Pharmacology Consult

Complementary and alternative medicine for pediatric infectious diseases: Are they helpful?

Because caregivers often view CAM therapies as more ‘natural,’ they may not consider the potential for interactions with other drugs.
Edward A. Bell, PharmD, BCPS
Edward A. Bell

Complementary and alternative medicine, or CAM, practices and use are increasingly popular among caregivers of infants and children in the United States.

CAM is defined by the National Center for Complementary and Alternative Medicine as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.” Many different practices and therapies can be included in this description, such as herbs, dietary supplements, homeopathy, acupuncture, massage, hypnosis and spiritual healing.

Prevalence, reasons for use

CAM use by the pediatric population is not uncommon. Published results of CAM-use surveys have demonstrated prevalence rates ranging from less than 10% and up to 70%. Among the general pediatrics population, it has been estimated that 20% to 30% have used a CAM therapy. Rates of CAM use have been reported to be higher (30% to 70%) among children with chronic disorders, such as autism or asthma.

One survey in Canada documented infectious illnesses as a reason for CAM use in 20% of the surveyed population. Users of CAM therapies often administer traditional drug or other conventional medical therapies concomitantly to their children. Data were reported in 1997 that more visits were made to CAM practitioners than to all primary care practitioners in the United States.

Disorders of the respiratory tract and otolaryngologic disorders are often listed among the most frequent cause for use of CAM therapies in published survey results. In several instances, caregivers of children given CAM therapies often did not inform their child’s health care provider of their use. This information implies that CAM use should be assessed when a medical or drug history is taken.

Why do children and their caregivers use CAM? A commonly reported justification for CAM use by caregivers relates to a “natural” description of some CAM therapies, such as herbs. Natural therapies may be viewed by caregivers as safer than traditional therapies, such as drug therapy. However, as discussed below, “natural” does not necessarily equate to “safe.”

Caregivers may become frustrated or disillusioned with traditional medical practice, especially with treatments of chronic diseases with no known cure like autism. CAM treatments may allow caregivers to have more of a sense of control over their child’s therapies. Related to this, CAM may also afford caregivers use of more of an individualized treatment plan than that provided by traditional medicine.

Additionally, the internet provides a variety of information about CAM use and supposed effectiveness, including numerous testimonials by users. CAM therapies frequently are less expensive than traditional medical therapies and can often be easily obtained.

Disadvantages of CAM use

Several potential problems are related to CAM use that can be easily overlooked by caregivers.

Adverse effects, toxicities and interactions with traditional drugs have been described with some CAM treatments. Examples include seizures from eucalyptus, bleeding from garlic, hypokalemia from licorice, dysrhythmias from ma huang (ephedrine) and tyramine reaction from St. John’s wort.

Some traditional Chinese CAM treatments have been contaminated with barbiturates, lead or arsenic. Other products have been contaminated with pesticides or potentially pathogenic bacteria.

The potential for clinically significant interactions with traditional drugs is also important to consider. Several herbal products can interact with drug therapies, including ginseng (warfarin), St. John’s wort (cyclosporine), ginkgo biloba (anticoagulants or antiplatelets) and sassafras (potential for inhibiting CYP450 hepatic drug metabolizing enzymes). With the variety of herbal products available and the lack of scientific data, the potential for additional herbal–drug interactions cannot be ignored.

Unlike traditional drug products, herbal products do not have to demonstrate efficacy and safety, as they are considered dietary supplements.

When one purchases an herbal product, the content and purity of the product can vary widely. Product label doses may not be accurate, as doses may depend upon the specific plant species used and how it was obtained, prepared and packaged (ie, unregulated manufacturing techniques).

Perhaps this may be analogous to prescription of an amoxicillin product for a specific child, when the concentration and content of the product have not been verified. When specific doses are given on an herbal product label, these doses are often based upon adult usage, with pediatric doses extrapolated from adult use. Few data exist about the pharmacokinetics of herbal products in infants and children.

CAM for infectious diseases

Despite these concerns, some CAM treatments may be logical. Some accepted and effective traditional drug therapies have been developed from natural sources, such as plants. Salicylates from willow bark and digitalis from foxglove are just a few examples. Thus, the use of a specific herb may be reasonable for treatment of a pediatric disorder. However, evidence of efficacy, safety and dosing from scientifically valid, controlled studies is often lacking.

