Trial reportDrugs & aging2017
N-of-1 Randomized Trials of Ultra-Micronized Palmitoylethanolamide in Older Patients with Chronic Pain.
Trial report in Drugs & aging, 2017. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02699281 (N-of-1 Randomised Trials to Assess the Efficacy of Ultra-micronized Palmitoylethanolamide), which is not on this map. Cited by 15 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
N-of-1 Randomised Trials to Assess the Efficacy of Ultra-micronized Palmitoylethanolamide (Um-PEA) in Geriatric Patients With Chronic Pain
Who cites it
15 citing papers in PubMed, 1 synthesis or guideline pooled it, 35 citations in OpenAlex.
- Pooled it
- Probiotics and palmitoylethanolamide (PEA) for osteoarthritic pain: individual effects in a multiple baseline design study.BMC complementary medicine and therapies · 2026Trial
- New Adjuvant Therapies for Obesity-Related Disorders Associated with Meta-Neuroinflammation.Pharmaceuticals (Basel, Switzerland) · 2026Review
- Real-World Before-After Study ofNutrients · 2026Article
- The Prospects of Palmitylethanolamide in Tumor Prevention and Treatment.Journal of inflammation research · 2026Review
- Palmitoylethanolamide supplementation for human health: A state-of-the-art systematic review of Randomized Controlled Trials in patient populations.Brain, behavior, & immunity - health · 2025Review
- Palmitoylethanolamide in the Treatment of Pain and Its Clinical Application Prospects.Drug design, development and therapy · 2025Review
- The development of a set of key points to aid clinicians and researchers in designing and conducting n-of-1 trials.Trials · 2024Article
- Individual Treatment Trials-Do Experts Know and Use This Option to Improve the Treatability of Mucopolysaccharidosis?Pharmaceuticals (Basel, Switzerland) · 2023Article
- Effects of Palmitoylethanolamide (PEA) on Nociceptive, Musculoskeletal and Neuropathic Pain: Systematic Review and Meta-Analysis of Clinical Evidence.Pharmaceutics · 2022Review
- Assessment of a Mobile Health iPhone App for Semiautomated Self-management of Chronic Recurrent Medical Conditions Using an N-of-1 Trial Framework: Feasibility Pilot Study.JMIR formative research · 2022Article
- Status of N-of-1 Trials in Chronic Pain Management: A Narrative Review.Pain and therapy · 2021Review
- Chronic Pain in Dogs and Cats: Is There Place for Dietary Intervention with Micro-Palmitoylethanolamide?Animals : an open access journal from MDPI · 2021Review
- Comparison of Aggregated N-of-1 Trials with Parallel and Crossover Randomized Controlled Trials Using Simulation Studies.Healthcare (Basel, Switzerland) · 2019Article
- Clinical applications of palmitoylethanolamide in pain management: protocol for a scoping review.Systematic reviews · 2019Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 5 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundUltra-micronized palmitoylethanolamide (um-PEA) represents an attractive option for chronic pain control in complex older patients at higher risk of adverse effects with traditional analgesics.
objectiveThe aim of this study was to determine the effectiveness of um-PEA versus placebo on chronic pain intensity and function in individual geriatric patients.
designWe performed randomized, blinded N-of-1 trials with two 3-week um-PEA versus placebo comparisons, separated by 2-week washout periods.
participantsThe study included outpatients aged ≥ 65 years with chronic, non-cancer, non-ischemic pain in the back, joints, or limbs.
interventionPatients were randomized to Um-PEA 600 mg or placebo twice daily. MEASUREMENTS: Pain intensity was measured using an 11-point visual numeric scale. Functional impairment was measured using a Back Pain Functional Scale. Impact of each N-of-1 trial was measured on the clinician's intention to treat and confidence.
resultsTen of 11 eligible patients consented over 7 months [all female, mean age 83.2 years (SD 4.6)]. Three patients interrupted the trial: one had diarrhea (under placebo), one for low adherence, and one for intercurrent pneumonia. A small statistically significant effect in favor of um-PEA was seen at the mixed method analyses in two patients (effect size equal to 8% of the baseline pain). A statistically significant impact on function was found in one patient. After the trial, um-PEA was prescribed to four patients; in two patients the clinician changed their pre-trial intention to treat; the clinician confidence in the treatment plan either increased (5) or remained the same (2).
conclusionsOur experience confirmed that N-of-1 trials may help make personalized evidence-based decisions in complex older patients, with special feasibility considerations. CLINICALTRIALS.GOV: NCT02699281.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.