Is there a role for modified probiotics as beneficial microbes: a systematic review of the literature

2017 ◽  
Vol 8 (5) ◽  
pp. 739-754 ◽  
Author(s):  
L. Zorzela ◽  
S.K. Ardestani ◽  
L.V. McFarland ◽  
S. Vohra

Our objective was to conduct a systematic review and meta-analysis for the use of modified (heat-killed or sonicated) probiotics for the efficacy and safety to prevent and treat various diseases. Recent clinical research has focused on living strains of probiotics, but use in high-risk patients and potential adverse reactions including bacteremia has focused interest on alternatives to the use of live probiotics. We searched MEDLINE/PubMed, Embase, Cochrane Central Register of Controlled Trials, CINAHL, Alt Health Watch, Web of Science, Scopus, PubMed, from inception to February 14, 2017 for randomised controlled trials involving modified probiotic strains. The primary outcome was efficacy to prevent or treat disease and the secondary outcome was incidence of adverse events. A total of 40 trials were included (n=3,913): 14 trials (15 arms with modified probiotics and 20 control arms) for the prevention of diseases and 26 trials (29 arms with modified probiotics and 32 control arms) for treatment of various diseases. Modified microbes were compared to either placebo (44%), or the same living probiotic strain (39%) or to only standard therapies (17%). Modified microbes were not significantly more or less effective than the living probiotic in 86% of the preventive trials and 69% of the treatment trials. Modified probiotic strains were significantly more effective in 15% of the treatment trials. Incidence rates of adverse events were similar for modified and living probiotics and other control groups, but many trials did not collect adequate safety data. Although several types of modified probiotics showed significant efficacy over living strains of probiotics, firm conclusions could not be reached due to the limited number of trials using the same type of modified microbe (strain, daily dose and duration) for a specific disease indication. Further research may illuminate other strains of modified probiotics that may have potential as clinical biotherapeutics.

BMJ ◽  
2021 ◽  
pp. m4825 ◽  
Author(s):  
Giovanni E Ferreira ◽  
Andrew J McLachlan ◽  
Chung-Wei Christine Lin ◽  
Joshua R Zadro ◽  
Christina Abdel-Shaheed ◽  
...  

Abstract Objective To investigate the efficacy and safety of antidepressants for back and osteoarthritis pain compared with placebo. Design Systematic review and meta-analysis. Data sources Medline, Embase, Cochrane Central Register of Controlled Trials, CINAHL, International Pharmaceutical Abstracts, ClinicalTrials.gov, and the World Health Organization International Clinical Trials Registry Platform from inception to 15 November and updated on 12 May 2020. Eligibility criteria for study selection Randomised controlled trials comparing the efficacy or safety, or both of any antidepressant drug with placebo (active or inert) in participants with low back or neck pain, sciatica, or hip or knee osteoarthritis. Data extraction and synthesis Two independent reviewers extracted data. Pain and disability were primary outcomes. Pain and disability scores were converted to a scale of 0 (no pain or disability) to 100 (worst pain or disability). A random effects model was used to calculate weighted mean differences and 95% confidence intervals. Safety (any adverse event, serious adverse events, and proportion of participants who withdrew from trials owing to adverse events) was a secondary outcome. Risk of bias was assessed with the Cochrane Collaboration’s tool and certainty of evidence with the grading of recommendations assessment, development and evaluation (GRADE) framework. Results 33 trials (5318 participants) were included. Moderate certainty evidence showed that serotonin-noradrenaline reuptake inhibitors (SNRIs) reduced back pain (mean difference −5.30, 95% confidence interval −7.31 to −3.30) at 3-13 weeks and low certainty evidence that SNRIs reduced osteoarthritis pain (−9.72, −12.75 to −6.69) at 3-13 weeks. Very low certainty evidence showed that SNRIs reduced sciatica at two weeks or less (−18.60, −31.87 to −5.33) but not at 3-13 weeks (−17.50, −42.90 to 7.89). Low to very low certainty evidence showed that tricyclic antidepressants (TCAs) did not reduce sciatica at two weeks or less (−7.55, −18.25 to 3.15) but did at 3-13 weeks (−15.95, −31.52 to −0.39) and 3-12 months (−27.0, −36.11 to −17.89). Moderate certainty evidence showed that SNRIs reduced disability from back pain at 3-13 weeks (−3.55, −5.22 to −1.88) and disability due to osteoarthritis at two weeks or less (−5.10, −7.31 to −2.89), with low certainty evidence at 3-13 weeks (−6.07, −8.13 to −4.02). TCAs and other antidepressants did not reduce pain or disability from back pain. Conclusion Moderate certainty evidence shows that the effect of SNRIs on pain and disability scores is small and not clinically important for back pain, but a clinically important effect cannot be excluded for osteoarthritis. TCAs and SNRIs might be effective for sciatica, but the certainty of evidence ranged from low to very low. Systematic review registration PROSPERO CRD42020158521.


