• 제목/요약/키워드: RCT(randomized controlled trials)

검색결과 212건 처리시간 0.025초

범불안장애의 한약 치료에 관한 체계적 문헌고찰 및 메타분석: 최근 5년 임상연구를 중심으로 (Systematic Review and Meta-Analysis on Herbal Medicine for Generalized Anxiety Disorder: Focusing on Clinical Studies over the Past 5 Years)

  • 김민재;박현섭;권찬영
    • 동의신경정신과학회지
    • /
    • 제34권4호
    • /
    • pp.403-420
    • /
    • 2023
  • Objectives: This study investigated the effectiveness of herbal medicine for generalized anxiety disorder (GAD) based on recent clinical studies. Methods: Studies were searched through four databases. Clinical research studies on herbal medicine treatment for GAD patients were included. The studies were analyzed according to study design, diagnostic criteria, population, and intervention. A risk of bias assessment was performed to assess the quality of the included randomized controlled trials (RCT). If the intervention applied to the treatment and control groups was the same and two or more studies were reporting the same items as outcome indicators, a meta-analysis was performed. Results: A total of 19 studies, including 12 RCTs were selected. The most common pattern identification was 'Phlegm fire disturbing upward' (痰熱上擾), and the most used herb for therapeutic purposes was 'Rhizome of Poria cocos' (茯苓). Meta-analysis results of three studies showed that there were no significant differences in effectiveness between the herbal medicine intervention and the Western medicine intervention. Meta-analysis results of five studies showed that the Hamilton Anxiety Rating Scale was significantly reduced in the case of herbal medicine intervention compared to Western medicine intervention. Conclusions: The results of our study demonstrated that herbal medicine treatment for GAD is effective in alleviating anxiety symptoms and chief symptoms of GAD. However, this study has several limitations; there was a lack of placebo-controlled RCT and an absence of objective diagnostic criteria in case reports. Therefore, further well-designed clinical studies, conducted based on the results of this study, are recommended.

중국 및 한국 Database에서의 위식도 역류질환에 대한 반하사심탕의 효과에 대한 최근 10년간의 연구경향 (A Study Trend for the Effects of Banxia-xiexin-tang Decoction (Banhasasim-tang) on Gastroesophageal Reflux Disease (GERD) in Chinese and Korean Databases over the Last Ten Years)

  • 정유진;김윤정;홍상훈
    • 대한한방내과학회지
    • /
    • 제41권3호
    • /
    • pp.362-413
    • /
    • 2020
  • Objectives: The purpose of this research is to examine the recent clinical research trends on the efficiency of traditional herb medicine (THM) on gastroesophageal reflux disease (GERD), and to provide clinical evidence of herbal medicine, Banhasasin-tang or Banxiexin decoction by using a systemic review and meta-analysis of randomized trials (RCTs). Methods: In this study, randomized controlled trials (RCTs) were included that verified effects of traditional herbal medicine (THM), including a Banxia-xiexin-tang decoction, as a treatment for GERD. A study of the literature in Chinese and Korean databases was performed for papers published from January 1, 2010, to January 1, 2020. The selected literature was assessed by Cochrane's risk of bias (RoB). Results: A total of 90 RCTs met the inclusion criteria. Except for four RCT studies, all studies identified the effect of a Banxia-xiexin-tang decoction in the treatment of GERD. The effectiveness of treatment was significantly higher in the intervention group than in the control group, as shown through various evaluation indicators, including the reflux disease diagnostic questionnaire (RDQ). Adverse effects were reported in 22 articles (24.44%). Conclusions: Treatment with Banhasasin-tang, or a Banxia-xiexin-tang decoction, was found to be effective in treating GERD. However, due to the low quality of available studies, the significance of this conclusion is somewhat limited. This study could serve as a foundation for further clinical studies on the development of diagnosis and treatment methods for GERD based on Korean medicine.

소아 천식의 한약 치료에 대한 임상연구 동향 - 중의학 무작위 대조군 임상시험을 중심으로 (Trends in Clinical Research on Herbal Medicine Treatment in Pediatric Asthma - Focusing on Randomized Controlled Clinical Trials in Traditional Chinese Medicine)

