• Sleep Medicine and Psychophysiology
• /
• v.4 no.2
• /
• pp.181-190
• /
• 1997

Zolpidem is a relatively new, short-acting, rapid onset, and nonbenzodiazepine hypnotics. Zolpidem selectively binds to the central benzodiazepine 1 (BZI) receptor subtype. The present study was designed to compare the hypnotic effects of zolpidem (10 mg), triazolam (0.25 mg), and placebo in 22 schizophrenic inpatients. Zolpidem, triazolam, and placebo were administered orally in a randomized, double-blind design. Compared with placebo, zolpidem and triazolam significantly decreased sleep latency (p<0.05), increased total sleep time (p<0.05), and increased improvement of satisfaction of sleep (p<0.05). Zolpidem decreased the number of awakenings significantly in comparison with placebo (p<0.05), but triazolam did not. In addition, both drugs were well tolerated and did not produce severe side effects. These results suggest that zolpidem is effective for transient insomnia of schizophrenic inpatients and zolpidem is superior to triazolam in hypnotic effect.

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

• Korean Journal of Biological Psychiatry
• /
• v.4 no.1
• /
• pp.127-131
• /
• 1997

Objective : To evaluate the clinical efficacy of adjuvant sertraline treatment in chronic schizophrenic patients, we carried out a double-blind, placebo controlled study. Method : Thirty six inpatients who fulfilled DSM-III-R criteria for chronic schizophrenia were randomly assigned to sertraline and placebo groups in a double-blinded fashion. A history of at least 2 years of illness and at least six months of hospitalization were prerequisities for inclusion in the study. Patients were received sertraline 50mg or placebo for 8 weeks in addition to their routine haloperidol regimen. Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression(CGI), Simpson-Angus Scale(S-A) were evaluated at 5 points ; baseline, 2, 4, 6, and 8 weeks of treatment. Results : The groups were controlled for age, gender, and length of illness. There were no significant differences in three PANSS factros(positive, negative, general), CGI, and S-A scale scores at any between sertaline and placebo treatment. Conclusion : This placebo controlled study showed no significant effects of sertraline on negative and positive symptoms in chronic schizophrenic patients.

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

• Nutrition Research and Practice
• /
• v.5 no.1
• /
• pp.20-27
• /
• 2011

We conducted this study to examine the effects of safflower seed granular tea containing physiologically active polyphenols on antioxidative activities and bone metabolism. Forty postmenopausal women ages 49 to 64-years were recruited from Daegu and Gyeongbuk and were randomly assigned to either a safflower tea supplement (Saf-tea) group (n=27) or a placebo group (n=13). The Saf-tea group received 20 g of safflower seed granule tea per day containing a 13% ethanol extract of defatted safflower seeds, whereas the placebo group received a similar type of tea that lacked the ethanol extract. No significant changes in nutrient intake for either the placebo or Saf-tea groups were observed before or after the study period, except vitamin A intake increased after 6 months in the Saf-tea group. Dietary phytoestrogen intakes were similar in the Saf-tea group (60.3 mg) and placebo group (52.5 mg). Significant increases in plasma genistein and enterolactone were observed in the Saf-tea group. After 6 months of supplementation, serum levels of antioxidant vitamins such as a-tocopherol and ascorbic acid increased significantly, and TBARS levels decreased in the Saf-tea group compared to the placebo group. Serum osteocalcin levels were reduced (P<0.05) in the Saf-tea group after 6 months, whereas serum osteocalcin did not change in the placebo group. Urinary deoxypyridinoline/creatinine excretion was not different between the two groups at baseline, and did not change in either group after 6 months. Bone mineral density decreased significantly in the placebo group (P<0.01) but not in the supplemented group. It was concluded that polyphenols (72 mg/day), including serotonin derivatives, in the Saf-tea had both antioxidant and potential bone protecting effects in postmenopausal women without liver toxicity.

• Proceedings of the Korean Society of Food Science and Nutrition Conference
• /
• 2001.12a
• /
• pp.52-60
• /
• 2001

