Research

Adverse event reporting in studies of penetrating acupuncture during pregnancy: a systematic review

Clarkson CE, O'mahony D, Jones DE.

The authors invested studies that compared an acupuncture group with a control or sham group to examine adverse events in pregnancy. They found 17 studies  (ten investigated pain, three nausea and/or vomiting, one depression, one emotional complaints, one heart burn and another insomnia). They reported that the information describing adverse events was often lacking in detail. However the majority of the adverse events were minor, with both groups reporting altered taste, tiredness, treatment discomfort, uterine contractions, being placed on bed rest, and treatment discomfort.  The incidence of adverse events was similar between the acupuncture and non-acupuncture groups (between 14 and 17% in the acupuncture groups and 15 and 19% in non-acupuncture groups). Suggesting that acupuncture produced neither more nor less adverse events compared with another intervention.

http://www.ncbi.nlm.nih.gov/pubmed/25603694

The safety of using acupuncture during pregnancy.

Park et al 2014, examined the safety of pregnancy through searching available electronic data bases for reports of adverse events. 

Summary and conclusion

The authors searched the electronic databases of: Medline, Embase, Cochrane Central Register of Controlled Trials, Cumulative Index to Nursing and Allied Health Literature (CINAHL), Allied and Complementary Medicine Database (AMED) and five Korean databases to February 2013 for articles reporting adverse events for pregnancy related acupuncture. They found that the most frequent adverse events related to pain at the needle site, with no incidence of severe adverse events considered likely to be related to acupuncture. They concluded that acupuncture during pregnancy appears to be associated with few adverse events when correctly applied. View Abstract

Nausea

Smith et al. published two articles from their research on nausea and vomiting in pregnancy which is the largest study to date. The first looked at the effectiveness of acupuncture and the second at the safety of acupuncture treatment in early pregnancy.

Summary and conclusion

The objective was to compare: traditional acupuncture treatment, acupuncture at one point only, sham acupuncture and no acupuncture treatment for nausea and vomiting. This study involved 593 women who were less than 14 weeks pregnant and were suffering pregnancy related nausea and vomiting. They were randomised into four groups and received treatment weekly. The acupuncture group, in which points were chosen according to a traditional acupuncture diagnosis, received two 20 minute acupuncture treatments in the first week followed by one weekly treatment for the next four weeks. The sham acupuncture group was needled at points close to but not on acupuncture points and both the sham and one acupuncture point acupuncture groups were treated with the same frequency as the traditional acupuncture group.

While all three acupuncture groups reported improvement with nausea and dry retching, it was the traditional acupuncture group that had the fastest response. Patients receiving traditional acupuncture also reported improvement in five aspects of general health status (vitality, social function, physical function, mental health and emotional role function) compared to improvement in two aspects with both the one acupuncture point group and sham acupuncture groups. In the no treatment group there was improvement in only one aspect.

Although there were no differences in vomiting found in any of the treatment groups the authors speculated that more frequent treatments might have produced greater benefits. In assessing the safety of acupuncture in early pregnancy data was collected on perinatal outcome, congenital abnormalities, pregnancy complications and problems of the newborn. View Abstract

No differences were found between study groups in the incidence of these outcomes suggesting that there are no serious adverse effects from the use of acupuncture treatment in early pregnancy. The authors concluded that acupuncture is a safe and effective treatment for women who experience nausea and dry retching in early pregnancy. View Abstract

Pelvic Pain in Pregnancy

Elden et al. 2005  published to date what is the largest randomised controlled trial of acupuncture for and pelvic pain in pregnancy involving 386 pregnant women.

Summary and conclusion

The objective of this study was to compare standard treatment for pelvic pain (a pelvic belt, patient education and home exercises for the abdominal and gluteal muscles) with standard treatment plus acupuncture or standard treatment plus extra  physiotherapy stabilising exercises (for the deep lumbopelvic muscles). The study time frame consisted of one week which was used to establish a baseline, followed by six weeks of treatment. The acupuncture treatment was given twice a week and the stabilising exercise sessions one hour per week (with patients then doing these exercises several times a day on a daily basis). Follow up was carried out one week after treatment finished. Pain was measured by a visual analogue scale and by an independent examiner before and after treatment. The authors concluded acupuncture was superior to stabilising exercises in the management of pelvic girdle pain in pregnancy, with acupuncture the treatment of choice for patients with one sided sacroiliac pain, one sided sacroiliac pain combined with symphysis pubis pain and bilateral sacroiliac pain. View Abstract

The latest Cochrane review (considered the ‘gold stranded’ in research for evaluating randomised controlled trials) examined 26 trials involving 4093 pregnant women with different therapies including acupuncture and physiotherapy. Eleven trials involved Lower Back Pain, 11 trials Lumbo-pelvic pain and four pelvic pain (including the Elden et al trail as discussed above). Their findings were reported as:

• Acupuncture significantly reduced pelvic pain more than usual care alone.

