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From the Townsend Letter
July 2016

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briefed by Jule Klotter
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Homeoprophylaxis
Homeoprophylaxis, the use of highly diluted preparations to prevent infectious disease, has effectively protected people during epidemics since Samuel Hahnemann used belladonna to prevent scarlet fever in his patients in 1799. Fran Sheffield has recorded numerous incidences in which homeopathic remedies and nosodes (homeopathic preparations derived from disease-causing microbes) have prevented illness and death during epidemics in her referenced paper "Homeoprophylaxis: Human Records, Studies and Trials." One of the most publicized examples was Cuba's use of a nosode made from four leptospirosis strains to prevent infection in 2.3 million people living in provinces with high risk of infection in late 2007.
     
Leptospirosis causes jaundice, fever, skin hemorrhage, hepatitis, renal failure, and mental changes. "Within weeks, the treated provinces had an 84% decrease in disease incidence while the numbers of those infected in untreated provinces continued at expect historical levels. ... Leptospirosis infections in untreated areas increased by 22%," says Sheffield. The data were reevaluated in a 2014 article, "A Reevaluation of the Effectiveness of Homeoprophylaxis Against Leptospirosis in Cuba in 2007 and 2008" (Journal of Evidence-Based Complementary & Alternative Medicine. July 2014;19[3]:155–160). The authors confirmed that homeopathy can effectively immunize people against infectious diseases.
     
India and Brazil have also employed homeoprophylaxis. In 2007, 156,000 doses of a combination of homeopathic remedies (not a nosode) were distributed to residents of Macaé county in Rio de Janeiro, Brazil, to protect against dengue fever. Dengue causes fever, rash, and severe head, neck, and back pain. "The disease incidence in the first three months of 2008 fell 93% in comparison to the corresponding period in 2007. The rest of the untreated state experienced an increase of 128%," Sheffield reports. In addition to dengue, government agencies in India have successfully used homeoprophylaxis to prevent and treat influenza, Japanese encephalitis, and malaria. Homeopathy has prevented malaria symptoms in murine studies and in small Kenyan clinical trials as well. Some patients in the clinical trials were experiencing symptoms at least once a month before homeopathic treatment.
     
Australian homeopath Isaac Golden, PhD, has studied the use of homeoprophylaxis to prevent childhood infectious disease for over three decades. In a 2006 interview with Manish Bhatia, Golden explained, "Since 2004, I have used (for long term prevention) a single dose of 200C to filter out those few children who are very sensitive to the remedy. Then a month later a triple dose of 200C (unless they reacted to the single dose), and then a year later a triple dose of 10M." Data that he collected from 1986 to 2004 showed that homeoprophylaxis for whooping cough prevention was 88.3% effective, for measles prevention 91% effective, and mumps prevention was 94.1% effective – which compares favorably to traditional vaccines. In addition, disease symptoms, if they occurred, were less severe in children treated with homeoprophylaxis. In addition to preventing infectious disease, Golden found a lower incidence of atopic conditions. A retrospective study that Golden conducted using data from parents of 781 children (aged 4–12) showed significantly lower incidence of asthma, eczema, ear and hearing problems, allergies, and behavioral problems in children who received homeoprophylaxis compared with those who were vaccinated.
     
Golden will be sharing data from current homeoprophylaxis research at the 2nd International Conference on Homeopathic Prophylaxis in St. Petersburg, Florida, on October 7–9, 2016 (www.WorldwideChoice.org). This year's conference theme is "Homeoprophylaxis: The Evidence-Based Choice." Speakers will examine immune system function, historical application/implementation on homeoprophylaxis, and current research from around the world, Other presenters include immunologist Tetyana Obukhanych, PhD; Cilla Whatcott, PhD; Debra Gambrell, DO; Pieter DeWet, MD; Sally Morell Fallon; and Drs. Srinivasulu Gadugu and Muhammed Rafeeque, who will share information on homeoprophylaxis in India.

Bhatia M. Interview with Dr. Isaac Golden [blog post]. Hpathy. December 15, 2006. Available at http://hpathy.com.
Golden I. Research [blog post]. Homstudy.net. 2013.
Jeutter R. What is homeoprophylaxis [blog post. Ralf Jeutter. Available at www.thehomeopath.org.uk. March 23, 2010.
Sheffield F. Homeoprophylaxis: human records, studies and trials. Homeopathy Plus! http://homeopathyplus.com. August 22, 2014 (updated).

