Search results for: randomized controlled trials

Authors: Hassan Abo Salem, Guo Feng, Xiaolin Huang

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The objective of this study is to determine the effectiveness of mirror therapy on motor recovery and functional abilities after stroke. The following databases were searched from inception to May 2014: Cochrane Stroke, Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, AMED, PsycINFO, and PEDro. Two reviewers independently screened and selected all randomized controlled trials that evaluate the effect of mirror therapy in stroke rehabilitation.12 randomized controlled trials studies met the inclusion criteria; 10 studies utilized the effect of mirror therapy for the upper limb and 2 studies for the lower limb. Mirror therapy had a positive effect on motor recover and function; however, we found no consistent influence on activity of daily living, Spasticity and balance. This meta-analysis suggests that, Mirror therapy has additional effect on motor recovery but has a small positive effect on functional abilities after stroke. Further high-quality studies with greater statistical power are required in order to accurately determine the effectiveness of mirror therapy following stroke.

Keywords: mirror therapy, motor recovery, stroke, balance

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Authors: Simin Shahvazi, Sepideh Soltani, Seyed Mehdi Ahmadi, Russell J. De Souza, Amin Salehi-Abargouei

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Background and Objectives: Vitamin D has received attention for its potential to disrupt cancer processes such as attenuating cell proliferation and exacerbating differentiation and apoptosis. However, whether there exists a role for vitamin D in the treatment of prostate cancer specifically remains controversial. We systematically review the literature to assess whether supplementation with vitamin D influences PSA response and overall survival in patients with prostate cancer. Methods: We searched PubMed, Scopus, ISI Web of Science and Google scholar from inception through up to 10 September 2017 for both before-and-after and randomized trials that evaluated the effect of vitamin D supplementation on the prostate specific antigen (PSA) response rate in participants with prostate cancer. The DerSimonian and Laird, inverse-weighted random-effects model was used to pool effect estimates from the studies. Heterogeneity and potential publication bias were evaluated. Subgroup analyses were also performed. Results: Twenty-two studies (16 before-after and 6 randomized controlled trials) were found and included in meta-analysis. The analysis on controlled clinical trials revealed that PSA change from baseline [weighted mean difference (WMD) = -1.66 ng/ml, 95%CI: -0.69, 0.36, P= 0.543)], PSA response (RR=1.18, 95%CI: 0.97, 1.45, P=0.104) and mortality rate (risk ratio (RR) = 1.05, 95% CI: 0.81-1.36; P=0.713) was not significantly different between vitamin D supplementation and placebo groups. Single arm trials revealed that vitamin D supplementation had had a modest effect on PSA response rate: 19% of those enrolled had at least a 50% reduction in PSA by the end of treatment (95% CI: 7% to 31%; p=0.002). Conclusion: We found that vitamin D modestly increases the PSA response rate in single arm studies. No effect on serum PSA levels, PSA response and mortality was seen in randomized controlled clinical trials. It does not seem patients with prostate cancer benefit from vitamin D supplementation.

Keywords: mortality, prostatic neoplasms, PSA response, vitamin D

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Authors: Yu-Chieh Huang, Pei-Shih Chen, Tao-Hsin Tung

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Background: Urinary tract infection is the most common bacterial infection to our best knowledge. Objective: This study is to investigate whether cranberry ingesting could improve the urinary tract infection. Methods: We searched the PubMed and Cochrane Library for relevant randomized controlled trials without language limitations between 9 March 1994 and June 30, 2017, with a priori defined inclusion and exclusion criteria. The search terms included (cranberry OR Vaccinium macrocarpon OR Vaccinium oxy-coccus OR Vaccinium microcarpum OR Vaccinium erythrocarpum OR Vaccinium) AND (urinary tract infection OR bacteriuria OR pyuria) AND (effect OR effective-ness OR efficacy) AND (random OR randomized). Results: There were 26 studies met the selection criteria included among 4709 eligible participants. We analyzed all trials in meta-analysis. The random-effects pooled risk ratio (RR) for the group using cranberry versus using placebo was 0.75; 95%CI[0.63, 0.880]; p-value=0.0002) and heterogeneity was 56%. Furthermore, we divided the subjects into different subgroup to analysis. Ingesting cranberry seemed to be more effective in some subgroups, including the patients with recurrent UTI (RR, 0.71; 95%CI[0.54,0.93]; p-value=0.002) (I²= 65%) and female population (RR, 0.73, 95%CI[0.58,0.92]; p-value=0.002) (I²= 59%). The prevention effect was not different between cranberry and trimethoprim (RR, 1.25, 95%CI[0.67, 2.33]; p-value=0.49) (I²= 68%). No matter the forms of cranberry were capsules or juice, the efficacy was useful. Conclusions: It is showed that cranberry ingesting is usefully associated with prevention UTI. There are more effective in prevention of UTI in some groups.

Keywords: cranberry, effectiveness, prevention, urinary tract infect

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Authors: Doua AlSaad, Ahmed Awaisu, Samah Elsalem, Palli Valapila Abdulrouf, Binny Thomas, Moza AlHail

