Studies on high-dose vitamin B1 in other health conditions

A. Inflammatory bowel disease
2021
Palle Bager, Christian Lodberg Hvas, Charlotte Lock Rud, Jens Frederik Dahlerup, Randomised clinical trial: high-dose oral thiamine versus placebo for chronic fatigue in patients with quiescent inflammatory bowel disease, Aliment Pharmacol Ther. 2021 Jan;53(1):79-86
(40 patients, high dose oral thiamine)

This study was carried out to investigate the effect and safety of high-dose oral thiamine on chronic fatigue in patients with inflammatory bowel disease (IBD).

We comment on this study, although it is not related directly to Parkinson’s Disease (PD), because its findings with their important implications go well beyond the treatment of fatigue in IBD. They lend further support to the use and beneficial effects of high-dose thiamine and confirm the effect of a vitamin used at pharmacological doses as a medicine rather than a supplement.

First, unlike previous case reports on high dose thiamine, this was a randomised, double-blinded, placebo-controlled crossover trial (RCT). It is the first time that we see the gold standard of research being used for high-dose thiamine (B1) therapy (HDT). Previous published papers were case reports or open-label studies, for which the issue of the lack of a control group (and therefore the "placebo effect") could be raised. Bager's study, instead, had a placebo control group to evaluate the effects of treatment.

Second, the study was conducted in a new site, in Denmark, unlike previous case reports on fatigue in IBD and clinical experience with B1 therapy in PD, which mostly came from the same Italian site.

Third, the protocol used in the study followed Dr Costantini’s protocol for the same condition, with thiamine doses based on gender and weight, as published in Costantini’s paper in 2013.

Fourth, participants were swapped from one group (thiamine or placebo) to the other group after 4 weeks of receiving either thiamine or placebo, and after a 4-week wash-out period (cross-over approach). This meant that all participants in the study were exposed to both high-dose thiamine and placebo, respectively, during the study. This method adds weight to the study.

Fifth, the study was conducted in 40 patients.

Sixth, the results confirmed the effectiveness of the use of high-dose thiamine: a mean reduction of 4.5 points in fatigue after thiamine was detected compared with a mean increase of 0.75 point after placebo, as measured by the Inflammatory Bowel Disease-Fatigue Questionnaire. An improvement in ≥ 3 points occurred in a high percentage of participants when they were on thiamine compared to when they were on placebo.

Seventh, treatment was well tolerated, with only mild side effects reported during the study period.

Bager, referring to Dr Costantini’s and Dr Fancellu’s hypothesis, concludes that “the theory of a dysfunction in thiamine transport from blood to mitochondria remains a plausible explanation.”

In conclusion, two observations are worth making, as they go beyond the issue of treating fatigue in IBD.

- The first observation is that thiamine treatment at high doses, based on Dr Costantini’s protocol, was confirmed to be highly effective by an RCT, as previously reported by Dr Costantini for this and other conditions.

- Next, thiamine at high doses was well tolerated during the period of the trial.

Obviously, more studies are needed to confirm HDT, specifically in PD, but we hope that this study will stimulate more interest in B1 therapy, opening new avenues for potential donors to fund an RCT on B1 therapy in PD.


2013
Costantini A., Pala M.I., Thiamine and fatigue in inflammatory bowel diseases: an open-label pilot study, J Altern Complement Med. 2013 Aug;19(8):704-8
(8 patients with ulcerative colitis, 4 patients with Crohn's disease; high dose oral thiamine)

B. Fibromyalgia
2013
Costantini A, M.I. Pala, S. Tundo, P. Matteucci, High-dose thiamine improves the symptoms of fibromyalgia, BMJ Case Rep 2013.
(3 patients)

C. Spinocerebellar ataxia type 2
2013
Costantini, M.I. Pala, M. Colangeli, S. Savelli, Thiamine and spinocerebellar ataxia type 2, BMJ Case Rep 2013
(1 patient, high dose intramuscular thiamine)

D. Friedreich ataxia
2013
Antonio Costantini 1, Rafaela Giorgi, Sonia D'Agostino, Maria Immacolata Pala, High-dose thiamine improves the symptoms of Friedreich's ataxia, BMJ Case Rep. 2013 May 22;2013:bcr2013009424
(2 patients, high dose intramuscular thiamine)


2016
Costantini A, Laureti T, Pala MI, Colangeli M, Cavalieri S, Elisa Pozzi, Alfredo Brusco, Sandro Salvarani, Carlo Serrati, Roberto Fancellu, Long-term treatment with thiamine as possible medical therapy for Friedreich ataxia. J Neurol. 2016, 263(11): 2170-2178.
(34 patients, high dose intramuscular thiamine)

E. Hashimoto’s Thyroiditis
2013
Costantini and M.I. Pala, Thiamine and Hashimoto’s Thyroiditis: A Report of Three Cases, J Altern Complement Med. 2014, Mar;20(3):208-11
(3 patients, high dose oral or parenteral thiamine)

F. Multiple sclerosis
2013
Costantini 1, A. Nappo, M.I. Pala, A. Zappone, High dose thiamine improves fatigue in multiple sclerosis, BMJ Case Rep. 2013 Jul 16; 2013:bcr2013009144
(15 patients, high dose oral or intramuscular thiamine)

G. Stroke
2014
A. Costantini, M.I. Pala, M.L. Catalano, C. Notarangelo, and P. Careddu, High-Dose Thiamine Improves Fatigue After Stroke: A Report of Three Cases, J Altern Complement Med. 2014 Sep;20(9):683-5
(3 patients, high dose oral or intramuscular thiamine)

H. Dystonia
2016, Dystonia Type 16
A. Costantini, E. Trevi, M.I. Pala, and Roberto Fancellu, Thiamine and dystonia 16, BMJ Case Rep. 2016, Jul 22 doi: 10.1136/bcr-2016-216721;
(3 patients, high dose oral thiamine)

2018, Dystonia Type 1
A. Costantini, M.I. Pala, E. Trevi, S. Maurini, S. Vecchietti, R. Fancellu, Thiamine Therapy for Dystonia Type 1, ARC Journal of Neuroscience Volume 3, Issue 1 2018, PP 1-4
(2 patients, high dose intramuscular thiamine)

I. Essential tremor
2018
A. Costantini, High-dose thiamine and essential tremor, BMJ Case Rep 2018
(2 patients)

J. Chronic cluster headache
2018
A. Costantini, M. Tiberi, G. Zarletti, M.I. Pala, E. Trevi, Oral high-dose thiamine improves the symptoms of chronic cluster headache. Case Reports in Neurological Medicine. 2018, Article ID 3901619.
(1 patient, high dose oral thiamine)
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Text author: Sergio Pièche
Page updated - 24/04/23