A Double-Blind Controlled Trial of a Single Dose Naproxen and an Amino Acid Medical Food Theramine for the Treatment of Low Back Pain

  title={A Double-Blind Controlled Trial of a Single Dose Naproxen and an Amino Acid Medical Food Theramine for the Treatment of Low Back Pain},
  author={William E. Shell and Elizabeth Charuvastra and Marcus A. Dewood and Lawrence A May and Debora H. Bullias and David S. Silver},
  journal={American Journal of Therapeutics},
To study the safety and efficacy of a new medical food (Theramine) in the treatment of low back pain, we performed a 28-day double-blind randomized controlled trial in 129 patients. Back pain was present for at least 6 weeks and was not mild. Patients were randomly assigned to receive medical food alone (n = 43), naproxen alone (250 mg/d, n = 42), or both medical food and naproxen (n = 44). All patients were assessed by using Roland–Morris Disability Questionnaire, Oswestry Low Back Pain Scale… 
Reduction in Pain and Inflammation Associated With Chronic Low Back Pain With the Use of the Medical Food Theramine
Treatment with amino acid precursors was associated with substantial improvement in chronic back pain, reduction in inflammation, and improvement in back pain correlated with increased amino acid Precursors to neurotransmitters in blood.
Combination Drug Therapy for the Management of Low Back Pain and Sciatica: Systematic Review and Meta-Analysis.
Sentra PM (a Medical Food) and Trazodone in the Management of Sleep Disorders
The data indicate that Sentra PM can improve the quality of sleep, the response to trazodone as a sleep medication and parasympathetic autonomic nervous system activity.
Theramine ( A Medical Food ) Versus Non-Steroidal Anti Inflammatory Agents in Elderly Patients : A Pharmacoeconomic Analysis
Theramine should be the preferred choice over NSAIDs in elderly patients, and the higher acquisition costs for Theramine are offset by the reduction in side effects and need for testing and other protective medications in patients over the age of sixty-five taking NSAIDs.
The pharmacological management of chronic lower back pain
Only baclofen, duloxetine, NSAIDs, and opiates showed to improve pain and disability levels in patients with LBP, but the patients’ demographics are heterogeneous, and the results must be interpreted with caution and in the light of possible adverse events connected to the use of these drugs.
Non-steroidal anti-inflammatory drugs for acute low back pain.
There is low quality evidence that NSAIDs are slightly more effective for short-term global improvement than placebo, but there was substantial heterogeneity between studies, and studies were prone to selective reporting bias, since most studies did not register their trials.
Administration of an Amino Acid–Based Regimen for the Management of Autonomic Nervous System Dysfunction Related to Combat-Induced Illness
It is demonstrated that addressing the increased dietary requirements of PTSD can improve symptoms of the disease while eliminating significant side effects, and a larger, double-blind, randomized, placebo-controlled trial is warranted.
Non-steroidal anti-inflammatory drugs and gabapentinoids for chronic lumbar pain: a Bayesian network meta-analysis of randomized controlled trials.
The effects of selective and non-selective NSAIDs and gabapentinoids in chronic LBP are probably over-estimated and the effect of behavioural changes, including exercise, should be explored, alone or in combination with drugs.
Hepatotoxicity of Nonsteroidal Anti-Inflammatory Drugs: A Systematic Review of Randomized Controlled Trials
Diclofenac had higher rates of hepatotoxic evidence compared to other NSAIDs, and was mostly demonstrated as aminotransferase elevation, while liver-related hospitalization or discontinuation was very low.
Combination drug therapy for low back pain
The effects of combination drug therapy in reducing pain and disability in patients with low back pain and/or sciatica presenting to primary care, compared to mono drug therapy, no/minimal treatment or placebo is investigated.


A randomized, double-blind, placebo controlled triphosphate in study of oral adenosine subacute low back pain.
Oral ATP might have an early acting effect in subacute low back pain and overall assessments of efficacy between groups at any time point during the study.
Efficacy and Safety of Rofecoxib in Patients with Chronic Low Back Pain: Results from Two 4-Week, Randomized, Placebo-Controlled, Parallel-Group, Double-Blind Trials
Rofecoxib significantly reduced chronic low back pain in adults and was well tolerated and superior to placebo in eight of nine secondary endpoints.
A Randomized, Placebo-Controlled Trial of an Amino Acid Preparation on Timing and Quality of Sleep
An amino acid preparation containing both GABA and 5-hydroxytryptophan reduced time to fall asleep, decreased sleep latency, increased the duration of sleep, and improved quality of sleep in patients with sleep disorders.
Pregabalin, celecoxib, and their combination for treatment of chronic low-back pain
Combination of celecoxib and pregabalin is more effective than monotherapy for chronic low-back pain, with similar adverse effects.
Non-steroidal anti-inflammatory drugs for low back pain.
The evidence from the 51 trials included in this review suggests that NSAIDs are effective for short-term symptomatic relief in patients with acute low back pain, and there does not seem to be a specific type of NSAID which is clearly more effective than others.
The gastrointestinal safety of the COX-2 selective inhibitor etoricoxib assessed by both endoscopy and analysis of upper gastrointestinal events
Treatment with etoricoxib reduced the incidence of investigator-reported and confirmed adverse upper GI events by approximately 50% compared with treatment with nonselective NSAIDs.
Risk assessment of NSAID-induced gastrointestinal toxicity in ambulatory care patients.
  • B. V. Sweet, K. Townsend, C. Tsai
  • Medicine
    American journal of health-system pharmacy : AJHP : official journal of the American Society of Health-System Pharmacists
  • 2004
Among patients in a managed care organization who were taking NSAIDs, most were at low risk for an NSAID-related GI adverse effect, and the risk of GI adverse effects did not differ significantly between patients treated with a traditional NSAID and those treated with an COX-2 inhibitor.
Guidelines for clinical studies assessing the efficacy of drugs for the management of acute low back pain.
With the application of these guidelines, LBP could serve as an appropriate disease for testing analgesic drugs and Rigorous evaluation may also help to improve the management of acute LBP.