• Acupuncture was significantly more effective than exercise for reducing pelvic pain.

• Acupuncture was more effective than physiotherapy at relieving lumbo-pelvic pain and improving function   View Cochrane Report

Breech Presentation

Cardini et al (1998) had the following randomised controlled trial published in the Journal of American Association (JAMA). This was the first trial of this kind to be published in the JAMA, This research subsequently was referenced to support the use of Moxibustion therapy for breech presentation in the New Zealand Evidence based Guidelines for Breech presentation www.nzgg.org.nz/guidelines/0074/caesarean (p 14) 

Summary and conclusion

The objective of the study was to evaluate the efficacy and safety of moxibustion to correct breech presentation. It involved 130 women with a breech presentation having their first baby (primigravidas) at 33 weeks gestation receiving moxibustion, while 130 women, also primigravida with a breech presentation received no intervention. Moxibustion was administered for seven days. Women were then assessed and a further seven days of moxibustion treatment given if the baby’s position had not changed. Outcomes were measured in terms of foetal movements, as counted by the mother for one hour each day for one week, and the number of cephalic (head down) presentations both at 35 weeks  and at delivery. At 35 weeks gestation 75.4% in the intervention group had changed to cephalic (47.7% in the control). In terms of foetal movement the moxibustion group experienced a greater number of movements. The authors concluded that in prigravidas at 33 weeks moxibustion treatment increased foetal activity and cephalic presentation. View Abstract

Further research into using moxibustion for breech presentation (van den Burg 2010) has included a mathematical modelling approach to investigate cost effectiveness. With the authors reporting that the use of moxibustion at 33 weeks would be more cost effective than usual care, including external cephalic version. It was interesting that the authors reported that if 16% or more of women offered moxibustion complied, it was more effective and less costly than expectant management. View Abstract

In a recent study involving 406 women with a breech baby at 33 – 35 weeks, the use of moxibustion plus usual care at the acupuncture point BL 67 point was reported to be more effective than using moxibustion or usual care at another acupuncture point or usual care alone (Vas J et al 2013).  View Abstract

Prebirth acupuncture.

Research on the use of acupuncture to prepare women for labour first appeared in 1974 with a study by Kubista and Kucera. Their research concluded that acupuncture once a week from 37 weeks gestation was successful in reducing the mean labour time of the women treated. They calculated the labour time in two ways. The first was the mean time between a cervical dilation of 3-4 cm and delivery. In the acupuncture group this was 4 hours and 57 minutes compared to five hours and 54 minutes in the control group. The second was the mean subjective time of labour, taken from the onset of regular (10-15 minute) contractions until delivery. The acupuncture group had a labour time of 6 hours and 36 minutes compared to eight hours and 2 minutes in the controls.

In 1998 Zeisler et al.used acupuncture  from 36 weeks gestation. This study concluded that acupuncture treatment had a positive effect on the duration of labour by shortening the first stage of labour, defined as the time between 3cm cervical dilation and complete dilation. The acupuncture group had a median duration of 196 minutes compared to the control group time of 321 minutes.

In 2004 there was an observational study (Betts & Lenox) examining the effect of prebirth acupuncture. This involved 169 women receiving prebirth acupuncture who were compared to local population for gestation at onset of labour, incidence of medical induction, length of labour, use of analgesia and type of delivery. In the acupuncture group there was an overall 35% reduction in the number of inductions (for women having their first baby this was a 43% reduction), 31% reduction in the epidural rate. When comparing midwifery only care there was a 32% reduction in emergency caesarean delivery and a 9% increase in normal vaginal births. The conclusion was that prebirth acupuncture appeared to provide some promising therapeutic benefits in assisting women to have normal vaginal births and that a further randomised controlled study is warranted.

Prebirth Acupuncture (59.0 KB)

Cervical ripening

A randomised controlled trial into the effects of acupuncture on cervical ripening was published by Rabl in 2001.

