• 제목/요약/키워드: Risk of bias(ROB)

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항암 치료 후 발생한 수족증후군에 대한 한의학적 치료의 효과에 대한 고찰 (The Effect of Traditional Korean Medicine for Chemotherapy-Induced Hand-Foot Syndrome in Cancer Patients: Review)

  • 김은지;박찬란;손창규;조정효;이남헌
    • 대한한방내과학회지
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    • 제42권3호
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    • pp.340-350
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    • 2021
  • Objectives: Hand-foot syndrome (HFS) is a common adverse effect of chemotherapy in cancer patients. This review synthesizes research results to assess the effect of traditional Korean medicine (TKM) on HFS in cancer patients. Methods: Four databases (PubMed, The Cochrane Central Register of Controlled Trials, Research Information Sharing Service, China National Knowledge Infrastructure) were searched for randomized controlled trials (RCTs) to assess the effects of TKM on HFS. The effects and quality of RCTs were assessed with the Cochrane risk of bias (ROB) tool. Results: Six RCTs met our study criteria. In all six, TKM showed improvement in HFS symptoms as well as quality of life scores when compared to the control group. However, the methodological quality of RCTs was relatively low due to the unclear or high ROB. Conclusions: TKM would be helpful to patients with HFS after chemotherapy. To clarify the clinical efficacy of TKM, well-designed studies are required in the future.

불안장애에 대한 침 치료 임상 연구의 체계적 고찰 (A Systematic Review of Clinical Studies on the Effects of Acupuncture on Anxiety Disorders)

  • 김경옥;김천중;서상일;김남열;김근우
    • 동의신경정신과학회지
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    • 제28권3호
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    • pp.249-262
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    • 2017
  • Objectives: The aim of this study was to investigate the clinical studies which focus on acupuncture's effect on anxiety disorder. Methods: We selected clinical studies through six databases. We then examined the characteristics of the selected studies and conducted an assessment for Risk of Bias (ROB). Results: Seventeen randomized-controlled trials were selected to determine the effects of acupuncture on anxiety disorders. We found that the risk of bias in most studies was unclear. The intervention of 7 seventeen randomized-controlled trials (RCT) was basic acupuncture, 8 RCT involved electric acupuncture, 2 RCT consisted of acupuncture and Moxibustion. Four of the 7 basic acupuncture RCTs and 5 of the 8 electric acupuncture RCTs had a significant effect on anxiety factors for anxiety disorders. Conclusions: Acupuncture treatment for anxiety disorders was found to be effective compared to the controls, or there was no difference in effectiveness compared to the controls. However, the quality of the included studies was low, and there only were a small number of studies. Therefore, well-designed studies and a greater number of the studies are needed.

Association between Praziquantel and Cholangiocarcinoma in Patients Infected with Opisthorchis viverrini: A Systematic Review and Meta-Analysis

  • Kamsa-Ard, Supot;Laopaiboon, Malinee;Luvira, Vor;Bhudhisawasdi, Vajarabhongsa
    • Asian Pacific Journal of Cancer Prevention
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    • 제14권11호
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    • pp.7011-7016
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    • 2013
  • Background: The liver fluke, Opisthorchis viverrini, and the associated incidence of subsequent cholangiocarcinoma (CCA) are still a public health problem in Thailand, and praziquantel (PZQ) remains the antihelminthic drug of choice for treatment. Evidence in hamsters shows that repeated infection and PZQ treatments could increase the risk of CCA. However, the existing evidence in humans is inconclusive regarding increased risk of CCA with frequency of PZQ intake. Objectives: To investigate the relationship between number of repeated PZQ treatments and CCA in patients with O viverrini infection. Materials and Methods: The reviewed studies were searched in EMBASE, MEDLINE, ProQuest, PubMed and SCOPUS from inception to October, 2012 using prespecified keywords. The risk of bias (ROB) of included studies was independently assessed by two reviewers using a quality scale from the Newcastle-Ottawa Scale (NOS). Risk effect of PZQ was estimated as a pooled odds ratio (OR) with its 95% confidence interval (95%CI) in the random-effects model using DerSimonian and Laird's estimator. Results: Three studies involving 637 patients were included. Based on the random effects model performed in two included studies of 237 patients, the association between PZQ treatments and CCA was not statistical significant with a pooled OR of 1.8 (95%CI; 0.81 to 4.16). Conclusions: The present systematic review and meta-analysis provides inconclusive evidence of risk effect of PZQ on increasing the risk of CCA and significant methodological limitations. Further research is urgently needed to address the shortcomings found in this review, especially the requirement for histological confirmation.

