New Studies Highlight Caution for Consumers on Potentially Misleading Promotions of Products and Services

San Francisco, CA (UroToday.com) – Today’s consumer is faced with an abundance of information and advertising that promotes a wide range of treatments, medicines and alternative therapies. This information is not always easily navigable by patients and, in some cases, may be misleading. Three new studies being shared at the 2019 AUA Annual Meeting highlight the need for today’s patient to vigilant. These studies will be presented to media during a special session, moderated by Dr. Stacy Loeb, on Sunday, May 5, 2019 at 10 a.m. Dr. Loeb is an Assistant Professor of Urology and Population Health at New York University and the Manhattan Veterans Affairs Medical Center. 

Abstracts presented include: 

Publication # PD34-12 “Testosterone Boosting” Supplements Composition and Claims are not Supported by the Academic Literature 

Over-the-counter supplements purporting to raise testosterone levels may be more than meets the eye, according to this study that evaluated 50 different supplements on the market. Researchers reviewed each of the products’ claims, as well as active ingredients (components), and then examined the recommended daily allowance (RDA) and upper tolerable intake level for each of the ingredients, and reviewed PubMed for literature to support the claims. The upper tolerable intake level is the maximum daily intake level at which no risk of adverse effects is expected. 

Key findings include: 
  • Across the supplements, 111 active ingredients were identified, with each product containing an average of seven active ingredients.
  • Prospective data was available for four of the components: fenugreek, shilajit, D-aspartic acid and vitamin D, with only fenugreek and shilajit showing a positive effect on testosterone levels. 
  • Of the remaining components, four had non-prospective human data showing a positive effect on testosterone and six had animal data showing a positive effect. 
  • In some cases, supplements contained levels of vitamins and minerals above the maximum RDA, occasionally above the upper tolerable intake level. 
Publication # MP72-02 Exposure To Cyberknife Advertising Is Associated With Over-Estimation Of Objective Benefits Compared With Other Prostate Cancer Treatments 

There is limited evidence comparing the use of stereotactic radiotherapy (such as Cyberknife) to other prostate cancer treatment options. Advertising of Cyberknife for prostate cancer may be misleading for patients, resulting in an overestimation of therapeutic benefits. In this study, researchers evaluated layperson impressions of this popular stereotactic radiosurgery when exposed to advertisements compared to factual information/controls. This survey of 400 men aged 40-80 demonstrated that patients exposed to advertisements had a more positive impression of Cyberknife than the control group. 

Key findings include: 
  • After reviewing either advertisements (with or without disclaimers) or scientific information, respondents indicated they would choose Cyberknife over other prostate cancer treatments, with a greater increase seen in participants who viewed advertisements (with our without disclaimers).
  • Respondents in the advertising groups were more likely consider Cyberknife to be superior compared to other treatments.
  • Respondents who viewed scientific information were less likely to rate Cyberknife as superior to alternative treatments relative to the side effects of erectile dysfunction and incontinence. 
Publication # MP12-18 Buyer Beware: Evidence-Based Evaluation of Dietary Supplements for Nephrolithiasis 

A growing number of supplements that claim to reduce -- or even prevent – the formation of kidney stones are available to patients without a prescription, but the majority contain ingredients with conflicting or no scientific evidence to support these claims. Researchers in Baltimore examined 27 commercially available supplements that claimed to dissolve stones, prevent stone formation, reduce stone symptoms and support overall kidney health, and reviewed the available medical literature on the efficacy of active ingredients included in each. 

Key findings include: 
  • The 27 supplements reviewed included 56 non-pharmacologic active ingredients, with only nine having published studies about their use in treating stone disease.
  • Only 18 studies about the ingredients were identified, of which six showed mixed or no benefit for stone disease. 
  • 12 studies supported use of ingredients in stone formers, but only five of the studies were human studies. 
  • Among the 27 supplements, 67 percent contained ingredients with conflicting, refuting or absent evidence of benefit in stone disease. 
“Today’s marketplace is filled with a plethora of information about treatments and services and it can be hard for patients to ascertain what is supported by science and what is not,” said Dr. Loeb. “It’s more important than ever to talk to your doctor about what supplements you’re taking, as well as discuss the ads you may be seeing that promise ‘the next big thing.’ If it sounds too good to be true, it probably is.”  

Abstracts: 

PD34-12 
“Testosterone Boosting” Supplements Composition and Claims are not Supported by the Academic Literature 
Hatim Thaker, Chase Clemesha, Mary K. Samplaski 

Introduction: Many men take over-the-counter &[Prime]testosterone (T) boosting&[Prime] supplements in hopes of improving their T naturally. However, these claims may not be supported by evidence. We sought to evaluate the composition of &[Prime]T boosting&[Prime] supplements, their advertised claims, and compare this with the published literature. 

Methods: 50 &[Prime]T booster&[Prime] supplements were evaluated for active ingredients and product claims. PubMed was reviewed for each component for any literature supporting the claims. We then reviewed the Recommended Daily Allowance (RDA) and upper tolerable intake level for each component. 

Results:
90% of supplements claimed to &[Prime]boost T&[Prime], 50% &[Prime]improve libido&[Prime] and 48% to make men &[Prime]feel stronger&[Prime]. Other claims included &[Prime]building body mass&[Prime] (62%), &[Prime]increased energy&[Prime] (30%) and &[Prime]burn fat&[Prime] (28%). 111 components were found, with a mean number of 7.1 per product (range 18, median 7, mode 6, standard deviation 4.32). At PubMed search, 4 components had prospective data. Fenugreek and Shilajit: positive effect on T; D-Aspartic acid and Vitamin D: no effect on T. 4 components had non-prospective human data showing positive effect on T; 6 had animal data showing positive effect; 2 had non-prospective human data showing negative effect; 8 had animal data showing negative effect. 67 (60.4%) had no published data on their effect on T. 27 supplements contained Fenugreek and/or Shilajit. 42 had components with non-prospective human data showing a positive effect on T; 42 had animal data showing a positive effect; 6 had non-prospective human data showing a negative effect; 21 had animal data showing a negative effect. One supplement had no components with human or animal data supporting a positive effect on T. For the 45 supplements that claimed to boost T, Table 1 lists the most common components, versus RDA. 2 supplements had over the upper tolerable intake of zinc. 

