• Title/Summary/Keyword: randomized controlled double blind study

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Study of Complementary Medical Therapy for Allergic Rhinitis in PubMed (PubMed를 통해 살펴 본 알레르기 비염에 대한 보완 의학적 최신 연구 경향)

  • Jung, Hye-Mi;Cho, Min-Jung;Seo, Un-Kyo
    • The Journal of Internal Korean Medicine
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    • v.30 no.3
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    • pp.534-549
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    • 2009
  • Objectives : To study trends in complementary medical therapy for the allergic rhinitis. This study analyzed research on allergic rhinitis in PubMed. Methods : We searched PubMed related to complementary medical therapy for allergic rhinitis. We analyzed 25 research papers and examined published journals, years countries, and their methods, objectives, results, interventions, participants, periods and instruments of assessment. Results : The method of studies was mostly randomized, double-blind, placebo-controlled trial. There were research papers concerning treatment and prevention with herbal medicine, acupuncture, diet, etc. There were more positive results compared to negative results for treatment and prevention. Most studies were carried out during the winter/spring period. The median for number of participants was 90.54 persons. Diagnostic criteria for enrolment were nasal symptoms, allergic skin test, serum, nasal discharge allergen specific IgE eosinophil, etc. Assessment for outcomes were nasal symptoms, serum, nasal discharge allergen specific IgE eosinophil and Quality of Life Questionnaire. Conclusions : It is necessary to study effects of acupuncture and herb medicines for allergic rhinitis and more in-depth research about trends in complementary medical therapy for allergic rhinitis.

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A Double-blind Comparison of 0.125% Ropivacaine with Fentanyl and 0.125% Bupivacine with Fentanyl for Labor Analgesia Using Patient-Controlled Epidural Infusion (지속적 통증조절기를 이용한 경막외강으로 Fentanyl을 첨가한 0.125% Ropivacaine과 0.125% Bupivacaine 주입시 분만통 조절에 대한 효과)

  • Choi, Jeong-Hwan;Lee, Hae-Jin;Sung, Choon-Ho
    • The Korean Journal of Pain
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    • v.13 no.1
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    • pp.67-73
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    • 2000
  • Background: This study intends to evaluate the benefits of the administation of continuous infusion and demand doses of 0.125% ropivacaine compared with 0.125% bupivacaine after addition of fentanyl using patient controlled epidural analgesia (PCEA) for pain control during labor. Methods: Thirty-nine American Society of Anesthesiologists physical status 1 or 2 parturients were randomized by double blind design to receive either 0.125% bupivacaine with fentanyl 1 ug/ml or equivalent concentration of ropivacaine/fentanyl using PCEA; with 6~8 ml/hr basal rate, 3 ml bolus, 5 min lockout, 30 ml/hr dose limit. We assessed analgesia, the amount of study solution used in PCEA, sensory levels, motor block (0~3 scales), side effects and patient satisfaction. A postpartum questionnaire was carried out afterward. Results: There were no differences in visual analogue scores (VAS) for pain, hourly study solution use, sensory levels, side effects and patient satisfaction between groups. However, patients administered ropivacaine/fentanyl had significantly less demand, less administered in PCEA, less numbness and restriction of movement compared with patients in the bupivacaine/fentanyl group. Conclusions: Ropivacaine 0.125% with fentanyl, when administerd epidurally by PCEA for labor analgesia, was equally efficious as bupivaciane 0.125% with fentanyl, having with minimal numbness and restriction of motion.

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The effects of treadmill training on dynamic balance and gait function in stroke patients: a pilot randomized controlled trial

  • Chung, Eun Jung;Lee, Byounghee
    • Physical Therapy Rehabilitation Science
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    • v.2 no.1
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    • pp.39-43
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    • 2013
  • Objective: The objective of this study is to investigate the effect of treadmill gait trainig on dynamic balance and gait functions in stroke patients. Design: Randomized, double-blind, controlled pilot study. Methods: Four subjects following first stroke participated in this study. They were divided randomly into the treadmill gait trainig group (TM group) (n=2) and the control group (n=2). Subjects in both groups received general training five times per week. Subjects in the TM group practiced an additional treadmill gait trainig program that consisted of 60 minutes, three times per week, during a period of four weeks. Timed up and go test (dynamic balance) and the GAITRite test (gait function) were evaluated before and after the intervention. Results: In dynamic balance (timed up and go test), the TM group (-14.235 sec) showed a greater decrease than the control group (-13.585 sec). In gait functions, the TM group showed a greater increase in gait speed (12.8 cm/s vs. 10.15 cm/s), step-length (5.825 cm vs. 3.735 cm), and stride-length (5.005 cm vs. 1.55 cm) than the control group. Conclusions: The treadmill gait trainig improved dynamic balance and gait functions. Further research is needed in order to confirm the generalization of these findings and to identify which stroke patients might benefit from treadmill gait trainig.

