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Effects of cerebrolysin on functional outcome of patients with traumatic brain injury: a systematic review and meta-analysis

https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6311329

 

We ran this systematic review and meta-analysis to assess the efficacy of the cerebrolysin treatment on functional outcome of patients with TBI. The results of the current study demonstrate that intravenous administration of cerebrolysin after TBI is associated with improved functional recovery in patients with different grades of the TBI (mild to severe). The functional outcome in the included studies was GOS and mRS and other indices, such as cognitive functions and memory could not be included in the pooled analysis due to lack of homogeneity and availability.

 

The study demonstrates large heterogeneity in the performed studies and reported outcomes. Also, lack of standard clinical trials decreases the level of evidence for this therapy in patients with TBI. The efficacy and safety of cerebrolysin for management of TBI has been tested in several animal studies with favorable results.^19^^–^^22

 

However, the clinical studies are scarce on the subject and the literature only includes limited number of standard studies addressing the effectiveness of the cerebrolysin on functional recovery after various grades of TBI.^23^^–^^25^,^^29^,^^30^,^^32 The studies are mostly prospective or retrospective cohorts and only limited randomized clinical trials are available.^27^,^^31 Currently, a large multicenter, placebo-controlled, randomized clinical trial is underway to address the subject but the results are not available yet.^33

 

The heterogeneity in the clinical studies could be classified in several fields. First, the inclusion criteria for the patients with TBI vary between these studies. While some authors have included only patients with severe TBI,^32 other included moderate and severe TBI patients^23^,^^29^^–^^31 and Chen et al^27 studied only mild TBI patients. These heterogeneous inclusion criteria led to limited power of analysis because the management and outcome of patients depend on the severity of TBI. The baseline GCS has been demonstrated to be the most important predictor of functional outcome in patients with TBI.^34

 

Thus, cerebrolysin could have various effects on the outcome of patients with different grades of TBI. The other factor contributing to heterogeneity of the studies is the dosage and duration of the treatment. Some studies administered the cerebrolysin in 10 mL/day dosage^23^,^^31^,^^32 while other used the 20–30 mL/day dosages.^27^,^^29 The highest dosage (50 mL/day) was given by Wong et al.^30 The duration also varied between 5 and 30 days.

 

As cerebrolysin is a newly investigated medication, the appropriate dosage and duration should be elucidated according to the pharmacokinetics and the clinical studies.^15^,^^25 The current treatment regimens are mainly based on the regimens that are given to the patients with ischemic stroke,^16^,^^18 Alzheimer’s,^35 and Parkinson’s disease.^36 König et al^25 also reported the beneficial effects of cerebrolysin given at the dosage of 50 mL/day for 21 days in patients with various grades of TBI measured by serial GCS and cognitive tests. Thus, the standard treatment protocol for TBI should be established based on the ongoing research.

 

The Cerebrolysin Asian Pacific Trial in Acute Brain Injury and Neurorecovery, which is underway, is using a 50 mg/day dosage over a 10-day period.^33 And finally, the outcome measures of functional recovery are heterogeneous between the studies. Most of the studies report the GOS, GOSE, and mRS^24^,^^29^^–^^32 while Chen et al^27 reported Mini-Mental State Examination (MMSE), and Cognitive Abilities Screening Instrument (CASI). This is due the fact that patients with mild TBI were included and GOS and mRS have limited value in evaluating the functional recovery in these patients.

 

Thus, cognitive measurement outcomes, such as MMSE and CASI should be included. In addition, some other studies used the EEG findings to determine the effects of cerebrolysin on outcome in patients with mild TBI.^23^,^^24 These variations reduced the number of studies that could be included in the meta-analysis, although there was heterogeneity between the studies. The findings of subgroup analyses indicated that heterogeneity between included studies had no significant effects on the outcome measures before and after subgroup analysis. Furthermore, all the studies, which were not included, demonstrated that cerebrolysin therapy is associated with improved functional, cognitive, and electrical outcomes in patients with mild, moderate, and severe TBI.

 

The neuroprotective and neuroregenerative properties of the cerebrolysin have increased its use in different neurologic and neurosurgical conditions. Recently, Hassanein et al^37 demonstrated that cerebrolysin administration dramatically improved the communication defects of the neonates with severe perinatal brain insults.

