Systematic review of randomised controlled trials:Probiotics for functional constipation

AIM:To systematically evaluate and update evidence on the efficacy and safety of probiotic supplementation for the treatment of constipation. METHODS:The MEDLINE,EMBASE,CINAHL,and Cochrane Library databases were searched in May 2009 for randomised controlled trials(RCTs)performed in paediatric or adult populations related to the study aim. RESULTS:We included five RCTs with a total of 377 subjects(194 in the experimental group and 183 in the control group).The participants were adults (three RCTs,n=266)and children(two RCTs,n= 111)with constipation.In adults,data suggests a favourable effect of treatment with Bifidobacterium lactis DN-173 010,Lactobacillus casei Shirota,and Escherichia coli Nissle 1917 on defecation frequency and stool consistency.In children,L.casei rhamnosusLcr35,but not L.rhamnosus GG,showed a beneficial effect. CONCLUSION:Until more data are available,we believe the use of probiotics for the treatment of constipation condition should be considered investigational.

Multicenter randomised controlled trial comparing the high definition white light endoscopy and the bright narrow band imaging for colon polyps

AIM To compare high definition white light endoscopy and bright narrow band imaging for colon polyps' detection rates. METHODS Patients were randomised to high definition white light endoscopy(HD-WLE) or the bright narrow band imaging(b NBI) during withdrawal of the colonoscope. Polyps identified in either mode were characterised using b NBI with dual focus(b NBI-DF) according to the Sano's classification. The primary outcome was to compare adenoma detection rates(ADRs) between the two arms. The secondary outcome was to assess the negative predictive value(NPV) in differentiating adenomas from hyperplastic polyps for diminutive rectosigmoid lesions.RESULTS A total of 1006 patients were randomised to HD-WLE(n = 511) or b NBI(n = 495). The mean of adenoma per patient was 1.62 and 1.84, respectively. The ADRs in b NBI and HD-WLE group were 37.4% and 39.3%, respectively. When adjusted for withdrawal time(OR = 1.19, 95%CI: 1.15-1.24, P < 0.001), the use of b NBI was associated with a reduced ADR(OR = 0.69, 95%CI: 0.52-0.92). Nine hundred and thirty three polyps(86%) in both arms were predicted with high confidence. The sensitivity(Sn), specificity(Sp), positive predictive value and NPV in differentiating adenomatous from non-adenomatous polyps of all sizes were 95.9%, 87.2%, 94.0% and 91.1% respectively. The NPV in differentiating an adenoma from hyperplastic polyp using b NBI-DF for diminutive rectal polyps was 91.0%.CONCLUSION ADRs did not differ between b NBI and HD-WLE, however HD-WLE had higher ADR after adjustment of withdrawal time. b NBI surpassed the PIVI threshold for diminutive polyps.

Adjunctive Peony-Glycyrrhiza decoction for antipsychotic-induced hyperprolactinaemia:a meta-analysis of randomised controlled trials

