• Title/Summary/Keyword: Randomized Response

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Randomized, Double Blind, Placebo-Controlled Study of Bofu-tsusho-san on Obese Patients (비만환자에 대한 방풍통성산(防風通聖散)의 무작위배정, 이중맹검, 위약-대조군 임상시험)

  • Lee, Ji-Eun;Song, Yun-Kyung;Lim, Hyung-Ho
    • Journal of Korean Medicine for Obesity Research
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    • v.10 no.1
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    • pp.1-16
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    • 2010
  • Objectives The clinical trial was designed to investigate the safety and effects of Bofu-tsusho-san extracts on the change of the weight, body compositions, serum in obese patients. Methods This study was a 4-weeks, double blind, comparative clinical trial. Eligible subjects had a body mass index(BMI) greater than $25\;kg/m^2$ and waist circumference(WC) longer than 85 cm in woman or 90 cm in man. Among 38 subjects, 36 subjects were randomized either to Bofu-tsusho-san or placebo. After 4 weeks of treatment, we measured anthropometric factors(weight, height, WC, BMI etc.), abdominal fat area by CT scanning, serum lipid(total cholesterol(TC), triglyceride(TG), HDL cholesterol, LDL cholesterol), blood level of variety(glucose, adiponectine, leptin, C-reactive protein(CRP) etc.), blood pressure(BP). Adverse events also evaluated. Results BMI, BP, TG, CRP were reduced and weight, WC, score of KOQOL(Korean version of obesity-related QOL scale), SRI(Stress response inventory) were significant changed in Bofu-tsusho-san. But there were no considerable difference between Bofu-tsusho-san and placebo. there were no serious adverse events in either group. Conclusion There were limitations in this study that it conducted within a short period of 4 weeks. but its weight and WC loss effect was significant and it had few adverse events.

Whole Brain Radiotherapy Plus Chemotherapy in the Treatment of Brain Metastases from Lung Cancer: A Meta-analysis of 19 Randomized Controlled Trails

  • Liu, Wen-Jing;Zeng, Xian-Tao;Qin, Hai-Feng;Gao, Hong-Jun;Bi, Wei-Jing;Liu, Xiao-Qing
    • Asian Pacific Journal of Cancer Prevention
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    • v.13 no.7
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    • pp.3253-3258
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    • 2012
  • Objective: To evaluate the efficacy and safety of whole brain radiotherapy (WBRT) plus chemotherapy versus WBRT alone for treating brain metastases (BM) from lung cancer by performing a meta-analysis based on randomized controlled trials (RCTs). Methods: The PubMed, Embase, CENTRAL, ASCO, ESMO, CBM, CNKI, and VIP databases were searched for relevant RCTs performed between January 2000 and March 2012. After quality assessment and data extraction, the meta-analysis was performed using the RevMan 5.1 software, with funnel plot evaluation of publication bias. Results: 19 RCTs involving 1,343 patients were included. The meta-analyses demonstrated that compared to WBRT alone, WBRT plus chemotherapy was more effective with regard to the objective response rate (OR = 2.30, 95% CI = 1.79 - 2.98; P < 0.001); however, the incidences of gastrointestinal reactions (RR = 3.82, 95% CI = 2.33 - 6.28, P <0.001), bone marrow suppression (RR = 5.49, 95% CI = 3.65 - 8.25, P < 0.001), thrombocytopenia (RR = 5.83, 95% CI = 0.39 - 86.59; P = 0.20), leukopenia (RR = 3.13, 95% CI = 1.77 - 5.51; P < 0.001), and neutropenia (RR = 2.75, 95% CI = 1.61 - 4.68; P < 0.001) in patients treated with WBRT plus chemotherapy were higher than with WBRT alone. There was no obvious publication bias detected. Conclusion: WBRT plus chemotherapy can obviously improve total efficacy rate, butalso increases the incidence of adverse reactions compared to WBRT alone. From the limitations of this study, more large-scale, high-quality RCTs are suggested for further verification.

Randomized Control Study of Nedaplatin or Cisplatin Concomitant with Other Chemotherapy in the Treatment of Advanced Non-small Cell Lung Cancer

