scholarly journals Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST): protocol for identification of novel biomarkers via neurophysiology

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Zafiris J. Daskalakis ◽  
Shawn M. McClintock ◽  
Itay Hadas ◽  
Elisa Kallioniemi ◽  
Reza Zomorrodi ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Adverse Effects ◽  
Resting State ◽  
Cortical Inhibition ◽  
Multiscale Entropy ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Eeg Activity ◽  
Magnetic Seizure Therapy ◽  
Link Type

Abstract Background Electroconvulsive therapy (ECT) is the most effective treatment for treatment-resistant depression (TRD), especially for acute suicidal ideation, but the associated cognitive adverse effects and negative stigma limit its use. Another seizure therapy under development is magnetic seizure therapy (MST), which could potentially overcome the restrictions associated with ECT with similar efficacy. The neurophysiological targets and mechanisms of seizure therapy, however, remain poorly understood. Methods/design This neurophysiological study protocol is published as a companion to the overall Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST-MST) protocol that describes our two-site, double-blind, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. Our aim for the neurophysiological component of the study is to evaluate two biomarkers, one to predict remission of suicidal ideation (primary outcome) and the other to predict cognitive impairment (secondary outcome). Suicidal ideation will be assessed through cortical inhibition, which according to our preliminary studies, correlates with remission of suicidal ideation. Cortical inhibition will be measured with simultaneous transcranial magnetic stimulation (TMS) and electroencephalography (EEG), TMS-EEG, which measures TMS-evoked EEG activity. Cognitive adverse effects associated with seizure therapy, on the contrary, will be evaluated via multiscale entropy analysis reflecting the complexity of ongoing resting-state EEG activity. Discussion ECT and MST are known to influence cortical inhibition associated with depression, suicidal ideation severity, and clinical outcome. Therefore, evaluating cortical inhibition and brain temporal dynamics will help understand the pathophysiology of depression and suicidal ideation and define new biological targets that could aid clinicians in diagnosing and selecting treatments. Resting-state EEG complexity was previously associated with the degree of cognitive side effects after a seizure therapy. This neurophysiological metric may help clinicians assess the risk for adverse effects caused by these useful and effective treatments. Trial registration ClinicalTrials.govNCT03191058. Registered on June 19, 2017.

scholarly journals Investigating the Efficacy of an Individualized Alpha/Delta Neurofeedback Protocol in the Treatment of Chronic Tinnitus

2019 ◽  
Vol 2019 ◽  
pp. 1-15 ◽  
Author(s):  
Dominik Güntensperger ◽  
Christian Thüring ◽  
Tobias Kleinjung ◽  
Patrick Neff ◽  
Martin Meyer
Keyword(s):  
Resting State ◽  
Peak Frequency ◽  
Chronic Tinnitus ◽  
Frequency Range ◽  
Tinnitus Questionnaire ◽  
Eeg Activity ◽  
Individual Level ◽  
Link Type ◽  
Delta Band

First attempts have demonstrated that the application of alpha/delta neurofeedback in the treatment of chronic tinnitus leads to a reduction of symptoms at the group level. However, recent research also suggests that chronic tinnitus is a decidedly heterogeneous phenomenon, one that requires treatment of distinct subgroups or even on an individual level. Thus, the purpose of this study was to evaluate an individually adjusted alpha/delta neurofeedback protocol. Following previous studies, the delta band fixed between 3 and 4 Hz was chosen as the frequency for inhibition. However, unlike the previous studies, the frequency range for the rewarded alpha band was not fixed between 8 and 12 Hz but rather individually determined according to each patient’s specific alpha peak frequency (IAF). Twenty-six chronic tinnitus patients participated in 15 weekly neurofeedback training sessions and extensive pre- and post-tests, as well as follow-up testing 3 and 6 months after training. The main outcome measures were tinnitus-related distress measured with the Tinnitus Handicap Inventory (THI) and Tinnitus Questionnaire (TQ), tinnitus loudness, and pre- and post-training resting-state EEG activity in trained frequency bands. In Results, the neurofeedback protocol led to a significant reduction of tinnitus-related distress and tinnitus loudness. While distress remained on a low level even 6 months after the completion of training, loudness returned to baseline levels in the follow-up period. In addition, resting-state EEG activity showed an increase in the trained alpha/delta ratio over the course of the training. This ratio increase was related to training-induced changes of tinnitus-related distress as measured with TQ, mainly due to increases in the alpha frequency range. In sum, this study confirms the alpha/delta neurofeedback as a suitable option for the treatment of chronic tinnitus and represents a first step towards the development of individual neurofeedback protocols. This clinical trial was registered online at ClinicalTrials.gov (NCT02383147) and kofam.ch (SNCTP000001313).