Background Hyperprolactinaemia is a common adverse effect of antipsychotics （APs）. The results of Peony-Glycyrrhiza decoction （PGD） as a potentially useful adjunctivetreatment for hyperprolactinaemia are inconsistent.Aim This meta-analysis of randomised controlled trials （RCTs） examined the effcacy and safety of adjunctive PGDtherapy for AP-induced hyperprolactinaemia.Methods English （PubMed, Embase, Cochrane Library, PsycINFO） and Chinese （Chinese National Knowledge Infrastructure, Wanfang Data） databases were systematicallysearched up to 10 June 2018. The inclusion criteria were based on PICOS-Participants： adult patients with schizophrenia; Intervention： PGD plus APs; Comparison： APs plus placebo or AP monotherapy; Outcomes： effcacy and safety; Study design： RCTs. The weighted mean difference （WMD） and risk ratio （RR） along with their 95% CIs were calculated using Review Manager （RevMan） V.5.3 software.Results Five RCTs （n=450） were included and analysed. Two RCTs （n=140） were double-blind and four RCTs （n=409） reported ‘random’ assignment with specifc description. The PGD group showed a signifcantly lower serum prolactin level at endpoint than the control group （n=380, WMD： ？32.69 ng/mL （95% CI -41.66 to 23.72）, p〈0.00001, I2=97%）. Similarly, the superiority of PGD over the control groups was also found in the improvement of hyperprolactinaemia-related symptoms. No difference was found in the improvement of psychiatric symptoms assessed by the Positive and Negative Syndrome Scale （n=403, WMD： -0.62 （95% CI -2.38 to 1.15）, p=0.49, I^2=0%）. There were similar rates of all-cause discontinuation （n=330, RR 0.93 （95% CI 0.63 to 1.37）, p=0.71, I^2=0%） and adverse drug reactions between the two groups. According to the Grading of Recommendations Assessment, Development and Evaluation approach, the level of evidence of primary and secondary outcomes ranged from ‘very low’ （14.3%）, ‘low’ （42.8%）, ‘moderate’ （14.3%）, to ‘high’ （28.6%）.Conclusions Current evidence supports the adjunctive use of PGD to suppress elevated prolactin and improve prolactin-induced symptoms without signifcant adverse events in adult patients with AP-induced hyperprolactinaemia. High-quality RCTs with longer duration are needed to confrm these fndings.

Biodegradable stent or balloon dilatation for benign oesophageal stricture: Pilot randomised controlled trial

AIM: To undertake a randomised pilot study comparing biodegradable stents and endoscopic dilatation in patients with strictures.

Acupuncture of different stimulation for the treatment of neck type cervical spondylosis:a randomised controlled trial

Objective:To observe the difference in clinical efficacy of acupuncture with strong and weak stimulation in treating neck type cervical spondylosis.Methods:64 patients with neck type cervical spondylosis were randomly divided into strong stimulation group and weak stimulation group,with 32 cases in each group.The acupoints selected are Jingjiaji 5-7(cervical acupoints EX-B2 C5-C7),Tianzhu(BL10)on both sides,Houxi(SI3)on both sides,Hegu(LI4)on both sides,Geshu(BL17)on both sides,and Ashi.In the strong stimulation group,deep needling with 0.25 mm×40 mm milli-needle was performed,with a mild reinforcing-reducing method.The twisting angle was 90°-180°,the frequency was 60-90 times/min,and the needles were applied for 1 min at each point.Keep the needle for 30 minutes,twisting was performed every 10 min during the retention period.Change hands once.In the weak stimulation group,shallow acupuncture with a 0.18 mm×40 mm milli-needle was performed,with a mild reinforcing-reducing method,with a twisting angle of 60°-90°,a frequency of 30-60 times/min,and acupuncture for 10 seconds at each acupoint.Keep the needle for 30 minutes,and no needle during the retention period.Patients in both groups were treated once every 1 to 2 days,3 times a week for 2 weeks,and followed up for 1 month after all treatments.The two groups of patients were compared before and after treatment and during follow-up.The McGill pain questionnaire score and the cervical spine dysfunction index score were compared to determine the clinical efficacy.Statistical analysis was performed using SPSS 22.0 statistical software.Results:1 case drop-out in the strong stimulation group and 1 case in the weak stimulation group.The total effective rate of the strong stimulation group was 90.32%,the total effective rate of the weak stimulation group was 83.87%,and the total effective rate of the strong stimulation group was higher than that of the weak stimulation group(P<0.05).The total scores of the short-form McGill pain questionnaire,the VAS score,and the cervical spine dysfunction index scores of the two groups of patients were significantly lower than those of this group before treatment,and the difference was statistically significant(P<0.05).The total scores of the short-form McGill pain questionnaire,visual analogue scale score,and cervical spine dysfunction index scores of the strong stimulation group after treatment and follow-up were significantly lower than those of the weak stimulation group(P<0.05).Conclusion:Acupuncture with strong and weak stimulation can effectively treat patients with cervical spondylosis,and deep acupuncture with filiform needles and strong stimulation have better effect.