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Background: It has been suggested that pyridoxine has an anti-lactogenic effect. Studies of the efficacy of pyridoxine in suppressing lactation have reported conflicting results. The aim of this review is to evaluate the effectiveness and safety of high-dose pyridoxine in postpartum lactation inhibition. Methods: This systematic review included published trials that compared the efficacy and/or safety of pyridoxine to placebo or to other pharmacological agents for the inhibition of postpartum lactation. We searched PubMed, Embase, ScienceDirect, CINAHL, AMED, the Cochrane library, and the clinical trials registry to identify relevant literature. No limit was imposed on the year of publication of the studies, and the review included studies published until 15 January 2016. Two reviewers independently extracted data and assessed the risk of bias. Results: Seven studies were included, with a total of 1155 women, of which 471 women received pyridoxine. Three studies were randomized controlled trials, while the remaining four studies were non-randomized controlled trials. All of the included studies were relatively small (n = 18 – 482). The studies compared pyridoxine with placebo, bromocriptine, and/or stilboestrol. Pyridoxine was given orally, with a total daily dose of 450 – 600 mg for 5 to 7 days. Two trials (n = 349 participants) indicated that pyridoxine was effective in inhibiting lactation in approximately 95% of the enrolled patients. All other studies failed to demonstrate pyridoxine efficacy through either clinical assessment or prolactin level measurements. Pyridoxine safety was assessed by two trials in which no serious untoward side-effects were reported. Overall, the risk of bias for most of the studies was low to moderate. Conclusion: Current evidence supporting the effectiveness of high dose pyridoxine in the inhibition of postpartum lactation is inconsistent and insufficient. Larger randomized trials are needed to confirm the efficacy of pyridoxine in postpartum lactation inhibition. Acknowledgment: This review received a grant from the Medical Research Center of Hamad Medical Corporation in Qatar (grant number: 15100/15).

Keywords: pyridoxine, safety, effectiveness, lactation inhibition

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Authors: Derick Shi-Chen Ou, Liang-Yu Chen

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Background: Acupuncture, a potential alternative, and complementary therapy revealed insufficient evidence in depression treatment. The efficacy of acupuncture treatment was still uncertainty. To evaluate the effect of acupuncture in treating depression, the randomized controlled trials (RCTs) were examined. Methods: RCTs of the acupuncture therapy in treating major depression were searched from MEDLINE from 2007 to 2017. Keywords used for searching strategy included acupuncture, acupoint, and major depressive disorder. Results: Among the nine RCTs, four studies demonstrated great improvement in acupuncture treatment and five studies revealed the effectiveness of acupuncture intervention in medication. General trends suggest that acupuncture treatment is as effective as antidepressants with minimal side effects. Conclusion: Despite the promising results from the RCTs, there are still a variety of limitations, including small sample size, imprecise enrollment criteria, difficulties with blinding, randomization, short duration of study and lack of longitudinal follow-up. Therefore, the evidence that acupuncture as an alternative therapy for depression is inconclusive. More rigorously designed RCTs should be conducted in the future.

Keywords: acupuncture, major depressive disorders, randomized clinical trials, antidepressants

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Authors: Emad Kouhestani

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Background: Despite the enormous success of anterior cruciate ligament (ACL) reconstruction, acute neuropathic pain can develop postoperatively and is both distressing and difficult to treat once established. Pregabalin, as an anticonvulsant agent that selectively affects the nociceptive process, has been used as a pain relief agent. The purpose of this systematic review of randomized controlled trials (RCTs) was to evaluate the pain control effect of pregabalin versus placebo after ACL reconstruction. Method: A search of the literature was performed from inception to June 2022, using PubMed, Scopus, Google Scholar, Web of Science, Cochrane, and EBSCO. Studies considered for inclusion were RCTs that reported relevant outcomes (postoperative pain scores, or cumulative opioid consumption, adverse events) following the administration of pregabalin in patients undergoing ACL reconstruction. Result: Five placebo-controlled RCTs involving 272 participants met the inclusion criteria. 75 mg and 150 mg of oral pregabalin were used in included trials. Two studies used a single dose of pregabalin one hour before anesthesia induction. Two studies used pregabalin 1 hour before anesthesia induction and 12 hours after. One study used daily pregabalin 7 days before and 7 days after surgery. Out of five papers, three papers found significantly lower pain intensity and cumulative opioid consumption in the pregabalin group compared with the placebo group. However, a decrease in pain scores was found in all trials. Pregabalin administration was associated with dizziness and nausea. Conclusion: The use of pregabalin may be a valuable asset in pain management after ACL reconstruction. However, future studies with larger sample sizes and longer follow-up periods are required.

Keywords: pregabalin, anterior cruciate ligament, postoperative pain, clinical trial

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Authors: Naser Shagerdi Esmaeli, Mohsen Hamidpour

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Purposes: The activation of coagulation in patients with cancer contributes significantly to morbidity and mortality rates and may play a fundamental role in the host response to growing tumor’s. Patients with cancer are clearly at high risk for the development of venous thromboembolism (VTE), particularly during chemotherapy and surgery. This situation is aggravated by the use of venous access catheters and possibly growth factors. Methods: Data derived from large, randomized, controlled trials have been used to determine the true incidence of this complication of cancer and its treatment. The incidence based on the analyses of these randomized controlled trials varies from 1% for limited stage patients with breast cancer treated with tamoxifen to 60% for patients with any type of cancer who are subjected to orthopedic surgery and do not receive prophylactic therapy. Results: In view of the morbidity and mortality attributable to VTE in cancer, widespread utilization of prophylactic anticoagulation therapy, which has proven safe and effective in a variety of situations, should be considered. While migratory thrombophlebitis is a clear indicator of an underlying neoplasm, the risk of cancer in patients with the more typical form of VTE has been the subject of intense debate over recent years. Conclusion: Some investigators have suggested that the relative risk of being diagnosed with occult cancer within six months of an episode of VTE (particularly recurrent VTE) could be up to 10-fold. However, the cost-effectiveness of aggressive screening for cancer in patients with VTE has not yet been defined adequately.