Additionally, product content, purity and manufacturing technique are frequently unknown. It is understandable that caregivers often do not consider these factors. Other CAM products, such as massage, may provide a significant placebo effect.

Among the various herbal products, Echinacea is more commonly used in children. Echinacea may have immunomodulatory effects, stimulating leukocyte activity and function. It has been evaluated in controlled trials of children.

In one placebo-controlled study, researchers found no benefit from Echinacea in reducing symptoms from upper respiratory tract infection in children; however, adverse effects were more common in this group. Researchers from two other controlled trials evaluated Echinacea in the treatment of upper respiratory tract symptoms in children, demonstrating benefit, although these studies were not placebo-controlled and were confounded by concomitant use of other herbal products.

A recent literature review (Caruso) evaluated published studies of Echinacea in adults and children, assessing the studies’ scientific rigor. Of nine studies evaluated, only two were judged to be well-done controlled trials. In both of these studies, the researchers found no benefit from Echinacea administration. A review of Echinacea from the website of the National Center for Complementary and Alternative Medicine (the lead agency of the NIH for scientific research on CAM) states, “Studies indicate that Echinacea does not appear to prevent colds or other infections.”

Cranberry products have been used in children to treat and prevent urinary tract infections. Data from two small, controlled studies showed benefit from cranberry juice ingestion in reducing UTI rates in young women in college. In two other small, controlled trials, cranberry products were given to children with neurogenic bladder. Neither trial’s results demonstrated benefit from cranberry product administration. Although the potential for benefit from cranberry administration may exist for this use, more studies in the pediatric population are needed.

An herbal product demonstrated to be effective in the treatment of pain from acute otitis media is naturopathic herbal extract (“ear oil”). In a randomized, double blind trial, topically applied natural herbal extract (Otikon Otic Solution, containing garlic, Mullien flower, St. John’s wort and Calendula flores) was found to be equally effective in children (aged 6 years and older) as a traditional topical analgesic/anesthetic product used for pain from AOM. This treatment is listed as one of several recommended therapies in the AOM treatment guidelines from the AAP published in 2004.

Other therapies have also been evaluated for AOM. In a small, controlled study evaluating homeopathic treatment for AOM, researchers used a placebo control and found no differences among the groups in treatment response. Given the inherent difficulties in evaluating symptomatic treatment response of AOM, the methodology and validity of this study is questionable.

Data from an interesting study published in 2003 evaluated the effects of osteopathic manipulation as adjuvant treatment in the therapy of recurrent AOM. In a randomized, single blind, trial, 57 children with a history of frequent AOM episodes were treated with routine pediatric care alone or routine pediatric care plus osteopathic manipulative treatment.

Beneficial results were shown in the treatment group, demonstrated by reduced AOM episodes, fewer surgical procedures and tympanometric performance. In an accompanying editorial, results of this trial were evaluated by an expert not involved in the study, whereby the author expressed concerns over this study’s methodology and findings.

Discussing CAM with caregivers, patients

Surveys of CAM use in pediatrics have frequently documented a lack of awareness of CAM use by the clinician. Thus, an important first step is asking if CAM therapies are used.

Caregivers of children with chronic or frequent illnesses may be more likely to be CAM users. It is important to consider the cultural background of patients and families, as some CAM therapies may be accepted and practiced more frequently. Also, it is reasonable to consider that many clinicians practicing conventional medicine may harbor biases toward CAM therapies.

The AAP published a statement in 2001 describing what issues should be considered when counseling patients and caregivers who use CAM. The AAP recommends that clinicians familiarize themselves with CAM therapies to adequately discuss the various treatments with families. The National Center for Complementary and Alternative Medicine provides an internet site (www.nccam.nih.gov) that can be useful to clinicians and patients.

It may be helpful to discuss with families the principles underlying the scientific method, how therapies are proven to be safe and effective, and how this applies to CAM. Clinicians should guard against the potential for negative bias toward CAM therapies as opposed to conventional therapies. Open discussions with families, with respect toward their beliefs and concerns, are essential. These discussions should include information on the documented efficacy (scientific studies, if any), potential harms, adverse effects and interactions with conventional drug treatments of CAM therapies, as many caregivers equate natural treatments with safe.

