• Title/Summary/Keyword: randomized clinical

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Is Axillary Dissection Necessary for Breast Cancer in Old Women? A Meta-analysis of Randomized Clinical Trials

  • Zhang, Pei-Zhen;Chong, Le;Zhao, Ye;Gu, Jing;Tian, Jin-Hui;Yang, Ke-Hu
    • Asian Pacific Journal of Cancer Prevention
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    • v.14 no.2
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    • pp.947-950
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    • 2013
  • Background: We performed this meta-analysis to assess the effectiveness and safety of axillary dissection in old women. Methods: The Cochrane Library, PubMed, EMBASE and Chinese Biomedical Literature Database were searched and all randomized controlled trials of axillary dissection in old women (at least 60 years old) were considered. Meta-analyses were completed using RevMan5.1. Results: Three eligible randomized controlled trials (RCTs) including 5,337 patients were considered. There was weak evidence in favour of axillary dissection (AD) in old women. The meta-analysis showed that the overall survival (OS) after 1, 3, 5 and 7 years and the disease free survival (DFS) after 1, 3 and 5 year were not statistically significantly different between AD and no AD groups. However, there was a difference in the 7 year DFS. Conclusions: Axillary dissection did not provide survival benefit to the old women with breast cancer analysed. Therefore, axillary dissection is not well-indicated in old women with breast cancer.

Current Research Trends of Traditional Herbal Medicine for Alcohol Use Disorder (알코올 사용장애의 한약치료 연구동향)

  • So-Hyeon Park;Jun-Hee Cho;Bo-kyung Kim;Jung-Hwa Lim
    • Journal of Oriental Neuropsychiatry
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    • v.34 no.4
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    • pp.385-401
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    • 2023
  • Objectives: To review clinical research trends of herbal medicine treatment for alcohol use disorder. Methods: Three domestic databases and eight foreign databases were used to search for published articles by November 1, 2023 in each database. A total of 9 studies were included. Results: There were eight randomized control studies and one non-randomized control study. All randomized control studies were designed with 2-arm paralleled. The non-randomized control study was designed with 2-arm crossover. The most commonly used prescriptions were Kudzu extract capsules and Seoganhaeul capsules. The most used herbs were Puerariae Radix, Hyperici Perforati Herba, and Acanthopanacis Senticosi Radix et Rhizoma seu Caulis. Conclusions: Traditional herbal medicine might be effective in alleviating drinking behavior, physical problems, and psychological problems of patients with alcohol use disorder. However, the limited number of included studies suggests that further methodologically rigorous research studies on herbal medicine treatment for alcohol use disorder are needed in the future.

Venlafaxine for Management of Hot Flashes: A Review of Randomized Controlled Trials in Human (Venlafaxine의 안면홍조 증상개선효과에 대한 최근 연구 고찰)

  • Lee, Yu-Jeung
    • Korean Journal of Clinical Pharmacy
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    • v.20 no.2
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    • pp.138-144
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    • 2010
  • The results from eight randomized controlled studies demonstrate that venlafaxine is effective in the treatment of hot flashes with tolerable adverse effects. Based on the results of the above studies, venlafaxine can be recommended for the treatment of hot flashes. However, there are limitations in the above studies. The inclusion criteria of 5 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 5 studies had less than 100 subjects included, and 18-week study was the longest one among studies reviewed in this paper. Therefore, large and long-term clinical studies with the general population should be conducted to use venlafaxine for the treatment of hot flashes in clinical practice.

Acupuncture Treatment of Adhesive Capsulitis of the Shoulder: A Randomized Controlled Pilot Trial

  • Kim, Jung-Eun;Kim, Sung-Phil;Kim, Ae-Ran;Park, Hyo-Ju;Kwon, Ojin;Jung, So-Young;Cho, Jung-Hyo;Kim, Joo-Hee;Choi, Sun-Mi
    • Journal of Acupuncture Research
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    • v.35 no.3
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    • pp.120-128
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    • 2018
  • Background: Adhesive capsulitis (AC) is a common condition that includes shoulder pain and limited movement. Despite more than 100 years of AC treatment, the most efficacious treatment remains unclear. The aim of this study was to evaluate the feasibility of a randomized controlled trial (RCT) using acupuncture for AC. Methods: Thirty participants with AC were randomly assigned to acupuncture (A) or sham acupuncture (SA) groups. The participants received 15 acupuncture sessions over 6 weeks, and follow-up occurred for an additional 4 weeks thereafter. The primary clinical outcome was the numeric rating scale (NRS) for shoulder pain 6 weeks from the baseline. Secondary outcomes included range of motion (ROM) in the shoulder, the shoulder pain and disability index (SPADI), the EuroQol-5 dimensions (EQ-5D), the Pittsburgh sleep quality index (PSQI), and the patient global impression of change (PGIC). Results: Thirty participants were enrolled out of 37 screened individuals. Recruitment was conducted between August 2014 until May 2015. A total of 28 participants (93%) completed the 6-week intervention, and 26 participants (87%) completed the study. NRS, ROM, SPADI, EQ-5D, PSQI, and PGIC scores improved in both the experimental group and the sham group after 6 weeks, but the difference between the groups was not statistically significant. Adverse events were reported by 12 participants, although these events were not associated with acupuncture. Conclusion: A future RCT for AC may be feasible with some modifications to the recruitment plan and the secondary outcome measurement methods.