scholarly journals Comparative study of efficacy and safety of garenoxacin and moxifloxacin in acute exacerbation of chronic bronchitis in COPD patients

2018 ◽  
Vol 7 (3) ◽  
pp. 410
Author(s):  
Ajay Kumar Sinha ◽  
Bhavana Srivastava ◽  
Dinesh Chand Punera ◽  
Renu Khanchandani
Keyword(s):  
Adverse Effects ◽  
Comparative Study ◽  
Chronic Bronchitis ◽  
Acute Exacerbation ◽  
Bacterial Infections ◽  
Clinical Success ◽  
Clinical Success Rate ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Once Daily

Background: Acute exacerbation of chronic bronchitis in COPD (AECB) is the major cause of morbidity, mortality and marked reduction in quality of life and imposes significant burden on both patients and healthcare systems. Bacterial infections causing AECB frequently require antibacterial treatment, so more evidences are needed to guide better antibiotic choice. Objective of the study was planned to compare efficacy and safety of Garenoxacin, a new fluoroquinolone versus moxifloxacin for treatment of Acute exacerbation of Chronic bronchitis in COPD patient.Methods: This was a prospective open label comparative study done in department of pharmacology and T.B & Chest of Government Medical College attached Dr Shusila Tiwari Hospital, Haldwani. 60 subjects with clinical symptoms suggestive of Anthonisen type II AECOPD (any two of following criteria: Increased dyspnea, cough, sputum purulence) were enrolled and randomized to receive either Moxifloxacin 400 mg once daily for 7 days or Garenoxacin 400mg once daily for 7 days. The primary outcome measure was clinical success rate at day 7 visit. Secondary outcome measures were changes in clinical global impression (CGI) scales and incidence of adverse events.Results: The mean age of patient was 60.98±9.9 years and 57.9±9.3 years in the Moxifloxacin and Garenoxacin groups. The clinical success rates were comparable with 86.2% in moxifloxacin group 84.6% and in garenoxacin group. Adverse effects were mild and self limiting. We observed two adverse effects in garenoxacin and three in moxifloxacin group.Conclusions: The result of study showed that garenoxacin is comparable to moxifloxacin in terms of efficacy and safety.

scholarly journals Confirmatory Efficacy and Safety Trial of Magnetic Seizure Therapy for Depression (CREST – MST): Study Protocol for a Randomized Non-Inferiority Trial of Magnetic Seizure Therapy versus Electroconvulsive Therapy

2021 ◽  
Author(s):  
Zafiris Daskalakis ◽  
Carol Tamminga ◽  
Alanah Throop ◽  
Lucy Palmer ◽  
Julia Dimitrova ◽  
...  
Keyword(s):  
Suicidal Ideation ◽  
Adverse Effects ◽  
Electroconvulsive Therapy ◽  
High Frequency ◽  
Antidepressant Treatment ◽  
Healthcare Providers ◽  
The United States ◽  
Eligibility Criteria ◽  
Magnetic Seizure Therapy ◽  
Double Blinded

