High-dose ginsenoside supplementation (UG0712) augmented the improvement of aerobic capacity by exercise training.

Effect of Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 on Acute Watery Diarrhea: A Randomized Double-Blind Placebo-Controlled Study in Indian Children

  • Ghosh, Apurba;Sundaram, Balasubramaniam;Bhattacharya, Piyali;Mohanty, Nimain;Dheivamani, Nirmala;Mane, Sushant;Acharyya, Bhaswati;Kamale, Vijay;Poddar, Sumon;Khobragade, Akash;Thomas, Winston;Prabhudesai, Sumant;Choudhary, Ankita;Mitra, Monjori
    • Pediatric Gastroenterology, Hepatology & Nutrition
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    • v.24 no.5
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    • pp.423-431
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    • 2021
  • Purpose: To assess the effect of combination probiotic Saccharomyces boulardii CNCM-I 3799 and Bacillus subtilis CU-1 in outpatient management of acute watery diarrhea in children. Methods: A randomized double-blind placebo-controlled study was conducted in 180 participants aged six months to five years with acute mild to moderate diarrhea. All were enrolled from six centers across India and centrally randomized to receive S. boulardii CNCM-I 3799 and B. subtilis CU-1 or a placebo along with oral rehydration salts and zinc supplementation. Each participant was followed up for three months to assess recurrence of diarrhea. Results: The mean duration of diarrhea in the probiotic and placebo groups were 54.16 hours and 59.48 hours, respectively. The difference in the duration of diarrhea in those administered with probiotic or placebo within 24 hours of diarrhea onset was 25.21 hours. Furthermore, the difference in duration of diarrhea was 13.84 hours (p<0.05) for participants who were administered with probiotics within 48 hours. There were no significant differences in the stool frequencies between the two arms. After three months, 15% in the probiotic group and 18.5% in the placebo group reported episodes of diarrhea. The mean duration of diarrhea was considerably lower in the probiotic group, 31.02 hours versus 48 hours in placebo (p=0.017). Conclusion: S. boulardii CNCM-I 3799 and B. subtilis CU-1 combination was effective in reducing the duration of diarrhea when administered within 48 hours of diarrhea onset. Similarly, it reduced recurrence of diarrhea and its intensity in the subsequent three months.

Effect of Hominis Placenta Pharmacopuncture for a Patient with Mild Cognitive Impairment: A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Trial

  • Kim, Yunna;Eom, Yoon Ji;Kwon, Dohyung;Lee, Jae Hyok;Jung, In Chul;Cho, Eun;Lee, Ji Eun;Cho, Seung-Hun
    • Journal of Oriental Neuropsychiatry
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    • v.32 no.2
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    • pp.81-93
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    • 2021
  • Objectives: Mild cognitive impairment (MCI) is condition of cognitive decline shown in transition from normal aging to dementia. Hominis placenta pharmacopuncture (HPP) is a treatment that combines effects of medication and acupuncture by injecting Hominis placenta into acupoints. The objective of this study was to evaluate the efficacy and safety of HPP for MCI. Methods: This was a randomized, double-blind, placebo-controlled, two-center clinical trial. Eligible patients were randomly allocated to either the HPP group or the placebo group. HPP or saline as placebo was administered to participants for eight weeks. Changes in symptoms were observed. The primary outcome was difference in mean change of Korean Version of the Montreal Cognitive Assessment (MoCA-K) score between the HPP group and the placebo group. Cognitive function, overall status of mood and sleep, and quality of life (QoL) were also assessed. Safety assessment and economic analysis were then conducted. Results: Thirty participants were enrolled. One participant in the placebo group dropped out. The score of MoCA-K increased after treatment. Its mean change was smaller in the HPP group than in the control group. HPP ameliorated Global Deterioration Scale and Korean Dementia Rating Scale subtests for attention, organization, and memory compared to the placebo. However, none of them was significantly different between the two groups. Mood, sleep, and QoL all improved more in the HPP group than in the placebo group, although differences between the two groups were not statistically significant. There was no adverse event probably related to the drug. HPP treatment needed KRW 345,000 more than the placebo group in improving Geriatric Quality of Life scale-Dementia score by one point for one year. Conclusions: Although HPP treatment did not significantly improve cognition, it changed behavioral and psychological symptoms in MCI.

Effect of Zinc Supplementation on Serum Cholesterol Concentration of Young Women (아연 보충이 젊은 여성의 혈청 콜레스테롤 농도에 미치는 영향)

  • 송미영
    • Journal of Nutrition and Health
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    • v.23 no.4
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    • pp.237-247
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    • 1990
  • This study was to investigate the effect of zinc supplementation on serum cholesterol concentration of young women. Thirty healthy students were divided into Zn and placebo groups, and were orally given with zinc(50mg/day, 220mg as ZnSO4·7H2O) or placebo for 2 month (June 9-August 7, 1988). Changes of plasma zinc, serum total cholesterol, HDL-cholesterol (HDL-C), LDL-cholesterol(LDL-C) and total lipid were analyzed from the initiation to 1 month after the end of zinc supplementation at monthly interval. Plasma zinc, serum LDL-C content and LDL-C/HDL-C were significantly increased by zinc supplementation. Serum total cholesterol content tended to be increased by zinc supplementation but was not significantly different between the two groups. Serum HDL-C content was significantly decreased by zinc supplementation. Serum total lipid content was not different between the two groups during experimental period. Thus, in this study considering the effect of zinc supplementation on serum cholesterol concentration, we conclude that the effect of zinc supplementation on coronary heart disease may be negative.

