European Elderberry
For centuries, both the flower and the fruit of the European elderberry (Sambucus nigra L.) shrub – delivered as teas, syrups, and juice – have been used to prevent and treat colds, flu, and feverish conditions that benefit from sweating. The flower has been studied longer than the fruit; but US consumers are probably more familiar with the dark purple elderberry syrup, found in health food stores and some pharmacies. So far, researchers have identified numerous flavonoid glycosides (including hyperoside, isoquercitrin, rutin) and anthocyan glycosides (including chrysanthemin, sambucin, sambucyanin) in the berry as well as several properties that makes the fruit useful in treating upper respiratory illnesses.

Elderberry fruit works as an antibacterial and antiviral agent, according to in vitro research. A 2011 study, led by Christian Krawitz, reported that a standardized elderberry liquid extract inhibited gram-positive bacteria Streptococcus pyogenes and group C and G Streptococci and gram-negative Branhamelia catarrhalis – all of which cause upper respiratory infections. In addition, the extract inhibited the replication of human influenza viruses in vitro and in clinical trials. The fruit also prevents hemagglutination (blood clotting) caused by influenza B viruses, according to an American Botanical Council monograph. Elderberry extract also increases production of inflammatory and anti-inflammatory cytokines in humans.

Two randomized, double-blind, placebo-controlled human trials indicate that a proprietary elderberry extract syrup reduces flu symptoms and speeds recovery. A 1995 Israeli study involved 27 adults and children with influenza B Panama. Flu symptoms resolved in about 90%of the elderberry group within two to three days; symptoms in the placebo group resolved within six days (p< 0.001).

A 2004 trial, reviewed by Donald J. Brown, ND, involved 60 adults with a fever ≥38.0 ºC (100.4 ºF) and at least one respiratory influenza symptom. Fifty-four were infected with an influenza type A virus, and the remaining six patients had a influenza type B virus. The patients were randomly assigned to take a proprietary elderberry syrup (38% elderberry extract with small amounts of raspberry extract, glucose, citric acid, and honey) or a placebo syrup with the same formula but without elderberry. All patients were permitted to use a nasal spray or oral paracetamol (Tylenol) as needed during the study. A 10-point visual analogue scale (0 = no improvement; 10 = pronounced improvement) was used to measure improvement in several flu symptoms: aches and pains, coughing frequency, sleep quality, respiratory mucus discharge, and nasal congestion. "Mean VAS scores for aches and pains, quality of sleep, mucus discharge in the respiratory tract, and nasal congestion were all greater than 9.0 by day 4 in the elderberry group and were ≤ 1.0 in the placebo group," writes Brown. In addition, the use of rescue medication was significantly less in the elderberry group (seven took paracetamol; five used the nasal spray) compared with the placebo group (26 paracetamol; 21 nasal spray).

Preparations using ripe elderberries (or elderflowers) are safe, according to American Herbal Products Association. Plant stems, roots, leaves, and unripe berries, however, can produce nausea, vomiting, diarrhea, and lethargy, as well as central nervous and respiratory depression. Herbalists and those who use elderberry fruit in homemade preserves, wines, and winter cordials know to use only ripe berries.

American Botanical Council. The ABC Clinical Guide to Elder Berry [online document].2003. http://abc.herbalgram.org/site/DocServer/Elderberry-scr.pdf?doc=ID=165. Accessed September 18, 2012.
Brown DJ. Standardized elderberry syrup shortens the severity and duration of influenza in adults. HerbalGram. 2004;63:16–17.
Krawitz C, Mraheil MA, Stein M, et al. Inhibitory activity of a standardized elderberry liquid extract against clinically-relevant human respiratory bacterial pathogens and influenza A and B viruses. BMC Complement Altern Med. February 25, 2011;11(16). Available at www.biomedcentral.com/1472-6882/11/16. Accessed September 18, 2012.

Static Electricity and Respiratory Infections
More times than not, shaking out a blanket on a cold night generates the crackle and sting of static electricity and a flurry of sparks. Synthetic materials, low humidity, and ungrounded electrical equipment are producing an unprecedented amount of electrostatic charge indoors, and these electrical fields may be contributing to increased risk of respiratory illness and other infections, according to a 2007 article in Atmospheric Environment. Indoors, most particles, including microbes and allergens, are so small (less than 1 microgram) that they could float in the air indefinitely; but electrical charges cause these miniscule particles to settle on surfaces and stick. These surfaces include skin and lungs. High electrostatic levels and increased deposition of airborne particles on skin have been linked to facial rashes, especially when humidity is low. Charged particles in the lungs increase the risk of infection and asthma.