Abstract BackgroundElectroconvulsive therapy (ECT) is well-established and effective for treatment resistant depression (TRD), but in Canada and the United States, less than 1% of patients with TRD receive ECT mainly due to its cognitive adverse effects (i.e., amnesia). Thus, new treatment alternatives for TRD are urgently needed. One such treatment is Magnetic Seizure Therapy (MST). ECT involves applying a train of high frequency electrical stimuli to induce a seizure, whereas MST involves applying a train of high frequency magnetic stimuli to induce a seizure. MethodsIn this manuscript, we introduce our international, two-site, double-blinded, randomized, non-inferiority clinical trial to develop MST as an effective and safe treatment for TRD. This trial will compare the efficacy of MST to right unilateral ultra-brief pulse width electroconvulsive therapy (RUL-UB-ECT) with a combined primary endpoint of remission of depression and superior cognitive adverse effects in 260 patients with TRD. Amelioration of suicidal ideation will be assessed as a secondary endpoint. Inpatients or outpatients, over 18 years of age with a MINI International Neuropsychiatric Interview (MINI) diagnosis of non-psychotic major depressive disorder (MDD) can be enrolled in the study provided that they meet illness severity and full eligibility criteria. Participants are randomized to receive MST or RUL-UB ECT, 2-3 days per week over seven weeks, or a maximum of 21 treatments. The study will involve before-, during-, and after-treatment assessments of depression severity, suicidal ideation, subjective side-effects, and cognitive performance consistent with an intent-to-treat study design approach. DiscussionPositive results from this trial could have an immediate and tremendous impact for patients with TRD. If MST demonstrates comparable antidepressant treatment efficacy to ECT, but with greater cognitive safety, it could rapidly be adopted into clinical practice. Indeed, given that the administration of MST is nearly identical to ECT, the majority of ECT facilities in North America could readily adopt MST. Furthermore, the potential for cognitive safety could lead to improved treatment acceptability. Healthcare providers, patients and care partners, and policymakers would therefore demand this form of convulsive therapy.Trial RegistrationClinical Trials Gov NCT03191058, Registered June 19, 2017

Inter-Method Reliability of Pulse Volume Related Measures Derived Using Finger-Photoplethysmography

2018 ◽  
Vol 32 (4) ◽  
pp. 182-190 ◽  
Author(s):  
Kenta Matsumura ◽  
Koichi Shimizu ◽  
Peter Rolfe ◽  
Masanori Kakimoto ◽  
Takehiro Yamakoshi
Keyword(s):  
Light Intensity ◽  
Adverse Effects ◽  
Light Source ◽  
Direct Current ◽  
Resting State ◽  
Current Component ◽  
Psychophysiological Measures ◽  
Pulse Volume ◽  
Optical Paths ◽  
Sensor Positions

Abstract. Pulse volume (PV) and its related measures, such as modified normalized pulse volume (mNPV), direct-current component (DC), and pulse rate (PR), derived from the finger-photoplethysmogram (FPPG), are useful psychophysiological measures. Although considerable uncertainties exist in finger-photoplethysmography, little is known about the extent of the adverse effects on the measures. In this study, we therefore examined the inter-method reliability of each index across sensor positions and light intensities, which are major disturbance factors of FPPG. From the tips of the index fingers of 12 participants in a resting state, three simultaneous FPPGs having overlapping optical paths were recorded, with their light intensity being changed in three steps. The analysis revealed that the minimum values of three coefficients of Cronbach’s α for ln PV, ln mNPV, ln DC, and PR across positions were .948, .850, .922, and 1.000, respectively, and that those across intensities were .774, .985, .485, and .998, respectively. These findings suggest that ln mNPV and PR can be used for psychophysiological studies irrespective of minor differences in sensor attachment positions and light source intensity, whereas and ln DC can also be used for such studies but under the condition of light intensity being fixed.

