• Title/Summary/Keyword: Controlled clinical trials

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Analysis of Recent Clinical Studies to Establish Korean Herbal Medicine Clinical Trial Guidelines for the Common Cold (감기 임상시험 가이드라인 제정을 위한 최신 임상시험 연구 분석)

  • Kim, Kwan-il;Lee, Ho-jung;Lee, Beom-joon;Jung, Hee-jae;Jung, Sung-ki;Lee, Jun-hee
    • The Journal of Internal Korean Medicine
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    • v.37 no.1
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    • pp.109-134
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    • 2016
  • Objectives: The aim of this study was to help develop a guideline for the common cold. We searched recent clinical studies of the common cold in Western medicine and reviewed their objectives, inclusion and exclusion criteria, primary outcome, secondary outcome, and assessment tools to establish evidenced-based guideline.Methods: We searched electronic databases (Cochrane Library, MEDLINE, EMBASE) to identify eligible randomized controlled trials (RCTs) about the common cold for the last 10 years. We included 29 RCTs and showed their research summary via their objectives, participants, interventions, control, treatment duration, and results. We also analyzed the definition of the common cold presented in the article, inclusion and exclusion criteria, primary and secondary outcomes, and assessment tools.Results: We reported the aforementioned areas in detail. At first, the definition of the common cold was confused across the articles. Second, herbal medication clinical trials for the common cold have been extensively studied recently. Third, the eligibility criteria frequently included the Jackson Symptom score. Fourth, validated assessment tools (i.e., the Wisconsin Upper Respiratory Symptom Survey-21) have only been used in a few recent studies.Conclusions: Our research will be helpful to establish Korean herbal medicine clinical trial guidelines for the common cold.

Citalopram and Escitalopram for Management of Hot Flashes: A Review of Recent Clinical Trials in Humans (Citalopram과 Escitalopram의 안면홍조 증상개선효과에 대한 최근 연구 고찰)

  • Lee, Yu-Jeung
    • Korean Journal of Clinical Pharmacy
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    • v.21 no.4
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    • pp.376-382
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    • 2011
  • The results from eight clinical studies demonstrate that citalopram and escitalopram could be an effective option in the treatment of hot flashes with tolerable adverse effects. However, there are limitations in the above studies. The inclusion criteria of 2 studies reviewed in this paper was breast cancer patients, so it's hard to apply the results to the general population in clinical practice. Also 4 studies had less than 50 subjects included, and the duration of study was 8 weeks or less in 7 studies reviewed in this paper. Moreover, only 4 studies were randomized, placebo-controlled trials (3 for citalopram and 1 for escitalopram). Therefore, further randomized, double-blind, placebo-controlled studies with the general population should be needed to use citalopram and escitalopram for the treatment of hot flashes in clinical practice.

A Systematic Review of Bee Venom Acupuncture for Ankle Sprain (족관절 염좌의 봉독 약침 치료에 대한 체계적 문헌 고찰)

  • Gu, Ji-Hyang;Li, Yu-Chen;Jo, Dong-Chan;Lee, Eun-Jung
    • Journal of Korean Medicine Rehabilitation
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    • v.28 no.3
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    • pp.55-66
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    • 2018
  • Objectives To evaluate the evidence supporting the effectiveness of bee venom acupuncture for ankle sprain. Methods We conducted search across 11 electronic databases (Pubmed, EMBASE, Cochrane CENTRAL [CENTRAL], KoreaMed, Kmbase, Koreanstudies Information Service System [KISS], National Digital Science Library [NDSL], Korea Institute of Science and Technology Information [KISTI], China National Knowledge Infrastructure [CNKI], Wanfang and Chinese Scientific Journals Database [VIP] database) to find clinical trials that used bee venom acupuncture as treatment for ankle sprain. The methodological quality of randomized controlled clinical trials (RCTs) were assessed using the Cochrane Risk of Bias (RoB) tool, while non-randomized controlled clinical trials (NRCTs) were assessed using the Cochrane Risk of Bias Assessment tool for Non-randomized Study (RoBANS) tool. Results Four RCTs and one nRCT met our inclusion criteria. Almost studies showed that bee venom acupuncture has positive effect on ankle sprain. 4 studies of same intervention and control included in the meta-analysis. When comparing bee venom acupuncture and acupuncture with acupuncture, the effect size of standardized mean difference (SMD) was -0.19 (95% confidence interval [CI]: -1.95~1.56, Z=0.55, p=0.83). And when comparing bee venom acupuncture with acupuncture, the effect size of SMD was -0.17 (95% CI: -0.65~0.31, Z=0.71, p=0.48). Conclusions Although our systematic review found encouraging but limited evidence of bee venom acupuncture for ankle sprain, most of the studies included in the analysis were evaluated as methodologically high risk of bias. From now on further well-designed RCTs should be encouraged.

