Authors' reply re: Safety of acupuncture during pregnancy: a retrospective cohort study in Korea

Hye-Yeon Moon, Me-riong Kim, Deok-Sang Hwang, Jun-Bock Jang, Jinho Lee, Joon-Shik Shin, I. Ha, Y. Lee
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Abstract

cohort study of its kind, and the authors concluded that acupuncture may be a safe therapeutic option for relieving discomfort in pregnancy. Although a study like this is much needed and provides essential information, we noticed several problems that should be addressed before any firm conclusion can be drawn. First, the authors reported that the incidences of preterm delivery were 8.45% and 6.93% in the acupuncture and control groups, respectively. Although comparison by chi-square test did not indicate significant differences, it should be noted that the P-value and lower confidence limit approached significance in both crude and adjusted analyses. Considering the retrospective nature of this study, a small number of errors during data collection could dramatically change the results, especially at the statistical margins. It would be advisable for the authors to add the absolute difference between groups with a 95% confidence interval. Second, the authors stated that women who received acupuncture therapy were frequently diagnosed with such ailments as functional dyspepsia, lower back pain and influenza, but the physical status of women in the control group remained unclear. As a result of the potential adverse effects of these disorders on pregnancy outcomes, a direct comparison between these two populations could be affected by the patient characteristics and so fail to fully reflect the effects of the acupuncture treatment itself. Notably, the women in the acupuncture group had significantly more visits to obstetrics and gynaecology specialists, suggesting that the comparable delivery outcomes might be to the result of more frequent monitoring and more prompt treatment than in the control group. We question why the number of visits was not adjusted as a confounder when other baseline features were all included in multivariable regression analysis. Important variables are also missing from the report. We refer to gravidity, parity, and previous history of preterm birth and stillbirth, all of which are very closely associated with the outcomes that the research team chose to analyse and so should have been taken into account for adjustment. Finally, we are interested in what effect acupuncture in pregnant women would have on babies apart from similar risks in abnormal delivery, such as neonatal birthweight and major congenital malformations. Given the benefits of acupuncture on maternal symptoms, a comprehensive safety validation for neonates would further promote the widespread use of this complementary therapy. In summary, although this study is meaningful, the conclusion would be more solid if more accurate, detailed and complete analyses were performed.&
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作者回复:妊娠期间针灸的安全性:韩国的一项回顾性队列研究
通过同类队列研究,作者得出结论,针灸可能是缓解妊娠不适的一种安全的治疗选择。虽然像这样的研究是非常需要的,并提供了必要的信息,但我们注意到在得出任何确切的结论之前应该解决几个问题。首先,针灸组早产发生率为8.45%,对照组早产发生率为6.93%。虽然卡方检验的比较没有显示显著性差异,但应该注意的是,在粗分析和调整分析中,p值和下置信限都接近显著性。考虑到本研究的回顾性,数据收集过程中的少量错误可能会极大地改变结果,特别是在统计边缘。建议作者以95%的置信区间添加组间绝对差值。其次,作者指出,接受针灸治疗的妇女经常被诊断出患有功能性消化不良、腰痛和流感等疾病,但对照组妇女的身体状况尚不清楚。由于这些疾病对妊娠结局的潜在不良影响,直接比较这两个人群可能会受到患者特征的影响,因此不能充分反映针灸治疗本身的效果。值得注意的是,针灸组的妇女去看妇产科专家的次数明显更多,这表明与对照组相比,更频繁的监测和更及时的治疗可能导致了类似的分娩结果。我们质疑为什么当其他基线特征都包含在多变量回归分析中时,访问次数没有作为混杂因素进行调整。报告中也缺少重要的变量。我们参考了妊娠、胎次、早产和死胎史,所有这些都与研究小组选择分析的结果密切相关,因此应该考虑到调整。最后,我们感兴趣的是,除了类似的异常分娩风险,如新生儿出生体重和重大先天性畸形,孕妇针灸对婴儿有什么影响。鉴于针灸对产妇症状的益处,对新生儿进行全面的安全性验证将进一步促进这种补充疗法的广泛使用。综上所述,虽然本研究具有一定的意义,但如果能进行更准确、更详细、更完整的分析,得出的结论将更加可靠
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