proof of efficacy
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2021 ◽  
Vol 17 (S9) ◽  
Author(s):  
Auriane Maïza ◽  
Gael Le Douaron ◽  
Aida Muntsant Soria ◽  
Yong Li ◽  
Kithika Ramakrishnan ◽  
...  


Author(s):  
Shruti Vimal ◽  
Pratiksha Naval ◽  
Manoj Sawadker ◽  
Pallavi Bhomia ◽  
Neha Jadhav ◽  
...  

The recent pandemic due to Corona virus more popularly known as COVID 19 has reassessed the usefulness of historic convalescent plasma transfusion. (CPT) The CPT is one of the promising therapies in the current pandemic situation. This review was conducted to evaluate the effectiveness of CPT therapy in COVID 19 patients based on the publications reported till date. PubMed, EMBASE and Medline databases were screened up to 30 April 2021. All the records were screened as per the protocol eligibility criteria.  The main features of the studies reviewed were, convalescent plasma can reduce mortality in severely ill patients, an increase in neutralizing antibodies titre and disappearance of SARS CoV 2 RNA was observed in all the patients on CPT therapy and over all a beneficial effect on clinical symptoms after administration of CP.  Based on the review findings and the limited scientific data, CPT therapy in COVID 19 patients appear safe, clinically effective and reduces mortality. However, the need of a multicentre clinical trials, unequivocal proof of efficacy, effectiveness and the need for the standardisation of the CPT needs to be addressed immediately for the full utilisation of potential of CPT.



Cancers ◽  
2021 ◽  
Vol 13 (15) ◽  
pp. 3721
Author(s):  
Nicolas Desbaillets ◽  
Andreas Felix Hottinger

Glioblastoma is the most frequent and the most aggressive brain tumor. It is notoriously resistant to current treatments, and the prognosis remains dismal. Immunotherapies have revolutionized the treatment of numerous cancer types and generate great hope for glioblastoma, alas without success until now. In this review, the rationale underlying immune targeting of glioblastoma, as well as the challenges faced when targeting these highly immunosuppressive tumors, are discussed. Innovative immune-targeting strategies including cancer vaccines, oncolytic viruses, checkpoint blockade inhibitors, adoptive cell transfer, and CAR T cells that have been investigated in glioblastoma are reviewed. From a clinical perspective, key clinical trial findings and ongoing trials are discussed for each approach. Finally, limitations, either biological or arising from trial designs are analyzed, and strategies to overcome them are presented. Proof of efficacy for immunotherapy approaches remains to be demonstrated in glioblastoma, but our rapidly expanding understanding of its biology, its immune microenvironment, and the emergence of novel promising combinatorial approaches might allow researchers to finally fulfill the medical need for GBM patients.



2021 ◽  
pp. bjsports-2019-101970
Author(s):  
Dylan Morrissey ◽  
Matthew Cotchett ◽  
Ahmed Said J'Bari ◽  
Trevor Prior ◽  
Ian B Griffiths ◽  
...  

ObjectiveTo develop a best practice guide for managing people with plantar heel pain (PHP).MethodsMixed-methods design including systematic review, expert interviews and patient survey.Data sourcesMedline, Embase, CINAHL, SPORTDiscus, Cochrane Central Register of Controlled Trials, trial registries, reference lists and citation tracking. Semi-structured interviews with world experts and a patient survey.Eligibility criteriaRandomised controlled trials (RCTs) evaluating any intervention for people with PHP in any language were included subject to strict quality criteria. Trials with a sample size greater than n=38 were considered for proof of efficacy. International experts were interviewed using a semi-structured approach and people with PHP were surveyed online.ResultsFifty-one eligible trials enrolled 4351 participants, with 9 RCTs suitable to determine proof of efficacy for 10 interventions. Forty people with PHP completed the online survey and 14 experts were interviewed resulting in 7 themes and 38 subthemes. There was good agreement between the systematic review findings and interview data about taping (SMD: 0.47, 95% CI 0.05 to 0.88) and plantar fascia stretching (SMD: 1.21, 95% CI 0.78 to 1.63) for first step pain in the short term. Clinical reasoning advocated combining these interventions with education and footwear advice as the core self-management approach. There was good expert agreement with systematic review findings recommending stepped care management with focused shockwave for first step pain in the short-term (OR: 1.89, 95% CI 1.18 to 3.04), medium-term (SMD 1.31, 95% CI 0.61 to 2.01) and long-term (SMD 1.67, 95% CI 0.88 to 2.45) and radial shockwave for first step pain in the short term (OR: 1.66, 95% CI 1.00 to 2.76) and long term (OR: 1.78, 95% CI 1.07 to 2.96). We found good agreement to ‘step care’ using custom foot orthoses for general pain in the short term (SMD: 0.41, 95% CI 0.07 to 0.74) and medium term (SMD: 0.55, 95% CI 0.09 to 1.02).ConclusionBest practice from a mixed-methods study synthesising systematic review with expert opinion and patient feedback suggests core treatment for people with PHP should include taping, stretching and individualised education. Patients who do not optimally improve may be offered shockwave therapy, followed by custom orthoses.



