• Title/Summary/Keyword: Placebo-controlled

Search Result 458, Processing Time 0.022 seconds

Cardiovascular Outcomes of Sodium-Glucose Cotransporter-2 Inhibitors Therapy in Patients With Type 2 Diabetes Mellitus and Chronic Kidney Disease: A Systematic Review and Updated Meta-Analysis

  • Nicole Felix;Mateus M. Gauza;Larissa Teixeira;Maria Eduarda S. Guisso;Alleh Nogueira;Caroline S. Dagostin;Amanda Godoi;Sandro A. G. Ribeiro;Juan C. Duque;Jose A. Moura-Neto;Rhanderson Cardoso
    • Korean Circulation Journal
    • /
    • v.54 no.9
    • /
    • pp.549-561
    • /
    • 2024
  • Background and Objectives: The efficacy of sodium-glucose cotransporter-2 inhibitors (SGLT2i) may depend on renal function, and this raises theoretical concern over its effects on cardiovascular outcomes in patients with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD). Methods: This systematic review and updated meta-analysis of randomized controlled trials (RCTs) compared cardiovascular outcomes of patients with T2DM and CKD treated with SGLT2i to placebo. PubMed, Embase, and Cochrane were systematically searched. Prespecified subgroup analyses were performed in strata of estimated glomerular filtration rate (eGFR) of <45 mL/min/1.73 m2 and 45 to 59 mL/min/1.73 m2. Results: Nine RCTs comprising 29,146 patients were selected. Average follow-up ranged from 0.75 to 4.2 years. SGLT2i were shown to reduce the risk of all-cause mortality (hazard ratio [HR], 0.88; 95% confidence interval [CI], 0.79-0.97; p=0.01), the composite of cardiovascular mortality or hospitalizations for heart failure (HHF: HR, 0.71; 95% CI, 0.65-0.78; p<0.001), cardiovascular mortality (HR, 0.86; 95% CI, 0.76-0.98; p=0.02), HHF (HR, 0.62; 95% CI, 0.55-0.71; p<0.001), major adverse cardiovascular events (HR, 0.85; 95% CI, 0.77-0.94; p=0.002), stroke (HR, 0.76; 95% CI, 0.59-0.97; p=0.03), and myocardial infarction (HR, 0.78; 95% CI, 0.67-0.91; p=0.001). These findings were consistent over strata of eGFR, albeit with a lower incidence of stroke in patients treated with SGLT2i with eGFR <45 mL/min/1.73 m2 (p-value for interaction=0.04). Conclusions: Compared with a placebo, patients with T2DM and CKD treated with SGLT2i experience a reduction in all-cause mortality, cardiovascular mortality, and HHF.

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
    • /
    • v.35 no.1
    • /
    • pp.12-23
    • /
    • 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.

A Study on Effectiveness of Socheongryong-tang for Allergic Rhinitis : A Systematic Review and Meta-analysis (알레르기 비염에 대한 소청용탕(小靑龍湯)의 효과 평가 연구 : 체계적 문헌고찰과 메타분석)

  • Min, Kyung-Jin;Shin, Seon-Ho;Kang, Jeong-In;Lee, Dong-Hyo
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
    • /
    • v.33 no.4
    • /
    • pp.74-99
    • /
    • 2020
  • Objectives : The purpose of this study is to assess the effectiveness and safety of Socheongryong-tang(SCRT) for allergic rhinitis(AR). Methods : We searched randomized controlled trials(RCTs) that used SCRT for AR in 8 databases(PubMed, Cochrane Library, CNKI, CiNii Articles, OASIS, NDSL, KISS, KMbase) from their inception until August 2019. The primary outcome was effective rate and scores evaluating the improvement of AR symptoms. The secondary outcome was quality of life scale, adverse events, recurrence rate, and laboratory indicators. Two researchers assessed the risk of bias in the included trials through the Cochrane Risk of Bias tool independently. The study synthesized outcomes using RevMan 5.3. Results : Eighteen RCTs involving 1686 participants were included in this review. The risk of bias was unclear for the majority of the included studies. Meta-analysis of 12 RCTs showed that there was no statistically significant difference between the SCRT group and usual care group in the effective rate(RR 1.18, 95% CI(0.98, 1.41), p=0.09, I2=46%). Meta-analysis of 5 RCTs showed that the combination treatment group of SCRT and usual care was significantly higher than the usual care group in the effective rate(RR 1.24, 95% CI(1.12, 1.38), p<0.0001, I2=0%). The SCRT group was more effective in improving nasal symptoms and quality of life than the placebo group according to one RCT. Mild adverse events such as dry mouth were identified in 5 RCTs, but no serious adverse events were reported. Conclusion : This review showed that in terms of the effective rate for AR, there was no statistically significant difference between SCRT and usual care and the combination treatment of SCRT and usual care was more effective than usual care. There were no serious adverse events. However, it is difficult to make a definite conclusion because of few included studies and heterogeneity between studies, and the quality of included studies was mostly insufficient. Further well-designed randomized controlled trials are needed.