Clinical Research Trends on Mindfulness Meditation in Korea (마음챙김 명상관련 국내 임상연구 동향 분석)

  • Yang, Yeong-Pil;Song, Ick-Soo;Moon, Jin-Seok;Han, Chang-Hyun;Park, Ji-Ha;Lee, Sang-Nam
    • Korean Journal of Oriental Medicine
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    • v.16 no.2
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    • pp.57-64
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    • 2010
  • Background : Meditation is one of the healing therapies used to prevent and cure ailments and to improve health through regular practice. Although Meditation is within the paradigm of modern Western medical science, effects on the human body could be possible. Objectives : This study performed a systematic review of the literature published in Korea focused on mindfulness meditation (MM), which is being applied as mind-body therapy around the USA lately. Method : Three hundred sixty six articles were found after searching with keyword, 'mindfulness meditation (MM)' in 6 journals and web databases. Ninety papers related MM were analyzed trend, Seventeen randomized controlled trials (RCTs) and 38 controlled clinical trials (CCTs) were researched by systematic review. Result : Most of them were studies about relationship between MM and syndrome such as stress, depression, anxiety and MM was also applied to some disease like hypertension, temporomandibular joint disorder in some cases. In 55 studies, It was shown that MM has positive effects on various symptoms and sometimes the effect of MM showed at post and follow-up study although there was no significant difference between control group and experimental group in some cases according to outcome measurement. Interestingly, there was no study reported about side effects of MM after the application. Conclusions : MM is being clinically applied at both western and oriental hospital in Korea, but more clinical trials with the high quality are needed to support its scientific basis.

Chuna Manual Therapy for Adhesive Capsulitis : A Systematic Review and Meta Analysis (유착성 관절낭염에 대한 추나요법의 효과: 체계적 문헌고찰과 메타분석)

  • Cho, Ju-Chan;Heo, In;Park, Sun-Young;Shin, Byung-Cheul
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.14 no.2
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    • pp.1-14
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    • 2019
  • Objectives : To evaluate the effectiveness of Chuna Manual Therapy for adhesive capsulitis by a systematic review manner. Methods : Five foreign electronic databases (Pubmed, Ovid-medline, Embase, Cochrane library, Chinese Academic Journals (CAJ)) and two Korean medical electronic databases (Oriental Medicine Advanced Searching Integrated System (OASIS) and Research Information Sharing Service (RISS)) were searched to find all randomized controlled trials (RCTs) using Chuna Manual Therapy as a treatment for adhesive capsulitis. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : Twenty-one RCTs met our inclusion criteria. The meta-analysis showed positive results on the use of Chuna Manual Therapy combined with acupuncture or exercise therapy in terms of the efficacy rate and pain using the Visual Analogue Scale (VAS), compared to acupuncture or exercise alone [SMD-1.81 (95% CI & -2.54, -1.08), P<0.001, RR 1.19 (95% CI 1.14, 1.23), P<0.001)]. Positive results in terms of efficacy rate were also obtained comparing Chuna Manual Therapy to acupuncture alone [RR 1.10 (95% CI 1.02, 1.18), P=0.01]. Conclusions : Our systematic review found favorable results on the effectiveness of Chuna Manual Therapy for pain and efficacy rate of adhesive capsulitis. However, evidence was limited due to the lack of well-designed RCTs. More qualified clinical trials are needed to obtain stronger evidence.

A Systematic Review and Meta-Analysis of Randomized Controlled Trials on Acupuncture for Improving Post-Operative Cognitive Dysfunction (POCD) and Chemotherapy-Related Cognitive Impairment (CRCI)

  • Kim, Ju-Young;Cho, Han-Byul;Kim, Man-Gi;Koo, Byung-Su;Kim, Geun-Woo
    • Journal of Oriental Neuropsychiatry
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    • v.33 no.1
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    • pp.49-78
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    • 2022
  • Objectives: This study was conducted to evaluate the efficacy of Korean Medicine Therapy (KMT) for the treatment of Chemotherapy-induced Cognitive Impairment (CICI) through systematic review and meta-analysis of randomized controlled trials (RCTs) as proceeding research to further research the efficacy of KMT for CICI patients. Methods: We conducted a systematic review and meta-analysis according to the Preferred Reporting Items for Systematic reviews and Meta-Analyses guidelines (PRISMA). The RCTs on the efficacy of KMT for treatment of CICI were searched by structured search strategies in MEDLINE, EMBASE, Cochrane library, CAJD, KISS, NDSL, KoreaMed, and OASIS. The searched RCTs were screened by inclusion and exclusion criteria. We evaluated the quality of the method in the included studies using the Jadad score and Cochran ROB tool. The efficacy outcomes were the Visual Analogue Scale (VAS) and the Clinical total Effective Rate (CER) of CICI. They were analyzed using mean difference for continuous variable or Relative Risk (RR) for Dichotomous variable in the random-effect model. The RevMan 5.3 program was used for meta-analysis. Results: We included 19 RCTs, including 653 participants, in the systematic review and meta-analysis. There were favorable results for the KMT group after the intervention compared with the pharmacotherapy group, physiotherapy group, and combined treatment group. KMT group showed improvement using CER and VAS compared with exercises, but their heterogeneities were slightly significant. KMT was more effective compared to the Rehabilitation program in CER and the subgroup analysis results showed that KMT had a significant difference compared to other therapies in VAS, to Medication therapy in CER. Conclusions: KMT presented reasonable evidence on improving the Clinical total Effective Rate and Visual Analogue Scale in CICI patients. However, further evaluation in future research is required.