scholarly journals Efficacy and safety of early target-controlled plasma volume replacement with a balanced gelatine solution versus a balanced electrolyte solution in patients with severe sepsis/septic shock: study protocol, design, and rationale of a prospective, randomized, controlled, double-blind, multicentric, international clinical trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Gernot Marx ◽  
Kai Zacharowski ◽  
Carole Ichai ◽  
Karim Asehnoune ◽  
Vladimír Černý ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Septic Shock ◽  
Severe Sepsis ◽  
Plasma Volume ◽  
Volume Replacement ◽  
Efficacy And Safety ◽  
Volume Responsiveness ◽  
Double Blind ◽  
Link Type ◽  
Icu Discharge

Abstract Background Sepsis is associated with capillary leakage and vasodilatation and leads to hypotension and tissue hypoperfusion. Early plasma volume replacement is required to achieve haemodynamic stability (HDS) and maintain adequate tissue oxygenation. The right choice of fluids to be used for plasma volume replacement (colloid or crystalloid solutions) is still a matter of debate, and large trials investigating the use of colloid solutions containing gelatine are missing. This study aims to investigate the efficacy and safety of plasma volume replacement using either a combined gelatine-crystalloid regime (1:1 ratio) or a pure crystalloid regime. Methods This is a prospective, controlled, randomized, double-blind, international, multicentric phase IV study with two parallel groups that is planned to be conducted at European intensive care units (ICUs) in a population of patients with hypovolaemia in severe sepsis/septic shock. A total of 608 eligible patients will be randomly assigned to receive either a gelatine-crystalloid regime (Gelaspan® 4% and Sterofundin® ISO, B. Braun Melsungen AG, in a 1:1 ratio) or a pure crystalloid regime (Sterofundin® ISO) for plasma volume replacement. The primary outcome is defined as the time needed to achieve HDS. Plasma volume replacement will be target-controlled, i.e. fluids will only be administered to volume-responsive patients. Volume responsiveness will be assessed through passive leg raising or fluid challenges. The safety and efficacy of both regimens will be assessed daily for 28 days or until ICU discharge (whichever occurs first) as the secondary outcomes of this study. Follow-up visits/calls will be scheduled on day 28 and day 90. Discussion This study aims to generate evidence regarding which regimen—a gelatine-crystalloid regimen or a pure crystalloid regimen—is more effective in achieving HDS in critically ill patients with hypovolaemia. Study participants in both groups will benefit from the increased safety of target-controlled plasma volume replacement, which prevents fluid administration to already haemodynamically stable patients and reduces the risk of harmful fluid overload. Trial registration The European clinical trial database EudraCT 2015-000057-20 and the ClinicalTrials.gov Protocol Registration and Results System ClinicalTrials.gov NCT02715466. Registered on 17 March 2016.

Brexanolone: A Novel Drug for the Treatment of Postpartum Depression

2020 ◽  
pp. 089719002097962
Author(s):  
Edna Patatanian ◽  
David R. Nguyen
Keyword(s):  
Adverse Effects ◽  
Postpartum Depression ◽  
English Language ◽  
Neuronal Excitability ◽  
Data Extraction ◽  
Background Information ◽  
Pharmacologic Therapy ◽  
Loss Of Consciousness ◽  
Efficacy And Safety ◽  
Pubmed Search

