Globally,
low back pain (LBP) is one of the most common chronic pain conditions with a
lifetime prevalence estimated to be >70% in industrialized countries.
Ultra-micronized palmitoylethanolamide
(um-PEA) may be an
innovative therapeutic intervention as an add-on therapy to Tapentadol (TP) for the management of chronic low back pain (CLBP), as
well as to improve patient’s quality of life. Additionally, this combination
treatment decreases the TP dose over time without any serious side effects.
Globally, low back pain (LBP) is one of the most common chronic pain conditions with a lifetime prevalence estimated to be >70% in industrialized countries. At present, various drugs like analgesics (paracetamol), non-steroidal anti-inflammatory drugs (NSAIDs), antidepressants, anticonvulsants, opioids, and topical treatments, with oral agents are recommended as first-line therapy. Although in relieving neuropathic pain, these classic drugs suffer from various side effects mainly at gastrointestinal level that limits their long-term uses. Tapentadol (TP) is a centrally acting analgesic used for the management of acute and chronic pain since 2009. Due to its dual analgesic principle (μ-opioid receptor agonism and noradrenaline reuptake inhibition) in a single molecule, this offers a better balance between efficacy and tolerability than other analgesic drugs. Palmitoylethanolamide (PEA), a member of the Nacylethanolamine family is produced by the mammalian cells and which is particularly abundant in brain tissues. It acts on the mast cells, cellular nucleus and inflammation genes involved in the generation and maintenance of pain. It down-regulates the mast cell activation and controlling microglial cell behaviors that plays important role in the pain modulation. Ultra-micronized-PEA (um-PEA) showed better pain control and tolerability when administered as an add-on therapy with low dose of any analgesics. Thus, Um-PEA may be considered as an effective add-on therapy to minimize the risks of chronic opioid treatment in diseases associated with chronic neuropathic pain.
Rationale behind the research:
Objective:
To assess the effectiveness of um-PTA at 6 months as an add-on therapy to TP in the treatment of chronic low back pain.
Study outcomes measures:
Time period: All the parameters were assessed at baseline (T0), 3 weeks (T1), 12 weeks (T2) and 24 weeks (T3–end of treatment).
Study Outcomes:
Figure 2: Visual Analog Scale
Figure 3: DN4 questionnaire scale
Figure 4: ODQ questionnaire score
Figure 5: Tapentadol dosage
This study concluded that um-PEA may be an advanced therapeutic intervention as an add-on therapy to TP for the management of CLBP with a neuropathic component, also to improve patient quality of life. Additionally, this combination treatment allowed a reduction in TP dose over time and did not show any serious side effects.
The results of this study are more accurate than the previous studies which showed significant reduction on VAS and DN4 score in um-PEA-TP group than the TP group alone (p<0.0001). Few clinical studies showed the pain-relieving properties of m-PEA alone and as an add-on treatment for different chronic pain disorders without and with a neuropathic component. Domnguez et al in 2012 reported the results of double blind study in patients with lumbosciat¬ica. Similarly, in 2012 Gatti et al also reported the effectiveness of PEA as an add-on therapy with already using analgesic drug in the treatment of chronic pain. Cobellis et al in 2011 also reported the use of N-Palmitoylethanolamine in the treatment of pelvic pain. No study till now has evaluated this interaction between um-PEA and TP for the treatment of CLBP. This preliminary study provides promotive findings on the potential benefits of PEA addition to TP in patients affected by c CLBP and should stimulate confirmatory trials with larger patient cohorts. Thus, further prospective studies with a double-blind design and larger patient numbers are needed to confirm these findings.
Drugs in this study (um-PEA and TP) may have synergistic effect in the treatment of CLBP. Also, this study helps in reduction of dose of TP that results in the more safer treatment with less adverse events.
BMC anesthesiology. 2017 Dec;17(1):171
The beneficial use of ultramicronized palmitoylethanolamide as add-on therapy to Tapentadol in the treatment of low back pain: a pilot study comparing prospective and retrospective observational arms
Passavanti MB et al.
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