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02 February 2009

Sinupret, con or cure...

There is a wave of marketing on television, in print and over the internet of an “herbal remedy” called Sinupret.  Sinupret is a concoction of a German company named Bionorica.  Sinupret falls into the grey area of a supplement, largely unregulated by the FDA.  There is no guarantee of standardization of dosage and the rules for efficacy are non-existent as compared to OTC (over-the-counter) medications.  Ironically, a pan European court ruled Sinupret “superfluous” and “ineffective” as early as 1992.   

 

Some have spent some time pondering the possible negative effects of the  "herbal remedy".  The product itself is 8% alcohol and many are under the mistaken impression that this is a homeopathic medicine, which it is not.  I am always very wary of any company claiming to have a “proprietary” claim on their ingredients.  This product is clearly an herbal, akin to St. John’s Wort and other herbs which have proven to be problematic for individuals when combined with other medicines. 

 

Sinupret is marketed by Dr. Bob Sears, a paid physician spokesman on Bionorica’s staff.  He carefully excludes any claims of efficacy and dances around the edges as to exactly what the mechanism of action is behind the drug.  Much like the bally hooed Head-On product, it is likely that any review of the product’s capabilities will come up far short.

 

Parents who administer this product to their children do so with good intent.  However, the lack of oversight, trials and data supporting even the most benign claim puts their children at risk.  There is no scientific data supporting the claims of stronger immune systems.  A stronger immune system is best enhanced by a healthy diet, good hygiene and rest.  Children who are stressed from too little of the aforementioned and placed in close contact (i.e. school or preschool) with other similar germ factories are likely to get colds.

 

In a world where the Snugli can sell more than 40 million units in a few months, a slickly promoted bottle of snake oil, pushed by the fears of millions of parents, can gain equal, if unearned profits. 

 

At least the Snugli will keep you warm.

 

Caveat emptor.

 

 

30 comments:

sonicfrog said...

The Biggie right now in the "alternative health industry" is liver / kidney detoxification. I was driving to a job the other day and caught part of a radio show (a 30 minute commercial) talking about a product that would help you cleanse your organs, lose weight, look and feel younger (20 years younger), keep you from catching cold (the host has not had a cold since she started using this product fifteen years ago), prevents pulled muscles, prevents bad breath, etc. etc.

Oh, and one "caller" has cancer that is in remission. He didn't say that this product was the reason, but you got the impression that it was.

Ver Word: Pasta (yum)

sonicfrog said...

Oh, I forgot - improve your sex life!

Citizen Deux said...

Right, if your liver weren't working properly - you'd be dead! This is the same myth from people who claim that there is five pounds of undigested meat in the intestine.

sonicfrog said...

..."pasted to your intestinal wall like spackle"...

Yeah, one of my little brother's ex girlfriends, a vegan of course, repeated the "10 year old cornflake found in colon" fabrication many times. Don't get me wrong, besides the militant veganistic tendencies, she was one of the better one's he had... up until the time when she cheated on him.

sonicfrog said...

I swear, sometimes I listen to this stuff, and see how many people actually believe and buy this crap, I think of how much money I could be making... if only I didn't have a conscience.

Gordon Marock said...

A timely post indeed, for others at least. I already fell victim to a liver detox product called 'Chummy Warm Popples.' I am ashamed to say that I was lured in by the free clinical trial and Wendy's gift certificates. Needless to say, I was shocked to awake during the trial to find my Liver soaking in a tub of 'CWP.' Fortunately, the incision was not closed, and I was able to beat a hasty retreat along with my loosely attached Liver. After the shock wore off, I must admit that my Liver feels pretty good.

onyx10577 said...

I agree that there are a lot of scams out there, but I have to say that I recently tried Sinupret and it really helped. A few days ago I came down with a sinus infection and decided to try a free sample of the stuff. I fully expected to feel no effect, but I was pleasantly surprised to find that it really helped.
I think it's a pretty fine line sometimes between being not being taken in and missing out.

Citizen Deux said...

Onyx,

You fail to indicate what relief you experienced. Did your symptoms immediately improve? Or did they get better within the realm of self-limitation? Sinupret is a collection of ineffective herbs. An interesting post on a site advocating its use says as much;

"Dr. Williams' latest discovery, called Sinupret +, naturally supports your body's normal inflammatory response and mucus production. You'll breathe more easily, and feel more comfortable, thanks to healthy, well-drained sinuses, well-ventilated nasal passages, and normal nasal tissues.

Sinupret + is based on a blend of common herbs and wildflowers that are balanced in extremely precise ratios. These ingredients are not effective when used individually, but the combination works synergistically to help keep your sinuses, nasal passages, and mucus at their healthiest.