  • Li, Chun-Hong;Liu, Mei-Yan;Liu, Wei;Li, Dan-Dan;Cai, Li
    • Asian Pacific Journal of Cancer Prevention
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    • v.15 no.2
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    • pp.731-736
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    • 2014
  • Objective: To observe the short-term efficacy, long-term survival time and adverse responses with nedaplatin (NDP) or cisplatin (DDP) concomitant with other chemotherapy in treating non-small cell lung cancer. Materials and Methods: A retrospective, randomized, control study was conducted, in which 619 NSCLC patients in phases III and IV who were initially treated and re-treated were randomly divided into an NDP group (n=294) and a DDP group (n=325), the latter being regarded as controls. Chemotherapeutic protocols (CP/DP/GP/NP/TP) containing NDP or DDP were given to both groups. Patients in both groups were further divided to evaluate the clinical efficacies according to initial and re-treatment stage, pathological pattern, type of combined chemotherapeutic protocols, tumor stage and surgery. Results: The overall response rate (ORR) and disease control rate (DCR) in the NDP group were 48.6% and 95.2%, significantly higher than in the DDP group at 35.1% and 89.2%, respectively (P<0.01). In NSCLC patients with initial treatment, squamous carcinoma and phase III, there were significant differences in ORR and DCR between the groups (P<0.05), while ORR was significant in patients with adenocarcinoma, GP/TP and in phase IIIa (P<0.05). There was also a significant difference in DCR in patients in phase IIIb (P<0.05). According to the statistical analysis of survival time of all patients and of those in clinical phase III, the NDP group survived significantly longer than the DDP group (P<0.01). The rates of decreased hemoglobin and increased creatinine, nausea and vomiting in the NDP group were evidently lower than in DDP group (P<0.05). Conclusion: NDP concomitant with other chemotherapy is effective for treating NSCLC, with higher clinical efficacy than DDP concomitant with chemotherapy, with advantages in prolonging survival time and reducing toxic and adverse responses.

Local ablative radiotherapy for oligometastatic non-small cell lung cancer

  • Suh, Yang-Gun;Cho, Jaeho
    • Radiation Oncology Journal
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    • v.37 no.3
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    • pp.149-155
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    • 2019
  • In metastatic non-small cell lung cancer (NSCLC), the role of radiotherapy (RT) has been limited to palliation to alleviate the symptoms. However, with the development of advanced RT techniques, recent advances in immuno-oncology therapy targeting programmed death 1 (PD-1) and programmed death ligand 1 (PD-L1) and targeted agents for epidermal growth factor receptor (EGFR) mutation or anaplastic lymphoma kinase (ALK) translocation allowed new roles of RT in these patients. Within this metastatic population, there is a subset of patients with a limited number of sites of metastatic disease, termed as oligometastasis that can achieve long-term survival from aggressive local management. There is no consensus on the definition of oligometastasis; however, most clinical trials define oligometastasis as having 3 to 5 metastatic lesions. Recent phase II randomized clinical trials have shown that ablative RT, including stereotactic ablative body radiotherapy (SABR) and hypofractionated RT, to primary and metastatic sites improved progression-free survival (PFS) and overall survival (OS) in patients with oligometastatic NSCLC. The PEMBRO-RT study, a randomized phase II study comparing SABR prior to pembrolizumab therapy and pembrolizumab therapy alone, revealed that the addition of SABR improved the overall response, PFS, and OS in patients with advanced NSCLC. The efficacy of RT in oligometastatic lung cancer has only been studied in phase II studies; therefore, large-scale phase III studies are needed to confirm the benefit of local ablative RT in patients with oligometastatic NSCLC. Local intensified RT to primary and metastatic lesions is expected to become an important treatment paradigm in the near future in patients with metastatic lung cancer.

Impact of GNB3, ADRB3, UCP2, and PPAR${\gamma}$-Pro12Ala polymorphisms on Boiogito response in obese subjects : A randomized, double-blind, placebo-controlled trial (방기황기탕의 유전자 다형성에 따른 비만 치료 효과 : 무작위 배정, 이중 맹검, 위약-대조군 임상시험)

  • Park, Jung-Hyun;Bose, Shambhunath;Lim, Chi-Yeon;Kim, Ho-Jun
    • Journal of Korean Medicine for Obesity Research
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    • v.12 no.2
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    • pp.28-43
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    • 2012
  • Objectives: The aim of the study was to investigate the efficacy of Boiogito for obesity. We examined the efficacy of Boiogito for obese patients and we expected the reaction of Boiogito would vary according to the single nucleotide polymorphism(SNPs). Methods: 111 subjects(body mass index${\geq}25m/kg^2$) were recruited and randomized to receive Boiogito(n=55) or Placebo(n=56) for 8weeks. Anthropometric factors, serum lipid profile, glucose, blood pressure(BP), pulse rate, resting metabolic rate and Korean version of obesity-related quality of life(KOQOL) scale measured at baseline and 8weeks. SNPs(${\beta}3$-adrenergic receptor(ADRB3), G protein ${\beta}3$(GNB3), peroxisome proliferator activated receptor gamma 2 gene(PPAR-${\gamma}2$), uncoupling protein(UCP2)) were conducted at baseline. Adverse reactions and safety outcome variables were also checked during trials. Results: Both groups showed significant improvement on obesity after treatment. Boiogito group decreased triglyceride than did control group and improved KOQOL. Boiogito showed a significant higher efficacy in C/T and T/T genotype of GNB3 gene / in Trp64 and Arg64 genotype of ADRB3 gene / in D/D genotype of UCP2 gene / in Pro/Pro genotype of PPAR-${\gamma}$ gene. Conclusions: Boiogito promoted obesity indexes without severe adverse reactions and proved its safety. Pharmacogenetical studies of Boiogito on obesity could be a effective method for the individualized treatment and prevention of obesity.