Keywords: venous thromboembolism, malignancy, cancer, tumor, heparin

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Authors: Daniela V. Bavaresco, Tamy Colonetti, Antonio Jose Grande, Francesc Colom, Joao Quevedo, Samira S. Valvassori, Maria Ines da Rosa

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Objective: Performed a systematic review and meta-analysis to evaluated the potential effect of the cyclo-oxygenases (Cox)-2 inhibitor Celecoxib adjunct treatment in Bipolar Disorder (BD), through of randomized controlled trials. Method: A search of the electronic databases was proceeded, on MEDLINE, EMBASE, Scopus, Cochrane Central Register of Controlled Trials (CENTRAL), Biomed Central, Web of Science, IBECS, LILACS, PsycINFO (American Psychological Association), Congress Abstracts, and Grey literature (Google Scholar and the British Library) for studies published from January 1990 to February 2018. A search strategy was developed using the terms: 'Bipolar disorder' or 'Bipolar mania' or 'Bipolar depression' or 'Bipolar mixed' or 'Bipolar euthymic' and 'Celecoxib' or 'Cyclooxygenase-2 inhibitors' or 'Cox-2 inhibitors' as text words and Medical Subject Headings (i.e., MeSH and EMTREE) and searched. The therapeutic effects of adjunctive treatment with Celecoxib were analyzed, it was possible to carry out a meta-analysis of three studies included in the systematic review. The meta-analysis was performed including the final results of the Young Mania Rating Scale (YMRS) at the end of randomized controlled trials (RCT). Results: Three primary studies were included in the systematic review, with a total of 121 patients. The meta-analysis had significant effect in the YMRS scores from patients with BD who used Celecoxib adjuvant treatment in comparison to placebo. The weighted mean difference was 5.54 (95%CI=3.26-7.82); p < 0.001; I2 =0%). Conclusion: The systematic review suggests that adjuvant treatment with Celecoxib improves the response of major treatments in patients with BD when compared with adjuvant placebo treatment.

Keywords: bipolar disorder, Cox-2 inhibitors, Celecoxib, systematic review, meta-analysis

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Authors: Jiwon Oh, Hyunjoo Oh, Seungwon Shin, Junghee Yoo, Euiju Lee

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Background and Aims: This systematic review aimed at briefly exploring how effective pharmacoacupuncture therapy for dizziness is. Methods: We searched publications in Medline, EMBASE, Cochrane Library, KoreaMed, China National Knowledge Infrastructure (CNKI), Cinii, DBpia, KSI, Kiss, KMbase, NDSL and RISS. We included randomized controlled trials and well-designed non-randomized controlled trials that compared the effects of only pharmacoacupuncture or pharmacoacupuncture and usual therapies with any controls for dizziness. Results: The risk of bias was assessed using the Cochrane tool. Three studies have been included with eligibility criteria. The prevalence of "unclear" ratings in the risk assessment results is predominantly due to the included studies reporting their findings inadequately. This review found evidence that pharmacoacupuncture therapy was effective as an add-on therapy to acupoint therapy physiotherapy and had additional benefits in increasing CER for cervical vertigo. Also, it was recommended that pharmacoacupuncture therapy was effective as an add-on therapy to Western medicine and had additional benefits in increasing CER for vasovagal syncope. Conclusions: Pharmacoacupuncture therapy had additional benefits as an add-on therapy for cervical vertigo and vasovagal syncope. However, further studies are required to overcome the limitations of the lack of study qualities.

Keywords: pharmacoacupuncture therapy, dizziness, systematic review, traditional Korean medicine

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Authors: Mohammad Javad Zehtab, S. Alireza Mirghasemi, Ali Majlesara, Parvin Tajik, Babak Siavashi

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Objective: There are different modalities proposed for tennis elbow treatment with few randomized trials comparing them. We designed a study to compare the effectiveness of five different modalities and determine the usefulness of recently proposed extensor grip test (EGT) in predicting the response to treatment. Methods: In a randomized controlled clinical trial 92 of 98 tennis elbow patients in Sina hospital of Tehran, Iran between 2006 and 2007 fulfill trial entry criteria, among these patients 56 (60.9%) had positive EGT result. Stratified on EGT result, patients allocated randomly to 5 treatment groups: Brace (B) group, physiotherapy (P), brace + physiotherapy (BP), injection (I) and injection + physiotherapy (IP). Results: Patients who had positive result of EGT had better response to treatments: less SOC (p = 0.06), less PFFQ and patients’ satisfaction scores (p < 0.001). Among the treatment IP was the most successful, then BP, P and B, respectively; injection was the worst treatment modality. Response to treatment was comparable in all groups between EGT positive and negative patients except bracing; in which positive EGT was correlated with a dramatic response to treatment. Conclusion: In all patients IP and then BP is recommended but in EGT negatives, bracing seems to be of no use. Injection alone is not recommended in either group.

Keywords: tennis elbow, extensor grip test, physiotherapy, tennis elbow treatment

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Authors: Hui-Ling Yang, Kuei-Ru Chou

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Background: Studies show that cognitive training can effectively delay cognitive failure. However, there are several gaps in the previous studies of cognitive training in mild cognitive impairment: 1) previous studies enrolled mostly healthy older adults, with few recruiting older adults with cognitive impairment; 2) they also had limited generalizability and lacked long-term follow-up data and measurements of the activities of daily living functional impact. Moreover, only 37% were randomized controlled trials (RCT). 3) Limited cognitive training has been specifically developed for mild cognitive impairment. Objective: This study sought to investigate the changes in cognitive function, activities of daily living and degree of depressive symptoms in older adults with mild cognitive impairment after cognitive training. Methods: This double-blind randomized controlled study has a 2-arm parallel group design. Study subjects are older adults diagnosed with mild cognitive impairment in residential care facilities. 124 subjects will be randomized by the permuted block randomization, into intervention group (Cognitive training, CT), or active control group (Passive information activities, PIA). Therapeutic adherence, sample attrition rate, medication compliance and adverse events will be monitored during the study period, and missing data analyzed using intent-to-treat analysis (ITT). Results: Training sessions of the CT group are 45 minutes/day, 3 days/week, for 12 weeks (36 sessions each). The training of active control group is the same as CT group (45min/day, 3days/week, for 12 weeks, for a total of 36 sessions). The primary outcome is cognitive function, using the Mini-Mental Status Examination (MMSE); the secondary outcome indicators are: 1) activities of daily living, using the Lawton’s Instrumental Activities of Daily Living (IADLs) and 2) degree of depressive symptoms, using the Geriatric Depression Scale-Short form (GDS-SF). Latent growth curve modeling will be used in the repeated measures statistical analysis to estimate the trajectory of improvement by examining the rate and pattern of change in cognitive functions, activities of daily living and degree of depressive symptoms for intervention efficacy over time, and the effects will be evaluated immediate post-test, 3 months, 6 months and one year after the last session. Conclusions: We constructed a rigorous CT program adhering to the Consolidated Standards of Reporting Trials (CONSORT) reporting guidelines. We expect to determine the improvement in cognitive function, activities of daily living and degree of depressive symptoms of older adults with mild cognitive impairment after using the CT.