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Safety and antifatigue effect of Korean Red Ginseng: a randomized, double-blind, and placebo-controlled clinical trial

  • Zhang, Li;Chen, Xiaoyun;Cheng, Yanqi;Chen, Qilong;Tan, Hongsheng;Son, Dongwook;Chang, Dongpill;Bian, Zhaoxiang;Fang, Hong;Xu, Hongxi
    • Journal of Ginseng Research
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    • v.43 no.4
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    • pp.676-683
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    • 2019
  • Background: Korean Red Ginseng (KRG) is widely used for strengthening the immune system and fighting fatigue, especially in people with deficiency syndrome. However, there is concern that the long-term application or a high dose of KRG can cause "fireness" (上火 in Chinese) because of its "dryness" (燥性 in Chinese). The aim of this study was to assess the safety and efficacy of a 4-week treatment with KRG in participants with deficiency syndrome. Methods: This was a 4-week, randomized, double-blind, placebo-controlled clinical trial. A total of 180 Chinese participants were randomly allocated to three groups: placebo control group, participants were given a placebo, 3.6 g/d; KRG 1.8 g and 3.6 g groups. The primary outcomes were the changes in fireness and safety evaluation (adverse events, laboratory tests, and electrocardiogram). The secondary outcomes were the efficacy of KRG on fatigue, which include the following: traditional Chinese medicine (TCM) symptom scale and fatigue self-assessment scale. Results: Of the 180 patients, 174 completed the full study. After 4 weeks of KRG treatment, the Fire-heat symptoms score including Excess fire-heat score and Deficient fire-heat score showed no significant change as compared with placebo treatment, and no clinically significant changes in any safety parameter were observed. Based on the TCM syndrome score and fatigue self-assessment score, TCM symptoms and fatigue were greatly improved after treatment with KRG, which showed a dose- and time-dependent effect. The total effective rate was also significantly increased in the KRG groups. Conclusion: Our study revealed that KRG has a potent antifatigue effect without significant adverse effects in people with deficiency syndrome. Although a larger sample size and longer treatment may be required for a more definite conclusion, this clinical trial is the first to disprove the common conception of "fireness" related to KRG.

Helicobacter pylori infection and abdominal pain in children (Helicobacter pylori 감염과 소아 복통)

  • Seo, Jeong Kee
    • Clinical and Experimental Pediatrics
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    • v.49 no.2
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    • pp.136-143
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    • 2006
  • The relationship between H. pylori(Hp) infection and recurrent abdominal pain(RAP) in children is not clear. Current data in the literature regarding a causal relationship between Hp infection and childhood RAP are conflicting. However, meta-analysis and most of the recently published studies have not supported an association between Hp infection and an increased prevalence of abdominal pain. Most published studies have some problems and have been criticized on methodological grounds. Most of the existing studies have not been designed to include double-blind placebo controls. And, because of the low incidence of Hp infection in children, they have a problem of obtaining sufficient numbers of the Hp infected children. There is also a concern about the heterogeneity of testing methodology in the studies and diagnostic accuracy problems of the non-invasive tests such as low sensitivity of the serology tests and false positive results of the UBT in children. And conflicting results may be explained, in part, by the poor definition of RAP or dyspepsia for the study subjects. To date, no consensus exists for the treatment of Hp-infected children with RAP. Some authors suggest the clinical efficacy of Hp. But others suggest that eradication of Hp is not associated with improvement of RAP. The problem of the most treatment studies is that they had usually no control groups and the number of the subjects was small. In order to make reasonable decisions about treatment of Hp infection in children with RAP, long-term, randomized, double blind, well controlled studies in large numbers of children will be required.

