New trials put Ginkgo and Hawthorn to test

Researchers expect that these new trials now under way will help answer some of the questions that previous botanical studies could not – and perhaps raise more questions in the process.

• Ginkgo biloba. The Ginkgo Evaluation of Memory Study (GEMS) has enrolled 3,072 subjects. That makes it the largest trial ever to test whether ginkgo can delay the onset of dementia, and the first to test its possible role in primary prevention of dementia, the primary investigator said at the workshop. The randomized, multi-center, placebo-controlled study also will measure the effect of ginkgo on overall memory decline and the incidence of cardiovascular disease and functional decline in adults 75 years or older who are initially free of cognitive impairment. In GEMS, patients will take a ginkgo preparation, EGb 761, twice daily for 4-5 years. Cognitive function will be assessed every six months, said at Wake Forest University, Winston-Salem, N.C. At one year into the trial, 97 percent of subjects have completed both clinical visits, and 87 percent are taking their assigned tablets.

• Hawthorn (Crataegus oxycantha or C. monogyna). The Hawthorn Extract Randomized Blinded and Congestive Heart Failure (HERB-CHF) trial will compare twice-daily use of 450mg of hawthorn extract WS1442 with placebo in 120 patients with mild to moderate CHF. The patients will receive standard medical therapy unless contraindicated or not tolerated. They will be followed for six months, with clinical visits and baseline and at three and six months, said by the primary investigator. The main outcome will be walking ability; data also will be compiled on patient quality of life ratings. A separate study, the Survival and Prognosis Investigation and Crataegus Extract (SPICE) trial in Eastern and Central Europe, will examine the effect of 450mg of WS 1442 hawthorn extract twice daily, or placebo, in about 2,600 patients with class II or III heart failure. The use of B-blockers and ACE inhibitors is encouraged but not required.