Abstract B22: Effectivness of a family-focused intervention to treat persistent fatigue in breast cancer surivivors: A pilot randomized trial
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Abstract B22 Background Thirty to forty percent of breast cancer survivors suffer from persistent fatigue lingering months to years after adjuvant therapy is completed. This persistent fatigue affects family dynamics feeding a continuing cycle of additional stress and resultant fatigue. We developed a mind-body medicine group intervention and demonstrated a forty percent reduction in fatigue with benefits persisting six months post intervention. A pilot randomized trial was conducted to test if combining the mind-body medicine group intervention with a family-focused intervention is more effective in reducing fatigue for breast cancer survivors than the group intervention only. For the family intervention, family members attended two of the eight weekly sessions and had two family-based counseling sessions with the clinical research therapist. Methodology Subjects who were at least three months post-completion of adjuvant chemotherapy and/or radiation therapy for breast cancer with a baseline fatigue score of <50 as measured by the vitality subscale of the SF-36 Health Survey were randomized to either the group mind-body medicine program or the group program with the integrated family intervention. Thirty-six women entered the pilot study but three dropped out after attending less than two of the eight weekly sessions and were not able to be evaluated. The primary outcome assessed was change in severity of fatigue as measured by the Piper Fatigue Scale. Results Seventeen women were randomized to the family intervention and nineteen to the comparison group intervention. There was no statistically significant difference between the groups by age, martial status or years of education. Those randomized to the family group were on average 4.8 years from the diagnosis of breast cancer compared to 2.8 for the comparison group intervention. Participants in both groups had a statistically significant improvement in fatigue scores at end-of-program with further improvement at two-month follow-up compared to baseline. Mean fatigue scores for the family intervention arm: (baseline-5.7; end -of-program-3.1; two-month-1.4; p<0.001). Fatigue scores for comparison group (baseline-6.5; end-of-program-3.4; two-month-2.7; p<0.001). Comparing the two intervention arms, there were no statistically significant differences at end-of-program (p=0.71) or at two-month follow-up (p=0.14). Recruitment for the trial was challenging, primarily due to the time commitment required from both the survivors and family members. Conclusions A holistic mind-body medicine intervention significantly improved fatigue but augmenting the program with an additional family component did not result in significant incremental improvement in fatigue. Qualitative data from interviews with participants noted that both family members and survivors found benefit in shared learning about fatigue and effective interventions and in discussing their feelings and concerns during counseling sessions. Although this pilot study had limited power to detect a difference between the two arms, the challenges in recruitment for the study suggest that future interventions require a more efficient method to incorporate family members into the program. Citation Information: Cancer Prev Res 2008;1(7 Suppl):B22.Keywords:
Cancer-related fatigue
Objective To evaluate the therapeutic effects of one visit root canal therapy(RCT) and several visit RCT for cracked teeth.Methods Cracked teeth with pulposis or apical disease were randomized to receive one visit RCTor several visit RCT,their responses were compared.Results The long-term therapeutic effects of one visit RCT were batter than those of several visit RCT,but the differences were not significant.The concomitant symptoms were significantly less and treatment time was significantly shorter in one visit RCT group as compared with several visit RCT group.Conclusion One visit RCT is recommended for the RCT of cracked teeth.
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Cancer-related fatigue
Muscle Fatigue
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Objective:In order to clarify the actual situations of the randomized control trial(RCT)or quasi-randomized trial(QRT)and prospective clinical experimental researches in the journals of opthalmology,the related materials from 7 major journals of opthalmology from the start publication up to the year of 1999 were hand searched.Method:We handsearching These journals hand searched. and according to the criteria of RCT and QCT were included according to Cochrane Center handsearch standards.Results:Seven Ophthalmologic Journals had 21317 papers,the RCT and QCT 280 papers were included,about 1.31%,A tolal of 7428 papers were in 179 issues of China Ophthalmologic Journal,62 papers could be included,about 0.84%.The RCT and QCT in the year of 60s are rare,after 1970,RCT and CCT increased year by year.Conclusion:As the Evidence-Based Medicine becoming gradually accepted of in clinical ophthalmology,the RCT and CCT would likely to be increased year by year in ophthalmologic journals.
Cochrane collaboration
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Objective To evaluate the clinical responses and effects after one visit RCT and several visits RCT. Meth-ods Cracked teeth with endodontitis or periapical disease were randomized into 2 groups according to they were treated by one visit RCT or several visits RCT,and their clinical responses and effects. Results The long-term effects of one visit RCT was better than that of several visits RCT. But There was no statistical differences between two groups. The clinical responses and treating time were reduced dramatically after one visit RCT was used. Conclusion One visit RCT is recom-mended for the cracked teeth RCT.
