• Title/Summary/Keyword: Randomized Clinical Trials

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Analysis of Studies on Ssanghwa-tang for Establishment of Evidence Based Medicine (EBM 구축을 위한 쌍화탕의 실험 연구 문헌 분석)

  • Lee, Jun-Kyoung;Lee, Nam-Hun;Ha, Hye-Kyoung;Lee, Ho-Young;Seo, Chang-Sub;Jung, Da-Young;Lee, Jin-Ah;Shin, Hyun-Kyu
    • Korean Journal of Oriental Medicine
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    • v.14 no.3
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    • pp.41-47
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    • 2008
  • Objective : The purpose of this report was to provide the information about activity and safety of Ssanghwa-tang by analyzing domestic papers and theses about Ssanghwa-tang. Methods : Domestic papers and theses related to Ssanghwa-tang were reviewed and analyzed. These papers were then classified by year, experimental method, and activity subject. Results : The following result s were obtained in this study. 1. The study of Ssanghwa-tang started from 1981 and continued steadily 1990s and it was decreased 2000s. 2. The paper of Ssanghwatang was entire domestic paper, 20 volumes. 3. In classified by experimental method and animal of Ssanghwa-tang paper, more than a half study used rat in vivo experiment. Furthermore clinical experiments were performed about anti-fatigue effect of Ssanghwa-tang and Ssanghwatang was proved a safety herbal medicine in acute toxicity experiment. 4. Decursin, glycyrrhizin, paeoniflorin were determined in Ssanghwa-tang by using HPLC analysis. 5. As these studies were classified by subject, papers related to anti-fatigue effect were most abundant by 7 papers. Besides there were several papers related to liver funtion, anti-inflammatory, alleviation, smooth muscle relaxation effect and so on. 6. According to experimental data, it is supported that Ssanghwa-tang was safety herbal medicine and it has a several activity about anti-fatigue, anti-inflammatory, alleviation, smooth muscle relaxation. Conclusion : Many study of basic science experiments and clinical experiments were performed and reported on Ssanghwa-tang in domestic journal. Ssanghwa-tang is being used in various ways associating with anti-fatigue, anti-inflammatory, alleviation and smooth muscle relaxation. furthermore Ssanghwatang was proved a safety herbal medicine in acute toxicity experiment. However, studies on randomized controlled trials of Ssanghwatang need to be completed at the clinical level.

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COMPARISON OF TRAMADOL/ACETAMINOPHEN AND CODEINE/ACETAMINOPHEN/IBUPROFEN IN ONSET OF ANALGESIA AND ANALGESIC EFFICACY FOR POSTOPERATIVE ACUTE PAIN (수술후 급성 동통에 대한 Tramadol/Acetaminophen과 Codeine/Acetaminophen/Ibuprofen의 효과 발현시점과 진통효과의 비교)

  • Jung, Young-Soo;Kim, Dong-Kee;Kim, Moon-Key;Kim, Hyung-Jun;Cha, In-Ho;Han, Moo-Young;Lee, Eui-Wung
    • Journal of the Korean Association of Oral and Maxillofacial Surgeons
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    • v.30 no.2
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    • pp.143-149
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    • 2004
  • Background: Some clinical trials have reported that a new analgesic combination of tramadol and acetaminophen provides good efficacy in various pain models. For the more clinical uses of this agent, comparisons about the onset of analgesia and analgesic efficacy in the acute state of pain with the other drugs known as strong analgesics were needed. Purpose: The goal of this study was to compare the times to onset of analgesia and the other analgesic efficacy of 75 mg tramadol/650 mg acetaminophen and 20 mg codeine/500 mg acetaminophen/400 mg ibuprofen in the treatment of acute pain after oral surgery. Patients and Methods: Using a randomized, single-dose, parallel-group, single-center, and active-controlled test design, this clinical study compared the times to onset of analgesia using a two-stopwatch technique and the other analgesic efficacy of the single-dose tramadol/acetaminophen and codeine/acetaminophen/ibuprofen. These were assessed in 128 healthy subjects with pain from oral surgical procedures involving extraction of one or more impacted third molars requiring bone removal. From the time of pain development, the times to onset of perceptible and meaningful pain relief, pain intensity, pain relief, an overall assessment, and adverse events of the study medications were recorded for 6 hours. Results: The demographic distribution and baseline pain data in the two groups were statistically similar. The median times to onset of perceptible pain relief were 21.0 and 24.4 minutes in the tramadol/acetaminophen and codeine/acetaminophen/ibuprofen groups respectively and those to onset of meaningful pain relief were 56.4 and 57.3 minutes, which were statistically similar. The other efficacy variables such as mean total pain relief (TOTPAR) and the sum of pain intensity differences (SPID) were also similar in the early period after pain development and drug dosing. The safety of tramadol/acetaminophen was well tolerated and very comparable to that of codeine/acetaminophen/ibuprofen. Conclusions: In this acute dental pain model, the onset of analgesia and analgesic efficacy of tramadol/acetaminophen was comparable to that of codeine/acetaminophen/ibuprofen. These results showed that tramadol/acetaminophen was recommendable for fast and effective treatment in the management of postoperative acute pain.