Conclusion

Although the reasons for CAM use are varied, many patients or caregivers of children view CAM treatments as natural, and thus safer, than conventional drugs or other medical therapies. Users likely are not aware of documented adverse effects, toxicities and herb–drug interactions with CAM therapies, nor are they likely to be familiar with the unknown effects of a lack of standardized content, purity, dosing and manufacturing of herbal products and other CAM treatments. It is incumbent upon pediatric clinicians to discuss these issues with patients and families.

For more information:
  • Carr R. Complementary and alternative medicine for upper-respiratory-tract infection in children. Am J Health Syst Pharmacists. 2006;63:33-93.
  • Caruso TJ, Gwaltney JM. Treatment of the common cold with Echinacea: A structured review. Clin Infect Dis. 2005;40:807-810.
  • Committee on Children with Disabilities. AAP: Counseling families who choose complementary and alternative medicine for their child with chronic illness or disability. Pediatrics. 2001;107:598-601.
  • Jean D. Use of complementary and alternative medicine in a general pediatrics clinic. Pediatrics. 2007;120:e138-e141.
  • Kemper KJ. Complementary and alternative medicine for children: Does it work? Arch Dis Child. 2001;84:6-9.
  • Lanski SL, Greenwald M, Perkins A, Simon HK. Herbal therapy use in a pediatric emergency department population: Expect the unexpected. Pediatrics. 2003:111:981-985.
  • Mills MV, Henley CE, Barnes LL, el al. The use of osteopathic manipulative treatment as adjuvant therapy in children with recurrent acute otitis media. Arch Pediatr Adolesc Med. 2003;157:861-866.
  • Pichichero ME. Osteopathic manipulation to prevent otitis media – Does it work? Arch Pediatr Adolesc Med. 2003;157:852-853.
  • Sarrell EM, Mandelberg A, Cohen HA. Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media. Arch Pediatr Adolesc Med. 2001;155:796-799.
  • Taylor JA, Weber W, Standish L, et al. Efficacy and safety of Echinacea in treating upper respiratory tract infections in children: A randomized, controlled trial. JAMA. 2003;290:2824-2830.
  • Tomassoni AJ, Simone K. Herbal medicines for children: An illusion of safety? Curr Opin Pediatr. 2001;13:162-169.
  • Woolf AD. Herbal remedies and children: Do they work? Are they harmful? Pediatrics. 2003;112:240-246.
Edward A. Bell, PharmD, BCPS
Edward A. Bell

Complementary and alternative medicine, or CAM, practices and use are increasingly popular among caregivers of infants and children in the United States.

CAM is defined by the National Center for Complementary and Alternative Medicine as “a group of diverse medical and health care systems, practices and products that are not presently considered to be part of conventional medicine.” Many different practices and therapies can be included in this description, such as herbs, dietary supplements, homeopathy, acupuncture, massage, hypnosis and spiritual healing.

Prevalence, reasons for use

CAM use by the pediatric population is not uncommon. Published results of CAM-use surveys have demonstrated prevalence rates ranging from less than 10% and up to 70%. Among the general pediatrics population, it has been estimated that 20% to 30% have used a CAM therapy. Rates of CAM use have been reported to be higher (30% to 70%) among children with chronic disorders, such as autism or asthma.

One survey in Canada documented infectious illnesses as a reason for CAM use in 20% of the surveyed population. Users of CAM therapies often administer traditional drug or other conventional medical therapies concomitantly to their children. Data were reported in 1997 that more visits were made to CAM practitioners than to all primary care practitioners in the United States.

Disorders of the respiratory tract and otolaryngologic disorders are often listed among the most frequent cause for use of CAM therapies in published survey results. In several instances, caregivers of children given CAM therapies often did not inform their child’s health care provider of their use. This information implies that CAM use should be assessed when a medical or drug history is taken.

Why do children and their caregivers use CAM? A commonly reported justification for CAM use by caregivers relates to a “natural” description of some CAM therapies, such as herbs. Natural therapies may be viewed by caregivers as safer than traditional therapies, such as drug therapy. However, as discussed below, “natural” does not necessarily equate to “safe.”

Caregivers may become frustrated or disillusioned with traditional medical practice, especially with treatments of chronic diseases with no known cure like autism. CAM treatments may allow caregivers to have more of a sense of control over their child’s therapies. Related to this, CAM may also afford caregivers use of more of an individualized treatment plan than that provided by traditional medicine.

Additionally, the internet provides a variety of information about CAM use and supposed effectiveness, including numerous testimonials by users. CAM therapies frequently are less expensive than traditional medical therapies and can often be easily obtained.

