• Title/Summary/Keyword: Cochrane Risk of Bias

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A Systemic Review of Randomized Controlled Trials on Interventions of Korean Medicine for Secondary Amenorrhea (속발성 무월경의 한의학적 치료에 대한 무작위 대조 임상시험의 체계적 문헌 고찰)

  • Eon-Ji Rho;Dong-Chul Kim
    • The Journal of Korean Obstetrics and Gynecology
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    • v.36 no.3
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    • pp.95-113
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    • 2023
  • Objectives: The purpose of this study is to review the recent clinical study trends on Korean Medicine treatment for Secondary Amenorrhea by analyzing randomized controlled trials. Methods: We searched relevant studies published from electric databases including 4 domestic databases and 3 foreign databases. Data retrieval was conducted on May 30, 2023. and the papers published from January 1, 2018 to May 30, 2023 were included. The risk of bias was assessed by using Cochrane's risk of bias tool. Results: 119 studies and 193 studies were searched in each domestic databases and foreign databases, and 9 studies were finally selected. The control group was all treated with only western medicine. Among the treatment group, 2 studies were treated with only oral herbal medicine, 1 study was treated with herbal medicine and acupuncture, 5 studies were treated with combined treatment of herbal medicine and western medicine, 1 study was treated with combined treatment of herbal medicine, acupuncture and western medicine. In all 9 studies, the total effective rate and cure rate were higher in the treatment group than those of the control group (p<0.05). Conclusions: Korean medicine alone or combined with western medicine is more effective for treating Secondary Amenorrhea compared to using western medicine alone.

The Effect of Intervention on Improving Cognitive Function of Patients with Dementia in Korea : A Systematic Review of Randomized Controlled Trials (국내 치매환자의 인지기능 향상을 위한 중재의 효과: 무작위 대조군 실험연구의 체계적 문헌고찰)

  • Jung, Jae-Hun
    • Journal of Industrial Convergence
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    • v.19 no.5
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    • pp.91-102
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    • 2021
  • The purpose of this study was to systematically review about randomized controlled trials the characteristics and effect of cognitive function intervention for patient with dementia. We searched studies published from January 2010 to June 2021 in 5 databases. A total 1,104 studies were found and included 27 studies in final analysis. Methodological quality was assessment with the Cochrane's RoB(risk of bias) tool. Mini-Mental State Examination(MMSE) was the most used as the assessment tool for identifying the cognitive function. Cognitive function intervention were exercise, art, cognitive stimulation, reminiscence, music, multimodal cognitive rehabilitation, virtual reality, horticultural, computerized cognitive training, intentional snoezelen, beauty, cooking, korean traditional familiarity program. Most of the intervention except exercise 2, virtual reality 1, beauty 1 were effective in improving cognitive function. This study provided a clinical evidence for planning and implementing intervention for cognitive function intervention. In the future, various intervention studies suitable for the characteristics of dementia should be conducted by improving the quality of research methods.

Is Gwibitang and its modification beneficial for alleviating symptoms in chronic fatigue syndrome: A systematic review and meta-analysis (귀비탕과 그 변방의 만성피로증후군 증상완화에 대한 효용성: 체계적인 문헌고찰)

  • Nam, Donghyun
    • Herbal Formula Science
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    • v.28 no.2
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    • pp.199-209
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    • 2020
  • Objectives : The purpose of this systematic review is to confirm whether Gwibitang is beneficial in chronic fatigue syndrome (CFS). Methods : Clinical trials were searched from databases including Pubmed, Embase, Central Cochrane, CNKI, Wanfang, CQVIP, CiNii, OASIS, Koreamed, and NDSL. The eligible study design was limited into randomized controlled trial, quasi-randomized controlled trial and controlled clinical trial. The outcomes included general effectiveness as nominal scale, and fatigue severity, insomnia severity and quality of life as interval or ratio scale. The meta-analysis and assessment of risk of bias was performed based on the data extracted from the selected trials. Results : The results of eight randomized controlled trials (n=596) were included in the meta-analysis. The results of the synthesis showed Gwibitang is beneficial substantially for relieving and managing the general symptoms, and its heterogeneity was not in important level (RR 0.26 [95% CI 0.17, 0.39], Z=6.47, P<0.00001, I2=0%). Gwibitang was beneficial for alleviating fatigue (SMD -0.78 [95% CI -1.27, -0.30], Z=3.17, P=0.002), but its certainty was low. In case of insomnia, too few trials had been found and their risk of bias was substantial, so no conclusions had been brought to. Conclusions : We found an evidence that Gwibitang could be beneficial for managing and alleviating main symptoms in CFS patients.

