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ObjectiveAssessing safety and immunogenicity of an inactivated whole virus particle vaccine.DesignSingle-centre, double-blind, randomised, placebo-controlled, phase I (stage I: 18–50, stage II: 51–75 years), phase II (18–75 years) clinical trials.Setting29 December 2020 to 22 April 2021.ParticipantsStage I-phase I: 56 participants; stage II-phase I: 32; phase II: 280.InterventionDuring stage I, participants randomly (3:3:1) received 3 µg, 5 µg vaccine or placebo in a 14-day interval. Participants in stage II received two shots of 5 µg vaccine or placebo (3:1). In phase II, participants received 5 µg vaccine or placebo (4:1) in a 28-day interval.Primary and secondary outcome measuresSafety assessment and immunogenicity assessment via antibody response and conventional virus neutralisation test (cVNT).ResultsAll adverse events (AEs) were mild or moderate and transient in both phase I and phase II, and no AEs of special interest were reported. The seroconversion-rate of neutralising, antireceptor binding-domain (RBD) and anti-spike-glycoprotein (anti-S) antibodies 14-days after second dose of 5 µg vaccine in stage I was 70.8% (95% CI 48.9% to 87.4%), 87.5% (95% CI 67.6% to 97.3%), 91.7% (95% CI 73.0% to 99.0%). The antibody titres increased more among 5 µg than 3 µg. The corresponding rates for 3 µg vaccine were 45.8% (95% CI 25.6% to 67.2%), 54.2% (95% CI 32.8% to 74.5%) and 70.8% (95% CI 48.9% to 87.4%), respectively. In stage II, 100% (95% CI 84.6% to 100%), 86.4% (95% CI 65.1% to 97.1%) and 86.4% (95% CI 65.1% to 97.1%) of participants seroconverted for neutralising, anti-RBD and anti-S antibodies. In phase II, the seroconversion rate of neutralising-antibody was 82.8% (95% CI 77.0% to 87.6%), anti-RBD 77.0% (95% CI 70.7% to 82.6%) and anti-S 79.9% (95% CI 73.8% to 85.1%) on day 42. In the cVNT, the sera at 1/64 times dilution would neutralise SARS-CoV-2 among 91.7%, 77.3% and 82.5% of vaccinated participants in phase I-stage I, phase I-stage II and phase II clinical trials, respectively.ConclusionsThese results support further evaluation of this inactivated whole virus particle vaccine.Trial registration numbersIRCT20201202049567N1 and IRCT20201202049567N2 for phase I and IRCT20201202049567N3 for phase II.

Background Defining the quality of life in the patients with epidermolysis bullosa (EB) is important in patient care and management. Evaluation of quality of life requires a valid and reliable scale. The Quality of Life in Epidermolysis Bullosa (EB-QoL) questionnaire, which is an English 17-item questionnaire, has emerged as a useful tool for assessing the quality of life in the patients with EB. Objective This study aimed to evaluate the psychometric properties of the Farsi version of the EB-QoL questionnaire among a group of Iranian patients with EB. Methods The Farsi version of the EB-QoL questionnaire was finalized after translation and back-translation. From the 100 patients with EB invited to participate in the study, 83 completed the questionnaire (response rate: 83%). Subsequently, the content validity and construct validity of the questionnaire were assessed. The reliability of the questionnaire was assessed with Cronbach's alpha. Moreover, the correlation between EB-QoL scores and EB severity scores (based on the Birmingham Epidermolysis bullosa severity score scale) was evaluated. Results A total of 83 patients (40 male and 43 female) with a median age of 15 years (interquartile range, 9–24 years) and an age range between 3 and 43 years were enrolled in this study. Mean ± standard deviation scores from the EB-QoL questionnaire were 43.7 ± 9.9. The translated EB-QoL questionnaire showed a high internal consistency (Cronbach alpha = 0.90) and adequate item-total correlation. Also, there was a significant correlation between EB-QoL and EB severity scores (r = 0.39; p Conclusion The Farsi version of EB-QoL questionnaire has acceptable validity and reliability. Thus, the questionnaire can be used for future studies to assess the quality of life among Iranian patients with EB.

