Acute treatment of moderate to severe depression with hypericum extract WS 5570 (St John's wort)

Research from Germany, published in the online version of the British Medical Journal, has compared the effect of St. John's wort with the GlaxoSmithKline (GSK) antidepressant drug Paxil or Seroxat. The researchers noted that half of those given St. John's wort for six weeks in this randomised double blind, reference controlled trial, reported an improvement in their symptoms, versus one third of those who took Seroxat. The group taking Seroxat also reported more side effects, consistent with the results of an investigation by the Medicines and Healthcare Regulatory Authority last year, which concluded that the drug should be avoided in cases of mild depressions, due to its side effects. In an article on iWon, a spokesperson from GSK noted that the study had drawn its conclusions from only one single clinical trial of only 251 outpatients, and commented on the interaction between St. John's wort and various drug products, reducing or altering the effectiveness of these medications. The herbal extract used in the study was WS5570, made by Dr Willmar Schwabe Pharmaceuticals, the company which funded the trial.

Press release issued by Dr Willmar Schwabe Pharmaceuticals:

Major New Study Finds Proprietary St. John's Wort Extract 'at Least as Effective as' Popular Prescription Anti-Depressant

SALT LAKE CITY, Feb 11, 2005 /PRNewswire via COMTEX/ -- For the nearly 19 million American adults suffering depression, new findings that a unique St. John's Wort extract is better at improving mood than a popular anti-depressant drug represents exciting news.

According to a randomized, double-blind, reference-controlled clinical study published today in the prestigious British Medical Journal, the proprietary St. John's Wort extract WS(R) 5570 is at least as effective in treating depression and better tolerated by patients than the widely prescribed anti-depressant paroxetine.(1)

"This study shows that WS(R) 5570 is at least equally effective and better tolerated than one of the leading synthetic antidepressants," says Professor Armid Szegedi, principal investigator of the study. "It therefore represents a real alternative in the treatment of depression."

In the study, 251 patients with moderate to severe forms of depression were divided into two groups: one receiving 900 mg/day of WS(R) 5570, and the other 20 mg/day of paroxetine, for six weeks. Any patients not responding after two weeks had their dose doubled at that time. WS(R) 5570 produced a significantly better improvement in patients as measured by internationally accepted diagnostics such as the Hamilton Depression Rating Scale (HAMD). In fact, WS(R) 5570 delivered a three point greater decrease in the average HAMD total score versus baseline than did paroxetine. This clinically relevant superiority was further supported by a responder rate of 70% versus 60% and a remission rate of 50% versus 35% for WS(R) 5570 and paroxetine respectively. In addition, all secondary efficacy measures, as well as a lower rate of adverse events, favoured WS(R) 5570.

Results are consistent with an earlier double-blind, randomized, placebo-controlled study of 375 depressed patients published in the American Journal of Psychiatry, in which the same St. John's Wort extract WS(R) 5570 was clearly superior to placebo.(2)

In the U.S., an identical strength version of WS(R) 5570 is sold as a natural dietary supplement for promoting a positive mood, rather than a drug for the treatment of depression. This extract (WS(R) 5572) contains the same patented, standardized and stabilized hyperforin content as WS(R) 5570, and is marketed as Perika(R) St. John's Wort by Nature's Way Products, Inc., Springville, Utah. Perika(R) is available nationwide at health and nutrition retail outlets.

WS(R) 5570 and WS(R) 5572 are patented extracts developed and produced by Dr. Willmar Schwabe Pharmaceuticals, Karlsruhe, Germany. They are uniquely standardized to hyperforin, the key constituent within St. John's Wort responsible for its mood balancing effect. The patent also ensures long-term stability of the hyperforin content.

Most other St. John's Wort products are standardized to a different constituent known as hypericin, and some may contain a non-stabilized amount of hyperforin. Consequently, the results of these two clinical studies cannot be extrapolated to other St. John's Wort products that do not contain the same standardized and stabilized potency of hyperforin as WS(R) 5570 and WS(R) 5572.

Note: Paroxetine is a potent SSRI (selective serotonin reuptake inhibitor) with proven efficacy in patients suffering from depression of any severity.

(1) Szegedi A, Kohnen R, Dienel A, Kieser M, "Acute Treatment of Moderate to Severe Depression with Hypericum Extract WS(R) 5570 (St. John's Wort): Randomized, Controlled, Double-Blind, Non-Inferiority Trial versus Peroxetine", British Medical Journal 2005, BMJ Online First

(2) Lecrubier Y, Clerc G, Didi R, Kieser M, "Efficacy of St. John's Wort Extract WS(R) 5570 in Major Depression: A Double-Blind, Placebo-Controlled Trial", American Journal of Psychiatry 2002; 159(8):1361-1366

SOURCE Dr. Willmar Schwabe Pharmaceuticals

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