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2 Minute Medicine Rewind September 25, 2023
1. Intravenous dihydroergotamine (DHE) was found in this retrospective study to be an effective therapeutic option for refractory chronic migraine.
2. DHE was additionally safe for individuals with elevated risk for cardiovascular events and other cardiovascular risk factors.
Evidence Rating Level: 2 (Good)
Chronic migraine is a debilitating condition that severely impacts the quality of life for many individuals. For those with cardiovascular risk factors (e.g., ischemic heart disease, prior coronary vasospasm, etc.), managing chronic migraines can be particularly challenging due to limited treatment options. For example, triptans, a first-line abortive treatment for migraines, are contraindicated in these patients. The current study aimed to evaluate the safety, tolerability, and effectiveness of repetitive intravenous dihydroergotamine (DHE), a derivative of ergotamine, as a treatment for refractory chronic migraine specifically in individuals with cardiovascular risk factors. Repetitive DHE infusions have long been used in migraine management, but their use in patients with cardiovascular risks has not been extensively studied until now. The current single-center, retrospective cohort study analyzed 347 refractory chronic migraine patients with either low (< 5.0%) or elevated (≥ 5.0%) 10-year cardiovascular risk scores. The elevated-risk group did have fewer patients receiving maximum doses of DHE (p = .002) and lower median doses of DHE on discharge (p < .001), however with respect to safety and tolerability, the study found that intravenous DHE was generally safe and well-tolerated in patients with cardiovascular risk factors. Adverse events were minimal (although the low-risk group did experience more nausea, 31.3% vs. 14.1%, p = 0.008), and there were no severe cardiovascular complications reported during the treatment course. The effectiveness of DHE infusions was evident in the significant reduction in frequency and intensity of pain associated with migraines (p = .037). The overall findings of the study suggest that DHE for refractory chronic migraines could be safe and effective for those with cardiovascular risk factors. However, further research is needed to confirm these findings in larger, controlled clinical trials.
Premenstrual Disorders, Timing of Menopause, and Severity of Vasomotor Symptoms
1. This prospective study found that women with severe premenstrual disorders (PMDs) were at increased risk for early onset of menopause.
2. PMDs were also found to be associated with severe or longstanding vasomotor symptoms in menopause.
Evidence Rating Level: 2 (Good)
Vasomotor symptoms including hot flashes and night sweats are common and often disruptive symptoms experienced by women during menopause. PMDs, on the other hand, encompass a range of physical and psychological symptoms that occur in the time leading to menstruation, affecting many women during their reproductive years. Understanding the interplay between these two phenomena and their potential impact on the timing and severity of menopausal symptoms is vital for women’s health and well-being. The data analyzed in this prospective study were from the Nurses’ Health Study II (NHSII) cohort study conducted in the UK, and included 1220 women with confirmed premenstrual disorders and 2415 without. It was found that overall, women with premenstrual disorders had an increased risk of early menopause (HR, 2.67; 95% CI, 1.27-5.59), but overall, both groups reached menopause at similar ages (51.4 years for PMD, 51.8 years for non-PMD). A positive correlation between PMDs and any vasomotor symptoms was found, with associations being particularly strong for those with moderate to severe vasomotor symptoms (OR, 1.68; 95% CI, 1.32-2.14) or symptoms lasting > 5 years (OR, 1.43; 95% CI, 1.01-2.02). These findings underscore the importance of recognizing and addressing premenstrual disorders in women’s health. Identifying women at risk for severe vasomotor symptoms during menopause based on their history of premenstrual disorders can inform personalized healthcare strategies and interventions. Further research will be essential to explore the underlying mechanisms and to develop targeted interventions that can improve the overall well-being of women during menopause.
1. The current randomized controlled trial is the first of its kind to demonstrate the efficacy of maggot debridement therapy (MDT) for full-thickness burns compared to the standard of care (silver dressings).
2. Time to debridement and time to full healing were both improved in the MDT group, and this finding was even more pronounced for full-thickness burns with over 50% necrosis at the commencement of the study.
Evidence Rating Level: 1 (Excellent)
Burns are a common cause of traumatic injuries and contribute to mortality, disability, and an abundance of adverse medical, psychological, and socioeconomic effects. The ICD-10 grading system for burns classifies those burns affecting the entire dermis layer of the skin as grade III, or ‘full-thickness’. It is this burn grade that is usually tied to the highest incidence of morbidity, mortality, and other adverse outcomes. The current standard of care for burns involves surgical debridement, as well as other nonsurgical options (silver dressings, antibiotics, creams, ointments). However, more novel literature studying the use of Lucilia Sericata maggots and larvae shows promise in its use for chronic wounds and in treating bacterial wound infections. The current open randomized controlled trial is the first to analyze MDT’s potential benefits in treating grade-III burns in comparison to silver dressings. A total of 31 male participants with different types of full-thickness burns who met other criteria were selected for the study, with 15 allocated to the conventional treatment group and 16 to the larval therapy group. The larval therapy group received loose larvae 3-4 times spread out into 2-day intervals. Silver dressings were replaced every three days. Time to debridement in preparation for skin autograft was significantly improved in the MDT group (p < .001), as was time to healing (defined as full wound closure) post-skin autograft (p < .001). There was also significantly reduced necrosis at days 2 and 4 of treatment compared to the conventional treatment group (ps < .05) and granulation was significantly improved in the MDT group (p < .001). Finally, a subgroup analysis demonstrated that even burns rated as ‘high necrotic burns’ (i.e., with other 50% necrosis of the area) fared significantly better in the MDT group than controls (p < .001). One parameter that was not different between the groups, however, was the amount of bacterial contamination. This is the first trial to investigate the relative efficacy of maggot debridement therapy’s effectiveness for full-thickness burn injuries versus the current standard of care, and future larger trials should be conducted to elucidate the full range of benefits of MDT therapy.
