Milk thistle ineffective for liver disease

Milk thistle, an herbal remedy used worldwide for liver disease, does not appear to be effective, and there is not enough evidence to conclude that it is safe, an international team of researchers has concluded.

“We can’t see beneficial effects, we can’t exclude harmful effects, and in order to know more we need to do more randomized trials to find out do they actually help,” said Dr. Christian Gluud of Copenhagen University Hospital in Denmark, the study’s lead author.

The market for milk thistle is enormous, Gluud noted, given that as many as 1 billion people around the world have liver disease due to alcoholism or hepatitis B or C. It could even be larger, he added, because some people may decide to take milk thistle for prevention.

Gluud and his colleagues reviewed 13 clinical trials of milk thistle for liver disease due to alcoholism or hepatitis B or C. The gold standard for clinical trials is for them to be placebo-controlled and double-blind, meaning neither patients nor the study administrators know whether a patient is taking the real drug or placebo. Just six of the trials analyzed met this standard.

As they report in the American Journal of Gastroenterology, the researchers found no effect of milk thistle versus placebo on mortality rates or liver disease complications. While the remedy appeared to reduce death from liver-related causes when all data was included, an analysis limited to the best-quality studies found no effect.

No increased risk of adverse events was seen with milk thistle, but this does not necessarily mean the remedy is harmless, Gluud said. Even the highest-quality clinical trials, he noted, can miss catching potential harm from drugs.

According to Gluud, herbal remedies should be held to the same standards as conventional medicine. Sellers of such remedies must be required, he said, to have good evidence for any claims they make.

“My advice to people is don’t use them before you have seen valid, trustworthy, low bias clinical trials that these drugs may actually benefit you more than they may harm you,” he concluded.

SOURCE: The American Journal of Gastroenterology, November 2005.

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