The Effect of Non-Pharmacological Intervention on Depressive Symptom in Elderly with Mild Cognitive Impairment : A Systematic Review of Randomized Controlled Trials (경도인지장애 노인의 우울증상을 위한 비약물적 중재 효과: 무작위 대조군 실험연구의 체계적 문헌고찰)

  • Jung, Jae-Hun
    • Journal of Industrial Convergence
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    • v.20 no.10
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    • pp.39-49
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    • 2022
  • The purpose of this study was to systematic review about randomized controlled trials the characteristics and effect of non-pharmacological intervention on depressive symptom in elderly with mild cognitive impairment. We searched studies published from January 2011 to July 2021 in 3 databases. A total 1,455 studies were found and included 11 studies in final analysis. Methodological quality was assessment with the Cochrane's RoB(risk of bias) tool. Geriatric Depression Scale(GDS) was the most used as the assessment tool for identifying the depressive symptom. Intervention were yoga, psychosocial intervention, cognitive training, health education, multi-component intervention, game training, aerobic/pulmonary physiotherapy, art therapy, music reminiscence activity, memory specificity training, cognitive stimulation therapy and SWTW(sleep well, think well) program. Among the intervention programs, yoga, multi-component intervention and game training were effective in improving depressive symptom. This study provided a clinical evidence for planning and implementing intervention on depressive symptom in elderly with mild cognitive impairment.

Herbal Medicine Treatment for Cold Urticaria: A Systematic Review and Meta-Analysis (한랭 두드러기에 대한 한약 치료: 체계적 문헌 고찰 및 메타분석)

  • Hae-Na Kim;Jeong-Hwa Oh;Hwa-Jung Yoon
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.36 no.4
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    • pp.122-144
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    • 2023
  • Objectives : The purpose of this study is to evaluate the effects of herbal medicine treatment in patients with cold urticaria. Methods : We searched randomized controlled trials(RCTs) reporting the effects of herbal medicine for cold urticaria through domestic and international databases from their inception to September 2023. The results were summarized in tables. We assessed the risk of bias in included RCTs through Cochrane risk of bias tool and the data synthesis was conducted through RevMan version 5.4. Results : A total of 12 RCTs were included in this review and all trials compared herbal medicine alone treatment(treatment group) with western medicine alone treatment(control group). The total effective rate(TER) of treatment group was statistically higher than that of control group(RR: 1.49, 95% CI: 1.38 to 1.62, p<0.00001, I2=65%). On the other hand, when comparing except for 1 trial with different evaluation period, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.36, 95% CI: 1.26 to 1.47, p<0.00001, I2=0%). And when comparing 8 trials using the total symptom score(TSS) change index as an indicator of TER, the TER of treatment group was statistically higher than that of control group and heterogeneity was very low(RR: 1.38, 95% CI: 1.26 to 1.51, p<0.00001, I2=0%). The treatment group showed more statistically significant decrease compared to the control group in TSS(MD: -2.51, 95% CI: -2.63 to -2.40, p<0.00001, I2=99%). The relapse rate of treatment group was statistically lower than that of control group(RR: 0.19, 95% CI: 0.10 to 0.40, p<0.00001, I2=0%). Mild adverse events such as sleepiness, dizziness were reported in control group and gastric discomfort was reported in treatment group. In the risk of bias assessment, many cases were evaluated as 'Unclear risk'. Conclusions : This review found that herbal medicine alone treatment could more effective and safe than western medicine alone treatment for cold urticaria. But further well-designed researches are needed because of heterogeneity between trials and the quality of the included trials.

Efficacy of alpha-lipoic acid in patients with burning mouth syndrome compared to that of placebo or other interventions: a systematic review with meta-analyses

  • Christy, Jessica;Noorani, Salman;Sy, Frank;Al-Eryani, Kamal;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.22 no.5
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    • pp.323-338
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    • 2022
  • Burning mouth syndrome (BMS) is a chronic oral disorder of unknown etiology which presents therapeutic challenges. Alpha-lipoic acid (ALA) has been studied as a potential treatment for BMS. The objective of this systematic review and meta-analysis was to evaluate the effectiveness of ALA compared to that of placebo or other interventions in individuals with BMS. Randomized controlled trials (RCT) using ALA to treat BMS were identified from MEDLINE, Cochrane Library, EMBASE, and Web of Science up to February 3, 2021. The assessment of the risk of bias in the included studies was based on the Cochrane guidelines. The primary outcome evaluated was the visual analog scale (VAS) pain intensity. ALA was compared with placebo, clonazepam, gabapentin, pregabalin, ALA plus gabapentin, capsaicin, Biotène®, and laser therapy. Altogether, 137 records were scanned for inclusion/exclusion, and nine RCTs (two unclear and seven at high risk of bias) were included in the qualitative and quantitative analyses, with a total of 594 patients with BMS included in this review. All studies reported an improvement in VAS pain scores ranging from -0.72 to -2.77. Meta-analysis results showed a non-significant reduction in pain intensity for ALA (P = 0.616) compared to that of placebo on a VAS of 0-10. Patients taking ALA were 1.923 times more likely to show an improvement in self-reported BMS symptoms (P = 0.031) than those in the placebo group. Clonazepam and pregabalin showed a significant VAS pain reduction of 4.08 and 4.68 (P < 0.001), respectively, compared to that with ALA. Although ALA intervention provided a non-significant improvement in the pain score and was more likely to produce a reduction in BMS symptoms, the evidence was of low quality. Further research is needed to establish clear guidelines for the use of ALA for BMS treatment.