Integrative Nanomedicine
In their informative 2013 literature review, Iris R. Bell, MD, PhD, and colleagues at the University of Arizona (Tucson) explain why nanotechnology using herbs and nutraceuticals can improve infectious disease treatment. Nanotechnology involves the use of minute forms of material substances that measure 1 to 100 nanometers (billionth of a meter) along at least one dimension. Researchers have found that nanoparticles (NPs) are more reactive and adsorptive than bulk forms of the same substance. Bell et al. say, "Chemicals used in the manufacturing process also adsorb, along with the intended drug or herb, onto the surface of the NPs. Consequently, nanotechnology engineers are increasingly seeking more eco-friendly ways to manufacture nanoparticles that avoid or limit reliance on toxic chemical methods. The adsorbed materials can modify the properties, effects, and/or toxicity of the NPs."
     
Smaller is truly more powerful. Studies involving nanomedicine show that fewer doses are required for a therapeutic effect. For example, three doses of a nano version of an antituberculosis drug had the same antibacilli effect as 45 doses of the bulk drug in a mouse study. Similarly, nanotechnology can greatly increase the bioavailability of poorly absorbed nutraceuticals, such as the antioxidant quercetin. In addition to decreasing therapeutic dosage, nanomedicines may produce fewer unwanted effects. Instead of indiscriminately affecting the entire body, nanoparticle drugs can be made to release the active agent inside targeted cells. NPs easily cross the blood–brain barrier and cell membranes, "making them an attractive tool for delivering treatment with drugs, herbs, and/or antioxidant nutraceuticals to intracellular pathogens," say the authors.
     
"Ironically, one of the most controversial systems of alternative medicine, homeopathy, could turn out to be one of the oldest and demonstrably safest forms of nanoparticle-based treatment already used worldwide for infectious diseases," the authors write. Electron microscopy and laboratory analytic methods have found source nanoparticles in homeopathic metal-derived medicines with potencies of greater than or equal to 12C or 24X. According to Avogadro's number, no source particles should be present in such dilutions. Research studies have also found that agitation of preparations in glass containers (which is part of the homeopathic manufacturing process) produces glass-derived silica nanoparticles and increases their aggregation of protein molecules in solution with them. Over 200 years of empirical evidence as well as recent animal and clinical research studies attest to homeopathy's effectiveness in treating infectious disease.
     
"Given limitations of conventional antibiotic drugs from the emergence of treatment-resistant organisms," say Bell et al.,"developing safe and effective nanomedicines from natural products that bolster host resistance and self healing mechanisms from infections should be a priority for new funding initiatives."

Bell IR, Schwartz GE, Boyer NN, Koithan M, Brooks AJ. Advances in Integrative Nanomedicine for Improving Infectious Disease Treatment in Public Health. Eur J Integr Med. April 1, 2013;5(2):126–140.

Extended Antibiotic Therapy for Lyme
Antibiotic treatment extended beyond the recommended 2-week regimen did not improve health quality in people with chronic Lyme disease in a 2016 double-blind, placebo-controlled study. Long-term antibiotic treatment is a common treatment for chronic Lyme, also known as post-Lyme disease syndrome. Many people with Lyme disease continue to experience symptoms such as pain, fatigue, and neurologic and/or cognitive dysfunction after completing recommended therapy. Some researchers and clinicians report evidence that
Borrelia, the bacteria that cause Lyme, can survive the 2-week treatment and recommend diverse antibiotic therapy long term.

This trial, led by Anneleen Berende, MD, recruited 280 patients with symptoms characteristic of Lyme that had persisted for at least a year. All had a history of a tick bite, erythema migrans rash, and/or
Borrelia burgdorferi IgG or IgM antibodies (which may or may not indicate active infection). About 90% had already received at least one course of antibiotics. The patients were randomized into one of three groups and given open-label intravenous ceftriaxone for 2 weeks. Then, the groups received an oral course of doxycycline (100 mg twice daily), clarithromycin-hydroxychloroquine (500 mg) combined with hydroxychloroquine (200 mg) twice daily, or placebo for 12 weeks. To assess treatment safety, researchers conducted physical exams, lab tests, and took medical histories during antibiotic treatment at weeks 2, 8, and 14. Participants completed the RAND-36 Health Status Inventory (RAND SF-36) at baseline, after completion of all antibiotic treatment (week 14), at 40 weeks, and at 52 weeks.
     
The researchers used the physical-component summary score of the RAND-SF 36 for the primary outcome. The physical component measures physical functioning, role limitations due to physical health problems, pain, and general health perceptions. By 14 weeks, the mean physical-component study score for all three groups had improved significantly from baseline, but the mean scores changed little thereafter. The amount of improvement did not significantly differ between the three groups. Despite the improvement, the mean scores were still well below that of the general population at the trial's end.
     
