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Medicine Science

Those Sleeping Pills May Be Killing You 237

Posted by timothy
from the ok-john-stick-to-the-vodka dept.
dstates writes "A recent article in in BMJ Open reports a strong association between the use of prescription sleeping pills and mortality. The study used electronic health records for 2.5 million people covered by the Geisinger Health System to find 12 thousand who had been prescribed sleeping pills and a matched set of controls. Death rates were much higher in the patients taking sleeping pills and the risk increases with age. Kudos to the authors for publishing this in an open access journal."
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Those Sleeping Pills May Be Killing You

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  • by recoiledsnake (879048) on Tuesday February 28, 2012 @12:35PM (#39186681)

    The people taking the medications might be dying sooner because they have insomnia which is not fixed by sleeping pills easily. The study should not compare with the general populace since they are, by definition, better sleepers than the group that isn't able to get good sleep.

    • by pclminion (145572)
      They said "matched set of controls," not "general populace." How do you know they did it wrong?
      • by vlm (69642) on Tuesday February 28, 2012 @12:42PM (#39186791)

        Two "identical" guys one gets pill one doesn't is an anecdote.
        12 thousand is not just a misdiagnosis. There must be something "different" about the 12K that did vs the 12K who did not, other than random chance. I don't think in the UK treatment plans are determined using dice or tarot cards, so there must be something special about the 12K who got the pills... or the 12K who didn't...

        • by u38cg (607297)
          They followed 12k users of sleeping pills, they didn't observe 12k deaths. They observed Cox hazard ratios on the order of 4/5 times, so there is unquestionably an effect; of course, now it's a correlation/causation question.

          The correct next step would be a randomised trial. However, I don't see how you can ethically design a trial for this setup.

      • by recoiledsnake (879048) on Tuesday February 28, 2012 @12:46PM (#39186869)

        They said "matched set of controls," not "general populace." How do you know they did it wrong?

        By RTFA, which I strongly advise you to do before jumping in to comment. They matched them on other factors like gender, sex, occupation etc, but not sleep trouble. Since lack of good sleep is a proven strong factor in heart disease and cancer, I feel that they did it wrong.

        • by Rakishi (759894) on Tuesday February 28, 2012 @01:44PM (#39187657)

          Listen to your own advice and read the paper yourself before commenting.

          They specifically compensated later on for difference in heart disease, asthma so on. The impact on the final result was minimal.

        • Re: (Score:3, Insightful)

          From the paper: "A randomised clinical trial of sufficient duration and size could provide definitive evidence for or against the disturbing mortality hazards suggested by our study. Some American NIH reviewers have opined that a randomised trial of hypnotic lethality would be unethical. No such trial has ever been mounted, perhaps for reasons similar to the absence of randomised trials of cigarettes and of skydiving without parachutes." It is absolutely unethical to give persons with no history of sleepi
        • Uh, they might not have but there is a real good chance they have not got it totally right since there are so many kinds of sleeping pills to begin with not to mention not sleeping is definitely not good for you. I wonder who is behind the funding of the study. Follow the money and find the answer.

      • by Dunbal (464142) *

        Because their results make absolutely no sense. According to the study you are more likely to die from any cause because you were prescribed sleeping pills. Therefore the act of receiving a prescription somehow increases your risk of heart disease, cancer, etc. They also state that statistically these patients did not already have disease when the experiment was begun.

        Well good thing science isn't just about explaining statistics. I'm waiting for an adequate plausible explanation for the above. The fact t

        • According to the study you are more likely to die from any cause because you were prescribed sleeping pills. Therefore the act of receiving a prescription somehow increases your risk of heart disease, cancer, etc. They also state that statistically these patients did not already have disease when the experiment was begun.

          I don't see anything that can't be explained by the simple fact that older people often have trouble sleeping, and are more likely to take sleeping pills. Ever see anyone under 50 in a So

          • by Dunbal (464142) *
            According to the study thr results were adjusted for age, so age as a factor is not supposed to be relevant.
    • by mystikkman (1487801) on Tuesday February 28, 2012 @12:40PM (#39186745)

      Bingo, this is like comparing the death rates of people taking heart medications versus people who don't and then claiming the medications are killing the folks when it could be that heart disease is what is killing them and the pills are not 100% effective at all times to deal with the problem.

      Also, it has been proved that bad sleep is a killer by itself, so comparing the death rates of people with sleep issues who did and who did not take medications may actually show that not taking sleeping pills might kill you if you have insomnia, which is the exact opposite of what the headline is claiming.