A Systematic Review of Korean Medicine for Non-Alcoholic Fatty Liver Disease (비알콜성 지방간질환의 한방치료에 대한 체계적 문헌고찰)

  • Lee, Yu-ri;Cho, Na-kyung;Choi, Hong-sik;Kim, Seung-mo;Kim, Kyung-soon
    • The Journal of Internal Korean Medicine
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    • v.40 no.1
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    • pp.13-37
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    • 2019
  • Objectives: The purpose of this study was to assess the effects of Korean medicine for non-alcoholic fatty liver disease (NAFLD). We analyzed the result of randomized controlled trials (RCTs) that applied Korean medicine to NAFLD patients through meta analysis and systematic review. Methods: The key question was to the effects of Korean medicine for NAFLD patients according to the PICO-SD (participants, intervention, comparison, outcome, study design) and we included only RCTs. We searched 10 databases including NDSL, KMBASE, KISS, KISTI, KoreaMed, Koreantk, OASIS, Cochrane, Pubmed, EMBASE without a language restriction. We assessed risk of bias by Cochrane group's Risk of Bias tool. Results: The finally selected 12 RCTs were analyzed. Total number of participants was 1189 (male 719, female 470) as 684 and 505 in the oriental medicine group (i.e. herbal drugs, acupuncture, acupoint embedding therapy) and control group (conventional drugs, placebo), respectively. The meta analysis results of examining 7 RCTs comparing the therapeutic efficacy of herbal medicine with that of Western medicine showed statistically significant (p<0.05) differences in the efficacy evaluation, liver function test results, blood lipids, and TNF-${\alpha}$. Furthermore, the meta analysis results of investigating 3 RCTs comparing the therapeutic efficacy of herbal medicine with that of a placebo showed statistically significant (p<0.05) differences in the liver function test results, blood lipids, and waist circumference. Conclusions: The research showed that Korean medicine for NAFLD can be effective treatment. But more studies are required to enhance the level of evidence and we should report on safety.

Comparison of the Effects of Topical Nasal Application on Allergic Rhinitis between Korean and Western Medicine : A Systematic Review of Randomized Controlled Trials (알레르기성 비염에 대한 한약 및 양약 국소비강외용제의 효과 비교 : 체계적 문헌 고찰)

  • Jo, Hyo-Rim;Oh, Se-Hee;Kim, Seon-Hye;Sung, Won-Suk;Hong, Seung-Ug;Kim, Eun-Jung
    • The Journal of Korean Medicine Ophthalmology and Otolaryngology and Dermatology
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    • v.32 no.4
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    • pp.62-89
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    • 2019
  • Objectives : The purpose of this study is to evaluate the effectiveness and safety of topical nasal application of Herbal medicine compared with Western medicine in the treatment of Allergic Rhinitis(AR). Methods : Electronic databases including Cochrane library, PubMed, EMBASE, CNKI, KMBASE, KISS, NDSL, OASIS, KISS and KJTK(Korean Traditional Knowledge Portal) were searched by the keywords such as 'allergic rhinitis', 'nasal sprays', 'herbal medicine', 'plant extracts', and 'external application'. The quality of each RCTs was assessed by Cochrane Collaboration of 'Risk of bias(RoB) Tool'. Results : 19 RCTs were finally selected from 1419 references screened. 19 RCTs were compared with the effects of topical nasal application of Herbal medicine and Western medicine. Based on the symptom scores from 13 RCTs, topical nasal application of herbal medicine generally has a better effect on relief of AR. The two treatments have similar effects on improving the level of specific factors like IgE, IgG, IL-13, $uLTD_4$ in blood and urine. 8 RCTs showed adverse effects(AEs) in both groups and severe AEs were not reported. Conclusions : This study shows that topical nasal application of herbal medicine can improve symptoms and related factors of allergic rhinitis. Well-designed RCT studies with low risk of bias should be conducted to confirm these findings.

