Anti-depressant medication improves motor function in stroke patients
A recent study named “Fluoxetine in Motor Recovery of Patients with Acute Ischemic Stroke (FLAME)” was published online last January. The study reported that stroke subjects who take the antidepressant medication fluoxetine after experiencing an ischemic stroke have a more improved mobility. It also reported that the stroke subjects receiving fluoxetine are more independent with their activities of daily living (ADL) compared with stroke victims who received placebo. Researchers of the clinical study are suggesting that fluoxetine, a selective serotonin reuptake inhibitor (SSRI), could signify a new approach to treating stroke patients.
Fluoxetine (also known by the tradenames Prozac, Sarafem, Fontex, among others) is an antidepressant of the selective serotonin reuptake inhibitor (SSRI) class used to treat depression obsessive-compulsive behavior, a number of eating disorders and panic attacks. SSRIs are the most commonly prescribed antidepressant medication. SSRIs are relatively safe and generally cause fewer side effects than any other type of antidepressant. They work by blocking the reabsorption or the reuptake of the neurotransmitter serotonin increasing its levels in the brain. This increase seems to help brain cells send and receive chemical messages which in turn boosts a person’s moods. They are called selective because they only affect serotonin and not the other neurotransmitters in the brain. Side effects of SSRIs may include:
- Nausea
- Dry mouth
- Headache
- Diarrhea
- Nervousness, agitation or restlessness
- Reduced sexual desire or difficulty reaching orgasm
- Inability to maintain an erection (erectile dysfunction)
- Rash
- Increased sweating
- Weight gain
- Drowsiness
- Insomnia
About the study
Dr. François Chollet, MD, the study’s lead author, a professor of neurology at the Toulouse University Hospital in France said that their team thinks that fluoxetine encourages an increase in the brain’s capacity to reorganize – it acts by helping in rewiring the brain. He added that using fluoxetine is like opening another capacity, another target and another pathway for treating patients who had experienced a stroke.
Currently, ischemic stroke patient are being treated with tissue plasminogen activator (tPA), a thrombolytic drug approved by the US Food and Drug Administration. Dr. Chollet’s team hopes that, in the near future, fluoxetine or other SSRIs can also be a treatment option for these stroke patients. However, Dr. Chollet said that before that can take place several questions must be answered first. He said that the researchers need to determine the length of time for optimal treatment; they also need to find out the long-term effects of the treatment on stroke patients; and what are the other possible effects on neuronal activity in general.
The participants of the study
118 subjects 5-10 days after ischemic stroke were randomized from 9 stroke centers in France. These stroke victims were between 18 and 85 years old and either had hemiplegia (paralysis on either the left or right side of the body) or hemiparesis (weakness on either the left or right side of the body) which are the most common deficits caused by a stroke, with a Fugl-Meyer motor scale of 55 or less. Patients with severe post stroke disabilities (NIHSS score > 20), clinically diagnosed with depression (MADRS > 19), pregnant or with other major diseases were excluded from the study.
Results: Fluoxetine vs. placebo
All of the stroke patients were randomly assigned into 2 groups of 59 members. One group was given 20 milligrams of fluoxetine while the other group was only given a placebo. The researchers started to administer fluoxetine or placebo 5-10 days after the onset of the stroke and they continued for a total of 3 months. All of the stroke victims were given standard post-stroke care and they also underwent physical rehab from physical therapists (PT) who were instructed to use conventional therapy according to the protocol of their medical centers. The PTs were also made to assess the motor functions of all the stroke victims starting from day 0 (the baseline), after 30 days and then 90 days after starting the program.
The result of the study shows that the group treated with fluoxetine recorded a 40% improvement on the Fugl-Meyer motor scale as compared to the placebo group (34 points in the fluoxetine group vs. 24.3 in the placebo group).
Fugl-Meyer Motor Assessment (FMA) is a clinical examination performed to assess the upper extremity and lower extremity motor and sensory impairments in post stroke patients. FMA is being increasingly being used for clinical assessment of motor recovery after a stroke. In a recent clinical trial from July 2011, FMA was used to evaluate safety and efficacy on motor recovery of NeuroAiD in 150 Caucasian subjects after stroke. Subjects on NeuroAiD achieved 27% higher recovery on their motor function as compared to the placebo group. Click here to learn more about the Fugl-Meyer Assessment after a stroke.
