*We have not had direct access to these studies.
Assessing the methods of a recently published study: four placebo groups?
Article first published online: 11 OCT 2011
© 2011 The Authors BJOG An International Journal of Obstetrics and Gynaecology © 2011 RCOG
BJOG: An International Journal of Obstetrics & Gynaecology
Volume 118, Issue 12, pages 1542–1543, November 2011
How to Cite
Xu, J., Midwinter-Morten, H., Cusick, C. and MacKenzie, I. (2011), Assessing the methods of a recently published study: four placebo groups?. BJOG: An International Journal of Obstetrics & Gynaecology, 118: 1542–1543. doi: 10.1111/j.1471-0528.2011.03087.x
- Issue published online: 11 OCT 2011
- Article first published online: 11 OCT 2011
- Accepted 20 June 2011.
We are impressed with the mean of 20 years of experience of the four authors1 of this letter in which they challenge our methodology using acupuncture needle stimulation for only 30 minutes with subsequent needle removal, used for analgesia after labour induction.2 Our three acupuncturists also had a mean experience of approximately 20 years.
The implication of the challenge is that stimulation of acupuncture needles, whether manual, electric or sham, should remain available for repeated stimulation throughout labour until delivery, as for intrapartum epidural analgesia. The published prospective randomised studies we identified or of which we were aware that examined the impact of acupuncture for this purpose had adopted strategies similar to that which we followed in our study and are tabulated below.
|Ramnero 2002||Stimulated until De-qi flowed; needles removed after 1–3 hours or when inconvenient; those inserted at 45° taped in place until delivery|
|Skilnand 2002||Stimulated for 20 minutes and either removed or taped in place until delivery|
|Nesheim 2003||Needles removed after 10–20 minutes, or taped in place until delivery|
|Ziaei 2006||Inserted until good De-qi flow then taped in place until delivery without stimulation|
|Zhang 2006*||No manipulation, electric current threshold individually adjusted, for 30 minutes|
|Zhou 2007*||No manipulation, electric current threshold individually adjusted, for 30 minutes|
|Hantoushzadeh 2007||Stimulated until De-qi flowed; needles left in place until delivery or removed when requested by patient|
|Martensson 2008||Needles manually stimulated every 10 minutes for 40 minutes with the option to repeat if necessary|
|Borup 2009||Needles left in for 30–120 minutes with the option to repeat or remove if not convenient|
We had referred to each of these studies in our report save two (Zhang 2006; Zhou 2007), for which we rely upon the analyses by Cho et al. 2010;3 we had not discussed the duration of needle manipulation for the sake of brevity. Most of the studies describe introducing the needles until De-qi is experienced, with needle stimulation usually limited to 30 minutes. None suggested continuous or sustained acupuncture therapy until delivery; two studies (Martensson 2008; Borup 2009) allowed for repeated stimulation if necessary, but information on how often that was given was not disclosed. In most studies, the needles were removed when convenient or requested by the subject, or alternatively were taped in position but not stimulated. The three studies where acupuncture appeared to provide analgesic benefit (Ramnero 2002; Skilnand 2002; Nesheim 2003), limited needle stimulation to 20 minutes, after which they were removed at various times or taped in place until delivery. The two studies in which repeated needle stimulation was available did not show any analgesic benefit. We had expressed our reservations about relying on the results of these studies for various reasons, including the mixed parity of the subjects studied, variations in stage of labour when entered into the trials and concerns when the acupuncturist provided continuing obstetric/midwifery care.
The approach suggested by Citkovitz and colleagues may offer greater therapeutic benefit but we have not identified any objective prospective randomised studies to discover whether this approach has been explored for the provision of intrapartum analgesia and whether it offers any advantage over the much less intensive and less prolonged treatment schedule that we and others have examined. In the absence of any objective evidence to support their view, a similar prospective randomised study similar to what we have described would be justified to evaluate their suggestion.