Randomized, Double Blind, Placebo-Controlled Study of Bofu-tsusho-san on Obese Patients (비만환자에 대한 방풍통성산(防風通聖散)의 무작위배정, 이중맹검, 위약-대조군 임상시험)

  • Lee, Ji-Eun;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine for Obesity Research
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    • v.10 no.1
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    • pp.1-16
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    • 2010
  • Objectives The clinical trial was designed to investigate the safety and effects of Bofu-tsusho-san extracts on the change of the weight, body compositions, serum in obese patients. Methods This study was a 4-weeks, double blind, comparative clinical trial. Eligible subjects had a body mass index(BMI) greater than $25\;kg/m^2$ and waist circumference(WC) longer than 85 cm in woman or 90 cm in man. Among 38 subjects, 36 subjects were randomized either to Bofu-tsusho-san or placebo. After 4 weeks of treatment, we measured anthropometric factors(weight, height, WC, BMI etc.), abdominal fat area by CT scanning, serum lipid(total cholesterol(TC), triglyceride(TG), HDL cholesterol, LDL cholesterol), blood level of variety(glucose, adiponectine, leptin, C-reactive protein(CRP) etc.), blood pressure(BP). Adverse events also evaluated. Results BMI, BP, TG, CRP were reduced and weight, WC, score of KOQOL(Korean version of obesity-related QOL scale), SRI(Stress response inventory) were significant changed in Bofu-tsusho-san. But there were no considerable difference between Bofu-tsusho-san and placebo. there were no serious adverse events in either group. Conclusion There were limitations in this study that it conducted within a short period of 4 weeks. but its weight and WC loss effect was significant and it had few adverse events.

Effect of Lactobacilli Oral Supplement on the Vaginal Microflora of Antibiotic Treated Patients: Randomized, Placebo-Controlled Study

  • Reid,Gregor;Hammond, Jo-Anne;Bruce, Andrew W.
    • Preventive Nutrition and Food Science
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    • v.8 no.2
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    • pp.145-148
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    • 2003
  • Many antibiotic monographs cite the induction of vaginal infections as a possible side effect. Invariably, this is believed to be due to Candide albicans, and empirical therapy is given. However, recent studies raise the question of the extent to which yeast do infect the host after antibiotic use. A double-blind, randomized, placebo-controlled study was undertaken on female patients to determine how many yeast infections occurred following 10 days antibiotic use. In addition, the study was designed to examine whether oval use of probiotic lactobacilli can reduce the risk of vaginal infection. Twenty four patients diagnosed with respiratory, oval or throat infections received one of several types of antibiotic for 10 days, and two capsules containing 10$^{9}$ dried Lactobacillus rhamnosus GR-1 and L. fermentum RC-14 from the day of commencement of antibiotic therapy for 21 days. The most commonly prescribed antibiotic was biaxin (clarithromycin). All but one patient had lactobacilli in the vagina upon entry to the study, and none developed yeast vaginitis or diarrhea during treatment or 20 days after completion of antibiotics. The mean Nugent score was higher in the placebo than the lactobacilli group (4.1 versus 2.4), and three cases of bacterial vaginosis arose (25 % incidence compared to 0% in the lactobacilli group) in the placebo group (2 receiving cefuroxime, 1 on biaxin). The study suggested that current antibiotic use is not necessarily associated with either diarrhea or yeast infection, as is often surmised. Nevertheless, daily use of probiotics was safe and could potentially reduce the risk of patients developing bacterial vaginosis after antibiotic use.

Preventive effects of ginseng against atherosclerosis and subsequent ischemic stroke: A randomized controlled trial (PEGASUS trial)

  • Kwon, Boseong;Song, Yunsun;Kim, Joong-Goo;Lee, Dongwhane;Lee, Sang-hun;Cho, Young-Keol;Kim, Jong S.;Suh, Dae Chul
    • Journal of Ginseng Research
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    • v.46 no.4
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    • pp.585-591
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    • 2022
  • Background: Korean Red Ginseng (KRG) extract has been shown to have beneficial effects in patients with atherosclerosis, suggesting that KRG extract may be effective in preventing subsequent ischemic stroke in patients with severe atherosclerosis. Methods: This double-blind, placebo-controlled trial randomized patients with severe atherosclerosis in major intracranial arteries or extracranial carotid artery, to ginseng group and placebo group. They were given two 500-mg KRG tablets or identical placebo tablets twice daily for 12 months according to randomization. The primary endpoint was the composite of cerebral ischemic stroke and transient ischemic attack during 12 months after randomization. The secondary endpoints were change in volumetric blood flow of the intracranial vessels and the incidence of newly developed asymptomatic ischemic lesions. Any adverse events were monitored. Results: Fifty-eight patients were randomized from June 2016 to June 2017, 29 to ginseng and 29 to placebo, and 52 (28 and 24, respectively) completed the study. One patient in the placebo group, but none in the ginseng group, experienced ischemic symptoms (p = 0.46). Changes in volumetric blood flow and the presence of ischemic brain lesions did not differ significantly in the two groups, and none of these patients experienced adverse drug reactions. Conclusion: Ginseng was well tolerated by patients with severe atherosclerosis, with these patients showing good compliance with ginseng dosing. Ginseng did not show significant effects compared with placebo, although none of the ginseng-treated patients experienced ischemic events. Long-term studies in larger patient populations are required to test the effect of ginseng.