Summary and conclusion

The objective of this study was to evaluate whether acupuncture at term can influence cervical ripening and thus reduce the need for postdates induction. On their due dates 45 women were randomised into either an acupuncture group (25) or a control group (20). The acupuncture group received acupuncture every two days. The women in both groups were examined every other day for cervical length (measured by vaginal trasonography, cervical mucus and cervical stasis according to Bishop’s score). If women had not delivered after 10 days labour was induced by administering vaginal prostaglandin tablets. The time from the woman’s due date to delivery was an average of 5 days in the acupuncture group compared to 7.9 days in the control group, and labour was medically induced in 20% of women in the acupuncture group compared to 35% in the control group. There were no differences between overall duration of labour or of the first and second stages of labour. The authors concluded that acupuncture at the points Hegu L.I.-4 and Sanyinjiao SP-6 supports cervical ripening and can shorten the time interval between the woman’s expected date of delivery and the actual time of delivery.

Acupuncture to induce Labour

The research to date does not support that women receiving acupuncture to stimulate contractions improves labour outcomes. In contrast to the use of prebirth acupuncture which aims to prepare a woman’s body for labour, an acupuncture induction aims to stimulate contractions. It may be that stimulating uterine contractions without an individualised approach to address factors such as cervical ripening, the baby’s position, emotional factors, and physical stamina has limited beneficial effects in terms of labour outcomes.   

Summary and conclusion

A Cochrane review in 2013 evaluated 14 studies involving 2220 women. The authors reported that while there was some evidence of changes in cervical maturation and the length of labor for women receiving acupuncture, there was no difference in the number of women using an epidural, in the rate of instrumental delivery or Caesarean sections. The authors concluded that further research is required to gaining a greater understanding of the specific components of acupuncture treatment with women who are overdue. View Cochrane Report

Acupuncture or Acupressure for pain relief in labour

A Cochrane review of 13 trials involving 1986 women, reported that acupuncture or acupressure may help relieve labour pain.

Summary and conclusion

Nine trials reported on women receiving acupuncture and four trials reported on the use of acupressure, with the finding that women receiving acupuncture or acupressure reported benefits in terms of reduced pharmacological analgesia, less intense pain and increased maternal satisfaction. However due to the small number of trials and the poor quality of reporting within some of these trials further high quality research is required. View Cochrane Report

 

References

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Betts D, Lennox S. Acupuncture for prebirth treatment: An observational study of its use in midwifery practice. Medical acupuncture 2006 May; 17(3):17-20

Cardini F, Weixin H. Moxibustion for correction of breech presentation. JAMA 1998; 280:1580-1584

Elden H, Ladfors l, Fagevik Olsen M, Ostaard H, Hagberg H. Effects of acupuncture and stabilising exercises as adjunct to standard treatment in pregnant women with pelvic girdle pain: randomised singleblind controlled trail. BMJ 2005;330:761.

Kubista E, Kucera H. Geburtshilfe Perinatol 1974; 178 224-9.
Smith C, Crowther C, Beilby J. Acupuncture to treat nausea and vomiting in early pregnancy: a randomized trial. Birth.2002, Mar:29 (1):1-9.
Smith C, Crowther C, Beilby J. Pregnancy outcome following women's participation in a randomised controlled trial of acupuncture to treat nausea and vomiting in early pregnancy. Complement Ther Med. 2002 Jun; 10(2):78-83.

Smith CA, Collins CT, Crowther CA, Levett KM. Acupuncture or acupressure for pain management in labour. Cochrane Database of Systematic Reviews 2011, Issue 7. Art. No.: CD009232. DOI: 10.1002/14651858.CD009232.

Smith CA, Crowther CA, Grant SJ. Acupuncture for induction of labour. Cochrane Database of Systematic Reviews 2013, Issue 8. Art. No.: CD002962. DOI: 10.1002/14651858.CD002962.pub3.

Rabl M, Ahner R, Bitschnau M, Zeisler H, Husslein P. Acupuncture for cervical ripening and induction of labour at term – a randomised controlled trail. Wien Klin Wochenschr 2001; 113 (23-24): 942-6.

Zeisler H, Tempfer C, Mayerhofe Kr, Barrada M, Husslein P. Influence of acupuncture on duration of labour Gynecol Obstet Invest 1998; 46:22-5.