Thursday, July 19, 2007

Acupuncture effective for hypertension?

A new study is being touted as demonstrating that acupuncture is effective for hypertension. However, looking closely at the study reveals the following:
  • It was not a truly "randomized, double-blind study" as the authors claim.
  • There was an element of the placebo effect at play that could have skewed the results.
  • The patients did not have significant hypertension to begin with.
  • The results disappeared after treatment was discontinued.
While the treatment group did better than the sham group, the doctors administering the treatment would have known they were giving what they believed to be true acupuncture, thus introducing a bias that has been shown to impact patients in countless other studies. If a doctor knows he is using the therapy he believes to work, there are subtle clues he will unconsciously provide to his patients. This is not double-blind and has a high risk of placebo effects. The results, while statistically significant, were not clinically significant. As the author writes:
For example, before treatment, the mean 24-hour systolic/diastolic reading was 131/81 for the active group and 129/80 for the sham group. By the end of the six weeks of treatment, the active group mean systolic/diastolic was 125/78 and the sham group was 130/80. The active group daytime systolic/diastolic scores before and during treatment were 136/84 and 128/80, respectively. The daytime sham group scores were 133/82 and 134/82, respectively. The nighttime scores for the active group, before and during treatment were 120/73 and 117/72. The sham group's nighttime scores were 120/73 before treatment and 120/74 during treatment. Blood pressure changes during peak bicycle stress-testing were also measured, but the changes were not significant.
I say this is clinically insignificant because according to the American Heart Association:
Your blood pressure can change from minute to minute, with changes in posture, exercise or sleeping, but it should normally be less than 120/80 mm Hg for an adult. Blood pressure that stays between 120–139/80–89 is considered prehypertension and above this level (140/90 mm Hg or higher) is considered high (hypertension).

In other words, the patients in both groups had only borderline prehypertension to begin with and neither group had normal blood pressure at the end of the study. It should be noted that the main risk of prehypertension is the later development of true hypertension. It does not pose an imminent risk if MI or stroke. Also, since exercise stress did not result in significant differences between the groups, the true risk is probably negligible as exercise stress is often a precipitating factor for an MI. The study also does not appear to control for other variables that may have influenced BP such as stress, diet, etc. Changes such as the one shown is this study are within the range of effects often seen with slight changes in diet, exercise, or stress levels. Acupuncture is an expensive therapy. While it is not noted in the article, acupuncture is China typically performed daily or every other day, meaning six weeks of treatment yielding only temporary effects would cost an American over $1000 and in most cases would not be covered by insurance. Other more cost-effective approaches such as yoga, meditation, diet and exercise would likely be just as beneficial and much cheaper.

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