      • by sjames (1099) on Tuesday February 28, 2012 @12:45PM (#39186851) Homepage

        A matched set of controls in your example would be people with comparable heart disease who were not given the medixation. It appears that they have done that in this study:

        Models addressing potential confounding of mortality association by health status To further address the possibility that hypnotic-associated hazards were due to use of hypnotic drugs by patients with a greater burden of disease, so that elevated risks of death might be attributable to comorbidities rather than to hypnotic medications, we conducted analyses within subgroups of hypnotic non-users and users defined by diagnoses in specific disease classes (supplemental table 7). Allowing for differences in sample size, hazards in subgroups restricted to patients with specific diseases were generally consistent with the overall findings. We also observed no statistically reliable differences in death HR in subgroups constructed to assess the overall burden of disease by stratifying on the total number of comorbidities diagnosed for each patient, and no reliable differences in death HR comparing groups diagnosed with different numbers of comorbidity classes. Whereas the raw death rate of the user cohort was 4.86 times that of non-user controls (table 1), adjustment for all covariates (eg, age, gender, BMI, smoking) with stratification by comorbidities only reduced the overall HR to 4.56 (95% CI 3.95 to 5.26).

        • by mystikkman (1487801) on Tuesday February 28, 2012 @12:58PM (#39187035)

          This was a not a controlled study but is a general experiment so that does raise the question of why a doctor would not prescribe sleeping pills to someone who is having a lot of trouble sleeping?

          The only way to conclusively prove this would be to take patients who are going to be prescribed sleeping pills, split them into two while adjusting for other controls and have one group take the pills and other placebos and then monitor them.

          • by nedlohs (1335013)

            So are you suggesting they deny a random group what is the current medication for a condition before this type of data analysis study?

            I suspect you'll have trouble getting ethics approval if you don't do the data study and have it show what this one does first.

          • This was a not a controlled study

            Statistical controls are controls.

            that does raise the question of why a doctor would not prescribe sleeping pills to someone who is having a lot of trouble sleeping?

            As is the case in many areas of medicine, different doctors will have different medical judgement about when the risks outweigh the benefits of prescription sleeping pills, when to recommend non-prescription remedies (and which remedies), and patients will vary in how the comply with and respond to non-prescripti

        • Whereas the raw death rate of the user cohort was 4.86 times that of non-user controls (table 1), adjustment for all covariates (eg, age, gender, BMI, smoking) with stratification by comorbidities only reduced the overall HR to 4.56 (95% CI 3.95 to 5.26).

          You know what I don't see in the list of variables they controlled for? Sleep issues. It's not a matched set of controls if your experimental group is diagnosed with a serious medical condition (in this case sleep disorders) and your control group is not.

          • by Rakishi (759894) on Tuesday February 28, 2012 @01:53PM (#39187787)

            They tried to do that under the assumption that in general a lack of sleep probably doesn't kill you. The hypertension, or diabetes, or heart disease, or liver failure or obesity is that kills you. They did control for differences in those factors and found no change in their results.

            Of course, the increased rate of crashing your car into to a wall at 90mph due to insomnia wouldn't be taken into account.

        • by jklovanc (1603149)

          The comparison is done using "specific disease classes". It does not rule out an unknown or undiagnosed illness in the patients that are causing them to use, misuse or abuse sleeping pills. The statistics can only be adjusted for known diagnosed illnesses.

          It also does not deal with the issue of people who use sleeping pills responsably; ie not often and only for a couple of nights at a time. Perhaps it is the chronic pill poppers whi are dieing and maybe there is an underlying reason for the insomnia that i

          • by jklovanc (1603149)

            I found it and the list is appauling;
            Hypertension, Peptic Ulcer Disease, Diabetes ,Cardiovascular Disease , Coronary Heart Disease , Obesity , Asthma, COPD, Cerebrovascular Disease , Heart Failure, Peripheral Vascular Disease, Chronic Kidney Disease.

            They sure missed a few biggies;
            Cancer, depression, liver disease.
            All of these diseases would cause in increase in the use of sleeping pills due to pain.

      • by nedlohs (1335013)

        Because of course you know this but the researchers doing the work didn't hink of that because they are idiots?

        So which part of their methodology specifically do you have a problem with, given you must have checked it before spouting off, right?