Effect of Beraprost Sodium in Patients with Chronic Obstructive Pulmonary Disease (만성폐쇄성폐질환 환자에서 Beraprost sodium의 효과에 대한 연구: 이중 맹검 무작위 임상시험)

  • Lee, Sang-Do;Seo, Kwang Won;Lee, Jung Yeon;Huh, Jin Won;Choi, Ik Su;Park, Jae Sun;Shim, Tae Sun;Oh, Yeon-Mok;Park, In Won;Ryu, Wang-Seong;Choi, Byoung Whui
    • Tuberculosis and Respiratory Diseases
    • /
    • v.57 no.4
    • /
    • pp.320-328
    • /
    • 2004
  • Background : Pulmonary vascular changes which occur early in the course of chronic obstructive pulmonary disease (COPD) are prevalent manifestation and later cause pulmonary hypertension, which is a bad prognostic factor in COPD. Beraprost sodium (BPS), an orally active prostacyclin analogue, has been shown to improve survival in patients with primary pulmonary hypertension. This study investigated the effect of BPS in the patients with COPD. Methods : This is a double-blind randomized placebo-controlled, two center clinical trial. Twenty one consecutive patients with COPD were enrolled from June 2003 to June 2004 (patients treated with BPS for 3 months, BPS group, n=11; those with placebo, placebo group, n=10). The baseline demographic, pulmonary function and hemodynamic data were not significantly different between two groups. Results : On echocardiographic examination, trans tricuspid valve pressure gradient has decreased significantly after 3 months with beraprost in the BPS group [17.7(${\pm}11.4$) to 8.2(${\pm}8.9$) mm Hg, p-value<0.05], while there was no significant change in the control group. Six-minute walking distance has decreased in the control group and increased in the BPS group, but there was no statistical significance. Conclusion : In patients with COPD oral administration of BPS reduced the pulmonary arterial pressure. The clinical significance of this finding, that is improving symptoms and natural course of the disease, needs further study.

Effects of Ishige okamurae Extract Supplement on Blood Glucose and Antioxidant Systems in Type 2 Diabetic Patients (패 추출물이 제2형 당뇨병 환자의 혈당 및 항산화 체계에 미치는 영향)

  • Kang, Yeon-Ju;Kim, Hak-Ju;Han, Ji-Sook
    • Journal of the Korean Society of Food Science and Nutrition
    • /
    • v.40 no.12
    • /
    • pp.1726-1733
    • /
    • 2011
  • We performed a randomized placebo-controlled trial to determine whether or not Ishige okamurae extract supplements modulate blood glucose and antioxidant systems in type 2 diabetic patients. A total of 46 patients were randomized to either an Ishige okamurae extract group or a placebo group. The patients consumed either 1,600 mg of Ishige okamurae extract or cornstarch supplement per day for 10 weeks. The lifestyle factors and dietary intake of patients were not altered during the 10 week trial period. After 10 weeks, the fasting blood glucose level was slightly decreased in the Ishige okamurae extract group, but a significant decrease was not observed. Also, glycosylated hemoglobin was significantly (p<0.01) decreased. Especially, low-glycosylated hemoglobin ($7.12{\pm}0.38%$ to $6.56{\pm}0.53%$) was significantly decreased compared to high-glycosylated hemoglobin ($8.65{\pm}0.92%$ to $8.60{\pm}0.85%$) in that group. The superoxide dismutase, catalase, and glutathione peroxidase levels were increased in the Ishige okamurae extract group compared to the placebo group. The increase of these enzymes was associated with the decrease of MDA concentration in the Ishige okamurae extract group, but a significant decrease was not observed. The Ishige okamurae extract supplement showed no adverse effects on liver and kidney functions. Findings from this study suggest that an Ishige okamurae extract supplement can help blood glucose status in type 2 diabetic patients without adverse effects.

