• Title/Summary/Keyword: double blind method

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Impact of GNB3, ADRB3, UCP2, and PPAR${\gamma}$-Pro12Ala polymorphisms on Boiogito response in obese subjects : A randomized, double-blind, placebo-controlled trial (방기황기탕의 유전자 다형성에 따른 비만 치료 효과 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Bose, Shambhunath;Lim, Chi-Yeon;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.12 no.2
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    • pp.28-43
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    • 2012
  • Objectives: The aim of the study was to investigate the efficacy of Boiogito for obesity. We examined the efficacy of Boiogito for obese patients and we expected the reaction of Boiogito would vary according to the single nucleotide polymorphism(SNPs). Methods: 111 subjects(body mass index${\geq}25m/kg^2$) were recruited and randomized to receive Boiogito(n=55) or Placebo(n=56) for 8weeks. Anthropometric factors, serum lipid profile, glucose, blood pressure(BP), pulse rate, resting metabolic rate and Korean version of obesity-related quality of life(KOQOL) scale measured at baseline and 8weeks. SNPs(${\beta}3$-adrenergic receptor(ADRB3), G protein ${\beta}3$(GNB3), peroxisome proliferator activated receptor gamma 2 gene(PPAR-${\gamma}2$), uncoupling protein(UCP2)) were conducted at baseline. Adverse reactions and safety outcome variables were also checked during trials. Results: Both groups showed significant improvement on obesity after treatment. Boiogito group decreased triglyceride than did control group and improved KOQOL. Boiogito showed a significant higher efficacy in C/T and T/T genotype of GNB3 gene / in Trp64 and Arg64 genotype of ADRB3 gene / in D/D genotype of UCP2 gene / in Pro/Pro genotype of PPAR-${\gamma}$ gene. Conclusions: Boiogito promoted obesity indexes without severe adverse reactions and proved its safety. Pharmacogenetical studies of Boiogito on obesity could be a effective method for the individualized treatment and prevention of obesity.

Effect of pre-operative medication with paracetamol and ketorolac on the success of inferior alveolar nerve block in patients with symptomatic irreversible pulpitis: a double-blind randomized clinical trial

  • Kumar, Umesh;Rajput, Akhil;Rani, Nidhi;Parmar, Pragnesh;Kaur, Amandeep;Aggarwal, Vivek
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.441-449
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    • 2021
  • Background: The efficacy of local anesthesia decreases in patients with symptomatic irreversible pulpitis. Therefore, it was proposed that the use of premedication with an anti-inflammatory drug might increase the success rate of pulpal anesthesia in mandibular posterior teeth with vital inflamed pulp. Methods: One hundred thirty-four patients who were actively experiencing pain willingly participated in this study. The Heft Parker (HP) visual analog scale (VAS) was used to record the initial pain intensity. Patients were randomly allocated to receive a placebo, 10 mg of ketorolac, and 650 mg of paracetamol. The standard inferior alveolar nerve block (IANB) was administered to all patients using 2% lidocaine with 1:200,000 adrenaline after one hour of medication. After 15 min, the patient was instructed to rate the discomfort during each step of the treatment procedure, such as access to remaining dentin, access to the pulp chamber, and during canal instrumentation on the HP VAS. IANB was considered successful if the patient reported no or mild pain during access preparation and instrumentation. Moderate or severe pain was classified as a failure of IANB and another method of anesthesia was used before continuing the treatment. Results: The rate of successful anesthesia in the placebo, paracetamol, and ketorolac groups was 29%, 33%, and 43%, respectively, and no statistically significant difference was found between the groups. Conclusion: Preoperative administration of paracetamol or ketorolac did not significantly affect the success rate of IANB in patients with irreversible pulpitis. No significant difference was observed between the paracetamol and ketorolac groups.

