• 제목/요약/키워드: Placebo Effect Analysis

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Effectiveness of Shortwave Therapy in Management of Knee Osteoarthritis : A Systematic Review and Meta-analysis of Randomized Controlled Trials (무릎 뼈관절염의 단파치료 효과 : 무작위임상시험의 메타분석과 체계적 고찰)

  • Lee, Jae-Hyoung;Cho, Hyuk-Shin;Song, In-Yong
    • 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.

The effects of Korean Red Ginseng on stress-related neurotransmitters and gene expression: A randomized, double-blind, placebo-controlled trial

  • Jihyun Yoon;Byoungjin Park;Kyung-Won Hong;Dong-Hyuk Jung
    • 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.

Low-Molecular Collagen Peptide Supplementation and Body Fat Mass in Adults Aged ≥ 50 Years: A Randomized, Double-Blind, Placebo-Controlled Trial

  • Jeongbin Park;Minji Kim;Hyeri Shin;Hyejin Ahn;Yoo Kyoung Park
    • Clinical Nutrition Research
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    • v.12 no.4
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    • pp.245-256
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    • 2023
  • A randomized, double-blind, placebo-controlled trial was conducted to confirm whether collagen peptide supplementation for 12 week has a beneficial effect on body fat control in older adults at a daily physical activity level. Participants were assigned to either the collagen group (15 g/day of collagen peptide) or the placebo group (placebo drink). Body composition was measured by bioelectrical impedance analysis (BIA) and dual-energy X-ray absorptiometry (DEXA). In total, 74 participants (collagen group, n = 37; placebo group, n = 37) were included in the final analysis. The collagen group showed a significant reduction in total body fat mass compared with the placebo group, as evidenced by both BIA (p = 0.021) and DEXA (p = 0.041) measurements. Body fat mass and percent body fat of the whole body and trunk reduced at 12 weeks compared with baseline only in the collagen group (whole body: body fat mass, p = 0.002; percent body fat, p = 0.002; trunk: body fat mass, p = 0.001; percent body fat, p = 0.000). Total fat mass change (%) (collagen group, -0.49 ± 3.39; placebo group, 2.23 ± 4.20) showed a significant difference between the two groups (p = 0.041). Physical activity, dietary intake, and biochemical parameters showed no significant difference between the groups. The results confirmed that collagen peptide supplementation had a beneficial effect on body fat reduction in older adults aged ≥ 50 years with daily physical activity level. Thus, collagen peptide supplementation has a positive effect on age-related changes.

Studies on the Sedative Activity of an Alkaloid from Atractylis Rhizoma (창출(蒼朮) 알칼로이드의 진정작용(鎭靜作用)에 관한 연구)

  • Cho, Hang-Yung
    • Korean Journal of Pharmacognosy
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    • v.5 no.3
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    • pp.159-166
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    • 1974
  • The Yellow needle crystal was isolated from Atractylis Rhizoma, having mp $124{\sim}126^{\circ}C$(decomp.), the chemical composition $C_{16}H_{21}N_{3}O_{6}$, and its m.w. 251. The pharmacological actions of this alkaloid were studied by various psycopharmacological experiments. 1) In order to see the effect of this Atractylis(=At.) alkaloid on gross general behaviors in mice, a behavioral analysis experiment was adapted. The occurrence number of sleep and lying in At. alkaloidal animals with the doses 10mg/kg or 20mg/kg was increased but the number of jumping, exploration, rearing and defecation was significantly decreased than those of placebo. 2) The effect of the At. alkaloid on unlearned emotional behaviors of mice was studied with an open-field method. The At. alkaloidal groups with the doses 20mg/kg or 30mg/kg showed less often the frequency of locomotion than that of placebo. 3) To know the effect of the At. alkaloid on the learning, a standard water maze experiment and conditioned avoidance response were conducted. As compared to placebo control, the aquisition rate of the maze learning in the alkaloidal mice with the dose of 10mg/kg or 20mg/kg was significantly impaired and the speed of swimming was also signficantly delayed. In the conditioned avoidance response, the extinction performances of the alkaloidal rats with doses of 20mg/kg or 30mg/kg did not differ significantly than that of placebo.