Healthcare ◽  
2021 ◽  
Vol 9 (3) ◽  
pp. 257 ◽  
Author(s):  
Luís Carlos Matos ◽  
Jorge Pereira Machado ◽  
Fernando Jorge Monteiro ◽  
Henry Johannes Greten

Traditional Chinese medicine (TCM) is a systematic healthcare system developed from clinical experience based on a scientific model of regulation. TCM relies on unique theories and practices to treat diseases and enhance health. These practices include Chinese herbal medicine and dietetics, acupuncture and moxibustion, and other non-medication therapies such as Chinese bodywork or manual therapy, known as “Tuina”, and traditional biofeedback exercises, known as “Qigong” and “Taijiquan”. The integration of TCM in Western health systems and research requires a rational communicable theory, scientific proof of efficacy and safety, and quality control measures. Understanding the structural concepts of the TCM language makes possible the parallelism to Western physiology, and the inherent rational use of the reflex therapeutic systems, anti-inflammatory mechanisms and mental training involved, for example, in acupuncture and “Qigong”. The results of TCM clinical trials and fundamental research on its nature and mechanisms have encouraged the development and application of well-designed research strategies such as double blinding in acupucture to overcome limitations and resistances in integrating these practices into the existing biomedical paradigms of the West. This review aims to overview some TCM theoretical concepts and the evidence-based clinical application of TCM’s leading practices to create an easy-to-consult and condensed source of information, available for the healthcare community, facilitating the understanding and communication between conventional health professionals and TCM practitioners and acupuncturists.



Healthcare ◽  
2021 ◽  
Vol 9 (2) ◽  
pp. 177
Author(s):  
Luís Carlos Matos ◽  
Jorge Pereira Machado ◽  
Fernando Jorge Monteiro ◽  
Henry Johannes Greten

The integration of Traditional Chinese Medicine (TCM) in Western health systems and research requires a rational communicable theory, scientific proof of efficacy and safety, and quality control measures. The existence of clear definitions and the diagnosis standardization are critical factors to establish the patient’s vegetative functional status accurately and, therefore, systematically apply TCM therapeutics such as the stimulation of reflex skin areas known as acupoints. This science-based conceptualization entails using validated methods, or even developing new systems able to parameterize the diagnosis and assess TCM related effects by objective measurements. Traditionally, tongue and pulse diagnosis and the functional evaluation of action points by pressure sensitivity and physical examination may be regarded as essential diagnostic tools. Parameterizing these techniques is a future key point in the objectification of TCM diagnosis, such as by electronic digital image analysis, mechanical pulse diagnostic systems, or the systematic evaluation of acupoints’ electrophysiology. This review aims to demonstrate and critically analyze some achievements and limitations in the clinical application of device-assisted TCM diagnosis systems to evaluate functional physiological patterns. Despite some limitations, tongue, pulse, and electrophysiological diagnosis devices have been reported as a useful tool while establishing a person’s functional status.



Author(s):  
Phani Kumar Devarasetti ◽  
Liza Rajasekhar ◽  
Ritasman Baisya ◽  
K. S. Sreejitha ◽  
Yerram Keerthi Vardhan
Keyword(s):  


Animals ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. 1450 ◽  
Author(s):  
Meredith Sheil ◽  
Adam Polkinghorne

Analgesic products for piglet castration are critically needed. This requires extensive animal experimentation such as to meet regulatory-required proof of efficacy. At present, there are no validated methods of assessing pain in neonatal piglets. This poses challenges for investigators to optimize trial design and to meet ethical obligations to minimize the number of animals needed. Pain in neonatal piglets may be subtle, transient, and/or variably expressed and, in the absence of validated methods, investigators must rely on using a range of biochemical, physiological and behavioural variables, many of which appear to have very low (or unknown) sensitivity or specificity for documenting pain, or pain-relieving effects. A previous systematic review of this subject was hampered by the high degree of variability in the literature base both in terms of methods used to assess pain and pain mitigation, as well as in outcomes reported. In this setting we provide a narrative review to assist in determining the optimal methods currently available to detect piglet pain during castration and methods to mitigate castration-induced pain. In overview, the optimal outcome variables identified are nociceptive motor and vocal response scores during castration and quantitative sensory-threshold response testing and pain-associated behaviour scores following castration.



Author(s):  
Meredith Sheil ◽  
Adam Polkinghorne

Analgesic products for piglet castration are critically needed. This requires extensive animal experimentation such as to meet regulatory-required proof of efficacy. At present, there are no validated methods of assessing pain in neonatal piglets. This poses challenges for investigators to optimize trial design and to meet ethical obligations to minimize the number of animals needed. Pain in neonatal piglets may be subtle, transient and / or variably expressed and, in the absence of validated methods, investigators must rely on using a range of biochemical, physiological and behavioural variables, many of which appear to have very low (or unknown) sensitivity or specificity for documenting pain, or pain-relieving effects. A previous systematic review of this subject was hampered by the high degree of variability in the literature base both in terms of methods used to assess pain and pain mitigation, as well as in outcomes reported. In this setting we provide a narrative review, to assist in determining the optimal methods currently available to detect piglet pain during castration and methods to mitigate castration-induced pain. In overview, the optimal outcome variables identified are nociceptive motor and vocal response scores during castration, and quantitative sensory-threshold response testing and pain-associated behaviour scores following castration.



Author(s):  
Meredith Sheil ◽  
Adam Polkinghorne

Analgesic products for piglet castration are critically needed. This requires extensive animal experimentation such as to meet regulatory-required proof of efficacy. At present, there are no validated methods of assessing pain in neonatal piglets. This poses challenges for investigators to optimize trial design and to meet ethical obligations to minimize the number of animals needed. Pain in neonatal piglets may be subtle, transient and / or variably expressed and, in the absence of validated methods, investigators must rely on using a range of biochemical, physiological and behavioural variables, many of which appear to have very low (or unknown) sensitivity or specificity for documenting pain, or pain-relieving effects. A previous systematic review of this subject was hampered by the high degree of variability in the literature base both in terms of methods used to assess pain and pain mitigation, as well as in outcomes reported. In this setting we provide a narrative review, to assist in determining the optimal methods currently available to detect piglet pain during castration and methods to mitigate castration-induced pain. In overview, the optimal outcome variables identified are nociceptive motor and vocal response scores during castration, and quantitative sensory-threshold response testing and pain-associated behaviour scores following castration.



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