Proficiency test for analyzing illegal compounds in food (식품 중 부정유해물질의 분석 능력평가)

  • Chang, Moonik;Yoon, Taehyung;Hong, Mooki;Choi, Dongmi
    • Analytical Science and Technology
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    • v.20 no.1
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    • pp.78-83
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    • 2007
  • To perform proficiency test for determining anti-impotence drug-like compounds in food, interlaboratory test has been done. Targets were 6 such as sildenafil, tadalafil, vardenafil, homosildenafil, hydroxy-homosildenafil and pseudo-vardenafilI. Total 13 institutes were participated and all is in charging of food analysis. To do double blind test, the reference materials were made as 13 different ginseng drink samples and each sample had random 3 targets. By the official method for anti-impotence drug-like compounds in food code, sample was just diluted in water, extracted in organic solvents, determined by HPLC/UV and then confirmed by LC/MS. The analytical duration was 60 days after receiving sample. Ten out of 13 institutes were satisfied by evaluation of Z-score and RSZ according to the regulation for managing analytical quality assurance.

Clinical effect of Vitamin C, Vitamin E, lysozyme, carbazochrome complex medicine($IGATAN^{(R)}$) in periodontal disease : Double blind, randomized control study (중등도 치주질환에 대한 Vitamin C, Vitamin E, lysozyme, carbazochrome (이가탄$^{(R)}$) 복합제제의 임상 효과)

  • Chang, Yun-Young;Jang, Yong-Ju;Jung, Im-Hee;Um, Yoo-Jung;Jung, Ui-Won;Kim, Chang-Sung;Kim, Baek-Il;Choi, Seong-Ho
    • The Journal of the Korean dental association
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    • v.47 no.12
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    • pp.830-837
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    • 2009
  • Purpose : The purpose of this study was to evaluate the clinical effect of Vitamin C, Vitamin E, lysozyme, carbazochrome complex medicine($IGATAN^{(R)}$) for periodontal disease. Material and Methods : The study was performed by double blinded, ramdomized method. Forty two subjects diagnosed as chronic incipient or moderate periodontitis at department of periodontology, Yonsei Dental Hospital were included in the study. This study was approved by Institutional Review Board, Yonsei University Hospital. All subjects received scaling at their first examination and second examination was scheduled after 2 weeks. At second examination, periodontal parameters such as plaque index(PI), gingival index(GI), probing depth(PD), bleeding on probing(BOP), gingival recession(GR) and clinical attachment level(CAL) were recorded(Baseline) with prescription of Vitamin C, Vitamin E, lysozyme, carbazochrome complex($IGATAN^{(R)}$) (Experimental group 23 subjects) or placebo medicine(Control group; 19 subjects). The subjects were recalled after 4 weeks for periodontal parameters measurement. Results : In the experimental groups, PI, GI, CAL and BOP scores were significantly reduced at 4 weeks compared to baseline. A statistically significant decrease in or and BOP scores were observed in the experimental group compared to the control group. Conclusion : It can be concluded that Vitamin C, Vitamin E, lysozyme, carbazochrome complex medicine($IGATAN^{(R)}$) have an effect in reducing gingival bleeding and improving periodontal inflammatory condition inchronic incipient- moderate periodontitis.

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A Review of Acupuncture and Moxibustion for the Treatment of Parkinson's Disease (파킨슨병의 침구치료 동향에 대한 고찰)