Monocyte chemoattractant protein-1 polymorphism interaction with spirulina immunomodulatory effects in healthy Korean elderly: A 16-week, double-blind randomized clinical trial

  • Park, Hee Jung;Lee, Hyun Sook
    • Nutrition Research and Practice
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    • v.11 no.4
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    • pp.290-299
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    • 2017
  • BACKGROUND/OBJECTIVES: Spirulina is a known a functional food related to lipid profiles, immune functions, and antioxidant capacity. Circulating monocyte chemoattractant protein-1 (MCP-1) level is associated with inflammation markers. Single nucleotide polymorphism in the MCP-1 promoter region -2518 have been identified and shown to affect gene transcription. Gene variation may also impact functional food supplementary effects. The current study investigated the interaction of MCP-1 -2518 polymorphism with spirulina supplements on anti-inflammatory capacity in Korean elderly. SUBJECTS/METHODS: After genotyping, healthy elderly subjects (n = 78) were included in a randomized, double blind, and placebo controlled study. Baseline characteristic, body composition, and dietary intake were measured twice (baseline vs. week 16). For 16 weeks, subjects consumed 8 g either spirulina or placebo daily. Plasma MCP-1, interleukin (IL) -2, IL-6, tumor necrosis factor (TNF)-${\alpha}$, complement (C) 3, immunoglobulin (Ig) G, and Ig A concentrations and lymphocyte proliferation rate (LPR) were analyzed as inflammatory markers. RESULTS: In the placebo group with A/A genotype, MCP-1 level was significantly increased, but the spirulina group with A/A genotype was unchanged. IL-2 was significantly increased only in subjects with spirulina supplementation. TNF-${\alpha}$ was significantly reduced in subjects with the G carrier. C3 was significantly increased in the placebo group, particularly when A/A increased more than G, but not when spirulina was ingested. LPR was significantly different only in subjects with A/A genotype; there was a significant increase in phytohemagglutinin and lipopolysaccharide induced LPR in the spirulina group. CONCLUSION: In healthy Korean elderly, spirulina supplementation may influence different inflammatory markers by the MCP-1 genotype. These results may be useful for customized dietary guidelines to improve immune function in Koreans.

Amiodarone Versus Propafenone to Treat Atrial Fibrillation after Coronary Artery Bypass Grafting: A Randomized Double Blind Controlled Trial

  • Nemati, Mohammad Hassan;Astaneh, Behrooz
    • Journal of Chest Surgery
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    • v.49 no.3
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    • pp.177-184
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    • 2016
  • Background: Atrial fibrillation (AF) is one of the most common complications after cardiac surgery. Several therapeutic and preventive strategies have been introduced for postoperative AF, but the treatment and prophylaxis of AF remain controversial. We aimed to compare the efficacy of intravenous amiodarone and oral propafenone in the treatment of AF after coronary artery bypass grafting (CABG). Methods: This was a randomized controlled trial performed in two hospitals in Shiraz, Iran from 2009 to 2012. We included all patients who underwent elective CABG and developed AF postoperatively. The patients were randomly assigned to receive propafenone or amiodarone. The duration of AF, the success rate of the treatment, the need for cardioversion, the frequency of repeated AF, and the need for repeating the treatment were compared. Results: The duration of the first (p=0.361), second (p=0.832), and third (p=0.298) episodes of AF, the need for cardioversion (p=0.998), and the need to repeat the first and second doses of drugs (p=0.557, 0.699) were comparable between the study groups. Repeated AF was observed in 17 patients (30.9%) in the propafenone group and 23 patients (34.3%) in the amiodarone group (p=0.704). Conclusion: Oral propafenone and intravenous amiodarone are equally effective in the treatment and conversion of recent-onset AF after CABG.