  • 서린;장수비;최봄;최봄;천진홍
    • 대한한방소아과학회지
    • /
    • 제37권4호
    • /
    • pp.70-90
    • /
    • 2023
  • Objective This study analyzed randomized clinical trials (RCTs) on pediatric asthma using traditional Chinese medicine (TCM) to determine its efficacy and safety. Methods We searched electronic databases in English, Chinese, Japanese, and Korean and evaluated 35 articles published up to December 28, 2022. Based on data from the literature, we analyzed treatments, results, composition of herbal medicine, frequency of medicinal herbs, and decoction. Results TCM for pediatric asthma was compared to supportive therapy, inhaled corticosteroids, and standardized treatments. Of the 35 studies, 32 showed that TCM treatments were effective in alleviating asthma symptoms. Furthermore, TCM treatment was considered safe compared to common asthma treatments. Among the TCM treatments for pediatric asthma, the most frequent decoctions were Gamisaganmahwangtang (加味射干麻黃湯) and Saganmahwangtang (射干麻黃湯). Ephedra Herba (麻黄), Armeniacae Semen (杏仁), Asiasari Radix et Rhizoma (細辛), Belamcandae Rhizoma (射干) were herbs that were frequently used for asthma in TCM decoctions. Conclusion This review showed that TCM is effective in treating pediatric asthma. More clinical RCTs are needed to confirm the efficacy and safety of TCM treatment.

Abiraterone for Treatment of Metastatic Castration-resistant Prostate Cancer: a Systematic Review and Meta-analysis

  • Zhou, Zhi-Rui;Liu, Shi-Xin;Zhang, Tian-Song;Xia, Jun;Li, Bo
    • Asian Pacific Journal of Cancer Prevention
    • /
    • 제15권3호
    • /
    • pp.1313-1320
    • /
    • 2014
  • Introduction: Although most prostate cancers initially respond to castration with luteinizing hormonereleasing analogues or bilateral orchiectomy, progression eventually occurs. Based on the exciting results of several randomized controlled trials (RCTs), it seems that patients with metastatic castration-resistant prostate cancer (mCRPC) might benefit more from treatment withabiraterone. Therefore we conducted a systematic review to evaluate the efficacy and toxicity of abiraterone in the treatment of mCRPC. Methods: Literature was searched from Embase, PubMed, Web of Science, and Cochrane Library up to July, 2013. Quality of the study was evaluated according to the Cochrane's risk of bias of randomized controlled trial (RCT) tool, then the Grading of Recommendations Assessment, Development and Evaluation (GRADE) System was used to rate the level of evidence. Stata 12.0 was used for statistical analysis. Summary data from RCTs comparing abiraterone plus prednisone versus placebo plus prednisone for mCRPC were meta-analyzed. Pooled hazard ratios (HRs) for overall survival (OS), radiographic progression-free survival (RPFS) and time to PSA progression (TTPP); Pooled risk ratios (RR) for PSA response rate, objective response rate and adverse event were calculated. Results: Ten trials were included in the systematic review; Data of 2,283 patients (1,343 abiraterone; 940 placebo) from two phase 3 trials: COU-AA-301 and COU-AA-302 were meta-analyzed. Compared with placebo, abiraterone significantly prolonged OS (HR, 0.74; 95% confidence interval [CI], 0.66 to 0.84), RPFS (HR, 0.59; 95% CI, 0.48 to 0.74) and time to PSA progression (HR, 0.55; 95% CI, 0.43 to 0.70); it also significantly increased PSA response rate (RR, 3.63; 95% CI, 1.72 to 7.65) and objective response rate (RR, 3.05; 95% CI, 1.51 to 6.15). This meta-analysis suggested that the adverse events caused by abiraterone are acceptable and can be controlled. Conclutios: Abiraterone significantly prolonged OS, RPFS and time to progression patients with mCRPC, regardless of prior chemotherapy or whether chemotherapy-na$\ddot{i}$ve, and no unexpected toxicity was evident. Abiraterone can serve as a new standard therapy for mCRPC.

B형 및 C형 간염에 대한 한약 치료의 효과 - 체계적 고찰 연구 (Herbal Medicine for the Treatment of Viral Hepatitis B and C: A Systematic Review of Randomized Controlled Trials)

  • 김승모;이유리;조나경;최홍식;김경순
    • 대한한방내과학회지
    • /
    • 제42권4호
    • /
    • pp.455-474
    • /
    • 2021
  • 본 연구는 B형 및 C형 간염에 대한 한약 치료의 효과를 평가하기 위해 무작위 임상연구를 대상으로 체계적 문헌고찰 및 메타분석을 시행하였다. 검색엔진은 EMBASE, Pubmed, NDSL, KMBASE, KISS, KISTI, Koreamed, Koreantk, Oasis database를 이용하였으며 국내의 검색 엔진 키워드는 '간염' 또는 '바이러스성간염', '한약', '무작위 배정 임상시험'을, 국외 검색 엔진 키워드는 'hepatitis' or 'viral hepatitis' and 'herbal medicine' or 'traditional chinese medicine' and 'randomized controlled trial'을 이용하였다. 연구 결과 15개의 무작위배정 임상시험을 선택되었으며, 그 중 통계적으로 유의미한 결과를 나타낸 연구는 한약과 양약 복합치료군이 양약을 투여한 대조군에 비해 HBV DNA loss에서 높은 효과를 보였다. 한약과 양약 복합치료군이 양약을 투여한 대조군에 비해 HBeAg loss에서 통계적으로 유의한 효과를 보였으며, 한약과 양약 복합치료군이 양약을 투여한 대조군에 비해 ALT가 감소하였다. 본 연구는 B형 및 C형 간염환자를 대상으로 한약의 효과를 확인하기 위해 기존에 시행된 RCT 연구를 대상으로 체계적 문헌고찰을 시행하였으며, 한약과 양약의 복합치료가 양약 단독치료에 비해 치료효과가 더 높은 것으로 나타났다.