What's more, Sinupret + comes from Germany, where it's grown on the manufacturer's own farms, and processed under strict German pharmaceutical quality standards. This is important because in Europe herbal formulas undergo the same rigorous testing as our over-the-counter remedies."

Finally, there is no comparable testing in Germany for herbal remedies as compared to pharmaceuticals. The only similarity is the European approach of verifying that all food and drug components are safe - meaning, harmless - save for the intended effect.

Finally, emed TV has a great short post on the "possible" efficacy of this product. When combined with traditional approaches for acute sinusitus, the product "seems" to work. Evidence Summary

Considering there are real side effects, including dizziness and nausea - one must way the purported efficacy with the identified ill effects. If the net balance is negative, then the medicine is ineffective. From the published information - my conclusion is that you are being taken for a ride.

Anonymous said...

During a recent trip to Geneva I had blocked and painful sinuses. Through some gesturing to the pharmacist I was given some Sinupret and had to trust in her and hope. Within an hour or so I was able to breath through my nose for the first time in two days. Always difficult to tell with cold like symptons how much is just the body going through a temporary improvement but they seemed to work for me. I should add they do not seem to be working as well three days later.

Anonymous said...

I have used sinupret for a couple of years having them recommended by my sister. They have really helped slow down the process of colds for me and my children. My son used to get sinus infections and even pneumonia. Now when I give him these pills at the first symptoms of a cold, he seems to get better quickly. So, whatever they are, THEY WORK!
Krista

Kristina said...

I have taken Sinupret in Germany since I was a 12 years old. I can only say that the product works and I never experienced any side effects. I start taking the product as soon as I get headaches from my clogged sinuses. Sinupret helps clear my sinus infections, alleviate sinus pressure and headaches, unclogs my nose, and takes that disconnected feeling away. Sinupret works better than any product I found in Germany or over the counter here in Florida or Texas. Since Sinupret uses natural ingredients and not chemicals it is a safer alternative even though it may take a little longer to fully recuperate from a sinus infection.

Citizen Deux said...

It seems from the source of these many posts on Sinupret, someone is actively campaigning on behalf of Sinupret. If one reads the comments carefully, none of the assertions are supported by evidence and nothing refute the European findings cited in the original article.

Sinupret's efficacy is solely bsed upon a placebo effect. It is "natural" only in that the active chemicals are non-standardized. Sinupret is a drug - make no mistake. Whether it is effective or safe as described remains to be seen.

href="http://abc.herbalgram.org/site/DocServer/Sinupret_clinOver.pdf?docID=882"ABC Herbal Review" found that there ar ein deed reported adverse side effects, including intestinal distress and allergic reactions. Furthermore, the review indicated a dearth of data for pediatric usage of the medicine.

Acute sinusitus usually self resoves in 5-7 days. In some instances the illness can progress to infection, requiring treatment with anti-biotics.

In short, doing nothing is likely more effective, and certainly more safe than using Sinupret.

Dawn said...

I just came across you blog while researching Sinupret. I live in Mexico, and over here the drug is marketed by Boehringer Ingelheim under the name Bisolsinus, but made by Bionorica which is the same lab that manufactures sinupret. I bought the pediatric version for my son, who's prone to sinus infection. After the first 2 doses he developed lots of gas and mild diarrhea. I immediately discontinued use and the problem stopped. The company those list gastrointestinal problems as a possible side effect. I think parents should read the possible side effects and be vigilant for any of them, "natural" does not always mean safe.

Shosho said...

My son is prone to sinus infections and upper respiratory infections as well. I started giving him Sinupret and he has been symptom free. One could say placebo effect but he is a 3 year old and has no idea what is going on! I must add that when I ran out recently, (I have yet to find another drugstore carrying it here in MD) in about a weeks time his sinuses began to trouble him again - sneezing, running nose etc. He is prone to these types of infections, according to his doctor, because he had a slight breathing problem when he was born. Either way, they work for my highly allergic (peanuts, eggs & mlk) and sensitive son so he will continue to use them.

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Heidi said...

So I just came across this blog while also researching a product that I thought would help my daughter this.. er. ... ummm...., I am embarrassed to admit, evening. I will be checking on her throughout the night as one would expect, especially after reading the adverse possibilities. The website for bionorica is a little bit of a giveaway that this product is most likely a hoax. The detail they reveal in the product development is jargon and I am not a chemist, although I did get a 'c' in college chem, but I know enough to know that they were trying to lose your interest by the 4th paragraph in hopes that you wouldn't notice they are FULL of it...
I will see how my daughter feels tonight and in the morning I will get back to you.
I really hope it didn't get her drunk, she turns 2 next week, a bit young to cope with a hangover.

Citizen Deux said...

