Statement in "pro-biotic" woo ad...

[Archae]

There's an ad in the USA Weekend magazine, for "align" probiotic supplement.

Ok...

On the box it says "Naturally helps."

But...

In the ad there is a statement that is a little hard to read.

"This statement has not been evaluated by the Food And Drug Administration."
"This product is not intended to diagnose, treat, cure, or prevent any disease."

But on the box, easily legible it says "Fortify your digestive system with healthy bacteria 24/7"

I smell a scam.

[1000words]

1. Yah ...

Something sure smells.

[ForgoTheConsequence]

2. Align is Bifidobacterium infantis 35624

It has been studied and it works.

RESULTS:
B. infantis 35624 at a dose of 1 x 10(8) cfu was significantly superior to placebo and all other bifidobacterium doses for the primary efficacy variable of abdominal pain as well as the composite score and scores for bloating, bowel dysfunction, incomplete evacuation, straining, and the passage of gas at the end of the 4-wk study. The improvement in global symptom assessment exceeded placebo by more than 20% (p < 0.02). Two other doses of probiotic (1 x 10(6) and 1 x 10(10)) were not significantly different from placebo; of these, the 1 x 10(10) dose was associated with significant formulation problems. No significant adverse events were recorded.

CONCLUSIONS:
B. infantis 35624 is a probiotic that specifically relieves many of the symptoms of IBS. At a dosage level of 1 x 10(8) cfu, it can be delivered by a capsule making it stable, convenient to administer, and amenable to widespread use. The lack of benefits observed with the other dosage levels of the probiotic highlight the need for clinical data in the final dosage form and dose of probiotic before these products should be used in practice.


http://www.ncbi.nlm.nih.gov/pubmed/16863564




Not woo, but not a ton of data for this product in particular either.

[Archae]

3. It's being marketed as woo.

"Fortifies your digestive system..."

This is what your link says it is being used for.

"Efficacy of an encapsulated probiotic Bifidobacterium infantis 35624 in women with irritable bowel syndrome."

[ForgoTheConsequence]

4. The word "woo" has no meaning.

You realize that, right? I'm not sure what point you're trying to make. If you have a problem regarding the legality of the way P&G is marketing Align you might want to contact the FDA. That being said I know gastroenterologists who have recommended products like Align to their patients who suffer from digestive problems.

[Ed Suspicious]

26. The study would seem to indicate a fortified

digestive system after consuming probiotics.

[HuckleB]

43. It doesn't say fortifies the digestive system of women with IBS.

Does it?

Nope.

[2pooped2pop]

6. yeah, I remember the vet telling me about this

when I was a vet tech. Especially if you are on antibiotics, they tend to wipe out all of the gut bacteria that was needed too and he would give the dog this.

[MattBaggins]

5. Fortify is a weasel word

[L0oniX]

7. IMO the more times you see the word "Free" in the commercial the more bullshit there is.

[NutmegYankee]

8. I have actually used this product. Samples were provided by a gastroenterologist

It actually does work fairly well, though it's way overpriced.

[WillowTree]

9. Don't take that particular brand.......

......but I did start taking a probiotic several years ago when I started experiencing some digestive issues. Those issues cleared right up, and reoccurred almost immediately.......and disturbingly.......when I went off them one time and went away again when I started taking it again. As far as I'm concerned, that doesn't seem like much of a coincidence to me. I'm on it for good now.

I also have a diabetic cat who occasionally develops diarrhea and cannot tolerate metronidazole, the standard medication my vet prescribes to treat it. Louses her blood sugar up terribly every time. The vet and I finally decided to try a feline probiotic and giving it to her once a day for 10 days has worked every time I've needed to try it, with no deleterious effect on her BG.

Or, to put it another way, I'm a believer in probiotics based on my own experience. Your mileage, as they say, may vary.

[bettyellen]

44. do you mind if I ask you which probiotic worked best for your cat? it is helping somewhat, but I'm

curious what you are using. Have you tried home fermented sauerkraut? I hear it is mazing for GI problems.

[WillowTree]

46. I don't mind at all.

I give her FortiFlora Feline. It can be a bit pricey, but if you shop around for it online, you can often find a box of 30 doses for about $20.

