Pyritinol was first developed by Merck Laboratories, an American pharmaceutical company. Its synthesis involved binding of two Vitamin B6 molecules. Its clinical use began in the 1970s after a series of clinical trials, and it was mainly used to treat patients with conditions like stroke and Alzheimer's while its use as a nootropic agent (as a dietary supplement within the U.S. ) started in the 1990s. A number of European nations have approved the use of Pyritinol as a therapy for chronic brain conditions (like dementia), learning disorders, rheumatoid arthritis, and to boost memory. Some of the countries that have approved the use of Pyritinol for treatment are Germany, Austria, Greece, France, Portugal, and Italy. France has only approved the use of Pyritinol for the treatment of rheumatoid arthritis.
Pyritinol is a very popular nootropic agent, and it ranks among the top nootropic agents currently available in the market regarding popularity. Within the EU alone, approximately 100,000 people used Pyritinol in the last five years. In various countries, Pyritinol is available as an over the counter supplement/substance. Over the years, Pyritinol has been expansively studied both scientifically and clinically. These studies gave positive results showing Pyritinol can have clinical uses as well as nootropic uses. However, the clinical studies conducted are not sufficient and as such are questionable since they only used small sample sizes that may not have been adequately representative of the general population. A sizeable amount of literature on Pyritinol is also published although much of it was published in the 1980s.
A key benefit of Pyritinol that was noticed in the 1960s is its ability to improve or restore glucose transfer/transport across the blood-brain barrier as well as boost the utilization of glucose by brain cells to generate more energy. In a double-blind study conducted by Hoyer and colleagues, 87 individuals with different brain disorders were evaluated. The study was also placebo controlled. The researchers measured the cerebral metabolic rate, oxygen uptake, cerebral blood flow, and glucose uptake in the patients. In 27 patients (among the 45 patients administered with Pyritinol) who had disturbed glucose uptake or cerebral energy metabolism, after receiving Pyritinol treatment, their cerebral uptake of glucose that was almost half of normal capacity increased and attained normal levels. The other conditions were also observed to improve in a similar manner to that observed for disturbed glucose metabolism.
A multicentre, double-blind clinical trial was performed aiming to contrast the effectiveness and tolerance of Pyritinol and Auranofin when used to treat rheumatoid arthritis. The study that lasted for one year involved the administration of 600mg of Pyritinol or 6mg of Auranofin to patients suffering from rheumatoid arthritis on a daily basis. The changes in the patients were ranked based on a defined enhancement that used joint swelling index, Ritchie index, functional index, rating scales for general well being and pain, ESR, and morning stiffness. The initial evaluable patients under Pyritinol treatment were 139, but 61 left the study after they began showing response failure or adverse events compared to 44 patients out of the initial 142 patients under Auronofin treatment. The efficacy of the parameters under study was noted to improve more in patients under Pyritinol treatment compared to those under Auranofin treatment after the 1-year long treatment. The differences noted in general wellbeing were P=0.022, ESR were P=0.029, and for hemoglobin were P=0.0042. In the Pyritinol treated patients, the response rate was at 78% (61/78 patients), and this was higher than 59 % (58/98 patients with P=0.009) response in Auranofin treated ones. To confirm this results, an intention to treat analysis was used to verify this outcome (p=0.030). Among the Pyritinol patients, 64% had adverse events compared to 58% in Auranofin patients. The key negative effects recorded included mucocutaneous symptoms at 64% in Pyritinol patients and 58% in Auranofin patients and gastrointestinal illnesses at 36% in Pyritinol patients and 23% in Auranofin patients.
In another double-blind clinical study that was placebo-controlled, researchers evaluated the effects of Pyritinol on dementia. The 40 individuals involved in the study had moderately advanced dementia, and they were assigned on a random basis to either Pyritinol treatment at doses of 800 mg every day or an identical placebo treatment with both therapies lasting for 3 months. Evaluations on the patients were conducted before Pyritinol treatment commenced and every month for the three months of the study with a follow-up of six months. Pyritinol treated patients exhibited significantly higher levels of enhancements compared to the placebo-treated patients.
A clinical trial was conducted to examine the therapeutic effects of Pyritinol when used to treat patients suffering from senile dementia of the Alzheimer's type (SDAT) and multi-infarct dementia (MID). The clinical trial started with screening of 183 inpatients, and 164 patients were selected for the study although only 156 completed this clinical study. Hachinski Ischemic Score, electroencephalographic (EGG), and computed tomography scans results were used to assign the patients to the senile dementia of SDAT or MID. The study involved a double-blind therapy session lasting 12 weeks with either 200mg Pyritinol or placebo administered thrice in a day. These results were confirmed using the Syndrom Kurz Test/Short Cognitive Performance Test (the total scores recorded), the Sandoz Clinical Assessment Geriatric Scale (considered the cognitive factor disturbances), and the Clinical Global Impression (considered item 2). The study also examined data collected on tolerance, responder analysis, and on EGG brain mapping according to descriptive statistics. The confirmatory analysis verified the therapeutic efficiency of Pyritinol since in all the three variables; Pyritinol was significantly superior to the placebo. The results were clinically emphasized by an in-depth analysis of the descriptive variables and by the linkages noted at the various observation levels. According to the EGG mapping, there was significant variation between Pyritinol and the placebo with Pyritinol decreasing slowly and rapidly boosting alpha and beta activity and these results in enhanced vigilance. The results from this particular trial show that Pyritinol has positive therapeutic effects in individuals suffering from mild to moderate dementia (in both degenerative and vascular etiology) that are superior to placebo.
An animal-based study showed increased acetylcholine concentrations within the brain of "old" rats after undergoing Pyritinol therapy. The old rats were treated 2-3 weeks, and Pyritinol was observed to boost the levels of endogenous acetylcholine within the striatum and the cortex although no increases were observed in the hippocampus. When old rats were pretreated with Pyritinol, the resting release increased as well as the in vitro K+ stimulated discharge of radioactive Ach by the brain cells.
In another clinical trial, researchers evaluated the effects of Pyritinol on functional impairments in patients suffering from organic mental disorders. The placebo-controlled and randomized double-blind study examined the effects of Pyritinol in 120 gastric patients who had been diagnosed with functional cerebral disorders (moderate to severe chronic brain syndrome). The results of the study revealed that Pyritinol had statistically significant therapeutic effects in the patients compared to the placebo in the two levels of symptomatology and performance that were employed in this particular study. Additionally, Pyritinol did not cause any significant adverse drug reactions that were not also noted in the individuals treated with the placebo. Pyritinol was exceptionally superior in the factor "social behavior" of the SCAG Although improvements were observed in both groups.
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