对JAMA“针刺与假针刺影响体外受精女性活产率”一文的思考和分析
|
摘要
2018年5月发表于JAMA的"针刺与假针刺影响体外受精女性活产率的临床随机试验"一文得出针刺不能提高接受体外受精-胚胎移植(IVF-ET)女性活产率的结论。笔者通过仔细研读文章,从针刺治疗方案和具体针刺操作两方面进行思考和分析,论证其可靠性。结果发现,针刺与假针刺组对照差异无统计学意义,无法证实假针刺对照不产生治疗效应,不能得出针刺治疗不提高疗效的结论;腧穴配伍与前期研究方案不符,其合理性存在争议;针刺治疗频率及治疗时间能否突显活产率值得商榷;此外,针灸操作医师的选择亦可能是研究结果未达到预期的原因。
The article "Effect of acupuncture vs sham acupuncture on live births among women undergoing in vitro fertilization: a randomized clinical trial", published in JAMA in May 2018, has concluded that acupuncture does not improve the rate of live births among women undergoing IVF. Through careful study of the article, the author analyzes its reliability from acupuncture therapeutic plan and specific acupuncture operation. As a result, although the research showed no significant difference between the acupuncture group and the sham acupuncture group, it could not prove no therapeutic effect in the sham acupuncture group, so the conclusion that the acupuncture did not improve the therapeutic effect could not be drawn; the compatibility of acupoints was inconsistent with the previous protocol, and its rationality was controversial; whether the frequency and duration of acupuncture treatment could highlight the live birth rate should be further discussed. In addition, the selection of acupuncturists may be another reason for the failure of the research aim.
The article "Effect of acupuncture vs sham acupuncture on live births among women undergoing in vitro fertilization: a randomized clinical trial", published in JAMA in May 2018, has concluded that acupuncture does not improve the rate of live births among women undergoing IVF. Through careful study of the article, the author analyzes its reliability from acupuncture therapeutic plan and specific acupuncture operation. As a result, although the research showed no significant difference between the acupuncture group and the sham acupuncture group, it could not prove no therapeutic effect in the sham acupuncture group, so the conclusion that the acupuncture did not improve the therapeutic effect could not be drawn; the compatibility of acupoints was inconsistent with the previous protocol, and its rationality was controversial; whether the frequency and duration of acupuncture treatment could highlight the live birth rate should be further discussed. In addition, the selection of acupuncturists may be another reason for the failure of the research aim.
引文
[1]Smith CA,De Lacey S,Chapman M,et al.Effect of acupuncture vs sham acupuncture on live births among women undergoing in vitro fertilization:a randomized clinical trial[J].JAMA,2018,319(19):1990-1998.
[2]Wu XK,Stener-Victorin E,Kuang HY,et al.Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome:a randomized clinical trial[J].JAMA,2017,317(24):2502-2514.
[3]Liu Z,Liu Y,Xu H,et al.Effect of electroacupuncture on urinary leakage among women with stress urinary incontinence:a randomized clinical trial[J].JAMA,2017,317(24):2493-2501.
[4]Stener-Victorin E,Waldenstr?MU,Nilsson L,et al.Aprospective randomized study of electro-acupuncture versus alfentanil as anaesthesia during oocyte aspiration in-vitro fertilization[J].Hum Reprod,1999,14(10):2480-2484.
[5]Paulus WE,Zhang M,Strehler E,et al.Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy[J].Fertil Steril,2002,77(4):721-724.
[6]张明敏,黄光英,陆付耳,等.针刺对胚胎移植怀孕率的影响及其机理:随机安慰对照研究[J].中国针灸,2003,23(1):3-5.
[7]Cakmak YO.Electroacupuncture reduces uterine artery blood flow impedance[J].Taiwan J Obstet Gynecol,2010,49(3):390.
[8]吴锦.针灸对IVF-ET患者心理压力和子宫内膜蠕动波影响的研究[D].衡阳:南华大学,2017.
[9]陈芊,郝翠芳.针灸对体外受精-胚胎移植者妊娠结局的影响[J].中国针灸,2015,35(4):313-317.
[10]Zheng CH,Huang GY,Zhang MM,et al.Effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization:a systematic review and meta-analysis[J].Fertil Steril,2012,97(3):599-611.
[11]Shen C,Wu M,Shu D,et al.The role of acupuncture in in vitro fertilization:a systematic review and meta-analysis[J].Gynecol Obstet Inves,2015,79(1):1-12.