Keywords: mild cognitive impairment, cognitive training, randomized controlled study

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Authors: Matthew Cameron, Stephen Yang, Latifa Al Kharusi, Adam Gosselin, Anissa Chirico, Pouya Gholipour Baradari

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Background: Iron supplementation has been evaluated in several randomized controlled trials (RCTs) for the potential to increase baseline hemoglobin and decrease the incidence of red blood cell (RBC) transfusion during cardiac surgery. This study's main objective was to evaluate the evidence for iron administration in cardiac surgery patients for its effect on the incidence of perioperative RBC transfusion. Methods: This systematic review protocol was registered with PROSPERO (CRD42020161927) on Dec. 19th, 2019, and was prepared as per the PRISMA guidelines. MEDLINE, EMBASE, CENTRAL, Web of Science databases, and Google Scholar were searched for RCTs evaluating perioperative iron administration in adult patients undergoing cardiac surgery. Each abstract was independently reviewed by two reviewers using predefined eligibility criteria. The primary outcome was perioperative RBC transfusion, with secondary outcomes of the number of RBC units transfused, change in ferritin level, reticulocyte count, hemoglobin, and adverse events, after iron administration. The risk of bias was assessed with the Cochrane Collaboration Risk of Bias Tool, and the primary and secondary outcomes were analyzed with a random-effects model. Results: Out of 1556 citations reviewed, five studies (n = 554 patients) met the inclusion criteria. The use of iron demonstrated no difference in transfusion incidence (RR 0.86; 95% CI 0.65 to 1.13). There was a low heterogeneity between studies (I²=0%). The trial sequential analysis suggested an optimal information size of 1132 participants, which the accrued information size did not reach. Conclusion: The current literature does not support the routine use of iron supplementation before cardiac surgery; however, insufficient data is available to draw a definite conclusion. A critical knowledge gap has been identified, and more robust RCTs are required on this topic.

Keywords: cardiac surgery, iron, iron supplementation, perioperative medicine, meta-analysis, systematic review, randomized controlled trial

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Authors: Ping Xu, Gregory T. Golm, Guanghan (Frank) Liu

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In the presence of competing events, traditional survival analysis may not be appropriate and can result in biased estimates, as it assumes independence between competing events and the event of interest. Instead, competing risk analysis should be considered to correctly estimate the survival probability of the event of interest and the hazard ratio between treatment groups. The COVID-19 pandemic has provided a potential source of competing risks in clinical trials, as participants in trials may experienceCOVID-related competing events before the occurrence of the event of interest, for instance, death due to COVID-19, which can affect the incidence rate of the event of interest. We have performed simulation studies to compare multiple competing risk analysis models, including the cumulative incidence function, the sub-distribution hazard function, and the cause-specific hazard function, to the traditional survival analysis model under various scenarios. We also provide a general recommendation on conducting competing risk analysis in randomized clinical trials during the era of the COVID-19 pandemic based on the extensive simulation results.

Keywords: competing risk, survival analysis, simulations, randomized clinical trial, COVID-19 pandemic

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Authors: Jong Yeop Kim, Sung Young Park, Dae Hee Kim, Han Bum Joe, Ji Young Yoo, Jong Bum Choi, Sook Young Lee

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Emergence agitation (EA) is commonly reported adverse events after sevoflurane anesthesia in pediatric patients. The efficacy of prophylactic remifentanil, one of mu opioid agonist, in preventing EA is controversial. This meta-analysis assessed the effectiveness of remifentanil to decrease the incidence of EA from sevoflurane anesthesia in children. We searched for randomized controlled trials comparing sevoflurane alone anesthesia with sevoflurane and remifentanil anesthesia to prevent EA in the Cochrane Library, Embase, Pubmed, and KoreaMed, and included 6 studies with 361 patients. The number of patients of reporting EA was summarized using risk ratio (RR) with 95% confidence interval (CI), with point estimates and 95CIs derived from a random effects Mantel-Haenszel method. Overall incidence of EA was about 41%. Compared with sevoflurane alone anesthesia, intravenous infusion of remifentanil with sevoflurane significantly reduced the incidence of EA (RR 0.53, 95% CI 0.39-0.73, P < 0.0001), (heterogeneity, I2 = 0, P = 0.42). This meta-analysis suggested that continuous infusion of remifentanil could be effective in decreasing the EA of about 47% after sevoflurane anesthesia. However, considering limitations of the included studies, more randomized controlled studies are required to verify our results.

Keywords: emergence agitation, meta-analysis, remifentanil, pediatrics

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Authors: Sarah-Anne Schumann, Chintan Shah, Sandeep Ponniah, Syeachia Dennis

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Effective interventions to prevent childhood obesity include limiting sugar-sweetened beverage intake (SOR: B, longitudinal study), school and home based strategies to reduce total screen time and increase physical activity, behavioral and dietary counseling, and support for parents and families (SOR: A, meta-analysis of randomized and non-randomized controlled trials). Risk factors for childhood obesity include maternal pre-pregnancy weight, high infant birth weight, early infant rapid weight gain and maternal smoking during pregnancy which may provide opportunities to intervene and prevent childhood obesity (SOR: B, meta-analysis of observational studies).

