The most commonly prescribed drugs for pain are Non-Steroidal Anti-Inflammatory drugs (NSAIDs). Approximately 98 million prescriptions for NSAIDs were filled in the United States in 2012 [IMS 2012] and this number does not include NSAIDs that are purchased over the counter. Although effective in treating pain and inflammation, NSAIDs are linked to adverse side effects which make them inappropriate for use in many patient populations. There are several serious side effects and toxicity related to use of traditional NSAIDs. Toxic side effects of traditional NSAIDs include:
- Stomach ulceration and/or bleeding
- Kidney damage
- Easy bruising because of loss of platelet function
- Exacerbation of cardiovascular conditions
Recent studies have also highlighted a higher risk of atrial fibrillation with NSAID use  and an increase risk of bleeding and events such as heart attack, stroke or cardiovascular death with the use of NSAIDs in conjunction with antithrombotic therapy .
NSAIDs work to reduce pain and inflammation by inhibiting cyclooxygenase, an enzyme. The action of inhibiting cyclooxygenases, reduces pain and inflammation but is also responsible for many of the side effects of NSAIDs. This inhibition is problematic because it also inhibits some important functions such as the repair and maintenance of the stomach lining. This is why stomach ulceration and irritation is so common with the use of NSAIDs.
Inhibition of cyclooxygenase is also associated with reductions in prostaglandin synthesis and is associated with less sodium being excreted in urine and constriction of blood vessels. This effect of NSAIDs on blood pressure may increase mean arterial pressure by as much as 5 to 6 mm Hg in hypertensive patients. This consequence may be of particular relevance in patients with preexisting hypertension, edema or congestive heart failure.
One study noted the rate of new-onset hypertension developing in elderly patients for whom nonselective NSAIDs were prescribed was 27% 
The extremely high risk of side effects with such commonly used medication resulted in a quest for an analgesic/anti-inflammatory that could provide therapeutic efficacy equivalent to that of traditional NSAIDs but without the gastrotoxicity.
The use of medical foods to treat the dietary deficiencies associated with pain and inflammation has proven to be a safe and effective method for pain control. Two double-blind, randomized, trials, which compared Theramine to low dose naproxen and ibuprofen demonstrated statistically significantly reduction in inflammation as measured by inflammatory markers, CRP and IL-6 as well as improvement in low back pain. Theramine was shown to be an effective pain medication but also an effective anti-inflammatory agent without the risk of gastrointestinal bleeding or other serious side effects.
All of the ingredients in Theramine are GRAS (generally recognized as safe) products and carries no risk of addiction or attenuation. Theramine has been on the market for 10 years without report of GI bleed or serious adverse side effects.
There are several patient populations that should avoid NSAIDs due to the high risk of side effects.
- Patients over 65 years of age
- Previous GI history such as peptic ulcers or previous GI bleed
- Patients with cardiovascular disease
- Patients with liver disease
- Patients with kidney disease
- Patients on anti-coagulants or low dose aspirin
The cumulative evidence of the danger of NSAIDs is an important reminder that the while NSAIDs can be helpful and at times necessary medications for satisfactory quality of life, use of these medications, particularly among high risk patients must be carefully considered.
1. Gang Liu, MD, PhD, Yu-Peng Yan, MD, Xin-Xin Zheng, MD, Phd, Yan-Lu Xu, MD, Phd, Jie Lu, MD, Ru-Tai Hui, MD, Phd, Xiao-Hong Huang, MD, Phd “Meta-Analysis of Nonsteroidal Anti-Inflammatory Drug Use and Risk of Atrial Fibrillation” The American Journal of Cardiology Nov. 15, 2014 Vol. 114, Iss. 10
2. Anne-Marie Schjerning Olsen, Gunnar H. Gislason, Patricia McGettigan, Emil Fosbøl, Rikke Sørensen, Morten Lock Hansen, Lars Køber, Christian Torp-Pedersen, Morten Lamberts. Association of NSAID Use With Risk of Bleeding and Cardiovascular Events in Patients Receiving Antithrombotic Therapy After Myocardial Infarction. JAMA, 2015; 313 (8): 805
3. Solomon DH, Schneeweiss S, Levin R, Avorn J. “Relationship between COX-2 specific inhibitors and hypertension” Hypertension. 2004; 44: 140–145