[12]He W,Tong Y,Zhao Y,et al.Review of controlled clinical trials on acupuncture versus sham acupuncture in Germany[J].JTradit Chin Med,2013,33(3):403-407.
[13]Park J,White A,Stevinson C,et al.Validating a new non-penetrating sham acupuncture device:two randomised controlled trials[J].Acupunct Med,2002,20(4):168-174.
[14]鞠露,吴晓亮,徐大可,等.国外近10年随机对照试验安慰针刺运用分析[J].中国针灸,2016,36(2):203-206.
[15]祝总骧,徐瑞民,谢君国,等.经络在表皮层和角质层的低阻抗特性及其形态学实质的研究[J].中国医药学报,1988,3(5):33-35,80.
[16]Kaptchuk TJ.Placebo needle for acupuncture[J].Lancet,1998,352(9132):992.
[17]杨会生,房繄恭,李晓彤,等.针灸对体外受精-胚胎移植患者妊娠结局影响的随机对照试验系统评价[J].中华中医药杂志,2017,32(12):5591-5598.
[18]何婉珊.穴位刺激配合辅助生殖技术提高妊娠结局的Meta分析及用穴规律研究[D].广州:广州中医药大学,2016.
[19]Smith CA,de Lacey S,Chapman M,et al.Acupuncture to improve live birth rates for women undergoing in vitro fertilization:a protocol for a randomized controlled trial[J].Trials,2012,13:60.
[20]王雪苔,丁一丹.中国针灸大全[M].郑州:河南科学技术出版社,1992.
[21]石学敏.针灸治疗学[M].北京:人民卫生出版社,2011.
[22]钟峰,曾芳,郑晖,等.腧穴配伍拮抗作用的研究现状[J].中国针灸,2011,31(12):1093-1096.
[23]李学惠.“内关”“神门”“心俞”间协同作用与拮抗作用实验研究[J].中国针灸,2002,22(12):819-821.
[24]徐放明,陈日新.腧穴配伍拮抗效应的实验观察[J].上海针灸杂志,1999,18(5):38-39.
[25]徐放明,陈日新.电针对油脂减弱小鼠胃肠推进功能的腧穴拮抗效应观察[J].河南中医,2000,20(2):19-20.
[26]徐放明,陈日新.腧穴拮抗效应的实验研究--电针对正常小鼠胃肠推进功能的影响[J].天津中医,2002,19(3):28-29.
[27]Anderson BJ,Rosenthal L.Acupuncture and IVFcontroversies[J].Fertil Steril,2007,87(4):1000.
[28]Anderson B,Rosenthal L.Acupuncture and in vitro fertilization:critique of the evidence and application to clinical practice[J].Complement Ther Clin Pract,2013,19(1):1-5.
[29]陈军,刘莉莉,崔薇,等.电针干预对卵巢低反应患者体外受精胚胎移植的影响[J].中国针灸,2009,29(10):775-779.
[30]崔薇,李静,孙伟,等.电针对多囊卵巢综合征患者体外受精-胚胎移植中卵细胞质量及妊娠的影响[J].中国针灸,2011,31(8):687-691.
[31]Jing LI,Cui W,Sun W,et al.Effect of electroacupuncture on egg quality and tumor necrosis factor-αof patients with polycystic ovarian syndrome[J].World J Acup-Mox,2014,24(3):9-15.
[32]谢政芸,姚兵,陈莉,等.针刺对体外受精-胚胎移植妊娠结局影响的问题及讨论[J].中国针灸,2016,36(5):449-455.
[33]Andersen D,L?ssl K,Nyboe Andersen A,et al.Acupuncture on the day of embryo transfer:a randomized controlled trial of 635patients[J].Reprod Biomed Online,2010,21(3):366-372.
[34]So EW,Ng EH,Wong YY,et al.Acupuncture for frozen-thawed embryo transfer cycles:a double-blind randomized controlled trial[J].Reprod Biomed Online,2010,20(6):814-821.
[35]Moy I,Milad MP,Barnes R,et al.Randomized controlled trial:effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization[J].Fertil Steril,2011,95(2):583-587.
[36]Madaschi C,Braga DPAF,De Cássia Savio Figneira R,et al.Effect of acupuncture on assisted reproduction treatment outcomes[J].Acup Med,2010,28(4):180-184.
