Clinical Briefs
With Comments from Russell H. Greenfield, MD. Dr. Greenfield is Clinical Assistant Professor, School of Medicine, University of North Carolina, Chapel Hill, NC; and Visiting Assistant Professor, University of Arizona, College of Medicine, Tucson, AZ.
Anti or Homeo: Use in Preschool Children
Source: Wye L, et al: Complementary or alternative? The use of homeopathic products and antibiotics amongst preschool children. BMC Fam Pract 2008;9:8.
Goal: To determine whether use of homeopathic remedies amongst pre-schoolers is associated with any change in the frequency of use of antibiotics in the same age group.
Study Design: Prospective, population-based observational trial (part of the Avon Longitudinal Study of Parents and Children, or ALSPAC).
Subjects: Children aged 3-4.5 years (n = 9,723) in Bristol, UK.
Methods: The ALSPAC trial recruited pregnant women who were expected to deliver their babies between April 1991 and December 1992. Questionnaires were completed by primary caregivers during pregnancy and throughout the child's first years that included answers about maternal antenatal use of homeopathics, and at age 4.5 years, responses regarding their child's exposure to antibiotics and homeopathic remedies over the prior 18 months.
Results: A total of 62% of children received antibiotics between the ages of 3-4.5 years, while just 6% were given homeopathic remedies. Children who received homeopathic remedies were more likely to have been given antibiotics per univariate analysis; but after controlling for other factors, no association between use of homeopathic products and antibiotic exposure was identified applying multivariate analysis. Among other findings, mothers of children who received antibiotics reported themselves as being anxious and more likely to contact their child's doctor when she/he was ill as compared to mothers whose children did not receive antibiotics.
Conclusion: Use of homeopathic remedies amongst pre-school children is not associated with either decreased or increased antibiotic use, suggesting that, in this age group, homeopathics are used primarily as a complement to conventional Western medical care, not instead of it.
Study strengths: Statistical analyses; community-based trial.
Study weaknesses: Old data and usage patterns have changed over time (for example, rates of antibiotic use amongst British pre-schoolers have dropped since the early 1990's); retrospective data collection with inherent risk of recall bias; no information on the diagnoses/indications for antibiotic or homeopathic use, nor on whether products were obtained through healthcare practitioners or simply over-the-counter.
Of note: The rate of antibiotic use among pre-school children in this trial was slightly higher than what is commonly reported; factors independently associated with use of homeopathic products in this study included maternal use of homeopathic remedies, higher maternal education, lower levels of confidence in doctors, and mothers reporting that they were less likely to seek physician care when their child was ill; studies out of Scotland show that almost half of all primary care practices there offer homeopathic remedies to their patients, with the highest prevalence of use amongst children under one year of age (the most frequent reasons for prescribing homeopathics being for colic, upper respiratory tract infections, and teething); some patients have been known to consult with their conventional doctors for a diagnosis, but then use complementary or alternative therapies, including homeopathy, for treatment; the authors are careful to state that homeopathic remedies are not generally considered viable alternatives to antibiotic therapy.
We knew that: Pre-school children consume more antibiotics than any other age group in the United Kingdom, and are among the most frequent users of Britain's National Health Service (most notably for respiratory tract infections); it has been suspected that parents who use homeopathic remedies for their children expose them to antibiotics far less frequently than non-users of homeopathy, but little data exist in this regard.
Comments: Results of this study are meant in part to allay fears often held by more conventional medical practitioners regarding CAM therapies, specifically homeopathy in this instance. Doctors are rightfully concerned that CAM therapies might be utilized instead of a clearly indicated conventional intervention, thereby delaying appropriate care and potentially placing the patient, especially children, at risk. In this trial, use of homeopathics among pre-schoolers did not translate into avoidance of antibiotic therapy; however, the results are seriously flawed. Without knowing the indications for intervening with antibiotics or homeopathic remedies in the children studied, it is fruitless to assign firm conclusions regarding the philosophy of caregivers who may favor homeopathics. It is noteworthy that mothers who offered their children homeopathic remedies were less likely to bring their children to the doctor when sick. Hopefully, this is in reference to mild illness, but readers can be forgiven should they harbor continued concerns that philosophical leanings might lead parents to more self-diagnosis and treatment of their young children exclusive of the family's healthcare partner, their doctor. Perhaps this paper is really most valuable for pointing out that distrust of conventional medical care still exists. Practitioners who appropriately empower families to care for themselves while simultaneously offering a healthcare partnership based in science and compassion best serve their patients. Now we simply need a healthcare system that supports the time necessary to create that healing relationship.
What to do with this article: Keep a copy of the abstract on your computer.
The "Wow" Factor An Alzheimer's Disease Case Report
Source: Tobinick EL, Gross H. Rapid cognitive improvement in Alzheimer's disease following perispinal etanercept administration. J Neuroinflamm 2008;5:2.
