A Qualitative Study to Explore Patient Perspectives of Prophylactic Treatment with OnabotulinumtoxinA for Chronic Migraine.

INTRODUCTION: OnabotulinumtoxinA (OBT-A) is one of the most studied prophylactic treatments for chronic migraine. Large clinical trials, and now real-world studies, continue to provide evidence to support the use of OBT-A as an effective treatment to manage chronic migraine. The objective of this study was to explore patient experience and perception of prophylactic treatment with OBT-A for chronic migraine. METHODS: Data were collected using semi-structured interviews using open-ended questions to uncover rich descriptive data on patient experiences. Interviews were transcribed and analysed using NVivo data analysis software to code and identify themes across the dataset. Three patient groups were included in the analysis: (1) patients who were receiving continued OBT-A treatment; (2) patients who discontinued OBT-A treatment; (3) patients who were recommended for OBT-A treatment but did not proceed. RESULTS: For patients who received at least one OBT-A treatment, four main themes emerged, which described patients' expectations, experiences, and feelings towards their treatment decisions. Two main themes emerged that were common to patients, who had discontinued their treatment and those, who were recommended for OBT-A treatment but did not proceed, which were identified as potential barriers to initiate or continue prophylactic treatment with OBT-A. CONCLUSION: Understanding patients' perspective is an important part of clinical practice and may impact on decision-making. Qualitative data can provide a more holistic view of patient care and treatment insights that may not be evaluated during a clinical trial. This study revealed potential barriers to treatment that can inform future policy and practice.

Effect of e-Cigarettes Plus Counseling vs Counseling Alone on Smoking Cessation: A Randomized Clinical Trial.

Importance: Electronic cigarettes (e-cigarettes) for smoking cessation remain controversial. Objective: To evaluate e-cigarettes with individual counseling for smoking cessation. Design, Setting, and Participants: A randomized clinical trial enrolled adults motivated to quit smoking from November 2016 to September 2019 at 17 Canadian sites (801 individuals screened; 274 ineligible and 151 declined). Manufacturing delays resulted in early termination (376/486 participants, 77% of target). Outcomes through 24 weeks (March 2020) are reported. Interventions: Randomization to nicotine e-cigarettes (n = 128), nonnicotine e-cigarettes (n = 127), or no e-cigarettes (n = 121) for 12 weeks. All groups received individual counseling. Main Outcomes and Measures: The primary end point was point prevalence abstinence (7-day recall, biochemically validated using expired carbon monoxide) at 12 weeks, changed from 52 weeks following early termination. Participants missing data were assumed to be smoking. The 7 secondary end points, examined at multiple follow-ups, were point prevalence abstinence at other follow-ups, continuous abstinence, daily cigarette consumption change, serious adverse events, adverse events, dropouts due to adverse effects, and treatment adherence. Results: Among 376 randomized participants (mean age, 52 years; 178 women [47%]), 299 (80%) and 278 (74%) self-reported smoking status at 12 and 24 weeks, respectively. Point prevalence abstinence was significantly greater for nicotine e-cigarettes plus counseling vs counseling alone at 12 weeks (21.9% vs 9.1%; risk difference [RD], 12.8 [95% CI, 4.0 to 21.6]) but not 24 weeks (17.2% vs 9.9%; RD, 7.3 [95% CI, -1.2 to 15.7]). Point prevalence abstinence for nonnicotine e-cigarettes plus counseling was not significantly different from counseling alone at 12 weeks (17.3% vs 9.1%; RD, 8.2 [95% CI, -0.1 to 16.6]), but was significantly greater at 24 weeks (20.5% vs 9.9%; RD, 10.6 [95% CI, 1.8 to 19.4]). Adverse events were common (nicotine e-cigarette with counseling: 120 [94%]; nonnicotine e-cigarette with counseling: 118 [93%]; counseling only: 88 [73%]), with the most common being cough (64%) and dry mouth (53%). Conclusions and Relevance: Among adults motivated to quit smoking, nicotine e-cigarettes plus counseling vs counseling alone significantly increased point prevalence abstinence at 12 weeks. However, the difference was no longer significant at 24 weeks, and trial interpretation is limited by early termination and inconsistent findings for nicotine and nonnicotine e-cigarettes, suggesting further research is needed. Trial Registration: ClinicalTrials.gov Identifier: NCT02417467.

Repeated Intravenous Lidocaine Infusions for Patients with Fibromyalgia: Higher Doses of Lidocaine Have a Stronger and Longer-Lasting Effect on Pain Reduction.