[37]So EW,Ng EH,Wong YY,et al.A randomized double blind comparison of real and placebo acupuncture in IVF treatment[J].Hum Reprod,2009,24(2):341-348.
[38]梁繁荣,赵吉平.针灸学[M].北京:人民卫生出版社,2012.
[39]杨运宽,余仲权.针刺留针琐谈[J].中国针灸,1984,4(3):25-27.
[40]Zhang R,Feng XJ,Guan Q,et al.Increase of success rate for women undergoing embryo transfer by transcutaneous electrical acupoint stimulation:a prospective randomized placebo-controlled study[J].Fertil Steril,2011,96(4):912-916.
[41]Dieterle S,Ying G,Hatzmann W,et al.Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection:a randomized,prospective,controlled clinical study[J].Fertil Steril,2006,85(5):1347-1351.
[42]周莉,夏有兵,卢静,等.序贯针灸治疗卵巢储备功能下降IVF-ET30例临床研究[J].江苏中医药,2015,47(8):58-60.
[43]周莉,夏有兵,马翔,等.针灸序贯疗法对卵巢储备功能下降患者IVF-ET的影响[J].中国针灸,2016,36(1):25-28.
[44]陈利国,蔡向红.留针的意义及时限探讨[J].中国针灸,1996,16(6):40-42.
[45]孙忠人,郭玉怀,张馨月,等.针灸临床疗效影响因素刍议[J].辽宁中医药大学学报,2015,17(7):7-10.
[46]张洪来,马洪举,陶慧芳.针灸疗效的一个关键因素--治神[J].新中医,2013,45(8):169-170.
[47]刘堂义,杨华元,蒯乐,等.“针刺手法信息分析系统”在针刺手法教学中的应用[J].中国针灸,2009,29(11):927-930.
[48]刘堂义,蒯乐,杨华元,等.针刺手法操作规范化初探[J].中国针灸,2008,28(5):356-358.
[49]苑鸿雯,马良宵,朱江.“病、穴、刺、时”与针刺疗效关系刍议[J].中华中医药杂志,2011,26(1):19-22.
[50]Moerman DE.Against the“placebo effect”:a personal point of view[J].Complement Ther Med,2013,21(2):125-130.
[51]Ewig S.Revisited:Michael balint.the doctor,his patient and the illness[J].Pneumologie,2010,64(5):278-280.
[52]Kaptchuk TJ,Kelley JM,Conboy LA,et al.Components of placebo effect:randomised controlled trial in patients with irritable bowel syndrome[J].BMJ,2008,336(7651):999-1003.
[53]Hinman RS,Mccrory P,Pirotta M,et al.Acupuncture for chronic knee pain:a randomized clinical trial[J].JAMA,2014,312(13):1313-1322.
[54]Macpherson H,White A,Cummings M,et al.Standards for reporting interventions in controlled trials of acupuncture:The STRICTA Recommendations[J].中国循证医学杂志,2003,3(3):231-234.
[55]陈芊,郝翠芳.针灸对IVF-ET反复种植失败患者子宫内膜血流及胞饮突表达的影响[J].生殖与避孕,2015,35(3):159-165.
[56]徐金龙,杨增荣,钱婧,等.分期针灸对IVF-ET反复移植失败患者子宫内膜厚度的影响[J].上海针灸杂志,2018,37(2):200-204.
[2]Wu XK,Stener-Victorin E,Kuang HY,et al.Effect of acupuncture and clomiphene in Chinese women with polycystic ovary syndrome:a randomized clinical trial[J].JAMA,2017,317(24):2502-2514.
[3]Liu Z,Liu Y,Xu H,et al.Effect of electroacupuncture on urinary leakage among women with stress urinary incontinence:a randomized clinical trial[J].JAMA,2017,317(24):2493-2501.
[4]Stener-Victorin E,Waldenstr?MU,Nilsson L,et al.Aprospective randomized study of electro-acupuncture versus alfentanil as anaesthesia during oocyte aspiration in-vitro fertilization[J].Hum Reprod,1999,14(10):2480-2484.
[5]Paulus WE,Zhang M,Strehler E,et al.Influence of acupuncture on the pregnancy rate in patients who undergo assisted reproduction therapy[J].Fertil Steril,2002,77(4):721-724.