Keith S. Jamieson, H. M. ApSimon, and J. N. B. Bell advocate several ways to decrease indoor static electricity and the accompanying health effects. One recommendation is to reduce electrical charges by grounding laptop computers and other electrical equipment. They also recommend unplugging equipment when it's not in use.

Another option is bipolar air ionization. (Long-term unipolar air ionization with negative ions has shortened lifespan of laboratory animals.) Air ionizers produce varying amounts of ozone, which damages the lungs, according to the EPA. Jamieson et al. urge people to use passive air ionization measures, such as grounding electrical equipment and choosing materials and furniture finishes that do not conduct electrical charges.

Another way to combat electrostatic is to use humidifiers. Indoor heating and cooling systems often reduce humidity levels. Low humidity encourages high electrostatic levels and decreases beneficial small air ion levels. (Small air ions kill microbes and reduce employee fatigue in the office workplace.) Humidifiers are often used to make breathing easier during respiratory infections; but humidifying indoor air, especially in winter months when furnaces are running, may prevent illness as well.

Jamieson KS, ApSimon HM, Bell JNB. Electrostatics in the environment: how they may affect health and productivity. Electrostatics 2007 Journal of Physics: Conference Series. doi:10.1088/1742-6596/142/1/012052. Available at http://iopscience.iop.org/1742-6596/142/1/012052. Accessed September 18, 2012.
Jamieson KS, ApSimon HM, Jamieson SS, Bell JNB, Yost MG. The effects of electric fields on charged molecules and particles in individual microenvironments [abstract]. Atmosph Environ. August 2007;41(25):5224–5235. Available at www.sciencedirect.com. Accessed April 27, 2011.
Reeves D. Electrical fields from everyday equipment and materials could increase infection risk [press release]. Imperial College London. July 20, 2007. Available at www3.imperial.ac.uk. Accessed September 18, 2012.

Homeopathic Home Care for Flu
Sniffles and aches that signal a cold are nature's way of saying the body is "a little run down," says classical homeopath Mary Aspinwall. "… your body is giving gentle warning signs to pay attention to your diet, drink more water, take gentle exercise, and get more sleep." Flu with its high fevers, severe body aches, extreme fatigue, and possibly vomiting, is another matter. It can last a week or longer and sometimes lead to bronchitis or pneumonia.

Homeopaths successfully treated influenza during the 1918 pandemic: 1.5% of flu patients treated with homeopathy died, compared with 30% treated by conventional doctors. Homeopathic medicines are prescribed according to an individual's symptoms. The more closely a remedy's description matches a person's symptoms, the more likely it is to have a positive effect. During epidemics, homeopaths share the most prevalent symptom patterns and most effective remedies with colleagues.

During an influenza A outbreak in Ireland in the 1990s, Aspinwall conferred with three nearby homeopaths. All four had noticed that most of their patients complained of an "overwhelming chilliness." "They could be lying near a roaring fire with layers of warm clothing and piles of blankets or quilts on top of them," she writes, "and yet they could not get warm. Most of these clients did very well on Hepar sulph." Other symptoms for Hepar sulph are irritability and very sore throats that can produce sharp pain in the ears.

Gelsemium matched the symptoms of most flu patients in 1918. Patients who respond to Gelsemium ache and tend to have shivers along the spine and headaches in the occipital area. Perhaps the most pronounced symptom is a physical exhaustion. "Some use the analogy of being in a glass coffin, as they have full mental awareness, but with heavy, almost paralyzed limbs. Even the eyelids are heavy and droopy," Aspinwall explains. She says that Gelsemium can also be helpful for post-flu weakness.

