Cerebrolysin: effective or dangerous

Thousands of new medicines appear in the world every year. Some remain forever “on guard” of human health, the second, without proving their effectiveness and importance, cease to be produced, and the third continue to be used, despite the fact that the therapeutic effect of their use is very controversial. The last group of drugs includes Cerebrolysin, which is not included in the WHO recommendations for the treatment of any disease, is not approved by the FDA and the European Medicines Agency. In the United States, Canada, Great Britain, Israel and most European countries, its use is prohibited and even punishable by law. ^[1]. While in China, Ukraine, Russia and the CIS countries, Cerebrolysin continues to be used for ischemic stroke, Alzheimer’s disease and dementia, traumatic brain injuries ^[2]. But, as practice shows, every year less and less, because the effectiveness of the remedy has not been proven.

What is the drug Cerebrolysin and what are its indications for use

Cerebrolysin is a biological preparation produced by the enzymatic purification of pig brain proteins. It consists of 80% low molecular weight peptides and 20% free amino acids. ^[3]. The agent penetrates the blood-brain barrier, directly entering the nerve cells. According to the instructions for the drug, Cerebrolysin has several pharmacological actions:

• increasing the efficiency of aerobic metabolism of the brain, improving intracellular protein synthesis in the aging and developing brain;
• positive impact on the processes of memorization in violation of cognitive function;
• protecting neurons from lactic acidosis, preventing the formation of free radicals, reducing the neurotoxic effect of excitatory amino acids;
• prevention of neuronal death during hypoxia and ischemia ^[4].

The manufacturer recommends the use of Cerebrolysin for the treatment of Alzheimer’s disease, dementia syndrome, ischemic stroke, mental retardation in children, disorders that are associated with a child’s attention deficit, as well as chronic cerebrovascular insufficiency. ^[4].

Why is the effectiveness of the remedy in doubt

A drug, if we are not talking about generics, goes a long way: from a molecule in a laboratory test tube to a drug. Every stage is important, from development to market launch. Cerebrolysin belongs to the original drugs, therefore, after its creation, clinical trials were carried out without fail, which were supposed to confirm the effectiveness of the drug. Only under this condition is it possible to register a medicinal product.

However, recent studies do not confirm the effectiveness of the drug in diseases and conditions of the body specified in the instructions.

According to the Cochrane Library, the most authoritative source of information in the field of evidence-based medicine, there have been seven studies on the effects of Cerebrolysin administration in ischemic stroke. They involved 1601 patients from hospitals in ten different countries. The effect of the drug was considered during the first two days after a stroke. In the complex, patients were also prescribed drugs to dissolve and prevent blood clots. The second group received placebo therapy. The studies lasted from 28 to 90 days.

As a result, it was determined:

• in all six studies, Cerebrolysin supplementation had no or little effect on the risk of death from stroke;
• in 4 studies, the drug practically did not change the number of patients with undesirable serious consequences – disability, death, long stay in the hospital;
• three studies confirmed a non-significant change in the number of deaths.

Four more studies involving 1435 people showed that patients in the Cerebrolysin group experienced more serious adverse effects than subjects taking placebo ^[5].

Tests were also carried out in the group of patients with vascular dementia. The number of participants in the six studies was 597. The results obtained are not positive. The authors of the trial argue that the positive effect of the drug is possible only in those patients whose symptoms are mild or moderate. ^[6].

Despite the unproven efficacy of Cerebrolysin, there is some good news in all of this. A meta-analysis confirmed the safety of using the drug for three years with temporary side effects including weight loss, dizziness, headache, agitation, anxiety and a feeling of heat without a change in body temperature. This information may reassure those to whom doctors have prescribed this medicine. ^[7].

Currently, the drug is not banned in Ukraine, Russia and the CIS countries, but given its high cost and low efficiency, the prospects for the disappearance of Cerebrolysin from the pharmaceutical market are high.

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