Limitations of the study
Although the results of this study shows the positive effect of fluoxetine in motor recovery on post ischemic stroke patients, we should not forget that there are some limitations to it. First, the number of patients included was small (118), also they were selected for motor deficit and do not represent the general population of stroke patients. Second, the treatment was performed for 90 days and it is not well known how the motor recovery evolves over time after the treatment has stopped. Third, a potential random error derived from the statistical analysis cannot be ignored, although this probability is remote (the change in FMA score at day 90 had a statistical relevance of p= 0.003, in other words, the odds that it is an error is 3 in 1000).
Benefits and side effects of SSRIs
Fluoxetine is relatively inexpensive and is commonly available. Fluoxetine, is not a new drug so its side effects are well known, generally mild and very infrequent. Other SSRIs aside from fluoxetine may have the same positive effects, as shown by a study published in 2010 which showed patients who are taking escitalopram (another type of SSRI) had a marked improvement in cognition, particularly memory, compared to patients who were given a placebo.
Depression post-stroke
It is not unusual for post-stroke patient to experience depressive symptoms especially if they have disabilities arising from the stroke. Dr. Chollet‘s team noted that the placebo group had a higher number of stroke patients having significant deficits (7%) compared with the fluoxetine group (5%), there were more depressed stroke patients in the placebo. Approximately 30%-50% of post-stroke patients develop some form of depression and fluoxetine could serve as both mood and motor recovery enhancer. This in turn is a welcome combination of benefits to post-stroke patients.
Fluoxetine was given to the stroke patients as soon as possible after their stroke and that there was no “stroke window” during which it must have been delivered. On the contrary, tPAs must be given within 3.5 hours after the onset of the stroke symptoms because of the risk for bleeding. The earlier fluoxetine is administered, the better for the stroke patient. Dr. Chollet added that what healthcare providers know about the natural history of stroke is that patients recover mainly during the first three months. This period is the time where stroke patients experience the biggest improvements. However, it is still not clear what the optimal duration of treatment is. The long-term effects of fluoxetine and possible other benefits on neurologic functions of this new possible treatment for stroke patients needs to be elucidated.
References
Medscape.com
Nlm.nih.gov
Mayoclinic.com
Medicine.mcgill.ca
Lowering body temperature in acute ischemic stroke
When our body is being besieged by disease-causing microorganisms or any unforeseen event, our body’s normal response is to maintain its homeostasis. Usually, the human body’s normal response to these events is to raise its core temperature. This action results to a person exhibiting hyperthermia (a fever). According to the U.S. National Library of Medicine, a fever is a temporary increase in the body’s temperature in response to a disease or an illness.
When you are or somebody you know is having a fever, your immediate action is controlling the increase in the body’s temperature. This may be done by taking medications, taking a shower or a sponge bath or just relaxing in a cool and restful environment.
Nowadays, cooling the body for therapeutic purposes (therapeutic hypothermia) is being incorporated into other medical purposes and not just only for controlling a fever. A good example is during surgery. Induced hypothermia is being employed to save vital organs when patient go under the knife.
Lately, it is being used during procedures involving the heart as well as the brains. Scientific studies had proven the benefits of lowering the body’s temperature when treating ischemic cerebrovascular diseases. This practice had been applied within the last decade especially during the clinical management of acute stroke.
Some people may disagree with induced hypothermia being employed during instances of acute ischemic stroke. They would argue that lowering the body’s temperature would be more harmful since it causes the constriction of the blood vessels. They would claim that blood flow to the brain is already diminished because of the blockage caused by the stroke. And inducing hypothermia would make the blood flow to the brain more diminished. They would vouch for increasing the body’s core temperature. They would say that this would be more beneficial to the stroke patient since the blood vessels become more dilated thus, increasing blood flow to the brain.
