Duration of Symptom Relief Between Injections for AbobotulinumtoxinA (Dysport®) in Spastic Paresis and Cervical Dystonia: Comparison of Evidence From Clinical Studies

A pathophysiologic relationship between allergic rhinitis and rhinosinusitis and asthma has long been suggested. However, few clinical studies of acupuncture have been conducted on these comorbid conditions. A 48-year-old male suffering from persistent allergic rhinitis with comorbid chronic rhinosinusitis and asthma since the age of 18 years was studied. He complained of nasal obstruction, sneezing, cough, rhinorrhea and moderate dyspnea. He occasionally visited local ear-nose-throat clinics for his nasal symptoms, but gained only periodic symptom relief. The patient was treated with acupuncture, infrared radiation to the face and electro-acupuncture. Needles were inserted at bilateral LI20, GV23, LI4 and EX-1 sites with De-qi. Electro-acupuncture was performed simultaneously at both LI20 sites and additional traditional Korean acupuncture treatments were performed. Each session lasted for 10 min and the sessions were carried out twice a week for 5 weeks. The patient’s Mini-Rhinoconjunctivitis Quality-of-Life Questionnaire score decreased from 38, at the beginning of treatment, to 23, 3 weeks after the last treatment. The Total Nasal Symptom Score was reduced from six (baseline) to five, 3 weeks after the last treatment. There was significant clinical improvement in the forced expiratory volume in 1 s—from 3.01 to 3.50 l—with discontinuation of the inhaled corticosteroid, and no asthma-related complaints were reported. Further clinical studies investigating the effectiveness of acupuncture for the patients suffering from allergic rhinitis and/or rhinosinusitis with comorbid asthma are needed.

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Sustained functional benefits after a single set of injections with abobotulinumtoxinA using a 2-mL injection volume in adults with cervical dystonia: 12-week results from a randomized, double-blind, placebo-controlled phase 3b study

PLoS ONE ◽

10.1371/journal.pone.0245827 ◽

2021 ◽

Vol 16 (2) ◽

pp. e0245827

Author(s):

Atul T. Patel ◽

Mark F. Lew ◽

Khashayar Dashtipour ◽

Stuart Isaacson ◽

Robert A. Hauser ◽

...

Keyword(s):

Cervical Dystonia ◽

Rating Scale ◽

Symptom Relief ◽

Placebo Treatment ◽

Subscale Score ◽

Spasmodic Torticollis ◽

Double Blind ◽

Injection Volume ◽

Patient Reported ◽

Single Set

Cervical dystonia (CD) is primarily treated with botulinum toxin, at intervals of ≥ 12 weeks. We present efficacy, patient-reported outcomes (PROs), and safety in adults with CD at the last available visit after a single set of abobotulinumtoxinA (aboBoNT-A) injections versus placebo using 500 U in a 2-mL injection volume. In this 12-week, randomized, double-blind trial, patients were ≥ 18 years of age with primary idiopathic CD, had a Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) total score ≥ 20, and TWSTRS-Severity subscale score > 10 at baseline. Patients (N = 134) were randomized (2:1) to aboBoNT-A (n = 89) or placebo (n = 45), with aboBoNT-A patients treated with 500 units (U) if toxin-naïve, and 250 to 500 U based on previous onabotulinumtoxinA dose if non-naïve. Endpoints included total TWSTRS, Pain Numeric Rating Scale (NRS-Pain; 24-hour), Treatment Satisfaction Questionnaire for Medication, and other PROs for pain, depression, and global health. Results are for the intent-to-treat population, with “Week 12” (Wk12) comprising the last available post-baseline assessment (end-of-study or early withdrawal). Mean TWSTRS total scores improved from 42.5 at baseline to 35.4 at Wk12 with aboBoNT-A and 42.4 to 40.4 with placebo (treatment difference: –4.8; 95% confidence interval [CI]: –8.5, –1.1; p = 0.011). At Wk12, mean (95% CI) change from baseline in NRS-Pain was –1.0 (–1.59, –0.45) for aboBoNT-A and –0.2 (–0.96, 0.65) for placebo. AboBoNT-A demonstrated numeric improvements in other PROs. More aboBoNT-A–treated patients than patients receiving placebo reported being at least “somewhat satisfied” with treatment (60.4% vs 42.2%, respectively), symptom relief (57.0% vs 40.0%), and time for treatment to work (55.8% vs 33.3%). No new adverse events were reported. Results indicate that in patients with CD, treatment with aboBoNT-A using a 2-mL injection provided sustained improvement in the TWSTRS total score and patient-perceived benefits up to 12 weeks. Trial registration: Clinicaltrials.gov Identified: NCT01753310.

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