• Title/Summary/Keyword: randomized controlled trials (RCTs)

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Clinical Application of Focused Ultrasound in Korean Medicine (집속초음파 치료의 한의 임상 활용에 대한 고찰)

  • Yoomin Choi;Maeum Lee;Nayeon Hur;Eunhee Lee;Hyugyong Choi;Hyung-Sik Seo;Eui-Hyoung Hwang;Insoo Jang
    • Korean Journal of Acupuncture
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    • v.40 no.3
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    • pp.79-89
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    • 2023
  • Objectives : The purpose of this study is to investigate various application methods of focused ultrasound and apply them to clinical use in Korean medicine. Methods : Search was performed using the search engines of electronic databases, including PubMed, ScienceDirect, Cumulative Index to Nursing and Allied Health Literature (CINAHL), ScienceON, Oriental Medicine Advanced Searching Integrated System (OASIS), China National Knowledge Infrastructure (CNKI), Wanfang Data, Japan Science Technology Information Aggregator, Electronic (J-STAGE) and Citation Information by NII (CiNii), from inception to July 2023 without language limitation. Inclusion criteria were clinical studies including randomized controlled trials (RCTs), and animal experimental studies related with focused ultrasound treatments for acupoints or meridian sinews. Results : Total 17 papers, 7 for RCT, 6 for in vivo animal studies, and other experimental studies, were finally selected. Indications used in studies were shoulder pain, back pain, chronic back pain, and degenerative knee arthritis. In experimental studies, studies on animal models of hypoxic ischemic brain damage and hyperlipidemia were also conducted. As for the acupoints, LR3, LI4, and ST36 were used in clinical studies and, in animal experimental studies, GV20, KI1, and ST36 were used. As for the dose, 4 studies below 3 W/cm2 and 3 studies in the range of 0.625 to 5 W/cm2 in clinical studies, and all studies did not exceed 5 W/cm2. In animal experimental studies, 0.5 W/cm2, 2 W/cm2, 7.5 WW/cm2, 15 W/cm2, 10~20 W/cm2 were used. In all three studies describing the penetration depth during irradiation, it was less than 1 cm. Conclusions : We suggest that focused ultrasound is an appropriate treatment tool for stimulating the acupoints to transfer heat energy. Future studies with rigorous and well-designed RCTs for various diseases will be required to ascertain the focused ultrasound stimulate acupoints or meridian sinews.

The Effect of Taeksa-tang for Dyslipidemia: A Systematic Review and Meta-Analysis (이상지질혈증에 대한 택사탕(澤瀉湯)의 효과 : 체계적 문헌 고찰 및 메타 분석)

  • Yeong-seo Lee;Tae-young Huh;Kyoung-min Kim
    • The Journal of Internal Korean Medicine
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    • v.44 no.3
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    • pp.485-505
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    • 2023
  • Objective: The purpose of this study is to assess the effectiveness and safety of using Taeksa-tang for dyslipidemia through a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: The search was conducted using keywords such as "dyslipidemia", "hyperlipidemia", "taeksa tang", "zexie tang", and "takusha to" in 12 databases (Pubmed, Cochrane, Embase, ScienceDirect, CNKI, Wanfang, CiNii, RISS, KISS, ScienceON, OASIS, and DBpia) on April 13, 2023. There were no limits on the publication period and language. Cochrane's risk of bias (RoB) was used to evaluate the quality of the studies. A meta-analysis was conducted according to the outcome measurements such as total effective rate (TER), total cholesterol (TC), triglyceride (TG), HDL-cholesterol (HDL-C), LDL-cholesterol (LDL-C), and adverse effects, using the Review Manager web. Results: A total of 9 RCTs were selected. In evaluating the RoB, 2 studies mentioning the random sequence generation, 1 study conducting double blindness, and 8 studies without missing values were evaluated as low risk, while 1 study without mentioning the random sequence generation was evaluated as high risk. All other parts were evaluated as unclear risk. The treatment group (Taeksa-tang or Taeksa-tang-gagam) showed more statistically significant effects compared to the control group (Western medicine or Chinese patent medicine) in TER (RR : 1.24, 95% CI 1.15 to 1.34, P<0.00001), TC (MD : -1.12, 95% CI -1.68 to -0.56, P<0.0001), TG (MD : -1.08, 95% CI -1.65 to -0.51, P=0.0002), HDL-C (MD : 0.63, 95% CI 0.34 to 0.93, P<0.0001), LDL-C (MD : -0.81, 95% CI -1.10 to -0.53, P<0.00001). In addition, the treatment group showed lower adverse effects compared to the control group (RR : 0.30, 95% CI 0.12 to 0.74, P=0.008). Conclusion: This study suggests that Taeksa-tang is effective and safe to use for treating dyslipidemia. However, due to the low quality of the included studies, more clinical studies need to be conducted in the future to increase the possibility of clinical use.

