PMID- 31525626
OWN - NLM
STAT- MEDLINE
DCOM- 20200519
LR  - 20200519
IS  - 2211-0356 (Electronic)
IS  - 2211-0348 (Linking)
VI  - 36
DP  - 2019 Nov
TI  - Nocebo in multiple sclerosis trials: A meta-analysis on oral and newer injectable 
      disease-modifying treatments.
PG  - 101389
LID - S2211-0348(19)30369-4 [pii]
LID - 10.1016/j.msard.2019.101389 [doi]
AB  - BACKGROUND: Nocebo phenomena are linked to decreased adherence to treatments in 
      clinical practice as well as difficulty in assessing the adverse effect profile 
      in clinical trials. OBJECTIVE: To estimate the incidence and severity of nocebo 
      responses in clinical trials of oral and newer injectable disease-modifying 
      treatments (DMTs) for relapsing multiple sclerosis (MS). METHODS: Meta-analysis 
      of the incidence of nocebo responses was performed by pooling the percentage of 
      placebo-treated patients that exhibited adverse events (AEs) in randomized, 
      placebo-controlled MS trials published between 2005 and 2018. Nocebo severity was 
      estimated as a percentage of placebo-treated patients who discontinued the 
      treatment due to drug-related AEs. RESULTS: The pooled incidence of nocebo was 
      89% (95% CI: 88%-90%) in trials for oral DMTs (cladribine, fingolimod, 
      teriflunomide and dimethyl fumarate) and 66% (95% CI: 51%-80%) in trials of newer 
      injectable DMTs (biosimilar glatiramer acetate 20 mg, innovator glatiramer 
      acetate 40 mg and pegylated interferon beta). The pooled nocebo severity was 8% 
      (95% CI: 5%-12%) for oral treatments and 2% (95% CI: 0-2%) for newer injectable 
      DMTs. CONCLUSIONS: Oral DMTs may be associated with a higher incidence and 
      greater nocebo severity than newer injectables.
CI  - Copyright (c) 2019 Elsevier B.V. All rights reserved.
FAU - Gklinos, Panagiotis
AU  - Gklinos P
AD  - First Neurology Department, Aeginition Hospital, Medical School, National and 
      Kapodistrian University of Athens, 74 V. Sofia's Avenue, Athens 11528, Greece.
FAU - Papadopoulos, Dimitrios
AU  - Papadopoulos D
AD  - Neurology Clinic, Athens Medical Center-Paleo Phaliro Clinic, Athens, Greece.
FAU - Mitsikostas, Dimos D
AU  - Mitsikostas DD
AD  - First Neurology Department, Aeginition Hospital, Medical School, National and 
      Kapodistrian University of Athens, 74 V. Sofia's Avenue, Athens 11528, Greece. 
      Electronic address: dmitsikostas@med.uoa.gr.
LA  - eng
PT  - Journal Article
PT  - Meta-Analysis
DEP - 20190909
PL  - Netherlands
TA  - Mult Scler Relat Disord
JT  - Multiple sclerosis and related disorders
JID - 101580247
RN  - 0 (Immunologic Factors)
RN  - 0 (Placebos)
SB  - IM
MH  - Clinical Trials as Topic/*statistics & numerical data
MH  - Humans
MH  - Immunologic Factors/administration & dosage/*pharmacology
MH  - Multiple Sclerosis/*drug therapy
MH  - *Nocebo Effect
MH  - Outcome Assessment, Health Care/*statistics & numerical data
MH  - Placebos/administration & dosage/*pharmacology
OTO - NOTNLM
OT  - Clinical trials
OT  - Disease-modifying treatments (DMTs)
OT  - Meta-analysis
OT  - Multiple sclerosis
OT  - Nocebo
OT  - Placebo
EDAT- 2019/09/17 06:00
MHDA- 2020/05/20 06:00
CRDT- 2019/09/17 06:00
PHST- 2019/05/31 00:00 [received]
PHST- 2019/07/31 00:00 [revised]
PHST- 2019/09/07 00:00 [accepted]
PHST- 2019/09/17 06:00 [pubmed]
PHST- 2020/05/20 06:00 [medline]
PHST- 2019/09/17 06:00 [entrez]
AID - S2211-0348(19)30369-4 [pii]
AID - 10.1016/j.msard.2019.101389 [doi]
PST - ppublish
SO  - Mult Scler Relat Disord. 2019 Nov;36:101389. doi: 10.1016/j.msard.2019.101389. 
      Epub 2019 Sep 9.