Keywords: childhood, obesity, prevent obesity, interventions to prevent obesity

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Authors: Hazel Ann Gianelli Cu, Stephanie Co, Radcliff Cobankiat

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Objectives: TRC101/Veverimer is an orally administered, non absorbed, sodium- and counterion-free hydrochloric acid binder for the treatment of metabolic acidosis associated with chronic kidney disease. The main objective of this study is to determine the efficacy of TRC 101/ Veverimer 6g/day in increasing serum bicarbonate levels of chronic kidney disease patients with metabolic acidosis. In this meta analysis, we also aim to look at safety outcomes, adverse effects and if the level of serum bicarbonate reached metabolic alkalosis when given TRC101/Veverimer. Methodology: Pubmed, Cochrane, Google Scholar and Science direct were used to search for randomized controlled trials about TRC101/Veverimer use in Chronic kidney disease patients with metabolic acidosis. Search strategy according to the Prisma checklist was done with evaluation of biases and synthesis of results using the Cochrane Review Manager software 5.4. Results: Two randomized controlled trials involving 371 chronic kidney disease patients were included in this study. Results show there was a significant increase in the serum bicarbonate level when given TRC101/Veverimer compared to the placebo. Both studies had a significant number of participants who completed the studies until the end. P value of <0.00001 was used in both studies with a confidence interval of 95%. Conclusion: TRC101/Veverimer 6g/day was shown to effectively and safely increase serum bicarbonate or achieve normalization in chronic kidney disease patients with metabolic acidosis as compared with a placebo. This was associated with delayed progression of kidney disease with improvement of physical functioning, however longer duration of future studies is ideal in order to assess further the long advantages and consequences of TRC 101/Veverimer.

Keywords: chronic kidney disease, metabolic acidosis, Veverimer, TRC101

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Authors: Sarina Sahmeddini, Fahimeh Safarpour, Forough Pazhuheian

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With the concepts of minimally invasive treatment and preventive dentistry gaining more and more recognition by dentists, there are many published clinical trials comparing the use of the erbium laser with traditional drilling for caries removal. However, the efficacy of the erbium laser is still controversial. The aim of this review study is to compare the effects of tooth preparation by laser irradiation and conventional preparation by bur to identify the best means for cavity preparation and reduction of recurrent caries. Randomized controlled trials, controlled clinical trials, and prospective, and retrospective cohort studies were included in this review. The eligibility criteria included studies in humans’ permanent teeth in which cavities were conducted in their cervical third and proximal surfaces. PubMed, Google scholar, and Scopus about Er:YAG laser and bur prepared cavities were carried out. The studies’ details were organized in four tables according to the groups: (1) Microleakage; (2) Morphological changes; (3) Microhardness; and (4) Bond strength. The initial search resulted in 134 articles, 12 studies published from 2012 up to March 2020 were included in this review. According to the risk of bias evaluation, all studies were classified as high quality. Clinical implications: Er:YAG lasers with the energy levels between 250 to 300 mJ can be proper alternatives to conventional burs, as minimal invasive instruments with no significant differences or better results in microleakage, microhardness, and bond strength compared with conventional burs. In conclusion, Er:YAG laser irradiations accompanied by phosphoric acid etching can reduce the chance of recurrent carries.

Keywords: lasers, drilling, caries, micro leakage

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Authors: Boshra Mozaffar, Arash Ardavani, Iskandar Idris

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Food taste and flavor affect food choice and acceptance, which are essential to maintain good health and quality of life. Reduced circulating zinc levels have been shown to adversely affect taste which can result in reduced appetite, weight loss and psychological problems, but the efficacy of Zinc supplementation to treat disorders of taste remains unclear. In this systematic review and meta-analysis, we aimed to examine the efficacy of zinc supplementation in the treatment of taste disorders. We searched four electronic bibliographical databases; Ovid MEDLINE, Ovid Embase, Ovid AMAD and PubMed. Article bibliographies were also searched, which yielded additional relevant studies. To facilitate the collection and identification of all available and relevant articles published before 7 December 2020, there were no restrictions on the publication date. We performed a systematic review and meta-analysis according to the PRISMA Statement. This review was registered at PROSPERO and given the identification number CRD42021228461. In total, we included 12 randomized controlled trials with 938 subjects. Intervention includes zinc (sulfate, gluconate, picolinate, polaprezinc and acetate); the pooled results of the meta-analysis indicate that improvements in taste disorder occurred more frequently in the intervention group compared to the control group (RR = 1.8; 95% CI:1.27 -2.57, p=0.009). The doses are equivalent to 17 mg- 86.7 mg of elemental zin for three to six months. Zinc supplementation is an effective treatment for taste disorders in patients with zinc deficiency or idiopathic taste disorders when given in high doses ranging from 68–86.7 mg/d for up to three months. However, we did not find sufficient evidence to determine the effectiveness of zinc supplementation in patients with taste disorders induced by chronic renal failure.

Keywords: taste change, taste disorder, zinc, zinc sulfate or Zn, deficiency, supplementation.

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Authors: Zyrah Lou R. Samar, Genecarlo Liwanag

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Type 2 Diabetes Mellitus is the more prevalent type, caused by a combination of insulin resistance and inadequate insulin response to hyperglycemia1. Aside from pharmacologic interventions, medical nutrition therapy is an integral part of the management of patients with Type 2 Diabetes Mellitus. Whey protein, which is one of the best protein sources, has been investigated for its applicability in improving glycemic control in patients with Type 2 Diabetes Mellitus. This systematic review and meta-analysis was conducted to measure the magnitude of the effect of whey protein on glycemic control in type 2 diabetes mellitus. The aim of this review is to evaluate the efficacy and safety of whey protein in patients with type 2 diabetes mellitus. Methods: A systematic electronic search for studies in the PubMed and Cochrane Collaboration database was done. Included in this review were randomized controlled trials of whey protein enrolling patients with type 2 diabetes mellitus. Three reviewers independently searched, assessed, and extracted data from the individual studies. Results: A systematic literature search on online databases such as Cochrane Central Registry, PubMed, and Herdin Plus was conducted in April to September 2021 to identify eligible studies. The search yielded 21 randomized controlled trials after removing duplicates. Only 5 articles were included after reviewing the full text, which met the criteria for selection. Conclusion: Whey protein supplementation significantly reduced fasting blood glucose. However, it did not reduce post-prandial blood glucose, HbA1c level, and weight when compared with the placebo. There has been a considerate heterogeneity across all studies, which may have contributed/confounded its effects. A larger sample size and better inclusion, and a more specific study may be included in the future reviews.

