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Infacol - no evidence that it works

  • 10-10-2012 9:40pm
    #1
    monkey8
    Registered Users, Registered Users 2 Posts: 386 ✭✭


    How did infacol get licenced by the Irish medicines board when there is no evidence that it works any more than placebo?


Comments

  • #2
    Xeyn
    Registered Users, Registered Users 2 Posts: 555 ✭✭✭Xeyn


    monkey8 wrote: »
    How did infacol get licenced by the Irish medicines board when there is no evidence that it works any more than placebo?

    Who said there was 'no evidence' ?


  • #3
    monkey8
    Registered Users, Registered Users 2 Posts: 386 ✭✭monkey8


    Xeyn wrote:

    Who said there was 'no evidence' ?

    It is widely accepted now that there is no evidence of any benefits and prescribing of infacol is based on anecdotal evidence.

    This study shows no benefit
    http://www.ncbi.nlm.nih.gov/m/pubmed/8008533/
    And there are no studies showing any benefit unless you know of one I'm not aware of?


  • #4
    opinion guy
    Closed Accounts Posts: 11,001 ✭✭✭✭opinion guy


    monkey8 wrote: »
    It is widely accepted now that there is no evidence of any benefits and prescribing of infacol is based on anecdotal evidence.

    Was there thought to be a benefit when it was licensed ?

    You are going to have to fill in some blanks for people here - you would appear to have some special interest in this - you can't assume everyone else on boards does too


  • #5
    monkey8
    Registered Users, Registered Users 2 Posts: 386 ✭✭monkey8


    opinion guy wrote: »
    Was there thought to be a benefit when it was licensed ?

    You are going to have to fill in some blanks for people here - you would appear to have some special interest in this - you can't assume everyone else on boards does too

    My special interest in it is that my doctor and pharmacist recommended it for colic, it didn't work and when i researched how it is supposed to work I find that there is no evidence at all that it works, only studies that show that it doesn't work!!
    Now I want to know why I was recommended this by two health professionals when there is no evidence that it works? Do doctors not use evidence based prescribing?
    Why don't the IMB use evidence based research before giving it a licence and marketing autorisation?


  • #6
    Finnt
    Closed Accounts Posts: 594 ✭✭✭Finnt


    We used infacol on our lady and found it useless, personally I don't think it was any use.


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  • #7
    monkey8
    Registered Users, Registered Users 2 Posts: 386 ✭✭monkey8


    Finnt wrote: »
    We used infacol on our lady and found it useless, personally I don't think it was any use.

    someone else will come on and swear by it.
    My point is that anecdotal evidence seems to be why its being prescribed. It may well be that the babies colic was going to clear anyways and the parent is putting it down to the infacol. It souldn't be prescribed on anecdotal evidence surely?


  • #8
    Xeyn
    Registered Users, Registered Users 2 Posts: 555 ✭✭✭Xeyn


    monkey8 wrote: »
    My special interest in it is that my doctor and pharmacist recommended it for colic, it didn't work and when i researched how it is supposed to work I find that there is no evidence at all that it works, only studies that show that it doesn't work!!
    Now I want to know why I was recommended this by two health professionals when there is no evidence that it works? Do doctors not use evidence based prescribing?
    Why don't the IMB use evidence based research before giving it a licence and marketing autorisation?

    Evidence based prescribing? Yes of course doctors do. But evidence as you put it is often subjective and debatable even when multiple studies are done. The anaylsis of studies done on every single prescribable medication is near endless. You can put forth a few studies to support your stance and others can put forth others to counter it. To answer your initial question I think you are making an extremely sweeping statement by declaring there is no research to back simethicone prior to it being licensed which even with some lazy internet research proves this to be false.
    Add this to the fact that simethicone has mutlitple proven benefits for other patients means that although the original licensed use may be dated its still a viable medication and there is no real reason to wirthdraw its use.
    Personally I see enough evidence to not prescribe it but then again its a rather safe medication - id rather see it prescribed unnecessarily than some more dangerous medication.


  • #9
    Xeyn
    Registered Users, Registered Users 2 Posts: 555 ✭✭✭Xeyn


    monkey8 wrote: »
    It souldn't be prescribed on anecdotal evidence surely?

    No it shouldnt.


  • #10
    anotherlostie
    Registered Users, Registered Users 2 Posts: 1,722 ✭✭✭anotherlostie


    If a product didn't work for anyone, it would be discontinued eventually because nobody would use it and there would be no commercial driver to make it. There can be lots of reasons for colic - one is lactose intolerance and there is a product Colief that contains lactase and can help in certain cases.

    Infacol contains simethicone - this agent absorbs excess gas that can be the cause of colic. It's the same stuff as in Rennie Deflatine. If you're full of gas due to some underlying condition, Deflatine might not give you any/ much relief either.

    If you went to the doctor or pharmacist and they said there was nothing they could recommend to try and help your baby, would you prefer that? Infacol might have helped and it was worth trying.

    I don't know how clinical trials can be done in babies - it's not like they can ask them to grade the relief the medicine gives them. The product is on the market 50 years now, so probably would not get a licence today. But neither would 300mg Aspirin for pain relief and lots of other drugs.


  • #11
    RobFowl
    Moderators, Science, Health & Environment Moderators Posts: 11,669 Mod ✭✭✭✭RobFowl


    Evidence based medicine suggests that colic does not exist...
    Hard to promote evidence based prescribing as a result...

    PS as a parent simply cannot accept there is no such entity as colic.


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  • #12
    opinion guy
    Closed Accounts Posts: 11,001 ✭✭✭✭opinion guy


    Hmmm on the quality of evidence base on medicine and how all this kind of stuff works in Ben Goldacre has a new book out:
    http://www.amazon.co.uk/Bad-Pharma-companies-mislead-patients/dp/0007350740

    I've not read it yet but his first book was awesome


  • #13
    Xeyn
    Registered Users, Registered Users 2 Posts: 555 ✭✭✭Xeyn


    opinion guy wrote: »
    Hmmm on the quality of evidence base on medicine and how all this kind of stuff works in Ben Goldacre has a new book out:
    http://www.amazon.co.uk/Bad-Pharma-companies-mislead-patients/dp/0007350740

    I've not read it yet but his first book was awesome

    Bad science, great read.


  • #14
    echo beach
    Registered Users, Registered Users 2 Posts: 1,252 ✭✭✭echo beach


    RobFowl wrote: »
    Evidence based medicine suggests that colic does not exist...
    Hard to promote evidence based prescribing as a result...

    PS as a parent simply cannot accept there is no such entity as colic.

    Colic may or may not exist but one thing we do know is that babies cry, often quite a lot. When they do and they can't tell you what is wrong with them it is very distressing for parents, especially new parents who assume they are doing something wrong. When you give the baby Infacol it makes you feel better because you have done something. It may or may not make the baby feel better, it is impossible to tell.

    If colic does exist it isn't a serious illness, in that despite the short term distress it doesn't cause any long term problems, the baby continues to feed and put on weight so there is no reason for parents to worry but they worry anyway. Infacol is very safe so if it makes you feel better use it, if not stick with the only other treatment I know of which is walking the floors with the baby over your shoulder. There is no evidence that I know of that it works either but parents still do it because doing something feels better than doing nothing.


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