  • Lee, Eun;Kang, Ki-Wan;Kim, Lak-Hyung;Kang, Sei-Young;Sun, Seung-Ho;Han, Chang-Ho;Jang, In-Soo
    • The Journal of Internal Korean Medicine
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    • v.35 no.1
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    • pp.12-23
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    • 2014
  • Objectives : The purpose of this study was to report possibility of acupuncture or moxibustion for the treatment of Parkinson's disease (PD) by reviewing literature about its effectiveness. Methods : In this review, PubMed, SCOPUS, Science Direct and CINAHL of EBSCOhost were used to search medical journals, using keywords "Parkinson's disease and acupuncture" and "Parkinson's disease and moxibustion". The search range included randomized controlled trials (RCT) about Parkinson's disease combined with another disease and other treatments with acupuncture or moxibustion. Non-randomized controlled trial (nRCT), case study, animal experiment, human experiment, review, survey, essay, letter, and protocol for review were excluded. Results : From 311 studies, 111 were selected during the title and the screening. Finally, 16 RCTs (15 for acupuncture research and one for moxibustion) were included in this review, after scanning and matching the inclusion and exclusion criteria. The number of patients varied between 5 and 88. A total of 12 studies using electroacupuncture (EA) were classified into acupuncture studies. The body acupuncture studies numbered 4, scalp acupuncture 4, body and scarp acupuncture mixed studies 4, and bee venom, ear and abdomen acupuncture were each one study. In evaluation methods, total effective rate method was used in 9 studies, the Unified Parkinson's Disease Rating Scale (UPDRS) was used in 8, and the Webster score in 2. In addition, the Berg balance scale (BBS), 30 m walking time, steps to walk 30 m, PD motor function score, and Motor Performance Series by Schoppe (MLS) method were used for evaluation. In 15 of the 16 studies, the verum acupuncture group showed significant improvement compared with the control. In 9 studies using total effective rate method, the effective rate was reported as 80.0-97.3% in verum acupuncture groups and 52.6-86.4% in controls. Conclusions : Acupuncture may be a plausible alternative method to care for the long term symptoms and treat movement impairment of Parkinson's disease. However, to confirm this result, high quality studies including randomized, placebo-controlled double-blind trials are warranted.

Overview of four subgroups in Soeum(Lessor Yin) Constitution, Which are classified based on 'Chang(=Viscera) and Fu(=Bowels) meridian theory' (소음인(小陰人)의 장부경락론적(臟腑經絡論的) 고찰(考察))

  • Yom, Tae-hwan
    • Journal of Sasang Constitutional Medicine
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    • v.12 no.1
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    • pp.10-23
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    • 2000
  • Four-constitutional theory proposed by Dr. Lee, Je-ma has been evolve for last 100years by his followers. One of the major progresses was the emergence of constitutional acupuncture proposed by Dr. Kwan Doh-won. Constitutional acupuncture included the new pulse diagnostic method to determine the body type, pulse diagrams and corresponding acupuncture method called five element acupuncture in which five-element points in 12 meridian channels are used. Dr. Sa-ahm proposed five-element acupuncture three and a half hundred years age. Conjunction of Dr Lee's theory to Dr. Kwan proposed eight constitutions with eight pulse diagrams. He also adopted eight acupuncture prescriptions out of twenty-four Sa-ahm's acupuncture prescriptions. The author, Dr. Yom Tae-hwa, proposed more inclusive theory of 24 constitutions with 24 diagnostic pulse diagrams in Las Vegas International Acupuncture Convention in 1986. This article reviews history of constitutional medicine briefly. Each step of theoretical evolution from four-constitutional theory to twenty-four-constitutional theory is explained. By understanding the theoretical connection between twelve meridian channels based on five-element theory and four-constitutional theory in the article, one will easily accept the emergence of twelve of twenty four constitutional theory. Next, the article is focused on four subcategories under Sao-Yin constitution, which are one-sixth of 24 constitution. in this section classification, pulse diagnostic method, pulse diagram acupuncture prescriptions and herbal prescriptions are explained in detail. Then, clinical trial reports of acupuncture treatment and/or herbal formulas for such constitutions are attached for the rest part of the article. the purpose of this paper is to present the new hypothesis with the result of preliminary clinical trial hoping that additional clinical reports from other practitioners in this field triggers well-designed clinical study in future.

