Heartburn describes the sensation of chest pain generally caused by common gastrointestinal (GI) disorders including gastroesophageal reflux disease (GERD), stomach ulcers, and dyspepsia. Others symptoms that could be caused by these upper GI disorders could include a sore throat, difficulty swallowing, dry cough, hoarse voice, acid reflux, and the feeling of something in your throat. Untreated heartburn can become very uncomfortable and lead to other potentially more harmful issues.
Millions of people experience these symptoms and use a common class of medication called proton pump inhibitors, or PPI’s. These medications can be purchased over-the-counter or can be prescribed by a physician (generally for higher doses). PPI’s work by reducing stomach acid production. The latest research has linked PPI use to C. difficile infection (a potentially life threatening GI infection), kidney disease, death, pneumonia, and dementia among other things. Given the fact that PPI medications are being prescribed frequently, easily accessible to consumers, and effective in treatment, are they safe to take or not?
The Latest Research
Despite the confounding information, PPI’s are still generally considered safe to take; hence they are available to purchase over the counter. The main thing to consider regarding studies that found potentially concerning finding is the difference between correlation (or association) versus causation. Dr. Susan Molchan, a psychiatrist with extensive experience in clinical research at the National Institutes of Health, states “An association does not indicate that the drugs cause or increase the risk.” It can be dangerous if the general public does not understand this. Individuals could read these studies and stop taking their medications, which could put them at risk for other health issues.
Correlation and association research should not be considered hard evidence but could be used as a word of caution to providers and users alike. Most studies that find correlation or association are done retrospectively (in hindsight) by reviewing and researching medical record and data. Research performed in this manner is difficult because it is incredibly hard to control factors such as other medical conditions, age, sex, etc. Thus the findings are often not conclusive. In reality, a randomized controlled trial would need to be performed to prove a factual, scientific causation between PPI use and any disease or health problem. Researchers do this by putting a group of people on a PPI trial while giving a different group a placebo, a medication thought to be a PPI but in reality not. Researchers then compare the effects of the medication between the group that actually received the medication and the group that got the placebo.
Previously retrospective studies found a link between PPI use and ineffectiveness of Plavix leading to cardiovascular morbidity and mortality. Once more rigorous research was performed it appeared that there was no link between PPI medications and Plavix failures.
Physicians and patient will have to weigh the risk of taking PPI medications against the risk of not taking PPI medications. Dr. Joel Howard Rubenstein, a gastroenterologist at Michigan Medicine, explains that over the span of 10 years on a PPI medication, your risk is increased about 2 or 3 percent. Over that same span of time the risk of uncontrolled GERD or another GI issue could lead to much more significant issues.
Further Research Needed
Still, further research is needed to determine if there is a genuine relationship between PPI use and some of these worrisome diseases. Dr. Molchan notes that some researchers can overstate their findings and urges medical researchers to use more accurate language to describe the difference between correlation and causation. Dr. David Johnson notes that studies with more rigor need to be performed regarding the potential harm of PPI’s. He argues that there are potentially more harmful effects from poorly designed studies related to misdirected messages of harm.
What Can You Do?
Some studies do suggest that over half of patients on PPIs are not on them for good reasons. Therefore patients should have an open dialogue with their providers. A few things to discuss with your doctor could include:
- The reason the PPI is being prescribed
- Taking the lowest dose possible to reach a therapeutic effect
- Length of treatment; if the medication can be stopped
- Risk versus benefits of the medication
- Alternatives to PPI’s like lifestyle modifications, H2 blockers, or other treatments
How Best to Take PPIs
When taking over the counter PPI’s for GERD consider the following tips:
- Take the medication about 30 minutes before breakfast on an empty stomach. This will help the medication to work properly.
- If you are taking a PPI twice daily take the second dose before dinner, not bedtime.
- If you take the medication for more than 14 days see your primary provider or GI specialist.
- Avoid symptoms that make your symptoms worse.
- If symptoms persist in spite of therapy, let your doctor know.
Patients should be on PPIs for a good reason, should take the lowest dose possible to achieve a therapeutic effect, and take the medication for the shortest amount of time possible treat the disease. PPIs have been around for almost 30 years and have been shown to be safe and effective in treating heartburn. If you have any questions or concerns about PPI’s contact your prescribing physician.