A Review on Treatment of Essential Tremor in Traditional Chinese Medicine (본태성 진전에 대한 중의학 연구동향)

  • Shin, A-Ri;Bae, Yeong-Long;Lim, Jae-Yu;Lee, Seung-Hwan;Kim, Sang-Ho;Lim, Jung-Hwa
    • Journal of Oriental Neuropsychiatry
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    • v.28 no.2
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    • pp.95-107
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    • 2017
  • Objectives: This study was performed to review studies on Essential Tremor (ET) in Traditional Chinese medicine (TCM). Methods: We reviewed papers in the China National Knowledge Infrastructure (CNKI) from 2007~2016. Search keywords were 原发性震颤, 特发性震颤, essential tremor and idiopathic tremor, and excluded non-clinical studies, non-related to ET or TCM studies, theses for degrees and non-Randomized Controlled Trial (RCT). The quality of the articles was assessed by Jadad scale and the Risk of Bias (RoB). Results: Thirteen studies were selected. 'Criteria for the diagnosis of ET' was most frequently used as diagnostic criteria. 'Tremor rating scale' was primarily used for outcome measurement. Meta-analysis of nine trials revealed the effective rate of acupuncture and Western medicine (WM+Acu) groups was significantly higher compared to the WM group (RR: 1.48, 95 percent CI: 1.20 to 1.82, p=0.0002, $I^2=0$ percent) and tremor rating scale was also significantly decreased in the treatment group (MD: -1.35, 95 percent CI: -2.17 to -0.54, p=0.001, $I^2=0$ percent). Also, effective rates of Electro-acupuncture (EA) and Chinese herbal medicine (CHM) groups were significantly higher than that of the WM group {(RR: 1.53, 95 percent CI: 1.22 to 1.92, p=0.0003, $I^2=0$ percent) in EA vs. WM and (RR: 1.35, 95 percent CI: 1.16 to 1.57, p<0.0001, $I^2=0$ percent) in CHM vs. WM}. However, the quality of selected clinical studies was poor. Conclusions: Treatment of ET in TCM may be more effective and safe than in Western medicine. Therefore, we hope this study will lead to further clinical research on treatment of ET in Korean medicine.

Efficacy of glycine powder air-polishing in supportive periodontal therapy: a systematic review and meta-analysis

  • Zhu, Mengyuan;Zhao, Meilin;Hu, Bo;Wang, Yunji;Li, Yao;Song, Jinlin
    • Journal of Periodontal and Implant Science
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    • v.51 no.3
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    • pp.147-162
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    • 2021
  • Purpose: This systematic review and meta-analysis was conducted to assess the effects of glycine powder air-polishing (GPAP) in patients during supportive periodontal therapy (SPT) compared to hand instrumentation and ultrasonic scaling. Methods: The authors searched for randomized clinical trials in 8 electronic databases for relevant studies through November 15, 2019. The eligibility criteria were as follows: population, patients with chronic periodontitis undergoing SPT; intervention and comparison, patients treated by GPAP with a standard/nozzle type jet or mechanical instrumentation; and outcomes, bleeding on probing (BOP), patient discomfort/pain (assessed by a visual analogue scale [VAS]), probing depth (PD), gingival recession (Rec), plaque index (PI), clinical attachment level (CAL), gingival epithelium score, and subgingival bacteria count. After extracting the data and assessing the risk of bias, the authors performed the meta-analysis. Results: In total, 17 studies were included in this study. The difference of means for BOP in patients who received GPAP was lower (difference of means: -8.02%; 95% confidence interval [CI], -12.10% to -3.95%; P<0.00001; I2=10%) than that in patients treated with hand instrumentation. The results of patient discomfort/pain measured by a VAS (difference of means: -1.48, 95% CI, -1.90 to -1.06; P<0.001; I2=83%) indicated that treatment with GPAP might be less painful than ultrasonic scaling. The results of PD, Rec, PI, and CAL showed that GPAP had no advantage over hand instrumentation or ultrasonic scaling. Conclusions: The findings of this study suggest that GPAP may alleviate gingival inflammation more effectively and be less painful than traditional methods, which makes it a promising alternative for dental clinical use. With regards to PD, Rec, PI, and CAL, there was insufficient evidence to support a difference among GPAP, hand instrumentation, and ultrasonic scaling. Higher-quality studies are still needed to assess the effects of GPAP.