Disadvantages of CAM use

Several potential problems are related to CAM use that can be easily overlooked by caregivers.

Adverse effects, toxicities and interactions with traditional drugs have been described with some CAM treatments. Examples include seizures from eucalyptus, bleeding from garlic, hypokalemia from licorice, dysrhythmias from ma huang (ephedrine) and tyramine reaction from St. John’s wort.

Some traditional Chinese CAM treatments have been contaminated with barbiturates, lead or arsenic. Other products have been contaminated with pesticides or potentially pathogenic bacteria.

The potential for clinically significant interactions with traditional drugs is also important to consider. Several herbal products can interact with drug therapies, including ginseng (warfarin), St. John’s wort (cyclosporine), ginkgo biloba (anticoagulants or antiplatelets) and sassafras (potential for inhibiting CYP450 hepatic drug metabolizing enzymes). With the variety of herbal products available and the lack of scientific data, the potential for additional herbal–drug interactions cannot be ignored.

Unlike traditional drug products, herbal products do not have to demonstrate efficacy and safety, as they are considered dietary supplements.

When one purchases an herbal product, the content and purity of the product can vary widely. Product label doses may not be accurate, as doses may depend upon the specific plant species used and how it was obtained, prepared and packaged (ie, unregulated manufacturing techniques).

Perhaps this may be analogous to prescription of an amoxicillin product for a specific child, when the concentration and content of the product have not been verified. When specific doses are given on an herbal product label, these doses are often based upon adult usage, with pediatric doses extrapolated from adult use. Few data exist about the pharmacokinetics of herbal products in infants and children.

CAM for infectious diseases

Despite these concerns, some CAM treatments may be logical. Some accepted and effective traditional drug therapies have been developed from natural sources, such as plants. Salicylates from willow bark and digitalis from foxglove are just a few examples. Thus, the use of a specific herb may be reasonable for treatment of a pediatric disorder. However, evidence of efficacy, safety and dosing from scientifically valid, controlled studies is often lacking.

Additionally, product content, purity and manufacturing technique are frequently unknown. It is understandable that caregivers often do not consider these factors. Other CAM products, such as massage, may provide a significant placebo effect.

Among the various herbal products, Echinacea is more commonly used in children. Echinacea may have immunomodulatory effects, stimulating leukocyte activity and function. It has been evaluated in controlled trials of children.

In one placebo-controlled study, researchers found no benefit from Echinacea in reducing symptoms from upper respiratory tract infection in children; however, adverse effects were more common in this group. Researchers from two other controlled trials evaluated Echinacea in the treatment of upper respiratory tract symptoms in children, demonstrating benefit, although these studies were not placebo-controlled and were confounded by concomitant use of other herbal products.

A recent literature review (Caruso) evaluated published studies of Echinacea in adults and children, assessing the studies’ scientific rigor. Of nine studies evaluated, only two were judged to be well-done controlled trials. In both of these studies, the researchers found no benefit from Echinacea administration. A review of Echinacea from the website of the National Center for Complementary and Alternative Medicine (the lead agency of the NIH for scientific research on CAM) states, “Studies indicate that Echinacea does not appear to prevent colds or other infections.”

Cranberry products have been used in children to treat and prevent urinary tract infections. Data from two small, controlled studies showed benefit from cranberry juice ingestion in reducing UTI rates in young women in college. In two other small, controlled trials, cranberry products were given to children with neurogenic bladder. Neither trial’s results demonstrated benefit from cranberry product administration. Although the potential for benefit from cranberry administration may exist for this use, more studies in the pediatric population are needed.

An herbal product demonstrated to be effective in the treatment of pain from acute otitis media is naturopathic herbal extract (“ear oil”). In a randomized, double blind trial, topically applied natural herbal extract (Otikon Otic Solution, containing garlic, Mullien flower, St. John’s wort and Calendula flores) was found to be equally effective in children (aged 6 years and older) as a traditional topical analgesic/anesthetic product used for pain from AOM. This treatment is listed as one of several recommended therapies in the AOM treatment guidelines from the AAP published in 2004.

Other therapies have also been evaluated for AOM. In a small, controlled study evaluating homeopathic treatment for AOM, researchers used a placebo control and found no differences among the groups in treatment response. Given the inherent difficulties in evaluating symptomatic treatment response of AOM, the methodology and validity of this study is questionable.