[6]张明敏,黄光英,陆付耳,等.针刺对胚胎移植怀孕率的影响及其机理:随机安慰对照研究[J].中国针灸,2003,23(1):3-5.
[7]Cakmak YO.Electroacupuncture reduces uterine artery blood flow impedance[J].Taiwan J Obstet Gynecol,2010,49(3):390.
[8]吴锦.针灸对IVF-ET患者心理压力和子宫内膜蠕动波影响的研究[D].衡阳:南华大学,2017.
[9]陈芊,郝翠芳.针灸对体外受精-胚胎移植者妊娠结局的影响[J].中国针灸,2015,35(4):313-317.
[10]Zheng CH,Huang GY,Zhang MM,et al.Effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization:a systematic review and meta-analysis[J].Fertil Steril,2012,97(3):599-611.
[11]Shen C,Wu M,Shu D,et al.The role of acupuncture in in vitro fertilization:a systematic review and meta-analysis[J].Gynecol Obstet Inves,2015,79(1):1-12.
[12]He W,Tong Y,Zhao Y,et al.Review of controlled clinical trials on acupuncture versus sham acupuncture in Germany[J].JTradit Chin Med,2013,33(3):403-407.
[13]Park J,White A,Stevinson C,et al.Validating a new non-penetrating sham acupuncture device:two randomised controlled trials[J].Acupunct Med,2002,20(4):168-174.
[14]鞠露,吴晓亮,徐大可,等.国外近10年随机对照试验安慰针刺运用分析[J].中国针灸,2016,36(2):203-206.
[15]祝总骧,徐瑞民,谢君国,等.经络在表皮层和角质层的低阻抗特性及其形态学实质的研究[J].中国医药学报,1988,3(5):33-35,80.
[16]Kaptchuk TJ.Placebo needle for acupuncture[J].Lancet,1998,352(9132):992.
[17]杨会生,房繄恭,李晓彤,等.针灸对体外受精-胚胎移植患者妊娠结局影响的随机对照试验系统评价[J].中华中医药杂志,2017,32(12):5591-5598.
[18]何婉珊.穴位刺激配合辅助生殖技术提高妊娠结局的Meta分析及用穴规律研究[D].广州:广州中医药大学,2016.
[19]Smith CA,de Lacey S,Chapman M,et al.Acupuncture to improve live birth rates for women undergoing in vitro fertilization:a protocol for a randomized controlled trial[J].Trials,2012,13:60.
[20]王雪苔,丁一丹.中国针灸大全[M].郑州:河南科学技术出版社,1992.
[21]石学敏.针灸治疗学[M].北京:人民卫生出版社,2011.
[22]钟峰,曾芳,郑晖,等.腧穴配伍拮抗作用的研究现状[J].中国针灸,2011,31(12):1093-1096.
[23]李学惠.“内关”“神门”“心俞”间协同作用与拮抗作用实验研究[J].中国针灸,2002,22(12):819-821.
[24]徐放明,陈日新.腧穴配伍拮抗效应的实验观察[J].上海针灸杂志,1999,18(5):38-39.
[25]徐放明,陈日新.电针对油脂减弱小鼠胃肠推进功能的腧穴拮抗效应观察[J].河南中医,2000,20(2):19-20.
[26]徐放明,陈日新.腧穴拮抗效应的实验研究--电针对正常小鼠胃肠推进功能的影响[J].天津中医,2002,19(3):28-29.
[27]Anderson BJ,Rosenthal L.Acupuncture and IVFcontroversies[J].Fertil Steril,2007,87(4):1000.
[28]Anderson B,Rosenthal L.Acupuncture and in vitro fertilization:critique of the evidence and application to clinical practice[J].Complement Ther Clin Pract,2013,19(1):1-5.
[29]陈军,刘莉莉,崔薇,等.电针干预对卵巢低反应患者体外受精胚胎移植的影响[J].中国针灸,2009,29(10):775-779.
[30]崔薇,李静,孙伟,等.电针对多囊卵巢综合征患者体外受精-胚胎移植中卵细胞质量及妊娠的影响[J].中国针灸,2011,31(8):687-691.
[31]Jing LI,Cui W,Sun W,et al.Effect of electroacupuncture on egg quality and tumor necrosis factor-αof patients with polycystic ovarian syndrome[J].World J Acup-Mox,2014,24(3):9-15.