An intensive and personalised care planning programme improves clinical outcomes in patients with diabetic retinopathy:a pilot randomised controlled trial

Background:Using a pilot randomised controlled trial(RCT),to assess the short-term effectiveness of a structured diabetic retinopathy(DR)-specific,intensive,and personalised care planning(DR-IPCP)intervention on diabetes control outcomes in Singaporeans with poorly controlled type 2 diabetes.Methods:Eighteen individuals with mild-moderate DR and poor glycemic control[HbA1c≥64 mmol/mol(≥8.0%)over two consecutive 6-month readings]were randomized to DR-IPCP(n=9)or usual care(UC,n=9).The intervention included a physician consultation,an initial personalised eye consultation with a experienced diabetes nurse educator,and three behaviour change follow-up calls.HbA1c(primary outcome),lipids and blood pressure were assessed at baseline and three months post-intervention.Participant feedback regarding the DR-IPCP program was collected at three months via a semi-structured telephone interview.Results:While no significant between-group differences were observed,DR-IPCP participants experienced significant within-group reductions in HbA1c,total cholesterol,and low density lipoprotein at follow-up compared to baseline[7 mmol/mol(−0.8%),−0.64 mmol/L,and−0.66 mmol/L,respectively].No significant within-group changes in these parameters were observed in the UC group.Following the DR-IPCP intervention,participants reported a clearer understanding of the link between diabetes management;the development and progression of DR.Conclusions:DR-IPCP provides an effective short-term improvement in diabetes control parameters in DR patients with poor diabetes control.An adequately powered and longitudinal RCT is warranted to assess the clinical,patient-centred and economic potential of this programme in this population.

Health insurance and social capital inGhana: a cluster randomised controlled trial

Background:The National Health Insurance Scheme(NHIS)was introduced in Ghana in 2003,enrolment is still far from the desired target of universal coverage.Low community engagement in the design and management of the system was identified as one of the main barriers.The aim of the current study was to explore the role of social capital in NHIS enrolment in two regions of Ghana,Western and Greater Accra.Methods:The study involved a cluster-randomised controlled trial of 3246 clients of 64 healthcare facilities who completed both a baseline and a follow-up survey.Thirty-two facilities were randomly selected to receive two types of intervention.The remaining facilities served as control.The interventions were co-designed with stakeholders.Baseline and follow up surveys included measures of different types of social capital,as well as enrolment in the health insurance scheme.Results:The study found that the interventions encouraged NHIS enrolment(from 40.29 to 49.39%(intervention group)versus 36.49 to 36.75%(control group)).Secondly,certain types of social capital are associated with increased enrolment(log-odds ratios(p-values)of three types of vertical social capital are 0.127(<0.01),0.0952(<0.1)and 0.15(<0.01)).Effectiveness of the interventions was found dependent on initial levels of social capital:respondents with lowest measured level of interpersonal trust in the intervention group were about 25%more likely to be insured than similar respondents in the control group.Among highly trusting respondents this difference was insignificant.There was however no evidence that the interventions effect social capital.Limitations of the study are discussed.Conclusion:We showed that the interventions helped to increase enrolment but that the positive effect was not realized by changes in social capital that we hypothesised based on result of the first phase of our study.Future research should aim to identify other community factors that are part of the enrolment process,whether other interventions to improve the quality of services could help to increase enrolment and,as a result,could provide community benefits in terms of social capital.Our findings can guide the NHIS in Ghana and other health organizations to enhance enrolment.Trial registration:Ethical Clearance by Ghana Health Service Ethical Committee No.GHS-ERC 08.5.11.