Gelsemium and Hepar sulph are not the only remedies that can help flu patients. Aspinwall lists others in her article: Arsenicum (chilly, anxious, burning pain, doesn't want to be left alone; good for gastric flu with diarrhea and vomiting); Baptisia (sudden onset, high fever, extreme prostration, muscles feel sore and bruised, face appears dark red, offensive odor from sweat and saliva); Bryonia (slow onset and very achy, feels worse with slight movement, irritates easily, dry cough), Eupatorium perfoliatum (terrible severe bone pain, chilly but wants cold food and drinks), Mercurius vivus (lots of sweating; generally smelly; increased saliva with a constant, painful need to swallow and bad taste in mouth), Nux vomica (gastric flu with diarrhea and vomiting, runny nose during day, impatient and cross), and Rhus tox (stiff joints, restlessness, a red triangle on the tip of the tongue).

The better a remedy matches the symptoms, the more likely it is to help. Having a homeopathic home care kit that contains several remedies increases the likelihood of having a matching remedy on hand. In lieu of a home care kit, Oscillococcinum, a homeopathic remedy for flu sold in some US pharmacies, has helped many – when taken at the first sign of flu symptoms.

Apinwall M. Contagion season! Homeopathy Today. Winter 2011;38–41.

Influenza Vaccine Benefit/Risk in Children
Two 2012 systematic reviews found no evidence that the recommended trivalent inactivated flu vaccine (TIV) prevents flu or flu-like symptoms in young children. Yet, "Summary of Rules for Childhood and Adolescent Immunization," posted on CDC's website, recommends flu vaccination for all children ages 6 to 23 months and for children older than 2 if they have asthma or other conditions that put them at risk for flu complications. Live attenuated influenza vaccine (LAIV), which trials indicate is more effective than TIV, is not recommended for children under age 2 or for children under age 5 who have asthma or a history of wheezing – according to 2011–2012 guidelines (www.cdc.gov/flu/pdf/protect/vis-flulive.pdf).

M. T. Osterholm and colleagues at the University of Minnesota's Center for Infectious Disease Research and Policy performed a systematic review and meta-analysis of flu vaccine efficacy studies that confirmed the presence of the virus using RT-PCR or culture. This review and meta-analysis, consisting of 17 randomized controlled trials and 14 observational studies, included patients of all ages. The authors found no randomized controlled trials involving TIV for children aged 2 to 17 or adults aged 65 and older that met their inclusion criteria. Ten randomized controlled trials showed LAIV efficacy in 9 of 12 seasons in children aged 6 months to 7 years. No randomized controlled trials testing LAIV efficacy in children aged 8 to 17 met inclusion criteria. As stated earlier, LAIV is not recommended for children under age 2. The review's abstract ends: "New vaccines with improved clinical efficacy and effectiveness are needed to further reduce influenza-related morbidity and mortality." This review provides no evidence that flu vaccines reduce morbidity or mortality; it simply looked at their ability to prevent confirmed flu (efficacy) and flu-like symptoms (effectiveness).

The August 15, 2012, Cochrane study, led by Tom Jefferson, looked specifically at the efficacy, effectiveness, and adverse effects associated with influenza vaccines in healthy children. To assess vaccine efficacy and effectiveness, they used 17 randomized controlled trials, 19 cohort studies, and 11 case-control studies that were independently assessed for trial quality. Inactivated flu vaccines, the type recommended for children under age 2, "are not significantly more efficacious than placebo," according to the one study they found. They report that 28 children, aged 6 and older, need to be vaccinated in order to prevent one case of influenza.

The authors undercut their conclusions with a statement that questions the integrity of flu vaccine research. The 2012 Cochrane team cautions that industry-funded studies are more likely to show positive results than studies funded from public sources. They state in their conclusion: "An earlier systematic review of 274 influenza vaccine studies published up to 2007 found industry-funded studies were published in more prestigious journals and cited more than other studies independently from methodological quality and size. … The review showed that reliable evidence on influenza vaccines is thin but there is evidence of widespread manipulation of conclusions and spurious notoriety of the studies. The content and conclusions of this review should be interpreted in the light of this finding."

Unlike the Minnesota researchers, the Cochrane Collaboration looked for evidence that flu vaccination reduces morbidity and mortality. In the 2012 review, the researchers found "no evidence of effect on secondary cases, lower respiratory tract disease, drug prescriptions, otitis media and its consequences and socioeconomic impact. … [just] weak single-study evidence of effect on school absenteeism by children and caring parents from work." This finding matches that of a 2005 Cochrane review, also led by Jefferson, which reported " … no convincing evidence that vaccines can reduce mortality, admissions, serious complications, and community transmission of influenza."

