• Title/Summary/Keyword: randomized controlled clinical trials

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Systematic Review on Presbycusis Treated by Herbal Medicine Focusing on Kidney Deficiency (노인성 난청의 한약 치료에 대한 체계적 문헌고찰: 신허(腎虛)을 중점으로)

  • Lim, Hui-yeong;Jin, Han-Sol;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.34 no.4
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    • pp.49-70
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    • 2021
  • Objectives : This study was conducted to approve the effectiveness and safety of herbal medicine on presbycusis with kidney deficiency. Methods : We searched randomized controlled trials(RCTs) on presbycusis patients diagnosed with kidney deficiency through 10 electronic databases from the start to Sep 7, 2021. Study collection and data extraction, and evaluation of risk of bias were conducted by two independent collaborator. The evaluation of the risk of bias in included RCTs was carried out by using Cochrane risk-of-bias tool. And the data synthesis was conducted by using Review Manager(RevMan, ver.5.4). Results : 1. The treatment group which used herbal medicine(HM) alone was more effective than the control group which used only western medicine(WM) on effective rate of hearing loss. 2. In 3 studies comparing the HM-WM combination treatment group with the control groups using the same WM treatment, the effective rate was statistically significantly higher in the HM-WM combination treatment group. 3. Of the 5 studies that reported adverse reactions, one study reported mild nausea and dizziness, but the difference between the HM treatment group and the WM control group was not statistically significant, and no side effects occurred in other 3 studies. 4. In studies comparing HM and WM, the HM treatment group improved hearing loss, whole blood viscosity, serum TNF-𝛼, IL-1𝛽, IL-6, and oxidative stress indicators better than the WM control group, and there was no significant difference. 5. In studies comparing the HM-WM treatment group with the WM control group, the severity of tinnitus, quality of life, and feelings of anxiety and depression were better in the treatment group than the control group. Conclusions : This study shows that the herbal medicine can improve symptoms of presbycusis with kidney deficiency.

Comparison of the Effectiveness of Herbal Medicine Eye Drops on Conjunctivitis : A Systematic Literature Review and Meta-Analysis (결막염에 대한 한방 점안액의 효과 비교 : 체계적 문헌 고찰과 메타 분석)

  • Lim, Hui-Yeong;Kim, Jee-Hee;Ko, Woo-Shin;Yoon, Hwa-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.35 no.3
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    • pp.48-65
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    • 2022
  • Objectives : This study was conducted to find out the effectiveness and safety of herbal medicine eye drops on conjunctivitis. Methods : We searched randomized controlled trials on conjunctivitis through 10 DBs from the start to April 27, 2022. Study collection and data extraction, and evaluation of risk of bias were conducted by two independent researchers. The evaluation of the risk of bias in included RCTs was carried out by using Cochrane risk-of-bias tool. And the data synthesis was conducted by using Review Manager(RevMan, ver.5.4). Results : Total of 106 studies are researched and 7 studies of them are finally included. 1. The herbal medicine eye drops are more effective on than the western medicine eye drops, but the heterogeneity was very high. So we conducted sensitivity analysis and compared to the herbal medicine eye drops and the western medicine eye drops, the total effective rate was higher in the herbal medicine eye drops and the heterogeneity was somewhat reduced. 2. In the subgroup analysis, Fufang Xiongdan eye drops and Houttuynia cordata Thunb eye drops are more effective than the western medicine. It may represent substantial heterogeneity. 3. In the subgroup analysis, the herbal medicine eye drops are more effective than antibiotic and antiviral eye drops on acute bacterial conjunctivitis, but showed high heterogeneity. On the other hand, the herbal medicine eye drops are more effective than antibiotic and antiviral eyed drops on acute viral conjuctivitis and showed low heterogeneity. 4. In the subgroup analysis, we compared the effectiveness of herbal and western medicine eye drops according to total effectiveness rate evaluation methods. When comparing the studies calculating the total effective rate by the sum of 'Cured', 'Significantly Impaired', and 'Improved', the effective rate of the herbal medicine eye drops was higher than that of the western medicine eye drops, and the heterogeneity was very low. 5. In most studies, side effects of herbal medicine eye drops were absent or mild. Conclusions : This study shows that herbal medicine eye drops may be more effective than western medicine eye drops and have safety. But further researches are needed to resolve the heterogeneity of this study.