Metformin Addition to Chemotherapy in Stage IV Non-Small Cell Lung Cancer: an Open Label Randomized Controlled Study

  • Sayed, Rana;Saad, Amr S;El Wakeel, Lamia;Elkholy, Engi;Badary, Osama
    • Asian Pacific Journal of Cancer Prevention
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    • v.16 no.15
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    • pp.6621-6626
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    • 2015
  • Purpose: To evaluate effects of metformin on clinical outcome of non-diabetic patients with stage IV NSCLC. Materials and Methods: A prospective, randomized, open-label, controlled pilot study was conducted on patients with stage IV NSCLC with an Eastern Cooperative Oncology Group Performance Status (ECOG PS) of 0-2, excluding patients with diabetes and lactic acidosis. Thirty chemo-$na\ddot{i}ve$, non-diabetic patients with stage IV NSCLC were enrolled. Fifteen patients received intravenous gemcitabine/cisplatin regimen alone (arm B) while fifteen patients received the same regimen plus daily oral metformin 500mg (arm A). The effect of metformin on chemotherapy-response rates, survival, and adverse events in these patients was evaluated. Results: Objective response rate (ORR) and median overall survival (OS) in arms A and B were 46.7% versus 13.3% respectively, p=0.109 and 12 months versus 6.5 months, respectively, p=0.119. Median progression free survival (PFS) in arms A and B was 5.5 months versus 5 months, p=0.062. No significant increase in toxicity was observed in arm A versus arm B. Percentage of patients who experienced nausea was significantly lower in arm A versus arm B, at 26.7% versus 66.7% respectively, p=0.028. Conclusions: Metformin administration reduced occurrence of chemotherapy induced-nausea. Non-statistically significant improvements in the ORR or OS were observed. Metformin had no effect on PFS.

Review of Clinical Researches for Herbal Medicine Treatment on Nocturnal Enuresis in Children (소아 야뇨의 한약치료에 대한 임상연구 동향 -중의학 논문을 중심으로-)

  • Shin, Hye Jin;Lee, Boram;Lee, Jihong;Chang, Gyu Tae
    • The Journal of Pediatrics of Korean Medicine
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    • v.32 no.2
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    • pp.43-63
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    • 2018
  • Objectives The purpose of this study is to evaluate the efficacy and safety of herbal medication for the treatment of nocturnal enuresis in children by analyzing randomized controlled trials conducted in China. Methods We searched literatures from China National Knowledge Infrastructure published up to 19 January, 2018. Selected literatures were collected and analyzed in order of publication year, and then demographic information, treatment method, duration of illness, duration of treatment, follow-up period, outcome measurement and adverse events. Results A total of 34 studies were selected for the analysis. In most studies, the total efficacy of the treatment group was reported to be higher than that of the control group, and the recurrence rate and complete cure rate were also found to be more effective in the herbal medicine treatment group. The most frequently used medical herb was Alpiniae Fructus (益智仁), and the use of medical herbs belong to tonifying yang (補陽藥), tonifying qi (補氣藥), and astringing essence strengthening collapse medicine (澁精縮尿止帶藥) were relatively high. The adverse events rate for the herbal medicine treatment group were significantly lower than those in the Western medicine treatment group. Conclusions This study showed that a herbal medicine treatment can be effective and safe option for treating pediatric nocturnal enuresis. However, additional well-designed clinical studies need to be performed to establish a basis.

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.

