Page 113 - JSOM Summer 2018

Qualified evidence-based recommendations in favor of par- and/or ease pain. Claims made on the product label (and in
4
ticular dietary ingredients were made when the evidence sup- advertising) often draw us in to purchase the product, and
porting such use outweighed evidence against the use. The sometimes we find ourselves doing this without reading the
recommendations were “qualified” because in many cases the Supplement Facts panel showing what ingredients are in the
quality of the evidence was not high (i.e., moderate to low product. As the dietary supplement market continues to grow
quality). For these ingredients, healthcare providers should be at a rapid pace, it is important to know what to look for on
aware of the evidence and prepared to help SOF Operators and how to read the product label in an objective manner.
make decisions. Importantly, Operators should consult their
healthcare provider before taking any dietary supplement for Are claims made on product labels regulated?
pain and learn how to select a product that conforms to rig- The US Food and Drug Administration (FDA) regulations
orous quality standards, such bearing as a USP or NSF cer- allow dietary supplements manufacturers to make claims
tified/verified product seal. No recommendations were made about health, nutrient content, and statements of nutritional
when the evidence reviewed was too speculative or tradeoffs support, often referred to as structure/function claims (e.g.,
(risk:benefits) were closely balanced to decide on the direction calcium builds strong bones) related to the ingredients in
of a recommendation. Conversely, recommendations against products. Because statements of nutritional support are not
the current use of ingredients were made when (1) the evidence approved by the FDA, product labels containing such claims
for a beneficial effect was lacking, (2) the evidence was sim- must also include a disclaimer that reads, “This statement
ply insufficient, or (3) the undesirable anticipated effects out- has not been evaluated by the FDA. This product is not in-
weighed the desirable effects, across factors specifically related tended to diagnose, treat, cure, or prevent any disease.” If
to SOF. Overall, the panel made no strong recommendations at any time a manufacturer intends to use a supplement to
across any of the ingredients claimed to combat pain and op- treat a condition (such as pain), it must go through the In-
timize performance, primarily due to the lack of high-quality vestigational New Drug application process. Because dietary
evidence. This finding emphasizes and reinforces the critical supplements are regulated as foods, unlike drug products, di-
3
importance of shared decision-making between Operators and etary supplement products are not evaluated for their safety
their healthcare provider. or effectiveness before they reach the consumer. However,
manufacturers must ensure the ingredients used are safe
Table 1 displays the dietary ingredients evaluated and the evi- and that the labeling and claims made are truthful and not
dence-based recommendations made for SOF. The evidence is misleading. If the product is deemed to be not safe or not
based on studies assessing the efficacy of the specific ingredi- consistent with label regulations, the FDA may remove the
ents. Importantly, research assessing the effectiveness of com- product from the marketplace or take other appropriate ac-
bining specific ingredients is lacking, and, therefore, drawing tions. Figure 1 provides an example of product label and a
5
any conclusions from science about the potential benefit of
combining such ingredients remains a challenge. This is dis- FIGURE 1 The FDA requires the following to appear on all product
cussed more in a series of reports detailing the evidence-based labels:
recommendations. 3

TABLE 1 Evidence-Based Recommendations for Musculoskeletal
Pain
Conditional
Recommendations No Recommendations
for Use Recommendations Against Current Use
Avocado soybean Boswellia Collagen
unsaponifiables
Capsaicin Rose hip Creatine
Curcuma* S-Adenoysl-l- Devil’s claw
methionine
Ginger* l-Carnitine General information
Glucosamine, Methylsulfonylmethane • Name of product, including the word “supplement”
prescription, over-the- • Net quantity of contents
counter • Name/place of manufacturer
Melatonin Pycnogenol • Directions for use
Supplement Facts Panel
Polyunsaturated fatty Vitamin E • Serving size, list of dietary ingredients, amount per serving size (by
acids weight), percent of Daily Value (%DV), if established
Vitamin D Willow bark extract • If the dietary ingredient is a botanical, the scientific name of the
*Conditionally recommend use as a food source, not as a dietary sup- plant or common or usual name standardized in the reference Herbs
plement at this time. of Commerce (1992 edition) and the name of the plant part used
• If the dietary ingredient is a proprietary blend (i.e., a blend
exclusive to the manufacturer), the total weight of the blend and the
Dietary Supplement Claims and Labels components of the blend in order of predominance by weight
Other ingredients
How many SOF medical personnel actually read the claims • Nondietary ingredients such as fillers, artificial colors, sweeteners,
and labels for dietary supplement products? flavors, or binders; listed by weight in descending order of
According to the Nutrition Business Journal, Americans spent predominance and by common name or proprietary blend
nearly $41.4 billion on dietary supplement products in 2016, The label of the supplement may contain a cautionary statement but
with much of that money going toward products promising to the lack of a cautionary statement does not mean no adverse effects
help you lose weight, build muscles, increase sexual function, are associated with the product. 5

Dietary Supplements for Musculoskeletal Pain | 111