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The Review on the Prostate Disease-related Studies with Acupuncture Therapy in PubMed (PubMed 검색(檢索)을 이용한 전립선(前立腺) 질환(疾患)의 침치료(鍼治療)관련 연구(硏究)에 대한 고찰(考察))

  • Song, Ho-Sueb
    • Journal of Pharmacopuncture
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    • v.7 no.2
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    • pp.65-73
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    • 2004
  • Objective : This study was to review on the prostate disease-related studies with Acupuncture therapy in renowned medical internet site of PubMed, and to make master plan of the study, especially, on Bee Venom Acupuncture(BVA) of Prostate disease and then to devise the idealistic therapeutic ways of it. Method : We made the internet search with the key words of bee venom(bee venom therapy, apitoxin, apitherapy, bee sting, bee sting therapy), acupuncture, prostate, prostatitis, prostrate cancer in Pubmed, from June 1st to July 1st,2004. Results : 1.25 papers were found in 19 publised jounals. of which two named'Urology'and Prostate' had three papars, two called 'JUrology' and 'Cancer Immunol Immunother' had two papers, and the others had a paper respectively. 2. In the classification by papers' types, Review papers were 8 and Original were 17 where there were 5 clinical trials, 11 experimental studies and 1 epidemiologic paper. Of 5 clinical trials, 2 belonged to Randomized Control Study, and of 11 experimental studies, 4 belonged to in vitro and 7 belonged to in vivo with in viro studies, and 1 epidemeologic belonged to meta-analysis. 3. In the classification by prostate diseases, 4 were about prostatitis, 3 were about prostate related symptoms, 16 were about prostate cancer, and two were about the others. 4. In the classification by applied treatment methods, 5 were related with Acupuncture, 10 were related with BVA(Bee Venom, Bee), and 10 were related with the others. Of 5 related with Acupuncture, 3 used general acupuncture, 1 used electrical acupuncture, and 1 used general acupuncture and electrical acupuncture at the same time. 5. In 2 RCTs of Clinical trials, Control group was set up to the group using different compatible treatment method or using meridians not related with treating prostate disease. Single or double blind methods couldn't be found. 6. In the clinical trials, IPSS, NIH, CPSI or subjective global assessment were used as the Index of Evaluation. 7. The Leg Greater Yang Bladder Meridian(B), The Leg Lesser Um Kidney Meridian(K) and Conception Vessel Meridian(CV) were used as major meridians, and B10(Taejo, Dazhu), B23(Shinsu, Shenshu), B28(Panggwangsu, Pangguangshu), B35(Hoeyang, Huiyang), B39(Wiyang, Weiyang), B40(Wijung, Weizhong), B54(chilbyon, Zhibian), K1(Yongchon, Yongquan), K10(Umgok, Yingu), CV3(Chungguk, Zhongji), CV4(Kwanwon, Guanyuan),S6(Hyopko, Jiache) were used as acupoints. Electrical acupuncture(EA) was considered to be more important and CV3(Chungguk, Zhongji), CV4(Kwanwon, Guanyuan) were mainly selected as EA applied acupoints. 8. It is mostly said that Acupuncture appeared to be a safe, effective, and durable treatment alternative in improving symptoms of patients with prostate diseases, refractory to conventional medicine. A larger controlled study was required to confirm these encouraging initial results. Conclusion : Papers about BVA of Prostate cancer or Prostatitis were not found, and low permeability of Prostate is concerned, BVA with the anti-inflammatory and anti-cancer effect can be adopted as a new alternatives of Prostate disease treatment, so it is thought that Study of how to make access to prostate, animal experiment including in vivo and in vitro and more clinical trials with using acupoints on related meridian should be followed.

