After my last post, I received an excellent comment regarding ZICAM® that I felt warranted a post of its own. This comment demonstrates some of the misconceptions regarding “safety” and “efficacy” of products. I glossed over some of the reasoning behind my statements in my last post, so to be fair, I will present the rest of the story. At the end of the day though, whether ZICAM® provides a marginal benefit for treating the common cold or not, and whether it is safe or not is not my point. My point is that tucked away in the amazing machine that is your body and its immune system is the perfect remedy for virtually every minor illnesses around. If you take care of this machine by eating right, exercising, and getting plenty of rest you will probably avoid most minor illnesses (and most major ones too). In the event that you do get ill, the only thing most people need is rest, fluids, and a little time to let the body works its magic. In my opinion, squirting zinc gel up your nose is probably not a good idea.
Zicam does have clinicals that show it can shorten the duration of the average cold from 9 days to 3 days.
The manufacturers didn’t bypass the FDA – they followed the guidelines by which the company was prescribed to go to market under the HPUS.
Mounting evidence isn’t exactly accurate either. There still isn’t a proven link between Zicam and anosmia. While there have been many studies that try to find this link, none have been conclusive. Anosmia’s most likely cause is the common cold which people have when they use Zicam. Whether there are 130 or 800 complaints, that’s less than 1% incidence rate given the billions of doses that have been administered over 10 years.
Matrixx Initiatives, the makers of Zicam, is a small company. It has been the target of lawyers since 2004 seeking to make money by collecting ‘assets’ for clients that simply claim they’ve lost their sense of smell from using Zicam. This has already gone to trial and Matrixx Initiatives won. Why? Can’t prove the link to the product. FDA has a new leadership with a new agenda.
This post details the research I do when I make a post. To many of my readers you will find this highly technical and/or mind-numbingly boring. However if you are truly interested in the pros and cons of ZICAM® and how I arrived at my opinion, keep reading.
Clinical trials for ZICAM®
In my review of the literature I find 6 different studies that look at the active ingredients of ZICAM® (zinc). Two of the studies examined the benefit of taking the zinc orally (by mouth). In one study they conclude “Zinc compounds appear to have little utility for common-cold treatment.” In the other study, they state, “We conclude that while zinc gluconate may produce a small reduction in overall severity of symptoms, this is not clinically significant.” In this same study they went on to report a 50% incidence of nausea and altered taste (which, by the way, is mediated by nerves). Thus based on these two studies, I am not sure why anyone would anyone consider using zinc for the common cold.
The plot thickens
Then in 2000, someone got the idea that spraying a zinc gel up your nose might be a good idea. This study was then published which showed that people who got the zinc gel were sick on average 2.3 days and those who did not were sick on average 9 days. Sounds like a miracle drug, right? Well, I am not so sure and will explore this in more detail below.
Since this original study in 2000, there have been 3 subsequent studies that have looked at the same concept – zinc in the nose when you get a cold. The first one published in 2001, came to this conclusion, “A low concentration of zinc sulfate nasal spray had no effect on the duration of the common cold.” To be fair though, they used a lower concentration of zinc than what is typically found in the ZICAM® product. Following this, another study came out in 2003. Their conclusion, “Zinc gluconate nasal gel shortens duration and reduces symptom severity of the common cold in healthy adults, when started within 24-48 h of the onset of illness.” Finally, a little later that same year another study came out looking at the same thing and concluded, “Zinc nasal gel (Zicam) reduced the duration of the common cold by 41 hours, was well tolerated, and was relatively inexpensive. More studies, in a broader population, comparing zinc nasal gel with other cold remedies (such as decongestants, antihistamines, antitussives, and antipyretics/analgesics) are needed before recommending it as first-line therapy.”
(Translation… do not go out and buy this stuff just because you have a cold, we are not sure that are results are accurate and there is not enough data to determine its safety.)
What Does This All mean?
It might help
At best, you may get a small improvement in your cold symptoms. However, you may also have adverse effects like nausea, change in taste, or nasal burning. But what about the study that showed ZICAM® shortened the duration of symptoms from 9 days down to 2.3 days?
A closer look at the ZICAM® landmark study
The first thing I notice is that this landmark finding is published in an obscure journal. I mean, shouldn’t something that is so successful against the common cold be shared with the entire medical community? Well, when things get published in obscure medical journals, it generally means it is not a very good study with all sorts of flawed scientific methodology. You can get just about any result you want if you look at it just the right way. Thus significant findings, if scientifically sound, are virtually always published in mainstream medical journals, which are critically reviewed.