"Although we did not find a significant benefit of longer-term antibiotic therapy, we did find that there were side effects from the use of antibiotics," the authors write. "The majority of patients (68.6%) reported a drug-related adverse event." Diarrhea, rash, and/or allergic reactions were the most common events during the open-label ceftriaxone phase, affecting 131 patients (46.8%). A similar number experienced an adverse event during the 12-week randomized period. The most common adverse effects in the doxycycline group were photosensitivity and nausea. Adverse events in the other treatment group were nausea, diarrhea, and rash.
     
The authors state that one of the study's limitations is that "... our results cannot show whether our study may have included patients with undiagnosed active
B. burgdorferi infection, who have benefited from ceftriaxone treatment." It would have been interesting to see if the RAND SF-36 scores improved after the initial 2-week antibiotic regimen and to mark further improvement (if any) after the additional treatment at 14 weeks.

Berende A, ter Hofstede HJM, Vos FJ, et al. Randomized trial of longer-term therapy for symptoms attributed to Lyme disease.
N Engl J Med. March 31, 2016;374(13);1209–1220.

New Lyme Test
C. S. Cheung and Maryland colleagues have found a way to detect
Borrelia burgdorferi membrane proteins in human serum shortly after infection. B. burgdorferi membrane proteins are ≈107 lower in abundance than serum proteins, according to their abstract. The new test permits early detection of Lyme disease. The researchers focused on a membrane protein that was easily differentiated from human serum proteins.
     
The researchers used a high-speed centrifuge to separate the serum proteins from the
B. burgdorferi membrane proteins and identified the spirochete's proteins using multiple reaction monitoring mass spectrometry.
     
Cheung and colleagues detected the membrane protein in serum samples taken from three patients with unconfirmed
Borrelia infection. The researchers were able to detect Borrelia infection in one patient 3 weeks before the standard blood test came back positive. Results from the new test and the standard test simultaneously confirmed infection in the other two patients. Although a characteristic bull's-eye rash is a defining symptom of Borrelia infection, 20% to 30% of people with Lyme never exhibit the rash. The standard blood test for Lyme measures accumulated antibodies to the infection. It takes 4 to 6 weeks before antibodies reach detectable levels. Because the new test measures bacteria membrane proteins, it can confirm diagnosis shortly after infection occurs, which means earlier treatment. The research team believes that its technique can be used for early detection in other bacterial infections as well.

Cheung CS, Anderson KW, Benitex KY, et al. Quantification of Borrelia burgdorferi membrane proteins in human serum: a new concept for detection of bacterial infection [abstract].
Anal Chem. November 17, 2015; 87(22):11383–11388.
New experimental test detects signs of Lyme disease near time of infection [press release]. National Institute of Standards and Technology (NIST). February 12, 2016.

Travel and Health Risks
Traveling to foreign lands, particularly tropical and subtropical nonindustrial regions, opens the possibility of infectious disease. Assessing health risk can be tricky because so many factors are involved. Incidence of many infectious illnesses vary seasonally and year to year. A traveler's exposure to high-risk settings via activities, accommodations, and length of stay are also factors. The environmental risks can be accentuated or lessened by the traveler's health status, past exposures/vaccination history, education level, finances, and adherence to preventive self-care.
     
In order to make informed decisions about mitigating disease risk during travel, practitioners and patients often depend upon epidemiological data that focus on the area's native inhabitants. Cohort studies involving travelers themselves are rare, as Karin Leder, MD, and colleagues explain in their 2015 article about risk data for pretravel advice. "Travelers are a very heterogeneous population, and most diseases are rare except for ... syndromes such as travelers' diarrhea and respiratory infections," they write. A large number of travelers would have to be recruited and tracked in order to determine the incidence of less common illnesses acquired during travel.
     
Traveler's diarrhea (TD) is "the most frequent infection acquired during travel to most destinations in the tropics and subtropics," according to Robert Steffen, MD, and colleagues. Influenza and hepatitis A are the other two relatively common vaccine-preventable illnesses. Estimated incidence of flu among travelers is 1 symptomatic case per 100 person-months, and estimated hepatitis A incidence is 12.8 cases per 100,000 travelers. TD, which has affected 20% to 60% of travelers over 2-week stays in various studies, usually lasts an average of four days. Steffen et al. state that an oral cholera vaccine has been licensed as protection against TD in some countries, but a 2013 Cochrane review found insufficient evidence to support its use in preventing TD caused by heat-labile enterotoxin producing enterotoxigenic
Escherichia coli.
     
