EXPERT ANALYSIS FROM AAP 2017

CHICAGO (FRONTLINE MEDICAL NEWS) – Nearly one in five people who take prescription medications also take herbal or mineral supplements, so it’s essential to make herbs, vitamins, and other supplements part of every patient medication history, emphasized Cora Breuner, MD, MPH, a professor of pediatrics at the University of Washington in Seattle.

“In chronically ill children, almost 80% to 90% of kids are using supplements, so it’s really almost imperative that this be asked when you’re taking your histories, not in the social history, but when you’re asking about medications,” Dr. Breuner told attendees at the annual meeting of the American Academy of Pediatrics. “Remember to ask it, and remember to ask it every time because it makes the patient actually realize it’s something like a medication, and so you can get the drug-herb interactions.”

Providers also should be familiar with the evidence base for complementary and alternative medicine (CAM). According to the 2012 U.S. National Health Interview Survey, which included 10,218 youths, 11.6% of those aged 4-17 years had taken or used some type of complementary health product within the previous year. Fish oil/omega-3 fatty acid supplements, melatonin, probiotics/prebiotics, and echinacea topped the list.

“For children, complementary approaches were most often used for back or neck pain, other musculoskeletal conditions, head or chest colds, anxiety or stress, attention-deficit hyperactivity disorder [ADHD], and insomnia or trouble sleeping,” Dr. Breuner said.

Regulation of herbal and other supplements

Dietary supplements, including vitamins, minerals, and herbal remedies, are regulated under the Dietary Supplement Health and Education Act of 1994 (DSHEA) – not the Food and Drug Administration. Not only can products enter the market without any testing for efficacy, but companies only have to provide “reasonable assurance” of a product’s safety, not proof.

“Supplements do not have to be manufactured according to any standards,” Dr. Breuner said, although reputable manufacturers support standards. “It’s basically up to the company that manufactures it to make sure the product is not contaminated and that the product is basically consistent. There’s no need whatsoever for the company to make sure it works.”

Yet many patients and parents don’t realize that, she said.

“It’s important for people to be aware that this is not a regulated industry per se by the federal government,” she said. “Patients really do think that it is.”

One voluntary quality indicator is the United States Pharmacopeia Dietary Supplement Verification Program , identified by a USP “dietary supplement verified” logo. ConsumerLab.com also provides an “approved quality” logo, tests samples voluntarily sent by manufacturers, and rates the quality of different brands.

“Supplements may not claim to cure or prevent a disease, but they can say how it affects the body’s structure and function,” she said, and companies do not need FDA approval for packaging or marketing claims. In this low regulatory environment, substantial variations exist in the quality and quantity of biological ingredients in marketed supplements.

Risks from herbal supplements

Dr. Breuner cited a 2011 study finding that 75% of 68 products tested had no key safety messages, including all 12 ginkgo products and all but 1 of the 21 garlic and seven Asian ginseng products tested. Most of the 13 echinacea products also lacked safety messages, but two-thirds of the 12 St John’s wort products did have safety information.

Risks can include contamination, inadequate packaging information, and unknown toxicities and interactions. Adverse reactions should be reported to the Food and Drug Administration’s MedWatch at 800-FDA-1088 (fax: 800-FDA-0178) and to Poison Control at 800-222-1222.

Two popular herbal remedies that are unsafe for children include licorice and ephedra. Although it is used for peptic ulcers, licorice lacks much evidence backing it and also shouldn’t be used (or eaten) during pregnancy. Ephedra (ma huang), an appetite suppressant and decongestant, can cause heart palpitations, heart attacks, and death.

“You can still get ephedra over the Internet, but it’s very, very dangerous,” Dr. Breuner said.

Dr. Breuner listed other herbal products available online but deemed unsafe for children: aconite (also known as bushi), species from the genus Aristolochia, belladonna, blue cohosh, borage, broom, calamus, chaparral, coltsfoot, comfrey, germander, life root, lobelia, pennyroyal, poke root, sassafras, skullcap, tansy ragwort, and wormwood.

Another set of herbs can be dangerous prior to surgery, she said, noting that an estimated 26% of patients scheduled for surgery use herbal products.

“Many, many of the herbs cause platelet aggregation issues,” Dr. Breuner said, so it’s very important to ask about different herbs before surgeries. Patients should discontinue echinacea, ephedra, garlic, ginkgo, ginseng, kava, St. John’s wort, and valerian before surgery. Risks include cardiovascular instability, prolonged sedation, bleeding, electrolyte disturbances, and immunosuppression. Additionally, four supplements also adversely interact with warfarin: garlic, ginger, and feverfew have additive effects (although small dietary amounts of ginger and garlic are fine), and St. John’s wort can decrease warfarin’s effects.

