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

Shell WE et al. – The medical food (Theramine) appeared to be effective in relieving back pain without causing any significant side effects and may provide a safe alternative to presently available therapies.

  • The authors 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, Visual Analog Scale Evaluation and laboratory analysis performed at baseline and at 28 days for assessing the safety and impact on inflammatory markers, which included complete blood counts, C–Reactive protein (CRP), and liver function (alkaline phosphatase, aspartate transaminase, and alanine transaminase).

  • At baseline, there were no statistically significant differences in low back pain when assessed by Roland–Morris function or Oswestry assessments nor were there differences in the blood indices of inflammation.
  • At day 28, both the medical food group and combined therapy group (medical food with naproxen) were statistically significantly superior to the naproxen–alone group (P < 0.05).
  • The medical food and naproxen group showed functional improvement when compared to the naproxen–alone group.
  • The naproxen–alone group showed significant elevations in CRP, alanine transaminase, and aspartate transaminase when compared with the other groups.
  • Medical food alone or with naproxen showed no significant change in liver function tests or CRP, with medical food potentially mitigating the effects seen with naproxen alone.

Please login or register to follow this author.
► Click here to access PubMed, Publisher and related articles...
<< Previous Article | Next Article >>

    Currently, there are no available articles.

Your Unread Messages in Orthopedics

See All >> Messages include industry-sponsored communications and special communications from MDLinx

Most Popular Orthopedics Articles

Indexed Journals in Orthopedics: Journal of Bone and Joint Surgery, Journal of Arthroplasty, Spine, The Kneemore

Make smarter career moves with less time.

Sign up for our free job placement service today and have a dedicated career consultant help locate the right physician job for you!
Click Here for more information.

Get Started Now!

Free-of-charge, no obligation.

Terms and Conditions For M3 Career Consult

By registering with the M3 Career Consult service you authorize M3 USA Corporation to represent you in your job search. The following is a summary of the terms of our service and our mutual obligations to help you find a job:

  • You designate M3 to act as your agent and represent you in your job search;
  • You will not pay us for this service
  • You will advise us of any companies or positions to which you apply or have applied;
  • You will advise us if you believe you are not capable of performing a position for which we submit you, or for which you interview;
  • You will keep all information we provide you about companies or positions strictly confidential;
  • You will promptly provide us with information we request of you;
  • You will make yourself reasonably available for phone, video and in-person conversations and interviews;
  • You will be truthful in all of your communications with us; and
  • You will advise us if anything above changes.

The Top Read Articles of 2014 are Now Available

Scouring thousands of peer-reviewed journals and popular press, Our Editors just released the Top Read Articles of the Year. See the Top Read List