The results of this trial are published hard on the heels of a negative trial with other supplements, vitamin E and vitamin C, in the prevention of cardiovascular disease and stroke in the Physicians’ Health Study II. Results of that study were published in the November 12 issue of the Journal of the American Medical Association and were reported at the American Heart Association Scientific Sessions 2008. A second analysis looking at cancer was reported this week at the American Association on Cancer Research prevention conference and, similarly, showed no benefit of either agent in the prevention of cancer.

These outcomes underline the importance of randomized controlled clinical trials to assess the safety and efficacy of these agents, said GEM study coauthor Steven T. DeKosky, MD, from the University of Pittsburgh in Pittsburgh, Pennsylvania, and now is at the University of Virginia School of Medicine in Charlottesville.

“One of the major outcomes of this study is we proved you can actually do the study,” he told Medscape Neurology & Neurosurgery. GEM is among the first trials that recruited a new cohort to look at a cognitive outcome using a supplement to actually finish and report findings. “It’s disappointing,” he says of their results, “but it’s the way the science has to be done. The design would have been identical if it were a medication from a major pharmaceutical company, and not an over-the-counter alternative medication.”

Preservation of Memory

In their study, the authors note that G biloba is prescribed in some areas of the world for the preservation of memory, although no medications are approved for the primary prevention of dementia. In the United States, worldwide sales of G biloba exceed $249 million annually.

The purported effect of G biloba is by the action of multiple antioxidants, although a recent in vitro study also suggested that has an antiamyloid aggregation effect, they note. Studies of G biloba in the setting of dementia have had mixed results, although a Cochrane Collaboration Review in 2007 found the evidence of a benefit, “not convincing,” the study authors write.

The current study was a randomized, placebo-controlled clinical trial carried out at 5 academic medical centers in the United States to see whether treatment with G biloba in a dose of 120 mg 2 times/day could prevent incident dementia or Alzheimer’s disease vs placebo. A total of 2587 subjects older than 75 years with normal cognition at baseline, and 482 subjects with mild cognitive impairment were included. Patients were assessed every 6 months for dementia.

After a median follow-up of 6.1 years, 523 subjects were diagnosed with dementia, 246 (16.1%) in the group taking placebo, and 277 (17.9%) in those taking G biloba. Of the total dementia cases, 92% were classified as possible or probable Alzheimer’s disease or Alzheimer’s disease with evidence of cerebrovascular disease.

The rate of total dementia did not differ between groups, with 3.3 vs 2.9 cases per 100 person-years with G biloba vs placebo. The rates of Alzheimer-type dementia were also similar, at 3.0 vs 2.6 cases per 100 person-years with G biloba vs placebo.

“Untenable” to Recommend Without Evidence

In an editorial accompanying the publication, Lon S. Schneider, MD, from the University of Southern California, Los Angeles, points out that the GEM trial is the largest and longest trial that “comprises the substantial bulk the non–industry-funded, placebo-controlled clinical database for G biloba extract” and provides no evidence that it contributes to clinically meaningful dementia risk reduction.

There was no reduction either in cardiovascular serious adverse events or in total mortality rates — 2 secondary endpoints of the trial, Dr. Schneider notes. The relationship with cardiovascular disease, though, is “potentially more complex,” he adds, in that subgroup analyses showed an increased risk for dementia in those with cardiovascular disease at baseline and a nonsignificant increase in hemorrhagic stroke with treatment, although vascular dementia was lower with G biloba.

Although these observations may be the result of chance, they suggest that, “at least in patients aged 75 years or older with cardiovascular disease, G biloba may have risks and the decision to use this agent should be carefully considered,” he writes.

“Users of this extract should not expect it to be helpful,” Dr. Schneider concludes. “Moreover, the potential adverse effects of G biloba extract illustrate why it is untenable to recommend a drug or nutraceutical in the absence of efficacy evidence simply because it could possibly help and initially appears harmless.”

Short-Term Improvements?

Dr. Schneider added that results for 2 other secondary outcomes — overall cognitive decline and functional disability — are not reported in this study, although he speculates that it is unlikely that they are positive in the setting of an overall negative trial. Nevertheless, the effects of treatment on actual cognitive test scores and daily function ratings “are important because individuals without cognitive impairment who use G biloba may expect it to noticeably improve their intellectual function over the short term but not necessarily to prevent Alzheimer disease or other dementia in the long term.”

Dr. DeKosky noted that these 2 secondary endpoints will be published at a later date. The follow-up testing on these endpoints was less sensitive to small changes in cognitive function, he explains. “We are going to look at those data and see if we can find something in there that gives us a signal, but that actually turns out to be a bit more complicated an analysis, and so we knew we would not be able to put it into this study in which there were some singular outcome and safety issues that we knew everyone would want to know about,” he said.

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“There is no consistent evidence, to our knowledge, that calcium supplementation affects…BMD in men, despite male osteoporosis being a common clinical problem,” write Ian R. Reid, MD, from University of Auckland in Auckland, New Zealand, and colleagues. “It is critically important to determine whether the widespread use of calcium supplements in older men is a worthwhile investment because 30% of older men experience a fragility fracture and men account for one-quarter of all hip fractures.”