Objectives: To review the pharmacology, efficacy, and safety of Brexanolone and define its role in the treatment of postpartum depression. Date Sources: A MEDLINE/PubMed search was conducted (1980-May 2020) using the following keywords: postpartum depression, antidepressants, pharmacologic therapy, drug therapy, and brexanolone to identify relevant articles. Study Selection/Data Extraction: Literature search was limited to human studies published in the English language. Phase I, II, and III studies evaluating the pharmacology, efficacy, safety of brexanolone for postpartum depression were included. Bibliographies of relevant articles evaluating postpartum depression and treatment were reviewed for additional citations and background information. Data Synthesis: Brexanolone is a soluble, proprietary, injectable formulation of allopregnanolone, a neuroactive steroid that modulates neuronal excitability. Allopregnanolone levels increase during pregnancy and decrease substantially after birth. These fluctuations have profound effects on anxiety and depression. Three clinical trials established the efficacy and safety of brexanolone in the treatment of postpartum depression. In all 3 trials, brexanolone had an acceptable safety profile and was well tolerated. The most common adverse effects were loss of consciousness, sedation, dry mouth, headache, dizziness, and flushing. Due to sudden loss of consciousness and excessive sedation, continuous pulse oximetry is recommended. Conclusion: Brexanolone has a novel mechanism of action and appears to be safe and effective for the treatment of moderate to severe postpartum depression. At present, high cost, serious adverse effects, and restricted access may limit its use in clinical practice.

scholarly journals PEP-CoV protocol: a PEP flute-self-care randomised controlled trial to prevent respiratory deterioration and hospitalisation in early COVID-19

BMJ Open ◽  
2021 ◽  
Vol 11 (6) ◽  
pp. e050582
Author(s):  
Annette Mollerup ◽  
Sofus Christian Larsen ◽  
Anita Selmer Bennetzen ◽  
Marius Henriksen ◽  
Mette Kildevaeld Simonsen ◽  
...  
Keyword(s):  
Randomised Controlled Trial ◽  
Hospital Admission ◽  
Usual Care ◽  
Pulmonary Disease ◽  
Controlled Trial ◽  
Self Care ◽  
Secondary Outcome ◽  
Link Type ◽  
Randomised Controlled ◽  
At Home

IntroductionInfection with SARS-CoV-2 may progress to severe pulmonary disease, COVID-19. Currently, patients admitted to hospital because of COVID-19 have better prognosis than during the first period of the pandemic due to improved treatment. However, the overall societal susceptibility of being infected makes it pivotal to prevent severe courses of disease to avoid high mortality rates and collapse of the healthcare systems. Positive expiratory pressure (PEP) self-care is used in chronic pulmonary disease and has been shown to prevent pneumonia in a high-risk cohort of patients with leukaemia. PEP flute self-care to prevent respiratory deterioration and hospitalisation in early COVID-19: a randomised trial (The PEP-CoV trial) examines the effectiveness on respiratory symptoms and need of hospital admission by regular PEP flute use among non-hospitalised individuals with confirmed SARS-CoV-2 infection and COVID-19 symptoms.Methods and analysisIn this randomised controlled trial, we hypothesise that daily PEP flute usage as add-on to usual care is superior to usual care as regards symptom severity measured by the COPD Assessment Test (CAT) at 30-day follow-up (primary outcome) and hospital admission through register data (secondary outcome). We expect to recruit 400 individuals for the trial. Participants in the intervention group receive a kit of 2 PEP flutes and adequate resistances and access to instruction videos. A telephone hotline offers possible contact to a nurse. The eight-item CAT score measures cough, phlegm, chest tightness, dyspnoea, activities of daily living at home, feeling safe at home despite symptoms, sleep quality and vigour. The CAT score is measured daily in both intervention and control arms by surveys prompted through text messages.Ethics and disseminationThe study was registered prospectively at www.clinicaltrials.gov on 27 August 2020 (NCT04530435). Ethical approval was granted by the local health research ethics committee (Journal number: H-20035929) on 23 July 2020. Enrolment of participants began on 6 October 2020. Results will be published in scientific journals.Trial registration numberNCT04530435; Pre-results.

scholarly journals Pulsed Shortwave Therapy in Cervical Osteoarthritis: an NSAID- Controlled, Randomized Clinical Trial

2021 ◽  
Author(s):  
A. Rachid El Mohammad ◽  
Sree Koneru ◽  
Richard Staelin ◽  
Kenneth McLeod ◽  
Omar Tabbouche ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Outcome Measures ◽  
Neck Disability Index ◽  
Primary Outcome Measure ◽  
Pain Medication ◽  
Secondary Outcome ◽  
Pain Duration ◽  
Cox 2 ◽  
Neck Disability ◽  
Pain At Rest