Efficacy of medications in adult patients with trigeminal neuralgia compared to placebo intervention: a systematic review with meta-analyses

  • Peterson-Houle, Georgia M.;AbdelFattah, Magda R.;Padilla, Mariela;Enciso, Reyes
    • Journal of Dental Anesthesia and Pain Medicine
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    • v.21 no.5
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    • pp.379-396
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    • 2021
  • Background: Trigeminal neuralgia (TN) is characterized by brief, unilateral, sharp, stabbing, and shooting pain of the fifth cranial nerve. The objective of this systematic review with meta-analysis was to determine the effect of medications compared to placebo in adult patients with TN. Methods: Review authors identified randomized placebo-controlled trials (RCTs) from PubMed, Web of Science, Cochrane, and EMBASE up to February 2021. We assessed the inclusion and exclusion criteria as well as the risk of bias of the studies based on the Cochrane Handbook. A total of 324 unduplicated references were scanned independently and reduced to eight relevant RCTs, with 89 patients included. Medications investigated included oral carbamazepine, subcutaneous sumatriptan, lidocaine (intranasal, 8% spray on the oral mucosa or intravenous), buprenorphine (ganglionic local opioid analgesia), and oral Nav1.7, a selective sodium channel blocker. Results: Meta-analyses showed that overall patients receiving lidocaine reported a significantly lower post-treatment intensity of pain -3.8 points on a 0-10 scale (95% Cl = -4.653 to -2.873; P < 0.001). Patients who received lidocaine were 8.62 times more likely to have pain improvement than patients on placebo (P < 0.001). In one RCT, patients receiving oral carbamazepine showed a significant improvement in pain intensity of -32% compared to the placebo (P < 0.001). In one trial, patients receiving 3 mg subcutaneous sumatriptan had a significantly lower intensity of pain on average -6.1 points on a scale of 0-10 compared to placebo (P < 0.001) and a significant improvement in pain intensity of -75% compared to the improvement in the placebo group (P < 0.001). Patients who received subcutaneous sumatriptan were 10 times more likely to have pain improvement than those who received placebo (P = 0.001) in one study. Due to the unclear/high risk of bias and small sample size, the quality of the evidence for lidocaine in the treatment of TN was low. Conclusion: Further studies are needed for carbamazepine, sumatriptan, buprenorphine, and oral Nav1.7 sodium channel blockers, as only one study reported outcomes.

A Systematic Review and Meta-analysis of Acupuncture Trials in Republic of Korea that Used Sham Acupuncture as a Control Group (거짓침을 대조군으로 사용한 국내 침 임상시험에 대한 체계적 고찰과 메타분석)

  • Kim, Jung-Eun;Kang, Kyung-Won;Kim, Tae-Hun;Lee, Seung-Hoon;Kim, Joo-Hee;Baek, Seung-Min;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.28 no.6
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    • pp.1-17
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    • 2011
  • Objectives : This study aimed to review randomized controlled trials of acupuncture performed in South Korea that used sham acupuncture as a control group. Methods : The following databases were searched through the end of September 2011: Koreanstudies information service system (KISS), Korean medical database (KMbase), national discovery OR science leaders (NDSL), oriental medicine advance searching integrated system (OASIS), and research information service system (RISS). The following search terms were used: acupuncture AND (sham or placebo). The reference lists of searched articles and Korea institute of oriental medicine (KIOM) reports(2005~2009) were identified. The following data were extracted: year/first author, disease, number of participants, blinding, intervention, outcome, and result. Where appropriate, we performed meta-analysis. The methodological quality was assessed according to the Jadad scale and 'risk of bias' by Cochrane Handbook procedure. Results : Twenty-nine studies were included in this review. In eighteen studies, penetrating sham controls were used as the control intervention, whereas the remaining eleven studies adopted non-penetrating sham controls such as the Park Sham Device or blunt auricular acupuncture. Nine studies showed statistically significant difference in outcomes. Twelve studies concerning insomnia after stroke, chronic tension-type headache, idiopathic Parkinson's disease, Hwa-Byung, and smoking cessation were included in meta-analysis. A meta-analysis of insomnia after stroke only found significant difference(MD -4.31, 95% Cl -6.19 to -2.42, $p$<0.00001). In general, all of the studies showed low methodological quality(Jadad score: mean 2.1). Risk of bias by Cochrane Handbook procedure varied. Conclusions : The results of this study could not suggest conclusive evidence that acupuncture is more effective than sham acupuncture in several diseases. In the future, more studies with rigorous acupuncture trials using sham controls should be conducted.