In his article for
Clinical Microbiology Reviews, David J. Diemert discusses preventive measures for avoiding TD. The first is to avoid exposure to contaminated water (i.e., drinking, bathing, swimming) and not to eat raw vegetables, salads, unpeeled fruit, or food from street vendors. Total avoidance can be difficult in some regions. Bismuth subsalicylate (e.g., Pepto-Bismol), which has mild antimicrobial and anti-inflammatory properties, can also prevent TD and reduce symptom duration, according to studies. Diemert recommends two tablets, four times a day. Lactobacillus GG has also shown preventive effects but not as strong as bismuth subsalicylate. Products containing bismuth subsalicylate are contraindicated for pregnant women and people with aspirin allergy. Although Diemert does not mention it, the correct homeopathic remedy can also prevent TD or hurry symptoms along. People with achlorhydria or who take proton pump inhibitors (PPIs) for GERD have a greater risk of developing TD, so they would be wise to seek protective measures before traveling to tropical and subtropical regions.
     
Before taking a trip, patients, with the help of practitioners, need to weigh the consequences of possible illness against the effectiveness and potential harms of interventions. Leder and colleagues write, "The actual decision about whether a risk is unacceptably high or acceptably low and whether or not an intervention will be accepted rely not only on risk numbers or clinical severity of outcomes, but also heavily on risk communication and – presumably even more importantly – on risk perception of both the health provider and the traveler."

Diemert DJ. Prevention and self-treatment of traveler's diarrhea.
Clin Microbiol Rev. July 2006;19(3):583–594.
Leder K, Steffen R, Cramer JP, Greenaway C. Risk assessment in travel medicine: how to obtain, interpret, and use risk data for informing pre-travel advice.
J Travel Med. 2015;22(1):13–20.
Steffen R, Behrens RH, Hill DR, Greenaway C, Leder K. Vaccine-preventable travel health risks: what is the evidence – what are the gaps?
J Travel Med. 2015;22(1):1–12.

Zika and Guillain-Barré
Serological evidence from a 2016 case-control study indicates that Zika virus can cause Guillain-Barré syndrome (GBS), a neuritis that can produce paralysis. Until recently, Zika infection had been considered a mild illness with clinical symptoms that include fever, maculopapular rash, joint and muscle pain, headache, and nonpurulent conjunctivitis. This case-control study, led by Van-Mai Cao-Lormeau, adds Zika to the list of other infections known to cause Guillain-Barré, including influenza and pseudoinfluenza,
Campylobacter jejuni, cytomegalovirus, Epstein-Barr, and dengue – a virus carried by the same species of mosquito that harbors Zika.
     
Cao-Lormeau and colleagues commenced the study after noticing a marked increase in Guillain-Barré incidence during a large Zika outbreak affecting an estimated 32,000 people between October 2013 and April 2014 in French Polynesia. Forty-two patients were diagnosed with Guillain-Barré between November 2013 and February 2014. Only 5 cases had been reported in 2009, 10 in 2010, 3 in 2011, and 3 in 2012. The researchers set up a case-control study using the 42 patients and 2 control groups. Group 1 consisted of age-, gender-, and residence-matched patients who came to the hospital during the same period with a nonfebrile illness (n = 98). The second control group consisted of age-matched patients with acute Zika and no neurological symptoms (n = 70).
     
Thirty-seven GBS patients (88%) had a transient illness shortly before Guillain-Barré symptoms arose. Forty-one patients (98%) with Guillain-Barré syndrome had anti-Zika virus IgM or IgG, and all had neutralizing antibodies against Zika virus. In comparison, 54 of 98 (56%) in control group 1 had neutralizing antibodies. RT-PCR results were positive for acute Zika infection in all patients in control group 2, but none of the patients with Guillain-Barré had positive RT-PCR results, which was consistent with the absence of a fever upon admission.
     
The researchers also checked for dengue viral involvement. They found an insignificant difference between patients with GBS and those in the control groups; 95% in the GBS group had a history of dengue compared with 89% and 83% in control groups 1 and 2. Serological evidence of anti-dengue IgM is difficult to interpret because of possible cross-reactivity with anti-Zika IgM.
     
The US Centers for Disease Control blames Zika virus for increased incidence of microcephaly in Brazil and other Central and South American countries. An Associated Press report (14 April 2016 ) from Bogotá, Columbia, allows for less certainty that Zika is the primary cause. Colombian authorities have reported 33 cases of newborns with microcephaly so far this year, which is similar to previous years. The country's National Institute of Health said that 2 of the 33 were caused by Zika and 16 have no connection to Zika infection. The remaining 15 were still being investigated. If Zika virus did not cause those 16 cases (48.5%), what did?

Associated Press. Colombia confirms first two cases of Zika-linked microcephaly. April 14, 2016.
Cao-Lormeau V-M, Blake A, Mons S et al. Guillain-Barré Syndrome outbreak associated with Zika virus infection in French Polynesia: a case-control study.
Lancet. 2016;387:1531–1539.
HealthDay News. U.S. health experts debate advice to women once Zika virus arrives. April 15, 2016.
        
Jule Klotter
jule@townsendletter.com

     

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