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The Effect of Theophylline on Improvement of Renal Function in Asphyxiated Neonates: A Systematic Review and Meta-analysis (주산기 가사가 있는 신생아에서 theophylline의 신기능 개선 효과에 대한 체계적 문헌고찰 및 메타분석)

  • Lee, Joo Won;Lee, So Yeon;An, Sook Hee
    • Korean Journal of Clinical Pharmacy
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    • v.29 no.2
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    • pp.115-124
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    • 2019
  • The purpose of this systematic review and meta-analysis was to assess the preventive effect of theophylline on acute kidney injury and the ameliorative effect of theophylline on renal function in asphyxiated neonates. A literature search of the PubMed/Medline, Embase, and Cochrane Library databases for information published up to February 2019 was conducted. All studies that reported the incidence rate of acute kidney injury, serum creatinine level, and glomerular filtration rate after the randomized administration of theophylline or placebo were included. In total, eight studies involving 498 neonates were eligible. The incidence rate of acute kidney injury was significantly lower in the theophylline group than in the placebo group (risk ratio [RR]: 0.42, 95% confidence interval [CI]: 0.32-0.55, p < 0.001). The changes in serum creatinine level in the theophylline group were significantly higher than those in the placebo group from the first day of life to 3 and 5 days of age (weighted mean difference [WMD]: -0.51, 95% CI: -0.62 to -0.40, p < 0.001, and WMD: -0.26, 95% CI: -0.34 to -0.18, p < 0.001, respectively). The changes in glomerular filtration rate in the theophylline group were significantly higher than those in the placebo group from the first day of life to 3 days of age and the last day of follow-up (WMD: 12.30, 95% CI: 9.39-15.21, p < 0.001, and WMD: 9.35, 95% CI: 6.43-12.27, p < 0.001, respectively). These results suggested that theophylline has a beneficial effect on the prevention of acute kidney injury in neonates with perinatal asphyxia.

Effects of Alcohol on Neurocognitive Function, Psychomotor Performance and Subjective Response in Koreans with Different ALDH2 Genotypes (한국인에서 Aldehyde Dehydrogenase 2 유전자 변이가 알코올의 신경인지 기능, 정신운동성 수행 및 주관적 반응에 미치는 영향)

  • Shin, Il-Seon;Yoon, Jin-Sang;Kim, Hyun;Yoon, Bo-Hyun;Lee, Hoon;Jung, Jae-Sung;Lee, Hyung-Yung
    • Korean Journal of Biological Psychiatry
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    • v.6 no.2
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    • pp.176-188
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    • 1999
  • Objective : The purpose of this study was to evaluate the effects of alcohol on neurocognitive function, psychomotor performance and subjective response in healthy Korean adults with different ALDH2 genotypes. Method : A total of 24 males, half with active $ALDH2^*1/2^*1$ and the other with inactive $ALDH2^*1/2^*2$, was selected through genotyping using restriction fragment length polymorphism. In a double-blind, placebo-controlled cross-over design, each subject consumed 0.5g/kg dose of alcohol, given as a mixture of 40% vodka and orange juice, and placebo(orange juice) on two separate occasions on an average of weekly intervals. The blood alcohol concentrations(BACs) were measured using a breath analyzer at baseline and at 30, 60 minutes after drinking. P300s were measured at baseline and at 30 minutes after alcohol and placebo intake. Vital signs and psychomotor performance[Critical Flicker Fusion Threshold(CFFT), Choice Reaction Time (CRT), Digit Symbol Substitution(DSS)] were measured at baseline and at 60 minutes after alcohol and placebo intake. Subjective responses were measured at the end of the study. The statistical analysis focused on whether there were any differences between groups with different ALDH2 genotypes. Results : The major results are as follows. 1) BACs in the inactive group were overall equivalent to those in the active group. Only in terms of time, BACs were significantly higher overall at 30 minutes than at 60 minutes after alcohol intake. 2) Pulse rates were significantly increased after alcohol intake compared with placebo, and the increase was greater in the inactive than in the active group. 3) P300 latencies in leads Fz(frontal), Cz(cental) and Pz(parietal) were significantly increased after alcohol intake compared to placebo, and the increase was greater in the inactive than in the active group. P300 amplitudes in leads Cz and Pz were significantly decreased overall after alcohol intake compared to placebo. 4) Compared with placebo, alcohol produced significant effect on the psychomotor performance : impairment in the inactive group, improvement in the active group. 5) Compared with placebo, alcohol significantly induced a negative or an intense effect on the subjective responses in the inactive group, but little negative and even a somewhat positive effect in the active group. Conclusions : These results suggest that ALDH isozyme variance might be an important factor to determine the effects of acute dose of alcohol on the various psychobehavioural functions and also to determine the alcohol use pattern and to predict the future development of alcohol overuse and/or abuse.