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
    • /
    • v.25 no.4
    • /
    • pp.129-138
    • /
    • 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.

  • PDF

The Effect of Korean Medicine Treatments on Facial Asymmetry: A Case Report (안면 비대칭에 대한 한의학적 치료의 효과: 증례보고)

  • Kwon, Chan-Young;Lee, Hoon-Hui;Im, Yong-Seok
    • Korean Journal of Acupuncture
    • /
    • v.34 no.3
    • /
    • pp.179-184
    • /
    • 2017
  • Objectives : Despite the applicability of Korean Medicine(KM) treatments for facial asymmetry, no relevant study has been reported. In this case report, we report the effect and safety of KM treatments on facial asymmetry by mandibular lateral displacement. Methods : Three patients suffering from facial asymmetry received twelve KM treatment sessions composed of Motion Style Treatment(MST), Yinyang Balance Appliance(YBA) of Functional Cerebrospinal Therapy(FCST), and Instrument Assisted Soft Tissue Mobilization(IASTM). The photos of each patient were taken before and after the treatment. And four primary reference lines were assessed before and after the treatment. Results : All subjects were improved after KM treatments on photos. However, no statistical significance was observed. Conclusions : This case report is the first to introduce the effect of KM treatments on facial asymmetry. Further well-designed, randomized, placebo-controlled trials are needed to verify these results.

The Effect of Bee Venom Acupuncture(BVA) on acute Ankle Sprain : A Randomized Controlled Trial and double blinding - Pilot study (급성 족관절 염좌에 대한 봉약침 효과-무작위대조시험, 이중맹검)

  • Song, Ho-Seub
    • Journal of Pharmacopuncture
    • /
    • v.8 no.2
    • /
    • pp.11-16
    • /
    • 2005
  • Objective : The aim of the study was to investigate the therapeutic effect of BVA in the treatment of patients with acute ankle sprain. Design : A prospective randomized double-blind study of BVA was conducted. Setting : The study was done in the Kyungwon University Seoul Hospital from August 1st, 2004 to June 15th, 2005. Patients : 30 patients diagnosed with acute ankle sprain, especially 2nd degree on the Ankle grade pain chart(AGPC) participated in the study, who were divided into two groups (A and B) randomly by a coordinator flipping a coin. Group A and B were relevant to control and BVA group respectively, of which a coordinator never informed any other participant involved. Eventually 13 of 17 in group A and 11 of 13 in Group B finished all the process of the clinical trial. Intervention : In both group A and B, The Procedure of acupuncture treatment was made similar by appearance that four acupoints such as 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41) of the injured side were selected and Normal saline aqua-acupuncture(control, as a placebo) or BVA was done and then acupuncture at 坵墟(GB40), 中封(LR4), 商丘(SP5), 解谿(ST41), 足三里(ST36), 陽陵泉(G34) of the affected side was given again. the needles were retained for 20 minutes under the infrared rays. The treatment was given daily for a week. Outcome Measures : Ankle-Hindfoot Scale (AHS) and Visual Analogue Scale(VAS) were followed by three treatments. Statistical Analysis : Analysis regarding variations in AHS and VAS is carried out by applying Mann-Whitney test and Wilcoxon signed rank test sign test with level of significance at 5%. Results : At the end of the treatment, there was significant statistical differences between the two groups in VAS and AHS as well, while at the 3rd day only a VAS showed statistical significance. In each group, both VAS and AHS showed statistical significance along with duration of treatment. Conclusions : BVA was thought to be effective alternatives for relieving symptoms of acute ankle sprain, although further study was needed on the large scale.