The entire rationale for the flu vaccination program in the US is to prevent more serious illness and death. Lack of evidence does not mean that vaccines do not prevent deaths. It is stunning, however, to learn that thousands of flu vaccine studies have failed to support this widely held assumption.

So far, we have no reliable evidence of efficacy to mandate influenza vaccination in young children and no convincing evidence that influenza vaccination reduces morbidity or mortality in children. What about safety?

The 2012 Cochrane reviewers were unable to perform a meta-analysis of safety data because of wide variations in study designs. Incidences of febrile convulsions, cataplexy, and narcolepsy in children have appeared in medical literature. For example, Australia suspended the use of a seasonal flu vaccine made by CSL Limited because of a high rate of febrile convulsions in young children in 2010.

In BMJ's "Recent Rapid Responses," Peter Collignon, an Australian infectious diseases physician and microbiologist, Peter Doshi at MIT, and Tom Jefferson comment, "We need much better and larger studies on both safety and efficacy before we roll out influenza vaccine programs to all populations, especially to children who appear to have much higher rates of adverse reactions."

Evidence-based medicine, anyone?

Australia suspends seasonal flu vaccination of young children. BMJ. 2010;340:c2419. Available at www.bmj.com/content/340/bmj.c2419?tab=responses. Accessed September 18, 2012.
Jefferson T, Rivetti A, Di Pietrantonj C, Demicheli V, Ferroni E. Vaccines for preventing influenza in healthy children [abstract]. Cochrane Database Syst Rev. August 15, 2012. Available at www.ncbi.nlm.nih.gov/pubmed/22895945. Accessed September 17, 2012.
Jefferson T, Smith S, Demicheli V, Rivetti A, Di Pietrantonj C. Assessment of the efficacy and effectiveness of influenza vaccines in healthy children: systematic review. Lancet. February 26, 2005;365:773-780. Available at CINAHL Plus database. Accessed November 30, 2011.
Osterholm MT, Kelley NS, Sommer A, Belongia EA. Efficacy and effectiveness of influenza vaccines: a systematic review and meta-analysis [abstract]. Lancet Infect Dis. January 2012;12(1):36-44. Available at www.ncbi.nlm.nih.gov/pubmed?term=22032844. Accessed April 18, 2012.

Homeopathic Lawsuits
Large homeopathic manufacturers have become the targets of class action lawsuits. Plaintiffs are charging manufacturers with false labeling and advertising. The lawsuits are based on the premise that homeopathic products "contain no active ingredients in sufficient quantities that could deliver [advertised] benefits."

That widely held premise is not supported by ongoing independent research. Nobel laureate Luc Montagnier has said, "'I can't say that homeopathy is right in everything. What I can say now is that the high dilutions (used in homeopathy) are right. High dilutions of something are not nothing. They are water structures which mimic the original molecules.'" Understandably, homeopathic manufacturers are not willing to debate science in court.

In a California-based lawsuit, Boiron Inc., maker of the flu remedy Oscillococcinum, agreed to a $5 million settlement to avoid further litigation. It will also make changes to its advertising of Oscillococcinum, Amicare, Quietude, Coldcalm, and other products. Oscillococcinum is sold in over 60 countries and "ranks 49th out of 318 cold and flu brand products that do more than $1 million in sales," according to the Chicago Tribune. US retail sales are estimated to be over $20 million per year.

Consumers who feel defrauded can receive up to $100 per household with proof of purchase or up to $50 per household without proof of purchase. It will be interesting to see how many households apply for settlement money. A similar class action lawsuit has been filed against Boiron Inc. and Shoppers Drug Mart (which markets Boiron products) in Canada.

Another large homeopathic manufacturer, Standard Homeopathic Company and its subsidiary Hyland's Inc., has been slapped with two class action lawsuits: Kim Allen v. Hyland's Inc. et al. and Forcellati v. Hyland's Inc. et al. Like the Boiron suits, these are based on the premise that homeopathic remedies are merely sugar pills and cannot possibly have an effect, a "fact" that is not reflected on product labeling.

Given homeopathy's rising popularity, homeopathic manufacturers are sure to attract more unwanted attention from supporters of the chemical-pharmaceutical paradigm.