Review of Clinical Research about Acupuncture for Spastic Hmiplegia after Stroke - Research on China Academic Journal (뇌졸중 후 경련성 편마비의 침치료에 대한 최신 임상 연구 동향 - CAJ 검색을 중심으로)

  • Jo, Myeong Jae;Kim, Da Hye;Kim, Seon U;Park, Cheol U;Kim, Young Kwang;Jang, Hye Yeon;Kim, Min Uk
    • Journal of Physiology & Pathology in Korean Medicine
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    • v.35 no.1
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    • pp.28-35
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    • 2021
  • To analyze the clinical efficacy of acupuncture for spastic hemiplegia after stroke, this study was accomplished by considering Randomized Controlled Trials. We searched for papers that performed acupuncture for spastic hemiplegia after stroke in the China Academic Journal of the China National Knowledge Infrastructure, from January 1, 2017 to June 30, 2020. In total, 23 reports were included in this review. There are 18 studies conducted with more than 50 subjects and less than 100 subjects. The largest number of treatment was 20 times. 28days(4weeks) was the largest number of treatment period, which accounted 10 studies. The most frequently used evaluation index was The Fugl-Meyer Assessment(FMA) and Clinical Efficacy, each used 21 times and 17 times. The most frequently used acupuncture point was LI3, which was used 13 times. The retention time was 30 minutes and 11 studies were conducted. Western medicine treatment was the most common control group in 15 studies. Most of studies showed result of the intervention group was statistically significant, compared with the control group. These results suggest that acupuncture for spastic hemiplegia after stroke was effective and it was statistically more significant than the control group. However, it is difficult to confirm a conclusion, because the quality of most of studies was low.

Trends in Domestic and International Clinical Research of Craniosacral Therapy: Scoping Review (두개천골요법의 국내외 임상 연구 동향: 스코핑 리뷰)

  • Kwak, Min-Jae;Han, Yun-Hee;Geum, Ji-Hye;Park, Shin-Hyeok;Woo, Hyeon-Jun;Ha, Won-Bae;Lee, Jung-Han
    • Journal of Korean Medicine Rehabilitation
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    • v.32 no.3
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    • pp.13-27
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    • 2022
  • Objectives This study investigated the trends in domestic and international clinical research in craniosacral therapy, classified as a type of Chuna manual therapy, and suggested further directions in Korean medicine. Methods This scoping review was performed using the Arksey and O'Malley methodological framework and preferred reporting items as per the preferred reporting items for systematic reviews and meta-analyses extension for scoping reviews checklist. Eight electronic databases (PubMed, EMBASE, Cochrane Library, Koreanstudies Information Service System [KISS], KMBASE, Oriental Medicine Advanced Searching Integrated System [OASIS], Research Information Sharing Service [RISS], ScienceON) were searched to identify articles with the search terms "craniosacral therapy" and "cranial osteopathy" until December 2021. Results Forty-five studies were eligible as per our inclusion criteria. Most research studies (n=44) were conducted in the field of medicine and pharmacy, especially in rehabilitation medicine (n=16). As a result of the study design, randomized controlled trials (n=20) were the most common, and chronic pain (n=9) was the most frequently targeted disease, followed by headache (n=7). Thirty-two studies suggested interventions and 20 studies used Upledger's 10-step protocol. The average duration of craniosacral therapy was 41 min per session, administered 1.4 times per week. Outcome measurements were analyzed and categorized with the examination procedure for the patient. Conclusions This is the first scoping review of craniosacral therapy in Korea, and we believe that our findings could support its utility as Chuna. In the future, more studies should be conducted to establish the evidence of clinical efficacy of craniosacral therapy and develop standard techniques in Korean medicine.