        Here you go, here's some of the methodology paragraphs from the linked article, though of course you also read the supplementary material to I hope (slashdot doesn't like some of the fancy characters like +/-):

        Using a query into the EHR, we selected all 224â757

      • by StillNeedMoreCoffee (123989) on Tuesday February 28, 2012 @02:40PM (#39188325)

        Another bogus study recently was on the correlation of Diet Soda to Heart desease.

        http://www.reuters.com/article/2012/02/20/us-soda-diet-idUSTRE81J03920120220 [reuters.com]

        The problem is the factors that bring people to diet soda are overweight or diabetes which are both factors that would tend to increase risk of heart desease. Here too the people that are prescribed sleeping pills are a self selected group on some problem associated with sleep. They can say they have factored in all the external variables but that may not be that case or there may be other factors related to sleep problems that are more to blame and this study would not be complete or accurate unless it followed an equally large group of people that would have been given sleeping pills but were not and/or given a placebo, You don't know if giving a pill is the problem say vs not giving a pill as one factor. If you give a placebo you don't test that variable.

        The study said it matched "matched controls with no hypnotic prescriptions" but they did not match with those who would have been prescribed meds but weren't. You may only be seeing the effect of the problems they had. I could be that the meds actually lengthened life vs the group not given them. This is the problem with vacines that have side effects, but the cure in general is much better for society than the side effects.

        But that kind of study is hard to come by so you may just have to go on the data you have but as in religion and politics attribution can be a grand evil.

    • That is the point of the controls.
      "Correlation != Causation" is used when you find a statistical trend in a group.
      But if you take a group and have some of that group be the controls (identical except for one variable) then you cannot say that.
      You could find a flaw in their control method, but simply saying "Correlation != Causation" is idiotic in all situations like this.

      • Re: (Score:2, Insightful)

        by Anonymous Coward

        Those were not controls. They were simply a group matched on a very few parameters. Not everything. Not nearly everything relevant.

        A control would have been to take people diagnosed exactly the same and giving some sleeping pills and the others placebos. That didn't happen. The sleeping pill group might have all had a family history of sleep apnea which was not diagnosed before giving the pills. We don't know because there was no randomization.

        "Correlation != Causation" is EXACTLY the case we have her

      • Most people are arguing that their controls - sex, gender, occupation - didn't control enough for sleep variations.

    • by Rogerborg (306625)

      But absence of evidence is not evidence of absence.

      Also, a bird in the hand is worth two in the bush, fools rush in where angels fear to tread, and do you believe in life after love?

      I'd go on, but XKCD has as usual provided appropriate mouseover text [xkcd.com].

    • by dmomo (256005)

      Correllation == Association though.

      That's what they're claiming. Just because it's not the cause, doesn't mean it's not useful to know. Your theory about insomnia certainly isn't one that the researchers are unaware of. They're collecting data as they should be.

    • by metlin (258108)

      I'm tired of seeing these stupid comments every time an article on statistics is brought up. Clearly, a bunch of scientists doing studies along these lines know less about statistics and research design than some random Slashdot poster. Gee. Get over yourself.

      • by recoiledsnake (879048) on Tuesday February 28, 2012 @01:09PM (#39187181)

        I'm tired of seeing these stupid comments every time an article on statistics is brought up. Clearly, a bunch of scientists doing studies along these lines know less about statistics and research design than some random Slashdot poster. Gee. Get over yourself.

        Are you sure?

        http://www.guardian.co.uk/commentisfree/2011/sep/09/bad-science-research-error [guardian.co.uk]

        But in just this situation, academics in neuroscience papers routinely claim to have found a difference in response, in every field imaginable, with all kinds of stimuli and interventions: comparing younger versus older participants; in patients against normal volunteers; between different brain areas; and so on.

        How often? Nieuwenhuis looked at 513 papers published in five prestigious neuroscience journals over two years. In half the 157 studies where this error could have been made, it was. They broadened their search to 120 cellular and molecular articles in Nature Neuroscience, during 2009 and 2010: they found 25 studies committing this fallacy, and not one single paper analysed differences in effect sizes correctly.

        These errors are appearing throughout the most prestigious journals for the field of neuroscience. How can we explain that? Analysing data correctly, to identify a "difference in differences", is a little tricksy, so thinking generously, we might suggest that researchers worry it's too longwinded for a paper, or too difficult for readers. Alternatively, less generously, we might decide it's too tricky for the researchers themselves.