AbstractAssess treatment superiority of pulsed shortwave therapy (PSWT) against COX-2 NSAID therapy, in reducing disability and pain due to cervical osteoarthritis. Two hundred chronic pain suffers (average pain duration about 2 years) diagnosed with cervical osteoarthritis by radiological imaging were randomized into one of two treatment arms: COX-2 NSAID treatment; etoricoxib 60 mg/day for 4 weeks; or PSWT treatment worn 24 h/day for 4 weeks. The primary outcome measure was the 4-week score on the Neck Disability Index (NDI), a 10-question assessment on a 50-point scale. Secondary outcome measures included pain (at rest and during activity) measured on a visual analog scale (VAS) of 0–100 mm, dose count of rescue pain medication (paracetamol) use, and a treatment satisfaction rating. These 4-week scores were compared across the two arms to assess superiority. After 4 weeks of treatment, subjects in both study arms reported statistically significant (p < 0.0001) reductions in NDI, with final scores of 11.24-NSAID and 9.34-PSWT, VASrest, with final scores of 30.08-NSAID; 22.76-PSWT, and VASactivity, with final scores of 36.40-NSAID; 27.42-PSWT. The absolute reduction from baseline in NDI was significantly greater in the PSWT arm than NSAID arm (3.66 points; 95% CI 2.3 to 5.02; p < 0.0001). Similarly, the reductions from baseline in VASrest and VASactivity were significantly greater in the PSWT arm than NSAID arm (10.89 mm; 95% CI 6.90 to 14.87; p < 0.0001; and 12.05 mm; 95% CI 7.76 to 16.33; p < 0.0001, respectively). The PSWT arm used 50% less rescue pain medication. Eleven adverse effects were reported in the NSAID arm and zero in the PSWT arm. Both NSAID and PSWT treatments resulted in statistically significant improvements in quality of life (NDI) and reduction in pain (VAS) resulting from cervical osteoarthritis. However, the PSWT intervention showed superior improvements in all outcome measures when compared to the NSAID arm with no adverse effects. Clinicaltrials.gov (NCT03542955).

scholarly journals Assessment of a combined strategy of seasonal malaria chemoprevention and supplementation with vitamin A, zinc and Plumpy’Doz™ to prevent malaria and malnutrition in children under 5 years old in Burkina Faso: a randomized open-label trial (SMC-NUT)

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Paul Sondo ◽  
Marc Christian Tahita ◽  
Toussaint Rouamba ◽  
Karim Derra ◽  
Bérenger Kaboré ◽  
...  
Keyword(s):  
Vitamin A ◽  
Burkina Faso ◽  
Malaria Incidence ◽  
Primary Outcome Measure ◽  
Secondary Outcome ◽  
Micronutrient Deficiencies ◽  
Open Label ◽  
Link Type ◽  
Potential Factors ◽  
Combined Strategy

