scholarly journals Effect of Combined Bee Venom Acupuncture and NSAID Treatment for Non-Specific Chronic Neck Pain: A Randomized, Assessor-Blinded, Pilot Clinical Trial

Toxins ◽  
2021 ◽  
Vol 13 (7) ◽  
pp. 436
Author(s):  
Boram Lee ◽  
Byung-Kwan Seo ◽  
O-Jin Kwon ◽  
Dae-Jean Jo ◽  
Jun-Hwan Lee ◽  
...  

This study aimed to investigate the feasibility of a combined treatment of bee venom acupuncture (BVA) and non-steroidal anti-inflammatory drugs (NSAIDs) for the treatment of non-specific chronic neck pain (NCNP). Patients with NCNP for ≥3 months were randomly allocated to a BVA, NSAIDs, or combined group (1:1:1), receiving 6 sessions of BVA, loxoprofen (180 mg daily), or a combination, respectively, for 3 weeks. Recruitment, adherence, and completion rates were calculated to assess feasibility. Bothersomeness, pain, disability, quality of life, depressive status, treatment credibility, and adverse events were assessed. In total, 60 participants were enrolled, and 54 completed the trial. Recruitment, adherence, and completion rates were 100%, 95%, and 90%, respectively. Bothersomeness, pain, disability, and depressive symptoms significantly improved in all groups after treatment (p < 0.05). The combined group showed continuous improvement during the follow-up period (p < 0.05). Quality of life was significantly improved (p < 0.05), and treatment credibility was maintained in the BVA and combined groups. No serious adverse events were reported. Combined treatment of BVA and NSAIDs are feasible for the treatment of NCNP, showing high persistence of the effect, credibility, and safety. Additional trials with longer follow-up are needed to confirm this effect.

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Henrik Bjarke Vaegter ◽  
Mette Terp Høybye ◽  
Frederik Hjorth Bergen ◽  
Christine E. Parsons

Abstract Objectives Sleep disturbances are highly prevalent in patients with chronic pain. However, the majority of studies to date examining sleep disturbances in patients with chronic pain have been population-based cross-sectional studies. The aims of this study were to 1) examine the frequency of sleep disturbances in patients referred to two interdisciplinary chronic pain clinics in Denmark, 2) explore associations between sleep disturbances and pain intensity, disability and quality of life at baseline and follow-up, and 3) explore whether changes in sleep quality mediated the relationships between pain outcomes at baseline and pain outcomes at follow-up. Methods We carried out a longitudinal observational study, examining patients enrolled in two chronic pain clinics assessed at baseline (n=2,531) and post-treatment follow-up (n=657). Patients reported on their sleep disturbances using the sleep quality subscale of the Karolinska Sleep Questionnaire (KSQ), their pain intensity using 0–10 numerical rating scales, their pain-related disability using the Pain Disability Index (PDI), and quality of life using the EuroQol-VAS scale. The average time between baseline and follow-up was 207 days (SD=154). Results At baseline, the majority of patients reported frequent sleep disturbances. We found a significant association at baseline between self-reported sleep disturbances and pain intensity, pain-related disability, and quality of life, where greater sleep disturbance was associated with poorer outcomes. At follow-up, patients reported significant improvements across all pain and sleep outcomes. In two mediation models, we showed that changes in sleep disturbances from baseline to follow-up were significantly associated with (i) pain intensity at follow-up, and (ii) pain disability at follow-up. However, baseline pain intensity and disability scores were not associated with changes in sleep disturbances and, we did not find evidence for significant mediation of either pain outcome by changes in sleep disturbances. Conclusions Self-reported sleep disturbances were associated with pain outcomes at baseline and follow-up, with greater sleep disturbances associated with poorer pain outcomes. Changes in sleep quality did not mediate the relationships between baseline and follow-up scores for pain intensity and disability. These findings contribute to a growing body of evidence confirming an association between sleep and chronic pain experience, particularly suggestive of a sleep to pain link. Our data following patients after interdisciplinary treatment suggests that improved sleep is a marker for a better outcome after treatment.


Neurology ◽  
2019 ◽  
Vol 93 (24) ◽  
pp. e2284-e2293 ◽  
Author(s):  
Casey H. Halpern ◽  
Veronica Santini ◽  
Nir Lipsman ◽  
Andres M. Lozano ◽  
Michael L. Schwartz ◽  
...  