Highlights • The study showed a high prevalence of incorrect technique among patients with COPD. • There is an association between inhaler technique (>30% error) and lower quality of life in these patients., Background Inhalers are the mainstay of treatment for patients suffering from chronic obstructive pulmonary disease. However, incorrect inhaler technique is a considerable challenge. Objective We aimed to evaluate inhaler technique and its association with quality of life in a sample of patients with chronic obstructive pulmonary disease. Methods This cross-sectional study included patients with confirmed chronic obstructive pulmonary disease who were prescribed at least 1 inhaler medication on a regular basis. Patients were recruited from the outpatient pulmonary clinic of a hospital in Tehran. Inhaler technique was assessed according to a validated checklist. Patients’ quality of life was evaluated using Chronic Obstructive Pulmonary Disease Assessment Test. Results One hundred seventy-five patients with mean (SD) age of 59.0 (10.1) years were included. Patients’ devices were 192 (62.3%) pressurized metered-dose inhalers (including pressurized metered-dose inhalers plus spacer) and 116 (37.7%) dry powder inhalers. Unfortunately, only 2.86% of patients used their inhalers completely correct. The highest rate of errors was committed by patients who used metered-dose inhalers plus spacer. Patients with a higher educational degree had significantly lower rate of errors on average (P = 0.001). The most frequent errors made by patients using pressurized metered-dose inhalers or Turbuhaler was priming the inhaler before the first administration in 90.6% and 78.3% of patients, respectively. Chronic Obstructive Pulmonary Disease Assessment Test scores in patients using different inhaler devices were not significantly different. However, in patients with lower quality of life, significantly more patients had poor inhaler technique (P = 0.0001). Conclusions There is still considerable need for interventions to optimize inhaler technique. We also noted that appropriate inhaler technique is associated with better quality of life. (Curr Ther Res Clin Exp. 2020; 81:XXX–XXX)

BACKGROUND: Appropriate pharmacotherapy, self-care and adherence to medications are crucial to diabetes control. We aimed to study the diabetes care and glycemic control in patients with type two diabetes living in an urban area of Iran. METHODS: In this cross-sectional study, patients with type 2 diabetes who attended a referral university affiliated community pharmacy and an accredited pathobiology laboratory in the 17th district of Tehran were evaluated. Data including demographics, medical and drug history were collected. Self-care activity (Diabetes Self-care Activity Measurement Scale) and medication adherence (8-item Morisky Medication Adherence scale) were also assessed. After completing the questionnaires, the patients were referred to the laboratory for Hemoglobin A1c test. RESULTS: Three hundred forty-eight patients (60.3% females) were recruited. The mean (SD) of patients’ age was 55.82 (12.72) and 75.3%of them were Illiterate or had primary education. Mean (SD) of Hemoglobin A1c levels was 8.39 (2.03) and 33% of patients had levels higher than 9%. Among study patients, 186 (53.4%) patients received monotherapy for diabetes type 2 and 200 (57.5%) patients had low adherence to medications. Physical activity, blood glucose self-monitoring and foot care were domains of self-care with the fewest practice. Re-using a pen or syringe needle more than once was reported by 83% of patients and mean (SD) time of re-using a pen needle was 9.11 (8.74). CONCLUSION: Poor glycemic control, low medication adherence, inadequate self-care activities, signals of inappropriate pharmacotherapy and inadequate medical visits and monitoring in the study patients highlight the importance of providing accessible and affordable health care services in the region. Moreover, educational needs of the patients should be considered especially in an area in which the majority of patients are old and illiterate and have low socioeconomic status.

