So, What Could Go Wrong with Unregulated Dietary Supplements?

As noted before on this blog (see below), dietary supplements, marketed as health aids, can be quite dangerous.  More data on the complications has been published (AI Geller et. NEJM 2015; 373:1531-1540).

Here is an excerpt of a summary from the NY Times: Dietary Supplements Lead to 20,000 E.R. Visits Yearly, Study Finds

A large new study by the federal government found that injuries caused by dietary supplements lead to more than 20,000 emergency room visits a year, many involving young adults with cardiovascular problems after taking supplements marketed for weight loss and energy enhancement.

The study is the first to document the extent of severe injuries and hospitalizations tied to dietary supplements, a rapidly growing $32 billion a year industry that has attracted increased scrutiny in the past year and prompted calls for tougher regulation of herbal products….

Among the injuries cited were severe allergic reactions, heart trouble, nausea and vomiting, which were tied to a broad variety of supplements including herbal pills, amino acids, vitamins and minerals. Roughly 10 percent, or about 2,150 cases yearly, were serious enough to require hospitalization, the researchers found…

More than a quarter of the emergency room visits occurred among people ages 20 to 34, and half of these cases were caused by a supplement that was marketed for weight loss or energy enhancement…

Medical experts say that these products can be particularly hazardous because they have potent effects on the body and are frequently adulterated with toxic chemicals. The new study found that cardiovascular problems were even more commonly associated with weight loss and energy supplements than prescription stimulants like amphetamine and Adderall, which by law must carry warnings about their potential to cause cardiac side effects…

Under a 1994 federal law that has been widely criticized by health authorities, supplements are considered safe until proved otherwise.

Other points from the study:

  • “Child-resistant packaging is not required for dietary supplements other than those containing iron”
  • While these supplements result in <5% of the numbers for hospitalizations and admissions for pharmaceutical products, “dietary supplements are not regulated and marketed under the presumption of safety.”

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Herbal Medicines for IBD and IBS

A nice review (Holtmann G, Talley NJ. Clin Gastroenterol Hepatol 2015; 13: 422-32) provides a summary of the experience of herbal medicines for disorders that include irritable bowel syndrome (IBS), functional dyspepsia, and inflammatory bowel disease (IBD).

A recurring theme in the review is that herbal medicines are poorly studied and vary greatly in the quality of their manufacturing.  “Physicians and regulators need to remain very cautious about the use of herbal remedies.” The available trials, with a long list of plant extracts, are summarized in tables in the review.

Specific points:

  • “A meta-analysis also showed that supplementation of peppermint oil, in addition to pharmacologic standard treatments, was of benefit to both constipation-predominant IBS and diarrhea-predominant IBS patients.”
  • “The use os STW5 [iberogast] also has been found to be effective compared with placebo in the treatment of IBS symptoms.”
  • Very small clinical studies have suggested possible efficacy of aloe vera and curcumin in the treatment of IBD.
  • Adverse effects: “there are numerous case reports on adverse events related to herbal medicines.” Some of these have been severe.
  • “The main driver for the use of herbal and complementary medicines is the unmet need of patients.” However, given that these preparations are non patentable, “there is limited investment of producers.”

Bottomline: There is little financial incentive for companies to determine more conclusively whether these agents are effective for functional disorders or for inflammatory bowel disease.

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John Snow and Hepatology Potpouri

If you mention the name “John Snow,” I bet most people would think about one of the characters from Game of Thrones.  However, a more important John Snow is referenced in a recent Hepatology review (Hepatology 2014; 60: 1124-25).  “In 1855, the physician and epidemiologist John Snow used the technique of medical geography to stem the cholera epidemic in London.  By mapping the number of choleras case and the local water supply, he found that the Broad Street pump station was responsible and after the pump handle was removed, incident cases declined.”

Hepatology 2014; 60: 1150-59, editorial 1124-25.  Using spatial (clustering) epidemiology, the authors show that parenteral antischistosomal therapy (PAT) alone cannot explain the high HCV prevalence in Egypt.  Other iatrogenic exposures and poor infection control are likely contributing factors.

Hepatology 2014; 60: 1222-30, editorial 1130.  In a prospective study (western Europe), the authors show that vitamin D (25-OH) levels were inversely associated with the risk of hepatocellular carcinoma (HCC).  What is remarkable about this study is the levels were obtained on average 6 years before HCC diagnosis.  Also, this study uses tertiles -comparing those in the top third to those in the lowest third.

Hepatology 2014; 60: 1399-1408.  More data showing injury from Herbals and dietary supplements.  Liver injury caused by bodybuilding herbal supplements (often anabolic steroids) were typically less severe than liver injury induced in non-bodybuilding herbals (predominantly middle-aged women). Table 3 identifies by name many of the herbal supplements/dietary supplements associated with death or liver transplantation.  “Contrary to popular belief, this study demonstrates that HDS products are not always safe.”

Liver Update: Headlines and Links Only

  1. From AGA: Hepatic failure flagged as unexpected boceprevir safety signal in adverse event review. GI & Hep News: http://ow.ly/rSCEF 
  2. From NY Times: Spike in Harm to Liver Is Tied to Dietary Aids nyti.ms/JPN9fK 
  3. From Jeff Schwimmer (The Liver Post): First case report of Liver Cancer in a child with Nonalcoholic Fatty Liver Disease. He is only 7 years-old. http://goo.gl/6dJbzs 
  4. “Recurrence of Hepatopulmonary Syndrome Post-Orthotopic Liver Transplantation in a Patient with Noncirrhotic Portal Hypertension” Hepatology 2013; 58: 2205-06.
  5. “Management of Hepatitis B: Our Practice and How It Relates to the Guidelines” Clin Gastroenterol Hepatol 2014; 12: 16-26.  Terrific review and insights.
  6. “Acute Liver Failure” NEJM 2013; 369: 2525-34.
  7. “Cesarean Section Reduces Perinatal Transmission of Hepatitis B Virus Infection from Hepatitis B Surface Antigen-Positive Women to Their Infants” Clin Gastroenterol Hepatol 2013; 11: 1349-55. Retrospective, nonrandomized study -“performing elective cesarean section only in highly viremic mothers with pre-delivery HBV DNA levels ≥1,000,000 copies/mL may be advisable.”

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