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The chapter discusses the randomized clinical trial (RCT) with noncompliance, in which only patients assigned to an experimental treatment group can have access to the experimental treatment, the simple noncompliance RCT. For certain treatments, such as flu vaccine or quitting smoking, it is not ethical to randomly assign high-risk patients to receive either the treatment or the placebo. Thus, to alleviate the ethical concern in application of the traditional RCT, the randomized encouragement design (RED) is often suggested. Based on whether noncompliance can occur in only one or both of the two randomized groups, the randomized consent designs can be classified as a single-consent randomized design (SCRD) and a double-consent randomized design (DCRD). Controlled Vocabulary Terms randomized controlled trial
Completely randomized design
Research Design
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为试用(一致) 陈述报导的巩固的标准已经证明了是为报导使随机化的控制试用(RCT ) 的质量的一个有效标准的目的。然而，大多数中国医药杂志没资助 CONSORT 陈述。关于在中国医药杂志的 RCT 的报导质量的当前的状况仍然是不清楚的。学习的目的是在在 5 本领先的中国医药杂志出版的报纸上评估 RCT 的报导质量。没有一致和在 2004 采用了一致的基于证据的药(杂志类型 2 ) 的中国杂志的采纳，我们用报导质量评估了 232 份原来的 RCT 报纸的方法在 5 本中国医药杂志(杂志类型 1 ) 从 2001 ～ 2006 基于一致陈述可伸缩。我们为报导优秀规模和每份 RCT 报告的 6 个核心项目测量了 26 个项目的包括，把 20 给了每个项目并且计算了在每份报告和包括单个项目的报告的比例获得的全部的分数。从 2001 ～ 2003 的 RCT 试用(采纳前时期) 的报导质量从 2004 ～ 2006 与那相比(采纳以后的时期) 。结果 RCT 的平均报导质量是中等的(吝啬的分数， 15.18 ) ，并且 6 个核心项目的吝啬的分数是低的(吝啬的分数， 1.09 ) 在 5 本领先的杂志。在全部的分数和在采纳前时期(20012003 ) 和采纳以后的时期(20042006 ) 之间的 6 个核心项目的分数的差别是统计上重要的(P=0.003；P=0.000 ) 。在杂志类型和时期之间的相互作用不是重要的(F=0.76；P=0.383 ) 。我们断定报导在杂志类型 1 和 2 之间的质量的变化趋势不是不同的。但是至于顺序隐匿和 intention-to-treat 分析的核心项目，当与杂志类型 1 作比较时，增加为杂志类型 2 是更大的(P=0.038；P=0.016 ) 。在 5 本领先的中国医药杂志的 RCT 试用的报导质量正在改进的结论。然而，在 RCT 试用的重要项目的缺乏仍然是一个严重问题。我们为在中国在基于证据的药上在中国医药杂志和持续教育试用陈述报导推荐巩固的标准的赞助。
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Zen Nihon Shinkyu Gakkai zasshi (Journal of the Japan Society of Acupuncture and Moxibustion) (2010)
【はじめに】経穴や局所反応点とは異なる、 強力反応点に適した鍼刺激の有効性を明らかにすることを目的として、 ランダム化比較試験 (RCT：Randomized Controlled Trial) を実施した。 【方 法】対象は2007年11月から2008年10月に、 明治国際医療大学附属鍼灸センター来院患者で筆者が担当した142名とした。 強力反応点への鍼刺激の臨床的有効性を検証するため、 1期を3ヶ月間として下記の4期に分けRCTを実施した。 RCT1は非特異点群と強力反応点群1、 RCT2は経穴群と強力反応点群2、 RCT3は局所反応点群1と強力反応点群3、 RCT4は局所反応点群2と強力反応点群4として検討した。 【結 果】非特異点、 経穴、 局所反応点よりも強力反応点への鍼刺激の方が高い臨床的有効性を示した。 また適刺激であれば刺激の量や質に関係することなく、 同等な臨床的有効性を示したことから、 刺激の場所が重要であることが示された。 【考 察】病態に応じて一人ひとり発現する場所が異なる、 強力反応点への適刺激であれば、 刺激の量と質に関係することなく、 再現性を有する臨床的有効性を示したことは、 テーラーメイドの医療や鍼灸医学の理論的基盤である 「随機制宜」 にも適い、 意義深いと考える。 【結 論】RCTの結果より、 非特異点、 経穴、 局所反応点への鍼刺激よりも、 強力反応点への鍼刺激の方が高い臨床的有効性を示した。 また、 強力反応点への適刺激であれば、 刺激の量・質・時間に関係することなく、 同等な臨床的有効性を示した。
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Background. Very elderly subjects (VES; aged 80 years or older) constitute a special population as they frequently present multiple diseases (polypathology). Results from trials on general adult populations therefore cannot be extrapolated to VES. We performed a census of randomized controlled trials (RCT) on VES published between 1990 and 2002, and carried out a descriptive and methodological analysis of these RCT/VES, comparing them with matched RCT on general adult populations (control RCT, RCT/C).
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Evidence-Based Medicine
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