Stimulated by Ormsby et al 2020.[1]
This is a pragmatic 3-arm comparative trial. It has feasibility in the title, so it may be that the authors are planning a much bigger version. I’ll ask! (No reply as yet…)
Pregnant women of 24 weeks gestation who scored 13 or more on the Edinburgh Postnatal Depression Scale (EPDS)[2] were recruited and randomised to either acupuncture, treatment as usual (TAU) or progressive muscular relaxation (PMR).
Acupuncture vs TAU vs PMR
Weekly sessions of acupuncture or PMR were given over 8 weeks. The acupuncture appears to have been rather gentle, using 2 to 10 needles of 0.12 or 0.16mm diameter and inserted 2 to 6mm with no attempt to elicit de qi. The lead author was the practitioner for both acupuncture and PMR sessions, so many of the contextual aspects would have been controlled for in this trial, but not the idea of receiving acupuncture or the expectations generated from that idea.
ITT – intention to treat
an analysis based on the groups formed at randomisation, not based on what they actually got or whether or not they withdrew from the trial
The methods (including ITT analysis) seem rather excessively rigorous for a feasibility study with just 19 participants in each arm, but that might be the lead author getting some practice in for a bigger project.
PP – per protocol
an analysis of only those participants who received the intended interventions
Acupuncture was significantly superior to TAU and to PMR after the intervention, but not at six weeks in the ITT. Acupuncture was superior at six weeks in the per protocol analysis, but on average the groups had all improved such that they no longer scored enough on the EPDS to be classified as depressed.
I thought we had published a paper on acupuncture treatment of depression in pregnancy in Acupuncture in Medicine some years ago, so I went to look for it. I was wrong, it was dyspepsia and insomnia (both in pregnancy).[3,4] But whilst looking I came across a couple of papers I had previously missed,[5,6] and the larger of the two was quite intriguing.[6]
This was another 3-arm trial (n=150), but with 2 acupuncture groups and a massage group. Why 2 acupuncture groups you might ask? Well one was acupuncture specifically tailored to depression, and the other was not. A senior acupuncturist saw each patient and designed both acupuncture prescriptions but was blind to allocation. A junior acupuncturist then applied the prescription based on allocation without knowing any of the details used to make up the prescription in the first place. Quite a clever approach, but not based on any scientific rationale in terms of possible mechanisms.
Since there can be no local or segmental approach to depression, any needling should have similar central effects in terms of stimulation-induced neurophysiological effects.
It is quite remarkable therefore that this research team managed to measure a difference between the two groups that were both needled in 7 to 12 points across the same regions of the body. Especially considering that a very similar prior trial in depression (n=151) with a waiting list third arm rather than massage found no such effect.[7] Indeed there seemed to be trends in favour of the non-depression-specific acupuncture group in this one.
“pregnancy is a unique period of change where acupuncture may be particularly effective”
Rosa S
I was intrigued enough to look up the first author of the positive trial in pregnancy and surprised to find that she is now a professor of psychiatry in Stanford. Since professors are generally happy to be faced with questions, I wrote to her and asked her opinion. She replied almost by return explaining that she was not trained in acupuncture, but that the methodological problems of trials of acupuncture had some similarity with those she encountered in her field on psychotherapy. She went on to say that her acupuncturist research colleagues ‘suggested that pregnancy is a unique period of change where acupuncture may be particularly effective.’
type I statistical error
is the rejection of a true null hypothesis; a false positive result; you have shown a difference (statistically) between to groups where there is actually no real difference…
Since the p values and CIs (confidence intervals) were perilously close to the margins and there was more than one test for the primary outcome without statistical correction for multiple tests, I guess this may be a type I error (a significant difference measured by random chance), possibly helped along by unblinding of the junior acupuncturists and a consequent subliminal influence on the women.
Whilst I was looking for the original paper in the Journal of Affective Disorders, which by the way is rather fittingly the official journal of ISAD (the International Society for Affective Disorders), I found another very recent acupuncture paper on depression. A small pragmatic trial (n=25) from Brazil that found in favour of ‘natural therapy’ (including mindfulness meditation, reiki, acupuncture and auriculotherapy) over a no treatment control.[8] Perhaps the most interesting aspect to this pilot study was that 4 participants dropped out because of the acupuncture. That is nearly 30%, so hopefully the authors will take this into account when recruiting of a subsequent trial.
The Effects of Antepartum Depressive Symptoms on Postcesarean Opioid Consumption
Finally, whilst researching for this blog, I must have searched for antenatal depression without acupuncture as a term, and I turned up a paper hot of the presses of the American Journal of Perinatology, with the title: The Effects of Antepartum Depressive Symptoms on Postcesarean Opioid Consumption.[9] The authors found an association between antepartum depressive symptoms and acute pain after caesarean delivery leading to increased opioid use. They went on to wonder whether treating the depression could mitigate the opioid use. Well that nicely ties things up doesn’t it! Acupuncture could treat the antenatal depression avoiding the use of drugs in pregnancy,[10] and also be used as pain relief for C section,[11] as has been introduced in the University Hospital of Greifswald by our friend Taras.
References
1 Ormsby SM, Smith CA, Dahlen HG, et al. The feasibility of acupuncture as an adjunct intervention for antenatal depression: a pragmatic randomised controlled trial. J Affect Disord 2020;275:82–93. doi:10.1016/j.jad.2020.05.089
2 Cox JL, Holden JM, Sagovsky R. Detection of Postnatal Depression. Br J Psychiatry 1987;150:782–6. doi:10.1192/bjp.150.6.782
3 da Silva JBG, Nakamura MU, Cordeiro JA, et al. Acupuncture for Dyspepsia in Pregnancy: A Prospective, Randomised, Controlled Study. Acupunct Med 2009;27:50–3. doi:10.1136/aim.2009.000497
4 Guerreiro da Silva JB, Nakamura MU, Cordeiro JA, et al. Acupuncture for Insomnia in Pregnancy – a Prospective, Quasi-Randomised, Controlled Study. Acupunct Med 2005;23:47–51. doi:10.1136/aim.23.2.47
5 Manber R, Schnyer RN, Allen JJB, et al. Acupuncture: a promising treatment for depression during pregnancy. J Affect Disord 2004;83:89–95. doi:10.1016/j.jad.2004.05.009
6 Manber R, Schnyer RN, Lyell D, et al. Acupuncture for Depression During Pregnancy. Obstet Gynecol 2010;115:511–20. doi:10.1097/AOG.0b013e3181cc0816
7 Allen JJB, Schnyer RN, Chambers AS, et al. Acupuncture for Depression. J Clin Psychiatry 2006;67:1665–73. doi:10.4088/JCP.v67n1101
8 Cardozo-Batista L, Tucci AM. Effectiveness of an alternative intervention in the treatment of depressive symptoms. J Affect Disord Published Online First: July 2020. doi:10.1016/j.jad.2020.06.060
9 Walker Z, Perkins C, Harper L, et al. The Effects of Antepartum Depressive Symptoms on Postcesarean Opioid Consumption. Am J Perinatol Published Online First: 18 July 2020. doi:10.1055/s-0040-1714392
10 Smith CA, Shewamene Z, Galbally M, et al. The effect of complementary medicines and therapies on maternal anxiety and depression in pregnancy: A systematic review and meta-analysis. J Affect Disord 2019;245:428–39. doi:10.1016/j.jad.2018.11.054
11 Hesse T, Henkel B, Zygmunt M, et al. Acupuncture for Pain Control after Caesarean Section: A Prospective Observational Pilot Study. Acupunct Med 2016;34:14–9. doi:10.1136/acupmed-2015-010852
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