Background A clear picture of interaction of Th1/Th2 cytokines in pathogenesis of chronic spontaneous urticaria (CSU), remains elusive. Impaired IFN-γ production and decreased levels of IL-2 have been reported. The aim of this study was to evaluate the association of Th1 cytokines; IL-2, IL-12 and IFN-γ polymorphisms with CSU. Methods 90 patients with CSU and 140 age-sex matched subjects were included in this study. DNA samples were evaluated through PCR-SSP assay in order to detect single nucleotide polymorphisms of IL-12 (A/C −1188) or (rs3212227), IFN-γ (A/T UTR5644) or (rs2069717) and IL-2 (G/T −330 and G/T +166) or (rs2069762 and rs2069763). Results G allele at −330 at promoter region of IL-2 gene was overrepresented in CSU. Heterozygotes (GT) at this locus and heterozygotes at +166 of IL-2 gene (GT) were more prevalent in CSU group. Additionally, the haplotype GT for loci −330 and +166 of IL-2 gene was powerfully associated with CSU (OR (95%CI) = 57.29 (8.43–112.7)). Conclusions SNP at position −330 and +166 of IL-2 gene are differently expressed in CSU. The haplotype GT of IL-2 at −330 and +166 might confer vulnerability to a number of immunological disorders in Iranian region.

Background: The world’s population is growing older. Inappropriate and irrational use of drugs in the elderly is a considerable health concern due to consequences such as increased morbidity and adverse drug events. This study aimed to evaluate the rationality of prescribing and determining the extent of inappropriate prescribing in a sample of geriatric patients in Tehran. Methods: This cross sectional study was performed on 1512 prescriptions of patients aged ≥ 65 years from 5 pharmacies affiliated to Tehran University of Medical Sciences in 2014. Prescription of potentially inappropriate medications (PIMs) was investigated using the Beers Criteria along with WHO prescribing indices. Date were analyzed using SPSS software, and significance level was set at less than 0.05. Results: Mean (SD) age of patients was 73.9(6.7) years. A total of 472 (31.2%) patients received at least 1 PIM. Benzodiazepines were the most frequent drug class and general practitioners (GPs) were the most frequent prescriber of PIMs. The highest and the lowest percentage of prescriptions containing brand-names were prescribed by subspecialists (62.5%) and GPs (42.2%), respectively. Antibiotics and injectable medications were prescribed for 26.8% and 28.5% of patients by GPs. Mean (SD) number of drugs per prescription was 3.57 (1.92). Prescriptions containing systemic antibiotics and PIMs had significantly higher mean number of drugs compared to those without these items (both P < 0.001). Conclusion: There is a need for interventions to improve the quality of prescribing for elderly patients, especially by GPs. Also, there are still some problems in rational use of drugs based on prescribing indices, especially, prescribing brand-names and injectable medications.

Objective: Craving for substance abuse is a usual and complicated problem in patients, with opioid addiction who are in opioid detoxifying process. Craving has been added as one of the diagnostic criteria of substance use disorders in DSM-5. The present trial aimed at comparing the effects of celecoxib versus ibuprofen in reducing pain and decreasing the desire to use opiates in patients undergoing opiate detoxification (n = 32). Method: A total of 32 patients (both inpatients and outpatients), who were undergoing opiate detoxification procedure and met the inclusion criteria entered this 4- week study. Participants who suffered from pain due to opiate withdrawal were randomized into 2 groups: Group 1 received celecoxib 200 milligrams once per day and group 2 received ibuprofen 400 milligrams 4 times per day. Self-reported Desire for Drug Questionnaire (DDQ) and 0-10 numeric pain scale were used at baseline and at the end of the study to evaluate changes in opiate craving and pain, respectively. Data analysis was done by SPSS-21 statistical software. Results: In this study, 16 patients received celecoxib 200 milligrams once daily, and 16 received ibuprofen 400 milligrams 4 times daily. After 4 weeks of treatment with both ibuprofen and celecoxib, the results revealed that celecoxib and ibuprofen equally reduced the pain symptoms. After 4 weeks of treatment, with either ibuprofen or celecoxib, significant improvement was observed in decreasing the craving in the celecoxib group, but not in the ibuprofen group. Conclusion: The study revealed a significant difference between the celecoxib and ibuprofen group in reducing craving in patients with opiate craving after 4 weeks of treatment. However there were no significant differences between these two groups in reducing pain.

