Evidence-Based Review of Patient-Reported Outcomes With Botulinum Toxin Type A

Abstract

This review systematically examines the effects of botulinum toxin type A (BTX-A) on patient-reported outcomes across disorders using evidence-based criteria. The evidence provided by these studies ranged from randomized, controlled trials to case series. The effects of BTX-A on quality of life or global treatment outcomes were assessed in 48 studies across 16 different conditions. All but 7 of these reported benefits of BTX-A over baseline or the comparator condition (placebo or other treatment). The effects of BTX-A on impairment, activities, or participation were assessed in 46 studies across 17 different conditions. All but 4 reported benefits of BTX-A over baseline or the comparison group. The effects of BTX-A on satisfaction or preference were assessed in 14 studies across 11 different conditions, all of which reported high rates of satisfaction with BTX-A or preference over the comparator. These studies provide evidence that BTX-A exerts meaningful benefits on the quality of life of patients treated with this biologic agent.

Relationship between various clinical outcome assessments in patients with blepharospasm

“…There has been a growing interest in assessing and demonstrating improved quality of life as a primary or secondary endpoint in clinical trials 28, 29. However, a limited number of publications specifically address this issue in blepharospasm patients 19, 23, 26, 27, 30–33. Muller et al reported that blepharospasm patients scored significantly worse on measures of health‐related quality of life and were more depressed than an age‐matched community sample 23.…”

Real-World, Long-Term Quality of Life Following Therapeutic OnabotulinumtoxinA Treatment

“…1 These conditions represent a group of disorders that result in muscle spasm, pain, and excessive sweating and may be associated with both physical and/or emotional disability that adversely impacts a patient's quality of life (QoL). 2 Over the past few decades, onabotulinumtoxinA injections have become an integral part of the therapeutic armamentarium for these disorders. The efficacy and safety of onabotulinumtoxinA has been established in numerous randomized, placebo-controlled trials for more than 20 years, and although many studies have demonstrated the efficacy of onabotulinumtoxinA using standardized clinical outcome measures, there is a paucity of data on QoL as reported by the patient, particularly within the Canadian population.…”

“…Regulatory bodies, reimbursement agencies, and third-party payers are ever more recognizing the need for patient-reported QoL data because clinical measures do not necessarily translate into real-world, meaningful functional outcomes as perceived by the patient. [2][3][4][5] Physicians strive to improve patient's QoL, which could in turn translate into better utilization of health care resources. 6 A multitude of tools, commonly referred to as utilities (which can be generic or disease specific and generally cover physical, mental, and social aspects) are available for assessing QoL.…”

Reduction of EEG Myogenic Artifact with Botulinum Toxin during Video‐EEG Monitoring

“…Weakness generally begins within a few days after treatment and persists for approximately 3 months (Tsui, 1996; Hallett, 1999; Wohlfarth et al, 2004). A number of clinical and cosmetic uses have been found for BTX‐A (Jankovic and Brin, 1991; Hallett, 1999; Carruthers et al, 2004; Jankovic et al, 2004). One study examined the utility of BTX‐A injected diffusely into temporalis and frontalis muscle in three epilepsy surgery candidates (Eisenschenk et al, 2002).…”