 

These results along with those previously reported on effectiveness of cerebrolysin on regeneration of injured nerves^38 suggest that the proposed treatment could be used along with stem cell therapies to induce neuroregeneration. The horizons of neural therapy with stem cell and regenerative medicine could be established by use of cerebrolysin. Most recently, Zhang et al^20 reported the results of a prospective, randomized, placebo-controlled study of cerebrolysin dose-dependent effects in animal model of mild TBI. They demonstrated that administration of cerebrolysin at doses of 0.8–7.5 mL/kg, administered 4 hours after mild TBI and then once daily for a total of 10 consecutive days, improved functional outcomes 3 months after injury.^20 In a similar study, Sharma et al^19 investigated the beneficial effects of cerebrolysin therapy on pathophysiological aspects of TBI.

 

They demonstrated that administration of cerebrolysin 5 minutes or 1 hour after TBI reduced blood–brain barrier and blood–cerebrospinal fluid barriers permeability changes, attenuated brain pathology and brain edema, and mitigated functional deficits. However, administration of cerebrolysin 2 hours after the injury had no beneficial effects. These findings suggest timely intervention with cerebrolysin to achieve appropriate functional outcome.^19 Taking all these together, it could be concluded that timely and dose-dependent effects of cerebrolysin should be considered in designing trials in TBI. The results of the current meta-analysis also confirm the efficacy of the cerebrolysin therapy in improving the functional outcome of patients with various grades of TBI.

 

Intravenous cerebrolysin administration has been associated with improved functional recovery after TBI as measured by mRS and GOS. There is a significant heterogeneity in dosage and duration of therapy as well as interval between the injury and treatment application, which limits the effect analysis. In addition, the various grades of TBI (mild, moderate, and severe) seem to benefit from cerebrolysin therapy after the injury with regard to the functional outcome indices. The lack of standard and high quality randomized clinical trials limits the clinical application and final conclusion on the efficacy of cerebrolysin in patients with TBI and the level of evidence remains low in results. Based on the results of the current study, intravenous could be recommended for treatment of patients with different grades of TBI with level II of evidence. More randomized clinical trials are recommended to elucidate the issue.

​

Beneficial effect of cerebrolysin on moderate and severe head injury patients: result of a cohort study https://pubmed.ncbi.nlm.nih.gov/16463821

 

Cerebrolysin is used as a neurotrophic agent for the treatment of ischemic stroke and Alzheimer's Disease. Exploratory studies in patients with post-acute traumatic brain injury have shown that this treatment might help improve recovery. Aim of this study was to investigate whether addition of Cerebrolysin to the initial treatment regimen of moderate and severe head injury patients would improve their outcome.

 

At 6 months, 67% of the patients (Cerebrolysin group) attained good outcome (GOS 3-5). The study group was compared with the historical cohort of patients from the hospital trauma data bank, with age, sex and admitting GCS matching. More patients tended to a good outcome in the Cerebrolysin group (P = 0.065). No significant side-effect requiring cessation of Cerebrolysin was noted. It can be concluded that the use of Cerebrolysin as part of the initial management of moderate and severe head injury is safe and well tolerated. The results suggest that Cerebrolysin is beneficial in regard to the outcome in these patients, especially in elderly patients.

https://nootriment.com/cerebrolysin-side-effects

NOOTROPIC DRUG

Brain Health, Cognitive Function, Memory

Anytime a new nootropic hits the market, there are always courageous early adopters who are the first to try it for cognitive enhancement purposes. This is certainly the case with Cerebrolysin – a nootropic that is still unknown to many members of the brain hacking community.

 

Cerebrolysin is reported to have incredible potential for improving brainpower and synaptic plasticity while preventing neurodegeneration due to aging. It is considered a promising treatment of Alzheimer’s and is observed to promote neurogenesis in key areas of the brain related to memory storage.

 

But many are cautious about trying such a novel nootropic without having a clear idea of the potential for long-term side effects as well as short-term adverse reactions. Cerebrolysin is believed to be highly safe, but there have been some Cerebrolysin side effects recorded and it is important that you observe all relevant precautions for usage.

 

HOW IT WORKS:

May decrease beta amyloid in the brain

Promotes neuron health & plasticity

May improve short-term memory

DOSAGE:

Between 5 - 30 mL per day

SAFETY:

Insufficient Research

 

Cerebrolysin is a neuropeptide that is used in several countries around the world to treat neurodegenerative disorders such as senile dementia, Alzheimer’s, cerebral contusions, concussions and other forms of brain trauma.

 

As a neuropeptide, it is thought to help neurons communicate with each other while offering neuroprotective as well as neurotrophic benefits.