ObjectiveTo test the hypothesis that transcranial magnetic resonance–guided focused ultrasound (tcMRgFUS) thalamotomy is effective, durable, and safe for patients with medication-refractory essential tremor (ET), we assessed clinical outcomes at 3-year follow-up of a controlled multicenter prospective trial.MethodsOutcomes were based on the Clinical Rating Scale for Tremor, including hand combined tremor–motor (scale of 0–32), functional disability (scale of 0–32), and postural tremor (scale of 0–4) scores, and total scores from the Quality of Life in Essential Tremor Questionnaire (scale of 0–100). Scores at 36 months were compared with baseline and at 6 months after treatment to assess for efficacy and durability. Adverse events were also reported.ResultsMeasured scores remained improved from baseline to 36 months (all p < 0.0001). Range of improvement from baseline was 38%–50% in hand tremor, 43%–56% in disability, 50%–75% in postural tremor, and 27%–42% in quality of life. When compared to scores at 6 months, median scores increased for hand tremor (95% confidence interval [CI] 0–2, p = 0.0098) and disability (95% CI 1–4, p = 0.0001). During the third follow-up year, all previously noted adverse events remained mild or moderate, none worsened, 2 resolved, and no new adverse events occurred.ConclusionsResults at 3 years after unilateral tcMRgFUS thalamotomy for ET show continued benefit, and no progressive or delayed complications. Patients may experience mild degradation in some treatment metrics by 3 years, though improvement from baseline remains significant.Clinicaltrials.gov identifierNCT01827904.Classification of evidenceThis study provides Class IV evidence that for patients with severe ET, unilateral tcMRgFUS thalamotomy provides durable benefit after 3 years.


2012 ◽  
Vol 34 (23) ◽  
pp. 1971-1977 ◽  
Author(s):  
Petri Salo ◽  
Niina Ylönen-Käyrä ◽  
Arja Häkkinen ◽  
Hannu Kautiainen ◽  
Esko Mälkiä ◽  
...  

2020 ◽  
Author(s):  
Christophe Pison ◽  
Pallav Shah ◽  
Dirk-Jan Slebos ◽  
Vincent Ninane ◽  
Wim Janssens ◽  
...  

Abstract Background: Targeted lung denervation (TLD) is a novel bronchoscopic therapy that disrupts parasympathetic pulmonary nerve input to the lung reducing clinical consequences of cholinergic hyperactivity. The AIRFLOW-1 study assessed safety and TLD dose in patients with moderate-to-severe, symptomatic COPD. This analysis evaluated the long-term impact of TLD on COPD exacerbations, pulmonary function, and quality of life over three years of follow up.Methods: TLD was performed in a prospective, energy-level randomized (29 W vs 32 W power), multicenter study (NCT02058459). Additional patients were enrolled in an open label confirmation phase to confirm improved gastrointestinal safety after procedural modifications. Durability of TLD was evaluated at one, two, and three years post-treatment and assessed through analysis of COPD exacerbations, pulmonary lung function, and quality of life. Results: Three-year follow-up data were available for 73.9% of patients (n=34). The annualized rate of moderate to severe COPD exacerbations remained stable over the duration of the study. Lung function (FEV1, FVC, RV, and TLC) and quality of life (SGRQ-C and CAT) remained stable over three years of follow-up. No new gastrointestinal adverse events and no unexpected serious adverse events were observed. Conclusion: TLD in COPD patients demonstrated a positive safety profile out to three years, with no late-onset serious adverse events related to denervation therapy. Clinical stability in lung function, quality of life, and exacerbations were observed in TLD treated patients over three years of follow up.


2021 ◽  
Vol 11 ◽  
Author(s):  
Honghong Li ◽  
Xiaoming Rong ◽  
Weihan Hu ◽  
Yuhua Yang ◽  
Ming Lei ◽  
...  

ObjectiveOur aim was to compare the clinical outcomes of patients treated with bevacizumab combined with corticosteroids and those with bevacizumab monotherapy from a radiation-induced brain necrosis (RN) registry cohort (NCT03908502).MethodsWe utilized clinical data from a prospective RN registry cohort (NCT03908502) from July 2017 to June 2020. Patients were considered eligible if they had symptomatic RN after radiotherapy for nasopharyngeal carcinoma (NPC) and received bevacizumab (5 mg/kg, two to four cycles) with a minimum follow-up time of 3 months. The primary outcome was a 2-month response rate determined by MRI and clinical symptoms. Secondary outcomes included quality of life [evaluated by the abbreviated World Health Organization Quality of Life (WHOQOL-BREF) questionnaire] and cognitive function (evaluated by the Montreal Cognitive Assessment scale) at 2 months, RN recurrence during follow-up, and adverse events.ResultsA total of 123 patients (34 in the combined therapy group and 89 in the monotherapy group) were enrolled in our study with a median follow-up time of 0.97 year [interquartile range (IQR) = 0.35–2.60 years]. The clinical efficacy of RN did not differ significantly between patients in these two groups [odds ratio (OR) = 1.642, 95%CI = 0.584–4.614, p = 0.347]. Furthermore, bevacizumab combined with corticosteroids did not reduce recurrence compared with bevacizumab monotherapy [hazard ratio (HR) = 1.329, 95%CI = 0.849–2.079, p = 0.213]. The most common adverse events of bevacizumab were hypertension (17.89%), followed by nosebleed (8.13%) and fatigue (8.13%). There was no difference in grade 2 or more severe adverse events between the two groups (p = 0.811).InterpretationOur results showed that the treatment strategy of combining bevacizumab with corticosteroids did not lead to better clinical outcomes for RN patients with a background of radiotherapy for nasopharyngeal carcinoma.