Continuous intra-lesional Infusion Combined with Interscalene Block for Effective Postoperative Analgesia after Arthroscopic Shoulder Surgery (상완신경총 사각근간 차단과 국소마취제의 병소내 지속주입법의 병용이 견관절경 수술 후 진통에 미치는 영향)

  • Oh Joo-Han;Kim Jae-Yoon;Gong Hyun-Sik;Kim Jae-Kwang;Kim Sang-Gee;Kim Tae-Yune;Rhee Ka-Young;Kim Woo-Sung
    • Clinics in Shoulder and Elbow
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    • v.8 no.2
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    • pp.141-147
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    • 2005
  • Purpose: The purpose of this study was to compare the effectiveness of postoperative pain control by intravenous patient-controlled analgesia (IV) to the effectiveness of postoperative pain control by continuous intra-lesional infusion of local anesthetics (IL) with or without an interscalene brachial plexus block (ISB) after arthroscopic shoulder surgery. Materials and Methods: We designed this prospective randomized case-controlled double-blind study, and allocated 84 consecutive patients to four groups according to postoperative analgesic method, i.e., Group IV, Group ISBIV, Group IL, and Group ISB-IL after arthroscopic shoulder surgery. Postoperative pain, side effects and supplemental analgesics were recorded at 1 hour and then at every 8 hours for 2 days. Result: The demographic and clinical characteristics of four groups were identical statistically. Interscalene block (Group ISB-IV, Group ISB-IL) was found to be effective at relieving pain and at reducing supplemental analgesic amounts at 1 and 8 hours postoperatively (p<0.05). Patients in the Group ISB-IL had less pain at 16 and 48 hours postoperatively than the other groups (p<0.05). Continuous intra-lesional infusion (Group IL, Group ISB-IL) was superior in reducing analgesic-related side effects (p<0.05). Conclusion: This study suggests that a combination of an interscalene brachial plexus block and continuous intralesional infusion of ropivacaine is an effective and safe method of postoperative pain control in patients after arthroscopic shoulder surgery.

Efficacy and Tolerability of Moclobemide Compared with Amitriptyline in Dysthymic Disorder (기분부전장애에서 Moclobemide와 Amitriptyline의 치료 효과와 내약성 비교 연구)

  • Lee, Min Soo;Nam, Jong Won;Ryu, Seung Ho;Cha, Ji Hyun;Kim, Yong Ku
    • Korean Journal of Biological Psychiatry
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    • v.6 no.1
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    • pp.96-101
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    • 1999
  • Background : Since dysthymia begins in late childhood or adolescence and has a chronic course, long-term pharmacotherapy may be required. New generation antidepressant, moclobemide, with more acceptable side effect profiles, is effective in the treatment of dysthymia. The main objective of this study was to determine whether they exhibit comparable efficacy and tolerability in dysthymia to amitriptyline. Method and Materials : The efficacy and tolerability of the moclobemide and amitriptyline, were compared in a eight-week single-centre double-blind study in patients(n=37) with dysthymia using he HAMD-17, the Clinical Global Impression Scale(CGI), the Montgomery-Asberg Depression Rating Scale (MADRS), Efficacy Index-Therapeutic Index(EITE), 4-point Index Side Effect Scale(4-PISES), and Efficacy Index- Side Effect Scale(EISE). Results : A total of 37 patients entered the study, 19 were randomly assigned to the moclobemide group and 18 to be amitriptyline group. Demo-graphic and illness characteristics were similar in both groups. There were no significant difference between two groups at the total 17-HDRS score, the HAMD-17% improvement, the total MADRS score, CGI response, and the EITE. In the comparison of EISE between two groups, the scores of the moclobemide group were relatively lower than the amitriptylinen group in full treatment. And the differences were significant(moclobemide group $1.39{\pm}0.61$ ; amitriptyline group $2.00{\pm}0.85$, p<.001). At the 4-PISE, There was no serious or treatment threatening side effects. And there was no specific difference in side effects between two groups. The moclobemide group reported higher EIR scores than the amitriptyline group at every follow up day, but the differences were not significant. And, there was no significant differences in the scores of five HRQOL subcategories which is compared between two groups at every follow up days. Conclusions : In terms of 17-HDRS and MADRS, moclobemide and amitriptyline are equally effective at least in allevating dysthymic symptoms. But moclobemide tended to be less troubling and better tolerated than amitriptyline. Therefore, moclobemide treatment can be used as a safe, and higher satisfactory treatment strategy for the dysthymia.

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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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