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
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    • v.54 no.9
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    • pp.549-561
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    • 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.

Systematic review of the effect of dried ginger powder on improvement of nausea and vomiting associated with early pregnancy or motion sickness (생강 건조 분말의 임신 및 멀미에 의한 오심, 구토 개선 기능성에 대한 체계적 고찰)

  • Kwak, Jin Sook;Paek, Ju Eun;Jeong, Sewon;Kim, Joohee;Kim, Ji Yeon;Kwon, Oran
    • Journal of Nutrition and Health
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    • v.47 no.1
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    • pp.45-50
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    • 2014
  • Purpose: Ginger (Zingiber officinale) has been widely used as an antiemetic agent. This systematic review was aimed at evaluation of the effect of dried ginger powder supplementation on improvement of nausea and vomiting associated with early pregnancy or motion sickness. Methods: We searched Pubmed, Cochrane, Science Direct, and KISS (Korean studies Information Service System) using keywords such as ginger or Zingiber officinale in combination with nausea, vomiting, motion sickness, or pregnancy, published in March 2013. Results: The strength of the evidence was evaluated on the selected 12 RCTs (randomized controlled trials). Eleven trials including 2,630 subjects showed that supplementation with dried ginger powder resulted in significant improvement of nausea or vomiting related to early pregnancy or motion sickness. Among the nine studies including 809 women in early pregnancy before 20 weeks of gestation, ginger supplementation was superior to placebo in five studies (n = 305), and as effective as positive control (vitamin $B_6$ or dimenhydrinate) in four studies (n = 504). Ginger intake significantly reduced the episodes or severity of vomiting related to motion sickness compared to placebo or showed the same effect as several antiemetic drugs in two studies (n = 1,821). Conclusion: Our findings added evidence indicating that ginger powder supplements might improve the symptoms of nausea or vomiting related to early pregnancy or motion sickness without significant adverse events.

Comparison Different Methods of Intraoperative and Intraperitoneal Chemotherapy for Patients with Gastric Cancer: A Meta-analysis

  • Huang, Jin-Yu;Xu, Ying-Ying;Sun, Zhe;Zhu, Zhi;Song, Yong-Xi;Guo, Peng-Tao;You, Yi;Xu, Hui-Mian
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.9
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    • pp.4379-4385
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    • 2012
  • Purpose: To investigate the efficacy and safety of intraperitoneal chemotherapy (IPC) for patients with gastric cancer and to compare effects between different regimens of IPC. Method: Randomized controlled trials comparing the effects of surgery plus intraperitoneal chemotherapy with surgery alone or comparing the efficacy between different regimens of intraperitoneal chemotherapy were searched for in Medline, Embase, Pubmed, the Cochrane Library and the Chinese BioMedical Disc and so on by two independent reviewers. After quality assessment and data extraction, data were pooled for meta-analysis using RevMan5.16 software. Tests of interaction were used to test for differences of effects among subgroups grouped according to different IPC regimens. Results: Fifteen RCTs with a total of 1713 patients with gastric cancer were included for quality assessment and data extraction. Ten studies were judged to be of fair quality and entered into meta-analysis. Hyperthermic intraoperative intraperitoneal chemotherapy (HR=0.60, P<0.01), hyperthermic intraoperative intraperitoneal chemotherapy plus postoperative intraperitoneal chemotherapy (HR=0.47, P<0.01) and normothermic intraoperative intraperitoneal chemotherapy (HR=0.70, P=0.01) were associated with a significant improvement in overall survival. Tests of interaction showed that hyperthermia and additional postoperative intraperitoneal chemotherapy did not impact on its effect. Further analysis revealed that intraperitoneal chemotherapy remarkably decrease the rate of postoperative hepatic metastasis by 73% (OR=0.27, 95% CI=0.12 to 0.67, P<0.01). However, intraperitoneal chemotherapy increased risks of marrow depression (OR=5.74, P<0.01), fever (OR=3.67, P=0.02) and intra-abdominal abscess (OR=3.57, P<0.01). Conclusion: The present meta-analysis demonstrates that hyperthermic intraoperative intraperitoneal chemotherapy and normothermic intraoperative intraperitoneal chemotherapy should be recommended to treat patients with gastric cancer because of improvement in overall survival. However, it is noteworthy that intraperitoneal chemotherapy can increase the risks of marrow depression, intra-abdominal abscesses, and fever.