Rhythmical massage improves autonomic nervous system function:a single-blind randomised controlled trial

Background： Rhythmical massage therapy（RMT） is a massage technique used in anthroposophic medicine.Objective： The authors aimed to investigate the physiological action of RMT on the cardiovascular system by analysing heart rate variability（HRV）.Design, setting, participants and intervention： This study was a randomised, controlled and single-blinded trial, involving 44 healthy women（mean age：（26.20 ± 4.71） years）. The subjects were randomised to one of three arms： RMT with aromatic oil（RA）, RMT without aromatic oil（RM） or standardised sham massage（SM）. In the study the subjects were exposed to a standardised stress situation followed by one of the study techniques and Holter electrocardiograms（ECGs） were recorded for 24 h.Main outcome measures： HRV parameters were calculated from linear（time and frequency domain） and nonlinear dynamics（symbolic dynamics, Poincare plot analysis） of the 24-h Holter ECG records.Results： Short-and long-term effects of massage on autonomic regulation differed significantly among the three groups. Immediately after an RMT session, stimulation of HRV was found in the groups RA and RM. The use of an aromatic oil produced greater short-term measurable changes in HRV compared with rhythmic massage alone, but after 24 h the effect was no longer distinguishable from the RM group.The lowest stimulation of HRV parameters was measured in the SM group.Conclusion： RMT causes specific and marked stimulation of the autonomic nervous system. Use of a medicinal aromatic oil had only a temporary effect on HRV, indicating that the RM causes the most relevant long-term effect. The effect is relatively specific, as the physiological effects seen in the group of subjects who received only SM were considerably less pronounced.

Effects of moderate-intensity aerobic exercise combined with acupuncture on attention function of mentally-retarded adolescents:a randomised controlled trial

OBJECTIVE:To detect the impact of moderate-intensity aerobic exercise combined with acupuncture on the attention function of mentally-retarded adolescents from the three dimensions of attention concentration,attention transfer and attention span.METHODS:A total of 48 adolescents with mild to moderate mental disabilities were recruited.The participants were randomly divided into four groups:control group(C),Traditional Chinese Medicine acupuncture group(M),moderate-intensity aerobic exercise group(E)and exercise and acupuncture combined intervention group(J).Before and after the experimental intervention,the participant’s height,weight and attention ability were measured.RESULTS:The improved range of attention total duration of the J group after the intervention was significantly higher than that of the E and M groups(P<0.05),whereas that of the latter groups was significantly higher compared to that of the C group(P<0.05).The J group showed significantly higher(P<0.05)attention span values after the intervention compared to the E,M and C groups.The C group did not show a significant difference in attention transfer at 12 weeks compared to before intervention(P>0.05),whereas the E,M and J groups increased significantly(P<0.05)after intervention than the C group.CONCLUSIONS:Moderate-intensity aerobic exercise combined with acupuncture can more effectively improve the attention concentration and attention span of mentally-retarded adolescents than aerobic exercise or acupuncture alone.

Ginkgo biloba Extract EGb 761® Improves Central Vestibular Vertigo in Patients Undergoing Vestibular Exercises: A Randomised Placebo-Controlled Trial

Background: Ginkgo biloba extract EGb 761® is widely used to treat various types of vertigo. Aims: An exploratory trial was conducted to evaluate the efficacy of EGb 761® in addition to vestibular exercises in central vestibular vertigo caused by vertebro-basilar ischaemia. Subjects and Methods: In this randomised, placebo-controlled, double-blind trial, 40 patients were enrolled in the vertigo clinic of a neurological university hospital and treated with daily doses of 240 mg EGb 761® or placebo for a period of 180 days. All patients regularly performed vestibular exercises in addition. Efficacy was assessed using: a visual analogue scale for the patients to rate the overall intensity of vertigo;a numeric scale for physician-rated change;a vertigo score based on intensity, duration, and frequency of vertigo;and electronystagmography. Results: Until day 180, the mean patient-rated intensity of vertigo decreased by 46% during EGb 761® treatment and by 19% with placebo (p ® group compared to the placebo group. Nystagmus or other eye movement disorders were present only in small subgroups of patients without sufficient statistical power to detect differences between treatment groups. Conclusions: EGb 761® alleviated vertigo caused by ischaemic lesions in the brainstem or cerebellum in patients undergoing vestibular exercises.