2017 ◽  
Vol 05 (01) ◽  
pp. E67-E75 ◽  
Author(s):  
Ashok Shiani ◽  
Seth Lipka ◽  
Andrew Lai ◽  
Andrea Rodriguez ◽  
Christian Andrade ◽  
...  

Abstract Background and study aims Carbon dioxide (CO2) insufflation has been suggested to be an ideal alternative to room air insufflation to reduce trapped air within the bowel lumen after balloon assisted enteroscopy (BAE). We performed a systematic review and meta-analysis to assess the safety and efficacy of utilizing CO2 insufflation as compared to room air during BAE. Patients and methods The primary outcome is mean change in visual analog scale (VAS; 10 cm) at 1, 3, and 6 hours to assess pain. Secondary outcomes include insertion depth (anterograde or retrograde), adverse events, total enteroscopy rate, diagnostic yield, mean anesthetic dosage, and PaCO2 at procedure completion. We searched MEDLINE and the Cochrane Central Register of Controlled Trials (CENTRAL) from inception until May 2015. Multiple independent extractions were performed, the process was executed as per the standards of the Cochrane collaboration. Results Four randomized controlled trials (RCTs) were included in the meta-analysis. VAS at 6 hours favored CO2 over room air (MD 0.13; 95 % CI 0.01, 0.25; p = 0.03). Anterograde insertion depth (cm) was improved in the CO2 group (MD, 58.2; 95 % CI 17.17, 99.23; p = 0.005), with an improvement in total enteroscopy rate in the CO2 group (RR 1.91; 95 % CI 1.20, 3.06; p = 0.007). Mean dose of propofol (mg) favored CO2 compared to air (MD, – 70.53; 95 % CI – 115.07, – 25.98; P = 0.002). There were no differences in adverse events in either group. Conclusions Despite the ability of CO2 to improve insertion depth and decrease amount of anesthesia required, further randomized control trials are needed to determine the agent of choice for insufflation in balloon assisted enteroscopy.


2016 ◽  
Vol 70 (11) ◽  
pp. 1221-1229 ◽  
Author(s):  
T Isomura ◽  
S Suzuki ◽  
H Origasa ◽  
A Hosono ◽  
M Suzuki ◽  
...  

Abstract There remain liver-related safety concerns, regarding potential hepatotoxicity in humans, induced by green tea intake, despite being supposedly beneficial. Although many randomized controlled trials (RCTs) of green tea extracts have been reported in the literature, the systematic reviews published to date were only based on subjective assessment of case reports. To more objectively examine the liver-related safety of green tea intake, we conducted a systematic review of published RCTs. A systematic literature search was conducted using three databases (PubMed, EMBASE and Cochrane Central Register of Controlled Trials) in December 2013 to identify RCTs of green tea extracts. Data on liver-related adverse events, including laboratory test abnormalities, were abstracted from the identified articles. Methodological quality of RCTs was assessed. After excluding duplicates, 561 titles and abstracts and 119 full-text articles were screened, and finally 34 trials were identified. Of these, liver-related adverse events were reported in four trials; these adverse events involved seven subjects (eight events) in the green tea intervention group and one subject (one event) in the control group. The summary odds ratio, estimated using a meta-analysis method for sparse event data, for intervention compared with placebo was 2.1 (95% confidence interval: 0.5–9.8). The few events reported in both groups were elevations of liver enzymes. Most were mild, and no serious liver-related adverse events were reported. Results of this review, although not conclusive, suggest that liver-related adverse events after intake of green tea extracts are expected to be rare.


2013 ◽  
Vol 2013 ◽  
pp. 1-9 ◽  
Author(s):  
Hui-ru Jiang ◽  
Shuang Ni ◽  
Jin-long Li ◽  
Miao-miao Liu ◽  
Ji Li ◽  
...  

