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Complementary alternative medication (CAM) including vitamins, herbals, supplements, homeopathy, and extracts seems to be as polarizing a topic as politics these days. Given that more than half of the US adult population uses at least 1 CAM, you can easily find passionate opinions on either side of the isle from the Herbal Tea Party and Abstinence Only factions.1 Children’s Hospital of Philadelphia (CHOP) recently fueled the debate by publically declaring they would no longer provide CAM.2 Families wishing to continue these agents during hospitalization have to sign a waiver and provide the product. Some hospitals have long held this abstinence policy (perhaps sans waiver), but were less vocal in their withdrawal. The motivation for disallowing use is based on risks to the patients due to the inherent unknowns of CAM. Patients seem to be increasingly motivated to continue consuming, however, as self-management with CAM skyrockets.
Complementary alternative medicine (CAM) including vitamins, herbals, supplements, homeopathy, and extracts seems to be as polarizing a topic as politics these days. Given that more than half of the US adult population uses at least 1 CAM, you can easily find passionate opinions on either side of the isle from the Herbal Tea Party and Abstinence Only factions.1 Children’s Hospital of Philadelphia (CHOP) recently fueled the debate by publically declaring they would no longer provide CAM.2 Families wishing to continue these agents during hospitalization have to sign a waiver and provide the product. Some hospitals have long held this abstinence policy (perhaps sans waiver), but were less vocal in their withdrawal. The motivation for disallowing use is based on risks to the patients due to the inherent unknowns of CAM. Patients seem to be increasingly motivated to continue consuming, however, as self-management with CAM skyrockets.
Do you have an official stance on CAM at your institution? Some key considerations when crafting or modifying your institution’s approach are: 1) Why do people take CAM? and 2) What is the evidence for limiting access?
In a National Institutes of Health study published earlier this year, the most commonly reported reason for adults using CAM was to improve overall health (45% of 11,956 survey respondents) and only 23% of products were recommended by a healthcare provider.3 Multivitamins, calcium, and fish oil (omega-3) supplements were the most common products reported. Children’s use of CAM was also studied with similar results. Supplement use was identified in 31% of children and 41% of respondents stated the reason was to improve overall health, but only 16% had had this recommendation made by a healthcare provider.4 Multivitamins and vitamin C were the most common products. The latest figures suggest that CAM is a nearly $30 billion per year market.5 Those expenditures are entirely consumer-based, as insurance does not cover them.
A fascinating psychologic reason for CAM use was identified in 2 studies from researchers in Taiwan.6,7 They monitored patients who believed they were taking dietary supplements (but were really taking a placebo) and found they engaged in riskier behaviors, such as eating more, smoking more, and exercising less compared to those who were told they were taking a placebo. The authors’ conclusions were that consumption of supplements potentially leads to “illusory invulnerability.” This essentially means that they were counting on supplements to negate the effects of bad habits and equal out their overall health. Although this is interesting data, it may not reflect the mind set of most CAM users with a genuine net health intention.
Unknown safety. We know that CAM is exempt from traditional FDA regulations. However, consumers assume that the products are safe because they are “natural.” Consumer Reports tallied a 5-year period of adverse events reported to FDA from 2007 to 2012 and found more than 6,300 were associated with supplements.5 Any of you who receive FDA recall notifications are constantly reminded that OTC, prescription, or illicit medications often are found in CAM: diclofenac, methamphetamine, doxepin, sildenafil, methasterone, dimethazine, fluoxetine, and chloramphenicol have all been identified within the past 3 months.8 Whether some of the FDA-reported adverse effects are related to the laced medication component is unknown.
Actual CAM content may differ from label. Aside from the medication contamination issue, there are additional risks that the labeled herb is not what is in the product. Canadian investigators analyzed 44 single-ingredient herbal products using DNA barcoding from 12 companies.9 Over half (59%) contained more ingredients than were specified on labels, 48% contained the active ingredient, but a third of those products had contaminants or fillers not specified on the label. One example cited was a product labeled as St. John’s wort, but it actually contained senna as the active ingredient. Feverfew was also identified as a common contaminant not listed on the label, increasing drug–drug interaction concerns. Only 2 of the 12 companies had all authenticated products without substitution, fillers, or contaminants. Whether these deviations are intentional or not, it is concerning.
Poor drug interaction screening. Some interaction screening programs are capable of capturing known CAM interactions. But what about the unknown interactions for poorly studied CAM? What about the unknown contaminants in CAM? Clearly we can’t analyze what we don’t know.
Given the relative lack of safety and efficacy data coupled with minimum oversight in a profit-driven industry, it makes the CHOP decision seem evidence based. However, your approach should depend on the risk-versus-benefit balance at your institution based on your patient population and resources available to optimize safety.
1. Gahche J, Bailey R, Burt V, et al. Dietary supplement use among U.S. adults has increased since NHANES III (1988–1994). NCHS data brief, no 61. Hyattsville, MD: National Center for Health Statistics; 2011.
2. Children’s Hospital of Philadelphia Research Institute. Children’s hospital first in nation to disallow use of dietary supplements. October 9, 2013. http://www.research.chop.edu/blog/childrens-hospital-first-nation-disallow-use-dietary-supplements/. Accessed January 7, 2014.
3. Bailey RL, Gahche JJ, Miller PE, et al. Why US adults use dietary supplements. JAMA Intern Med. 2013;173:355–361.
4. Bailey RL, Gahche JJ, Thomas PR, Dwyer JT. Why US children use dietary supplements. Pediatr Res. 2013;74:737–741
5. Consumer Reports. 10 surprising dangers of vitamins and supplements. September 2012. http://www.consumerreports.org/cro/magazine/2012/09/10-surprising-dangers-of-vitamins-and-supplements/index.htm. Accessed January 7, 2014.
6. Chiou WB, Yang CC, Wan CS. Ironic effects of dietary supplementation: illusory invulnerability created by taking dietary supplements licenses health-risk behaviors. Psychol Sci. 2011;22:1081–1086.
7. Chiou WB, Wan CS, Wu WH, Lee KT. A randomized experiment to examine unintended consequences of dietary supplement use among daily smokers: taking supplements reduces self-regulation of smoking. Addiction. 2011;106:2221–2228.
8. FDA. Recalls, market withdrawals, & safety alerts. http://www.fda.gov/Safety/Recalls/ucm2005683.htm. Accessed January 7, 2014.
9. Newmaster SG, Grguric M, Shanmughanandhan D, et al. DNA barcoding detects contamination and substitution in North American herbal products. BMC Med. 2013;11:222–235.
Dr Harper graduated from the University of Florida with her doctor of pharmacy and then went on to complete a pharmacy residency at Buffalo General Hospital in Buffalo, N.Y. She then became a clinical coordinator/clinical manager at Millard Fillmore Gates in Buffalo, NY; Roosevelt Hospital in New York City, N.Y.; Chippenham Hospital in Richmond, Va.; and Vail Valley Medical Center in Vail, Colo., before coming to Poudre Valley Hospital in 2007. In addition to being the clinical coordinator at Poudre Valley Hospital, she also is the residency program director for post graduate year-1 pharmacists.