2022 ◽  
Author(s):  
Feng Yin ◽  
Mingming Zhao ◽  
Xin Yan ◽  
Tong Li ◽  
Hui Chen ◽  
...  

Abstract Subthalamic nucleus (STN) deep brain stimulation (DBS) has been proven to be an alternative target choice for refractory isolated cervical dystonia (CD). However, assessments of its short and long-term safety, efficacy, and sustained effectiveness have been limited to few reports. Here, we evaluated nine consecutive refractory isolated CD patients who underwent bilateral STN DBS and accepted to short and long-term follow-up in this retrospective study. Seven time points were used to see the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) scores (pre-operation [baseline], 1, 3, 6, 12, 24 months post-operation and last follow-up) to assess improvement of dystonic symptoms. The 36-item Short-Form General Health Survey (SF-36) scores obtained at pre-operation and last follow-up to assess the changes in quality of life. All patients tolerated surgery well and acquired observable clinical benefits from STN DBS therapy. All patients achieved a considerable improvement in quality of life at the last follow-up. The hardware-related adverse events can be tolerated and the stimulation-related adverse events can be ameliorated by programming. Our data support the idea that bilateral STN DBS is a safety and effective method for the treatment of refractory isolated CD, with persistent and remarkable improvement in both movement and quality of life.


Author(s):  
Paxton Loke ◽  
Kuang-Chih Hsiao ◽  
Adriana Lozinsky ◽  
Sarah Ashley ◽  
Melanie Lloyd ◽  
...  

Background: Combined treatment with probiotic and peanut oral immunotherapy (PPOIT) was shown to induce sustained unresponsiveness (SU) in a proof-of-concept randomized trial. Additional data on safety and long-term outcomes are needed. This study aimed to evaluate the safety and long-term effects of PPOIT in children with peanut allergy. Methods: Open-label study of 20 children aged 1-12 years with challenge-confirmed peanut allergy; all children received 18-months of PPOIT. Efficacy endpoints were desensitization, 8-week SU, and persistence of 8-week SU at 3-years post-treatment, assessed by double-blind placebo-controlled food challenge (cumulative 4950mg peanut protein). Treatment emergent adverse events and relationship to study treatment were recorded. Immunologic measures and health related quality of life (HRQL) were evaluated at screening, end-of-treatment and 3-years post-treatment. Results: Sixteen children (75%) completed treatment. By intention-to-treat analysis, 75% (15/20) achieved desensitization and 60% (12/20) achieved 8-week SU. Ten of 12 participants with SU at end-of-treatment consented to the 3-year SU challenge; 6 (60%) had persistence of SU. PPOIT was associated with significantly reduced peanut skin prick test wheal size and serum peanut specific-IgE levels at end-of-treatment, 12-months and 3-years post-treatment. There were no serious adverse events. HRQL scores improved (exceeding the Minimal Clinically Important Difference of 0.45) at 12-months post-treatment with benefit sustained at 3-years post-treatment. Conclusions: Eighteen months of PPOIT induced high rates of desensitization and SU, and SU persisted to 3-years post-treatment in a majority of initial responders. PPOIT led to long-lasting suppression of peanut sIgE and long-lasting clinically important improvement in HRQL.


2013 ◽  
Vol 12 (4) ◽  
pp. 304-307
Author(s):  
Asdrubal Falavigna ◽  
Orlando Righesso ◽  
Alisson Roberto Teles ◽  
Fabrício Diniz Kleber ◽  
Carolina Travi Canabarro ◽  
...  

OBJECTIVE: Evaluate the predictive value of the Lasègue sign on self-reported quality of life measures (HRQoL) in patients who undergo microdiscectomy. METHODS: 95 patients with clinical and radiological diagnosis of LDH who underwent microdiscectomy were included. The patients were assessed by a neurological examination and answered validated instruments to assess pain, disability, quality of life, and mood disorder in the preoperative period, and 1, 6 and 12 months after surgery. RESULTS: Preoperative Lasègue sign was identified in 56.8% (n=54/95) of the cases. There was no difference between the groups in the preoperative period regarding HRQoL. At one year follow-up no statistically significant difference in HRQoL was observed in the Lasègue group. The discrimination capacity of the preoperative Lasègue sign to determinate variations in HRQoL outcomes one year postoperatively was low. CONCLUSION: Lasègue sign is not a good predictor of outcome after microdiscectomy for LDH.


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