CONSORT-CHM 2017 지침에 근거한 대한한의학회지 및 회원학회지에 투고된 경구투여 한약 중재를 활용한 무작위 배정 비교 임상 연구(RCT)의 양적, 질적 평가 연구 (Orally Administered Korean Herbal Medicine Medications of Randomized Controlled Trials Published in the Journal of Korean Medicine and Related Journals: A Narrative Analysis using CONSORT-CHM 2017)

  • 문세훈;조정호;최승관; 한윤희;우현준;전병현;하원배;이정한
    • 대한한방내과학회지
    • /
    • 제44권6호
    • /
    • pp.1212-1242
    • /
    • 2023
  • Objectives: This study aims to explore the current usage status of orally administered Korean herbal medicine in randomized controlled trials (RCTs) published in the Journal of Korean Medicine and member journals using the CONSORT-Chinese Herbal Medicine Formulas 2017 (CONSORT-CHM 2017) checklist. Methods: We searched the OASIS, RISS, and KMBASE archives as well as the websites of the Journal of Korean Medicine and 45 member journals to identify RCTs that used herbal interventions. Two independent researchers searched and categorized the RCTs and performed a quantitative evaluation by journal, study design, and target disease, as well as qualitative evaluation of the literature using CONSORT-CHM 2017. Results: After the search, 66 articles were selected. The quantitative evaluation resulted in 13 articles (19.6%) that were published in the Journal of Korean Medicine and 12 articles (18.1%) in the Journal of Internal Korean Medicine. In terms of study design, 62 articles (93.9%) were parallel, 4 articles (6%) were crossover, and 2-arm parallel study designs were the most common in 45 articles (68.2%). In terms of the study participants, physiological characteristics and mechanisms in healthy individuals were the most common in 21 studies (31.8%) and obesity in 9 studies (13.6%). In terms of assessing completeness in the CONSORT-CHM 2017 items, 29 articles were rated high, 31 were rated moderate, and 6 were rated low. Items 4a, 6a, and 7a had low reporting rates (≤ 30%), while items 2a, 2b, and 12a were completely reported in all studies. Conclusion: Future RCTs using orally administered Korean herbal medicine need to be reported completely, and the CONSORT-CHM 2017 checklist can be a helpful tool for this purpose.

다계통 위축증의 치료에 대한 임상연구 동향 - CNKI검색을 중심으로 (A Review of Clinical Studies for Treatment of Multiple System Atrophy Using the CNKI Database)

  • 김민지;원서영;김해융;유주영;정은선;유호룡;설인찬;김윤식
    • 대한한방내과학회지
    • /
    • 제41권4호
    • /
    • pp.612-623
    • /
    • 2020
  • Objectives: The aim of this research was to investigate and review the trends in recent clinical studies of multiple system atrophy (MSA) in China. Methods: We searched for clinical studies discussing Oriental medicine-based treatments for MSA in the China National Knowledge Infrastructure (CNKI) database. The search focused on the authors; publication year; type of study; method and duration of treatment; evaluation criteria; and results of the selected articles. Results: Among the articles retrieved from the database, eight case series, two randomized controlled trials (RCTs), and one non-randomized controlled trial (nRCT) were analyzed. Eight articles used acupuncture; ten used herbal medicine. The most frequently used acupoints were GV20, GV24, GB20, PC6, Hyeopcheok Acupoint, CV4, EX-HN3, and GV17. Jihwangeumja was the most commonly used herbal prescription. All 13 studies confirmed the efficacy of Oriental medicine treatments. Conclusions: More varied and scientifically designed clinical studies are required to develop treatments for MSA. The results of this study may provide guidance for further studies of MSA.