Criteria for diet pattern and meal management to improve cognitive function: A systematic review (체계적 문헌 고찰을 통한 인지기능 개선에 도움을 주는 식사 관리에 대한 연구)

  • Park, Young-Sook;Lee, Hyun-Jung;Choi, Kui-Jeong;Xu, Lin;Nam, Ye-Rim;Kim, Yoon-Ha;Kim, Min-Ji;Shin, Weon-Sun
    • Korean Journal of Food Science and Technology
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    • v.52 no.5
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    • pp.450-458
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    • 2020
  • The purpose of this study was to conduct a systematic review of the current published research related to improvement in cognitive function. A systematic search was performed in three bibliographic databases (PubMed, Cochrane Library, and EMBASE) using "dementia", "memory", "food", "diet", and "nutrition" as keywords. Meal management intervention, including Dietary Approaches to Stop Hypertension (DASH) diet, Mediterranean (Med) diet, Diet Mediterranean-DASH Intervention for Neurodegenerative Delay (MIND) diet, and other studies, was also included in the analysis. Through extensive screening, 21 articles, out of 2101 papers retrieved, were used for the final systematic review. The methodological quality of the randomized controlled clinical trials (RCTs) was assessed using the Cochrane Risk of Bias tool. These articles recommended vegetables, fruits, whole grains, olive oil, fish, berries, nuts, and beans. In conclusion, this study suggests the potential use of meal management to improve cognitive function.

A Systematic Review of Randomized Controlled Trials on Acupuncture Treatment for Low Back Pain Based on FEAS (요통에 대한 침치료 무작위대조군임상연구(RCT)의 FEAS 분석을 통한 계통적 분석 연구)

  • Nam, Dong-Woo;Kang, Jung-Won;Kim, Eun-Jung;Kim, Hyun-Wook;Song, Ho-Sueb;Kim, Sun-Woong;Kim, Kap-Sung;Lee, Geon-Mok;Choi, Dong-Young;Lee, Jae-Dong
    • Journal of Acupuncture Research
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    • v.26 no.3
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    • pp.133-147
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    • 2009
  • Objectives : To review RCTs on acupuncture treatment for low back pain in order to establish a standard acupuncture treatment model in treating low back pain. Methods : RCT articles on traditional acupuncture treatment for low back pain were searched through online database. Study Quality was assessed using the FEAS. Results : Ten out of the one hundred six articles searched were reviewed. Among the ten articles reviewed, six articles compared acupuncture treatment with no treatment or non-penetrating sham acupuncture. All six articles concluded significantly positive effect of acupuncture compared to the control. Conclusions : The ideal acupuncture treatment model for low back pain was obtained as follows. A sterile disposable stainless steel(0.30mm${\times}$40mm) should be inserted to more than six acupuncture points on the BL, GV and GB meridians such as $BL_23$, $BL_25$, $BL_40$, $BL_60$, $GV_4$ and $GB_30$. Sparrow pecking method to obtain 'de-qi' is recommended and repeated stimulation during the 20 minute retention time is necessary. Ideal treatment frequency would be more than one a week for about 7 weeks.

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Clinical Practice Guideline on Acupuncture for Post-stroke Spasticity (뇌졸중후 경직에 대한 침치료 임상진료지침)

  • Kim, Je-Shin;Shin, Seung-Won;Lee, Eui-Ju;Shin, Byung-Cheul;Lee, Myeong-Soo;Lim, Sung-Min;Nam, Dong-Woo;Moon, Sang-Kwan
    • The Journal of Korean Medicine
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    • v.36 no.1
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    • pp.1-8
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    • 2015
  • Objectives: This study is aimed to develop a Clinical Practice Guideline (CPG) on acupuncture treatment for the patients with post-stroke spasticity. Methods: Experts committee, consisting of stroke or methodology specialists, searched Medline, EMBASE, Cochrane Library, China National Knowledge Infrastructure, and 19 Korean medicine journals. The search terms were selected to screen the randomized controlled trials (RCTs) or systematic reviews for the effectiveness of acupuncture on post-stroke spasticity, compared with placebo or conventional group. Levels of evidence and grades of recommendations were appraised based on Recommendations for Development of Clinical Practice Guideline in Korean Medicine. Results & Conclusions: One systematic review and 7 RCT were included to build the CPG. There was a strong evidence to support the effectiveness of electroacupuncture treatment for post-stroke spasticity. However, it did not show any sufficient evidence to treat the patients with post-stroke spasticity with the sole acupuncture. The moderate evidence was presented that over 3 times of the electroacupuncture treatments with 1-100 Hz frequency should be performed every week on the acupoints, such as LI11, LI10, TE5, LI4, ST36, GB34, ST40, or LR3, for 20-30 minutes. It was also suggested that the procedure should begin at the acute stage just after the vital signs of the patients are stabilized. Finally, there was a moderate evidence to support safety of acupuncture treatment for post-stroke spasticity.