Does transcutaneous electrical nerve stimulation affect pain, neuropathic pain, and sympathetic skin responses in the treatment of chronic low back pain? A randomized, placebo-controlled study

  • Yaksi, Elif;Ketenci, Aysegul;Baslo, Mehmet Baris;Orhan, Elif Kocasoy
    • The Korean Journal of Pain
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    • v.34 no.2
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    • pp.217-228
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    • 2021
  • Background: The purpose of this study was to assess the effectiveness of transcutaneous electrical nerve stimulation (TENS) in chronic low back pain and neuropathic pain. Methods: Seventy-four patients aged 18-65 with chronic low back pain were included in the study. Baseline measurements were performed, and patients were randomized into three groups. The first group received burst TENS (bTENS), the second group conventional TENS (cTENS), and the third group placebo TENS (pTENS), all over 15 sessions. Patients' visual analogue scale (VAS) scores were evaluated before treatment (preT), immediately after treatment (postT), and in the third month after treatment (postT3). Douleur Neuropathique 4 Questions (DN4), the Modified Oswestry Low Back Pain Disability Questionnaire (MOS), the Beck Depression Inventory (BDI), and sympathetic skin response (SSR) values were also evaluated preT and postT3. Results: A statistically significant improvement was observed in mean VAS scores postT compared to preT in all three groups. Intergroup comparison revealed a significant difference between preT and postT values, that difference being assessed in favor of bTENS at multiple comparison analysis. Although significant improvement was determined in neuropathic pain DN4 scores measured at postT3 compared to preT in all groups, there was no significant difference between the groups. No statistically significant difference was also observed between the groups in terms of MOS, BDI, or SSR values at postT3 (P > 0.05). Conclusions: bTENS therapy in patients with low back pain is an effective and safe method that can be employed in short-term pain control.

Review of Clinical Studies for Herbal Medicine Treatment on Acute Leukemia - Focusing on Studies from the China Academic Journal (CAJ) - (중의학 데이터베이스 (CAJ)를 이용한 급성백혈병의 한약치료에 대한 임상 연구 동향)

  • Kim, Jeong Eun;Jang, Jin Woo;Park, Beom Chan;Kim, Ki Bong;Cheon, Jin Hong
    • The Journal of Pediatrics of Korean Medicine
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    • v.35 no.1
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    • pp.48-62
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    • 2021
  • Objectives The purpose of this study is to obtain knowledge from clinical studies conducted in China to examine the effectiveness of herb medicine in childhood acute leukemia. Methods We searched the randomized controlled trials (RCTs) with herbal medicine treatment on childhood acute leukemia from the 'CAJ', Chinese Academic Journal from China National Knowledge Infrastructure (CNKI). And then, demographic data, duration of illness, intervention, treatment period, outcome, adverse events, and composition of herbal medicine were analyzed for this study. Result 10 RCT studies were selected and analyzed. The control group were given western medicine therapy, the treatment group was given herbal medicine on the basis of the control group. The most commonly used herbal medicine were 淸熱解毒藥, 補氣藥, 補陰藥, 活血祛瘀藥 in 'boosting vital force and driving out evil spirit (扶正祛邪)' way to 'relieve heat (熱毒)' and 'assist the vital force (正氣)'. In the treatment group, complete remission was significantly higher than control group and the decrease in TCM syndrome scores also showed significant effects. Adverse events were significantly lower in the treatment group. Conclusions Herbal medicine treatment on childhood acute leukemia can be suggested as a new treatment for children who have less response to the conventional therapy, and can supplement the limitations of the western medicine by increasing complete remission and reducing adverse events.