견관절 통증에 대한 팔단금 운동의 효과: 체계적 문헌 고찰 (Baduanjin Exercise for Shoulder Pain: A Systematic Review)

  • 김현태;이상현;박선영;허인;황만석;신병철;황의형
    • 척추신경추나의학회지
    • /
    • 제15권1호
    • /
    • pp.89-100
    • /
    • 2020
  • Objectives : This study aimed to verify the clinical effectiveness of Baduanjin for shoulder pain. Methods : We searched 10 electronic databases (PubMed, EMBASE, Cochrane Library, CAJ, KISS, KISTI, KMBASE, RISS, NDSL, and OASIS) up to May 2020. We included randomized controlled trials (RCTs) using Baduanjin for shoulder pain. The methodological quality of each RCT was assessed using the Cochrane risk of bias tool. Results : As a result of the search, a total of 6 RCTs were eligible for analysis. Of these 6 studies, one applied Baduanjin alone and 5 cases used Baduanjin in combination with other treatments, such as acupuncture or electroacupuncture. Except for 2 studies, descriptive analysis was performed without meta-analysis due to the high level of heterogeneity between studies. A high risk of bias was observed in all studies. Conclusions : When considering the results of the included papers, there was limited information derived on the therapeutic effect of using Baduanjin as a single intervention, but the results showed significant effectiveness when Baduanjin was combined with other oriental interventions, such as acupuncture and electroacupuncture, in the clinical field. Although all RCTs included in the analysis were biased to CAJ and the number was limited, this study was conducted in accordance with the methodological process of systematic literature reviews and revealed the clinical effects of Baduanjin on shoulder pain.

경도인지장애의 침 치료에 대한 무작위배정 대조 임상시험(RCT) 연구 논문에 대한 질 평가 : STRICTA와 CONSORT 지침을 바탕으로 (Quality Assessment of Studies on Randomized Controlled Trials (RCTs) of Acupuncture Treatment for Mild Cognitive Impairment: Based on the STRICTA and CONSORT Guidelines)

  • 신여옥;허우영;이인
    • 대한한방내과학회지
    • /
    • 제40권6호
    • /
    • pp.1101-1111
    • /
    • 2019
  • Objective: The purpose of this study was to investigate quality of reporting acupuncture intervention for mild cognitive impairment (MCI) based on the STRICTA and CONSORT guidelines Methods: We searched for randomized controlled trial studies of acupuncture treatment for MCI in the MEDLINE (PubMed) database. Once the online search was completed, studies were selected manually by the inclusion criteria, and the selected studies were evaluated by STRICTA and CONSORT guidelines. Results: Five studies were included. The most frequently selected points for acupuncture treatment of MCI were on the head, such as GV20, EX-HN1, GV24, and GB20. By STRICTA guidelines, all items from STRICTA were reported except three items on the checklist. By CONSORT guidelines, apart from six items which were not available, quality assessment was performed with 31 items. Eighteen items were reported by 80% of the studies. Four items were reported by 40% of the studies and another four items were reported by 20% of the studies. One item was not reported in all studies. Conclusion: Most items were reported by STRICTA guidelines, whereas many items were insufficiently reported based on CONSORT guidelines. This needs to be considered in future RCTs of acupuncture treatment for MCI.

Meta-analysis for Efficacy and Safety of Propofol during Dental Sedation

  • Choi, Seong-Seok;Seo, Kwang-Suk;Kim, Hyun-Jeong
    • 대한치과마취과학회지
    • /
    • 제12권2호
    • /
    • pp.75-91
    • /
    • 2012
  • Background: Dental sedation reduces fear and phobia during dental treatment and helps patients get quality treatment by inducing adequate consciousness control. Propofol has recently grabbed the spotlight, but no meta-analysis for efficacy and safety of propofol in dentistry has yet been performed. Thus, the purpose of this study was to perform meta-analysis to verify the efficacy and safety of propofol for use in dental sedation. Methods: Articles published between 1980 and 2010 were searched in the web sites, journals and medical database including The Cochrane Library, MEDLINE and EMBASE. And a total of 22 studies were selected among the randomized controlled trials (RCTs) that compared the use of propofol with other sedatives (control group). The data was collected from these studies and meta-analysis for efficacy and safety was performed using Comprehensive Meta-Analysis 5.0 (CMA 5.0). Results: The patient recovered significantly faster and discharged significantly earlier in the propofol group (SMD = -1.442, P < 0.001). The satisfaction of patient and that of operator was higher in the propofol group (P < 0.05). The incidence of arrhythmia and apnea/ hypoventilation was significantly lower in the propofol group (OR = 0.071, P < 0.05), and there was no significant difference in the other side effects. On the level of sedation, although the sedation score was significantly lower in the propofol group (SMD = -0.430, P < 0.05). Conclusions: The present analysis showed that the use of propofol resulted in high satisfaction levels on the part of the patients and operators, a shorter recovery time, and faster hospital discharge. The incidence of complications, however, was lower in the propofol groups or not much different between the propofol and control groups. Thus, the adequate use of propofol in dentistry is believed to be helpful for the effective and safe sedation of the patients.