There is also a good chance that this study received some funding from the makers of ZICAM®. Since the article is published in such an obscure journal, I cannot access it to see about funding disclosures. Virtually any positive study funded by the people who stand to make money off the positive results should be reviewed very cautiously. I must admit though, this is only an assumption on my part.
Another potential problem of the ZICAM® landmark study is that it comes out of The Center for Integrative Medicine in Tarzana, California. This alone represents significant bias, in that The Center for Integrative Medicine is an organization that tends to prefer a homeopathic approach to illness.
The one objective thing that I find most confusing about the study is how long the patients were sick who did not get ZICAM®. This was NOT a normal group of patients. The average duration of major symptoms related to having a cold is typically 7 days or less. In the other studies that looked at patients with the common cold who were given a placebo (nothing), they were sick anywhere from 3.5 to 7 days. In the ZICAM® favorable study the patients given placebo were sick for 9 days. This is atypical and no doubt skewed their results. If the patients given placebo in this study had been normal (i.e. they only had a cold for the normal duration of 3.5-7 days) their favorable results no longer attain statistical significance.
Now, I am not saying that the ZICAM® results are FALSE. Rather I am saying that when I critically review this study it appears to me that their results may represent a significant bias on the part of the researchers. Perhaps their results look so good simply because those patients who received placebo just happened to be sicker than those patients who received the ZICAM®. This of course, is just my opinion. However, I suspect that those people who review studies submitted to major medical journals would have come to the same conclusion.
What about the FDA?
Following the rules
I have no doubt that the makers of ZICAM® followed the regulations exactly as laid out by the FDA. However, the regulations for homeopathic products are WAY different than for those of medical products – especially as it relates to safety. Let me give you an example…
The Rotavirus vaccine
The new Rotavirus vaccine, which is heavily regulated by the FDA, is a great example. To prove its safety, several huge clinical trials were performed. One of the most important studies was published in the New England Journal of Medicine in 2006. This is THE most respected medical journal in the world. In this study roughly 35,000 children were given the vaccine and 35,000 children were given placebo (nothing). Their results, “This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception (the most common serious adverse event) was similar in vaccine and placebo recipients.”
Now contrast this with the landmark ZICAM® study that had 108 patients who were give the zinc and 105 patients who were given the placebo. Studying safety in 100 patients is just not the same as studying it in 35,000.
Again, I am certain that the makers of ZICAM® followed the letter of the law when it comes to FDA regulation. However, their conclusion that it is both safe and efficacious is just not true. Regarding safety, at best, one can draw the conclusion that the incidence of serious adverse events is less than 1 in 108. Regarding efficacy, the water is even murkier. At best, there is a suggestion that people who take ZICAM®, may get better slightly sooner, but even this is debatable.
What about the billions of doses that have been given?
Until someone does a large scale epidemiological study looking at people with loss of smell, we simply do not know if there is a definitive connection to ZICAM®. If 1 billion doses have been given and there are over 100 that have lost their sense of smell, one could argue that if there is a risk from taking ZICAM®, it is probably less than 1 in 10 million. Again, though, I would argue: Why take ANY risk when it is unclear if ZICAM® actually works and it is crystal clear that the common cold will get better without ZICAM®, even if it takes 41 hours longer.
Until the makers of ZICAM®, or better, some unbiased medical researchers do a large randomized double-blind placebo controlled study, the best we can do is make careful observations – and this has been my point all along.
Bringing It Home
It is debatable if ZICAM® is in anyway helpful for the treatment of the common cold. Maybe it is and maybe it isn’t – we just do not know for sure based on the currently published research. However, we do know that the common cold is virtually harmless in normal healthy individuals. We also do not know if ZICAM® is safe or not. Maybe it causes permanent loss of smell or maybe it doesn’t – again we just do not know based on the currently published research.
What we do know is that some people who have taken ZICAM® have lost their sense of smell. Perhaps this happens to 1 in 1,000 people, or 1 in 10 million. Perhaps it was unrelated to ZICAM® and caused by something else. However, I am not sure why anyone would want to spend money on a product that may or may not work and may or may not cause you to permanently loose your sense of smell – especially when if you just do nothing things will get better anyway in 3-7 days.
Of course, that is just me. For you and your family… You Decide.
This study looks at people who took oral zinc when they had a cold. They did not see any significant benefit when taking zinc.
This is another study that looked at taking zinc for the common cold. Again they did not see any significant benefit.
This is the study cited by the makers of ZICAM® showing the greatness of their product.
This study shows a small benefit to nasal zinc.
This study also shows a small benefit to taking nasal zinc when you have a cold.
This study did not find any benefit to using nasal zinc.