OBJECTIVES This study sought to evaluate graft outcome of kidneys from deceased-donor pediatric donors in adult recipients, and compare it with outcomes of kidney transplants from adult donors. MATERIALS AND METHODS This historical cohort study involved 2 groups. Group 1 included 23 first kidney adult recipients who received their first renal transplant from pediatric deceased-donor donors. Group 2 consisted of 33 first renal transplant adult recipients with kidneys coming from adult deceased donors. The Kaplan-Meier method was used to generate graft survival and patient survival curves. The log-rank test was done to compare differences between survival outcomes. RESULTS Graft survival rates at 1 and 5 years were 96% and 85% in group 1, and 91% and 85% in group 2. No significant difference existed in graft survival rates between the groups. Patient survival rates at 1 and 5 years in group 1 were 94% and 94% compared with 91% and 91% for group 2. No significant difference existed in graft survival rates between the groups. CONCLUSIONS This study demonstrates that with our experience, improvement in surgical technique and immunosuppressive therapy, pediatric deceased-donor kidneys may be considered as an alternate option for adult recipients. Renal transplants from pediatric donors into adult recipients is associated with good graft and patient survival outcomes.

Purpose To propose an evidence based diagnostic algorithm using mass characteristics to determine malignancy in patients with adrenal incidentaloma by CTscan. Methods A systematic review in Medline, Scopus, relevant reference books and desk searching was performed up to January 2016 with relevant reference checking. The summery estimates of sensitivity, specificity, positive and negative likelihood ratio of different characteristics were calculated in two groups of the articles investigating the cases without previous malignancy and the articles investigating the oncologic cases. Results Thirty six articles were included in this study. In the first group with no history of malignancy a positive and negative LR of 3.1 and 0.13 in 4 cm threshold and positive and negative LR of 2.85 and 0 in 10HU density were found. In the second group with history of malignancy positive and negative LR of 2.3 and 0.27 in 3 cm threshold and positive and negative LR of 3.6 and 0.08 in 20HU density were resulted. Conclusion The results retrieved in this study considering the limitations show that adrenal incidentaloma with a size less than 4 cm or a mass larger than 4 cm with density less than 10HU in the first group can be managed with imaging follow up. For masses larger than 4 cm with density more than 10HU another diagnostic procedure should be performed. In the second group an adrenal mass larger than 3 cm or less than 3 cm with density more than 20HU should go under operation. But masses smaller than 3 cm with less than 20HU density can be followed by imaging.