Clinical and microbiological effects of egg yolk antibody against Porphyromonas gingivalis as an adjunct in the treatment of moderate to severe chronic periodontitis: a randomized placebo-controlled clinical trial

  • Xu, Yan;Selerio-Poely, Tshepiso;Ye, Xingru
    • Journal of Periodontal and Implant Science
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    • v.48 no.1
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    • pp.47-59
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    • 2018
  • Purpose: To evaluate the clinical and microbiological effects of the local use of egg yolk immunoglobulin against Porphyromonas gingivalis (anti-P.g. IgY) as an adjunct to scaling and root planing (SRP) in the treatment of moderate to severe chronic periodontitis. Methods: This was a randomized, placebo-controlled, double-blind trial involving 60 systematically healthy patients with moderate to severe chronic periodontitis. Subjects (n=20/group) were randomly assigned to receive SRP combined with subgingival irrigation of anti-P.g. IgY and anti-P.g. IgY mouthwash, subgingival irrigation of 0.2% chlorhexidine and 0.2% chlorhexidine mouthwash, or subgingival irrigation of placebo and placebo mouthwash for 4 weeks. Probing pocket depth, clinical attachment level, bleeding on probing, and the plaque index were evaluated at baseline and at 4 weeks. Subgingival plaque, gingival crevicular fluid, and saliva were simultaneously collected for microbiological analysis. Results: Our results showed that anti-P.g. IgY mouthwash was as effective as chlorhexidine at improving clinical parameters over a 4-week period. All the groups showed a significant reduction in levels of P.g. at 4 weeks. No significant difference was observed in the test group when compared to placebo regarding the reduction in the levels of P.g. Anti-P.g. IgY significantly suppressed the numbers of red complex bacteria (RCB) in subgingival plaque and saliva in comparison with placebo. No adverse effects were reported in any of the subjects. Conclusions: Within the limitations of the study, the present investigation showed that passive immunization with anti-P.g. IgY may prove to be effective in the treatment of chronic periodontitis due to its ability to improve clinical parameters and to reduce RCB. No significant differences were found between the anti-P.g. IgY and placebo groups in the reduction of P.g.

Non-Randomized Confirmatory Trial of Laparoscopy-Assisted Total Gastrectomy and Proximal Gastrectomy with Nodal Dissection for Clinical Stage I Gastric Cancer: Japan Clinical Oncology Group Study JCOG1401

  • Kataoka, Kozo;Katai, Hitoshi;Mizusawa, Junki;Katayama, Hiroshi;Nakamura, Kenichi;Morita, Shinji;Yoshikawa, Takaki;Ito, Seiji;Kinoshita, Takahiro;Fukagawa, Takeo;Sasako, Mitsuru
    • Journal of Gastric Cancer
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    • v.16 no.2
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    • pp.93-97
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    • 2016
  • Several prospective studies on laparoscopy-assisted distal gastrectomy for early gastric cancer have been initiated, but no prospective study evaluating laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy has been completed to date. A non-randomized confirmatory trial was commenced in April 2015 to evaluate the safety of laparoscopy-assisted total gastrectomy and laparoscopy-assisted proximal gastrectomy for clinical stage I gastric cancer. A total of 245 patients will be accrued from 42 Japanese institutions over 3 years. The primary endpoint is the proportion of patients with anastomotic leakage. The secondary endpoints are overall survival, relapse-free survival, proportion of patients with completed laparoscopy-assisted total gastrectomy or laparoscopy-assisted proximal gastrectomy, proportion of patients with conversion to open surgery, adverse events, and short-term clinical outcomes. The UMIN Clinical Trials Registry number is UMIN000017155.

A Literature Review of Clinical Trials on Alternative Medicine (대체의학 임상실험 현황에 대한 문헌고찰)

  • Cho, Hyun;Yoo, Jin-Yeong;Park, Soo-Hee
    • Journal of the Korea Academia-Industrial cooperation Society
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    • v.11 no.11
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    • pp.4395-4403
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    • 2010
  • The aim of this study is to know about condition of alternative medicine. Methods which An literature search in Pubmed January 2000 to March, 2010 was performed. RCT(Randomized Controlled Trial), CCT(Controled Clinical Trials), and OD(efficacy studies with either a controlled or an Other than controlled Design) were included. PubMed databases were searched using key terms relating to alternative medicine. 19 clinical trials were included among 682 studies searched. RCT was 44%, CCT was 16% and OD was 40% in the review. In the all of included studies, the acupuncture and the massage was the biggest part. The using rate was 20% of pain control about Disease of the Musculoskeletal system and Connective tissue, 15% of Certain infectious and parasitic diseases, and 15% of Neoplasms. There was lack of evidence that alternative medicine was effective for progress. Future well-designed clinical trials is needed.