• Title/Summary/Keyword: Placebos

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Clinical Evaluation of Efficacy of Moltase by Double-blind Test (Double-blind test에 의한 Moltase 의 효력평가(?力評價))

  • Lee, Tong-Ho;Lee, Tae-Hee
    • The Korean Journal of Pharmacology
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    • v.6 no.1
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    • pp.23-26
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    • 1970
  • 1) Efficacy of Moltase, a digestive enzyme preparation, was evaluated by double-blind test. 2) The clinical symptoms assessed in this study were anorexia, vomiting, nausea, eructation, hunger pain, epigastralgia, fullness in epjgastrium, abdominal fullness, constipation, and diarrhea. Effect of Moltase on gastric acidity was also examined by double-blind test. 3) People subjected to this study were 42 students and 22 patients who had signs of chronic dyspepsia. 4) In general, the clinical symptoms were more effectively improved by Moltase than placebos. The marked differences in efficacy between both medication were observed in epigastralgia, fullness in epigastrium, abdominal fullness, and anorexia. 5) Six out of 9 patients with no free gastric acid became to have free gastric acid after Moltase medication.

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The Effects of Chromium Picolinate Supplementation on Glucose and Lipid Level in Rats Fed in High Fat Diet (Chromium Picolinate 보충이 고지방 식이를 섭취한 흰쥐의 체내 지질 농도에 미치는 영향)

  • 오유진;장유경
    • Journal of Nutrition and Health
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    • v.35 no.8
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    • pp.834-839
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    • 2002
  • This study aimed to investigate the effects of chromium picolinatec (CrP) supplementation on the glucose and lipid metabolism of rats. Five-week-old male Sprague-Dawley rats were fed a high-fat diet fir 110 days and further treated with CrP or placebos for 6 weeks. The effect of CrP supplementation on body weight, blood glucose, insulin and lipid levels was examined. The results suggested that body weight gain was not significantly different between the control and the CrP supplemented group. Plasma glucose, triglyceride and cholesterol levels in the CrP treated group significantly decreased compared to those of the control group (p < 0.05). The total lipid, triglyceride and cholesterol concentrations in the livers of the CrP treated group significantly decreased compared to those of the control group (p < 0.05). These results indicate that supplementation of chromium picolinate ran reduce triglyceride and glucose concentrations in the blood and total lipid and total cholesterol levels in the liver.

Evaluating the Efficacy of Pharmacological Therapy for Prader-Willi Syndrome: A Systematic Review and Meta-analysis

  • Alim Yoo;Sohyeon Park;Heeyoung Lee
    • Korean Journal of Clinical Pharmacy
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    • v.32 no.4
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    • pp.336-351
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    • 2022
  • Background: Prader-Willi Syndrome (PWS) is a rare genetic disorder. To improve the health deterioration of PWS, investigating optimal treatment options for PWS is required. Thus, we aimed to evaluate the efficacy of pharmacotherapies compared with supportive care or placebos in patients with PWS. Methods: PubMed and EMBASE databases were used to search for randomized controlled trials (RCTs) evaluating the efficacy of pharmacotherapy in PWS patients. Only RCTs that evaluating the efficacy of pharmacotherapy in PWS patients were retrieved. Results: A total of 26 studies were included to evaluate body composition, hormones, glucose levels and hyperphagia behavioral status. Pharmacological treatment group showed a significant decrease of body fat (mean difference (MD): -6.32, 95% confidence interval (CI): -10.58 to -2.06, p=0.004), a significant increase of lean body mass (LBM) (MD: 1.86, 95% CI: 1.43 to 2.30, p<0.00001) and insulin-like growth factor 1 (IGF-1) levels (MD: 241.62, 95% CI: 68.59 to 414.64, p=0.006) compared with the control group. Nevertheless, based on other outcomes evaluated by the current systematic review, pharmacological options showed different efficacy in treating PWS. Conclusion: Pharmacological therapies were effective to decrease significantly in body fat and increase significantly on LBM and IGF-1 levels in patients with PWS. However, still, individualized therapies should be considered in real-world practice in PWS treatment.

