Editorial: Confusion Rains

By Len Monheit

The past few weeks have been sensational for the number of headlines dealing with supplements and natural health products, most recently last week’s New England Journal of Medicine (NEJM) study result based on the Women's Health Initiative (WHI) trial involving the effect of calcium and vitamin D supplementation on the risk of fractures, the other on the consumption of calcium and vitamin D on the risk of colorectal cancer, and then this week’s study result and editorial in NEJM regarding the Glucosamine/chondroitin Arthritis Intervention Trial (GAIT).

In either of these most recent cases, media pick up on the story was predictably neutral to negative, as was pick up of the story a few weeks ago regarding saw palmetto and benign prostatic hyperplasia (BPH), also published in the New England Journal of Medicine, which observed that the supplement was ineffective and contradicted (and called into question the validity of) previous research. In this particular case, the research involved moderate to severe BPH, whereas previous positive research involving saw palmetto predominantly involved mild to moderate BPH.

In the WHI fracture risk analysis, the researchers randomly assigned post-menopausal participants to take supplements containing 1,000 milligrams of calcium and 400 international units of vitamin D or placebo pills, and followed them for seven years on average, observing that hip bone density was 1% higher in women in the supplement group, and overall, the improvement in hip bone density was accompanied by a 12% reduction in fracture risk. Significantly, among women who said they took at least 80% of their study pills, there was a statistically significant 29% drop in hip fractures in the supplement group. (NEJM Abstract: http://content.nejm.org/cgi/content/abstract/354/7/669?hits=20&where=fulltext&andorexactfulltext=and&searchterm=calcium&sortspec=Score%2Bdesc%2BPUBDATE_SORTDATE%2Bdesc&excludeflag=TWEEK_element&searchid=1&FIRSTINDEX=0&resourcetype=HWCIT)

Those not reading the fine print of story saw only that calcium and vitamin D supplementation was ineffective, or at least if limited value. It took a bit of analysis to realize the significance of the result when program compliance was followed. One certainly didn't pick this information up from a scan of headlines, and when the industry response came in claiming that the study in fact, supported, to a certain extent the efficacy of supplementation, the net effect of the communication was confusion.

This week’s GAIT publication examined the multicenter, double-blind, placebo- and celecoxib-controlled study which determined that while overall, glucosamine and chondroitin sulfate were not significantly better than placebo in reducing knee pain (the combination was 6.5% higher than placebo), patients with moderate-to-severe pain at baseline experienced a rate of response that was significantly higher with combined therapy than with placebo (79.2% vs. 54.3%). (NEJM Abstract http://content.nejm.org/cgi/content/abstract/354/8/795). The presentation of these particular results on the NEJM home page states “In this trial, glucosamine and chondroitin sulfate were not more effective, alone or in combination, than placebo in controlling pain in patients with osteoarthritis of the knee.”

The calcium and vitamin D and fracture risk study might involve a dose issue (the vitamin D dose was 400 IU), and certainly does involve a regimen compliance issue. The GAIT study appears to involve a target population issue (moderate to severe pain associated with a positive result, versus mild to moderate with a non-significant result), ironically exactly the opposite contention to those reviewing the saw palmetto study a few weeks ago where past positive results had been observed with mild to moderate BPH rather than moderate to severe. (One analysis of the GAIT study also notes the high placebo positive response of 60% making it much more difficult to achieve statistical significance on improvements above that level with any treatment. Here again, both 'sides' claim partial victory in the study findgings, the end result again - confusion.

In this column two weeks ago (http://www.npicenter.com/anm/templates/newsATemp.aspx?articleid=14859&zoneid=42) I spoke about the significance of the current scientific debate specifically relating to the saw palmetto study. The ongoing investigation and research is a positive thing, the importance of proper selection of population and health condition groups is critical, and industry examination and response/context to the study is very important. All of these observations apply equally here, but the scene is now overlaid (especially with these recent headlines and results) with another very strong factor – confusion.

Many believe the marketplace is confusing enough – numerous products, various standards, certifications, brands etc., and the recent dissemination of science has emphasized the potential confusion that lies in attempting to comprehend the state of the science on single ingredient products, let alone combination products and brands. Issues such as dose, product quality, specificity of health condition, target population, period of use and numerous other factors all must be understood in order to begin to make sense of the information and misinformation that exists. For the confused consumer who primarily wants to know two critical pieces of information, the landscape can be frustrating as they ask – “Is this product going to work?” and “Which one should I buy?”

Some consumers will have their own belief set regarding the first question, but based on the mixed or negative messaging over the past few weeks, (and it’s not just about calcium and vitamin D and glucosamine and chondroitin sulfate, it’s also about soy, fiber, low-fat diets and other emerging information), a good portion of the population will have a high level of uncertainty. There are two possible outcomes to heightened confusion and uncertainty. In the first scenario, the audience becomes increasingly skeptical and challenging of all sources of information, baseline knowledge of facts increases and personal responsibility for ‘finding out more’ increases. In the second scenario, confusion adds stress to what should be simple life decisions, and rather than investigate ‘details’ the average consumer decides to ‘wait until it’s all straightened out’. (And we know with evolving science that it never all gets straightened out.)

I hope that we, as an industry, take any and all steps to support the first scenario – to recognize and assist those that challenge the information presented to them as they seek facts and details - to increase the state of their scientific understanding, and also their ability to make choices for themselves and their families. Collectively, we’ve got to prevent those inclined to do so from throwing up their hands and saying, “it’s just too confusing”.

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