일차성 사구체신염의 육미지황탕과 양약 병용요법에 대한 체계적 문헌고찰 및 메타분석 (The Effect of Combination Therapy of Yukmijihwang-tang and Western Medicine on Primary Glomerulonephritis: Systemic Review and Meta-analysis)

  • 허태영;김예슬;김경민
    • 대한한방내과학회지
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    • 제44권1호
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    • pp.12-34
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    • 2023
  • Objective: This study was conducted to evaluate the effectiveness of the combination therapy of Yukmijihwang-tang and Western medicine on primary glomerulonephritis. Methods: We conducted a search using keywords, such as Yukmijihwang-tang and Liuwei Dihuang, in eight databases (CNKI, CiNii, Pubmed, Embase, Cochrane, Science On, OASIS, RISS). There was no limit to the publication period of the papers. A meta-analysis was conducted and classified according to the outcome measurements, such as the total effective rate (TER), serum creatinine (SCr), and blood urea nitrogen (BUN). Data analysis was performed using the RevMan 5.4.1 software, and Cochrane's risk of bias (ROB) was used to assess the quality of the papers. Results: A total of 12 randomized control trials were selected. The meta-analysis showed that the treatment group combining Yumijihwang-tang and Western medicine was more efficient than the control group using Western medicine alone (RR: 1.29, CI: 1.20 to 1.39 p=<0.00001). The treatment group also reduced the BUN (MD: -2.40, CI: -2.90 to -1.89, p<0.00001) and Scr (MD: -33.34, CI: -40.85 to -25.82, P<0.00001) more than the control group. Conclusion: This study suggests that the combination therapy of Yukmijihwang-tang with Western medicine is effective in treating primary glomerulonephritis. However, these findings should be interpreted cautiously due to the unknown or high risk of bias in the included trials.

뇌졸중 환자의 다리 기능에 대한 경두개직류자극의 효과: 국내 연구의 메타분석 (Effects of Transcranial Direct Current Stimulation on Lower Extremity Function of Stroke Patients : A meta-analysis of domastic research)

  • 이정우;임지선
    • 대한통합의학회지
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    • 제9권3호
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    • pp.87-97
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    • 2021
  • Purpose : The purpose of this meta-analysis was to evaluate the effects of transcranial direct current stimulation on the lower extremity function of stroke patients. Methods : Domestic data were gathered from studies that conducted clinical trials associated with transcranial direct current stimulation and its impact on lower extremity function of stroke patients. A total of 592 studies published between 2012 and 2020 were identified, with 7 studies satisfying the inclusion data. The studies consisted of patient, intervention, comparison, and outcome (PICO) data. The search outcomes were items associated with muscle activity, balance, muscle strength and walking ability. Cochrane risk of bias (ROB) was used to evaluate the quality of 3 randomized control trials. The quality of 4 non-randomized control trials was evaluated using risk of bias assessment tool for non-randomized studies (RoBANS). Effect sizes in this study were computed as the corrected standard mean difference (SMD). A random-effect model was used to analyze the effect size because of the high heterogeneity among the studies. Egger's regression and 'trim-and-fill' tests were carried out to analyze the publishing bias. Results : The following factors had a large total effect size (Hedges's g=2.10, 95 %CI=1.54~2.66) involving transcranial direct current stimulation on stroke patients: muscle activity (Hedges's g=2.38, 95 %CI=1.08~3.68), balance (Hedges's g4=2.41, 95 %CI=1.33~3.60), walking ability (Hedges's g=1.54, 95 %CI=0.49~2.59), and muscle strength (Hedges's g=2.45, 95 % CI: 0.85~4.05). Egger's regression test showed that the publishing bias had statistically significant differences but 'trim-and-fill' test showed that there was still statistical difference. Conclusion : This study provides evidence for the effectiveness of transcranial direct current stimulation on the lower extremity in terms of muscle activity, balance, walking ability, and muscle strength in stroke patients. However, due to the low quality of studies and high heterogeneity factors, the results of our study should be interpreted cautiously.

