June 7, 2007 (Erlangen, Germany) - A study billed as the first rigorous, randomized trial in the West to test acupuncture against a sham needle technique to treat hypertension suggests that, performed properly, acupuncture may produce blood-pressure changes on a par with monotherapy in mild to moderate hypertension .
"It's certainly not like a wonder drug; it's not a massive effect, but it's a clear effect," lead investigator Dr Frank A Flachskampf (Universittsklinikum Erlangen, Germany) told heartwire.
Smaller randomized trials have been performed in China, with mixed results, while one randomized study in the West found no difference in blood-pressure lowering between traditional Chinese acupuncture, standardized acupuncture, and a sham procedure, the authors note. This earlier study did not use ambulatory blood-pressure measurements, believed to be superior to office-based measurements.
Results of their study are published online June 4, 2007 in Circulation.
For the study, 160 outpatients with uncomplicated, mild to moderate hypertension were randomized to six weeks of acupuncture performed by Chinese medicine practitioners, trained in China, or to a sham procedure. In both arms, patients underwent 22 sessions, each 30 minutes in length. By the end of the six weeks, 24-hour ambulatory systolic and diastolic blood pressures were significantly reduced from baseline in the acupuncture-treated patients (5.4 mm Hg and 3.0 mm Hg, respectively), and this change was also significantly different from values in the sham-treated patients, in whom no meaningful changes were seen.
After three and six months, however, the blood-pressure reductions disappeared, leading investigators to conclude that ongoing acupuncture treatments would be required to maintain the blood-pressure reductions.
"The main finding is that for the first time in a reasonably sized but still relatively small randomized study, this establishes beyond a reasonable doubt that acupuncture lowers blood pressure," Flachskampf commented. "It's a modest but undeniable effect on both systolic and diastolic blood pressure."
The extent of the blood-pressure reductions are comparable to those seen with ACE-inhibitor monotherapy or aggressive lifestyle changes, including radical salt restrictions, he added.
Flachskampf had some caveats, acknowledging that the regular acupuncture sessions used in the study represent a significant time investment: each acupuncture session lasted 30 minutes--not including transportation and administrative time--and took place several times a week. The study subjects were also reasonably healthy, with no other major risk factors and with only mild to moderate hypertension.
"This is clearly something that would probably not work as well with very sick people or people with blood pressure at dangerous levels," he said. "We cannot easily extrapolate to people, for example, with complicated hypertension who have had a myocardial infarction."
Flachskampf believes, however, that acupuncture likely represents an attractive option in specific patients, particularly those averse to taking medical therapy who are open to so-called "alternative" medicine.
"This is probably only for people who somehow relate to this spiritually, who say I am profoundly against taking drugs and I'm very fond of Oriental wisdom or things like that," Flachskampf told heartwire. "I don't want to make a joke about this, but this certainly needs more compliance than taking two or three pills a day. It's much more demanding."
Unlike drugs, acupuncture appeared to have few or no side effects, although two people complained that the needles were painful. "Clearly, many millions of Chinese get acupuncture without any major problems so I think this is really a minor point," Flachskampf observed.