Benson J. Popular homeopathic cold and flu remedy Oscillococcinum under attack in Canada [online article]. May 19, 2012. NaturalNews.com. www.naturalnews.com/z035916_oscillococcinum_homeopathy_Canada.html. Accessed September 20, 2012.
Hyland's homeopathic cold & flu medicines case moves forward [online article]. Bursor & Fisher P.A. June 1, 2012. www.bursor.com/news/20120601Hylands. Accessed October 1, 2012.
Deardorff J. Homeopathy prospers even as controversy rages. Chicago Tribune. March 6, 2011. Available at http://articles.chicagotribune.com/2011-03-06/news/ct-met-0306-homeopathy-20110306_1_homeopathy-oscillococcinum-products. Accessed September 20, 2012.
Gallucci v. Boiron, Inc. settlement: frequently asked questions [Web page]. www.gilardi.com/boironsettlement/Home/FAQ. Accessed September 20, 2012.
Mirando K. Hyland's homeopathy class action lawsuit moves forward [online article]. Top Class Actions. May 7, 2012. www.topclassactions.com/lawsuit-settlements/lawsuit-news/1831-hylands-homeopathy-class-action-lawsuit-moves-forward. Accessed October 1, 2012.
Ullman D. Luc Montagnier, Nobel Prize winner, takes homeopathy seriously. The Huffington Post. January 30,2011. Available at www.huffingtonpost.com/dana-ullman/luc-montagnier-homeopathy-taken-seriously_­b_814619.html. Accessed October 1, 2012.

Mercury/Thimerosal and Autism
With the publication of a 2003 Danish study in Pediatrics, speculation that the mercury-containing vaccine preservative thimerosal contributed to autism was discredited. The study reported no correlation between thimerosal and autism, a conclusion that made some CDC scientists very happy. The Danish study refuted a 2001 Institute of Medicine report that found a connection between mercury in thimerosal and autism to be "biologically plausible."

The Pediatrics article was a fraud. The Coalition for Mercury-free Drugs used the Freedom of Information Act to obtain CDC e-mail correspondence with Danish researchers. The e-mails revealed that study authors knew that a significant decrease in autism incidence had occurred in the years following Denmark's ban on thimerosal in children's vaccines. The Pediatrics article left out significant information in order to come to the opposite conclusion.

Denmark stopped using thimerosal in childhood vaccines in 1992. An e-mail from one of the study authors, dated November 23, 2002, states: "Attached I send you the short and long manuscript about Thimerosal and autism in Denmark … [redacted] I need to tell you that the figures in the manuscripts do not include the latest data from 2001. I only have these figures as a paper version and they are at work … [redacted] … But the incidence and prevalence are still decreasing in 2001." (See http://mercury-freedrugs.org)

The e-mails also discuss some of the factors which were contributing to the increase in autism rates that occurred after thimerosal was discontinued. In response to questions from Diane M. Simpson at CDC, Dr. Kreesten M. Madsen stated that autism rates did increase after 1993, " … but not very dramatically and there could be more reasons for that. First of all we had a change from ICD8 to ICD10 [diagnostic criteria] in 1994 and furthermore our outpatient clinics were registered in our surveillance from 1995." Lisa K. Sykes with CoMeD explains that the change in diagnostic criteria "would lead to an approximate 5-fold increase in autism cases," according to an estimation presented by Jeffrey Trelka and Brian Hooker (Am Physicians Surgeons. Winter 2004; 9[4]:101).

In addition, Danish autism rates before 1995 were    based only on inpatient (hospital) visits. Children who attended outpatient clinics were not counted. Danish researchers, however, included a large Copenhagen outpatient clinic in 1992 data without explanation. Trelka and Hooker say that this outpatient clinic saw 20% of the nation's children with autism.

The Danish researchers state in their article's "Discussion" that diagnostic criteria changes and the inclusion of outpatient clinics could account for increase in autism rates. Yet, the conclusion reads: "The discontinuation of thimerosal-containing vaccines in Denmark in 1992 was followed by an increase in the incidence of autism. Our ecological data do not support correlation between thimerosal-containing vaccines and the incidence of autism. …" Study authors have ignored requests for original data, according to Sykes.