A Pilot Study to Assess the Effect of Gami-Jiwhang-Tang on Cognitive Effects in Healthy Children

  • Bahn Geon-Ho;Kim Chang-Ju;Chung Joo-Ho;Kim Yong-Hee;Paik Eun-Kyung;Park Jae-Hyung
    • The Journal of Korean Medicine
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    • v.25 no.4
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    • pp.129-138
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    • 2004
  • Objective : Treatments for patients with mental retardation and pervasive developmental disorders are not curative, and are designed to help those with disabilities adjust to their environments and daily demands. As clinicians, the present authors tried to find agents with potentially curative properties. Among the numerous herbal formulations available, we chose and assessed Gami-jiwhang-tang (GJT) in the hope that it would improve cognitive development of children. Methods : Subjects were typically-developing healthy, 7- to 8-year-old boys and girls living in Seoul, Korea. The experimental group took GJT for six weeks and was followed up six weeks after discontinuation of GJT. The control group was assessed at the same intervals but did not receive placebos. To measure the effects of GJT, neuropsychological tests and intelligence test were taken before commencing GJT and twelve weeks later. Resulets and Conclusion : For all of the ANOVAs, the treatment by time interaction terms was not significant. However, the experimental group showed the tendency to be progressed in most subscales compared with the control group, especially on performance intelligence, visual organization, and verbal fluency. Conclusion : Although GJT failed to reveal significant improvement in cognition, we remain hopeful about the compound and believe that it should be evaluated by a double-blind, placebo-controlled trial in the future.

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Clincal Efficacy of Korean Red Ginseng for Erectile Dysfunction -Multi-national Approach

  • Choi, Hyung-Ki;Choi, Young-Deuk;Lee, Woong-Hee
    • Proceedings of the Ginseng society Conference
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    • 1998.06a
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    • pp.208-215
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    • 1998
  • Ginseng has been used in maintaining physical vitality all over the East Asian countries and recently its metabolism and actions on neurologic, cardiovascular and endocrinologic systems are being elucidated. Korean red ginseng (KRG) has been used in various aliments, and to prove its efficacy icy erectile dysfunction an international study on Asians other than Korean was performed. Patients with borderline organic and psychogenic erectile dysfunction were included. KRG were given daily, and placebos were given as controls. Treatment lasted a total of 3 months. Surveys including libido, erectile potency, the sexual satisfactions were given. Serum testosterone and erectile function study were taken. Among the 23 patients with KRG, 18 patients were followed. Four had diabetes, 2 hypertension, 3 hyperchole, iterolemia, 1 low testosterone,4 psychogenic, and 4 idiopathic. In 10 patients with placebo, 7 were followed for more than three months. The clinical efficacy of KRG was 66.7% on objective Questionnaire and 72.2% on subjective analysis. When KRG were given, all parameters surveyed have shown improvements compared to the controls. Serum testosterone Bevels were normalized in 2 patients with KRG, whose serum testosterone levels were reduced from prestudy. When the erectile functions after audiovisual stimuli evaluated using Rigiscan in 6 patients with KRG,4 showed rigidity move than 70oyc. One patient reported constipation, and 2 gastric up-sets in the KRG group. In conclusion, KRG has beneficiary action on male erectile capabilities with minimal side effects. Thus KRG has been proven effective in Koreans, and a result on other Asians is pending. The exact action mechanism and the active ingredients in KRC need to be itudied.