This post still generates a lot of traffic. There are few sites which have any sort of commentary on Sinupret. In general, the product will not "harm" the patient, but its efficacy is certainly unproven.

Redman said...

your comment is not true. Sinupret is made by Bionorica. they have done a lot of research and are tightly regulated in Germany. they are number one seller in over 15 countries. check out
http://cms.herbalgram.org/press/2009/SinupretMonograph.html

Citizen Deux said...

Redman, Bionorica is neither tightly regulated or supported by research. In the USA they sell their products as "supplements", thus avoiding FDA oversight. Ono their own website is the classic "quack miranda" warning.

Bionorica's products are registered as natural medicines in 49 countries outside the US. Any mention of drugs, medicine or the treatment of any disease or condition apply specifically to Brionorica's corporate history in Europe. In the US, Bionorica sells Dietary Supplements which are not intended to diagnose, treat, cure, or prevent any disease.

Their evidence is anecdotal and unsupported by double blind, RCT studies. If you don't know what that is, you should spend some time educating yourself.

Anonymous said...

I'm just now getting over a horrible sinus infection that has lasted 2 months. It started as allergies and quickly escalated into a nightmare. I was prescribed 2 different antibiotics with no relief. After researching natural remedies online, I decided to try Sinupret. Voila!! Relief after all this time...with NO side effects. I've been breathing clearly through my nose for the first time in weeks, and it feels wonderful. I ordered another box of pills to have on hand in case I end up in the same situation again.

Citizen Deux said...

More posters are dropping spam comments about the "efficacy" of Sinupret. This concoction, promoted by Bionorica may be more effective than placeb, however, it is certainly not comparable to anti-biotics. A brief review of the posting history shows a predominant point of origination from Google by folks searching for Sinupret.

I would submit that the posters are either professional "web relations" folks or people who have no idea that their spontaneously resolving sysmptoms have no connection to Sinupret.

Citizen Deaux said...

Sadly, Anonymous fails to recall that the plural of anecdote is not data. Despite the number of "positive" stories, Sinupret remains a placebo, debunked by european scientific panels and unsupported in any studies. If you choose to treat your self limiting illness with hoax cures, then no harm done. If however, you delay treatment of more serious illnesses with bogus treatments, you are at risk.

sg said...

Dear Citizen Deaux,

I am experiencing a heavy duty sinusitis right now and it's been over the 5-7 days (you mentioned earlier, that's how long it takes for it to clear up). My doctor prescribed antibiotics several days ago; however, the sinus pressure does not go away. And while I was pondering what else I could do to alleviate the symptoms, I remembered Sinupret, which I used to get prescribed in for a case like this, when I was still living in Germany (in addition to antibiotics, mind you - because those are indeed two different things) . Yes, you can call it anecdotal evidence, but, boy, it always worked for me and much else of what the pharmaceutical industry is putting out there, doesn't. So, I am not a big fan of pharma, by any means. Your blog still comes up when googling Sinupret and English language sources. So, that's why it gets traffic. I was trying to find out where the hell I could buy the stuff here in Canada. And I must say, I got upset, about your critique. I find it contrary to my experience and contrary to the experience of many of my family members and friends, so .... just saying. And to put comments like mine down as originating from "professional "web relations" folks" or "people who have no idea that their spontaneously resolving symptoms have no connection to Sinupret" is just cheap. When you have dealt with chronic Sinusitis, you get a clear sense of what helps and what doesn't.

One questions: have you ever had severe sinusitis? Have you ever tried it?

Citizen Deux said...

Wishful thinking about efficay does not create the same, and as the most recent poster has indicated, the plural of anecdote is not data. Sinupret remains as "unproven" and likely ineffective in the treatment of sinusitus.

A recent review of Canadian clinical guidelines for sinusitus and bronchitis treatments actually discouraged the use of Sinupret and other "herbal" cures.

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3055847/?tool=pmcentrez

The bottom line is as follows; Most sinusitus resolves in 7-10 days untreated. Antibiotics, expectorants and antihistimines can reduce the duration and severity.

There are NO studies (despite claims on the Sinupret website) of the product's effectiveness or safety.

sg said...

Dear Citizen Deux,

while I thank you for the posting of the link above (I will spend some time with the document ... once my head is clear again) the fact that you label me as a wishful thinker has kindled my ambition. It didn't take me more than 2 minutes to locate this study on the effectiveness of Sinupret:

http://www.springerlink.com/content/l07527q80325223u/

What do you think now?

Best regards

sg said...