The evidence of acupressure is limited in the management of dysmenorrhea. To evaluate the efficacy of acupressure in the treatment of primary dysmenorrhea based on randomized controlled trials (RCTs), we searched MEDLINE, the Chinese Biomedical Database (CBM), and the Cochrane Central Register of Controlled Trials (CENTRAL) databases from inception until March 2012. Two reviewers independently selected articles and extracted data. Statistical analysis was performed with RevMan 5.1 software. Eight RCTs were identified from the retrieved 224 relevant records. Acupressure improved pain measured with VAS (−1.41 cm 95% CI [−1.61, −1.21]), SF-MPQ at the 3-month followup (WMD −2.33, 95% CI [−4.11, −0.54]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]), and MDQ at the 3-month followup (WMD −2.31, 95% CI [−3.74, −0.87]) and 6-month followup (WMD −4.67, 95% CI [−7.30, −2.04]). All trials did not report adverse events. These results were limited by the methodological flaws of trials.


10.2196/22821 ◽  
2020 ◽  
Vol 9 (10) ◽  
pp. e22821
Author(s):  
Negin Hesam-Shariati ◽  
Wei-Ju Chang ◽  
James H McAuley ◽  
Andrew Booth ◽  
Zina Trost ◽  
...  

Background Chronic pain is a global health problem, affecting around 1 in 5 individuals in the general population. The understanding of the key role of functional brain alterations in the generation of chronic pain has led researchers to focus on pain treatments that target brain activity. Electroencephalographic neurofeedback attempts to modulate the power of maladaptive electroencephalography frequency powers to decrease chronic pain. Although several studies have provided promising evidence, the effect of electroencephalographic neurofeedback on chronic pain is uncertain. Objective This systematic review aims to synthesize the evidence from randomized controlled trials to evaluate the analgesic effect of electroencephalographic neurofeedback. In addition, we will synthesize the findings of nonrandomized studies in a narrative review. Methods We will apply the search strategy in 5 electronic databases (Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, PsycInfo, and CINAHL) for published studies and in clinical trial registries for completed unpublished studies. We will include studies that used electroencephalographic neurofeedback as an intervention for people with chronic pain. Risk-of-bias tools will be used to assess methodological quality of the included studies. We will include randomized controlled trials if they have compared electroencephalographic neurofeedback with any other intervention or placebo control. The data from randomized controlled trials will be aggregated to perform a meta-analysis for quantitative synthesis. The primary outcome measure is pain intensity assessed by self-report scales. Secondary outcome measures include depressive symptoms, anxiety symptoms, and sleep quality measured by self-reported questionnaires. We will investigate the studies for additional outcomes addressing adverse effects and resting-state electroencephalography analysis. Additionally, all types of nonrandomized studies will be included for a narrative synthesis. The intended and unintended effects of nonrandomized studies will be extracted and summarized in a descriptive table. Results Ethics approval is not required for a systematic review, as there will be no patient involvement. The search for this systematic review commenced in July 2020, and we expect to publish the findings in early 2021. Conclusions This systematic review will provide recommendations for researchers and health professionals, as well as people with chronic pain, about the evidence for the analgesic effect of electroencephalographic neurofeedback. Trial Registration International Prospective Register of Systematic Reviews (PROSPERO) CRD42020177608; https://www.crd.york.ac.uk/PROSPERO/display_record.php?RecordID=177608 International Registered Report Identifier (IRRID) PRR1-10.2196/22821


BMJ Open ◽  
2020 ◽  
Vol 10 (8) ◽  
pp. e039366
Author(s):  
Luda Feng ◽  
Ning Liang ◽  
Tingting Li ◽  
Qinyu Yang ◽  
Ping Jiang ◽  
...  

