Ethical considerations in the treatment of multiple sclerosis fatigue

被引:6
作者
Nourbakhsh, Bardia [1 ]
Waubant, Emmanuelle [2 ]
Evers, Andrea W. M. [3 ]
Solomon, Andrew J. [4 ]
机构
[1] Johns Hopkins Univ, Dept Neurol, Baltimore, MD 21218 USA
[2] Univ Calif San Francisco, Dept Neurol, San Francisco, CA 94143 USA
[3] Leiden Univ, Inst Psychol, Dept Hlth Med & Neuropsychol, Leiden, Netherlands
[4] Univ Vermont, Dept Neurol Sci, Larner Coll Med, Burlington, VT USA
关键词
QUALITY-OF-LIFE; RANDOMIZED CONTROLLED-TRIAL; DOUBLE-BLIND; PHYSICAL-ACTIVITY; CLINICAL-TRIALS; PLACEBO; EXERCISE; DEPRESSION; EFFICACY; SAFETY;
D O I
10.1016/j.msard.2021.103129
中图分类号
R74 [神经病学与精神病学];
学科分类号
摘要
Fatigue is the most common symptom and a leading cause of disability multiple sclerosis (MS). Despite the lack of evidence, several medications are frequently prescribed by physicians to ameliorate fatigue in patients with MS. However, a recent study demonstrated that improvement in fatigue severity with these medications appears to be due to placebo effect and is also is associated with more frequent adverse events than the placebo. These findings raise ethical concerns surrounding the initiation and discontinuation of these treatments for fatigue in MS. Starting these medications for the treatment of MS fatigue for their placebo effect may not be justified. However, stopping the medications in patients who report symptomatic benefits and have no side effects may also not be ethical. In MS care non-pharmacological approaches for fatigue treatment, such as exercise and cognitive behavioral therapy, should now be prioritized. Novel study designs may be necessary to address placebo response in future clinical trials evaluating interventions for fatigue in MS.
引用
收藏
页数:3
相关论文
共 39 条
[1]   Quality of life in multiple sclerosis: the impact of depression, fatigue and disability [J].
Amato, MP ;
Ponziani, G ;
Rossi, F ;
Liedl, CL ;
Stefanile, C ;
Rossi, L .
MULTIPLE SCLEROSIS JOURNAL, 2001, 7 (05) :340-344
[2]   The relationship between subjective fatigue and cognitive fatigue in advanced multiple sclerosis [J].
Bailey, A. ;
Channon, S. ;
Beaumont, J. G. .
MULTIPLE SCLEROSIS JOURNAL, 2007, 13 (01) :73-80
[3]   The opposite effects of the opiate antagonist naloxone and the cholecystokinin antagonist proglumide on placebo analgesia [J].
Benedetti, F .
PAIN, 1996, 64 (03) :535-543
[4]   THE LIE THAT HEALS - THE ETHICS OF GIVING PLACEBOS [J].
BRODY, H .
ANNALS OF INTERNAL MEDICINE, 1982, 97 (01) :112-118
[5]   Open-label placebo treatment in chronic low back pain: a randomized controlled trial [J].
Carvalho, Claudia ;
Caetano, Joaquim Machado ;
Cunha, Lidia ;
Rebouta, Paula ;
Kaptchuk, Ted J. ;
Kirsch, Irving .
PAIN, 2016, 157 (12) :2766-2772
[6]   Safety and efficacy of MD1003 (high-dose biotin) in patients with progressive multiple sclerosis (SPI2): a randomised, double-blind, placebo-controlled, phase 3 trial [J].
Cree, Bruce A. C. ;
Cutter, Gary ;
Wolinsky, Jerry S. ;
Freedman, Mark S. ;
Comi, Giancarlo ;
Giovannoni, Gavin ;
Hartung, Hans-Peter ;
Arnold, Douglas ;
Kuhle, Jens ;
Block, Valerie ;
Munschauer, Frederick E. ;
Sedel, Frederic ;
Lublin, Fred D. .
LANCET NEUROLOGY, 2020, 19 (12) :988-997
[7]   The placebo effect in Parkinson's disease [J].
de la Fuente-Fernández-, R ;
Stoessl, AJ .
TRENDS IN NEUROSCIENCES, 2002, 25 (06) :302-306
[8]   Association of Central Hypersomnia and Fatigue in Patients With Multiple Sclerosis A Polysomnographic Study [J].
Dubessy, Anne-Laure ;
du Montcel, Sophie Tezenas ;
Viala, Frederique ;
Assouad, Rana ;
Tiberge, Michel ;
Papeix, Caroline ;
Lubetzki, Catherine ;
Clanet, Michel ;
Arnulf, Isabelle ;
Stankoff, Bruno .
NEUROLOGY, 2021, 97 (01) :E23-E33
[9]   Implications of Placebo and Nocebo Effects for Clinical Practice: Expert Consensus [J].
Evers, Andrea W. M. ;
Colloca, Luana ;
Blease, Charlotte ;
Annoni, Marco ;
Atlas, Lauren Y. ;
Benedetti, Fabrizio ;
Bingel, Ulrike ;
Buechel, Christian ;
Carvalho, Claudia ;
Colagiuri, Ben ;
Crum, Alia J. ;
Enck, Paul ;
Gaab, Jens ;
Geers, Andrew L. ;
Howick, Jeremy ;
Jensen, Karin B. ;
Kirsch, Irving ;
Meissner, Karin ;
Napadow, Vitaly ;
Peerdeman, Kaya J. ;
Raz, Amir ;
Rief, Winfried ;
Vase, Lene ;
Wager, Tor D. ;
Wampold, Bruce E. ;
Weimer, Katja ;
Wiech, Katja ;
Kaptchuk, Ted J. ;
Klinger, Regine ;
Kelley, John M. .
PSYCHOTHERAPY AND PSYCHOSOMATICS, 2018, 87 (04) :204-210
[10]   The double-blind variable placebo lead-in period: Results from two antidepressant clinical trials [J].
Faries, DE ;
Heiligenstein, JH ;
Tollefson, GD ;
Potter, WZ .
JOURNAL OF CLINICAL PSYCHOPHARMACOLOGY, 2001, 21 (06) :561-568