Staying clear of respiratory infections is a high priority issue for many CLL patients. This is particularly hard to do during the holiday and flu seasons. Our guys lack sufficient immune function to fight off all the nasty bugs floating out there and since they don’t respond worth a damn to annual flu shots, their best bet is “social distancing” and “herd immunity” – two terms you should understand by now, since your health may depend on them!
Here is an interesting clinical trail that caught my attention. “COLD-FX” is an over the counter cold remedy that is readily available. You can get it from Amazon for $11.00 for 30 capsules. Does it work? Below is the press release from Afexa, the company that makes COLD-FX. It seems there may be small but statistically significant benefit to taking this drug.
Afexa Announces Results of Clinical Trial With Chronic Lymphocytic Leukemia Patients
EDMONTON, ALBERTA–(Marketwire – June 2, 2011) – Afexa Life Sciences Inc. (TSX:FXA) – the maker of COLD-FX® – today announced results of a clinical trial exploring the potential application of CVT-E002™, in chronic lymphocytic leukemia (CLL). The immune system, particularly antibody responses, in CLL patients is compromised and, as in all cases of immune suppression, infection is common in this population. This is the first time CVT-E002 has been studied in a cancer clinical trial exploring the role of CVT-E002 in reducing the incidence and severity of acute respiratory infections for CLL patients.
The clinical trial was led by researchers from Wake Forest Baptist Medical Centre in Winston-Salem, N.C., a U.S. National Cancer Institute (NCI) designated Comprehensive Cancer Center. The NCI-approved multi-centre, randomized, double-blind, placebo-controlled clinical trial involved 293 CLL patients from sites affiliated with Wake Forest Baptist’s Community Clinical Oncology Program Research Base. Participants were randomized to take either 400 mg of CVT-E002 or placebo per day for a minimum of 4 months during the 2008/2009 cold and flu season. The study explored the impact of CVT-E002 on the incidence, duration and severity of acute respiratory illness, the reduction in antibiotic use and overall immunological response.
The results, awaiting final peer-review, demonstrated that patients taking CVT-E002 showed a statistically significant reduction in the incidence of moderate to severe acute respiratory infection (ARI) symptoms (relative risk reduction of 20.1%; p = 0.02), and a trend of reduced incidence of moderate to severe ARI (32% vs. 39%, 95% C.I. -18%, 4%). There was no significant difference shown for patients with mild ARI symptoms, average number of ARI days or antibiotic use.
In addition, when investigators analyzed immunological response, greater seroconversion (antibody levels) was observed against nine common upper respiratory viral pathogens with CVT-E002 versus placebo (16% vs. 7%, p = 0.04). This is thought to reflect a CVT-E002 induced increase in antibody response and may be important since CLL patients generally have impaired antibody responses and immune suppression.
OK, I am inclined to give this one a pass (unless peer review counters this press release). If you are itching to try alternate and herbal remedies in any case, this may be a relatively safe thing to try this year during the cold and flu season. I am impressed the company actually bothered to do a multi-center, double-blinded and placebo controlled clinical trial, with close to 300 CLL patients. Mind you, the patients took COLD-FX for 4 months, 400 milligrams each day – that would be two of the capsules/day of the 200mg capsules Amazon had listed. The reduction in incidence of acute respiratory infection went from 39% to 32%. Is that a huge difference? you be the judge.
There was an earlier study looking at similar things in geriatric (“elderly”) patients in old folks homes. The abstract is below. ( “COLD-FX” is the brand name of CVT-002. )
J Am Geriatr Soc. 2004 Jan;52(1):13-9.
A placebo-controlled trial of a proprietary extract of North American ginseng (CVT-E002) to prevent acute respiratory illness in institutionalized older adults.
McElhaney JE, Gravenstein S, Cole SK, Davidson E, O’neill D, Petitjean S, Rumble B, Shan JJ.
Eastern Virginia Medical School, Norfolk, Virginia, USA. firstname.lastname@example.org
OBJECTIVES: To compare a proprietary extract of American ginseng, CVT-E002, with placebo in preventing acute respiratory illness (ARI) in an institutional setting during the influenza season.
