Self-massage with Enzyme-rich Ginger Oil in the Treatment of Primary Dysmenorrhea：a Randomized，Double-blind，Controlled Clinical Trial

doi:10.12114/j.issn.1007-9572.2019.00.134

Abstract

Abstract: Background　Primary dysmenorrhea（PD）is characterized by high incidence and low treatment rate.Massage has obvious effect on PD.Moreover，self-massage can be performed without restrictions in time or space，helping to motivate patients to undergo treatment.Massage medium has multiple influences on massage treatment，but related studies are limited.Objective　To examine the effects of self-massage with Enzyme-rich Ginger Oil（EGO）in treating PD.Methods　A block-randomized，double-blind，placebo-controlled clinical trial approach was applied in this study.From November 2016 to June 2017，sixty-five PD patients were enrolled and randomly divided into EGO group（n=32）and placebo group（n=33），receiving three consecutive cycles of treatment with self-massage with EGO，self-massage with placebo（each cycle started from the first day of the menstrual period，and lasted for 7 consecutive days，during which the intervention was performed twice daily），respectively.Dysmenorrhea symptom and PD-induced pain were measured by Symptoms Scoring Criteria for Dysmenorrhea（SSCD）and numerical rating scale（NRS），respectively，before and after treatment for efficacy evaluation.Results　During the intervention period，2 cases and 1 dropped out of the treatment group，control group，respectively，so 62 cases were included in the final analysis.After treatment，average SSCD scores decreased significantly in both groups（P<0.05），but showed no obvious intergroup difference（P>0.05）.Average NRS scores decreased significantly in both groups after treatment（P<0.05）．EGO group showed much lower post-treatment average NRS score than placebo group（P<0.05）.Syndrome-based efficacy analysis of self-massage with EGO found that，the alleviation in PD-induced pain was much better in those with cold syndrome than that of those with heat syndrome（P<0.05），while the relief in PD symptoms showed no differences between the two subgroups（P>0.05）．Conclusion　Self-massage with EGO and self-massage with placebo therapies could reduce PD-induced pain and PD symptoms，but self-massage with EGO achieved better result in reducing pain degree.Furthermore，self-massage with EGO is more suitable for patients with cold syndrome.

Key words: Dysmenorrhea, Tuina, Ginger, Ginger oil, Enzyme, Randomized controlled trial

摘要： 背景　原发性痛经在女性中有着高发病率、低治疗率的特点，推拿治疗疗效确切，且自我推拿不受时间、地点的限制，有利于提高患者的治疗积极性。推拿介质对推拿效果有多方面的影响，但目前针对推拿介质的临床研究较少。目的　观察以酵素姜油为介质的自我推拿法治疗原发性痛经的临床效果。方法　2016年11月—2017年6月，采用双盲、安慰剂对照、区组随机化的研究方法，将纳入的65例原发性痛经患者随机分为治疗组（酵素姜油+自我推拿）和对照组（安慰剂+自我推拿），其中治疗组32例，脱落2例；对照组33例，脱落1例。受试者从经期第1天起连续治疗7 d，每天2次，连续治疗3个月经周期。观察治疗前后痛经症状评分、疼痛数字评分法（NRS）疼痛评分的变化以评估疗效。结果　治疗后，两组患者的痛经症状评分均较治疗前减少（P<0.05），但两组间差异无统计学意义（P>0.05）。两组患者的NRS疼痛评分均较治疗前减少，且治疗组疼痛改善程度优于对照组（P<0.05）。治疗组不同证型患者的疗效比较，寒证NRS疼痛评分改善程度优于热证（P<0.05）；而痛经症状评分改善程度比较，寒热证型间差异无统计学意义（P>0.05）。结论　以酵素姜油或安慰剂为介质的自我推拿均能改善原发性痛经患者的疼痛度和痛经症状；但在改善疼痛度上，以酵素姜油为介质的自我推拿效果更优，且此方法更适用于寒证痛经患者。

关键词: 痛经, 推拿, 生姜, 姜油, 酵素, 随机对照试验

DENG Yun,YI Wei,YE Xiaoxin, et al. Self-massage with Enzyme-rich Ginger Oil in the Treatment of Primary Dysmenorrhea：a Randomized，Double-blind，Controlled Clinical Trial　[J]. Chinese General Practice, 2019, 22(19): 2388-2392. DOI: 10.12114/j.issn.1007-9572.2019.00.134.
邓韵,易玮,叶宵欣等. 以酵素姜油为介质的自我推拿治疗原发性痛经的随机、双盲、对照试验[J]. 中国全科医学, 2019, 22(19): 2388-2392. DOI: 10.12114/j.issn.1007-9572.2019.00.134.