The Effect of Mahuang(Ephedra sinica Stapf)-Chuanwu(Aconitum carmichaeli Debx) Pharmacopuncture Treatment in Obese Patients (마황천오약침이 비만에 미치는 영향)

  • Kim, Jin-Hyuk;Shin, Min-Seop;Choi, Seok-Woo;Song, Beom-Yong;Yook, Tae-Han
    • Journal of Acupuncture Research
    • /
    • v.26 no.5
    • /
    • pp.77-83
    • /
    • 2009
  • Objectives : We investigated the effects of Mahuang-Chuanwu Pharmacopuncture Treatment in Obese Patients by analysing Body mass index(BMI), waist measurement and weight. Methods : We investigated on 52 volunteers consisted of 24 subjects in experiment(Mahuang-Chuanwu Pharmacopuncture) group and 28 subjects in control(Normal Saline) group. The Study form was a single-blind and placebo-controlled clinical trial. 24 subjects in experiment group were injected Mahuang-Chuanwu Pharmacopuncture with additional common treatment and 28 subjects in control group were injected Normal Saline with additional common treatment with Dietic Theraphy and Exercise. We measured BMI, waist measurement and weight on 3 times : before 1st session, after first 5 sessions, and after 10 sessions. The SPSS 13.0 for Windows was used to analyze the data and the wilcoxon signed ranks test (in group), mann Whitney u t-test(between two groups) and ${\chi}^2$-test(description of number) were used to verify the result. Results : In experiment group. BMI, waist measurement and weight were significantly low at the period of after first 5 sessions and after 10 sessions. In control group, BMI, waist measurement and weight were significantly low at the period of after 10 sessions but weren't significantly low at the period of after first 5 sessions. The changes of BMI, waist measurement and weight in experiment group were significantly more than that in control group. Conclusions : The Results suggest that Mahuang(Ephedra sinica Stapf)-Chuanwu(Aconitum carmichaeli Debx) Pharmacopuncture is effective on the treatment of obesity, compared to Normal Saline.

  • PDF

Clinical Study of the Efficacy and. Safety of Jetongdan on Patients with Osteoarthritis of the Knee (퇴행성 슬관절염에 대한 제통단의 안전성과 효능 임상연구)

  • Seo Byung-Kwan;Ryu Seong-Ryong;Kang Jung-Won;An Kyungeh;Lee Sang-Hoon;Choi Do-Young;Kim Keon-Sik;Lee Doo-Ik;Lee Yun-Ho;Lee Jae-Dong
    • The Journal of Korean Medicine
    • /
    • v.26 no.2 s.62
    • /
    • pp.231-240
    • /
    • 2005
  • Objectives: In order to investigate the efficacy and safety of the newly developed herbal medicine Jetongdan, a placebo­controlled, randomized clinical trial of patients with osteoarthritis of the knee was undertaken. Methods: Data were obtained from 80 patients with OA of the knee. After enrollment, they were asked to answer a disease-specific questionnaire (Western Ontario and McMaster Universities (WOMAC) OA index) and analyzed with the erythrocyte sedimentation rate (ESR) in order to evaluate the efficacy of Jetongdan, and analyzed for aspartate transaminase (AST) level, alanine transaminase (ALT) level, blood mea nitrogen (BUN) level, and creatinine (Cr) level in order to evaluate the safety of Jetongdan. Results: The liver function and renal function did not deteriorate after treatment with Jetongdan. Composite WOMAC score and physical function subscale was improved, but pain subscale, stiffness subscale, and ESR were not improved by. This was possibly because the baseline characteristics of the two groups were not homogenized after randomization. Conclusions: Jetongdan could be a promising treatment option for osteoarthritis of the knee. Further study in a larger population with appropriate severity grades is recommended.

  • PDF