Effects of perioperative rosuvastatin on postoperative delirium in elderly patients:A randomized,double-blind,and placebo-controlled trial

BACKGROUND Experimental evidence has indicated the benefits of statins for the treatment of postoperative delirium.Previously,clinical trials did not reach definite conclusions on the effects of statins on delirium.Some clinical trials have indicated that statins reduce postoperative delirium and improve outcomes,while some studies have reported negative results.AIM To evaluate whether perioperative rosuvastatin treatment reduces the incidence of delirium and improves clinical outcomes.METHODS This randomized,double-blind,and placebo-controlled trial was conducted in a single center in Jiangsu,China.This study enrolled patients aged greater than 60 years who received general anesthesia during elective operations and provided informed consent.A computer-generated randomization sequence(in a 1:1 ratio)was used to randomly assign patients to receive either rosuvastatin(40 mg/d)or placebo.Participants,care providers,and investigators were all masked to group assignments.The primary endpoint was the incidence of delirium,which was assessed twice daily with the Confusion Assessment Method during the first 7 postoperative days.Analyses were performed on intention-to-treat and safety populations.RESULTS Between January 1,2017 and January 1,2020,3512 patients were assessed.A total of 821 patients were randomly assigned to receive either placebo(n=411)or rosuvastatin(n=410).The incidence of postoperative delirium was significantly lower in the rosuvastatin group[23(5.6%)of 410 patients]than in the placebo group{42(13.5%)of 411 patients[odds ratios(OR)=0.522,95%confidence interval(CI):0.308-0.885;P<0.05]}.No significant difference in 30-d all-cause mortality(6.1%vs 8.7%,OR=0.67,95%CI:0.39-1.2,P=0.147)was observed between the two groups.Rosuvastatin decreased the hospitalization time(13.8±2.5 vs 14.2±2.8,P=0.03)and hospitalization expenses(9.3±2.5 vs 9.8±2.9,P=0.007).No significant differences in abnormal liver enzymes(9.0%vs 7.1%,OR=1.307,95%CI:0.787-2.169,P=0.30)or rhabdomyolysis(0.73%vs 0.24%,OR=3.020,95%CI:0.31-29.2,P=0.37)were observed between the two groups.CONCLUSION The current study suggests that perioperative rosuvastatin treatment reduces the incidence of delirium after an elective operation under general anesthesia.However,the evidence does not reveal that rosuvastatin improves clinical outcomes.The therapy is safe.Further investigation is necessary to fully understand the potential usefulness of rosuvastatin in elderly patients.

Educational Video Increases Maternal Self-Efficacy for Prevention of Diarrhoea in Young Children:A Randomised Clinical Trial

The aim of this study was to compare the scores of maternal self-efficacy for child diarrhoea prevention, between intervention and control groups, according to sanitary, social and demographic characteristics. A randomised clinical trial was carried out on 163 mothers of children under 5 years old. Data collection was conducted during two months, at two different moments (M0 and M1);at the moment M0 only the intervention group watched the educational video to promote self-efficacy for child diarrhoea prevention;at M1 (two months later) the scale was applied to both groups. In the intervention group, greater mean self-efficacy scores were obtained compared with the control group. The following variables showed statistically significant associations (p < 0.05) with maternal self-efficacy: age 35 or over;high school education;working outside the home;residence with 4 to 5 people;house not of brick or mortar;public refuse collection;piped water supply;consumption of mineral water;and public sewerage network. After use of the video “Diarrhoea: you can prevent it”, the maternal self-efficacy increased, proving that this strategy is able to assist the nursing staff in educational practices.