OBJECTIVES: To determine the effect of escalating doses of lidocaine infusion with or without added magnesium on pain levels and the duration of pain relief in patients with fibromyalgia (FM). METHODS: A retrospective chart review of 74 patients diagnosed with FM who underwent at least three escalating doses of intravenous (IV) lidocaine infusions (5 mg/kg of body weight, 7.5 mg/kg, and 7.5 mg/kg of lidocaine + 2.5 g of magnesium sulfate) was conducted. Each patient's subjective impression of change in pain intensity and duration of pain relief after each treatment was recorded, along with an 11-point numeric rating scale (NRS) for pain intensity, immediately before and after each infusion. RESULTS: Short-term lidocaine analgesia was evaluated by the reduction in NRS pain score according to the patients reported pre- (immediately before treatment) and post-treatment (immediately after treatment) values. There was a statistical difference in the NRS score reduction between doses 5 mg/kg and 7.5 mg/kg of lidocaine (P = 0.009). Long-term analgesia was evaluated at follow-up visits by the patient's subjective impression of change in pain intensity and duration of pain relief. There was a statistical difference in the percentage of pain relief and the mean duration of pain relief between the treatments with 5 mg/kg and 7.5 mg/kg of lidocaine (P = 0.007 and P = 0.003). Although there was a trend of greater response to magnesium sulfate as a beneficial adjunct to the lidocaine infusion, we were unable to find a statistically significant difference for any of the variables studied. CONCLUSIONS: This study demonstrated that escalating doses of IV lidocaine to 7.5 mg/kg safely and effectively reduced the pain with prolonged effect in a significant number of patients diagnosed with fibromyalgia. Larger, prospective clinical studies are required to confirm this finding.

Meniscus-Targeted Injections for Chronic Knee Pain Due to Meniscal Tears or Degenerative Fraying: A Retrospective Study.

OBJECTIVES: Meniscal tears caused by acute trauma or degenerative fraying affect a wide array of individuals. An effective, long-lasting treatment has widely been sought after. Intra-articular corticosteroid injections have been among the methods of controlling pain for more than 60 years. However, such injections tend to produce short-lasting results, with profound effects lasting an average of up to 4 weeks. The purpose of this study was to determine the average duration and magnitude of pain relief after meniscal-targeted injections. METHODS: The electronic medical records of 135 patients were accessed for this retrospective chart review. Patients who had meniscal tears or degenerative fraying and were treated with meniscal-targeted injections were selected. Patients' visual analog scale (VAS) pain scores (before and after treatment) were recorded, along with the percentage of pain relief and duration of pain relief. RESULTS: Ultrasound-guided meniscus-targeted corticosteroid injections for meniscal tears or degenerative fraying produced 5.68 (SD, 5.28) weeks of pain relief on average, with a decrease in pain from initial to follow-up visits of 2.14 (P < .0001) as per the visual analog scale score, and an Integral of Pain Relief score of 3.98. CONCLUSIONS: Our findings indicate a substantial benefit from 20- or 40-mg meniscus-targeted triamcinolone injections, granted the limitations of chart review research and no control group comparison. Results highlight the need for future prospective research comparing meniscus-targeted injections with intra-articular injections to identify a better modality for treating patients with chronic knee pain caused by meniscal tears or degenerative fraying.

Seasonality of month of birth of children and adolescents with type 1 diabetes mellitus in homogenous and heterogeneous populations.

BACKGROUND: Type 1 childhood-onset diabetes mellitus has a multifactorial origin involving an interplay between genetic and environmental factors. We have previously shown that many children who subsequently develop T1DM have a different seasonality of birth than the total live births of the same population, supporting the hypothesis that perinatal viral infection is a trigger for the autoimmune process of T1DM. OBJECTIVES: To compare the seasonality of children with T1DM in different populations around the world for which data were available. METHODS: We analyzed large cohorts of T1DM patients with a clinical disease onset before age 14 or 18 years. RESULTS: We found a seasonality pattern only in ethnically homogenous populations (such as Ashkenazi Jews, Israeli Arabs, individuals in Sardinia and Canterbury, New Zealand, and Afro-Americans) but not in heterogeneous populations (such as in Sydney, Pittsburgh and Denver). CONCLUSIONS: Our findings attempt to explain the controversial data in the literature by showing that ethnically heterogeneous populations comprising a mixture of patients with various genetic backgrounds and environmental exposures mask the different seasonality pattern of month of birth that many children with diabetes present when compared to the general population.