It comes in little envelopes of a very fine powder that my vet tells me is pork based. Any time I notice any indication of diarrhea, I mix one envelope into Gracie's evening meal (she only gets very low carb canned food) and she's never given any indication that she even notices it. It clears her issues right up and I continue it for about 10 days to get her regulated and then she's fine, often for months. Great stuff!

Haven't tried the sauerkraut thing. Remember, our primary problem is diabetes so, since the FortiFlora does the job so well with no noticeable side-effects, I would be hesitant to try anything else that may or may not play havoc with her blood sugar.

[bettyellen]

47. Thank you- that is one brand I tried that worked a while for me. Might need to go back to it....

They go crazy for the taste. I have to hide it in the freezer or Patsy will find the box, and chew the foil packets clean, then swallow the foil. Yep!
ANyway- the sauerkraut is for humans, haven't seen any suggested for cats yet! But I hear it is incredible.

[KT2000]

10. For every human cell,

we are made up of something like 10 bacteria. Some are good and some are bad. Some need to be kept in check. Please do read up on this research. It is a new avenue of research that will have great implications for our health and treatments.

[laundry_queen]

11. I'll let my gastroenterologist know he's prescribing woo

according to some guy online that's obsessed with the word woo and apparently doesn't do enough research to know is some evidence behind Align. And also doesn't understand that companies put that FDA statement on everything as a CYA thing.

[Archae]

13. If you have irritiable bowel syndrome, this pro-biotic stuff might help.

But it's being marketed to anyone and everyone, that means woo.

Would you take penicillin if your gastroenterologist told you it would "fortify" your digestive system?

[laundry_queen]

15. Would a gastroenterologist tell anyone that?

doubtful, so it's a moot point.

I have IBS, non-ulcer dyspepsia and chronic gastritis.

You taking that 'fortify' out of context is silly - in a way it does 'fortify' my system - it keeps me from running to the bathroom on an hourly basis, so long as I'm consistent with taking it. It is 'fortifying' my system by ensuring (theoretically, supported by studies) there is a high enough 'good' bacterial count to keep my symptoms at bay. So that statement is not wrong.

[Archae]

16. Yes, they would.

Every year the big drug makers, one to several of them, are caught marketing their drugs for things the FDA doesn't approve.

You do have IBS, and I hope this "align" does help.

But if that gastroenterologist told you to take an anti-depressant, and was getting kickbacks from the maker of that pill you'd be justifiably furious.

And this ad markets "align" to anyone and everyone.
The ad says it will "fortify" your digestive system.
Build and support a healthy digestive system.
And maintain digestive balance.

This is woo.

[laundry_queen]

19. Your definition of woo isn't anyone else's

and prescribing drugs 'off label' is something doctors do all the time. I'd like you to go tell some obstetricians that cytotec shouldn't be used to induce labor - because they do it all of the time. Is that included in your woo definition?

[Archae]

21. And a lot of times off-label is illegal.

Like here:

In 1993, the US FDA approved gabapentin, marketed by Pfizer under the name "Neurontin", only for treatment of seizures. Pfizer subsidiary Warner-Lambert illegally used scientific activities, including continuing medical education and research, to commercially promote gabapentin, so that within 5 years the drug was being widely used for the off-label treatment of pain and psychiatric conditions - conditions that had not been approved by FDA. In 2004, Warner-Lambert admitted to charges that it violated FDA regulations by promoting the drug for these off label uses: pain, psychiatric conditions, migraine, and other unapproved uses.[15] The company paid $430 million to the federal government to settle the case.[16]

http://en.wikipedia.org/wiki/Off-label_use

[laundry_queen]

22. But is it woo?

In many cases where it isn't illegal, it's either not studied, or not studied enough but doctors still use it. With cytotec, it's become standard of care. I want to know if you consider THAT woo?

[LeftyMom]

30. Off-label use of cytotec isn't "standard of care" There's an FDA warning about it.

http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm111315.htm

Misoprostol (marketed as Cytotec) Information

FDA ALERT – Risks of Use in Labor and Delivery

This Patient Information Sheet is for pregnant women who may receive misoprostol to soften their cervix or induce contractions to begin labor. Misoprostol is sometimes used to decrease blood loss after delivery of a baby. These uses are not approved by the FDA. No company has sent the FDA scientific proof that misoprostol is safe and effective for these uses.