Keywords: whey protein, diabetes, nutrition, fasting blood sugar, postprandial glucose, HbA1c, weight reduction

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Authors: K. B. Chathyushya, M. Shiva Prakash, R. Hemalatha

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Introduction: Gastrointestinal (GI) tract has a number of microorganisms (microbiota) that influences the host’s health. The imbalance in the gut microbiota, which is also called as gut dysbiosis, affects human health which causes various metabolic, inflammatory, and infectious diseases. Probiotics play an important role in reinstating the gut balance. Probiotics are involved in the maintenance of healthier gut microbiota and have also been identified as effective adjuvants in insulin resistance therapies. Methods: This paper systematically reviews different randomized, controlled, blinded trials of probiotics for the treatment of various diseases along with the therapeutic or prophylactic properties of probiotic bacteria in different metabolic, inflammatory, infectious and anxiety-related disorders. Conclusion: The present review summarises that probiotics have some considerable effect in the management of various diseases, however, the benefits are strain specific, although more clinical trials are need to be carried out with different probiotic and symbiotic combinations as some probiotics have broad spectrum of benefits and few with specific activity

Keywords: life style diseases, cognition, health, gut dysbiosis, probiotics

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Authors: Van Truong Pham

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Background: Self-management was described as a potential strategy for blood pressure control in patients with hypertension. However, the effects of self-management interventions on blood pressure, self-efficacy, medication adherence, and body mass index (BMI) in older adults with hypertension have not been systematically evaluated. We evaluated the effects of self-management interventions on systolic blood pressure (SBP) and diastolic blood pressure (DBP), self-efficacy, medication adherence, and BMI in hypertensive older adults. Methods: We followed the recommended guidelines of preferred reporting items for systematic reviews and meta-analyses. Searches in electronic databases including CINAHL, Cochrane Library, Embase, Ovid-Medline, PubMed, Scopus, Web of Science, and other sources were performed to include all relevant studies up to April 2019. Studies selection, data extraction, and quality assessment were performed by two reviewers independently. We summarized intervention effects as Hedges' g values and 95% confidence intervals (CI) using a random-effects model. Data were analyzed using Comprehensive Meta-Analysis software 2.0. Results: Twelve randomized controlled trials met our inclusion criteria. The results revealed that self-management interventions significantly improved blood pressure control, self-efficacy, medication adherence, whereas the effect of self-management on BMI was not significant in older adult patients with hypertension. The following Hedges' g (effect size) values were obtained: SBP, -0.34 (95% CI, -0.51 to -0.17, p < 0.001); DBP, -0.18 (95% CI, -0.30 to -0.05, p < 0.001); self-efficacy, 0.93 (95%CI, 0.50 to 1.36, p < 0.001); medication adherence, 1.72 (95%CI, 0.44 to 3.00, p=0.008); and BMI, -0.57 (95%CI, -1.62 to 0.48, p = 0.286). Conclusions: Self-management interventions significantly improved blood pressure control, self-efficacy, and medication adherence. However, the effects of self-management on obesity control were not supported by the evidence. Healthcare providers should implement self-management interventions to strengthen patients' role in managing their health care.

Keywords: self-management, meta-analysis, blood pressure control, self-efficacy, medication adherence, body mass index

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Authors: Radu Soflau, Lia-Ecaterina Oltean

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Background: Increasing evidence supports the efficacy of psychological interventions for psychosis. However, it is unclear which one of these interventions is most likely to address negative psychotic symptoms and related outcomes. We aimed to determine the relative efficacy of psychological and psychosocial interventions for negative symptoms, overall psychotic symptoms, and related outcomes. Methods: To attain this goal, we conducted a systematic review and network meta-analysis. We searched for potentially eligible trials in PubMed, EMBASE, PsycInfo, Cochrane Central Register of Controlled Trials, and ClinicalTrials.gov databases up until February 08, 2022. We included randomized controlled trials that investigated the efficacy of psychological for adults with psychosis. We excluded interventions for prodromal or “at risk” individuals, as well as patients with serious co-morbid medical or psychiatric conditions (others than depressive and/or anxiety disorders). Two researchers conducted study selection and performed data extraction independently. Analyses were run using STATA network and mvmeta packages, applying a random effect model under a frequentist framework in order to compute standardized mean differences or risk ratio. Findings: We identified 47844 records and screened 29466 records for eligibility. The majority of eligible interventions were delivered in addition to pharmacological treatment. Treatment as usual (TAU) was the most frequent common comparator. Theoretically driven psychological interventions generally outperformed TAU at post-test and follow-up, displaying small and small-to-medium effect sizes. A similar pattern of results emerged in sensitivity analyses focused on studies that employed an inclusion criterion for relevant negative symptom severity. Conclusion: While the efficacy of some psychological interventions is promising, there is a need for more high-quality studies, as well as more trials directly comparing psychological treatments for negative psychotic symptoms.