Dr. Breuner urged attendees to use resources like PubMed Dietary Supplement Subset to find out more about supplements; this subset limits results of a PubMed search of citations and abstracts to just those related to dietary supplements. It was created through a partnership between the Office of Dietary Supplements and the National Library of Medicine, both parts of the National Institutes of Health.

Information on specific herbs

 Ginkgo. Although commonly used to boost memory and concentration, only limited studies in adults shows some potential benefit from ginkgo at 40 mg three times a day. “There isn’t any evidence to show any reason to use it in children,” Dr. Breuner said. Adverse effects can include gastrointestinal irritation, headache, bleeding, and contact dermatitis.

 Echinacea. Although people use echinacea to treat or prevent the common cold or upper respiratory infections, the evidence does not show significant reductions of incidence, duration, or severity of upper respiratory infections and common colds. Anyone immunocompromised with an allergy or autoimmune disease should not take it.

 Zinc. Some evidence from a pediatric Cochrane Review, albeit with heterogeneous studies, supports using 75 mg of zinc a day to reduce duration of common cold and sore throat symptoms in healthy people. Adverse effects include a bad taste, nausea, and anosmia.

 Valerian. Children can take 400 mg nightly of valerian to help with sleep, although there are some caveats.

“The problem with Valerian is that it takes 2-6 weeks before it has any effect,” Breuner said. “It tastes terrible, and it’s only in a capsule form. It isn’t dosed for age at all, so you have to be careful about this, and it’s not like Ambien,” she added. It does not work instantaneously, and stopping it abruptly can cause withdrawal symptoms, although she would recommend it over melatonin. Despite its use for sleep, it can have adverse effects, such as anxiety, restlessness, and heart palpitations, and it can interfere with barbiturates.

 St. John’s wort. No one is quite sure how it works, but research has shown St. John’s wort extracts can treat mild to moderate depression about as well as standard antidepressants. However, the dose is 300 mg three times a day. “There’s no St. John’s XL,” Dr. Breuner joked. It can also interfere with a wide range of prescribed medications, including oral contraception.

 Butterbur. Those taking pyrrolizidine alkaloids should avoid butterbur, but it otherwise can help prevent migraine when dosed at 50-75 mg daily divided up into 2-3 for ages 8-9 years and 100-150 mg daily divided up into 2-3 for ages 10-17 years. “Most of the neurologists at my institution are recommending butterbur,” Dr. Breuner said. “It’s not an abortive, but it’s a preventive, with decreased intensity and severity in childhood migraine 6 weeks after using it. This is absolutely something to consider in your patients with chronic headaches.” Adverse effects include diarrhea, stomach upset, belching, and dermal and allergic symptoms, such as itchy eyes, asthma, and rash.

 Magnesium. Also recommended by pediatric neurologists at her institution, 300-500 mg daily of magnesium can reduce migraine incidence, but doses should be titrated up at first. “Don’t start with the higher doses,” she said. “You have to be careful about starting at too high of a dose because of diarrhea,” which is its primary adverse effect. Magnesium also can interfere with bisphosphonates, antibiotics, and diuretics; proton pump inhibitors may reduce magnesium levels.

 Melatonin. Unlike most supplements that are herbal or mineral, melatonin is a synthetic hormone, but Dr. Breuner said many patients don’t realize that. “Because it’s a hormone, I’m very, very careful about it,” she said, never recommending more than 0.5 to 5 mg a night for help falling asleep. “I’m really not a fan of melatonin,” she said. “You develop a tolerance to it, and this is not something parents or children should be taking chronically because we do not know long-term outcomes at all. It’s not benign even though you can just toss it into your grocery basket.”

She briefly wrapped up with mentions of omega-3 fatty acid supplements (docosahexaenoic acid and eicosapentaenoic acid); most of the evidence for these supplements comes from adults with psychiatric disorders. However, one study showed reduced tics in children with Tourette’s – if they can stand the fishy taste. It also can cause belching, nosebleeds, nausea, loose stools, and, at higher doses, decreased blood coagulation.

Peppermint can be used to reduce nausea, coughs, anxiety, and irritable bowel syndrome symptoms, but it needs to be taken as 1-2 enteric capsules, not as tea or another form.

“Chamomile is very helpful for generalized colic and also for those with chronic anxiety,” Dr. Breuner said, and arnica can be used topically for bruising. Ginger also can be used to reduce nausea but can cause heartburn. A combination of peppermint, chamomile, arnica, and ginger may be appropriate to address various chemotherapy symptoms in a child, she said.

Several articles are useful for looking up interactions between herbs and drugs, including Pediatrics. 2017. doi: 10.1542/peds.2010-2720C ; J Emerg Med. 2005 Apr;28(3):267-71 ; and Clin Med (Lond). 2013 Feb;13(1):7-12 .

No funding was used for this presentation, and Dr. Breuner reported having no disclosures.

pdnews@frontlinemedcom.com

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