A Review of Clinical Research Trends on Korean Medicine Treatment for Bell's Palsy during Pregnancy (임신 중 벨 마비 한방치료에 대한 국내외 증례 연구 고찰)

  • Hyo-Jeong Kim;Young-Tae Ahn;Ji-Soo Hyun;So-Youn Choi;Back-Jun Kim;Yoon-Jae Lee
    • The Journal of Korean Obstetrics and Gynecology
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    • v.37 no.3
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    • pp.1-19
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    • 2024
  • Objectives: The purpose of this study is to analysis the clinical study trends on Korean Medicine treatment for Bell's palsy during pregnancy. Methods: Key words such as 'facial palsy', 'Bell's palsy, 'Korean medicine', 'herbal medicine', 'acupuncture', 'pregnancy' were searched through the 'RISS', 'OASIS', 'KISS', 'PubMed' and 'CNKI' databases. Results: Ten clinical studies with 107 patients were selected, and 1 randomized controlled trial and 9 case reports were included as the target studies. In the 9 case reports, the gestational age at the onset of facial palsy was most common in the third trimester (29-42 weeks) in 38 cases (56.7%). The most commonly used Korean medicine interventions were acupuncture, with the most frequently used acupoints being ST4, ST2, ST6, BL2, TE23, LI20, GB1, GB14, SI18, and CV24. The herbal medicine treatment most commonly utilized was Geumgwedanggwi-san (金匱當歸散), which is related to the principles of clearing heat, nourishing blood, and stabilizing the fetus (淸熱養血安胎). Among the 65 participants evaluated using the House-Brackmann facial nerve grading system, 81.5% showed complete recovery to grade 1, while 6% remained at grade 4 with no effect, indicating the efficacy of Korean medicine treatment for facial palsy during pregnancy. All the selected studies reported no abnormalities in the mothers or fetal growth, and all participants who had the reported delivery had full-term childbirth. Conclusions: The effect on Korean Medicine treatment for Bell's palsy during pregnancy had mostly positive results. However, further large, well-designed clinical trials are needed to establish the foundation of Korean Medicine treatment for Bell's palsy during pregnancy.

New techniques for wound management: A systematic review of their role in the management of chronic wounds

  • Bekara, Farid;Vitse, Julian;Fluieraru, Sergiu;Masson, Raphael;De Runz, Antoine;Georgescu, Vera;Bressy, Guillaume;Labbe, Jean Louis;Chaput, Benoit;Herlin, Christian
    • Archives of Plastic Surgery
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    • v.45 no.2
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    • pp.102-110
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    • 2018
  • Debridement is a crucial component of wound management. Recent technologies such as hydrosurgery (Versajet), ultrasound therapy (the MIST therapy device), or plasma-mediated bipolar radio-frequency ablation therapy (Coblation) seem to represent interesting alternatives for wound debridement. The purpose of this systematic review was to describe, evaluate, and compare these three recently developed methods for the management of chronic wounds. In January 2016, an electronic database search was conducted of MEDLINE, PubMed Central, and Embase for articles concerning these three innovative methods for the management of chronic wounds. A total of 389 references were identified by our search strategy, and 15 articles were included. We extracted data regarding the number and age of patients, indications, operating time, number of procedures, costs, wound healing time, decrease in exudation, perioperative blood loss, bacterial load, and the occurrence of complications. The 15 articles included studies that involved 563 patients who underwent hydrosurgery (7 studies), ultrasound therapy (6 studies), or Coblation (2 studies). Six randomized controlled trials were included that compared the use of a scalpel or curette to hydrosurgery (2 studies) or ultrasound therapy (6 studies). Hydrosurgery, in addition to being a very precise and selective tool, allows significantly faster debridement. Ultrasound therapy provides a significant reduction of exudation, and improves the wound healing time. No comparative study dedicated to Coblation was identified. Despite the obvious clinical interest of the topic, our review of the current literature revealed a lack of prospective randomized studies comparing these devices with each other or with standard techniques, particularly for Coblation and hydrosurgery.