Keywords: psychosis, network meta-analysis, psychological interventions, efficacy, negative symptoms

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Authors: Parastoo Parhizkar, Jaber Yaghini, Omid Fakheran

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Background: Third molar surgery is often associated with postoperative problems which cause serious impediments on daily activities and quality of life. Steroidal anti-inflammatory drugs may decrease these common post-operative complications. The purpose of this review is evaluating the available evidence regarding the efficacy of corticosteroids used as adjunctive therapy for patients undergoing third molar surgery. Methods: PubMed, Google scholar, Scopus, web of science, clinicaltrials.gov, scirus.com, Cochrane central register for controlled trials, LILACS, OpenGrey, centerwatch, isrctn, who.int and ebsco were searched without restrictions regarding the year of publication. Randomized clinical trials assessing patient-reported outcomes in patients undergoing surgical therapy, were eligible for inclusion. Study quality was assessed using the CONSORT-checklist. No meta-analysis was performed. Results: A total of twelve Randomized Clinical Trials were included in this study. Methylprednisolone and Dexamethasone may decrease postoperative side effects such as pain, trismus and edema. Based on the results both of them could improve patients’ satisfaction, and there is no significant difference between these two types of corticosteroids regarding the patient centered outcomes (p > 0.05). Intralesional and intravenous injection of Dexamethasone showed an equivalent result, with statistically significant better results (P < 0.05) in comparison with the oral treatment. Conclusion: various types of corticosteroids can enhance the patient’s satisfaction following third molar surgery. However, there is no significant difference between Dexamethasone, Prednisolone and Methylprednisolone groups in this regard. Comparing the various administration routs, local injection of Dexamethasone is quite simple, painless and cost-effective adjunctive therapy with better drug efficacy.

Keywords: third molar surgery, corticosteroids, patient-reported outcomes, health related quality of life

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Authors: Yuxi Wang, Xuan Gao

Abstract:

Traditional Chinese medicine has been used in the treatment of coronary heart disease (CHD) for centuries, and in recent years, the research data on the efficacy of traditional Chinese medicine through clinical trials has gradually increased to explore its real efficacy and internal pharmacology. However, due to the complexity of traditional Chinese medicine prescriptions, the efficacy of each component is difficult to clarify, and pharmacological research is challenging. This study aims to systematically review and clarify the clinical efficacy of traditional Chinese medicine in the treatment of coronary heart disease through a meta-analysis. Based on PubMed, CNKI database, Wanfang data, and other databases, eleven randomized controlled trials and 1091 CHD subjects were included. Two researchers conducted a systematic review of the papers and conducted a meta-analysis supporting the positive therapeutic effect of traditional Chinese medicine in the treatment of CHD.

Keywords: coronary heart disease, Chinese medicine, treatment, meta-analysis

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Authors: Terentes Printzios Dimitrios, Loanna Gourgouli, Vlachopoulos Charalambos

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Aims: Atrial fibrillation (AF) remains one of the major causes of stroke, heart failure, sudden death and cardiovascular morbidity. Ablation techniques are becoming more appealing after the latest results of randomized trials showing the overall clinical benefit. On the other hand, imaging techniques and the frontier application of 3D printing are emerging as a valuable ally for cardiac procedures. However, no randomized trial has directly assessed the impact of preprocedural imaging and especially 3D printing guidance for AF ablation. The present study is designed to investigate for the first time the effect of 3D printing of the heart on the safety and effectiveness of the ablation procedure. Methods and design: The 3D-GALA trial is a randomized, open-label, controlled, multicentre clinical trial of 2 parallel groups designed to enroll a total of 100 patients undergoing ablation using cryo-balloon for paroxysmal and persistent AF. Patients will be randomized with a patient allocation ratio of 1: 1 to preprocedural MRI scan of the heart and 3D printing of left atrium and pulmonary veins and cryoablation versus standard cryoablation without imaging. Patients will be followed up to 6 months after the index procedure. The primary outcome measure is the reduction of radiation dose and contrast amount during pulmonary veins isolation. Secondary endpoints will include the percentage of atrial fibrillation relapse at 24h-Holter electrocardiogram monitoring at 6 months after initial treatment. Discussion: To our knowledge, the 3D-GALA trial will be the first study to provide evidence about the clinical impact of preprocedural imaging and 3D printing before cryoablation.

Keywords: atrial fibrillation, cardiac MRI, cryoablation, 3-d printing

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Authors: Moses Mwangi, Geert Verbeke, Geert Molenberghs

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Cross-over designs are commonly used in randomized clinical trials to estimate efficacy of a new treatment with respect to a reference treatment (placebo or standard). The main advantage of using cross-over design over conventional parallel design is its flexibility, where every subject become its own control, thereby reducing confounding effect. Jones & Kenward, discuss in detail more recent developments in the analysis of cross-over trials. We revisit the simple piecewise linear mixed-effects model, proposed by Mwangi et. al, (in press) for its first application in the analysis of cross-over trials. We compared performance of the proposed piecewise linear mixed-effects model with two commonly cited statistical models namely, (1) Grizzle model; and (2) Jones & Kenward model, used in estimation of the treatment effect, in the analysis of randomized cross-over trial. We estimate two performance measurements (mean square error (MSE) and coverage probability) for the three methods, using data simulated from the proposed piecewise linear mixed-effects model. Piecewise linear mixed-effects model yielded lowest MSE estimates compared to Grizzle and Jones & Kenward models for both small (Nobs=20) and large (Nobs=600) sample sizes. It’s coverage probability were highest compared to Grizzle and Jones & Kenward models for both small and large sample sizes. A piecewise linear mixed-effects model is a better estimator of treatment effect than its two competing estimators (Grizzle and Jones & Kenward models) in the analysis of cross-over trials. The data generating mechanism used in this paper captures two time periods for a simple 2-Treatments x 2-Periods cross-over design. Its application is extendible to more complex cross-over designs with multiple treatments and periods. In addition, it is important to note that, even for single response models, adding more random effects increases the complexity of the model and thus may be difficult or impossible to fit in some cases.