산후 유즙분비부전에 대한 침 치료 효과 : 체계적 문헌 고찰 (The Clinical Effect on Acupuncture Treatment of Postpartum Hypogalactia: A Systematic Review of Randomized Controlled Trials)

  • 김유정;박경선;황덕상;이진무;장준복;이창훈
    • 대한한방부인과학회지
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    • 제30권3호
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    • pp.79-91
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    • 2017
  • Objectives: The purpose of this systematic review is to overview and evaluate the effect on postpartum hypogalactia after acupuncture treatment. Methods: Relevant randomized controlled trials (RCTs) were identified by database searches in Embase, Pubmed, CENTRAL, CNKI, KISS. Searching keywords were "Hypogalactia" or "Hypolactaion" and "Acupuncture". After searching qualified articles, we independently assessed the risk of bias according to the Cochrane Rob criteria. Results: Among the 81 articles five RCTs were finally selected. Four of the selected were statistically significant. One of them was not statistically significant because it was comparative study of chinese medicine and acupuncture treatment. The quality of the evidence for specific comparisons ranged from low to high. Conclusions: Our systematic review found encouraging. Acupuncture treatment would be effective way to increase insufficient milk supply on postpartum hypogalactia.

근육뼈대계 질환에 대한 도수치료의 효과: 메타분석 (Effects of Manual Therapy on Musculoskeletal Diseases : A Meta-Analysis)

  • 이정우;공광식;김동연;고운
    • 대한통합의학회지
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    • 제9권1호
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    • pp.203-217
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    • 2021
  • Purpose: The purpose of this meta-analysis was to examine the high-level evidence of the effects of manual therapy on musculoskeletal diseases. Methods: Domestic databases were searched for studies that conducted clinical trials associated with manual therapy on chronic musculoskeletal diseases. A total of 591 studies published between 2005 and 2018 were identified, with 18 studies satisfying the inclusion data. The studies were classified according to patient, intervention, comparison, and outcome (PICO). The search outcomes were items associated with pain and physical function. The 18 studies included in the study were evaluated by using the R meta-analysis (version 4.0). The quality of 18 randomized control trials was evaluated by using the Cochrane risk of bias (ROB). The effect sizes were computed as the corrected standardized mean difference (SMD). Subgroup and meta-regression analyses were also used. Egger's regression test was carried out in order to analyze the publication bias. Cumulative meta-analysis and sensitivity analysis were also conducted in order to analyze the data error. Results: The following factors showed the large effect size of manual therapy on chronic musculoskeletal diseases: pain (Hedges's g = 2.66; 95% CI = 1.47 ~ 3.85), and physical function (Hedges's g = 2.15; 95% CI: 1.22 ~ 3.08). The subgroup analysis only showed a statistical difference in the type of manual therapy (pain) and outcome (physical function). No statistically significant difference was found in the meta-regression analysis. Publication bias was found in the data, but the results of the trim-and-fill method showed that such bias did not largely affect the obtained data. Furthermore, there were no data errors in the cumulative meta-analysis and sensitivity analysis. Conclusion: This study provides evidence for the effectiveness of manual therapy on chronic musculoskeletal diseases in pain and physical function. Subgroup analysis suggests that only the type of manual therapy for pain and the type of outcome for physical function differed in effect size.

임상연구의 고혈압 침치료법에 대한 고찰 (Review of Acupuncture Treatment for Hypertension in Clinical Trials)

  • 정소영;박지은;김정은;김애란;최선미
    • 대한한의학회지
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    • 제33권1호
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    • pp.12-23
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    • 2012
  • Objectives: This study evaluated clinical trials of acupuncture treatment for hypertension and to assess their methodology and results. Methods: Eight Korean databases and four international databases were searched for clinical trials of acupuncture treatment for hypertension up to June 2011. Study quality was assessed using the risk of bias (ROB) tool. Results: Twenty-four trials of acupuncture for hypertension were included. There were 14 randomized and 1 non-randomized controlled trials and 9 before-after studies. The most frequently used acupuncture points were zsnli (ST36), qch (LI11), fngch (GB20), snynjio (SP06), snjin (LI03) and hgu (LI04). In more than half of the studies, needle retention time was 20~30 minutes. Compared to baseline, change of blood pressure after treatment was significant in all studies. However, the results of effect on blood pressure between acupuncture and control were not consistent. Conclusions: There is insufficient evidence to suggest that acupuncture is an effective treatment for hypertension. Further well-designed clinical trials will be required to evaluate the effects and safety of acupuncture treatment for hypertension.

