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Poor Study Design Can Show Anything You Like: Acupuncture For Hot Flashes

In the most recent issue of The Journal of clinical Oncology is a study comparing acupuncture to Effexor in the treatment of vasomotor symptoms (hot flashes) in women with breast cancer who cannot take hormone replacement therapy. The study found that the two treatments are equivalent, with longer duration and fewer side effects from acupuncture. However, the study is designed as a pilot study (very preliminary) and therefore the conclusions are highly unreliable – given prior research, this raises the question as to why the study was performed at all.

The study included only 50 women, which is a small number for a clinical trial and alone means this is at best a preliminary study. There were 25 women randomized to one of two arms – either acupuncture or Effexor (which is standard treatment for vasomotor symptoms in women with breast cancer). However, the two arms were not blinded in any way, and there was no acupuncture control group – no sham or placebo acupuncture.

It is unclear why the researchers undertook a small unblinded study such as this, given that previous studies were better designed.

Acupuncture for Hot Flashes in Other Conditions

The largest literature for acupuncture and vasomotor symptoms is not in cancer patients, but in post-menopausal women. It is unclear if these two groups are comparable for treatment effects, but at least acupuncture for any vasomotor symptoms touches on the plausibility of this treatment in any context.

A recent systematic review of the literature included six trials in which acupuncture was compared to sham acupuncture – 5 of the 6 studies were negative. The reviewers concluded:

There is no evidence from RCTs that acupuncture is an effective treatment in comparison to sham acupuncture for reducing menopausal hot flashes. Some studies have shown that acupuncture therapies are better than hormone therapy for reducing vasomotor symptoms. However, the number of RCTs compared with a nonpenetrating placebo control needle or hormone therapy was too small, and the methodological quality of some of the RCTs was poor. Further evaluation of the effects of acupuncture on vasomotor menopausal symptoms based on a well-controlled placebo trial is therefore warranted.

This would seem to be sufficient evidence to conclude that acupuncture lacks efficacy. For those who believe that further research is required, it only makes sense to perform larger and more rigorous studies.

Acupuncture has also been studied for the treatment of hot flashes in men being treated for prostate cancer. A systematic review of this research concludes:

The evidence is not convincing to suggest acupuncture is an effective treatment for hot flush in patients with PC. Further research is required to investigate whether acupuncture has hot-flush-specific effects.

There was much less literature to review in this case, and there were no large blinded studies.

Acupuncture for Hot Flashes in Breast Cancer

A recent systematic review of studies looking at acupuncture for breast cancer side effects concluded:

In conclusion, the evidence is not convincing to suggest acupuncture is an effective treatment of hot flash in patients with breast cancer. Further research is required to investigate whether there are specific effects of acupuncture for treating hot flash in patients with breast cancer.

There were only three controlled trials comparing acupuncture to sham acupuncture, one positive, and two negative. The review also included some studies of electroacupuncture – but I maintain that electroacupuncture, which uses electrical stimulation through acupuncture needles, is not acupuncture (it’s electrical stimulation) and should not be considered in the same therapeutic category.


The history of acupuncture research in general has been that the technology of performing acupuncture studies and properly blinding them has actually improved. At first blinded sham acupuncture was the standard, but that was improved by sheathed non-penetrating acupuncture needles allowing for double-blinding.

Also, the general trend within clinical research of any question is to progress from small unblinded pilot studies to progressively larger and more rigorous studies, if warranted, until there are a few large well-designed trials that together sufficiently settle an issue.

Overall, the results of acupuncture for any indication are very similar to the results I outline above for hot flashes – small studies with mixed results, followed by better-designed studies that are mostly negative. For any indication the evidence is either inadequate or shows that acupuncture does not work.

This study is therefore of dubious utility. It is a very preliminary study in an area where there is already several more rigorously designed studies, trending negative. Given the overall acupuncture research, and the minimal prior plausibility, in my opinion there is already sufficient evidence to conclude that acupuncture probably does not work for hot flashes in patients with breast cancer. However, if researchers feel that there is some potential to acupuncture and more research is deserved, the only utility would be from a large rigorously designed trial – which this study definitely is not.

In short, this study changes nothing and is a step backwards. It does, however, result in another round of press releases with the very misleading title that acupuncture works for hot flashes.

*This blog post was originally published at Science-Based Medicine*

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