Effects of Ginkgo Biloba Special Extract EGb 761^(█) in Very Mild Cognitive Impairment(vMCI)

Objective: To assess effects of EGb 761? on cognition and quality of life in subjects with very mild cognitive impair-ment. Methods: We randomized 300 subjects aged 45 to 65 with cognitive complaints and low functioning (more than one standard deviation below appropriate norm) in at least one cognitive test to double-blind treatment with once daily 240 mg EGb 761? or placebo for 12 weeks. Results: The exploratory intention-to-treat analysis showed significant im-provement (p < 0.025, one-sided) beyond practice effects for EGb 761? in a measure of attention (Vienna Test System - Work Performance Series) and trends in favour of EGb 761? in measures of memory (Wechsler Memory Scale III - Faces I, Appointments Test – delayed recall), and perceived physical health (SF36 - factor score Physical Health). Cognitive effects were more pronounced and more consistent (p < 0.025 in 4 of 5 tests) in subjects with lower memory function at baseline. Specifically, practice effects in the more demanding tests were attenuated or absent in these sub-jects. Conclusion: Ginkgo biloba extract EGb 761? improved cognitive functioning and aspects of quality of life in sub-jects with very mild cognitive impairment.

Fate of meta-analyses: The case of Helicobacter pylori

AIM: To overview the current diversity of meta-analysis and the implementation of their results in international guidelines. METHODS: Relevant meta-analysis were identifiedfrom Pub Med/Medline. The topics of meta-analyses were determined. Some topics(genetics, extragastric tumors) were analysed separately. Core journals publishing meta-analyses on Helicobacter pylori were ranked. The rate of citation of meta-analysis in major guidelines was calculated. RESULTS: Between 1992 and 2014, some 356 metaanalyses were published on Pub Med. These mainly appeared in core journals, but were also found in 128 other journals. Eradicating of the infection was the most addressed topic with 134 articles. Meta-analyses were rarely used in formulating statements and recommendations in the international guidelines. In other topics- genetics, extraintestinal manifestations-meta-analyses were rather overused. CONCLUSION: The implementation of meta-analysis in current guidelines is rather rare, while other topics benefit from many studies. A more extensive use of metaanalyses in evidence-based medicine is recommended in the future, otherwise their continuous proliferation will lose reason and scientific significance.

Simplified figure to present direct and indirect comparisons:Revisiting the graph 10 years later

A“simplified”figure was proposed in 2011 to summarize the results of controlled trials that evaluate different treatments aimed at the same disease condition.The original criteria for classifying individual binary comparisons included superiority,inferiority and no significance difference;hence,they did not differentiate between no proof of difference vs proof of no difference.We updated the criteria employed in the original“simplified”figure in order to include this differentiation.A revised version of the simplified figure is proposed and described herein.An example of application is also presented.The example is focused on first-line treatments for paroxysmal atrial fibrillation.Three treatments(medical therapy,cryoballoon ablation,radiofrequency ablation)are compared with one another through direct and indirect comparisons.

Use of fibrates in the metabolic syndrome:A review

The use of fibrates in the treatment of dyslipidaemia has changed significantly over recent years.Their role appeared clear at the start of this century.The Helsinki Heart Study and Veterans Affairs High-Density Cholesterol Intervention Trial suggested significant benefit,especially in patients with atherogenic dyslipidaemia.However,this clarity disintegrated following the negative outcomes reported by the Bezafibrate Infarction Prevention,Fenofibrate Intervention and Event Lowering in Diabetes and Action to Control Cardiovascular Risk in Diabetes randomised controlled trials.In this review we discuss these and other relevant trials and consider patient subgroups such as those with the metabolic syndrome and those needing treatment to prevent the microvascular complications associated with diabetes in whom fibrates may be useful.We also discuss observations from our group that may provide some explanation for the varying outcomes reported in large trials.The actions of fibrates in patients who are also on statins are interesting and appear to differ from those in patients not on statins.Understanding this is key as statins are the primary lipid lowering agents and likely to occupy that position for the foreseeable future.We also present other features of fibrate treatment we have observed in our clinical practice;changes in creatinine,liver function tests and the paradoxical high density lipoprotein reduction.Our purpose is to provide enough data for the reader to make objective decisions in their own clinical practice regarding fibrate use.

