Probiotics and palmitoylethanolamide (PEA) for osteoarthritic pain: individual effects in a multiple baseline design study
Abstract
Background/objectives: Osteoarthritis (OA) is a leading cause of chronic pain. As healthcare services struggle to meet demand to treat chronic pain, many individuals self-manage their symptoms. Probiotics and palmitoylethanolamide (PEA) may be promising therapeutic options because of their anti-inflammatory properties. PEA is an endogenously produced N-acylethanolamine, considered "endocannabinoid-like" due to its structural similarity to endocannabinoids. While it has non-direct influence on the endocannabinoid system, it primarily acts via non-cannabinoid pathways, most notably through activation of peroxisome proliferator-activated receptor alpha (PPARα). PEA has demonstrated both analgesic (pain-relieving) and mood-modulating effects in preclinical studies, and preliminary clinical studies. To date, no clinical studies have investigated the combined use of PEA and probiotics for the treatment of OA pain.
Methods: A multiple baseline design (MBD) study was used over 11 weeks to assess the individual effects in four participants recruited from a naturopathic practice. Participants were randomised into one of two pathways, both starting with a placebo phase, followed by an active intervention involving probiotics and PEA. This design allowed for the concealment and blinding of the introduction of active treatment in a double-blind manner. The primary outcome was daily pain scores using a Visual Analogue Scale (VAS). Secondary outcomes incorporated a patient-reported measure…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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