Complete withdrawal is the most effective approach to reduce disability in patients with medication-overuse headache: A randomized controlled open-label trial

Cephalalgia ◽  
2019 ◽  
Vol 39 (7) ◽  
pp. 863-872 ◽  
Author(s):  
Mia Nielsen ◽  
Louise Ninett Carlsen ◽  
Signe Bruun Munksgaard ◽  
Ida Maria Storm Engelstoft ◽  
Rigmor Højland Jensen ◽  
...  

Background Medication-overuse headache leads to high disability and decreased quality of life, and the best approach for withdrawal has been debated. Aim To compare change in disability and quality of life between two withdrawal programs. Methods We randomized medication-overuse headache patients to program A (two months without acute analgesics or migraine medications) or program B (two months with acute medications restricted to two days/week) in a prospective, outpatient study. At 6 and 12 months, we measured disability and headache burden by the Headache Under-Response to Treatment index (HURT). We estimated quality of life by EUROHIS-QOL 8-item at 2-, 6-, and 12-month follow-up. Primary endpoint was disability change at 12 months. Results We included 72 medication-overuse headache patients with primary migraine and/or tension-type headache. Fifty nine completed withdrawal and 54 completed 12-month follow-up. At 12-month follow-up, 41 patients completed HURT and 38 completed EUROHIS-QOL 8-item. Disability reduction was 25% in program-A and 7% in program-B ( p = 0.027). Headache-burden reduction was 33% in program-A and 3% in program-B ( p = 0.005). Quality of life was increased by 8% in both programs without significant difference between the programs ( p = 0.30). At 2-month follow-up, quality of life increased significantly more in program-A than program-B ( p = 0.006). Conclusion Both withdrawal programs reduced disability and increased quality of life. Withdrawal without acute medication was the most effective in reducing disability in medication-overuse headache patients. Trial registration Clinicaltrials.gov (NCT02903329).

Cephalalgia ◽  
2018 ◽  
Vol 39 (1) ◽  
pp. 135-147 ◽  
Author(s):  
Sara Bottiroli ◽  
Marta Allena ◽  
Grazia Sances ◽  
Roberto De Icco ◽  
Micol Avenali ◽  
...  

Aim To identify factors that may be predictors of the outcome of a detoxification treatment in medication-overuse headache. Methods Consecutive patients entering a detoxification program in six centres in Europe and Latin America were evaluated and followed up for 6 months. We evaluated anxious and depressive symptomatology (though patients with severe psychiatric comorbidity were excluded), quality of life, headache-related disability, headache characteristics, and prophylaxis upon discharge. Results Of the 492 patients who completed the six-month follow up, 407 ceased overuse following the detoxification (non overusers), another 23 ceased overuse following detoxification but relapsed during the follow-up. In the 407 non-overusers, headache acquired an episodic pattern in 287 subjects (responders). At the multivariate analyses, lower depression scores (odds ratio = 0.891; p = 0.001) predicted ceasing overuse. The primary headache diagnosis – migraine with respect to tension-type headache (odds ratio = 0.224; p = 0.001) or migraine plus tension-type headache (odds ratio = 0.467; p = 0.002) – and the preventive treatment with flunarizine (compared to no such treatment) (odds ratio = 0.891; p = 0.001) predicted being a responder. A longer duration of chronic headache (odds ratio = 1.053; p = 0.032) predicted relapse into overuse. Quality of life and disability were not associated with any of the outcomes. Conclusions Though exploratory in nature, these findings point to specific factors that are associated with a positive outcome of medication-overuse headache management, while identifying others that may be associated with a negative outcome. Evaluation of the presence/absence of these factors may help to optimize the management of this challenging groups of chronic headache sufferers.


Cephalalgia ◽  
2017 ◽  
Vol 38 (2) ◽  
pp. 225-236 ◽  
Author(s):  
Louise Ninett Carlsen ◽  
Signe Bruun Munksgaard ◽  
Rigmor Højland Jensen ◽  
Lars Bendtsen

Background There is lack of evidence on how to detoxify medication-overuse headache. Aim To compare the effect of complete stop of acute medication with restricted intake. Methods Medication-overuse headache patients were included in a prospective, outpatient study and randomized to two months’ detoxification with either a) no analgesics or acute migraine-medication (program A), or b) acute medication restricted to two days/week (program B). Detoxification was followed by preventives if indicated. Patients were followed up at 2, 6 and 12 months. Percentage reduction in headache days/month after 6 months was the primary outcome. Results We included 72 medication-overuse headache patients with a primary migraine and/or tension-type headache diagnosis. Fifty-nine completed detoxification, 58 (81%) were followed up at month 6 and 53 (74%) at month 12. At month 6, program A reduced headache days/month by 46% (95% CI 34–58) compared with 22% (95% CI 11–34) in program-B ( p = 0.005), and 70% in program A versus 42% in program B were reverted to episodic headache ( p = 0.04). Migraine-days/month were reduced by 7.2 in program A ( p < 0.001) and 3.6 in program B ( p = 0.002) after 6 months. Conclusion Both detoxification programs were very effective. Detoxification without analgesics or acute migraine-medication was the most effective program. Trial registration Clinicaltrials.gov (NCT02903329).


