발표논문

제목 [항암요법 말초신경병증] 항암요법으로 인한 말초신경병증에 대한 전침의 효과 : 환자-평가자 눈가림, 다기관 무작위배정 대조군 예비 임상시험 프로토콜
항암요법으로 인한 말초신경병증에 대한 전침의 효과 : 환자-평가자 눈가림, 다기관 무작위배정 대조군 예비 임상시험 프로토콜
Electroacupuncture for chemotherapy-induced peripheral neuropathy: study protocol for a pilot multicentre randomized, patient-assessor-blinded, controlled trial
저자 강동경희대병원 의료진 : 서병관(공동)
타기관 의료진 : 최선미, 김주희, 김은정, 이상훈, 이승훈, 정소영, 이민희, 김애란, 박효주, 신미숙
저널명 TRIALS
게재일 2013.08
논문소개 Background : Chemotherapy-induced peripheral neuropathy (CIPN) is the main dose-limiting side effect of neurotoxic chemotherapeutic agents. CIPN can lead not only to loss of physical function, difficulties in activities of daily living (ADLs), and decreased quality of life, but also to dose reduction, delay or even cessation of treatment. Currently, there are few proven effective treatments for CIPN. This randomized controlled clinical trial is designed to evaluate the effects and safety of electroacupuncture (EA) for patients with CIPN.

Methods/design : This is a multicenter, two-armed, parallel-design, patient-assessor-blinded, randomized, sham-controlled clinical trial. Forty eligible patients with CIPN will be randomized in a ratio of 1:1 to the EA or sham EA arms. During the treatment phase, patients will undergo eight sessions of verum EA or sham EA twice weekly for four weeks, and then will be followed-up for eight weeks. Electrical stimulation in the EA group will consist of a mixed frequency of 2/120 Hz and 80% of bearable intensity. Sham EA will be applied to non-acupoints, with shallow needle insertion and no current. All outcomes and analyses of results will be assessed by researchers blinded to treatment allocation. The effects of EA on CIPN will be evaluated according to both subjective and objective outcome measures. The primary outcome measure will be the European Organization for Research and Treatment of Cancer (EORTC) quality of life questionnaire to assess CIPN (QLQ-CIPN20). The secondary outcome measures will be the results on the numerical rating scale, the Semmes-Weinstein monofilament test, the nerve conduction study, and the EORTC QLQ-C30, as well as the patient's global impression of change and adverse events. Safety will be assessed at each visit.

Discussion : The results of this on-going study will provide clinical evidence for the effects and safety of EA for CIPN compared with sham EA.

페이지 URL http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3751258/

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