        Why is it wrong for a Slashdot poster to have a conversation over the statistics involved when the headline is so sensationalist? What if someone reading stops taking sleeping pills that are helping them sleep and then get needlessly killed by insomnia because of bad statistics? Can't there atleast be a discussion on the statistics used?

        I am tired of seeing stupid comments like yours that actually don't refute anything and instead attack the poster and call scientists infallible and above question.

        • by Dahamma (304068)

          He has a point... if you actually read the article the authors specifically pointed this out already. Clearly they understand the usual trite statistics adage, but that doesn't mean the study wasn't interesting.

          Cohort studies demonstrating association do not necessarily imply causality, but the preferable randomised controlled trial method for assessing hypnotic risks may be impractical due to ethical and funding limitations.

          Which IMO kind of makes the title of your comment almost as sensationalist/mislead

    • by Dasher42 (514179)

      Having had insomnia and tackled it one time around with sleeping pills and another time around by kicking energy drinks, caffeine, sugars, and artificial additives to the curb and integrating healthy food and teas, I can tell you there's a difference.

      Like most anything that leads to trading on Wall Street, sleeping pills are about making money off of your ailments, not bettering your health.

    • There are also plenty of sleeping pills that act totally different on a person. They need a much larger study.

  • How often is healthcare data used for these sorts of studies? Not that I have a problem with it, quite the opposite, so long as the data is sanitized. To me it makes more sense to data mine existing records than set up and conduct expensive studies, am I missing something or is this actually commonly done?
    • by canajin56 (660655) on Tuesday February 28, 2012 @12:57PM (#39187013)
      They're called "statistical studies" and they are used as evidence that a real study should be done, not that there's an actual effect in play. The problem with such studies is that they try their best to select an identical control group, but it's hard to do so. In this case it means matching the 15,000 people on the drug with 15,000 people who also have been diagnosed with insomnia (and for similar reasons), but all elected not to be medicated for it. Then you hope that that decision isn't in any way correlated with other behaviors that might increase or decrease the death rate.
  • Neat, but not surprising.

    Taking pills to help/force you to fall asleep on a consistent basis can't be good for you. That said, neither can not sleeping on a consistent basis. Even with the risks in mind, I imagine in many cases it still makes sense to keep taking the pills?

    Luckily I sleep like a log.

    • I quit smoking because I don't want to get cancer, and I don't want to smell bad all the time, and I don't want to be out of breath walking up the stairs. That said, I loved smoking. I still miss it every day, but the risks are greater than the rewards.

      Stop taking my sleeping pills? Hah. Have you ever been so tired that you get a sore throat? Or that you argue with yourself at a stop light, "no, don't close your eyes, I know it would feel really really good but if you do that you'll miss the green and might not wake up until somebody knocks on your window"? Your legs shake, you feel sick to your stomach, your palms sweat constantly, your eyes try to close with all their might until you can hear the muscles straining in your ears.

      Now try feeling like that for months on end. Stop taking my sleeping pills? Fuck that shit, I'd rather die early.

      • Your username is apt.

      • by TheLink (130905)

        Sure looks like you CAN sleep without sleeping pills:

        Or that you argue with yourself at a stop light, "no, don't close your eyes, I know it would feel really really good but if you do that you'll miss the green and might not wake up until somebody knocks on your window"?

        So maybe you're a nocturnal person?

  • by Dunbal (464142) *
    Ahh those overlapping confidence intervals.
  • by Hatta (162192) on Tuesday February 28, 2012 @12:47PM (#39186879) Journal

    Drug companies spend more on marketing than they spend on research. Is it any surprise that these stories keep coming up? SSRIs were going to cure everyone's depression. Now we find out that they're addictive, and only effective in the very worst cases of depression. Vioxx was going to usher in a new age of pain relief for arthritis, turns out it killed tens of thousands of people. Hormone replacement therapy was considered essential to prevent osteoporosis in women. Turns out it also causes bone remodeling that makes certain types of fractures even more common. Don't be surprised if we find out in the future that wonder drugs like statins carry risks we haven't been made aware of.

    Pharmaceutical companies should not be allowed to market. Not to the general public, and not to doctors either.

    • by dgatwood (11270)

      Don't be surprised if we find out in the future that wonder drugs like statins carry risks we haven't been made aware of.

      As opposed to all the serious risks we have been made aware of? Muscle damage, cognitive dysfunction, etc.