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Pregabalin and gabapentin in neuropathic pain management after spinal cord injury: a systematic review and meta-analysis

  • Davari, Majid;Amani, Bahman;Amani, Behnam;Khanijahani, Ahmad;Akbarzadeh, Arash;Shabestan, Rouhollah
    • The Korean Journal of Pain
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    • v.33 no.1
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    • pp.3-12
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    • 2020
  • Neuropathic pain after spinal cord injury (SCI) has a significant negative impact on the patients' quality of life. The objective of this systematic review is to examine the safety and efficacy of pregabalin (PGB) and gabapentin (GBP) in the treatment of neuropathic pain due to SCI. PubMed, the Cochrane Library, Embase, Scopus, and the Web of Science were searched up to December 2018. The reference lists of key and review studies were reviewed for additional citations. The quality of the studies was evaluated using the Cochrane Collaboration's tools for assessing the risk of bias. A meta-analysis was performed for primary and secondary outcomes. Eight studies were eligible for inclusion. Meta-analysis of PGB vs. placebo showed that PGB was effective for neuropathic pain (standardized mean difference [SMD] = -0.40; 95% confidence interval [CI]: -0.78, -0.01), anxiety (MD = -0.68; 95% CI: -0.77, -0.59), depression (mean difference [MD] = -0.99; 95% CI: -1.08, -0.89), and sleep interference (MD = -1.08; 95% CI: -1.13, -1.02). Also, GBP was more effective than a placebo for reducing pain. No significant difference was observed between the efficacy of the two drugs (MD = -0.37; 95% CI: -1.67, 0.93). There was no significant difference between the two drugs for discontinuation due to adverse events (risk ratio = 3.00; 95% CI: 0.81, 11.15). PGB and GBP were effective vs. placebos in decreasing neuropathic pain after SCI. Also, there was no significant difference between the two drugs for decreasing pain and adverse events.

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.

Analysis of Existing Guidelines and Randomized, Controlled, Clinical Trials for Development of [Guideline of Clinical Trial on Herbal Medicinal Product for Liver Cancer] (간암 한약제제 임상시험 가이드라인 개발을 위한 한약제제 무작위배정 대조군 임상시험 고찰)

  • Han, Ga-jin;Kim, Dong-hun;Park, Eun-joo;Seong, Sin;Kim, Sung-su;Leem, Jung-tae
    • The Journal of Internal Korean Medicine
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    • v.40 no.1
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    • pp.89-116
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    • 2019
  • Objective: This study aimed to ascertain what should be considered in the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer," by analyzing existing guidelines and clinical trials. Methods: Committee for the development of a guideline, consisting of 6 Korean medicine doctors, reviewed guidelines and clinical trials on using herbal medicine for treating liver cancer. The trials were analyzed in terms of inclusion and exclusion of participants, intervention, comparators, outcomes, and trial design. We then compared the results of our analysis with the guidelines to identify issues we must to consider when following the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer." Several guidelines for antitumor agents and clinical trials on herbal medicine were obtained from the Ministry of Food and Drug Safety homepage, etc. The search terms were as follows: "liver neoplasms"; "herbal medicine"; "medicine, Korean traditional"; and "medicine, Chinese Traditional.". Results: Ten articles were obtained from pubmed and Embase. There was no guideline for clinical trials on using herbal medicine for treating liver cancer. All the participants in the reviewed articles had primary liver cancer, and the type of intervention varied (e.g., decoction, patches, and capsules. The comparators included placebos and conventional treatments such as chemotherapy. The outcome assessment methods were tumor response, quality of life, survival, and liver function tests. Adverse events occuring during the trial were also evaluated. Conclusion: Findings were derived by reviewing existing guidelines and comparing them with clinical trials on liver cancer and herbal medicinal products. These results will be utilized in the development of the "Guideline for Clinical Trials with Herbal Medicinal Products for Liver Cancer."