There can be serious side effects, including a torn uterus (womb), when misoprostol is used for labor and delivery. A torn uterus may result in severe bleeding, having the uterus removed (hysterectomy), and death of the mother or baby. These side effects are more likely in women who have had previous uterine surgery, a previous Cesarean delivery (C-section), or several previous births.

[laundry_queen]

32. That warning came after a decade (at least) of issues.

It's still used though, although now they more often use cervidil. I still say if some obgyns use it, then it is still part of standard of care. The ACOG statement on it only warns against using it for women with previous C-sections and tells doctors to use caution with induction in general, and says nothing about completely discontinuing use of cytotec.

The FDA was extremely late with that warning given that I did most of my research before 2000 and knew about the issues back then even. Still wondering if off label use such as this is considered woo.

[LeftyMom]

33. I think rather than getting hung up on "woo" it's better to aim for practices supported by evidence.

Childbirth unfortunately is plagued by unevidenced and outright discredited practices, and both the medical and natural practitioners are guilty.

As far as cytotec goes, the manufacturer had stated not to use it for childbirth years before. That should have stopped the practice, but it's cheap. I assume that's why the FDA finally had to step in.

[laundry_queen]

34. I agree with the second part of your post

more than you know - it was a major part of study for me for years...after I experienced the effects of those discredited practices...

but I was speaking to the OP's definition of woo - which apparently includes remedies that have been supported by studies. I want to know if he would call cytotec woo if it was advertised to obgyns. Because right now his definition of woo is apparently anything he doesn't agree with or anything that doesn't meet his wording standards in advertisement.

ETA: I see you edited. Yes, not only was a cheap but it was quite successful in induction - meaning it made for a quicker labor, significantly quicker. We all know how much some obgyns love those quick labors. Also, it was better than oxytocin/syntocinon/Pitocin drips at ripening and thinning the cervix (which made it a 'better' choice for early inductions).

[Marrah_G]

31. Neurotin is fantastic for nerve pain

I take it for Peripheral nueropathy (nerve damage) in all my extremities. Life without it is very uncomfortable. This is a very common use for the drug and works wonders. My daughter uses it for migraines brought on by pressure in her brain.

[KT2000]

27. it is likely that everyone

needs probiotics since the American diet is high in carbohydrates which causes proliferation of some bacteria. Balance is lost.
Candy and sweets are plentiful here.
Probiotics are meant to balance the flora in the intestines.
There are many brands of probiotics so one would be wise to read the label to make sure they are getting the one that is best for them.

Really not understanding the problem here.

[ForgoTheConsequence]

36. The problem is a knee jerk reaction and lack of knowledge.

...

[HuckleB]

42. Exactly. The claims are not supported by the state of the science.

Thus, the quack Miranda warning.

[WillowTree]

28. So are aspirin and ibuprophen "woo", as well?

I mean, they're "marketed to anyone and everyone", so by your repeated assertions, they must be "woo". Whoda thunk?

[ForgoTheConsequence]

35. Anti depressants and sleeping pills are marketed to anyone and everyone too.

By your definition any drug that advertises is "woo". You have no idea what you're talking about.

[flvegan]

12. Hey look, it's Saturday! Hi Archae.

[Archae]

14. Hi flvegan.

And it's not Saturday.
It's Caturday!

[flvegan]

20. Split the difference?

It's both?

[Puzzledtraveller]

17. Dude, what big pharma company do you work for?

What's the pay like?

[mathematic]

24. Probably not Procter & Gamble, the maker of Align

I'm happy to see that you're standing up for the little guy. Small, ground-breaking entrepreneurial companies like Procter & Gamble really need all the support they can get to break the Big Pharma vice grip on consumer health products.

[HuckleB]

38. +1,000,000 ... 000

[alp227]

18. Hey, SOMEBODY has to pay the bills for USA weekend.

since a lot of advertisers are pulling out of print media, print media has to rely on woo shysters to get $ for payroll.

[MohRokTah]

23. IF you are on strong antibiotics you will kill off some of your gut bacteria.

My wife goes on a yogurt eating spree whenever she has to take antibiotics due to her having ulcerative colitis.