Full-Endoscopic versus Minimally Invasive Lumbar Interbody Fusion for Lumbar Degenerative Diseases : A Systematic Review and Meta-Analysis

  • Son, Seong;Yoo, Byung Rhae;Lee, Sang Gu;Kim, Woo Kyung;Jung, Jong Myung
    • Journal of Korean Neurosurgical Society
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    • v.65 no.4
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    • pp.539-548
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    • 2022
  • Objective : Although full-endoscopic lumbar interbody fusion (Endo-LIF) has been tried as the latest alternative technique to minimally invasive transforaminal lumbar interobody fusion (MIS-TLIF) since mid-2010, the evidence is still lacking. We compared the clinical outcome and safety of Endo-LIF to MIS-TLIF for lumbar degenerative disease. Methods : We systematically searched electronic databases, including PubMed, EMBASE, and Cochrane Library to find literature comparing Endo-LIF to MIS-TLIF. The results retrieved were last updated on December 11, 2020. The perioperative outcome included the operation time, blood loss, complication, and hospital stay. The clinical outcomes included Visual analog scale (VAS) of low back pain and leg pain and Oswestry disability index (ODI), and the radiological outcome included pseudoarthosis rate with 12-month minimum follow-up. Results : Four retrospective observational studies and one prospective observational study comprising 423 patients (183 Endo-LIF and 241 MIS-TLIF) were included, and the pooled data analysis revealed low heterogeneity between studies in our review. Baseline characteristics including age and sex were not different between the two groups. Operation time was significantly longer in Endo-LIF (mean difference [MD], 23.220 minutes; 95% confidence interval [CI], 10.669-35.771; p=0.001). However, Endo-LIF resulted in less perioperative blood loss (MD, -144.710 mL; 95% CI, 247.941-41.478; p=0.023). Although VAS back pain at final (MD, -0.120; p=0.586), leg pain within 2 weeks (MD, 0.005; p=0.293), VAS leg pain at final (MD, 0.099; p=0.099), ODI at final (MD, 0.141; p=0.093) were not different, VAS back pain within 2 weeks was more favorable in the Endo-LIF (MD, -1.538; 95% CI, -2.044 to -1.032; p<0.001). On the other hand, no statistically significant group difference in complication rate (relative risk [RR], 0.709; p=0.774), hospital stay (MD, -2.399; p=0.151), and pseudoarthrosis rate (RR, 1.284; p=0.736) were found. Conclusion : Relative to MIS-TLIF, immediate outcomes were favorable in Endo-LIF in terms of blood loss and immediate VAS back pain, although complication rate, mid-term clinical outcomes, and fusion rate were not different. However, the challenges for Endo-LIF include longer operation time which means a difficult learning curve and limited surgical indication which means patient selection bias. Larger-scale, well-designed study with long-term follow-up and randomized controlled trials are needed to confirm and update the results of this systematic review.

Effects of Yigong-san for the Treatment of Anorexia in Children: A Systematic Review and Meta-Analysis (소아 식욕부진에 대한 이공산(異功散) 치료의 효과 : 체계적 문헌고찰 및 메타분석)

  • Lee, Bo-ram;Ha, Da-jung;Huh, Tae-young;Park, Sang-eun;Lee, Sun-haeng;Chang, Gyu-tae
    • The Journal of Internal Korean Medicine
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    • v.43 no.4
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    • pp.542-558
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    • 2022
  • Objectives: The purpose of this study was to assess the effect of Yigong-san on anorexia in children by conducting a systematic review and meta-analysis of randomized controlled trials (RCTs). Methods: Eleven electronic databases were searched on May 30, 2022 to collect relevant studies. All studies published up to the search date were considered. RCTs reporting the effect of Yigong-san on the treatment of anorexia in children were included. The primary outcome was an improvement in clinical anorexia symptoms after treatment. In this meta-analysis, continuous and binary outcomes were assessed, and the data were presented as the mean difference and risk ratio with their 95% confidence intervals. The risk of bias was assessed using the Cochrane Collaboration's risk of bias tool. Results: A total of nine studies were included in this systematic review. The treatment group (Yigong-san only or Yigong-san plus conventional treatment) showed a statistically significant effect compared to the control group (conventional treatment only) in total effective rate (Yigong-san only: RR 1.26, 95% CI 1.17, 1.36, I2=0%; Yigong-san plus conventional treatment: RR 1.32, 95% CI 1.18, 1.47, I2=0%), clinical symptoms, some of the anthropometric outcomes, and biological markers related to appetite and growth in children with anorexia. No serious adverse events related to Yigong-san were reported. Conclusions: Yigong-san showed statistically significant effects as a treatment for anorexia in children. However, the number of studies included in the meta-analysis was insufficient, and the herbs contained in the Yigong-san used in the included studies were not standardized. Future research should focus on the implementation of methodologically robust clinical research.