History
Induced hypothermia had been used as early as the 17th century BC. Its use was first described in the Edwin Smith Surgical Papyrus. The Edwin Smith Surgical Papyrus is one of the oldest of all known medical documents.
During the 1930s, Dr. Temple Fay, an American neurosurgeon applied this technology in treating neurological diseases. It was then used in cardiac arrest victims during cardiac bypass surgery during the 1950s. Induced hypotension was then applied to intracranial aneurysm surgery to create a bloodless operation for better handling of delicate brain tissues. Fifty years later, it is now being used by medical practitioners as an effective brain-protecting agent for out-of-hospital cardiac arrest patients. Today, induced hypothermia is the only treatment which has been proven to protect brain cells during global ischemia such as heart attacks. These benefits gained from induced hypothermia have created interest in the application such technology as a brain-protector in acute ischemic strokes.
Lowering the body’s temperature
Therapeutic hypothermia is deliberately causing a controlled reduction of a patient’s core temperature below 36°C. It may either be classified as mild therapeutic hypothermia (34°C – 35.9°C), moderate (32°C – 33.9°C), moderate/deep (30°C – 31.9°C), or deep (< 30°C).
The aftermath of an ischemic event is different levels of tissue damage. The end result of which is cellular death. The same is true for brain tissues. This is most evident during instances of ischemic strokes where brain cells are subjected to diminished blood flow. Brain cells eventually die because of decreased blood flow to brain tissues.
Past studies of induced hypothermia on animal subjects had shown positive results. These studies had shown that inflammatory responses of the body were inhibited when body temperature is lowered. Such results are beneficial in the application of the technology to stroke patients. These had shown that hypothermia works against cellular injury by inhibiting swelling of brain cells after an acute stroke.
Different methods
There are several ways of inducing therapeutic hypothermia. Lowering the body’s temperature can be induced by cooling the surface, the core (intravascular) and other selective methods. Note that induced hypothermia should be performed in a health center under the supervision of a health professional.
Among the 3, surface cooling is the most noninvasive, least expensive and is the easiest to implement. However, there may be fluctuations in body temperature and a longer time is needed to achieve the desired temperature. Surface cooling methods include the use of air, volatile liquids, cold water and/or ice as media for the transfer of heat.
Intravascular cooling is done by administering ice-cold fluids, inserting intravascular catheters with electronic feedback temperature control, using devices which irrigates the peritoneum (the lining of the abdominal cavity) and extracorporeal (occurring outside the body) circulation. These methods require a shorter amount of time to reach desired temperatures. Also, achieving desired temperatures are more precisely controlled.
Lately, the interest in selective cooling methods is increasing most notably in the field of stroke. Proponents of therapeutic hypothermia are studying the benefits of using selective therapeutic hypothermia to counter the effects of an ischemic stroke. They had devised a cooling helmet for inducing hypothermia. They found out that stroke patients undergoing selective hypothermia had a lower brain temperature compared with other stroke patients.
Advocates of selective cooling say that there are no complications when using a cooling helmet compared with whole body hypothermia. They also vouched for using a cooling helmet during emergency situations. They said that it was safe for implementation by emergency medical services (EMS).
Disadvantages of induced hypothermia
Induced hypothermia also has its share of disadvantages. The most common type is shivering but it can be controlled. Methods of controlling shivering include re-warming the patient and using medications.
Another drawback to such technology is the frequent electrolyte shifting while inducing hypothermia. Important electrolytes (sodium, potassium, calcium, etc.) can move from the within the cells and into the blood and vice versa while the body’s temperature is decreasing. This shifting action may cause a decrease in the amount of needed electrolytes within the cells of the body.
Heart rate and cardiac output (the volume of blood pumped by the heart per minute) are also decreased when a person experiences mild to moderate hypothermia. However, such action is negated by the fact that the body slows down its normal metabolic rate when experiencing cold temperature. This normal response of the body helps in conserving oxygen levels in the blood.
Lastly, a person may also acquire pneumonia. It is the most common infectious complication when a person experiences cold temperatures. Acquiring the disease depends on the duration and the degree of hypothermia.