2015 ◽  
Vol 16 (S1) ◽  
Author(s):  
Samantha Bellini ◽  
Monica Migliorati ◽  
Federica Ricci ◽  
Denise Erbuto ◽  
Maurizio Pompili

2021 ◽  
Vol 0 (0) ◽  
Author(s):  
Nina Honkanen ◽  
Laura Mustonen ◽  
Eija Kalso ◽  
Tuomo Meretoja ◽  
Hanna Harno

Abstract Objectives To assess the long-term outcome of breast reconstructions with special focus on chronic postsurgical pain (CPSP) in a larger cohort of breast cancer survivors. Methods A cross-sectional study on 121 women with mastectomy and breast reconstruction after mean 2 years 4 months follow up. The mean time from breast reconstruction to the follow-up visit was 4 years 2 months. We studied surveys on pain (Brief Pain Inventory, BPI and Douleur Neuropathique 4, DN4), quality of life (RAND-36 health survey), sleep (insomnia severity questionnaire, ISI), mood (Beck’s Depression Index, BDI; Hospital Anxiety and Depression Scale, HADS), and a detailed clinical sensory status. Patients were divided into three groups: abdominal flap (Deep inferior epigastric perforator flap, DIEP; Free transverse rectus abdominis flap, fTRAM, and Pedicled transverse rectus abdominis flap, pTRAM), dorsal flap (Latissimus dorsi flap, LD and Thoracodorsal artery perforator flap, TDAP), and other (Transverse myocutaneous gracilis flap, TMG; implant). Clinically meaningful pain was defined ≥ 4/10 on a numeric rating scale (NRS). We used patients’ pain drawings to localize the pain. We assessed preoperative pain NRS from previous data. Results 106 (87.6%) of the patients did not have clinically meaningful persistent pain. We found no statistically significant difference between different reconstruction types with regards to persistent pain (p=0.40), mood (BDI-II, p=0.41 and HADS A, p=0.54) or sleep (p=0.14), respectively. Preoperative pain prior to breast reconstruction surgery correlated strongly with moderate or severe CPSP. Conclusions Moderate to severe CPSP intensity was present in 14% of patients. We found no significant difference in the prevalence of pain across different reconstruction types. Preoperative pain associated significantly with postoperative persistent pain.


2021 ◽  
pp. 000313482198905
Author(s):  
John A. Perrone ◽  
Stephanie Yee ◽  
Manrique Guerrero ◽  
Antai Wang ◽  
Brian Hanley ◽  
...  

Introduction After extensive mediastinal dissection fails to achieve adequate intra-abdominal esophageal length, a Collis gastroplasty(CG) is recommended to decrease axial tension and reduce hiatal hernia recurrence. However, concerns exist about staple line leak, and long-term symptoms of heartburn and dysphagia due to the acid-producing neoesophagus which lacks peristaltic activity. This study aimed to assess long-term satisfaction and GERD-related quality of life after robotic fundoplication with CG (wedge fundectomy technique) and to compare outcomes to patients who underwent fundoplication without CG. Outcomes studied included patient satisfaction, resumption of proton pump inhibitors (PPI), length of surgery (LOS), hospital stay, and reintervention. Methods This was a single-center retrospective analysis of patients from January 2017 through December 2018 undergoing elective robotic hiatal hernia repair and fundoplication. 61 patients were contacted for follow-up, of which 20 responded. Of those 20 patients, 7 had a CG performed during surgery while 13 did not. There was no significant difference in size and type of hiatal hernias in the 2 groups. These patients agreed to give their feedback via a GERD health-related quality of life (GERD HRQL) questionnaire. Their medical records were reviewed for LOS, length of hospital stay (LOH), and reintervention needed. Statistical analysis was performed using SPSS v 25. Satisfaction and need for PPIs were compared between the treatment and control groups using the chi-square test of independence. Results Statistical analysis showed that satisfaction with outcome and PPI resumption was not significantly different between both groups ( P > .05). There was a significant difference in the average ranks between the 2 groups for the question on postoperative dysphagia on the follow-up GERD HRQL questionnaire, with the group with CG reporting no dysphagia. There were no significant differences in the average ranks between the 2 groups for the remaining 15 questions ( P > .05). The median LOS was longer in patients who had a CG compared to patients who did not (250 vs. 148 min) ( P = .01). The LOH stay was not significantly different ( P > .05) with a median length of stay of 2 days observed in both groups. There were no leaks in the Collis group and no reoperations, conversions, or blood transfusions needed in either group. Conclusion Collis gastroplasty is a safe option to utilize for short esophagus noted despite extensive mediastinal mobilization and does not adversely affect the LOH stay, need for reoperation, or patient long-term satisfaction.