Purpose: We performed a randomized, double-blind, placebo-controlled trial in mild to moderate myopia patients to evaluate the benefit of taking a nutrient supplement containing anthocyanoside oligomers for improving nocturnal visiual function and/or clinical symptoms. Methods: The subjects included have refractive error between -lD(Diopters) $\~$-8D in both eyes, symptoms of decreased night vision and asthenopia based on the scoring result of a pre-structured questionnaire, and abnormal results of mesopic contrast sensitivity(MCS) screening test showing abnormal curve of contrast sensitivity in the middle and high frequency level, between 6.0 and 30.0 CPD(Cycles per degree) at mesopic condition(-2$\~$0 log cd/$m^2$). Total 60 people who qualified the criteria above were enrolled and the subjects were instructed to take the investigational product (anthocyanoside or placebo) twice daily for a 4 week period. The enrolled subjects were investigated for nocturnal vision performance by MCS and clinical symptoms at their first visit and re-evaluated at post-intervention (4 weeks later). MCS was measured and improvement of contrast threshold level according to each CPD was calculated by subtracting initial values from final values. Age, refractive error, and MCS were compared between the placebo and anthocyanoside. Results: After 4 weeks of drug administration 22 of the anthocyanoside group showed symptom improvement compared to 1 of the placebo group (p=0.000). Contrast sensitivity levels according to each CPD before and after drug treatment showed significant improvement in the anthocyanoside group but not in the placebo group. Mean MCS change of anthocyanoside group is 2.41$\pm$1.91 which showed significant improvement compared to -0.40$\pm$2.47 of the placebo group(p=0.000). MCS changes of anthocyanoside group showed significant improvement compared to placebo group in all levels of CPD(p<0.05). During our investigation none of the subjects complained of specific side effects related to anthocyanoside use. Conclusion: Our results show that under careful selection of people with significant symptoms and definite MCS abnormalities, anthocyanoside oligomers may improve the subjective symptoms and objective MCS results.

• Journal of Periodontal and Implant Science
• /
• v.48 no.1
• /
• pp.47-59
• /
• 2018

Purpose: To evaluate the clinical and microbiological effects of the local use of egg yolk immunoglobulin against Porphyromonas gingivalis (anti-P.g. IgY) as an adjunct to scaling and root planing (SRP) in the treatment of moderate to severe chronic periodontitis. Methods: This was a randomized, placebo-controlled, double-blind trial involving 60 systematically healthy patients with moderate to severe chronic periodontitis. Subjects (n=20/group) were randomly assigned to receive SRP combined with subgingival irrigation of anti-P.g. IgY and anti-P.g. IgY mouthwash, subgingival irrigation of 0.2% chlorhexidine and 0.2% chlorhexidine mouthwash, or subgingival irrigation of placebo and placebo mouthwash for 4 weeks. Probing pocket depth, clinical attachment level, bleeding on probing, and the plaque index were evaluated at baseline and at 4 weeks. Subgingival plaque, gingival crevicular fluid, and saliva were simultaneously collected for microbiological analysis. Results: Our results showed that anti-P.g. IgY mouthwash was as effective as chlorhexidine at improving clinical parameters over a 4-week period. All the groups showed a significant reduction in levels of P.g. at 4 weeks. No significant difference was observed in the test group when compared to placebo regarding the reduction in the levels of P.g. Anti-P.g. IgY significantly suppressed the numbers of red complex bacteria (RCB) in subgingival plaque and saliva in comparison with placebo. No adverse effects were reported in any of the subjects. Conclusions: Within the limitations of the study, the present investigation showed that passive immunization with anti-P.g. IgY may prove to be effective in the treatment of chronic periodontitis due to its ability to improve clinical parameters and to reduce RCB. No significant differences were found between the anti-P.g. IgY and placebo groups in the reduction of P.g.

• Journal of Society of Preventive Korean Medicine
• /
• v.26 no.3
• /
• pp.97-108
• /
• 2022

Objectives : The purpose of this study is to confirm the efficacy and safety of Gongjin-dan and Ssanghwatang for chronic fatigue. Methods : A total of 90 people, between 19 and 65 years old, will be recruited to participate in a randomized, double-blind, and placebo-controlled a clinical trial. Participants in the Gongjin-dan group will take one pill of Gongjin-dan along with three packs of placebo oral liquid Ssanghwa-tang per day for 4 weeks. Participants in the Ssanghwa-tang group will take three packages of liquid Ssanghwa-tang and one placebo Gongjindan pill per day for 4 weeks. In the placebo group, participants will take one pill of placebo Gongjin-dan and three packs of placebo liquid Ssanghwa-tang per day, for 4 weeks. Outcomes will be measured at the baseline, 4^th week, and 6^th week. The primary outcome is the change in the Fatigue Severity Scale (FSS). Secondary outcomes are the change of Multidimensional Fatigue Inventory-20 (MFI-20), Chalder Fatigue Scale (CFQ), Short-Form 36 Health Survey (SF-36), Korean Version of Schedule of Fatigue and Anergy/General Physician (SOFA/GP), Glucose, Lactate, Ammonia, Free Fatty Acid (FAA), d-ROMs&BAP, Selenium, and Cortisol. Results : This trial was approved by the institutional review board of Pusan National University Korean Medicine Hospital (registry number: PNUKHIRB 2021-10-005). Recruitment opened in November 2021 and is supposed to be completed by December 2022. Conclusions : This trial will provide clinical information to determine the efficacy and safety of Gongjindan and Ssanghwa-tang for chronic fatigue.

• Korean Journal of Biological Psychiatry
• /
• v.6 no.2
• /
• pp.176-188
• /
• 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.

• Journal of Oriental Neuropsychiatry
• /
• v.32 no.2
• /
• pp.81-93
• /
• 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.