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Effect of premedication on postoperative pain after root canal therapy in patients with irreversible pulpitis: a systematic review and meta-analysis

  • Kumar, Gaurav;Sangwan, Pankaj;Tewari, Sanjay
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.397-411
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    • 2021
  • This systematic review aimed to assess the effect of premedication on postoperative pain after root canal treatment in vital teeth. Five electronic databases were searched for randomized clinical trials, and two independent reviewers selected eligible studies, extracted data, and assessed the quality of studies using the Cochrane Risk of Bias tool. Meta-analysis was conducted using the random-effects model, and the pooled effect estimate of the standardized mean difference (SMD) between premedication and placebo was calculated. Subgroup analysis was conducted based on the class and route of the drug. Studies with a high risk of bias were excluded from the sensitivity analysis. Ten trials satisfied the inclusion criteria, of which eight were included in the meta-analysis. Premedication was more effective in reducing postoperative pain than placebo at 6 hours (SMD = -1.00; 95% confidence interval [CI] = -1.33 to -0.66), 12 hours (SMD = -0.80; 95% CI = -1.05 to -0.56), and 24 hours (SMD = -0.72; 95% CI = -1.02 to -0.43). The results of the sensitivity analysis confirmed the findings of the primary analysis. Based on these results, it can be concluded that premedication is effective in reducing postoperative pain in teeth with irreversible pulpitis. However, additional quality studies are required for further validation.

Effect of Mahuang on Heart Rate Variability in Adults : a Double-Blind, Placebo-Controlled, Randomized Trial (마황 복용이 정산인의 심박변이도에 미치는 영향에 대한 무작위배정 이중맹검 임상연구)

  • Son, Dong-Hyuk;Hsing, Li-Chang;Kim, Lak-Hyung;Jeong, Seung-Il;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Korean Medicine
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    • v.28 no.1 s.69
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    • pp.105-116
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    • 2007
  • Objectives : Mahuang (Ephedra sinica), well known as an herbal medicine in the East and West, contains a relatively high percentage of ephedrine known as sympathomimetic alkaloid. We investigated the effects of Mahuang on sympathetic nervous system with heart rate variety (HRV). Time and frequency domain analysis of HRV is a noninvasive technique capable of providing information on autonomic modulation of the sinus node. Methods : We investigated 57 healthy volunteers consisting of 37 subjects in the Mahuang group and 20 subjects in the placebo group. Study form was a randomized, placebo-controlled, double-blind clinical trial. The 37 subjects in the Mahuang group took 3 Mahuang capsules (1 capsule equivalent to 2g herb Mahuang) twice a day at 10 a.m. and 2 p.,., while the 20 subjects in the placebo group took 3 placebo-capsules filled with glutinous rice powder at the same times. Mahuang medicine and placebo medicine were made into opaque capsules. We measured HRV at 3 p.m. 1 or 2 days before medication and at 3 p.m. after medication. Results : Mean-RR and SDNN of the Mahuang group significantly decreased compared with that of the placebo group, but the heart rate of the Mahuang group significantly increased compared with the placebo. HRV-Index, RMSSD and SDSD of the Mahuang group significantly decreased compared with that of the placebo group, but PNN50 of the Mahuang group significantly increased compared with placebo. Ln(TP), Ln(VLF), Ln(LF) and Ln(HF) of the Mahuang group significantly decreased compared with those of the placebo group. There were no significant differences in normalized LF, normalized HF and LF/HF ratio between the Mahuang and placebo groups. Conclusion : The results suggest that Mahuang in healthy adults tends to reduce the autonomic nervous system within the normal range.

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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.

Effects of Ephedra on Weight Loss and Heart Rate Variability: A Double-Blind Randomized Controlled Pilot Study (마황복용이 정상성인의 체중 감소와 심박변이도에 미치는 영향에 관한 예비 연구: 무작위배정 이중맹검시험)

  • Yang, Chang-Sop;Hsing, Li-Chang;Yeo, Jin-Ju;Seo, Eui-Seok;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.27 no.4
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    • pp.836-844
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    • 2006
  • Background: Mahuang (Ephedra sinica STAPF) is well known as an herbal medicine and has been widely used to reduce body weight and increase athletic ability. However, as a result of reporting many cases of adverse effects on the cardiovascular system, use of dietary supplements containing ephedra was prohibited by the FDA. Objectives : The object of this study was to find the effectiveness of ephedra on weight loss without severe adverse effect. Methods : 16 healthy volunteers consisting of an ephedra group (N=8) and a placebo group (N=8) were investigated. Study form was a randomized, controlled, double-blind clinical trial. The ephedra group took 12g of ephedra while the placebo group took 12g of glutinous rice powder. Both groups were measured with BCA (body composition analysis) on weight loss and with HRV (heart rate variability) on its adverse effect before and after medication. Results : The following results were obtained after taking 12g of ephedra for 14 days. In the ephedra group, body weight reduced significantly. In the placebo group, there were no significant differences of body weight between before and after placebo treatment. There was a slight increase of heart beat rate and deactivation of cardiac activity. Parasympathetic nerves were deactivated, but balances of autonomic nervous system were well maintained. Conclusions : The results suggest that ephedra in healthy adults tends to reduce body weight and deactivation of autonomic nervous system and cardiac activity.

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