Data from an interesting study published in 2003 evaluated the effects of osteopathic manipulation as adjuvant treatment in the therapy of recurrent AOM. In a randomized, single blind, trial, 57 children with a history of frequent AOM episodes were treated with routine pediatric care alone or routine pediatric care plus osteopathic manipulative treatment.

Beneficial results were shown in the treatment group, demonstrated by reduced AOM episodes, fewer surgical procedures and tympanometric performance. In an accompanying editorial, results of this trial were evaluated by an expert not involved in the study, whereby the author expressed concerns over this study’s methodology and findings.

Discussing CAM with caregivers, patients

Surveys of CAM use in pediatrics have frequently documented a lack of awareness of CAM use by the clinician. Thus, an important first step is asking if CAM therapies are used.

Caregivers of children with chronic or frequent illnesses may be more likely to be CAM users. It is important to consider the cultural background of patients and families, as some CAM therapies may be accepted and practiced more frequently. Also, it is reasonable to consider that many clinicians practicing conventional medicine may harbor biases toward CAM therapies.

The AAP published a statement in 2001 describing what issues should be considered when counseling patients and caregivers who use CAM. The AAP recommends that clinicians familiarize themselves with CAM therapies to adequately discuss the various treatments with families. The National Center for Complementary and Alternative Medicine provides an internet site (www.nccam.nih.gov) that can be useful to clinicians and patients.

It may be helpful to discuss with families the principles underlying the scientific method, how therapies are proven to be safe and effective, and how this applies to CAM. Clinicians should guard against the potential for negative bias toward CAM therapies as opposed to conventional therapies. Open discussions with families, with respect toward their beliefs and concerns, are essential. These discussions should include information on the documented efficacy (scientific studies, if any), potential harms, adverse effects and interactions with conventional drug treatments of CAM therapies, as many caregivers equate natural treatments with safe.

Conclusion

Although the reasons for CAM use are varied, many patients or caregivers of children view CAM treatments as natural, and thus safer, than conventional drugs or other medical therapies. Users likely are not aware of documented adverse effects, toxicities and herb–drug interactions with CAM therapies, nor are they likely to be familiar with the unknown effects of a lack of standardized content, purity, dosing and manufacturing of herbal products and other CAM treatments. It is incumbent upon pediatric clinicians to discuss these issues with patients and families.

For more information:
  • Carr R. Complementary and alternative medicine for upper-respiratory-tract infection in children. Am J Health Syst Pharmacists. 2006;63:33-93.
  • Caruso TJ, Gwaltney JM. Treatment of the common cold with Echinacea: A structured review. Clin Infect Dis. 2005;40:807-810.
  • Committee on Children with Disabilities. AAP: Counseling families who choose complementary and alternative medicine for their child with chronic illness or disability. Pediatrics. 2001;107:598-601.
  • Jean D. Use of complementary and alternative medicine in a general pediatrics clinic. Pediatrics. 2007;120:e138-e141.
  • Kemper KJ. Complementary and alternative medicine for children: Does it work? Arch Dis Child. 2001;84:6-9.
  • Lanski SL, Greenwald M, Perkins A, Simon HK. Herbal therapy use in a pediatric emergency department population: Expect the unexpected. Pediatrics. 2003:111:981-985.
  • Mills MV, Henley CE, Barnes LL, el al. The use of osteopathic manipulative treatment as adjuvant therapy in children with recurrent acute otitis media. Arch Pediatr Adolesc Med. 2003;157:861-866.
  • Pichichero ME. Osteopathic manipulation to prevent otitis media – Does it work? Arch Pediatr Adolesc Med. 2003;157:852-853.
  • Sarrell EM, Mandelberg A, Cohen HA. Efficacy of naturopathic extracts in the management of ear pain associated with acute otitis media. Arch Pediatr Adolesc Med. 2001;155:796-799.
  • Taylor JA, Weber W, Standish L, et al. Efficacy and safety of Echinacea in treating upper respiratory tract infections in children: A randomized, controlled trial. JAMA. 2003;290:2824-2830.
  • Tomassoni AJ, Simone K. Herbal medicines for children: An illusion of safety? Curr Opin Pediatr. 2001;13:162-169.
  • Woolf AD. Herbal remedies and children: Do they work? Are they harmful? Pediatrics. 2003;112:240-246.