PS: The study above was supported by the manufacturer of Sinupret and there seems to be another study that was carried out in Sweden. Another google result brought up a pharmacology textbook (2009) which attests that Sinupret has been proven to have an antibiotic effect. The textbook quotes a study from 1999 (couldn't get my hands on it). If you are interested, I could translate the relevant sections.

http://books.google.ca/books?id=ZZJk-J_YLUAC&pg=PT206&lpg=PT206&dq=sinupret+wirkungs+studie&source=bl&ots=KKNpiELUGf&sig=YD7UGEeAFDvurjrdbhD1sZP0uU4&hl=en&sa=X&ei=W4iLT4rKNtHOgAfs6aRX&ved=0CEkQ6AEwBA#v=onepage&q=sinupret%20wirkungs%20studie&f=false

Citizen Deux said...

Sg, I think we should begin with full disclosure. You are accessing this site from a Bionorica IP address.

IP Address 62.157.87.# (Bionorica AG)

Now for those readers who may be in the dark, Bionorica is the manufacturer of Sinupret. As such, unless you have some amazing reason to dispute the facts, I consider you a pure sock puppet and intend to showcase this as evidence that your firm is unable to scientifically demonstrate efficacy of your product.

I have no personal ax to grind with Biornorica. Their company sponsored studies, however, should be viewed with a highly critical eye and I would consider proper peer reviewed documents to be more appropriate, of which the majority indicate Sinupret has NO discernable effect when comared in a double-blind, random controlled trial.

Do you intend to come clean on your identity? I am sure sock puppetry violates whatever ethical standards Bionorica purports to sustain.

sg said...

Dear Citizen Deux ... quite frankly, I don't know what to say .... there is no way in hell that you would see me come in through Bionorica's IP address... cuze I am not, I don't have anything to do with them. Last night, though, I sent them an email asking for an independent study, if available. So, maybe the incoming traffic results from that inquiry.

I am sitting here in Halifax, Canada, trying to get over my sinusitis, that's all. Being sick provides me with the time necessary to put my research skills to good use, and I have access to my university's technical journals, that's how came across 2005 study. I don't know how to prove this to other people reading this, though.

Further, I have been as clear about my identity as you have - I am using an alias just as you. I have my opinion just as you. Do I suggest you have been paid by big corporations, misleading others? No, I just provide some additional information to what you have put out, for the benefit of others, who can then form their own opinion. And I would hope that they don't form their opinion just on the basis of my writing or your writing or on the basis of whatever skewed studies there are, but on the basis of their own experience. For some people the product we have been talking about will be helpful, for others it may not. The same is true for many other medications, tips, tricks, what have you. Jeeez .... This is your blog, and I respect your space; however, I'd ask your respect as well. Please do not suggest I was anything else but a person who holds a different point of view, based on a different personal experience.

I agree that a sponsored study has to be regarded with a critical eye, but the study you quoted earlier, has received funding from 5 pharma companies, as well .... quote "Funding was obtained via an unrestricted grant obtained from 5 pharmaceutical manufacturers, with each contributing equally to this project. In order to minimize any appearance of conflict of interest, all funds were administered via a trust account held at the Canadian Society of Otolaryngology-Head and Neck Surgery (CSO-HNS). "

Let's not kid ourselves ... the studies that fulfill your requirements of "double blind, randomized, and so forth" are much too expensive to be funded by truly independent parties.

I am independent, write to me at sunnygaruda@gmail.com and I will disclose who I am.

Now what is my beef? I don't care if you believe in Sinupret or not. But I have observed you ripping apart other people's well-meant contributions, with what I perceive (and excuse me if I am wrong, and I have been known to be wrong before) a very self-righteous attitude. That's why I have been writing and researching. My ethical standards require me to look for and understand the different angles in every discussion. And so I go and present what you have not presented.

I appreciate your willingness to put yourself and your opinions out there. The art of blogging probably requires the willingness to be controversial ... and this sure is.

All the best

Citizen Deux said...

My apologies.

It is possible that SiteMeter simply recorded your last IP visited prior to the site as your origination IP.

I will take your comments at face value on the Bionorica IP.

Studies by Bionorica are simply self-promotion under a scientific guise. A RCBT would be no more expensive than the trials that they funded.

Bionorica's own team is replete with individuals with advanced degrees and capability to validate the efficacy of their own products. Because botanicals and non-regulated materials require a lower standard of proof, in my opinion Bionorica is misleading the public on their product, Sinupret. Much the same way Boiron misleads their consumers on their homeopathic remedies.

As you are in Canada, I am sure that the Canadian recommendations for treatment should resonate. The Canadian health agencies are well regarded for their diligence as well as openness to "alternative" approaches. The fact that they discount Sinupret should speak volumes.

I challenge people when they put forward faulty logic, magical thinking or by into unsubstantiated claims. As you know, blogging is pretty self-indulgent. Bloggers are rarely "unbiased" and often times overly provacative.

Strangely, this post gets the most traffic of all the items I have written and it is more than three years old!