IntroductionIntracerebral haemorrhage (ICH) is a life-threatening condition with no effective internal treatment options. However, edaravone is a promising therapeutic agent, although its beneficial effects are inconclusive based on previous systematic reviews and meta-analyses. While several trials in the last 8 years have reported the favourable long-term functional outcomes, a few reports indicated edaravone to be associated with an increase in adverse events.Methods and analysisThis protocol was performed in accordance with the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols. We will perform the comprehensive and manual search for published articles, ongoing trials, dissertations and grey literature. The following databases will be searched from inception to 23 April 2020: Medline, Embase, the Cochrane Central Register of Controlled Trials, China National Knowledge Infrastructure, Chinese scientific periodical database of VIP INFORMATION, Wanfang Data and SinoMed, with no language restrictions. All randomised controlled trials that (1) compared edaravone with placebo or no treatment, and (2) compared edaravone plus routine treatment or cointervention with routine treatment or cointervention for treating acute ICH will be included. Mortality and long-term dependency will be the primary outcomes. The incidence of adverse events will be assessed for safety evaluation. Two reviewers in pairs will independently carry out the article selection, data extraction and quality assessment. Assessment of the risk of bias and data synthesis will be performed using software Review Manager V.5.3. Finally, we will use the Grading of Recommendations Assessment, Development and Evaluation approach to evaluate the quality of the overall evidence.Ethics and disseminationThere are no ethical considerations associated with this updated systematic review and meta-analysis. The findings will be disseminated in peer-reviewed journals or conference presentations.PROSPERO registration numberCRD42019147801.


2010 ◽  
Vol 37 (6) ◽  
pp. 1096-1104 ◽  
Author(s):  
JASVINDER A. SINGH ◽  
SHAHRZAD NOORBALOOCHI ◽  
GURKIRPAL SINGH

Objective.To perform a Cochrane systematic review of benefit (American College of Rheumatology 50% improvement criteria; ACR50) and safety (adverse events and withdrawals) of golimumab in patients with rheumatoid arthritis (RA).Methods.We searched the Cochrane Central Register of Controlled Trials (CENTRAL), OVID Medline, CINAHL, Embase, Science Citation Index (Web of Science), and Current Controlled Trials databases for randomized or controlled clinical trials of golimumab compared to placebo or disease-modifying antirheumatic drug in adults with RA. Two authors independently selected appropriate studies and abstracted study characteristics and safety and efficacy data and performed risk-of-bias assessment. We calculated mean differences for continuous measures, and relative risks for categorical measures.Results.Four randomized controlled trials with 1231 golimumab-treated and 483 placebo-treated patients were included. Of these, 436 were treated with golimumab at 50 mg every 4 weeks [a dosage approved by the US Food and Drug Administration (FDA)]. At an average of 4–6 months, compared to patients treated with placebo and methotrexate (MTX), patients treated with the FDA-approved dosage of golimumab and MTX were 2.6 times more likely to reach ACR50 (p = 0.005, 95% CI 1.3, 4.9; absolute percentage, 38% vs 15%) and 0.5 times as likely to have overall withdrawals (p = 0.005, 95% CI 0.3, 0.8; absolute percentage, 5% vs 10%). Golimumab-treated patients were significantly more likely than those taking placebo to achieve remission (22% vs 4%; p < 0.00001), and to have improvement in functional ability on the Health Assessment questionnaire [0.2 points lower (p < 0.00001, 95% CI 0.25, 0.15); absolute risk difference, −20% (95% CI −25% to −15%); relative percentage difference, −11% (95% CI −14% to −8.3%)]. The studies were too small and short to be powered sufficiently for safety outcomes, but no substantive statistically significant differences were noted between golimumab and placebo regarding adverse events, serious adverse events, infections, serious infections, lung infections, tuberculosis, cancer, withdrawals due to adverse events, and withdrawals due to inefficacy and deaths.Conclusion.At the approved dosage, in patients with active RA taking background MTX, golimumab is significantly more beneficial than placebo. The short-term safety profile is reasonable. Longterm surveillance studies are needed for safety assessment.