Conclusions: 90% of &[Prime]T booster&[Prime] supplements claimed to boost T. However, only 12% of these had prospective human data to support these claims, based on their components. 48% contained components with data to suggest a negative effect on T. Many had supra-therapeutic doses of vitamins and minerals, occasionally over the upper tolerable limit, with associated risks. Patients need to know that &[Prime]T booster&[Prime] supplements may not contain components with mechanisms to support their claims. 

Funding: none 

MP72-02  Exposure To Cyberknife Advertising Is Associated With Over-Estimation Of Objective Benefits Compared With Other Prostate Cancer Treatments 
Joseph M Caputo, Henry J Lee, Bennett Chiles, Elias Hyams 

Introduction: There has been increased direct-to-consumer advertising for Cyberknife (CK), a brand of stereotactic radiotherapy for prostate cancer. Evidence comparing CK with other prostate cancer therapies is limited. We hypothesized that those viewing CK advertisements would have inaccurate impressions regarding its effectiveness and safety. In this study, we evaluated impressions of CK among laypersons exposed to actual advertisements versus factual information/controls. 

Methods:
Through Qualtrics Panel, a survey management organization, 400 men aged 40-80 were randomly assigned to one of four arms, including a de-identified CK advertisement (ad), the same advertisement with disclaimers (ad+d), scientific information obtained from a review of contemporary peer-reviewed literature, and a control. Subjects responded to questions on risks and benefits of CK and their likelihood of pursuing CK versus other treatments. T-tests were utilized to evaluate differences in outcomes for each intervention vs. the control group. 

Results: 400 men with largely matched characteristics (Table 1) were included. Compared to controls, those who viewed any of the three interventions were more likely to pursue CK over other treatments (p<0.01), with a greater increase in the ad and ad+d groups (Table 2). Respondents who viewed scientific information were less likely to agree that CK is superior to alternatives regarding side effects of erectile dysfunction and urinary problems. The addition of disclaimers decreased positive impressions of CK regarding side effects, but did not affect impressions of effectiveness (Table 2). Both ad and ad+d respondents were more likely to consider CK superior to other PCa treatments. 

Conclusions: Advertisements regarding CK are misleading and impact laypersons&[prime] impressions regarding effectiveness and safety. Direct-to-consumer advertising for cancer care is problematic, and relies on the advertiser and surrounding community to ensure accuracy and transparency. 

Funding: none 

MP12-18 Buyer Beware: Evidence-Based Evaluation of Dietary Supplements for Nephrolithiasis 
Kevin Koo, Tareq Aro, Brian Matlaga 

Introduction:
An increasing number of dietary supplements have recently been brought to market with the purported benefit of kidney stone risk reduction. These products may be purchased without a prescription and carry claims to reduce or even prevent kidney stone formation. However, the evidence for these claims is not clear. We performed a study to assess the scientific evidence supporting commercially available dietary supplements for patients with urinary stone disease. 

Methods: The online marketplace Amazon.com was queried for dietary supplements to treat, alleviate, or prevent stone disease. A Google search was similarly performed to capture products not available on Amazon. Product labels were reviewed to compile specific stone-related claims and non-pharmacological active ingredients (ie, excluding vitamins and ion salts) in each supplement. The cost of a 30-day course of recommended treatment was assessed. We queried Google Scholar with all non-pharmacological active ingredients to assess the scientific evidence from published and lay sources. Non-English studies and conference proceedings were excluded. Two investigators independently performed the searches and analysis. 

Results:
Of 113 products reviewed in the searches, 27 dietary supplements containing 56 non-pharmacological active ingredients were analyzed. Products made a variety of claims: 12 (44%) claimed to dissolve stones, 7 (26%) claimed to prevent stone formation, 6 (22%) claimed to reduce stone symptoms, and the majority (19, 70%) could be used to support kidney health. The mean 30-day cost was $32 (range $4-$189), and 10 (37%) products offered a money-back guarantee. Nearly all products were highly rated, with 21 products receiving &[ge]4 stars on a 5-star scale (mean 4.2, range 3.4-5.0). Of the 56 non-pharmacological ingredients, 9 (16%) had any published studies for use in stone disease, and 5 (9%) had exclusively studies supporting their use. A total of 18 scientific publications about the ingredients were identified, of which 6 showed mixed or no benefit for stone disease. In the other 12 publications supporting use in stone formers, only 5 were human studies. Overall, among the 27 supplements, 18 (67%) contained ingredients with conflicting, refuting, or absent evidence of benefit in stone disease. 

Conclusions: In this analysis of commercially available dietary supplements claiming to treat or prevent kidney stones, two-thirds contained ingredients with conflicting or no scientific evidence to support their claims. These findings may assist clinicians in counseling stone formers about the use of these unregulated products. 

Funding: None 

Complete AUA 2019 Conference Coverage 
E-Newsletters

Newsletter subscription

Free Daily and Weekly newsletters offered by content of interest

The fields of GU Oncology and Urology are rapidly advancing. Sign up today for articles, videos, conference highlights and abstracts from peer-review publications by disease and condition delivered to your inbox and read on the go.

Subscribe