针刺治疗妊娠早期恶心呕吐试验中的安慰剂反应及时间效应。
The placebo response and effect of time in a trial of acupuncture to treat nausea and vomiting in early pregnancy.
作者信息
Smith C, Crowther C
机构信息
Department of Obstetrics and Gynaecology, The University of Adelaide, Adelaide, SA, Australia.
出版信息
Complement Ther Med. 2002 Dec;10(4):210-6. doi: 10.1016/s0965-2299(02)00072-9.
OBJECTIVES
The sham control is widely used in acupuncture research, and its adequacy may be assessed by exploring the 'credibility' of the intervention. We aimed to examine the credibility of the study intervention, to quantify the size of the placebo response and effect of time in reducing nausea in early pregnancy.
DESIGN
Five hundred and ninety-three women with nausea or vomiting in early pregnancy volunteered to participate in a randomised controlled trial, conducted at the Women's and Children's Hospital, South Australia.
OUTCOME MEASURES
Women completed the Rhodes Index of Nausea and Vomiting and the Credibility Rating Scale.
RESULTS
The credibility of the acupuncture and sham acupuncture interventions were not different. The relative change in nausea at the end of the first week of the study was estimated to be 28% attributed to a time effect and 7% to the placebo response. At the end of the third week, there was a further small increase in time effect (32%) and the placebo response (17%).
CONCLUSION
Sham acupuncture is a credible control and allows assessment of the size of the placebo response.
目的
假针刺对照在针灸研究中广泛应用，可通过探究干预措施的“可信度”来评估其适用性。我们旨在检验研究干预措施的可信度，量化安慰剂效应的大小以及时间对减轻早孕恶心的影响。
设计
593名早孕恶心或呕吐的女性自愿参与在南澳大利亚妇女儿童医院进行的一项随机对照试验。
观察指标
女性完成恶心呕吐罗德指数和可信度评定量表。
结果
针刺与假针刺干预措施的可信度并无差异。研究第一周结束时，恶心的相对变化估计有28%归因于时间效应，7%归因于安慰剂效应。第三周结束时，时间效应（32%）和安慰剂效应（17%）进一步小幅增加。
结论
假针刺是一种可信的对照，可用于评估安慰剂效应的大小。
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