Recent Trends in the Treatment of Voice Disorders: Evidence-based Practice and Translational Biology Research (음성 장애 치료 연구의 최근 동향: 증거에 기초한 임상 치료 및 전이 생물학적 연구)

  • Choi, Seong-Hee
    • Phonetics and Speech Sciences
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    • v.2 no.1
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    • pp.99-112
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    • 2010
  • This study attempted to review the recent, high-quality evidence-based practical research related to the treatment effectiveness of voice disorders which focus on randomized controlled trials (RCTs) and translational research of vocal fold tissue engineering for vocal fold regeneration. Methodology including PICO (P; Populations or Patients, I; Interventions, C; Comparison group (control, placebo, gold standard), O; Outcomes or measures made) information for RCTs and animal models (species), regenerative therapy method, and outcomes of translational research for clinical application was summarized and discussed for future voice disorder research.

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Clinical Trials and Accuracy of Diagnostic Tests (진단법의 임상시험연구와 진단정확도)

  • Lee, You-Kyoung;Lee, Sang-Moo
    • Journal of Genetic Medicine
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    • v.8 no.1
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    • pp.28-34
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    • 2011
  • Most clinicians understand clinical trials as the evaluation process for new medicine before their use. However, clinical trials can also be applied to laboratory diagnostic tests (LDTs) to verify diagnostic accuracy and efficacy before their clinical laboratory implementation for patients. The clinical trial of LDT has two distinctive characteristics that are different from the case of pharmaceuticals and thus worth special consideration. One of them is the level of evidence. The well-designed randomized controlled trials (RCTs) are known to provide the best evidence to prove the clinical efficacy of any pharmaceutical products. However, RCTs lose practicality when applied to LDTs due to various issues including ethical complications. For this reason, comparative study format is considered more feasible approach for LDTs. In addition pharmaceuticals and LDTs are different in that the user's intervention is not required for the former but critical to the latter. Moreover, in the case of pharmaceuticals, end-products are produced by manufacturers before being used by clinicians. However, in LDTs, once reagents and instruments are provided by manufacturers, they are first utilized by clinical laboratories to produce test results in order for clinicians to use them later. In other words, when it comes to LDTs, clinical laboratories play the role of manufacturers, providing reliable test results with improved quality assurance. Considering the distinctive characteristics of LDTs, we would like to offer detailed suggestions to successfully perform clinical trials in LDTs, which include analytical performance measures, clinical test performance measures, diagnostic test accuracy measures, clinical effectiveness measures, and post-implementation surveillance.

A Review of Clinical Studies about Acupuncture Therapy for Whiplash Associated Disorder (교통사고로 인한 편타 손상의 침 치료에 대한 임상연구의 국내외 동향)

  • Jeon, Jun-Young;Yoo, Duk-Joo;Maeng, Tae-Ho;Shim, Jae-Woo;Cho, Woo-Young;Kim, Hyungsuk;Lim, Woong-jin;Lee, Jong-soo
    • Journal of Korean Medicine Rehabilitation
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    • v.25 no.4
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    • pp.47-54
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    • 2015
  • Objectives This study aimed to research current trends of acupuncture treatment of whiplash associated disorder (WAD). Methods Clinical studies about acupuncture therapy on WAD were searched in 7 databases. The included studies were classified according to their publication dates, methods, interventions, outcome measures. Interventions were analyzed by accompanied intervention, acupoint, acupuncture retaining time and treatment period. Results 14 articles were included. The number of studies on acupuncture for WAD shows increasing tendency since 1990. The included studies consist of 6 randomized controlled trials (RCTs), 2 non-randomized controlled trials (nRCTs), 2 cohort studies, 1 before and after study, 1 case study and 2 case reports. Most studies used visual analogue scale (VAS) as primary outcome. Conclusions This review demonstrates that further clinical studies need to be carried out under the formal clinical practice guidelines of acupuncture therapy for WAD in order to support clinical treatment objectively.