Effects for kangaroo care: systematic review & meta analysis (캥거루 케어가 미숙아와 어머니에게 미치는 효과 : 체계적 문헌고찰 및 메타분석)

  • Lim, Junghee;Kim, Gaeun;Shin, Yeonghee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.17 no.3
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    • pp.599-610
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    • 2016
  • This paper reports the results of a systematic review (SR) and meta-analysis research to compare the effect of Kangaroo care, targeting mothers and premature infants. A randomized clinical trial study was performed until February 2015. The domestic literature contained the non-randomized clinical trial research without restriction according to the level of the study design. A search of the Ovid-Medline, CINAHL, PubMed and KoreaMed, the National Library of KOREA, the National Assembly Library, NDSL, KISS and RISS. Through the KMbase we searched and combined the main term ((kangaroo OR KC OR skin-to-skin) AND (care OR contact)) AND (infant OR preterm OR Low Birth Weight OR LBW), ((kangaroo OR kangaroo OR kangaroo) AND (care OR nursing care OR management OR skin contact)) was made; these were all combined with a keywords search through the selection process. They were excluded in the final 25 studies (n=3051). A methodology checklist for randomized controlled trials (RCTs) designed by SIGN (Scottish Intercollegiate Guidelines Network) was utilized to assess the risk of bias. The overall risk of bias was regarded as low. In 16 studies that were evaluated as a grade of "++", 9 studies were evaluated as a grade of "+". As a result of meta-analysis, kangaroo care regarding the effects of premature mortality, severe infection/sepsis had an insignificant effect. Hyperthermia incidence, growth and development (height and weight), mother-infant attachment, hypothermia incidence, length of hospital days, breast feeding rate, sleeping, anxiety, confidence, and gratification of mothering role were considered significant. In satisfaction of the role performance, depression and stress presented contradictory research results for individual studies showing overall significant difference. This study has some limitations due to the few RCTs comparing kangaroo care in the country. Therefore, further RCTs comparing kangaroo care should be conducted.

Clinical Efficacy of Repetitive Transcranial Magnetic Stimulation for Treatment of Depression and Latest Trends in TMS Techniques (반복 경두개자기자극술의 우울증 치료효과 및 최신동향에 대한 고찰)

  • Kim, Shin Tae;Kim, Hae Won;Kim, Se Joo;Kang, Jee In
    • Korean Journal of Biological Psychiatry
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    • v.24 no.3
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    • pp.95-109
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    • 2017
  • Repetitive transcranial magnetic stimulation (rTMS) is a non-invasive neuromodulation technique which can change cortical excitability in targeted area by producing magnetic field pulses with an electromagnetic coil. rTMS treatment has been used to treat various neuropsychiatric disorders including depression. In this review, we evaluate the literature on rTMS for depression by assessing its efficacy on different subtypes of depression and different technical parameters. In particular, we focus on the results of randomized clinical trials and meta-analyses for depression after the US Food and Drug Administration approval in 2008, which acknowledged its efficacy and acceptability. We also review the new forms of rTMS therapy including deep TMS, theta-burst stimulation, and magnetic seizure therapy (MST) that have been under recent investigation. High frequency rTMS over left dorsolateral prefrontal cortex (DLPFC), low frequency rTMS over right DLPFC, or bilateral rTMS is shown to be effective and acceptable in treatment for patients with non-psychotic, unipolar depression either as monotherapy or adjuvant. Deep TMS, theta-burst stimulation and MST are promising new TMS techniques which warrant further research.