Goal: To detail the clinical response of an 81-year-old man with late-onset Alzheimer's disease who was given treatment with perispinal etanercept, a tumor necrosis factor-alpha (TNF-alpha) inhibitor.
Study Design: Case report.
Subject: A relatively healthy man until 2 years prior when he developed progressive cognitive deficits. He had been treated with multiple medical regimens for Alzheimer's disease, but either could not tolerate treatment or experienced no therapeutic benefit. Upon examination, the patient had difficulty naming common items and was unable to draw a clock correctly (he drew a square with a single line for the hour / minute hands, and no numbers). His score on the Montreal Cognitive Assessment test (MOCA) was 7/30, consistent with moderate-to-severe dementia.
Methods: The patient was questioned by the author of the report immediately before receiving perispinal etanercept. He knew neither the year nor his current location. He received a posterior cervical interspinous injection of 25 mg etanercept at C6-7, followed by placement into Trendelenburg position for 5 minutes, and then a return to the sitting position.
Results: At 10 minutes post-administration, the patient correctly identified his current location and appeared more calm and attentive. Two hours post-etanercept administration he was oriented to place, month, and day of the week. He was markedly better at naming common items, and drew a clock as a circle with an hour and minute hand (still no numbers). When the MOCA was re-administered, his score was now 15/30. One week after the initial administration of etanercept, the patient was oriented to year, month, season, day of the week, and state.
Conclusion: There is a rapidly reversible, TNF-alpha-related component to the cognitive dysfunction seen with Alzheimer's disease, and this reversible pathophysiologic process occurs before irreversible neuronal structural damage. It is likely that a physiologic range of cerebral TNF-alpha exists above which neurodegenerative and cognitive derangements may occur.
Of note: Recent data suggest that TNF-alpha is a gliotransmitter and exerts distinct effects on neural synapses; large molecules like etanercept cannot cross the blood-brain barrier when administered by more conventional means; markedly high levels of TNF-alpha have been found in the CSF of people with Alzheimer's disease, and progressively higher levels seem to correlate with worsening cognitive function for our loved ones, might get better.
We knew that: Neuroinflammation with overexpression of cytokines is characteristic of brain pathology in the setting of Alzheimer's disease; synaptic dysfunction also appears to be a component of the disease; TNF-alpha has been suspected of playing a role in the pathophysiology of Alzheimer's disease, as it appears to interfere with normal synaptic function, something that has been known for over a decade; TNF-alpha can promote degenerative changes when levels are chronically elevated, as it increases IL-1 expression, which increases production of the precursors to amyloid plaques, neurofibrillary tangles, and Lewy bodies; etanercept binds to TNF-alpha, blocking its interaction with cell surface TNF-alpha receptors; etanercept was initially approved for use in the treatment of another inflammatory condition, rheumatoid arthritis; participants in a previously published six-month, open-label trial of perispinal extrathecal etanercept administration in adults with probable Alzheimer's disease showed sustained cognitive improvements, but also displayed apparent rapid clinical improvement essentially immediately after the intervention, which served as the genesis of the current case report.
Comments: It is extremely unusual for the editors of Alternative Medicine Alert to choose a case report on which to offer abstract commentary for our readership. But this case report is unlike most others. It is an unabashed sign of hope.
The authors describe rapid clinical improvement in an elderly man with Alzheimer's disease who was given direct-to-the-brain delivery of anti-cytokine therapy in the form of etanercept. Prior study strongly suggests that clinical response to such treatment is also long-lasting.
The author of an accompanying editorial describes being present as three people diagnosed with probable Alzheimer's disease received perispinal etanercept, and how she noticed clinical improvement within minutes of treatment. She ends by saying, "I was amazed!" When was the last time any of us saw the word "amazed" used without cynicism in a peer-reviewed journal?
There are many novel ways to decrease inflammation in the body, from dietary modification, to stress management, to the use of specific herbs and supplements. Perhaps such actions begun early in life, and adhered to, can help prevent Alzheimer's disease in the first place. Still, it is remarkable that in the setting of established disease, intrathecal administration of a potent anti-inflammatory agent appears to rapidly reverse some of the cognitive deficits commonly seen with this mind-stealing disorder.
Hope springs eternal as patients, family members, and their healthcare providers struggle with the management of Alzheimer's disease. We cling to any reason to believe that we, or our loved ones, might get better. In an era of widespread chronic illness, we need more "Wow" moments; they reinforce possibility and hope. Is more research into perispinal etanercept required? Of course, but this article provides a much needed "shot" of research direction and amazement. May there be more to come.
What to do with this article: Make copies to hand out to your peers.
Goal: To determine whether use of homeopathic remedies amongst pre-schoolers is associated with any change in the frequency of use of antibiotics in the same age group.You have reached your article limit for the month. Subscribe now to access this article plus other member-only content.
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