A stroke is a condition where brain cells get irreversibly damaged either by a haemorrhage in the brain or by a blood clot cutting off oxygen supply. This process leaves most patients with neurological deficits such as difficulties in moving, speaking, concentrating etc. As other parts of the brain learn to take over, these problems can partly or completely resolve themselves over time, but many patients are left with permanent handicaps. Stroke-rehabilitation can minimise these problems, and there is a long-standing debate as to which measures are most effective. Acupuncture has been discussed as a method to improve the results of stroke-rehabilitation, but the evidence is hotly disputed. This is why a new study in this area is an important contribution to our existing knowledge.
The aim of this randomised trial was to test the effectiveness of acupuncture in promoting the recovery of patients with ischaemic stroke and to determine whether the outcomes of combined physiotherapy and acupuncture are superior to those with physiotherapy alone. The Chinese investigators recruited 120 patients who received one of three daily treatments: 1) acupuncture, 2) physiotherapy, 3) physiotherapy combined with acupuncture. Motor function in the limbs was measured with the Fugl-Meyer assessment (FMA); the modified Barthel index (MBI) was used to rate activities of daily living; both of these measures are validated and well-established. All evaluations were performed by assessors blinded to treatment allocation.
At baseline, FMA and MBI scores did not significantly differ among the treatment groups. Compared with baseline, on day 28 of therapy, the mean FMA scores of the physiotherapy, acupuncture, and combined treatment groups had increased by 65.6%, 57.7%, and 67.2%, respectively; on day 56, FMA scores had increased by 88.1%, 64.5%, and 88.6%, respectively. The respective MBI scores in the three groups had increased by 85.2%, 60.4%, and 63.4% at day 28 and by 108.0%, 71.2%, and 86.2% at day 56, respectively. However, FMA scores did not significantly differ between the three treatment groups on the 28th day. By the day 56, the FMA and MBI scores of the physiotherapy group were 46.1% and 33.2% greater, respectively, than those in the acupuncture group. No significant differences were seen between the combined treatment group and the other groups. The FMA subscores for the upper extremities did not show significant improvements in any group on day 56.
The authors draw the following conclusion: “Acupuncture is less effective for the outcome measures studied than is physiotherapy. Moreover, the therapeutic effect of combining acupuncture with physiotherapy was not superior to that of physiotherapy alone. A larger-scale clinical trial is necessary to confirm these finding.”
Our own study arrived at similarly disappointing conclusions: “Acupuncture is not superior to sham treatment for recovery in activities of daily living and health-related quality of life after stroke, although there may be a limited effect on leg function in more severely affected patients“. Our review of all 10 sham-controlled RCTs in this area is also in line with the results of this new study: “Our meta-analyses of data from rigorous randomized sham-controlled trials did not show a positive effect of acupuncture as a treatment for functional recovery after stroke”
I am quite sure that some acupuncture-enthusiasts will dispute this evidence. They might argue that I am too critical, the trials were not done optimally, that acupuncturists have seen plenty of good results in their clinical practice, that acupuncture is a complex intervention that does not fit into the straight jacket of an RCT, that this or that “prestigious” organisation recommends acupuncture for stroke patients, that it would be wrong not to give acupuncture a try etc. etc. I would counter that the reliable evidence available to date is sufficiently conclusive to stop claiming that acupuncture is effective and thus give false hope to severely suffering, vulnerable patients. Moreover, I would advocate using the sparse available resources to help stroke victims with treatments that demonstrably work.
12 Responses to Acupuncture: if it looks like a placebo, feels like a placebo, behaves like a placebo, perhaps it is a placebo??
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No, a larger-scale study is not necessary to confirm these findings. Given that the a-priori probability of acupuncture not being a placebo, already pretty much zero to begin with, didn’t exactly improve as a result of this study, it’s time to defenestrate the whole nonsense.
If I were a member of any ethics committee tasked with approval of any acupuncture study whatsoever, I’d certainly oppose spending any money, or time, on the stuff.
How much money will be spent on this null field*? Time will tell. Seems quite a lot.
* The term is from here: http://www.plosmedicine.org/article/info:doi/10.1371/journal.pmed.0020124
It is better to spend money on things with a higher probability of working.
‘I would counter that the reliable evidence available to date is sufficiently conclusive to stop claiming that acupuncture is effective and thus give false hope to severely suffering, vulnerable patients’.