Although thimerosal has been removed from most US childhood vaccines (except some flu vaccines), the mercury-containing preservative is still used in vaccines sold or donated to developing countries. United Nations Environmental Programmes (UNEP) has been struggling with a way to decrease mercury exposure since 2001. A legally binding international instrument that addresses mercury clean-up and use is nearing completion. Chile is one developing nation that is not waiting for global agreement. The country decided in April 2012 to end the use of mercury-containing vaccines.

King P. Chile stops use of mercury in vaccines [press release]. CoMeD. April 5, 2012. Available at www.laleva.org/eng/2012/04/chile_stops_use_of_mercury_in_vaccines.html. Accessed September 18, 2012.
Madsen KM, Lauritsen MB, Pedersen CB, et al. Thimerosal and the occurrence of autism: negative ecological evidence from Danish population-based data. Pediatrics. September 3, 2003;112(3):604–606. Available at www.whale.to/vaccine/madsen2003.pdf. Accessed September 18, 2012.
Summary of the Fourth Meeting of the Intergovernmental Negotiating Committee to Prepare a Global Legally Binding Instrument on Mercury: 27 June–2 July 2012. Earth Negotiations Bulletin. July 5, 2012. Available at www.iisd.ca/mercury/inc4. Accessed September 20, 2012.
Sykes LK. Response to Danish Committee on Scientific Dishonesty [online document]. September 27, 2011. Available at http://mercury-freedrugs.org. Accessed September 18, 2012.

Vitamin D, Children, and Flu
Two recent randomized, double-blind, placebo-controlled trials provide evidence that vitamin D supplementation reduces the incidence of respiratory infections in children. Vitamin D, which regulates immune response, is made in human skin exposed to sunlight. Without supplementation, D levels decline during the dark days of winter – the season of colds and flu.

A 2010 Japanese trial, led by Mitsuyoshi Urashima, tested the effect of vitamin D supplements on verified influenza. The research team followed 334 schoolchildren from December 2008 through March 2009. Half of these children (n = 167) were given 1200 IU of D3 per day. This group had fewer confirmed cases of influenza A: 10.8% (n = 18) compared with 18.6% (n = 31) in the placebo group. Only two children in the vitamin D group had asthma attacks compared with 12 in the placebo group. This study showed no significant difference between the D3 and placebo groups in the incidence of influenza B or influenzalike illness.

Instead of focusing on influenza, a 2012 trial looked at vitamin D supplementation's effect on acute respiratory tract infections. This study enrolled 247 Mongolian children in late January. Serum 25-hydroxyvitamin D was measured at baseline and at the study's conclusion seven weeks later. Both groups started with a very low median serum D concentration of 7 ng/mL (17 nmol/L). Researchers fortified local milk with vitamin D (300 IU/day) and gave it to 143 children. The remaining 104 participants received unfortified milk. Median serum D concentration in the supplemented group rose to 19 ng/mL (47 nmol/L) by study's end. The incidence of respiratory infections, according to parent reports, was about 50% lower in the vitamin D group compared with the control group.

Dr. Carlos Camargo, who led the study, explains: "' … The large benefit was undoubtedly related to the low baseline vitamin D levels of these children, so I would not expect the supplement to provide similar benefit in children who start with healthy levels of vitamin D. The key question for future research is at what initial vitamin D level would children no longer receive benefit from winter supplementation?'"

Camargo CA, Ganmaa D, Frazier AL et al. Randomized trial of vitamin D supplementation and risk of acute respiratory tract infection in Mongolia [abstract]. Pediatrics. Epub August 20, 2012. Available at http://pediatrics.aappublications.org/content/early/2012/08/15/peds.2011-3029.abstract. Accessed October 3, 2012.
Rattue P. Vitamin D supplements may lower risk of respiratory problems in kids [online article]. Medical News Today. August 22, 2012. http://www.medicalnewstoday.com/articles/249297.php. Accessed September 17, 2012.
Urashima M, Segawa T, Okazaki M et al. Randomized trial of vitamin D supplementation to prevent seasonal influenza A in schoolchildren. Am J Clin Nutr. 2010;91:1255–1260. Available at http://ajcn.nutrition.org/content/91/5/1255.full.pdf+html. Accessed September 17, 2012.
Vitamin D supplementation cuts childhood colds and flu in half. Life Extension. August 28, 2012. Available at www.lef.org. Accessed October 3, 2012.

Jule Klotter
jule@townsendletter.com