DESIGN: Two randomized, double-blind, placebo-controlled trials conducted late in the 2000 (8 week) and 2000-2001 (12 week) influenza seasons.
SETTING: Long-term care setting that included nursing home and assisted living at three sites.
PARTICIPANTS: Eighty-nine (2000) and 109 (2000-2001) enrolled subjects, average age 81 and 83.5, respectively; 74% women. Approximately 90% had received influenza vaccine in each of the 2 years.
INTERVENTION: Oral twice-daily administration of a proprietary ginseng extract, CVT-E002, 200 mg or placebo.
MEASUREMENTS: ARI was defined as two new respiratory symptoms or one with a constitutional symptom. Confirmation of viral ARI was by culture (influenza or respiratory syncytial virus (RSV)) or serology for influenza. Laboratory safety monitoring was done at 0, 4, and 8 or 12 weeks.
RESULTS: An intent-to-treat analysis of pooled data corrected for drug exposure time showed that the incidence of laboratory-confirmed influenza illness (LCII) was greater in placebo- (7 cases/101 subjects) than CVT-E002-treated (1/97) groups (odds ratio (OR)=7.73, P=.033). Combined data for LCII and RSV illness were also greater in placebo- (9/101) than CVT-E002-treated (1/97) groups (OR=10.50, P=.009), for an overall 89% relative risk reduction of ARI in the CVT-E002 group.
CONCLUSION: CVT-E002 was shown to be safe, well tolerated, and potentially effective for preventing ARI due to influenza and RSV.
As far as I can tell, CVT-E002 is a proprietary concoction of ginseng. But apparently it works better than garden variety ginseng extracts. Go figure. I must confess I am not really familiar with this area of research or the quality of the journals where it is published. But there seems to be relatively little toxicity, so it might be OK to try it – if you are so inclined in any case. But I would still pay attention to the well known benefits of social distancing and herd immunity, if I were you.
Int Immunopharmacol. 2008 Aug;8(8):1134-42. Epub 2008 May 7.
Effect of CVT-E002 (COLD-fX) versus a ginsenoside extract on systemic and gut-associated immune function.
Biondo PD, Goruk S, Ruth MR, O’Connell E, Field CJ.
Alberta Institute for Human Nutrition, Department of Agricultural, Food and Nutritional Science, University of Alberta, Edmonton, Alberta, Canada T6G 2P5.
CVT-E002 (sold commercially as COLD-fX) is a patented, polysaccharide-rich extract of North American ginseng (Panax quinquefolium) with purported beneficial effects on influenza and the common cold, although its mechanism of action is largely unknown. This study was conducted to determine the effects of feeding CVT-E002 versus a ginsenoside-containing extract on systemic and gut-associated immune function. For 7 days, male weanling Sprague-Dawley rats (n=10/group) were fed one of four diets: control, low CVT-E002 (450 mg/kg), high CVT-E002 (900 mg/kg), or ginsenoside (450 mg/kg). Lymphocytes were isolated from spleen, mesenteric lymph nodes and Peyer’s patches, and immune cell proportions and cytokine production were measured. IgA-positive cells in the jejunum were also assayed. CVT-E002 consumption (particularly at the higher dose) decreased spleen IL-2 and IFN-gamma production following ConA and/or LPS stimulation for 24 or 48 h (P<0.05). Also, CVT-E002-fed rats had a lower proportion of total CD3+ cells and activated T cells (P<0.05). After 48 h of ConA stimulation, spleen IL-1beta production was higher (P<0.05) for animals fed the high dose CVT-E002, whereas TNF-alpha production did not differ significantly from the control group. Feeding the ginsenoside diet resulted in lower (P<0.05) spleen IL-2 production, but the IFN-gamma, TNF-alpha and IL-1beta response to ConA was not different from control animals at 48 h. A higher proportion of jejunal IgA-positive cells was found in rats fed the ginsenoside diet (P<0.05). In conclusion, feeding CVT-E002 modifies systemic immune responses and appears to affect gut-associated immunity in a manner distinct from that of ginsenoside-containing extracts of North American ginseng.
Disclaimer: I own no stock in Afexa, I have not been paid a dime by them. Zero conflicts of interest. As always, “Buyer Beware” is a good mantra to remember.