Abstract
Background: Ultra-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. Objective: The aim of this study was to determine the effectiveness of um-PEA versus placebo on chronic pain intensity and function in individual geriatric patients. Design: We performed randomized, blinded N-of-1 trials with two 3-week um-PEA versus placebo comparisons, separated by 2-week washout periods. Participants: The study included outpatients aged ≥ 65 years with chronic, non-cancer, non-ischemic pain in the back, joints, or limbs. Intervention: Patients 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. Results: Ten 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). Conclusions: Our 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.
| Original language | English |
|---|---|
| Pages (from-to) | 941-952 |
| Number of pages | 12 |
| Journal | Drugs and Aging |
| Volume | 34 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - Dec 1 2017 |
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ASJC Scopus subject areas
- Geriatrics and Gerontology
- Pharmacology (medical)
Cite this
N-of-1 Randomized Trials of Ultra-Micronized Palmitoylethanolamide in Older Patients with Chronic Pain. / Germini, Federico; Coerezza, Anna; Andreinetti, Luca; Nobili, Alessandro; Rossi, Paolo Dionigi; Mari, Daniela; Guyatt, Gordon; Marcucci, Maura.
In: Drugs and Aging, Vol. 34, No. 12, 01.12.2017, p. 941-952.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - N-of-1 Randomized Trials of Ultra-Micronized Palmitoylethanolamide in Older Patients with Chronic Pain
AU - Germini, Federico
AU - Coerezza, Anna
AU - Andreinetti, Luca
AU - Nobili, Alessandro
AU - Rossi, Paolo Dionigi
AU - Mari, Daniela
AU - Guyatt, Gordon
AU - Marcucci, Maura
PY - 2017/12/1
Y1 - 2017/12/1
N2 - Background: Ultra-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. Objective: The aim of this study was to determine the effectiveness of um-PEA versus placebo on chronic pain intensity and function in individual geriatric patients. Design: We performed randomized, blinded N-of-1 trials with two 3-week um-PEA versus placebo comparisons, separated by 2-week washout periods. Participants: The study included outpatients aged ≥ 65 years with chronic, non-cancer, non-ischemic pain in the back, joints, or limbs. Intervention: Patients 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. Results: Ten 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). Conclusions: Our 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.
AB - Background: Ultra-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. Objective: The aim of this study was to determine the effectiveness of um-PEA versus placebo on chronic pain intensity and function in individual geriatric patients. Design: We performed randomized, blinded N-of-1 trials with two 3-week um-PEA versus placebo comparisons, separated by 2-week washout periods. Participants: The study included outpatients aged ≥ 65 years with chronic, non-cancer, non-ischemic pain in the back, joints, or limbs. Intervention: Patients 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. Results: Ten 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). Conclusions: Our 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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UR - http://www.scopus.com/inward/citedby.url?scp=85037655102&partnerID=8YFLogxK
U2 - 10.1007/s40266-017-0506-2
DO - 10.1007/s40266-017-0506-2
M3 - Article
AN - SCOPUS:85037655102
VL - 34
SP - 941
EP - 952
JO - Drugs and Aging
JF - Drugs and Aging
SN - 1170-229X
IS - 12
ER -