Effects of GV1001 on Language Dysfunction in Patients With Moderate-to-Severe Alzheimer's Disease: Post Hoc Analysis of Severe Impairment Battery Subscales

  • Hyuk Sung Kwon;Seong-Ho Koh;Seong Hye Choi;Jee Hyang Jeong;Hae Ri Na;Chan Nyoung Lee;YoungSoon Yang;Ae Young Lee;Jae-Hong Lee;Kyung Won Park;Hyun Jeong Han;Byeong C. Kim;Jinse Park;Jee-Young Lee;Kyu-Yong Lee;Sangjae Kim
    • Dementia and Neurocognitive Disorders
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    • v.22 no.3
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    • pp.100-108
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    • 2023
  • Background and Purpose: The efficacy and safety of GV1001 have been demonstrated in patients with moderate-to-severe Alzheimer's disease (AD). In this study, we aimed to further demonstrate the effectiveness of GV1001 using subscales of the Severe Impairment Battery (SIB), which is a validated measure to assess cognitive function in patients with moderate-to-severe AD. Methods: We performed a post hoc analysis of data from a 6 month, multicenter, phase 2, randomized, double-blind, placebo-controlled trial with GV1001 (ClinicalTrials.gov, NCT03184467). Patients were randomized to receive either GV1001 or a placebo for 24 weeks. In the current study, nine subscales of SIB-social interaction, memory, orientation, language, attention, praxis, visuospatial ability, construction, and orientation to name-were compared between the treatment (GV1001 1.12 mg) and placebo groups at weeks 12 and 24. The safety endpoints for these patients were also determined based on adverse events. Results: In addition to the considerable beneficial effect of GV1001 on the SIB total score, GV1001 1.12 mg showed the most significant effect on language function at 24 weeks compared to placebo in both the full analysis set (FAS) and per-protocol set (PPS) (p=0.017 and p=0.011, respectively). The rate of adverse events did not differ significantly between the 2 groups. Conclusions: Patients with moderate-to-severe AD receiving GV1001 had greater language benefits than those receiving placebo, as measured using the SIB language subscale.

Efficacy and Toxicity of Anti-VEGF Agents in Patients with Castration-Resistant Prostate Cancer: a Meta-analysis of Prospective Clinical Studies

  • Qi, Wei-Xiang;Fu, Shen;Zhang, Qing;Guo, Xiao-Mao
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.19
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    • pp.8177-8182
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    • 2014
  • Background: Blocking angiogenesis by targeting vascular endothelial growth factor (VEGF) signaling pathway to inhibit tumor growth has proven to be successful in treating a variety of different metastatic tumor types, including kidney, colon, ovarian, and lung cancers, but its role in castration-resistant prostate cancer (CRPC) is still unknown. We here aimed to determine the efficacy and toxicities of anti-VEGF agents in patients with CRPC. Materials and Methods: The databases of PubMed, Web of Science and abstracts presented at the American Society of Clinical Oncology up to March 31, 2014 were searched for relevant articles. Pooled estimates of the objective response rate (ORR) and prostate-specific antigen (PSA) response rate (decline ${\geq}50%$) were calculated using the Comprehensive Meta-Analysis (version 2.2.064) software. Median weighted progression-free survival (PFS) and overall survival (OS) time for anti-VEGF monotherapy and anti-VEGF-based doublets were compared by two-sided Student's t test. Results: A total of 3,841 patients from 19 prospective studies (4 randomized controlled trials and 15 prospective nonrandomized cohort studies) were included for analysis. The pooled ORR was 12.4% with a higher response rate of 26.4% (95%CI, 13.6-44.9%) for anti-VEGF-based combinations vs. 6.7% (95%CI, 3.5-12.7%) for anti-VEGF alone (p=0.004). Similarly, the pooled PSA response rate was 32.4% with a higher PSA response rate of 52.8% (95%CI: 40.2-65.1%) for anti-VEGF-based combinations vs. 7.3% (95%CI, 3.6-14.2%) for anti-VEGF alone (p<0.001). Median PFS and OS were 6.9 and 22.1 months with weighted median PFS of 5.6 vs. 6.9 months (p<0.001) and weighted median OS of 13.1 vs. 22.1 months (p<0.001) for anti-VEGF monotherapy vs. anti-VEGF-based doublets. Conclusions: With available evidence, this pooled analysis indicates that anti-VEGF monotherapy has a modest effect in patients with CRPC, and clinical benefits gained from anti-VEGF-based doublets appear greater than anti-VEGF monotherapy.

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.

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.