Medicina ◽  
2021 ◽  
Vol 57 (8) ◽  
pp. 747
Author(s):  
Rafal Berger ◽  
Hasan Hamdoun ◽  
Rodrigo Sandoval Boburg ◽  
Medhat Radwan ◽  
Metesh Acharya ◽  
...  

Background and Objectives: Over the past decade, veno-arterial extracorporeal membrane oxygenation (VA-ECMO) has developed into a mainstream treatment for refractory cardiogenic shock (CS) to maximal conservative management. Successful weaning of VA-ECMO may not be possible, and bridging with further mechanical circulatory support (MCS), such as urgent implantation of a left ventricular assist device (LVAD), may represent the only means to sustain the patient haemodynamically. In the recovery phase, many survivors are not suitably prepared physically or psychologically for the novel issues encountered during daily life with an LVAD. Materials and Methods: A retrospective analysis of our institutional database between 2012 and 2019 was performed to identify patients treated with VA-ECMO for CS who underwent urgent LVAD implantation whilst on MCS. Post-cardiotomy cases were excluded. QoL was assessed prospectively during a routine follow-up visit using the EuroQol-5 dimensions-5 level (EQ-5D-5L) and the Patient Health Questionnaire (PHQ-9) surveys. Results: Among 126 in-hospital survivors of VA-ECMO therapy due to cardiogenic shock without prior cardiac surgery, 31 (24.6%) urgent LVAD recipients were identified. In 11 (36.7%) cases, cardiopulmonary resuscitation (CPR) was performed (median 10, range 1–60 min) before initiation of VA-ECMO, and in 5 (16.7%) cases, MCS was established under CPR. Mean age at LVAD implantation was 51.7 (+/−14) years and surgery was performed after a mean 12.1 (+/−8) days of VA-ECMO support. During follow-up of 46.9 (+/−25.5) months, there were 10 deaths after 20.4 (+/−12.1) months of LVAD support. Analysis of QoL questionnaires returned a mean EQ-5D-5L score of 66% (+/−21) of societal valuation for Germany and a mean PHQ-9 score of 5.7 (+/−5) corresponding to mild depression severity. When compared with 49 elective LVAD recipients without prior VA-ECMO therapy, there was no significant difference in QoL results. Conclusions: Patients requiring urgent LVAD implantation under VA-ECMO support due to CS are associated with comparable quality of life without a significant difference from elective LVAD recipients. Close follow-up is required to oversee patient rehabilitation after successful initial treatment.


Hernia ◽  
2021 ◽  
Author(s):  
M. M. J. Van Rooijen ◽  
T. Tollens ◽  
L. N. Jørgensen ◽  
T. S. de Vries Reilingh ◽  
G. Piessen ◽  
...  

Abstract Introduction Information on the long-term performance of biosynthetic meshes is scarce. This study analyses the performance of biosynthetic mesh (Phasix™) over 24 months. Methods A prospective, international European multi-center trial is described. Adult patients with a Ventral Hernia Working Group (VHWG) grade 3 incisional hernia larger than 10 cm2, scheduled for elective repair, were included. Biosynthetic mesh was placed in sublay position. Short-term outcomes included 3-month surgical site occurrences (SSO), and long-term outcomes comprised hernia recurrence, reoperation, and quality of life assessments until 24 months. Results Eighty-four patients were treated with biosynthetic mesh. Twenty-two patients (26.2%) developed 34 SSOs, of which 32 occurred within 3 months (primary endpoint). Eight patients (11.0%) developed a hernia recurrence. In 13 patients (15.5%), 14 reoperations took place, of which 6 were performed for hernia recurrence (42.9%), 3 for mesh infection (21.4%), and in 7 of which the mesh was explanted (50%). Compared to baseline, quality of life outcomes showed no significant difference after 24 months. Despite theoretical resorption, 10.7% of patients reported presence of mesh sensation in daily life 24 months after surgery. Conclusion After 2 years of follow-up, hernia repair with biosynthetic mesh shows manageable SSO rates and favorable recurrence rates in VHWG grade 3 patients. No statistically significant improvement in quality of life or reduction of pain was observed. Few patients report lasting presence of mesh sensation. Results of biosynthetic mesh after longer periods of follow-up on recurrences and remodeling will provide further valuable information to make clear recommendations. Trial registration Registered on clinicaltrials.gov (NCT02720042), March 25, 2016.


