Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer.

Randomized sham-controlled pilot trial of weekly electro-acupuncture for the prevention of taxane-induced peripheral neuropathy in women with early stage breast cancer.
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DOI:
10.1007/s10549-016-3759-2
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发表时间:
2016-04
影响因子:
3.8
通讯作者:
Hershman DL
Hershman DL
中科院分区:
医学2区
文献类型:
--
作者:
Greenlee H;Crew KD;Capodice J;Awad D;Buono D;Shi Z;Jeffres A;Wyse S;Whitman W;Trivedi MS;Kalinsky K;Hershman DL

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目的探讨电针作为一种非药物干预方法对乳腺癌紫杉类化疗患者化疗诱发周围神经病变(CIPN)的预防或减轻作用。计划接受紫杉烷治疗的I-III期乳腺癌患者随机接受标准化方案,即每周12次真或假EA(SEA)治疗,同时接受紫杉烷治疗。受试者在基线和第6、12和16周完成简明疼痛量表-简表(BPI-SF)、癌症治疗功能评估-紫杉烷神经毒性子量表(FACT-NTX)和其他评估。共筛选了180例受试者,63例入组,48例完成第16周评估。平均年龄为50岁,其中25%为白色,25%为黑人,43%为西班牙裔; 52%既往未接受过化疗。第12周时,两组均报告平均BPI-SF最差疼痛评分增加,但未发现组间平均差异(SEA 2.8 vs. EA 2.6,p= 0.86)。到第16周,SEA组恢复到基线水平,而EA组继续恶化(SEA组平均值=1.7,EA组平均值= 3.40,p= 0.03)。第16周时,EA组BPI-SF最差疼痛评分的增加比SEA组高1.62分(p= 0.04)。在一项随机、假手术对照的EA预防紫杉烷诱导的CIPN的试验中,在第12周,两组之间的疼痛或神经病变没有差异。值得关注的是,EA受试者的恢复速度比SEA受试者慢。未来的研究应该集中在EA治疗,而不是预防CIPN。
To investigate the effect of electro-acupuncture (EA) as a non-pharmacological intervention to prevent or reduce chemotherapy-induced peripheral neuropathy (CIPN) in breast cancer patients undergoing chemotherapy of taxane. Women with stage I-III breast cancer scheduled to receive taxane therapy were randomized to receive a standardized protocol of 12 true or sham EA (SEA) weekly treatments concurrent with taxane treatment. Subjects completed the Brief Pain Inventory-Short Form (BPI-SF), Functional Assessment of Cancer Therapy-Taxane neurotoxicity subscale (FACT-NTX), and other assessments at baseline and weeks 6, 12, and 16. A total of 180 subjects were screened, 63 enrolled and 48 completed week 16 assessments. Mean age was 50 with 25% white, 25% black, and 43% Hispanic; 52% had no prior chemotherapy. At week 12, both groups reported an increase in mean BPI-SF worst pain score, but no mean differences were found between groups (SEA 2.8 vs. EA 2.6, p=.86). By week 16, the SEA group returned to baseline, while the EA group continued to worsen (mean=1.7 in SEA vs. 3.40 in EA, p=.03). The increase in BPI-SF worst pain score was 1.62 points higher in the EA group than in the SEA group at week 16 (p=.04). In a randomized, sham-controlled trial of EA for prevention of taxane-induced CIPN, there were no differences in pain or neuropathy between groups at week 12. Of concern, subjects on EA had a slower recovery than SEA subjects. Future studies should focus on EA for treatment as opposed to prevention of CIPN.