PMID- 37530658
OWN - NLM
STAT- MEDLINE
DCOM- 20231216
LR  - 20231216
IS  - 1872-6623 (Electronic)
IS  - 0304-3959 (Linking)
VI  - 165
IP  - 1
DP  - 2024 Jan 1
TI  - Placebo and nocebo responses in painful diabetic neuropathy: systematic review 
      and meta-analysis.
PG  - 29-43
LID - 10.1097/j.pain.0000000000003000 [doi]
AB  - This preregistered (CRD42021223379) systematic review and meta-analysis aimed to 
      characterize the placebo and nocebo responses in placebo-controlled randomized 
      clinical trials (RCTs) on painful diabetic neuropathy (PDN), updating the 
      previous literature by a decade. Four databases were searched for PDN trials 
      published in the past 20 years, testing oral medications, adopting a 
      parallel-group design. Magnitude of placebo or nocebo responses, Cochrane risk of 
      bias, heterogeneity, and moderators were evaluated. Searches identified 21 
      studies (2425 placebo-treated patients). The overall mean pooled placebo response 
      was -1.54 change in the pain intensity from baseline [95% confidence interval 
      (CI): -1.52, -1.56, I 2 = 72], with a moderate effect size (Cohen d = 0.72). The 
      pooled placebo 50% response rate was 25% [95% CI: 22, 29, I 2 = 50%]. The overall 
      percentage of patients with adverse events (AEs) in the placebo arms was 53.3% 
      [95% CI: 50.9, 55.7], with 5.1% [95% CI: 4.2, 6] of patients dropping out due to 
      AEs. The year of study initiation was the only significant moderator of placebo 
      response (regression coefficient = -0.06, [95% CI: -0.10, -0.02, P = 0.007]). 
      More recent RCTs tended to be longer, bigger, and to include older patients (N = 
      21, rs = 0.455, P = 0.038, rs = 0.600, P = 0.004, rs = 0.472, P = 0.031, 
      respectively). Our findings confirm the magnitude of placebo and nocebo 
      responses, identify the year of study initiation as the only significant 
      moderator of placebo response, draw attention to contextual factors such as 
      confidence in PDN treatments, patients' previous negative experiences, 
      intervention duration, and information provided to patients before enrollment.
CI  - Copyright (c) 2023 International Association for the Study of Pain.
FAU - Frisaldi, Elisa
AU  - Frisaldi E
AUID- ORCID: 0000-0002-3783-1997
AD  - Rita Levi Montalcini Department of Neuroscience, University of Turin Medical 
      School, Turin, Italy.
FAU - Vollert, Jan
AU  - Vollert J
AUID- ORCID: 0000-0003-0733-5201
AD  - Pain Research, Department of Surgery and Cancer, Imperial College London, London, 
      United Kingdom.
AD  - Division of Neurological Pain Research and Therapy, Department of Neurology, 
      University Hospital of Schleswig-Holstein, Campus Kiel, Kiel, Germany.
AD  - Department of Anaesthesiology, Intensive Care and Pain Medicine, University 
      Hospital Muenster, Muenster, Germany.
AD  - Neurophysiology, Mannheim Center of Translational Neuroscience (MCTN), Medical 
      Faculty Mannheim, Heidelberg University, Heidelberg, Germany.
FAU - Al Sultani, Husam
AU  - Al Sultani H
AUID- ORCID: 0000-0003-0444-7566
AD  - Nerve and Muscle Center of Texas, Houston, TX, United States.
FAU - Benedetti, Fabrizio
AU  - Benedetti F
AUID- ORCID: 0000-0003-4057-1150
AD  - Rita Levi Montalcini Department of Neuroscience, University of Turin Medical 
      School, Turin, Italy.
AD  - Medicine and Physiology of Hypoxia, Plateau Rosa, Switzerland.
FAU - Shaibani, Aziz
AU  - Shaibani A
AUID- ORCID: 0000-0001-9828-0861
AD  - Nerve and Muscle Center of Texas, Houston, TX, United States.
AD  - Baylor College of Medicine, Houston, TX, United States.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
PT  - Systematic Review
DEP - 20230802
PL  - United States
TA  - Pain
JT  - Pain
JID - 7508686
SB  - IM
MH  - Humans
MH  - Nocebo Effect
MH  - *Diabetic Neuropathies/drug therapy
MH  - Placebo Effect
MH  - Pain Measurement
MH  - *Diabetes Mellitus
EDAT- 2023/08/02 13:09
MHDA- 2023/12/17 09:44
CRDT- 2023/08/02 10:13
PHST- 2022/10/05 00:00 [received]
PHST- 2023/06/08 00:00 [accepted]
PHST- 2023/12/17 09:44 [medline]
PHST- 2023/08/02 13:09 [pubmed]
PHST- 2023/08/02 10:13 [entrez]
AID - 00006396-990000000-00369 [pii]
AID - 10.1097/j.pain.0000000000003000 [doi]
PST - ppublish
SO  - Pain. 2024 Jan 1;165(1):29-43. doi: 10.1097/j.pain.0000000000003000. Epub 2023 
      Aug 2.