[Crunchy Frog]

25. Dupe.

http://www.democraticunderground.com/10024937055

[Jesus Malverde]

40. ^^^^Good Catch^^^^

and well played.

[tridim]

29. Kefir and Potato Starch is the secret to gut perfection. No pills needed.

[HuckleB]

37. It's the quack Miranda Warning!

http://rationalwiki.org/wiki/Quack_Miranda_Warning

You can find it on many similar products, including homeopathic nonsense and many worthless supplements.

[HuckleB]

39. I've been prescribed an antibiotic? Should I take a probiotic?

Maybe: http://www.sciencebasedmedicine.org/ive-been-prescribed-an-antibiotic-should-i-take-a-probiotic/

Of course, the supplement sellers also push these things for all kinds of nonsense for which there is zero evidence.

[Mosby]

41. Probiotics aren't woo

But having said that I'm not impressed with Align (I tried them).

I use the sam's club version which includes 4 different strains of bacteria.


eta if you don't want to pay for probiotics just eat fermented vegis like kimchi. it's easy to make.

[HuckleB]

45. Some healthy skepticism about probiotics

http://www.minnpost.com/second-opinion/2012/02/some-healthy-skepticism-about-probiotics

[pnwmom]

48. Most people who take probiotics do so for digestive issues, not respiratory issues.

http://www.mayoclinic.org/diseases-conditions/lactose-intolerance/basics/alternative-medicine/con-20027906


By Mayo Clinic Staff
Probiotics

Probiotics are living organisms present in your intestines that help maintain a healthy digestive system. Probiotics are also available as active or "live" cultures in some yogurts and as supplements in capsule form. They are sometimes used for gastrointestinal conditions, such as diarrhea and irritable bowel syndrome. They may also help your body digest lactose. Probiotics are generally considered safe and may be worth a try if other methods don't help.

[HuckleB]

49. I like how you ignore the actual science of the matter.

Boring.... And, yes, the Mayo Clinic has chosen money over science. Not a big surprise.

[pnwmom]

50. I like how you ignore NIH funded and published studies

such as this one from the American Journal of Gastroenterology.



http://www.ncbi.nlm.nih.gov/pubmed/16863564

And these others, and lots more like them.

But probiotics don’t make huge profits for Big Pharma, so you’re against them.

http://www.ncbi.nlm.nih.gov/pubmed/24411521

Two hundred ninety-four infants received probiotics, and 317 infants formed the comparison group. Introduction of probiotics was associated with a reduction in NEC (from 9.8% to 5.4%, P < .02), a nonsignificant decrease in death (9.8% to 6.8%), and a significant reduction in the combined outcome of death or NEC (from 17% to 10.5%, P < .05). After adjustment for gestational age, intrauterine growth restriction, and sex, the improvements remained significant (OR for NEC, 0.51; 95% CI, 0.26-0.98; OR for death or NEC, 0.56; 95% CI, 0.33-0.93). There was no effect of probiotics on health care-associated infection.
DISCUSSION:
A product that is readily available in North America, that has excellent quality control, and that contains strains similar to those that have been shown effective in randomized controlled trials substantially reduced the frequency of NEC in our neonatal intensive care unit.

http://www.ncbi.nlm.nih.gov/pubmed/23361033

Conclusions: Supplementation with probiotics could be a potential strategy to reduce gastrointestinal Candida colonization and candiduria in critically ill children receiving broad spectrum antibiotics.

http://www.jfponline.com/index.php?id=22143&tx_ttnews[tt_news]=177632

PRACTICE CHANGER
Recommend that patients taking antibiotics also take probiotics, which have been found to be effective both for the prevention and treatment of antibiotic-associated diarrhea (AAD).1
STRENGTH OF RECOMMENDATION
A: Based on a systematic review and meta-analysis of randomized controlled trials.
Hempel S, Newberry S, Maher A, et al. Probiotics for the prevention and treatment of antibiotic-associated diarrhea. JAMA. 2012;307: 1959-1969.

[BuddhaGirl]

51. +1

Excellent information in those studies - thanks for posting

[HuckleB]

54. The usual cherry-picked preliminary studies that have not been reproduced!

Oddly, this same crap study was pushed earlier yesterday. You seem to think that repeatedly posting the same study is like the study being shown to be valid by other researchers, but that's not how science works.