Keywords: Evaluation, Grizzle model, Jones & Kenward model, Performance measures, Simulation

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Authors: Mohammad Mohammadi, Mohammad Pashmchi

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Background: Malnutrition commonly develops and worsens following gastric cancer surgery, particularly after discharge, which is associated with adverse outcomes. Former studies have primarily focused on patients during their hospital stay period, and there is limited evidence regarding the recommendation of nutritional interventions for patients after discharge from the hospital following gastric cancer surgery. This review is aimed to evaluate the efficiency of post-discharge dietary counseling with oral nutritional supplements (ONS), and dietary counseling alone on post-surgical nutritional outcomes in patients undergoing gastric cancer surgery. Methods: The four databases of Embase, PubMed, web of science, and google scholar were searched up to November 2022 for relevant randomized controlled trials. The Cochrane Collaboration’s assessment tool for randomized trials was used to evaluate the quality of studies. Results: Compared to patients who only received dietary counseling, patients who received both dietary counseling and ONS had considerably higher SMI, BMI, and less weight loss and sarcopenia occurrence rate. The patients who had received dietary counseling and ONS had significantly lower risk of chemotherapy intolerance. No differences in the readmission rate between the two groups was found. In terms of the quality of life, concomitant dietary advice and ONS significantly was associated with lower appetite loss and fatigue rate, but there was no difference in the other outcomes between the two groups. Conclusions: Post-discharge dietary advice with ONS following gastric cancer surgery may improve skeletal muscle maintenance, nutritional outcomes, quality of life variables, and chemotherapy tolerance. This evidence supports the recommendation of post-discharge dietary advice with ONS for patients who underwent gastric cancer surgery.

Keywords: gastric cancer surgery, oral nutritional supplements, malnutrition, gastric cancer

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Authors: Mai Ashraf Talaat

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Objectives: The aim of this review article is to assess the success of dental implants in breast cancer patients receiving bisphosphonate therapy and to evaluate the risk of developing bisphosphonate-related osteonecrosis of the jaw following dental implant surgery. Materials and Methods: A thorough search was conducted, with no time or language restriction, using: PubMed, PubMed Central, Web of Science, and ResearchGate electronic databases. Medical Subject Headings (MeSH) terms such as “bisphosphonate”, “dental implant”, “bisphosphonate-related osteonecrosis of the jaw (BRONJ)”, “osteonecrosis”, “breast cancer, MRONJ”, and their related entry terms were used. Eligibility criteria included studies and clinical trials that evaluated the impact of bisphosphonates on dental implants. Conclusion: Breast cancer patients undergoing bisphosphonate therapy may receive dental implants. However, the risk of developing BRONJ and implant failure is high. Risk factors such as the type of BP received, the route of administration, and the length of treatment prior to surgery should be considered. More randomized controlled trials with long-term follow-ups are needed to draw more evidence-based conclusions.

Keywords: dental implants, breast cancer, bisphosphonates, osteonecrosis, bisphosphonate-related osteonecrosis of the jaw

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Authors: K. Hariohm, V. Prakash, J. Saravana Kumar

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Introduction and Rationale: Increased scope of Physiotherapy (PT) practice also has contributed to research in the field of PT. It is essential to determine the production and quality of the clinical trials from India since, it may reflect the scientific growth of the profession. These trends can be taken as a baseline to measure our performance and also can be used as a guideline for the future trials. Objective: To quantify and analyze qualitatively the RCT’s from India from the period 2000-2013’ May, and classify data for the information process. Methods: Studies were searched in the Medline database using the key terms “India”, “Indian”, “Physiotherapy”. Clinical trials only with PT authors were included. Trials out of scope of PT practice and on animals were excluded. Retrieved valid articles were analyzed for published year, type of participants, area of study, PEDro score, outcome measure domains of impairment, activity, participation; ‘a priori’ sample size calculation, region, and explanation of the intervention. Result: 45 valid articles were retrieved from the year 2000-2013’ May. The majority of articles were done on symptomatic participants (81%). The frequencies of conditions repeated more were low back pain (n-7) and diabetes (n-4). PEDro score with mode 5 and upper limit of 8 and lower limit 4 was found. 97.2% of studies measure the outcome at the impairment level, 34% in activity level, and 27.8% in participation level. 29.7% of studies did ‘a priori’ sample size calculation. Correlation of year trend and PEDro score found to be not significant (p>.05). Individual PEDro item analysis showed, randomization (100%), concealment (33%) baseline (76%), blinding-subject, therapist, assessor (9.1%, 0%, 10%), follow-up (89%) ITT (15%), statistics between groups (100%), measures of variance (88 %). Conclusion: The trend shows an upward slope in terms of RCTs published from India which is a good indicator. The qualitative analysis showed some gaps in the clinical trial design, which can be expected to be, fulfilled by the future researchers.

Keywords: RCT, PEDro, physical therapy, rehabilitation

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Authors: Catarina Ramos Pereira, Jorge Rodrigues, Natália Oliveira, Jorge Machado, Maria Begoña Criado, Jorge Machado, Henri J. Greten

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Background: Parkinson's disease is a multi-system neurodegenerative disorder characterized by motor and non-motor symptoms. To slow disorder progression, different treatment options are now available, but in most cases, these therapeutic strategies also involve the presence of important side effects. This has led many patients to pursue complementary therapies, such as acupuncture, to alleviate PD symptoms. Therefore, an update on the efficacy of this treatment for patients of PD is of great value. This work presents a systematic review of the efficacy of acupuncture treatments in relieving PD symptoms. Methods: EMBASE, Medline, Pubmed, Science Direct, The Cochrane Library, Cochrane Central Register of Controlled Trials (Central), and Scielo databases were systematically searched from January 2011 through July 2021. Randomized controlled trials (RCTs) published in English with all types of acupuncture treatment were included. The selection and analysis of the articles were conducted by two blinding authors through the Rayyan application. Results: 720 potentially relevant articles were identified; 52 RCTs met our inclusion criteria. After the exclusion of 35, we found 17 eligible. The included RCTs reported positive effects for acupuncture plus conventional treatment compared with conventional treatment alone in the UPDRS score. Conclusions: Additional evidence should be supported by rigorous methodological strategies. Although firm conclusions cannot be drawn, acupuncture treatment, in the framework of an interdisciplinary care team, appears to have positive effects on PD symptoms.

Keywords: systematic review, Parkinson disease, acupuncture, traditional Chinese medicine

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