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. While in China, Ukraine, Russia and the CIS countries, Cerebrolysin continues to be used for ischemic stroke, Alzheimer's and dementia, traumatic brain injuries. But, as practice shows, every year less and less, because the effectiveness of the remedy has not been proven.

What is Cerebrolysin and what are its indications for use

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

  • increase the efficiency of aerobic metabolism of the brain, improve intracellular protein synthesis in the aging and developing brain;
  • a positive effect 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.

The manufacturer recommends the use of Cerebrolysin for the treatment of Alzheimer's disease, dementia, ischemic stroke, mental retardation in children, disorders that are associated with a child's attention deficit, and with chronic cerebrovascular insufficiency.

Why is the effectiveness of the drug in doubt

A drug, if we are not talking about generics, goes a long way: from a molecule in a laboratory 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.

The result was:

  • in all six studies, the addition of Cerebrolysin had no or little effect on the risk of death from stroke;
  • in 4 studies, the drug did not practically change the number of patients with undesirable serious consequences - disability, death, prolonged hospital stay;
  • 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 had more serious adverse effects than subjects taking placebo.

Trials 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.

Despite Cerebrolysin's unproven efficacy, there is 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 who have been prescribed this medicine by doctors.

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.

Sources
  1. Wikipedia. – Cerebrolysin.
  2. Portal “Look”. – How to prepare and fence in different countries, but are available in Ukraine.
  3. NeuroNews Journal: Psychoneurology and Neuropsychiatry. – Cerebrolysin in the treatment of vascular dementia.
  4. Vidal Medicines Handbook. - Cerebrolysin® (Cerebrolysin®) instructions for use. ​​
  5. Cochrane Library website. – Cerebrolysin in acute ischemic stroke.
  6. Information and service portal “Indicator”. – How they treat us: Cerebrolysin. Where did they put the pig?
  7. Alzheimer's Drug Discovery Foundation. – Cerebrolysin.