Awesome! The usual anti-science BS. Oh, and they make BIG PHARMA/BIG SUPPLEMENT huge money, but you pretend otherwise.

Derp.

You know you're not going to impress with same old routine!

[pnwmom]

56. You were too lazy to read even the whole post, much less the studies.

The one from the Journal of Family Practice cited a meta-analysis of 82 studies, with a result it said was a "practice changer" and a recommendation for practitioners.

http://www.jfponline.com/index.php?id=22143&tx_ttnews[tt_news]=177632

PRACTICE CHANGER
Recommend that patients taking antibiotics also take probiotics, which have been found to be effective both for the prevention and treatment of antibiotic-associated diarrhea (AAD).1

STRENGTH OF RECOMMENDATION
A: Based on a systematic review and meta-analysis of randomized controlled trials.
Hempel S, Newberry S, Maher A, et al. Probiotics for the prevention and treatment of antibiotic-associated diarrhea. JAMA. 2012;307: 1959-1969.

ILLUSTRATIVE CASE
When you prescribe an antibiotic for a 45-year-old patient with Helicobacter pylori, he worries that the medication will cause diarrhea. Should you recommend that he take probiotics?

More than a third of patients taking antibiotics develop AAD,2 and in 17% of cases, AAD is fatal.3,4 Although the diarrhea may be the result of increased gastrointestinal (GI) motility in some cases, a disruption of the GI flora that normally acts as a barrier to infection and aids in the digestion of carbohydrates is a far more common cause.

SNIP

STUDY SUMMARY: Probiotics significantly reduce AAD

Hempel et al reviewed 82 studies and pooled data from 63 RCTs (N=11,811) to identify the relative risk (RR) of AAD among patients who received probiotics during antibiotic treatment compared with those who received no probiotics or were given a placebo.1 The studies encompassed a variety of antibiotics, taken alone or in combination, and several probiotics, including Lactobacillus, Bifidobacterium, Saccharomyces, and some combinations.


SNIP

This meta-analysis reached a similar conclusion as the 2006 meta-analysis: Probiotics appear to be effective in preventing and treating AAD in children and adults receiving a wide variety of antibiotics for a number of conditions. The results were also consistent with those of a new meta-analysis that looked specifically at one pathogen—and found a reduction of 66% in C difficile-associated diarrhea in patients taking probiotics with their antibiotics.10

[HuckleB]

57. Woo hoo! That's not exactly a world-beating journal.

In fact, it's credentials are quite questionable, as are the list of studies, but you don't care about that.

You don't care that almost none of the studies have anything to do with humans! Hmm. Practice changer? Not if you're a clinician who gives a shit. And, again, only in regard to a very specific issue. The claims made by BIG SUPPLEMENT go way beyond the evidence base. Why do you support BIG SUPPLEMENT so BLINDLY?

[LanternWaste]

52. The founding premise of the free market

"I smell a scam..."

The founding premise of the free market; though compared to many other examples of conspicuous consumerism, this one seems particularly benign.

[HuckleB]

58. How so?

Snake oil has always been among the worst of the free market scams. Why give this a free ride? I mean, selling a product as a solution to a health care issue when the science doesn't support your claims is actually rather dangerous.

[pnwmom]

53. Probiotics have been shown in numerous studies to aid with diarrhea and other

GI problems. Doctors frequently tell patients to use them.

http://www.democraticunderground.com/?com=view_post&forum=1002&pid=4946786

[HuckleB]

55. With antibiotic diarrhea, yes. Though the research is not profound.

As for anything else, nope.

[pnwmom]

59. Wrong. Ever hear of The Lancet? You really don't keep up.

Here are more studies, each a meta-analysis of numerous other studies, that demonstrate the efficacy of probiotics for various forms of diarrhea and GI illness.

http://www.thelancet.com/journals/laninf/article/PIIS1473-3099(06)70495-9/abstract

Efficacy of probiotics in prevention of acute diarrhoea: a meta-analysis of masked, randomised, placebo-controlled trials