You state elsewhere on this site that Cochrane reviews are ‘considered to be the most reliable evidence available to date’. The Cochrane review for acupuncture and stroke rehab concludes:
‘There is no clear evidence of the effects of acupuncture on stroke rehabilitation. Acupuncture has biological effects that might improve recovery from stroke or facilitate rehabilitation… More large, high quality randomised trials are needed.’
So, far from ‘sufficiently conclusive’. It suggests that acupuncture has very real biological effects, and therefore is not a placebo, and that more studies are needed. It is accepted within the acupuncture community that the intervention is most likely to help when treatment commences as soon as possible after stroke (unlike any of the Cochrane trials). Considring all this, I would argue that more investigation is certainly justified.
the 2nd sentence of the Cochrane review is odd: the review is NOT about biological effects but about clinical effectiveness. i’d say that this bit of the conclusion is therefore not warranted. otherwise, we are in agreement, except, of course, that the Cochrane review does not include the new trial which is the subject of my post.
To quote from the Cochrane review:
‘Many studies in animals and humans have demonstrated that acupuncture can cause multiple biological responses, including
circulatory and biochemical effects. These responses can occur locally or close to the site of application, or at a distance. They are mediated mainly by sensory neurons to many structures within the central nervous system. This can lead to activation of pathways affecting various physiological systems in the brain as well as in the periphery (Jansen 1989; Johansson 1993; Magnusson 1994; Sun 2001;Wang 2001). Whether acupuncture can really improve recovery in patients with stroke is still uncertain’.
Although the review itself is not about biological effects, the reviewers have done the responsible scientific thing and looked at the wider evidence in order to arrive at a fair and rounded conclusion. The two statements ‘there is no clear evidence of the effects of acupuncture on stroke rehabilitation…More large, high quality randomised trials are needed’ (Cochrane review), and ‘the reliable evidence available to date is sufficiently conclusive to stop claiming that acupuncture is effective’ (yours) are very different. The former is a balanced scientific appraisal; the latter, it seems to me, is misleading, and I can only assume based on personal prejudices. The Cochrane review is anything but conclusive, and one extra study does not alter that. The authors themselves conclude ‘A larger-scale clinical trial is necessary to confirm these findings.’
My gripe, and that of many other practitioners and advocates of CAM, is that there is an obvious bias against CAM in what you write. You regularly omit important information in the way that you criticise the CAM field of doing, and almost exclusively highlight the negative. That would be fine if you made it clear that this was your personal opinion, but instead you present it as cold hard fact. I understand that you want to provoke debate, but is it not your responsibility as an esteemed scientist to present the whole truth?
the Cochrane conclusion regarding clinical effectiveness is justified. mine is more negative because it is focussed on a new study which was not included in the former review. is this really so difficult to grasp?
Tom, I think you’d find it more fruitful to look at recent literature on acupuncture and stroke rather than try to debate with Edzard on the Cochrane review (which is a bit long in the tooth now). There’s another recent RCT comparing acupuncture and physiotherapy (Zhuang et al, 2012). This was a larger study (n=310) that found all three arms to perform similarly. Both the acupuncture and physio groups had significantly improved outcomes (using the same measures in the study Edzard has highlighted) over baseline, as did the combined treatment group, but there were no differences between the groups. The conclusions were that acupuncture could offer an alternative to physio, but that there did not seem to be any advantage in combining the two.
It would be interesting to compare the inclusion and exclusion criteria, details of the interventions, the way the stats were done etc to try to explain the different results in these two trials. For example, there may be types of stroke patients that are more likely to benefit from acupuncture than others.
So, looks like there is a good case for more research after all (don’t worry, the Chinese will probably pay for it).
As for systematic reviews, my cherry-pick would again be different from Edzard’s. I’ll go for the Canadian meta-analysis of Wu et al (2010): it included Chinese and Western trials, had high class authors, and, of course, delivered some (guardedly) positive conclusions
I am more interested in the rate of failure of the acupuncture. After all physio (adjusted to the condition of the patient) has to be started as soon as possible, without waiting whether acupunture does or does not work miracles. Combine? Well, it is a nice way to increase expenses of the stroke patient/family.
Thanks Mark, I bow to your superior knowledge on the available data. No reply from Edzard yet on this for some reason…