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内脏性整骨手法治疗可减少乳腺癌辅助化疗引起的患者报告的消化道毒性:一项随机对照临床研究。

Visceral osteopathic manipulative treatment reduces patient reported digestive toxicities induced by adjuvant chemotherapy in breast cancer: A randomized controlled clinical study.

机构信息

Medical Oncology Unit, Centre Georges-François Leclerc, Dijon, France.

Methodology and Biostatistics Unit, Centre Georges-François Leclerc, Dijon, France.

出版信息

Eur J Obstet Gynecol Reprod Biol. 2019 Oct;241:49-55. doi: 10.1016/j.ejogrb.2019.08.003. Epub 2019 Aug 12.

DOI:10.1016/j.ejogrb.2019.08.003
PMID:31430616
Abstract

OBJECTIVE

Breast cancer patients often benefit from adjuvant chemotherapy, a protocol whose effectiveness is accompanied by disabling adverse effects. The aim of this controlled clinical study was to determine the impact of visceral osteopathy on the incidence of nausea/vomiting, constipation and overall quality of life (QoL) in women operated for breast cancer and undergoing adjuvant chemotherapy in Centre Georges François Leclerc, CGFL.

STUDY DESIGN

Ninety-four women operated for a breast cancer stage 1-3, in complete resection and to whom a 3 FEC 100 chemotherapy was prescribed, were randomly allocated to experimental or placebo group. Experimental group underwent a visceral osteopathic technique and placebo group was subjected to a superficial manipulation after each chemotherapy cycle. Rate of grade ≥1 nausea/vomiting or constipation, on the first 3 cycles of FEC 100, were reported. QoL was evaluated using the EORTC QLQ-C30 questionnaire.

RESULTS

Rate of nausea/vomiting episodes of grade ≥1 was high in both experimental and placebo group. Constipation episodes of grade ≥1 were also frequent. No significant differences were found between the two groups concerning the rate of nausea/vomiting (p = 0.569) or constipation (p = 0.204) according to clinician reported side-effects but patient reported impact of constipation and diarrhoea on quality of life was significantly lower in experimental group (p = 0.036 and p = 0.038, respectively).

CONCLUSION

Osteopathy does not reduce the incidence of nausea/vomiting in women operated for breast cancer and undergoing adjuvant chemotherapy. In contrast, patient reported digestive quality of life was significantly ameliorated by osteopathy. Clinicaltrials.gov Identifier: NCT02840890.

摘要

目的

乳腺癌患者通常受益于辅助化疗,这种方案的有效性伴随着使人丧失能力的不良反应。本对照临床研究的目的是确定内脏 osteopathy 在接受辅助化疗的乳腺癌术后女性中的恶心/呕吐、便秘和总体生活质量(QoL)中的影响。

研究设计

94 名接受乳腺癌 1-3 期手术、完全切除且接受 3 FEC 100 化疗的女性被随机分配到实验组或安慰剂组。实验组接受内脏 osteopathy 技术,安慰剂组在每个化疗周期后接受浅表操作。报告了 FEC 100 的前 3 个周期中≥1 级恶心/呕吐或便秘的发生率。使用 EORTC QLQ-C30 问卷评估 QoL。

结果

实验组和安慰剂组的≥1 级恶心/呕吐发生率均较高。≥1 级便秘发生率也很高。根据临床医生报告的副作用,两组间恶心/呕吐(p=0.569)或便秘(p=0.204)的发生率无显著差异,但实验组患者报告的便秘和腹泻对生活质量的影响明显较低(p=0.036 和 p=0.038)。

结论

在接受辅助化疗的乳腺癌术后女性中,Osteopathy 并不能降低恶心/呕吐的发生率。相反,Osteopathy 显著改善了患者报告的消化 QoL。Clinicaltrials.gov 标识符:NCT02840890。

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