BMC Complementary and Alternative Medicine | |
Moxibustion for cephalic version: a feasibility randomised controlled trial | |
Virginia Schmied1  Andrew Bisits2  Hannah Dahlen5  Caroline A Smith4  Carole K Do3  | |
[1] School of Nursing and Midwifery, University of Western Sydney, Locked Bag 1797, Penrith South DC, NSW 2751, Australia;Royal Women's Hospital, Sydney, Australia;School of Biomedical and Health Sciences, University of Western Sydney, Locked Bag 1797, Penrith South DC, NSW 2751, Australia;Centre for Complementary Medicine Research, University of Western Sydney, Locked Bag 1797, Penrith South DC, NSW 2751, Australia;Family and Community Health Group, School of Nursing and Midwifery, University of Western Sydney, Locked Bag 1797, Penrith South DC, NSW 2751, Australia | |
关键词: feasibility; randomised controlled trial; moxibustion; breech; | |
Others : 1232967 DOI : 10.1186/1472-6882-11-81 |
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received in 2011-06-21, accepted in 2011-09-26, 发布年份 2011 | |
【 摘 要 】
Background
Moxibustion (a type of Chinese medicine which involves burning a herb close to the skin) has been used to correct a breech presentation. Evidence of effectiveness and safety from systematic reviews is encouraging although significant heterogeneity has been found among trials. We assessed the feasibility of conducting a randomised controlled trial of moxibustion plus usual care compared with usual care to promote cephalic version in women with a breech presentation, and examined the views of women and health care providers towards implementing a trial within an Australian context.
Methods
The study was undertaken at a public hospital in Newcastle, New South Wales, Australia. Women at 34-36.5 weeks of gestation with a singleton breech presentation (confirmed by ultrasound), were randomised to moxibustion plus usual care or usual care alone. The intervention was administered over 10 days. Clinical outcomes included cephalic presentation at birth, the need for ECV, mode of birth; perinatal morbidity and mortality, and maternal complications. Feasibility outcomes included: recruitment rate, acceptability, compliance and a sample size for a future study. Interviews were conducted with 19 midwives and obstetricians to examine the acceptability of moxibustion, and views on the trial.
Results
Twenty women were randomised to the trial. Fifty one percent of women approached accepted randomisation to the trial. A trend towards an increase in cephalic version at delivery (RR 5.0; 95% CI 0.7-35.5) was found for women receiving moxibustion compared with usual care. There was also a trend towards greater success with version following ECV. Two babies were admitted to the neonatal unit from the moxibustion group. Compliance with the moxibustion protocol was acceptable with no reported side effects. Clinicians expressed the need for research to establish the safety and efficacy of moxibustion, and support for the intervention was given to increase women's choices, and explore opportunities to normalise birth. The sample size for a future trial is estimated to be 381 women.
Conclusion
Our findings should be interpreted with caution as the study was underpowered to detect statistical differences between groups. Acceptance by women and health professionals towards moxibustion suggest further research is warranted.
Trial Registration
Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12609000985280
【 授权许可】
2011 Do et al; licensee BioMed Central Ltd.
【 预 览 】
Files | Size | Format | View |
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20151116204212201.pdf | 249KB | download | |
Figure 1. | 35KB | Image | download |
【 图 表 】
Figure 1.
【 参考文献 】
- [1]Hickok DE, Gordon DC, Milberg JA, Williams MA, Daling JR: The frequency of breech presentation by gestational age at birth: a large population-based study. Am J Obstet Gynecol 1992, 166:851-2.
- [2]Hofmeyr GJ, Kulier R: External cephalic version for breech presentation at term. Cochrane Database of Systematic Reviews 1996., (Issue 1)
- [3]Hutton EK, Hofmeyr GJ: External cephalic version for breech presentation before term. Cochrane Database of Systematic Reviews 2006., (1)
- [4]Hutton E, Hannah M, Ross S, Delisle M, Carson G, Windrim R, Ohlsson A, Willan A, Gafni A, Sylvestre G, Natale R, Barrett Y, Pollard J, Dunn M, Turtle P, for the Early ECV2 Trial Collaborative Group: The Early External Cephalic Version (ECV) 2 Trial: an international multicentre randomised controlled trial of timing of ECV for breech pregnancies. BJOG 2011, 118:564-577.
- [5]Mitchell M, Allen K: An exploratory study of women's experiences and key stakeholders views of moxibustion for cephalic version in breech presentation. Complement Ther Clin Prac 2008, 14:264-272.
- [6]Kingdon C, Baker L, Lavender T: Systematic review of nulliparous women's views of planned cesarean birth: the missing component in the debate about a term cephalic trial. Birth 2006, 33:229-237.
- [7]Gamble J, Creedy DK, McCourt C, Weaver J, Beake S: A critique of the literature on women's request for cesarean section. Birth 2007, 34:331-340.
- [8]McCourt C, Weaver J, Statham H, Beake S, Gamble J, Creedy DK: Elective cesarean section and decision making: a critical review of the literature. Birth 2007, 34:65-79.
- [9]Wen W: Correcting abnormal fetal positions with "Moxibustion". Midwives Chron 1979, 92:432.
- [10]Bodeker G, Kronenberg F: A public health agenda for traditional, complementary, and alternative medicine. Am J Public Health 2002, 92:1582-1591.
- [11]Budd S: Moxibustion for breech presentation. Complement Ther Nurs Midwifery 2000, 6:176-179.
- [12]Kim WY, Chae Y, Lee SN, Lee H, Park HJ: The effectiveness of moxibustion: an overview during 10 years. Evid Based Complement Alternat Med 2009, in press.
- [13]Pach D, Brinkhaus B, Willich SN: Moxa sticks: thermal properties and possible implications for clinical trials. Complement Ther Med 2009, 17:243-6.
- [14]Kawakita K, Shinbara H, Imai K, Fukuda F, Yano T, Kuriyama K: How do acupuncture and moxibustion act? - Focusing on the progress in Japanese acupuncture research. J Pharmacol Sci 2006, 100:443-59.
- [15]Vas J, Aranda JM, Nishishinya B, Mendez C, Martin MA, Pons J, Liu JP, Wang CY, Perea-Milla E: Correction of nonvertex presentation with moxibustion: a systematic review and metaanalysis. Am J Obstet Gynecol 2009, 201:241-59.
- [16]Coyle ME, Smith CA, Peat B: Cephalic version by moxibustion for breech presentation. Cochrane Database of Systematic Reviews 2005., (2)
- [17]Cardini F, Lombardo P, Regalia AL, Regaldo G, Zanini A, Negri MG, Panepuccia L, Todros T: A randomised controlled trial of moxibustion for breech presentation. BJOG 2005, 112:743-747.
- [18]Guittier MJ, Pichon M, Dong H, Irion O, Boulvain M: Moxibustion for breech version: a randomized controlled trial. Obstet Gynecol 2009, 114:1034-1040.
- [19]Braun V, Clark JA: Using thematic analysis in psychology. Qual Res Psychol 2006, 3:77-101.
- [20]Adams J, Lui CW, Sibbritt D, Broom A, Wardle J, Homer C, Beck S: Women's use of complementary and alternative medicine during pregnancy: a critical review of the literature. Birth 2009, 36:237-45.
- [21]Hall HG, McKenna LG, Griffiths DL: Midwives' support for complementary and alternative medicine: A literature review. Women and Birth 2011, in press.
- [22]Garish K, Lacey A: The research process in nursing. 6th edition. Oxford. Wiley-Blackwell; 2010.