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FAQ > Stomach Acid > I already have osteopenia or osteoporosis and worry about breaking a hip. Are these drugs safe for me?

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I read somewhere that Proton Pump Inhibitors prevent calcium from being absorbed in the intestinal tract and thereby increase the risk of hip fractures.  I already have osteopenia or osteoporosis and worry about breaking a hip.  Are these drugs safe for me?

This is a complex and controversial issue, and as a general rule, the risks of osteoporosis and hip fractures are dependent upon the coexistent presence or absence of many individual factors in each person.  Also, one must remember that everything doctors and patients do in medicine is a balance of risk and benefit considerations.  Sometimes doctors and patients find that it is necessary to accept some elements of risk for one condition in the process of preventing the risk of developing another more serious condition.  Many mild dyspeptic disorders can be treated to patient comfort with the episodic use of antacids or H2 blockers.  Gastroesophageal reflux disease is a more serious condition because, if untreated, uncontrolled, or undertreated, serious problems can develop such as adenocarcinoma (glandular cancer) of the esophagus, esophageal stricture, hemorrhage, or pulmonary aspiration with the development of aspiration pneumonia, asthma, emphysema, bronchiectasis, or lung abscess.  Among the 3 categories of acid lowering drugs, Proton Pump inhibitors are the strongest acid reducers and, because the consequences of inadequately treated gastroesophageal reflux are so severe, the PPI's are an essential  part of the standard treatment reflux.  High doses of Proton Pump inhibitors are essential for people with Barrett's esophagus, a premalignant condition which can be transformed to cancer by further acid exposure.  That is the background for the use of PPI's.

The research literature which attempts to point out the risks of PPI's leaves a lot to be desired if the researchers expect their findings to be considered credible.  Most of this literature is retrospective -- in other words, backward looking.  Imagine casting a fine mesh fishing net into the water and catching a lot of fish and other stuff; figuring out what you have caught and why, however, is a different matter.  That is the problem with much of the PPI hazard research.  In one British study, the National Health Service turned on its computer, pulled out the records of 145,000 patients taking any acid lowering drug (antacids, H2 blockers, and PPI's), and asked the computer to tabulate what medical problems these people had.  The findings were reported as showing hip fractures as if they were related only to PPI's when in fact, there were 3 different drug types that were studied.  There was no control group in this study for comparison, so aside from being speculative or interesting reading, the article did not account for other potential risk factors which might have been present to explain the calcium issues.   It was also not clear what the relative risk was for each category of stomach acid lowering drug studied.  Offhand, I can think of several factors which were not even mentioned in the article.  As another consideration, because of the large sample size, it was likely that clinically irrelevant observations reached "statistical significance".  An American study, attempting to improve upon the British study, was a retrospective description of the calcium problems in 33,000 people taking PPI's and 132,000 not taking PPI's.  There was no effort to balance the two patient groups for other risk factors related to calcium metabolism .  Also, I have never encountered a study that had 4 times as many subjects in a control group compared to the number in the study group, and I strongly suspect that the researchers kept adding control subjects after the fact to get the statistical analysis to achieve statistical significance for their predetermined conclusions.

There is a better way to study whether a treatment works or causes harm.  In the United States, the preferred research method is called the prospective randomized stratified controlled clinical trial.  A prospective trial is one that is forward looking.  The rules of the trial, the items to be measured, and the definitions of response, failure to respond, or toxicity are set in advance.  A stratified trial is one in which the research subjects are divided into groups with equal risk factors such as age, sex, coexistent medical problems for the matter to be studied.  This is done so that the groups are alike in all relevant characteristics except for the treatment given.  Once the two populations are equalized, the randomization procedure assigns the research subject without pattern or preference to the treatment group or the control group (possibly a no treatment or placebo assignment).  Randomization assures that there is no effort to assign healthier, younger, or lower risk patients to one group or the other in order to increase the chances of producing a particular outcome.  A double blind trial is a research study in which neither the research subject nor the investigator know whether the patient was assigned to the treatment or the placebo group until the trial is over.  In such a trial there is a safety monitor who is not involved in data gathering or data analysis; this researcher reviews the data and is an overseer who calls a halt to the trial if there is a safety hazard that becomes apparent or if a response to a treatment is so dramatic that it becomes unethical to withhold the treatment from the members of the control group.

Although I may have bored you to tears with the discussion of research methods, I wanted to illustrate how the assertion that PPI's cause hip fractures is based on highly manipulated research design and heavy data massage.  There were vested interests in the PPI research since the National Health Service in the United Kingdom and prescription benefit plans everywhere else hate to pay for PPI's since they are more expensive than other categories of drugs for stomach acid suppression.