Effect of Oral Saccharomyces Cerevisiae Hansen CBS 5926 Therapy on Gastrointestinal Symptoms and Nutrition in Gastrectomized Patients (Saccharomyces Cerevisiae Hansen CBS 5926의 경구 투여요법이 위절제 환자의 위장관 증상 및 영양에 미치는 영향)

  • Park, Do-Joong;Lee, Hyuk-Joon;Lee, Kuhn-Uk;Yang, Han-Kwang
    • Journal of Gastric Cancer
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    • v.6 no.2
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    • pp.69-75
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    • 2006
  • Purpose: We aimed to investigate the effect of oral Saccharomyces cerevisiae Hansen CBS 5926 therapy (Saccharomyces boulardii) on gastrointestinal symptoms and nutrition in gastrectomized patients. Materials and Methods: Ninety patients who underwent a gastrectomy due to early gastric cancer were randomly divided into case and control (placebo) groups and were given medicine or placebos for 12 weeks. The gastrointestinal symptom rating and the nutritional status were evaluated by using double blind methods at 4, 16, and 20 weeks after discharge. Results: The ratio of males to females was 2.3 : 1, and the mean age was $56.3{\pm}10.2$ years. The numbers of subtotal gastrectomies and total gastrectomies were 69 and 21, respectively. Fourteen (15.6%) patients dropped, of whom 5 belonged to the case group. Of the remaining 76 patients, those in the case group had higher levels of serum albumin (P=0.046). For patients who underwent subtotal gastrectomy (n=57), the case group had higher level of serum albumin (P=0.049). Conclusion: This double blind study showed that oral Saccharomyces boulardii therapy could improve the postoperative nutrition of gastrectomized patients because gastrectomized patients with oral Saccharomyces boulardii therapy had higher levels of serum albumin than the control group.

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Correlations of Abnormal Involuntary Movements with Blood Glucose, Lipid Levels in Chronic Schizophrenics (만성정신분열병 환자들에서 비정상적 불수의 운동과 혈당, 지질과의 상관관계)

  • Kim, Hyeong-Seob;Kim, Eung-Jo;Lee, Joo-Ho;Ji, Seong-Hak
    • Korean Journal of Biological Psychiatry
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    • v.11 no.2
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    • pp.117-126
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    • 2004
  • Objects:It has been reported that the incidence of tardive dyskinesia(TD), the remarkable abnormal involuntary movement, was higher in the schizophrenics with high blood sugar levels and that TD had been improved by small amount of insulin-injection for 90 days. And also it was generally known that the blood lipids were higher in the schizophrenics with tardive dyskinesia. Thus, we tried to replicate the correlations of abnormal involuntary movements with blood sugar levels and blood lipids in chronic schizophrenics treated with antipsychotics. Methods:Thirty-eight male schizophrenic inpatients who were stable in clinical state with medications, were included. The patients who had been already diagnosed as diabetes mellitus(DM), organic brain disorder, substance- related disorder, physical illness were excluded and also we excluded female patients to remove the hormonal effect on TD. Eleven patients who ranked higher(above five) in the Abnormal Involuntary Movement Scale(AIMS) were assigned into 2 groups, a dibenese group and a placebo group. Diabinese or placebos were administrated for 3 weeks with antipsychotics and AIMS was rechecked. Results:There were no correlations between the total AIMS scores and blood sugar and lipids levels in all subjects. The means of total and subscale scores(objective, face, and extremity) of AIMS did not reveal statistical significances between diabinese and placebo groups. However(total, jaw, face, upper arm, and objective feeling), were statistically higher in the diabinese group than those in the placebo group. And correlations of total cholesterol(TC) with fast blood sugar(FBS), weight with body mass index(BMI) and waist, total glycerol (TG) with BMI were statistically significant. Conclusion:In this study, there were statistical significances in the changes in ratings of AIMS scores between the diabinese group and the placebo group. Application of oral hypoglycemic agent might be a way of improving abnormal involuntary movements in schizophrenics with abnormal involuntary movements or TD. Althogugh it was not certain that there were correlations of abnormal involuntary movement with blood sugar and lipids, correlations of TC/TG with AIMS, of FBS with AIMS cautiously suggest that the regular check of $HbA_1C$, waist, and weight are recommended for schizophrenics.

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