      • by gewalker (57809)

        Death is also correlated with use of statin drugs, a rather poor outcome for the patient if you ask me. There have been major studies on this, and takiing statins results in more deaths during the study period, but fewer deaths due to heart attacks. Big deal, dead is still a negative outcome in a drug study.

        I personally consider the huge number of prescriptions for statins to be malpractice. If drug-induced cholesterol lowing was effective in treating hyperlipidemia, why did not the non-statin drugs that l

        • by TheLink (130905)
          Regular flossing reduces cardiac events too.

          Maybe one day they might find that certain bacteria infections increase your chance of getting heart disease.

          Just like the link between h.pylori and stomach ulcers.
    • Vioxx was a really god pain killer yet Celebrex is probably just as dangerous but is still on the market. Go figure? It IS about money for sure.

  • by PPH (736903) on Tuesday February 28, 2012 @12:57PM (#39187007)

    ... I want to go quietly, in my sleep. Like my grandfather.
    Not screaming in terror, like his passengers.

  • A recent post to /. pointed to several articles that brought up the fact that a solid 8 hours of sleep may not be normal.
    http://www.bbc.co.uk/news/magazine-16964783
    http://en.wikipedia.org/wiki/Segmented_sleep
    http://www.history.vt.edu/Ekirch/sleepcommentary.html
    http://www.nytimes.com/2006/02/19/opinion/19ekirch.html
    Our brains may very well be wired to a distrupted sleep and taking pills to 'correct' this is not a good idea!

  • I stopped taking sleeping pills because they had an unintended side affect for me. They kept me awake.

    Caffeine has no affect on me- but taking a sleeping pill keeps me awake all night. I have some odd body chemistry no doubt.

  • by satuon (1822492) on Tuesday February 28, 2012 @01:15PM (#39187279)

    Urgent bulletin. A new study has found that people having extended stays inside hospitals have a much higher mortality rate than people who don't. Avoid hospitals at all costs.

  • by rs1n (1867908) on Tuesday February 28, 2012 @01:24PM (#39187399)
    ...it could be the fact that those who have trouble sleeping are pre-dispositioned to having lower mortality. The fact that they also taking sleeping pills is a side issue. I'm just sayin...
  • Great Work (Score:4, Insightful)

    by trongey (21550) on Tuesday February 28, 2012 @01:26PM (#39187409) Homepage

    I'm glad they discovered that death risk increases with age.
    Did you ever wonder how they come up with death rates that are less than 100%?

  • by ridgecritter (934252) on Tuesday February 28, 2012 @01:37PM (#39187563)

    And the authors recognize this - from TFA:

    "Cohort studies demonstrating association do not necessarily imply causality, but the preferable randomised controlled trial method for assessing hypnotic risks may be impractical due to ethical and funding limitations."

    It's well-known that sleep disturbances are correlated with higher mortality. This study could simply be uncovering that people who have sleep disturbances (and who are therefore in a higher mortality group) are more likely to ask for meds to help them sleep. Can't see that there's any big news here.

  • I just lived through six years of chronic insomnia and went down the whole path of doctors and pills. What it turned out to be was a undiagnosed heart arrhythmia caused by a untreated infection which was exasperated by fluroquinalone which almost killed me. It just shows that Doctors just collect a paycheck and push what ever pills big pharma claims works.( it took 6 years and about $300,000 in medical bills and completely wiped out my financials and credit) After getting on propafenone for the arrhythmia f

  • cue the mass tort lawyers - perhaps Big Pharma already knew about the problems and kept quiet, wouldn't be the first time that's happened.

  • My own 0.02 suggests that Big Pharma probably isn't completely blind to some of the problems behind sleeping medications. Addiction side effects no withstanding, there are thoughts that these medications could have diliterious effects on the brain's neurochemistry. The trouble with Big Pharma is that it has little or no interest in curing disease because there is no profit in it. The profit is in long term symptom mitigation and sleep medications are simply just that - mitigations. Sleep needs to be mor
  • And no one really understands why most mammals sleep. You monkey around with such a core function and you may effects side-effects.
  • You know I track this stuff as my father died of cancer, so I am rather keenly aware when new cancer treatments pop up.

    However, over the past 2 years I have noticed a trend that just about every major medication from cholsterol pills, to sexual disfunction to vaccines, have 3-5 times the elevated risk factors for people to die of cancer.

    If I didn't know any better the industry is astroturfing for patients to increase profits.

    -Hackus

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