Abstract Background Malaria and malnutrition represent major public health concerns worldwide especially in Sub-Sahara Africa. Despite implementation of seasonal malaria chemoprophylaxis (SMC), an intervention aimed at reducing malaria incidence among children aged 3–59 months, the burden of malaria and associated mortality among children below age 5 years remains high in Burkina Faso. Malnutrition, in particular micronutrient deficiency, appears to be one of the potential factors that can negatively affect the effectiveness of SMC. Treating micronutrient deficiencies is known to reduce the incidence of malaria in highly prevalent malaria zone such as rural settings. Therefore, we hypothesized that a combined strategy of SMC together with a daily oral nutrients supplement will enhance the immune response and decrease the incidence of malaria and malnutrition among children under SMC coverage. Methods Children (6–59 months) under SMC coverage receiving vitamin A supplementation will be randomly assigned to one of the three study arms (a) SMC + vitamin A alone, (b) SMC + vitamin A + zinc, or (c) SMC + vitamin A + Plumpy’Doz™ using 1:1:1 allocation ratio. After each SMC monthly distribution, children will be visited at home to confirm drug administration and followed-up for 1 year. Anthropometric indicators will be recorded at each visit and blood samples will be collected for microscopy slides, haemoglobin measurement, and spotted onto filter paper for further PCR analyses. The primary outcome measure is the incidence of malaria in each arm. Secondary outcome measures will include mid-upper arm circumference and weight gain from baseline measurements, coverage and compliance to SMC, occurrence of adverse events (AEs), and prevalence of molecular markers of antimalarial resistance comprising Pfcrt, Pfmdr1, Pfdhfr, and Pfdhps. Discussion This study will demonstrate an integrated strategy of malaria and malnutrition programmes in order to mutualize resources for best impact. By relying on existing strategies, the policy implementation of this joint intervention will be scalable at country and regional levels. Trial registration ClinicalTrials.gov NCT04238845. Registered on 23 January 2020 https://clinicaltrials.gov/ct2/show/NCT04238845

scholarly journals Efficacy and safety of anti-epidermal growth factor receptor agents for the treatment of oesophageal cancer: a systematic review and meta-analysis

BMJ Open ◽  
2021 ◽  
Vol 11 (3) ◽  
pp. e046352
Author(s):  
Lijuan Zhang ◽  
Yanli Song ◽  
Nan Jiang ◽  
Yaqi Huang ◽  
Bo Dong ◽  
...  
Keyword(s):  
Systematic Review ◽  
Growth Factor ◽  
Outcome Measures ◽  
Oesophageal Cancer ◽  
Meta Analysis ◽  
Growth Factor Receptor ◽  
Cochrane Library ◽  
Secondary Outcome ◽  
Efficacy And Safety ◽  
Positive Effects

ObjectivesDespite remarkable advances in the treatment of oesophageal cancer (OC), the role of antiepidermal growth factor receptor (anti-EGFR) agents in treating OC remains controversial. Herein, a systematic review and meta-analysis were conducted to elucidate the efficacy and safety of anti-EGFR agents in patients with OC.DesignMeta-analysis of randomised controlled trials (RCTs) identified by searching the PubMed, Embase, Web of Science, ClinicalTrials.gov, Cochrane Library, Chinese Biology Medicine, China National Knowledge Infrastructure and Wanfang Data Knowledge Service Platform databases from inception to December 2019. We followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses guidelines.SettingRCTs from any country and healthcare setting.ParticipantsPatients with OC.InterventionsCombination therapy with anti-EGFR agents and conventional treatments versus conventional treatments alone in patients with OC.Primary and secondary outcome measuresOverall survival (OS) and progression-free survival (PFS) were primary outcome measures, and objective response rate (ORR), disease control rate (DCR) and treatment toxicities were secondary outcome measures.ResultsIn total, 25 RCTs comprising 3406 patients with OC were included. Overall, anti-EGFR treatment significantly improved the OS (HR: 0.81, 95% CI 0.74 to 0.89, p<0.00001), ORR (relative risk (RR): 1.33, 95% CI 1.16 to 1.52, p<0.0001) and DCR (RR: 1.22, 95% CI 1.11 to 1.34, p<0.0001) but not PFS (HR: 0.91, 95% CI 0.76 to 1.08, p=0.26). Anti-EGFR treatment was significantly associated with higher incidences of myelosuppression, diarrhoea, acne-like rash and hypomagnesaemia.ConclusionsOverall, anti-EGFR agents have positive effects on OS, the ORR and DCR in OC. However, considering the high incidence of adverse effects, such as myelosuppression, diarrhoea, acne-like rashes and hypomagnesaemia, careful monitoring of patients with OC is recommended during anti-EGFR treatment.Trial registration numberCRD42020169230.

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