2014 ◽  
Vol 17;1 (1;17) ◽  
pp. 1-8
Author(s):  
Ou Jin Zheng

Background: Randomized clinical trials assessing the efficacy and tolerability of tonabersat compared with placebo as prophylaxis for migraine were systematically reviewed in this study. By analyzing all available data, we aimed to establish an overall estimate of any association in order to more accurately inform clinicians and care-givers about how to prevent migraines. Objective: To evaluate the efficacy and tolerability of tonabersat when it is used for migraine prevention. Study Design: Systematic review of tonabersat for migraine prophylaxis. Methods: Computerized database search of The Cochrane Pain, Palliative & Supportive Care Trials Register, The Cochrane Central Register of Controlled Trials (CENTRAL, The Cochrane Library), Pubmed, and EMBASE for randomized, double-blind, placebo-controlled trials on tonabersat for migraine until January, 2013. We also searched the ongoing trials. We did not impose any language restrictions. The quality assessment and clinical relevance criteria utilized were the Cochrane Pain, Palliative & Supportive Care review group criteria as utilized for randomized trials. Outcome Measures: The primary outcome measure was the change in mean number of migraine headache days. The secondary outcome measures were change in attacks, responder rates, the reduction of the consumption of rescue medication, and adverse events. Results: For this systematic review, 133 studies were identified. Of these, 131 studies were excluded, and a total of 2 studies (after removal of duplicate publications) met inclusion criteria for methodological quality assessment with the randomized trial study. The evidence for tonabersat for migration prophylaxis failed to demonstrate a reduction when compared to placebo because of a lack of evidence. But the good tolerability supports further exploration of tonabersat in the prevention of migraine attacks. Limitations: The limitation of this systematic review was a lack of available evidence. Conclusion: There is fair evidence for migraine prophylaxis, but a lack of available evidence for tonabersat for migraine prophylaxis. Although tonabersat failed to demonstrate a significantly greater reduction of migraine headache days than placebo, it was well tolerated. Future work should further investigate the utility of tonabersat in the preventive management of migraine. Key words: Systematic review, tonabersat, migraine, prophylaxis


2020 ◽  
Vol 2 ◽  
pp. 25
Author(s):  
Stephanie Haugh ◽  
Laura O'Connor ◽  
Brian Slattery ◽  
Michelle Hanlon ◽  
Jack Flynn ◽  
...  

Introduction: There is increasing evidence for the use of psychotherapies, including cognitive behavioural therapy, acceptance and commitment therapy, and mindfulness based stress reduction therapy, as an approach to management of chronic pain. Similarly, online psychotherapeutic interventions have been shown to be efficacious, and to arguably overcome practical barriers associated with traditional face-to-face treatment for chronic pain. This is a protocol for a systematic review and network meta-analysis aiming to evaluate and rank psychotherapies (delivered in person and online) for chronic pain patients. Methods/ design: Four databases, namely the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE and PsycINFO will be searched from inception. Randomised controlled trials that have evaluated psychological interventions for pain management delivered online or in person will be included in the review. Data will be independently extracted in duplicate and the Cochrane Collaboration Risk of Bias Tool will be used to assess study quality. Measures of pain interference will be extracted as the primary outcome and measures of psychological distress will be extracted as the secondary outcome. A network meta-analysis will generate indirect comparisons of psychotherapies across treatment trials. Rankings of psychotherapies for chronic pain will be made available.   Discussion: A variety of psychotherapies, delivered both online and in person, have been used in an attempt to help manage chronic pain. Although occasional head to head trials have been conducted, little evidence exists to help identify which psychotherapy is most effective in reducing pain interference. The current review will address this gap in the literature and compare the psychotherapies used for internet delivered and in person interventions for chronic pain in relation to the reduction of pain interference and psychological distress. Results will provide a guide for clinicians when determining treatment course and will inform future research into psychotherapies for chronic pain. PROSPERO registration: CRD42016048518 01/11/16


2021 ◽  
pp. emermed-2020-210464
Author(s):  
Hamza Malik ◽  
Andrew Appelboam ◽  
Michael Nunns

ObjectiveTo conduct a systematic review of the clinical literature to determine whether ultrasound can be used to improve the reduction of distal radius fractures in adults in the ED.MethodologyA study protocol was registered on PROSPERO. EMBASE, PubMed/MEDLINE, the Cochrane Central Register of Controlled Trials and ClinicalTrials.gov of the US National Library of Medicine were searched for studies evaluating ultrasound-assisted distal radial fracture reductions in comparison with standard care. The primary outcome of interest was manipulation success rates, defined as the proportion of fracture manipulations resulting in acceptable anatomical alignment, with secondary outcome being subsequent surgical intervention rates in ultrasound and standard care group of patients.Results248 were screened at title and abstract, and 10 studies were included for a narrative synthesis. The quality of this evidence is limited but suggests ultrasound is accurate in determining distal radius fracture reduction and may improve the quality of reduction compared with standard care. However, there is insufficient evidence to determine whether this affects the rate of subsequent surgical intervention or functional outcome.ConclusionThere is a lack of evidence that using ultrasound in the closed reduction of distal radius fractures benefits patients. Properly conducted randomised controlled trials with patient-orientated outcomes are crucial to investigate this technology.


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