Chuna Manual Therapy on Gynecologic Disease: A Systematic Review and Meta-analysis (부인과 질환에 대한 추나 요법: 체계적 문헌 고찰 및 메타분석)

  • Yeon-Woo Lee;Jae-Uk Sul;Jin-Hyun Lee;Dong-Chan Jo;Yun-Kyung Song;Man-Suk Hwang
    • The Journal of Churna Manual Medicine for Spine and Nerves
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    • v.17 no.2
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    • pp.27-37
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    • 2022
  • Objectives This study aimed to investigate the clinical trial trends of Chuna manual therapy (CMT) on gynecologic disease and suggest the effectiveness and safety evidence for further study. Methods We searched nine electronic databases (CENTRAL, CiNii, CNKI, EMBASE, KMbase, KISS, MEDLINE PubMed, NDSL, and OASIS) using the search terms "Chuna" and "Tuina" and identified relevant literature that investigated the CMT as an intervention for gynecologic disease. All relevant papers were extracted and selected to be analyzed. Results Among the 1456 studies that were searched and screened, 18 randomized controlled trials (RCTs) satisfied the designated criteria. A meta-analysis showed that CMT had a curative effect on patients with primary dysmenorrhea, postpartum hypogalactia, breast hyperplasia, postpartum urinary retention, and pelvic pain. Conclusions Based on this study, CMT should be comprehensively considered for gynecologic disease. The treatment response was significantly enhanced after treatment; however, there were some limitations in the study. More well-designed RCTs are needed to ensure that all gynecologic patients have a safe and effective therapy.

erratum : The effectiveness and safety of cupping therapy for stroke survivors: A systematic review and meta-analysis of randomized controlled trials

  • Mikyung Kim;Chang-ho Han
    • The Journal of Korean Medicine
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    • v.44 no.2
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    • pp.201-201
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    • 2023
  • Objectives: Cupping therapy (CT) has been widely used in traditional medicine worldwide for various indications, including stroke. The aim of this study was to systematically review the clinical evidence of CT for stroke. Methods: To identify randomized controlled trials (RCTs) reporting the effectiveness and/or safety of CT, seven databases including PubMed, EMBASE, and Cochrane Library were searched for articles published from January 2000 to February 2021 without language restrictions. Meta-analysis was performed using Review Manager 5.4 software and the results were presented as mean difference (MD) or standard mean difference (SMD) for continuous variables and odds ratio (OR) for diverse variables with 95% confidence intervals (CIs). Assessment of the methodological quality of the eligible trials was conducted using the Cochrane Collaboration tool for risk of bias in RCTs. Results: Twenty-two RCTs with 1653 participants were included in the final analysis. CT provided additional benefit in improving upper limb motor function (Fugl-Meyer assessment for upper limb motor function, MD 6.91, 95% CI 4.64 to 1.67, P<0.00001) and spasticity (response rate, OR 3.28, 95% CI 1.31 to 8.22, P=0.08) in stroke survivors receiving conventional medical treatment. These findings were supported with a moderate level of evidence. CT did not significantly increase the occurrence of adverse events. Conclusions: This study demonstrated the potential of CT to be beneficial in managing a variety of complications in stroke survivors. However, to compensate for the shortcomings of the existing evidence, rigorously designed large-scale RCTs are warranted in the future.

Anti-hypertensive Effects of Artichoke Supplementation in Adults: A Systematic Review and Dose-response Meta-analysis of Randomized Controlled Trials

  • Mohammad Reza Amini;Fatemeh Sheikhhossein;Mohsen Alvani;Seyyed Morteza Seyyed Shoura;Asma Sohrabnavi;Ehsan Heidarian;Azita Hekmatdoost
    • Clinical Nutrition Research
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    • v.11 no.3
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    • pp.214-227
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    • 2022
  • Despite controversies, no earlier study has systematically summarized findings from earlier studies on the effect of artichoke supplementation on blood pressure. Therefore, current systematic review and meta-analysis was done on the effect of artichoke supplementation on systolic blood pressure (SBP) and diastolic blood pressure (DBP) in adults. Five databases were searched from inception to January 2022 using relevant keywords. All randomized clinical trials investigating the impact of oral artichoke supplementation on any of the blood pressure parameters including SBP or/and DBP were included. Out of 1,507 citations, 7 trials that enrolled 472 subjects were included. Artichoke supplementation resulted in significant reduction in SBP (weighted mean difference [WMD], -2.01 mmHg; 95% confidence interval [CI], -3.78, -0.24; p = 0.026) and DBP (WMD, -1.45 mmHg; 95% CI, -2.81, -0.08; p = 0.038). Greater effects on SBP were detected in trials using ≤ 500 mg artichoke, lasted > 8 weeks, participants aged < 50 years' old and sample size ≤ 70. There was also a similar impact of artichoke on DBP. However, significant non-linear associations were found between artichoke supplementation dosage and study duration with both SBP (for dosage: pnon-linearity = 0.002, for duration: pnon-linearity = 0.016) and DBP (for dosage: pnon-linearity = 0.005, for duration: pnon-linearity = 0.003). We found a significant reduction in both SBP and DBP following artichoke supplementation in adults. It could be proposed as a hypotensive supplement in hypertension management.