Hypothermia and stroke
During the late 1990s, the Copenhagen Stroke Study Registry ascertained that there is a direct relationship between body temperature and stroke. When stroke patients are admitted after experiencing an acute stroke, they found out that for every 1°C increase in the body’s temperature, there is also an increase in risk of having a poor outcome.
This data was used as a starting point for the research of inducing hypothermia in stroke patients in 2000. The second study determined that patients who had an acute stroke and underwent induced hypothermia did not have poor outcomes, the incidence of death was decreased and had a lower incidence of complications brought about by infection. They reached these results after inducing hypothermia on acute stroke patients within 12 hours of the onset of the symptoms of stroke. They did note that the most common uncomfortable event was shivering which was controlled using medication.
These outcomes resulted in an increase in interest in lowering the body’s temperature in other stroke patients. The results of these later studies also yielded favorable outcomes.
Currently, there is an increasing body of data which espouses the induction of hypothermia on acute stroke patients. However, there had been no large-scale study proving the effectiveness of such technology on acute stroke. Still, lowering the body’s temperature remains a mode of treatment for stroke. Additional studies are still needed to determine the optimal time to induce hypothermia for best results. And when that happens, this technology will eventually alter the pattern of acute stroke management in clinical practice.
Reference:
Medscape.com
NeuroAiD survey report
At Moleac we are well aware that medicine is for the people, and people is what we care for. NeuroAiD has been and continues to be tested clinically for its safety and efficacy on a variety of conditions. The results continue to be published in peer-reviewed medical journals.
We did not want to stop there, we want to hear more from our own customers about their experience, that is why we continuously survey our customers and monitor their progress. We thought such a survey would help answer the frequent question “what are my chances and risk with NeuroAiD?” Here below are the result of a survey conducted in 2010 on patients who purchased NeuroAiD for at least 1 month (inclusive) of treatment between January 1st 2009 and February 28th, 2010. Customers were emailed an on-line questionnaire in three different languages (English, French and Spanish). We received 144 answers which are the basis for the chart below. We are currently conducting a survey of all customers who purchased NeuroAiD in 2011 and results will be published by the second quarter of 2012.
Here are the results of our last customer survey on patients who purchased NeuroAiD and we would love to share these insights with you.
Tolerance to NeuroAiD
NeuroAiD is a natural product and has no known drug interactions. Several studies have proven the safety profile of NeuroAiD. Our customer report support the findings in these clinical studies: 90% of patients report no side effect when taking NeuroAiD.
Side effects reported are mild and usually in the form of digestive discomfort (due to the high herbal concentration), allergy or headache.
Efficacy of NeuroAiD
There are many factors that can affect the outcome of NeuroAiD treatment. These factors include age of the patient, the diverse nature of strokes and the different degree of rehabilitation intensity and effort to which patients are exposed. Therefore the observed improvement when taking NeuroAiD varies from patient to patient. Nevertheless, we are happy to see that 70% of patients experience improvement when taking NeuroAiD.
The reported efficacy tends to be better in patients who suffered a stroke more recently. Furthermore, 68% of the respondents experienced a better recovery in motor functions and 52% experienced a noticeable improvement in aphasia.
The take home message
We are glad to see that the reported tolerability and efficacy are in consonance with published clinical studies. The reasons why most patients respond positively to the treatment is because NeuroAiD have shown to trigger multiple mechanisms enhancing the brain’s own capability to recover after an injury, a process called neuroplasticity (you can learn more about it here). However we would like to stress that NeuroAiD is not a miracle cure, in any given treatment there is a percentage of patients that does not respond well or does not respond at all. The reasons for this vary greatly from patient to patient. Some of the factors affecting the outcome of the treatment may be the own and unique genetic background of the patient, the age of the patient, how long after stroke NeuroAiD treatment started, the severity and type of stroke, other concomitant diseases, rehabilitation routine, etc. We are happy to see that about 70% of customers have reported improvement but we also empathize that 30% have not benefited from the NeuroAiD treatment.
NeuroAiD helps stroke recovery by providing a good environment for the growth of new neurons in the brain and it is especially effective when combined with rehabilitation exercises. Clinical studies have indicated that NeuroAiD acts as a booster in stroke recovery.
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