자하거 약침의 신경정신과 임상 응용에 관한 체계적 문헌 고찰 (A Systematic Review of Placenta Pharmacopuncture for Neuropsychiatric Diseases in Practice)

  • 신혜규;이재혁;강형원
    • 동의신경정신과학회지
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    • 제33권2호
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    • pp.157-180
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    • 2022
  • Objectives: To perform a systematic review of placenta pharmacopuncture for treating neuropsychiatric diseases, focusing on its efficacy and the safety so that evidence on its clinical use could be obtained, thus contributing to further studies. Methods: Through Korean, English, and Chinese databases (OASIS, Korean TK, KISS, RISS, ScienceON, Pubmed, Cochrane, EMBASE, CINAHL, AMED, CNKI, and Wanfang), combinations of keywords (placenta, pharmacopuncture, etc.) were used to select clinical studies published until January 2021 about placenta pharmacopuncture for neuropsychiatric diseases. Interventions included combined treatments. Study design included cases studies, series, and clinical trials. Cohort studies, literature reviews, in vitro and animal experiments were excluded. The primary outcomes involved measurements of symptoms, Visual Analogue Scale, or questionnaires. Data extracted from databases were imported to Endnote X7 to remove duplicates. The quality of the literature was assessed based on CAse REports Guidelines and Cochrane's Risk of Bias (ROB). Results: Twenty-one studies were selected, including ten case reports, three case series, two one-armed clinical trials, one non-randomized clinical trial, and five randomized clinical trials. There were six studies on sleep disorders, five studies on stroke sequela, two on mood disorders, two on enuresis, two on Guillain-Barré syndrome, two on multiple sclerosis, one on neurocognitive disorder, and one on vertigo. The most frequent combined treatment was acupuncture in both the experimental group (n=10) and the control group (n=3). Acupoints were ST36, SP6, BL23, CV4, GB20, GV20, N-HN54, and so on. All studies reported improvement of symptoms. The quality of case studies was relatively high. Assessment of ROBs resulted in low risks. Conclusions: Placenta pharmacopuncture is effective for neuropsychiatric diseases such as sleep disorders, mood disorders, enuresis, and neurocognitive disorders. Regarding insomnia, several studies have reported significant improvements with placenta pharmacopuncture. There was no adverse event associated with placenta pharmacopuncture.

혈부축어탕의 본태성 고혈압에 대한 치료 효과 관한 메타 분석 및 체계적 고찰 (Xuefuzhuyu Decoction for Essential Hypertension: Meta-Analysis and Systemic Review)

  • 한인식;장인수;선승호
    • 대한한방내과학회지
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    • 제39권6호
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    • pp.1150-1167
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    • 2018
  • Objective: The purpose of this study was to investigate the effect reducing blood pressure (BP) using Xuefuzhuyu Decoction (XFZYD) in adults with essential hypertension (EH). Method: Search engine, such as PubMed, EMBASE, Cochrane library, Web of Science, J-STAGE, CiNii, CNKI, OASIS, NDSL, KISS, RISS, and DBpia, were used. The search period was from the beginning of the search engine to June 30, 2018 and there were no limits regarding languages. The selection and extraction of literatures were performed independently by two authors. Meta-analysis was done on the total effective rate (TER), Systolic BP (SBP) and Diastolic BP (DBP). Cochrane's risk of bias (ROB) was used as the methodological quality assessment scale. Results: Twenty studies were finally selected. We observed that a combination treatment using XFZYD and an antihypertensive drug (AHD) was 5.1 times more effective in lowering BP than using AHD alone on TER. The mean differences in SBP and DBP were -10.65 mmHg (95% Confidential Interval (CI) -13.55 mmHg, -7.74 mmHg, P<0.00001), -5.92 mmHg (95% CI -7.14, -4.38, P<0.00001), respectively. Conclusion: A combination treatment using XFZYD and AHD may be more effective in reducing BP than using AHD alone. Because of the poor methodological quality of the studies conducted thus far, high-quality clinical trials will be required in the future.