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The immediate effects of 830-nm low-level laser therapy on the myofascial trigger point of the upper trapezius muscle in visual display terminal workers: A randomized, double-blind, clinical trial

  • Lee, Jung-Hoon;Lee, Sun-Min
    • 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.

Effect of Socheongryong-tang on Punghan and Pungyeol Type Common Cold : A Double Blind, Placebo Controlled Study (풍한형 및 풍열형 감모에 대한 소청룡탕의 효과 - 이중맹검, 위약대조군연구)

  • Park, Yang-Chun
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.19 no.2
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    • pp.524-529
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    • 2005
  • Socheongryong-tang(SCRT) is widely used to treat the common cold. The purpose of this study was to evaluate the efficacy of SCRT on Punghan type(風寒型) and Pungyeol type(風熱型) common cold. 98 registered students with commom colds of recent onset were randomized to the double blind, placebo-controlled study. SCRT extract in capsule, $5.4g(1.8g{\times}3cap)$, orally dissolved 3 times a day. The severity of illness was assessed by the physician, using a 5-point scale on start and finish. In Pungyeol type common cold, no statistically significant differences were detected between the SCRT and placebo groups for any of the measured outcomes. In Punghan type common cold, SCRT significantly reduced rhinorrhea (p=0.034) and nasal stuffiness (p=0.048) compared with placebo. This study shows that SCRT is effective in treating cold symptoms in Punghan type common cold. If patients with cold are able to be administered SCRT according to common cold type, the benefit would be expected to increase.

Comparison of the effects of transcutaneous electrical nerve stimulation, low level laser, and placebo treatment on temporomandibular joint disorders: a single-blind randomized controlled trial

  • Kim, Hyunjoong
    • Physical Therapy Rehabilitation Science
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    • v.9 no.4
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    • pp.244-251
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    • 2020
  • Objective: Physical therapy techniques are required for patients with temporomandibular joint disorder (TMD), but the effects of treatment have not been compared. Therefore, effects of transcutaneous electrical nerve stimulation (TENS) and low level laser (LLL), which are most commonly used interventions, were compared. Design: Randomized controlled trial. Methods: Thirty-six participants with pain in the temporomandibular joint were enrolled, and 12 participants were randomly assigned to either the TENS group, LLL group, or placebo group. Each intervention was performed for a total of 6 sessions for 2 weeks. For the evaluation of the participants, the mouth opening (MO), pressure pain threshold (PPT), and stress were measured at three time periods: baseline, post-test, and follow-up at 2 weeks. Results: Significant interaction between groups according to each evaluation point was found only in PPT-masseter (p<0.05). The evaluation time point at which a significant difference appeared was at the post-test and follow-up at 2 weeks time periods. As a result of the post-test, the LLL group showed a significant improvement compared to the TENS group (p<0.05), and at 2 weeks follow-up, the TENS group showed a significant improvement compared to the placebo group (p<0.05). Conclusions: In this study, an experiment was conducted to compare the treatment effects when TENS, LLL, and placebo were given to patients with TMD. In addition, by quantitatively presenting the effect size of each treatment, this study suggests clinical use of TENS and LLL treatment for TMD.

Curcumin supplementation attenuates the decrease in endothelial function following eccentric exercise

  • Choi, Youngju;Tanabe, Yoko;Akazawa, Nobuhiko;Zempo-Miyaki, Asako;Maeda, Seiji
    • Korean Journal of Exercise Nutrition
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    • v.23 no.2
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    • pp.7-12
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    • 2019
  • [Purpose] Eccentric exercise induces a decrease in vascular endothelial function. Curcumin, a major component of turmeric, has potent antioxidant and anti-inflammatory properties that are associated with vascular protective effects. The present study examined the effect of acute supplementation of curcumin on eccentric exercise-induced endothelial dysfunction in healthy young men. [Methods] Fourteen healthy sedentary young men (range, 21-29 years) were assigned to either the curcumin (n = 6) or placebo (n = 8) group. All subjects consumed either curcumin or placebo before exercise, and eccentric exercise of the elbow flexors was performed with their nondominant arm. Before and 60 min after exercise, brachial artery flow-mediated dilation (FMD), as an indicator of endothelial function, was measured in the non-exercised arm. [Results] Brachial artery FMD significantly decreased following eccentric exercise (p < 0.05) in the placebo group, but acute supplementation with curcumin before exercise nullified this change. The change in FMD before and after eccentric exercise between the placebo and curcumin groups was significantly different (p < 0.05). [Conclusion] The present study found that acute curcumin supplementation could attenuate the decrease in endothelial function, as measured by FMD, following eccentric exercise in healthy young men.