Stroke ◽  
2020 ◽  
Vol 51 (Suppl_1) ◽  
Author(s):  
Joan M ODonnell ◽  
Maurizio Manuguerra ◽  
Jemma L Hodge ◽  
Greg Savage ◽  
Michael K Morgan

Background: Studies have questioned the effectiveness of surgery for the management of unruptured intracranial aneurysm (uIA). Few studies have examined the ability to drive and quality of life (QOL) after surgery for uIA. Objective: This study examined the effectiveness of surgical management of uIA by measuring patients’ perceived quality of life and their cognitive abilities related to driving. Methods: Between January 2011 and January 2016 patients with a uIA were assessed using the Quality Metric Short Form 36 (SF36) and the off-road driver screening instrument DriveSafeDriveAware. Reassessments were conducted at the 6-week post-operative follow-up for surgical patients and at 12-month follow-up for surgical and conservatively managed patients. Results: 175 patients enrolled in the study, of which 112(66%) had surgical management of their aneurysm. For the surgical cases who completed all assessments (N=74), there was a trend for the DriveSafe pre-operative mean score of 108 (SD 10.7) to be lower than the 6-week and 12-month post-operative mean scores (111 SD 9.7 and 112 SD 10.2 respectively)(p=0.05). There were no significant changes in DriveAware scores at any epoch or between patient groups nor in the MCS in the surgical group.. There was a significant decline in PCS scores at 6 weeks post-operatively which recovered at 12 months (52 SD 8.1, 46 SD 6.8 and 52 SD 7.1 respectively)( p <0.01). There was no significant difference in 12-month mRS scores between the surgical cases who completed with cases who did not complete all assessments. Conclusion: Surgery for uIA did not affect cognitive abilities for driving at 6 weeks or 12 months after surgery. There was a decline in the QOL in the first months after surgery, however QOL returned to pre-surgical status 12 months after surgery. If the risk of seizures is low and there are no post-operative complications, returning to driving can be recommended.


Cancers ◽  
2021 ◽  
Vol 13 (22) ◽  
pp. 5636
Author(s):  
Michael Chaloupka ◽  
Lina Stoermer ◽  
Maria Apfelbeck ◽  
Alexander Buchner ◽  
Vera Wenter ◽  
...  

(1) Background: local treatment of the primary tumor has become a valid therapeutic option in de-novo oligo-metastatic prostate cancer (PC). However, evidence regarding radical prostatectomy (RP) in this setting is still subpar, and the effect of cytoreductive RP on postoperative health-related quality of life (HRQOL) is still unclear. (2) Methods: for the current study, patients with de-novo oligo-metastatic PC (cM1-oligo), defined as ≤5 bone lesions in the preoperative staging, were included, and matched cohorts using the variables age, body-mass index (BMI), and pT-stage were generated. Patient-reported outcome measures (PROMS) were assessed pre- and postoperatively using the validated EORTC-QLQ-C30, IIEF-5, and ICIQ-SF questionnaires. The primary endpoint for univariate and multivariable analysis was good general HRQOL defined by previously validated cut-off values. (3) Results: in total, 1268 patients (n = 84 (7%) cM1-oligo) underwent RP between 2012 and 2020 at one tertiary care center. A matched cohort of 411 patients (n = 79 with oligo-metastatic bone disease (cM1-oligo) and n = 332 patients without clinical indication of metastatic disease (cM0)) was created. The median follow-up was 25mo. There was no significant difference in good general HRQOL rates between cM1-oligo-patients and cM0-patients before RP (45.6% vs. 55.2%, p = 0.186), and at time of follow-up (44% vs. 56%, p = 0.811). Global health status (GHS) worsened significantly in cM0-patients compared to baseline (−5, p = 0.001), whereas GHS did not change significantly in cM1-oligo-patients (+3.2, p = 0.381). In multivariate analysis stratified for good erectile function (IIEF5 > 18; OR 5.722, 95% CI 1.89–17.36, p = 0.002) and continence recovery (OR 1.671, 95% CI 1.03–2.70, p = 0.036), cM1-oligo was not an independent predictive feature for general HRQOL (OR 0.821, 95% CI 0.44–1.53, p = 0.536). (4) Conclusions: in this large contemporary retrospective analysis, we observed no significant difference in HRQOL in patients with the oligometastatic bone disease after cytoreductive radical prostatectomy, when compared to patients with localized disease at time of surgery.


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