References

［1］谢幸，苟文丽．妇产科学［M］．8版．北京：人民卫生出版社，2013：362-363．
［2］王亚平，孙爱军，郁琦．北京协和医院妇科诊疗常规［M］．北京：人民卫生出版社，2012：265-266．
［3］罗颂平．中医妇科学［M］．北京：高等教育出版社，2008．
［4］原卫生部．中药新药临床研究指导原则［M］．南京：南京大学出版社，1993： 263-266．
［5］顾亮亮，姚兰红，龚爱琴，等．中医耳穴压籽法在缓解癌痛中的应用价值分析［J］．中国全科医学，2017，20（18）：2249-2252．DOI：10.3969/j.issn.1007-9572.2017.18.017.
GU L L，YAO L H，GONG A Q，et al．Value and feasibility of auricular point sticking with the medicinal herb seed in relieving cancer pain［J］．Chinese General Practice，2017，20（18）：2249-2252．DOI：10.3969/j.issn.1007-9572.2017.18.017.
［6］刘清国，胡玲．经络腧穴学［M］．北京：中国中医药出版社，2015：14．
［7］王得志．推拿治疗原发性痛经的研究进展［J］．医学综述，2018，24（2）：367-377．
WANG D Z．Advances in massage therapy for primary dysmenorrhea［J］．Medical Recapitulate，2018，24（2）：367-377．
［8］彭亮．不同推拿手法对原发性痛经患者血清PGF2α含量及疼痛症状的影响［J］．湖南中医药大学学报，2012，32（7）：64-74．
PENG L．Effects of different massage manipulation on serum PGF2α content and pain symptoms in patients with primary dysmenorrhea［J］．Journal of Traditional Chinese Medicine University of Hunan，2012，32（7）：64-74．
［9］陈勇．推拿对原发性痛经患者子宫动脉血流动力学参数及血清前列腺素的影响［J］．中国中西医结合杂志，2011，31（10）：1355-1358．
CHEN Y．Effects of massage on the hemodynamic parameters in uterine arteries and serum prostaglandin in patients with primary dysmenorrhea［J］．Chinese Journal of Integrated Traditional and Western Medicine，2011，31（10）：1355-1358．
［10］马王堆汉墓整理小组．五十二病方［M］．北京：文物出版社，1979：52．
［11］李智，李静．古代膏摩发展简史［J］．山东中医药大学学报，2011，35（2）：161-163．DOI：10.16294/j.cnki.1007-659x.2011.02.001.
LI Z，LI J．A brief history of the development of ancient ointment massage［J］．Journal of Shandong University of Traditional Chinese Medicine，2011，35（2）：161-163．DOI：10.16294/j.cnki.1007-659x.2011.02.001.
［12］张笑菲．中医外治演变规律初探［J］．中医外治杂志，1996，6
（5）：5．
ZHANG X F．Study on the evolution of external treatment in traditional Chinese medicine［J］．Journal of External Therapy of Traditional Chinese Medicine，1996，6（5）：5．
［13］龚利．摩与药俱：试论推拿介质［J］．按摩与导引，1993，9（6）：4-7．
GONG L．Massage with medicine：on the massage media［J］．Chinese Manipulation & Qigong Therapy，1993，9（6）：4-7．
［14］黄兆胜．中药学［M］．北京：人民卫生出版社，2002：39．
［15］国家药典委员会．中华人民共和国药典［M］．北京：中国医药科技出版社，2010．
［16］张一粟，陈志伟．推拿介质葱姜水的应用发展及研究现状［C］//第十二次全国推拿学术年会暨推拿手法调治亚健康临床应用及研究进展学习班论文集，南宁，2011：196-199．
［17］刘德荣．陈修园《医学从众录》的外治法介绍［J］．福建中医学院学报，1996，6（4）：11．DOI：10.13261/j.cnki.jfutcm.000404.
LIU D R．Introduction to external therapies in Chen Xiuyuan's Yixue Congzhonglu［J］．Journal of Fujian College of TCM，1996，6（4）：11．DOI：10.13261/j.cnki.jfutcm.000404.
［18］李梃．医学入门［M］．北京：人民卫生出版社，2006．
［19］陈士铎．本草新编［M］．太原：山西科学技术出版社，2011．
［20］周颖，韦仕静，葛亚中，等．生姜酵素发酵过程中生物活性成分含量及其抗氧化性的变化［J］．食品工业科技，2018，39（18）：45-50．DOI：10.13386/j.issn1002-0306.2018.18.008.
ZHOU Y，WEI S J，GE Y Z，et al．Changes of bioactive components and antioxidant activities in ginger fermentation［J］．Science and Technology of Food Industry，2018，39（18）：45-50．DOI：10.13386/j.issn1002-0306.2018.18.008.
［21］张旭．生姜提取液抗炎镇痛作用研究［J］．河南大学学报（医学版），2015，34（1）：26-28．DOI：10.15991/j.cnki.41-1361/r.2015.01.007.
ZHANG X．Study on the anti-inflammatory and analgesic effects of ginger extract［J］．Journal of Henan University（Medical Science），2015，34（1）：26-28．DOI：10.15991/j.cnki.41-1361/r.2015.01.007.
［22］张思，王蕾，张志旭，等．16种市售酵素食品功能分析与评价［J］．食品与机械，2016，32（9）：196-200．DOI：10.13652/j.issn.1003-5788.2016.09.046.
ZHANG S，WANG L，ZHANG Z X，et al．Functional analysis and evaluation on commercially available enzyme food［J］．Food & Machinery，2016，32（9）：196-200．DOI：10.13652/j.issn.1003-5788.2016.09.046.
［23］朱复南．吴师机外治法的理法方药别论［J］．中医药学报，1987，15（4）：1-4．DOI：10.19664/j.cnki.1002-2392.1987.04.001.
ZHU F N．A review of principle-method-recipe-medicines on Wu Shiji's theory and method of external treatment［J］．Acta Chinese Medicine and Pharmacology，1987，15（4）：1-4．DOI：10.19664/j.cnki.1002-2392.1987.04.001.
［24］卢露，杨中林，孙明珍．几种挥发油对苦杏仁苷膜剂促透作用的比较研究［J］．中成药，2005，27（3）：342-343．
LU L，YANG Z L，SUN M Z．A comparative study on the penetration enhancing effect of several essential oil on amygdalin film agent［J］．Chinese Traditional Patent Medicine，2005，27（3）：342-343．
［25］BURNETT M，WINNIPE G，LEMYRE M，et al．NO．345-primary dysmenorrhea consensus guideline［J］．Journal of Obstetrics and Gynaecology Canada，2017，39（7）：585-595．DOI：10.1016/j.jogc.2016.12.023.

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