1. This phase 2 randomized clinical trial found that patients with metastatic colorectal cancer who were treated with cetuximab maintenance therapy had improved progression-free survival and median overall survival compared to those undergoing observation alone in the maintenance phase.
2. There was no statistical difference in adverse events when comparing the control to patients taking Cetuximab.
Evidence Rating Level: 1 (Excellent)
Metastatic colorectal cancer (mCRC), particularly in patients with RAS wild-type tumours, presents a significant clinical challenge. While initial treatments like FOLFIRI (a chemotherapy regimen) combined with cetuximab have shown promise, the question of how to sustain these positive outcomes over the long term remains unanswered. This recent Phase 2 randomized clinical trial investigated the use of cetuximab as maintenance therapy after an initial response to FOLFIRI plus cetuximab in patients with RAS wild-type mCRC. After first-line induction therapy, 214 patients without disease progression were randomized to biweekly maintenance with cetuximab or observation. The 6-month progression-free rate from randomization was significantly higher in the cetuximab group (38.8%; 95% CI, 27.1%-51.5%) compared to the observation group (5.6%; 95% CI, 1.5%-13.6%). At follow-up (median 40.5 months), median progression-free survival was 5.3 months in the cetuximab group and 2 months in the observation group, whereas medial overall survival was 24.8 months for cetuximab-treated patients (95% CL, 18.7-30.4) and 19.7 months for those who underwent observation only (95% CI, 13.3-24.4). These results suggest that cetuximab may be a valuable tool in prolonging disease control after an initial positive response. Biomolecular exploratory analyses also demonstrated that any tumorigenic mutation in the MAPK pathway was associated with worse progression-free survival rates (HR, 1.63 [95% CI, 1.01-2.62]; P = .04). With respect to its safety profile, maintenance with cetuximab was generally well-tolerated with manageable side effects. There was no significant difference found in adverse events with this compared to the control group. This Phase 2 trial shows promise, but further research is required to confirm these findings. Additionally, investigations into cetuximab maintenance therapy’s optimal duration and timing will be essential in refining its clinical applications.
A Randomized, Controlled Neuroimaging Trial of Cognitive-Behavioral Therapy for Fibromyalgia Pain
1. This randomized controlled trial found that an 8-week cognitive behavioural therapy (CBT) intervention was more effective than fibromyalgia (FM) education in reducing pain catastrophizing and improving pain interference scores.
2. Functional magnetic resonance imaging (fMRI) demonstrated that pain catastrophization was associated with increased ventral posterior cingulate cortex (vPCC) activation, and that post-CBT, patients showed reduced firing in the somatosensory and salience networks.
Evidence Rating Level: 1 (Excellent)
Fibromyalgia (FM) is a chronic rheumatic condition causing widespread pain throughout the body, fatigue, and a range of other symptoms, often leading to negative affect and reduced quality of life. While various treatments have been explored, there is no one-size-fits-all solution. The current randomized controlled trial applied neuroimaging in order to better understand CBT’s relative effectiveness compared to conventional fibromyalgia patient education, as well as the underlying neural mechanisms involved in such changes. More specifically, the study assessed the effects of CBT on pain interference and pain catastrophizing. Participants underwent initial fMRI scanning while undergoing an adapted pain catastrophizing task, then were randomized to either an 8-week intervention of CBT or 8 weeks of FM education. At the termination of treatment, a repeat fMRI scan was completed. A total of 114 women with FM were enrolled. The primary outcome, pain interference, was significantly reduced from baseline in the CBT group compared to the education group (p < .05). Pain catastrophizing scores also reduced from baseline to post-treatment in both groups, but more so in the CBT group (p < .05). The study demonstrated that CBT significantly reduced fibromyalgia impact compared to the control group (p < .05) as well. When fMRI was employed, it was found that pain catastrophizing produced increased vPCC activation and that vPCC connectivity during catastrophizing was reduced in the somatomotor network and salience network regions after receiving CBT(p = .03). These findings underscore the potential of CBT as a non-pharmacological option in managing chronic pain secondary to FM, and fMRI-adapted tasks also shed further light on the neural underpinnings of the FM illness experience. This study is limited in that it only included female participants, and that CBT for chronic pain can vary in its protocol. Thus, future studies should include a wider participant pool and seek to elucidate which aspects and skills acquired through CBT specifically are most useful in mitigating the effects of FM.
Image: PD
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