Why divorce should be easy!

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Couples come together for a common purpose. They bear children and start parenting them. But at times, they may grow apart and not want to remain a couple. They may want to separate. But society and law often prevents this separation. Because they feel that children might get affected due to the separation. Hence, law has made divorce difficult and asks couples the reason for the separation. They need to show some fault in the partner in order to get legal separation. But this only opens another Pandora's box in which false accusations and blame game begins. This is unhealthy and stressful not only for the couple but also for their children. Divorce of their parents does affect children. It can lead to stress and academic struggles in them. They might suffer severe mental stress and demonstrate behaviour changes in them. They may have anxiety, depression, feeling of guilt and shame and sadness. This may affect them in school and their social circle. They could become an object of r...
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CERVICAL DYSTONIA-Causes, symptoms, signs, treatment, and newer trials!

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 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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