 

The primary effect of this substance is that it stimulates the development and growth of neurons which can improve the memory and learning capacity of the brain while also delaying signs of aging. It has undergone extensive testing internationally, though its use in North America is limited.

 

Cerebrolysin is a Nootropic compound produced using purified swine brain proteins. It should be emphasized that this is a natural supplement and it is produced through a safe enzymatic process to ensure pharmaceutical grade quality.

 

However, it is not vegetarian and the only currently available form is through an injection. For this reason, it may not appeal to everyone and there seems to be greater apprehension about the possibility of side effects.

 

Why Use Cerebrolysin

Before discussing the safety of this drug, let’s first look at the reasons for using it as a cognitive enhancer or in the treatment of dementia and Alzheimer’s disease.

 

It appears to be most effective in the treatment of vascular dementia, which is caused by damage to the network of blood vessels supplying the brain.

 

This is good news since there is no current treatment for vascular dementia. This drug is said to improve concentration, memory processing, and mood in vascular dementia patients.

 

Cerebrolysin is also observed to decrease levels of amyloid build-up in the brain. Amyloids are plaque accumulations within brain tissue and are linked as a possible cause of Alzheimer’s. When too much amyloid builds up in the brain, an individual is likely to suffer from impairments in cognitive function as well as declining memory capacity.

 

cerebrolysin safetyCerebrolysin has been found to control and reduce the level of this plaque progression, therefore slowing down the overall progression of the disease.

 

In fact, the main therapeutic reason for prescribing Cerebrolysin is to slow down the development of Alzheimer’s or dementia when it is first recognized.

 

There is also some evidence to suggest that healthy people with no cognitive impairments may benefit from using this supplement. Cerebrolysin injections can increase the rate of neurogenesis in the brain, causing the development of new nerve cells and networks of neurons.

 

This seems to be very critical in the hippocampus area of the brain, where researchers think memory encoding occurs. If you are able to increase the number of hippocampal neurons, it is theorized that you can achieve better memory retention as well as synaptic plasticity.

 

These improvements in long-term memory formation and learning capacity are possible both for individuals with dementia as well as normal adults or students who are not experiencing memory deficits at present.

 

The effects of Cerebrolysin also carry over to facets of fluid intelligence and other cognitive abilities; in studies on dementia patients, giving daily dosages of Cerebrolysin resulted in better mathematical reasoning as well as improved short-term memory recall.

 

Cerebrolysin Side Effects:

cerebrolysin side effectWith all the positives listed above, are there any reasons to be wary of using Cerebrolysin dosages? Although research is ongoing, this supplement does appear to have an excellent safety record.

 

There have not been any notable toxicity or safety concerns including any drug interactions or contraindications. No instances of Cerebrolysin overdose have been reported and this nootropic is believed safe for daily long-term use; however, in most cases Cerebrolysin is administered for a 2 – 3 week period and users are suggested to take an equal length break between usages.

 

There have been some mild Cerebrolysin side effects observed which include headaches, dizziness, and fatigue. In rare instances, it has led to feelings of agitation, restlessness, difficulty falling asleep, and aggression.

 

More serious (but extremely rare) side effects including hyperventilation, hypertension, depression, tremors, and vomiting were reported in one study. In other rare cases, it has been known to lead to stomach discomfort, vomiting, nausea, sensations of heat, increased perspiration and lightheadedness.

 

Contraindications for Cerebrolysin use include hypersensitivity to the active ingredient, Epilepsy and renal failure. While animal studies have not found it to cause birth defects when given to pregnant mother, it is still not recommended for use by pregnant women or nursing mothers. It is also not recommended for people who have kidney issues or are taking anti-depressants or MAO-inhibitors.

 

Using Cerebrolysin:

One of the main limiting factors about Cerebrolysin at this point in time is the fact that it is only available in an injection. Oral formulations of Cerebrolysin are believed to be ineffective due to the way this compound is processed by the digestive system.

 

The best method for taking this drug under the care of a physician or qualified medical professional. It must be injected either into a vein or directly into a muscle (not a very pleasant procedure). If you intend to use this nootropic, the generally accepted method is to use one 5 ml ampule each day for a period of five to ten consecutive days.

 

Following this, take an equally long break from usage and then begin again for up to three or four cycles. The cyclical dosage administration may help to reduce the risk of Cerebrolysin side effects while allowing your body time to adjust and reset its natural balances

 

 

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