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Foods provide us with nutrition and are fuels for our daily activities and movements. This includes thinking and such mental activities as well.  Foods have varying amounts of carbohydrates, proteins, fats, vitamins, minerals, and trace metals. These are basic components of food and should be in right proportions in daily diet for health and prevention of diseases. Diseases result from shortage of food, excess of food, as well as deficiency and excess of any of the above components of food.  Also, read Ways of eating idlis  Humans learned to cook food after fire was made using stones. They also use sun for drying and fermenting of foods. Some vegetables and fruits are eaten raw such as in form of salads. Spices were discovered and cultivated and humans started using them in their foods to enhance flavour, taste, and aroma of foods.  Foods are cereals, pulses, vegetables, oils and fats, fruits, nuts etc. These can be made into different dishes by combining or alone. M...

CERVICAL DYSTONIA-Causes, symptoms, signs, treatment, and newer trials!

 Phase 3 clinical trials of injectable DaxibotulinumtoxinA for cases of cervical dystonia were on as ASPEN-1 study. The results are heartening and it has met all the primary and secondary endpoints outlined in the study, Revance Therapeutics has revealed.

Injectable daxibotulinumtoxinA for cervical dystonia

The said drug in an injection form has been found to decrease the frequency of cervical dystonia attacks by up to 50% annually, the company stated in a news release.

The trial investigator Joseph Jankovic, MD, professor of neurology, Baylor College of Medicine, Houston, Texas said:

"I was delighted to see both the degree and duration of relief that DaxibotulinumtoxinA for Injection provided trial subjects in ASPEN-1,"

DaxibotulinumA (DAXI) for cervical dystonia [Source: Science Direct]


He continued:

"Currently, most patients with cervical dystonia visit their physician 3 to 4 times a year for injections, which places a heavy burden on patients' time and schedule. Often, the treatment effect wears off between injections, significantly impacting the quality of their work and personal lives,"

"If a treatment could offer a longer duration of effect, thus requiring fewer trips each year for reinjection, I imagine patients would find this quite beneficial,"

The ASPEN-1 study

In the study, 301 patients with cervical dystonia from 60 clinical places in the USA, Canada, and Europe were enrolled. It was a double-blind, randomized, placebo-controlled, parallel-group study.

The participants received either a single injection of 125 or 250 units of daxibotulinumtoxinA or of a placebo. They were chosen randomly for it and were followed up for at least 36 weeks.

The findings found that patients who received daxibotulinumtoxinA had a significant improvement in the symptoms and signs of cervical dystonia. This improvement was noticeable by around 4-6 weeks after the treatment and persisted. The improvement from baseline on the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) was clinically meaningful.

ASPEN-1 TRIAL [Source: Health Science Center Jacksonville University]

Click to read on face mask and severity of COVID-19-The relation! 

The useful effect persisted for 24 weeks with the lower dose and 20.3 weeks with the higher dose of medicine.

Clinical Global Impression of Change (CGIC) and Patients' Global Impression of Change (PGIC) scales were used as two secondary endpoints and at 4 and 6 weeks, these showed a significant improvement compared to placebo.

DaxibotulinumtoxinA in this trial was found to be safe and with benefits lasting for up to 36 weeks. No serious treatment-related adverse events were encountered. The most common treatment-related adverse events were pain and erythema at the site of injection and a transient headache. Muscle weakness and dysphagia were rare.

The result of the company’s ASPEN-OLS phase 3, open-label, long-term safety trial would be available in 2021.

What is cervical dystonia?

Cervical dystonia is a painful condition that causes the head to twist in different directions. It is also called spasmodic torticollis. These involuntary head movements might be chin to shoulders (common), ear to shoulders, chin straight up, or chin straight down. There might be a combination of these movements in one patient. Sometimes, jerking head movements are also seen. Neck pain radiating into the shoulders or headaches are also felt. The severity would vary from mild to disabling.

Cervical dystonia [Source: Pacific NeuroScience Institute]

The cause is unknown but family history is elicited in some. Past history of injuries in the area or stress is found. It is seen in 40-60 years of age and more common in women. Clinical examination suffices for diagnosis but some blood tests and MRI may be needed to rule out other conditions. There is no cure but spontaneous regressions are known. Recurrences are also seen. Botulinum toxin and some oral medicines help. Tricks such as touching the opposite side of the face or back of head sometimes stop the dystonia temporarily. Hot fomentation and massages might help in relaxation and exercises to strengthen local muscles might have some benefit. Stress management is also of use. Deep brain stimulation and some other surgical methods also assist in the control of dystonia. Support groups also help in reducing the feeling of isolation and depression.

 

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