To evaluate the evidence for the use of probiotics in the prevention of acute diarrhoea, we did a meta-analysis of the available data from 34 masked, randomised, placebo-controlled trials. Only one trial was community based and carried out in a developing country. Most of the remaining 33 studies were carried out in a developed country in a health-care setting. Evaluating the evidence by types of acute diarrhoea suggests that probiotics significantly reduced antibiotic-associated diarrhoea by 52% (95% CI 35—65%), reduced the risk of travellers' diarrhoea by 8% (?6 to 21%), and that of acute diarrhoea of diverse causes by 34% (8—53%). Probiotics reduced the associated risk of acute diarrhoea among children by 57% (35—71%), and by 26% (7—49%) among adults. The protective effect did not vary significantly among the probiotic strains Saccharomyces boulardii, Lactobacillus rhamnosus GG, Lactobacillus acidophilus, Lactobacillus bulgaricus, and other strains used alone or in combinations of two or more strains. Although there is some suggestion that probiotics may be efficacious in preventing acute diarrhoea, there is a lack of data from community-based trials and from developing countries evaluating the effect on acute diarrhoea unrelated to antibiotic usage. The effect on acute diarrhoea is dependent on the age of the host and genera of strain used.


http://www.plosone.org/article/info%3Adoi%2F10.1371%2Fjournal.pone.0034938

A Meta-Analysis of Probiotic Efficacy for Gastrointestinal Diseases

Probiotics had a positive significant effect across all eight gastrointestinal diseases with a relative risk of 0.58 (95% (CI) 0.51–0.65). Six of the eight diseases: Pouchitis, Infectious diarrhea, Irritable Bowel Syndrome, Helicobacter pylori, Clostridium difficile Disease, and Antibiotic Associated Diarrhea, showed positive significant effects. Traveler's Diarrhea and Necrotizing Enterocolitis did not show significant effects of probiotcs. Of the 11 species and species mixtures, all showed positive significant effects except for Lactobacillus acidophilus, Lactobacillus plantarum, and Bifidobacterium infantis. Across all diseases and probiotic species, positive significant effects of probiotics were observed for all age groups, single vs. multiple species, and treatment lengths.

http://www.ncbi.nlm.nih.gov/pubmed/23362517

Probiotics for the prevention of Clostridium difficile-associated diarrhea: a systematic review and meta-analysis.

Conclusion: Moderate-quality evidence suggests that probiotic prophylaxis results in a large reduction in CDAD without an increase in clinically important adverse events.

[HuckleB]

60. All diarrhea associated. And not exactly the best research, to be kind.

You're pushing the usual cherry picked crap, that you clearly haven't bothered to look at in detail.

Keep coming with those ad hominem attacks!

[pnwmom]

61. That's what I've been saying all along. That there is a great deal of science

backing up the utility of probiotics for treating diarrhea and other intestinal problems.

See post #53.

And diarrhea can be a life-threatening problem, so this is not insignificant.

[HuckleB]

62. So you haven't read my posts in this discussion.

I have noted that there is a great deal of preliminary evidence that probiotics can help with diarrhea associated with antibiotics, for them most part.

However, as the OP notes, probiotics supporters, like most supplement lovers, like to pretend that probiotics can solve everything. You seem to have chosen to support that line in your responses. In other words, you're wasting my time by failing to acknowledge my acknowledge my actual responses.

That's disrespectful to the core.

And now you've shown your anti-science soul by "liking" the latest anti-vaccine post at DU.

[pnwmom]

63. You are "disrespectful to the core" for ignoring my post 53 that started this very thread.

You are also disrespectful to probiotics supporters by claiming that they "like to pretend that probiotic can solve everything." My doctor told me to take probiotics with antibiotics, and since then I've discovered that it can help with diarrhea from other conditions. (Sometimes I get "glutened.&quot But I don't think it will cure the common cold, and I don't think most probiotic supporters believe that, either.

[HuckleB]

64. Hogwash.

Your own posts fail to hedge that factor. You're preconceived notions do not serve you well. Try reading. Attack is your only mode, and it does not serve you well. Your responses here were not hedged to that. Further, that hedge needs to acknowledge that even the diarrhea issue is very preliminary in terms of research. Anecdotes are fun but mostly worthless, as you should know.

[bettyellen]

65. they can actually help a lot of people, but they do not understand how exactly.

it's interesting to read about how they are just learning about gut flora, and flora in general.