[32]谢政芸,姚兵,陈莉,等.针刺对体外受精-胚胎移植妊娠结局影响的问题及讨论[J].中国针灸,2016,36(5):449-455.
[33]Andersen D,L?ssl K,Nyboe Andersen A,et al.Acupuncture on the day of embryo transfer:a randomized controlled trial of 635patients[J].Reprod Biomed Online,2010,21(3):366-372.
[34]So EW,Ng EH,Wong YY,et al.Acupuncture for frozen-thawed embryo transfer cycles:a double-blind randomized controlled trial[J].Reprod Biomed Online,2010,20(6):814-821.
[35]Moy I,Milad MP,Barnes R,et al.Randomized controlled trial:effects of acupuncture on pregnancy rates in women undergoing in vitro fertilization[J].Fertil Steril,2011,95(2):583-587.
[36]Madaschi C,Braga DPAF,De Cássia Savio Figneira R,et al.Effect of acupuncture on assisted reproduction treatment outcomes[J].Acup Med,2010,28(4):180-184.
[37]So EW,Ng EH,Wong YY,et al.A randomized double blind comparison of real and placebo acupuncture in IVF treatment[J].Hum Reprod,2009,24(2):341-348.
[38]梁繁荣,赵吉平.针灸学[M].北京:人民卫生出版社,2012.
[39]杨运宽,余仲权.针刺留针琐谈[J].中国针灸,1984,4(3):25-27.
[40]Zhang R,Feng XJ,Guan Q,et al.Increase of success rate for women undergoing embryo transfer by transcutaneous electrical acupoint stimulation:a prospective randomized placebo-controlled study[J].Fertil Steril,2011,96(4):912-916.
[41]Dieterle S,Ying G,Hatzmann W,et al.Effect of acupuncture on the outcome of in vitro fertilization and intracytoplasmic sperm injection:a randomized,prospective,controlled clinical study[J].Fertil Steril,2006,85(5):1347-1351.
[42]周莉,夏有兵,卢静,等.序贯针灸治疗卵巢储备功能下降IVF-ET30例临床研究[J].江苏中医药,2015,47(8):58-60.
[43]周莉,夏有兵,马翔,等.针灸序贯疗法对卵巢储备功能下降患者IVF-ET的影响[J].中国针灸,2016,36(1):25-28.
[44]陈利国,蔡向红.留针的意义及时限探讨[J].中国针灸,1996,16(6):40-42.
[45]孙忠人,郭玉怀,张馨月,等.针灸临床疗效影响因素刍议[J].辽宁中医药大学学报,2015,17(7):7-10.
[46]张洪来,马洪举,陶慧芳.针灸疗效的一个关键因素--治神[J].新中医,2013,45(8):169-170.
[47]刘堂义,杨华元,蒯乐,等.“针刺手法信息分析系统”在针刺手法教学中的应用[J].中国针灸,2009,29(11):927-930.
[48]刘堂义,蒯乐,杨华元,等.针刺手法操作规范化初探[J].中国针灸,2008,28(5):356-358.
[49]苑鸿雯,马良宵,朱江.“病、穴、刺、时”与针刺疗效关系刍议[J].中华中医药杂志,2011,26(1):19-22.
[50]Moerman DE.Against the“placebo effect”:a personal point of view[J].Complement Ther Med,2013,21(2):125-130.
[51]Ewig S.Revisited:Michael balint.the doctor,his patient and the illness[J].Pneumologie,2010,64(5):278-280.
[52]Kaptchuk TJ,Kelley JM,Conboy LA,et al.Components of placebo effect:randomised controlled trial in patients with irritable bowel syndrome[J].BMJ,2008,336(7651):999-1003.
[53]Hinman RS,Mccrory P,Pirotta M,et al.Acupuncture for chronic knee pain:a randomized clinical trial[J].JAMA,2014,312(13):1313-1322.
[54]Macpherson H,White A,Cummings M,et al.Standards for reporting interventions in controlled trials of acupuncture:The STRICTA Recommendations[J].中国循证医学杂志,2003,3(3):231-234.
[55]陈芊,郝翠芳.针灸对IVF-ET反复种植失败患者子宫内膜血流及胞饮突表达的影响[J].生殖与避孕,2015,35(3):159-165.
[56]徐金龙,杨增荣,钱婧,等.分期针灸对IVF-ET反复移植失败患者子宫内膜厚度的影响[J].上海针灸杂志,2018,37(2):200-204.