Implementation and fidelity of a participatory learning and action cycle intervention to prevent and control type 2 diabetes in rural Bangladesh

Introduction:There is an urgent need to address the growing type 2 diabetes disease burden.20-30%of adults in rural areas of Bangladesh have intermediate hyperglycaemia and about 10%have diabetes.We report on the implementation and fidelity of a Participatory Learning and Action(PLA)intervention,evaluated through a threearm cluster randomised controlled trial which reduced the incidence of diabetes and intermediate hyperglycaemia in rural Bangladesh.PLA interventions have been effective in addressing population level health problems in low income country contexts,and therefore we sought to use this approach to engage communities to identify and address community barriers to prevention and control of type 2 diabetes.Methods:We used a mixed methods approach collecting quantitative data through field reports and qualitative data through observations and focus group discussions.Through descriptive analysis,we considered fidelity to the participatory approach and implementation plans.Results:One hundred twenty-two groups per month were convened by 16 facilitators and supervised by two coordinators.Groups worked through a four phase PLA cycle of problem identification,planning together,implementation and evaluation to address the risk factors for diabetes-diet,physical activity,smoking and stress.Groups reported a lack of awareness about diabetes prevention and control,the prohibitive cost of care and healthy eating,and gender barriers to exercise for women.Groups set targets to encourage physical activity,kitchen-gardening,cooking with less oil,and reduced tobacco consumption.Anti-tobacco committees operated in 90 groups.One hundred twenty-two groups arranged blood glucose testing and 74 groups organized testing twice.Forty-one women’s groups established funds,and 61 communities committed not to ridicule women exercising.Experienced and committed supervisors enabled fidelity to a participatory methodology.A longer intervention period and capacity building could enable engagement with systems barriers to behaviour change.Conclusion:Our complex intervention was implemented as planned and is likely to be valid in similar contexts given the flexibility of the participatory approach to contextually specific barriers to prevention and control of type 2 diabetes.Fidelity to the participatory approach is key to implementing the intervention and effectively addressing type 2 diabetes in a low-income country.

Advance in hyperbaric oxygen therapy in spinal cord injury

Spinal cord injury(SCI)is a severe lesion comporting various motor,sensory and sphincter dysfunctions,abnormal muscle tone and pathological reflex,resulting in a severe and permanent lifetime disability.The primary injury is the immediate effect of trauma and includes compression,contusion,and shear injury to the spinal cord.A secondary and progressive injury usually follows,beginning within minutes and evolving over several hours after the first ones.Because ischemia is one of the most important mechanisms involved in secondary injury,a treatment to increase the oxygen tension of the injured site,such as hyperbaric oxygen therapy,should theoretically help recovery.Although a meta-analysis concluded that hyperbaric oxygen therapy might be helpful for clinical treatment as a safe,promising and effective choice to limit secondary injury when appropriately started,useful and well-defined protocols/guidelines still need to be created,and its application is influenced by local/national practice.The topic is not a secondary issue because a well-designed randomized controlled trial requires a proper sample size to demonstrate the clinical efficacy of a treatment,and the absence of a common practice guideline represents a limit for results generalization.This narrative review aims to reassemble the evidence on hyperbaric oxygen therapy to treat SCI,focusing on adopted protocols in the studies and underlining the critical issues.Furthermore,we tried to elaborate on a protocol with a flowchart for an evidence-based hyperbaric oxygen therapy treatment.In conclusion,a rationale and shared protocol to standardize as much as possible is needed for the population to be studied,the treatment to be adopted,and the outcomes to be evaluated.Further studies,above all,well-designed randomized controlled trials,are needed to clarify the role of hyperbaric oxygen therapy as a strategic tool to prevent/reduce secondary injury in SCI and evaluate its effectiveness based on an evidence-based treatment protocol.We hope that adopting the proposed protocol can reduce the risk of bias and drive future studies.