Vitamin B1, also known as thiamine, is a metabolic enzyme that supports the central nervous system and the levels of energy in the body. In 2021, a scientific report published in Nature revealed that thiamine interacts with receptors that stimulate dopamine transmission in specific areas of the brain. Through the modulation of the dopaminergic system, may thiamine have a beneficial role in Parkinson’s disease, as well?
What is Parkinson’s?
Parkinson’s is a disorder that induces the progressive death (neurodegeneration) of the neurons in a specific region of the brain (striatum). These neurons produce dopamine, a neurotransmitter that controls movement, emotions, stress resistance, learning, and memory. The unknown cause of Parkinson’s and its progressive and complex nature make it extremely hard to treat.
So far, the disease has been treated with levodopa, a molecule that replaces the loss of dopamine in the brain, a typical feature of Parkinson’s.
Unfortunately, this molecule loses efficacy over time and is unable to stop the disease progression, which, in turn, may cause severe motor dysfunction and cognitive impairment.
That is why the interest of many PD patients is focusing on a different therapeutic approach that can address the discomfort of the disease in a more natural way and without the side effects of the current levodopa therapy, which, after many years, can also cause further complications such as psychosis and dyskinesia.
The Vitamin B1 Treatment
The effects of Vitamin B1 for Parkinson’s were tested for the first time in 2012 by a research team guided by Professor Antonio Costantini (see the image), neurologist at the Department of Neurological Rehabilitation, Villa Immacolata Clinic, in Viterbo, Italy.
Professor Costantini treated PD patients with high doses of vitamin B1 through intramuscular injection. After careful follow-up, the treatment, administered to 50 patients who took levodopa, showed significant improvement in motor function and in the action of the drug traditionally used to manage the symptoms of Parkinson’s.
The study of Professor Costantini’s team was then published in 2015 in The Journal of Alternative and Complementary Medicine. But another study published in CNS Neuroscience & Therapeutic, in 2013, and conducted by a team from the Vietnamese American Medical Research Foundation, Westminster, CA, USA, demonstrated the beneficial role of thiamine to restore the motor abilities that are dramatically suppressed with Parkinson’s. In the clinical trial, three patients got back their normal motor function and stopped taking levodopa.
Ever since, further studies have been conducted on rats, but aside from the open studies of Professor Costantini (without placebos), nobody else has ever verified the efficacy of vitamin B1 on humans affected by Parkinson’s disease. Why?
And, above all, why was this protocol forgotten, and didn’t give rise to randomized controlled trials with a placebo?
Vitamin B1 for Parkinson’s. What Experts Say
“Despite the positive feedback, our research projects on vitamin B1 were not among those that were funded,” said Dr. Roberto Fancellu, neurologist at IRCCS of San Martino Hospital in Genoa, former collaborator and heir of Professor Antonio Costantini, who died from COVID-19 in 2020.
“However,” Dr. Fancellu continued, “we didn’t give up and are still looking for financial supporters. Furthermore, with the same passion as Professor Costantini, we have continued to visit Parkinson’s patients and prescribe vitamin B1, if necessary.”
The lack of funding has also been confirmed by Professor Giovanni Abruzzese, neurologist and professor at the Department of Neuroscience of Genoa University, who, at the time, was mistakenly considered the heir of Costantini.
“Only a randomized/controlled clinical trial Vs a placebo can validate the results of a treatment, but the randomized/controlled protocol is quite expensive. For this reason, the coordinator of the study requested the Italian Ministry of Health to fund it. Unfortunately, the funds were never granted. Hence, the study was not activated for the lack of financial support,” Professor Giovanni Abruzzese said.
The latter also explained the benefits of vitamin B1 for Parkinson’s patients.
“There are modest benefits of the vitamin B1 treatment, such as protection of dopaminergic neurons and oxidative stress, backed by some studies in PD subjects with vitamin B1 deficiency, but, aside from the studies of Professor Costantini, there is no scientific evidence of these benefits, and the treatment has never been validated by the international scientific community. Moreover, vitamin B1 deficiency does not cause Parkinson’s. The causes of the disease are still the subject of scientific debate and are likely multiple. The main cause is the accumulation of the alpha-synuclein protein, modified by genetic or inflammatory factors (there are also theories regarding the role of changes in the gut microbiome). B1 deficiency may make dopaminergic neurons more susceptible to degeneration induced by other causes. Therefore, supplementing B1 in those with a deficiency may partially protect them. However, as mentioned, this hypothesis has not been scientifically confirmed,” Professor Abruzzese affirmed.
“If scientific evidence means a statistically significant effect emerging from a double-blind, randomized, placebo-controlled pharmacological trial, I can only agree with this hypothesis. However, I can also firmly support the fact that, based on data from our open-label trials on large groups of patients and from real-world observations, the effects of vitamin B1 on Parkinson’s disease symptoms are clear and long-lasting. Many patients continue with this therapy for a long time without clinical worsening and without having to increase their treatment with traditional dopaminergic drugs. Obviously, in today’s treatment landscape and in the absence of an official validation, the vitamin B1 treatment must be considered a supplement for Parkinson’s and not a substitute for levodopa,” Dr. Fancellu added.
Besides the missing funds, there could be other reasons for the abandonment of this therapy.
Why Was The Vitamin B1 Protocol For Parkinson’s Abandoned?
One of the reasons for the abandonment of the vitamin B1 therapy could be the death of Professor Antonio Costantini in 2020. According to the EU regulation n. 536/2014, in fact, clinical trials on humans must be conducted by a doctor who must have the role of principal researcher. Moreover, a clinical trial on humans must have four phases. Phase 1 can be conducted on a restricted number of patients (from 20 to 80), phase 2 must be conducted on a larger number of patients (100-300), and it is preferable to do that with a placebo (inactive substance), to verify if the effects really depend on the treatment and not on suggestion. Phase 3 must be conducted on 1000-3000 patients through a random administration of the treatment to verify any side effects. Phase 4, instead, is finalized to compare all the benefits and adverse effects that emerge in the same study.
In this case, the principal researcher was Professor Antonio Costantini, who started the first stage of the study a decade ago and died before starting the second one.
Another reason could be the fact that the scenery of medical research for Parkinson’s has profoundly changed by now, because the favor (and support) of the scientific community is directed to other therapies, such as gene therapy and stem cells.
Conclusion
The hope of PD patients is obviously that the Vitamin B1 Protocol clinical trials are completed, to know if this treatment is an opportunity or an illusion.
Studies report that Parkinson’s is on the rise, due to aging and pollution, and that the new cases could double by 2050, affecting nearly 25 million people. Currently, the affected people are over 10 million.
Furthermore, a study of 2021 found that subjects with advanced symptoms of Parkinson’s disease also have vitamin B1 deficiency, and this finding could contain a grain of truth on the use and benefits of thiamine for this neurological disorder.
“The goal of our work is to demonstrate the efficacy and safety of thiamine in the treatment of Parkinson’s disease. Currently, available data show that thiamine has a symptomatic effect. With the double-blind trial, we aim to confirm these effects and evaluate, if possible, a neuroprotective effect in further studies, which was also the idea proposed by Antonio Costantini,” Dr. Roberto Fancellu concluded.
Only the completion of the missing study with a placebo will be able to provide the answers that millions of Parkinson’s patients in the world are waiting for. Otherwise, the risk is that the Vitamin B1 Protocol remains a forgotten therapy with no possibility of being effectively tested.
Photocredits:
ConsumerLab.com
Neuro Challenge Foundation for Parkinson’s
Highdosethiamine.org
