Traumeel Epidural? The FDA, Spine applications and more about this Homeopathic treatment

PainExam Podcast Show Notes: Exploring Traumeel as an Alternative for Back Pain Relief

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Introduction:

• Today, Long Island Based Pain Physician David Rosenblum, MD  delves into the latest advancements and alternative treatments for pain management.
• In today's episode, we shine a spotlight on Traumeel®, a homeopathic alternative gaining traction for its anti-inflammatory properties, with fewer reported side effects compared to corticosteroids.

Understanding Traumeel:

• Traumeel, a fixed combination of diluted plant and mineral extracts, has been available over-the-counter in Europe for over 60 years.
• Contrary to corticosteroids, Traumeel's popularity has surged due to its limited side effect profile, with reported contraindications primarily linked to allergies [9].

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Scientific Insights:

• A study by Lussignoli et al. demonstrated Traumeel's efficacy in decreasing systemic interleukin-6 production and reducing edema, countering an unregulated inflammatory response [10].
• In vitro studies revealed Traumeel's inhibition of pro-inflammatory mediators (IL-1β, TNFα, IL-8) in immune cells, suggesting its potential in stabilizing the immune system [8].
• Notably, Traumeel's effectiveness seems to surpass the sum of its individual components, indicating a synergistic interaction [9-10].

Clinical Applications:

• Traumeel has shown efficacy comparable to nonsteroidal anti-inflammatory drugs (NSAIDs) in treating various inflammatory conditions.
• It is available in oral, topical, and injectable preparations, making it a versatile option for pain relief [8-9].

Research Gaps and Potential:

• Despite its established use, current research lacks information on Traumeel's efficacy in epidural injections for short-term back pain relief.
• No studies have compared Traumeel to corticosteroid injections, although the TRARO study protocol proposes a potential avenue for comparison in rotator cuff syndrome patients [11].

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Clinical Cases:

• Five patients seeking back pain relief opted for Traumeel injections due to either a contraindication to or a preference against steroids.
• This real-world scenario lays the groundwork for further exploration into Traumeel's efficacy in epidural injections, providing additional pain-relieving options for patients unable to tolerate corticosteroid injections.

Conclusion:

• Traumeel presents a promising alternative for pain management, particularly in cases where corticosteroids may be unsuitable, however the FDA has yet to approve it and therefore it has failed to gain traction in the US. [14]
• As we wrap up, stay tuned for future developments in the research landscape surrounding Traumeel and its potential role in enhancing pain relief options.

Disclaimer:

• Consult with a healthcare professional before considering any alternative treatments. The information provided in this podcast is for educational purposes only and does not replace medical advice.

 

David Rosenblum, MD
President, NRAP Academy
Clinical Assistant Professor 
Department of Anesthesiology
SUNY Downstate Medical Center 
Director of Pain Management
Maimonides Medical Center

 

References 

1. Cassidy JD, Carroll LJ, Côté P: The Saskatchewan health and back pain survey. The prevalence of low back pain and related disability in Saskatchewan adults. Spine (Phila Pa 1976). 1998, 23:1860-66. 10.1097/00007632-199809010-00012 

2. Rudy TE, Weiner DK, Lieber SJ, Slaboda J, Boston JR: The impact of chronic low back pain on older adults: a comparative study of patients and controls. Pain. 2007, 131:293-301. 10.1016/j.pain.2007.01.012 

3. Fyneface-Ogan S: Anatomy and Clinical Importance of the Epidural Space. Epidural Analgesia - Current Views and Approaches. IntechOpen. IntechOpen (ed): IntechOpen, Internet; 2012. 1-14. 10.5772/39091 

4. Waldman SD: Complications of cervical epidural nerve blocks with steroids: a prospective study of 790 consecutive blocks. Reg Anesth. 1989, 14:149-51. 

5. McGrath JM, Schaefer MP, Malkamaki DM: Incidence and characteristics of complications from epidural steroid injections. Pain Med. 2011, 12:726-31. 10.1111/j.1526-4637.2011.01077.x 

6. Watters WC 3rd, Resnick DK, Eck JC, et al.: Guideline update for the performance of fusion procedures for degenerative disease of the lumbar spine. Part 13: injection therapies, low-back pain, and lumbar fusion. J Neurosurg Spine. 2014, 21:79-90. 10.3171/2014.4.SPINE14281 

7. Understanding Potential Complications Of Epidural Steroid Injections . (2011). Accessed: October 1, 2019: https://www.practicalpainmanagement.com/treatments/interventional/injections/understanding-potentialcomplications-ep…. 

8. Schneider C: Traumeel - an emerging option to nonsteroidal anti-inflammatory drugs in the management of acute musculoskeletal injuries. Int J Gen Med. 2011, 4:225-34. 10.2147/IJGM.S16709 9. Grech D, Velagala J, Dembek DJ, Tabaac B: Critical literature review of the homeopathic compound Traumeel for treatment of inflammation. Pharmacology & Pharmacy. 2018, 9:67-83. 10. Lussignoli S, Bertani S, Metelmann H, Bellavite P, Conforti A: Effect of Traumeel S®, a homeopathic formulation, on blood-induced inflammation in rats. Complement Ther Med. 1999, 7:225-30. 

10.1016/S0965-2299(99)80006-5 

11. Vanden Bossche L, Vanderstraeten G: A multi-center, double-blind, randomized, placebo-controlled trial protocol to assess Traumeel injection vs dexamethasone injection in rotator cuff syndrome: the TRAumeel in ROtator cuff syndrome (TRARO) study protocol. BMC Musculoskelet Disord. 2015, 16:8. 10.1186/s12891- 015-0471-z 

12. Birnesser H, Oberbaum M, Klein P, Weiser M: The homeopathic preparation Traumeel® S compared with NSAIDS for symptomatic treatment of epicondylitis 

13. Ehlert, Dianna, and Ariel Majjhoo. "Traumeel® Epidural Injection: A Viable Alternative to Corticosteroids-A Five-Patient Case Study." Cureus 11.11 (2019)

14. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/medinatura-inc-596269-06112020