The Efficacy of Acupuncture for Postoperative Pain in Patients with Solid Tumor : A Systematic Review and Meta Analysis (고형암 환자의 수술 후 통증에 대한 침 치료 효과 : 체계적 문헌고찰 및 메타분석)

  • Yoon, Sung Soo;Ryu, Han Sung;Oh, Hye Kyung;Lee, Jee Young;Yoon, Seong Woo
    • Journal of Korean Traditional Oncology
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    • v.22 no.2
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    • pp.1-11
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    • 2017
  • Objectives: Postoperative pain is one of postoperative complications in patients with solid tumor. This systematic review and meta-analysis were aimed to evaluate the efficacy of acupuncture for postoperative pain in solid tumor. Methods: We searched for randomized controlled trials (RCTs) using acupuncture for postoperative pain in adult patients with solid tumor up to September 2016. Acupuncture was defined as manual acupuncture, electroacupuncture and pharmacopuncture. The following databases were searched: PubMed, EMBASE, Cochrane Library, CNKI, CiNii, KoreaMed, Kmbase, KISS, NDSL, KISTI. The results of the studies were meta-analyzed and the risk of bias was assessed. Results: Five studies were included in this review. When acupuncture was compared with usual care, Prince-Henry pain scale score was significantly lower in acupuncture group (MD=-0.44, 95% CI: -0.62 to -0.26, P<0.001, $I^2=87%$) and 10 points pain score (including Numeric Rating Scale and Visual Analog Scale) was lower in acupuncture group but not significantly (MD=-1.00, 95% CI: -2.00 to -0.00, p=0.05). When acupuncture was compared with sham acupuncture, 10 points pain score was significantly lower in acupuncture group (MD=-0.39, 95% CI: -0.65 to -0.14, p=0.002, $I^2=0%$). Any serious adverse events were not reported. Conclusion: This review shows that acupuncture may be considered for postoperative pain in patients with solid tumor without serious adverse events. However, only a few studies were included in this study, further investigation is needed in this area.

Effect of luteal phase support with vaginal progesterone on pregnancy outcomes in natural frozen embryo transfer cycles: A meta-analysis

  • Seol, Aeran;Shim, Yoo Jin;Kim, Sung Woo;Kim, Seul Ki;Lee, Jung Ryeol;Jee, Byung Chul;Suh, Chang Suk;Kim, Seok Hyun
    • Clinical and Experimental Reproductive Medicine
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    • v.47 no.2
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    • pp.147-152
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    • 2020
  • Objective: The purpose of this study was to determine the effect of vaginal progesterone for luteal phase support (LPS) on the clinical pregnancy rate (CPR) in natural frozen embryo transfer (FET) cycles via a meta-analysis. Methods: We performed a meta-analysis of randomized controlled trials (RCTs) and retrospective studies that met our selection criteria. Four online databases (PubMed, Embase, Medline, and the Cochrane Library) were searched between January 2017 and May 2017. Studies were selected according to predefined inclusion criteria and meta-analyzed using R software version 2.14.2. The main outcome measure was CPR. Results: A total of 18 studies were reviewed and assessed for eligibility. One RCT (n = 435) and three retrospective studies (n = 3,033) met the selection criteria. In a meta-analysis of the selected studies, we found no significant difference in the CPR (odds ratio [OR], 0.96; 95% confidence interval [CI], 0.60-1.55) between the vaginal progesterone and control groups. An analysis of the two retrospective cohort studies that reported the live birth rate (LBR) following FET showed a significantly higher LBR in the vaginal progesterone group (OR, 1.72; 95% CI, 1.21-2.46). A subgroup meta-analysis of FET conducted 5 days after injection of human chorionic gonadotropin showed no significant differences between the two groups with regard to the CPR (OR, 1.18; 95% CI, 0.90-1.55) or miscarriage rate (OR, 0.73; 95% CI, 0.36-1.47). Conclusion: The results of this meta-analysis of the currently available literature suggest that LPS with vaginal progesterone in natural FET cycles does not improve the CPR.