For a 2-year period at an academic clinical research center, 323 healthy men 40 years or older (mean age, 57 years) were recruited by newspaper advertisement and randomly assigned to receive daily supplementation with calcium 600 mg/day, calcium 1200 mg/day, or placebo. Follow-up was complete in 96% of subjects.

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In men receiving calcium at 1200 mg/day, there were dosage-related, sustained decreases at 2 years in serum parathyroid hormone levels (25% decrease; P < .001), total alkaline phosphatase activity (8% decrease; P = .01), and procollagen type 1 N-terminal propeptide levels (20% decrease; P < .001).

Calcium supplementation did not appear to affect tooth loss, constipation, or cramps. Although falls occurred less often in the group receiving calcium at 1200 mg/day, both calcium-supplemented groups tended to have more vascular events vs the placebo group.

Limitations of this study include single-center study in a predominantly white cohort of vitamin D–sufficient men, use of calcium citrate, and insufficient statistical power for many other end points.

"Calcium, 1200 mg/d, has effects on BMD in men comparable with those found in postmenopausal women but a dosage of 600 mg/d is ineffective for treating BMD," the study authors write. "These findings provide a rationale for conducting randomized studies of the effect of calcium supplementation on fracture incidence in men. Such studies should also assess the incidence of cardiovascular events so that the balance of risk and benefit can be clearly determined."

Clinical Context

Calcium supplementation is essential to the prevention of osteoporosis in postmenopausal women, but less is known about the efficacy of calcium supplementation on fractures and BMD in men. There are 30% of older men who experience fragility fractures, with men accounting for one quarter of all hip fractures.

This is a double-blind, randomized, placebo-controlled trial to examine and compare the effects of 2 doses of calcium supplementation on BMD, fractures, falls, and adverse events in men without calcium insufficiency.

Study Highlights

* Included were healthy men 40 years and older recruited by newspaper advertisement.
* Excluded were men with any major illness, estimated cardiovascular risk of more than 15% for 5 years, renal dysfunction, or use of hormones.
* After a 1 month run-in, only those with at least 70% adherence to medication were accepted.
* Men were randomly assigned to receive 1 placebo tablet twice daily (n = 107), one 600-mg/day calcium citrate tablet for the 600-mg/day group (n = 108), or two 600-mg/day calcium citrate tablets for the 1200-mg/day group (n = 108) for 2 years.
* BMD was measured at 6-month intervals in the lumbar spine, the proximal part of both femora, and total body with use of a Prodigy dual-energy x-ray absorptiometer (GE-Lunar, Madison, Wisconsin).
* Vertebral morphometry was performed at baseline and at 2 years.
* Subjects were asked about fractures and kept a diary of their falls.
* Follow-up visits occurred every 6 months.
* Grip strength was measured in the dominant hand.
* Dietary calcium intake was assessed with a food frequency diary.
* Serum-25 hydroxyvitamin D level was measured as were levels of bone turnover markers.
* Mean age of participants was 56 years, 1% to 6% were current smokers, mean weight was 83 kg, and mean body mass index was 26 kg/m2.
* Complete follow-up was achieved in 96% of subjects: 93% for placebo, 91% for the low-dose calcium group, and 86% for the high-dose calcium group.
* Medication compliance was 85% for the placebo group, 86% for the low-dose calcium group, and 83% for the high-dose calcium group.
* The 600-mg/day group showed no difference from the placebo group for BMD at 2 years.
* The 1200-mg/day group showed a significant increase in BMD of 1% at 1 year; this difference was maintained to the end of the study.
* For total hip BMD, there was no difference between the 600-mg/day group and the placebo group, and the 1200-mg/day group showed a significant increase of 0.9% in year 1 with an additional 0.5% improvement in year 2.
* The hip changes showed improvement with time.
* The improvements in BMD for the 1200-mg/day group were not dependent on dietary calcium intake.
* Total body scans showed a similar pattern to the lumbar spine for the 1200-mg/day group, with an increase of 1.2% in the first 6 months and a more gradual increase to 1.5% above baseline by the end of the study.
* Falls decreased significantly in the 1200-mg/day group, but not in the 600-mg/day group, vs placebo (fall rates of 45, 65, and 59, respectively, per 100 person-years).
* Fasting levels of parathyroid hormone showed a dose-related decrease in the 2 supplemented groups.
* Bone turnover measured by markers showed dose-related sustained changes in response to calcium.
* There were no significant differences in fracture rates among the 3 groups and no differences in height loss.
* Adverse events including constipation, tooth loss, and cramps were similar among the 3 groups.
* Grip strength was similar in the 3 groups.

Pearls for Practice

* Calcium supplementation with 1200 mg/day, but not 600 mg/day, for 2 years vs placebo is associated with an increase in BMD in men with adequate dietary calcium intake.
* Calcium supplementation for 2 years with 1200 mg/day is associated with a reduction in falls, but not fractures, in men with adequate dietary calcium intake, and adverse events are not increased.

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