Background Hydrocoeles are common cystic scrotal abnormalities, described as a fluid-filled collection between the visceral and parietal layers of the tunica vaginalis of the scrotum. There are two approaches for treatment of hydrocoeles: surgical open hydrocoelectomy and aspiration followed by sclerotherapy. Objectives We compared the benefits and harms of aspiration and sclerotherapy versus hydrocoelectomy for the management of hydrocoeles. Search methods We searched the Cochrane Renal Group's Specialised Register to 2 August 2014 through contact with the Trials' Search Co-ordinator using search terms relevant to this review. Selection criteria Randomised controlled trials (RCTs) and quasi-RCTs comparing aspiration and sclerotherapy versus hydrocoelectomy for the management of hydrocoeles. Data collection and analysis Two authors independently extracted data and assessed risk of bias in the included studies. Random effects meta-analyses were performed using relative risk (RR) for dichotomous outcomes and mean differences (MD) for continuous outcomes, with 95% confidence intervals (CI). Main results We found four small studies that met the inclusion criteria. These studies enrolled 275 patients with 282 hydroceles. Participants were randomised to aspiration and sclerotherapy (155 patients with 159 hydroceles) and surgery (120 patients with 123 hydroceles). All studies were assessed as having low or unclear risk of bias for selection bias, detection bias, attrition bias and selective reporting bias. Blinding was not possible for participants and investigators based on the type of interventions. Blinding for statisticians was not reported in any of included studies. There were no significant difference in clinical cure between the two groups (3 studies, 215 participants: RR 0.45, 95% CI 0.18 to 1.10), however there was significant heterogeneity (I² = 95%). On further investigation one study contributed all of the heterogeneity. This could be due to the agent used or perhaps due to the fact that this is a much older study than the other two studies included in this analysis. When this study was removed from the analysis the heterogeneity was 0% and the result was significant (in favour of surgery) (2 studies, 136 participants: RR 0.74; 95% CI 0.64 to 0.85).There was a significant increase in recurrence in those who received sclerotherapy compared with surgery (3 studies, 196 participants: RR 9.37, 95% CI 1.83 to 48.4). One study reported a non-significant decrease in fever in the sclerotherapy group (60 participants: RR 0.25, 95% CI 0.06 to 1.08). There was an increased number of infections in the surgery group however this increase was not statistically significant (4 studies, 275 participants): RR 0.31, 95% CI 0.09 to 1.05; I² = 0%). Three studies reported the frequency of pain in the surgery group was higher than aspiration and sclerotherapy group but because of different measurement tools applied in these studies, we could not pool the results. Radiological cure was not reported in any of the included studies. There was no significant difference in haematoma formation between the two groups (3 studies, 189 participants: RR 0.57, 95% CI 0.17 to 1.90; I² = 0%). Only one study reported patient satisfaction at three and six months; there was no significant difference between the two groups. Authors' conclusions Postoperative complications as well as cost and time to work resumption were less in the aspiration and sclerotherapy group; however the recurrence rate was higher. The cure rate in short-term follow-up was similar between the groups, however there is significant uncertainty in this result due to the high heterogeneity. There is a great need for further methodologically rigorous RCTs that assess the effectiveness of different type of sclerosant agents, sclerosing solution concentration and injection volume for the treatment of hydrocoeles. It is important that the RCTs have sufficiently large sample size and long follow-up period. Studies should evaluate clinical outcomes such as pain, recurrence, satisfaction, complications and cure using validated instruments. The protocols for all studies should be registered in clinical trial registries and the reports of these studies should conform with international guidelines of trial reporting such as CONSORT. Cost-effectiveness studies should also be undertaken.

Recently, the clinical pemphigus disease activity indexes of Pemphigus Disease Area Index (PDAI), Autoimmune Bullous Skin Disorder Intensity Score (ABSIS), and Pemphigus Vulgaris Activity Score (PVAS) were validated to correlate with physician global assessment. The antidesmoglein (anti-Dsg) autoantibodies are known to correlate mostly with pemphigus disease activity. The correlation between these indexes and anti-Dsg1 and anti-Dsg3 enzyme-linked immunosorbent assay values has not been previously evaluated.To evaluate the PDAI, ABSIS, and PVAS in a large number of patients with pemphigus vulgaris and to compare the interrater reliability of these indexes and the convergent validity according to anti-Dsg values.A cross-sectional study was performed in 2012 in a referral university center for autoimmune bullous diseases. One hundred patients with confirmed diagnoses of pemphigus vulgaris and clinical pemphigus lesions (mean [SD] age, 43.3 [1.7] years; age range, 14-77 years; female-male ratio, 1:3) were studied. Three dermatologists familiar with immunobullous diseases and the indexes rated the patients.All 100 patients were evaluated with the PDAI, ABSIS, and PVAS. Three dermatologists independently rated all 3 indexes for each of the patients on the same day. Serum anti-Dsg1 and anti-Dsg3 enzyme-linked immunosorbent assay values were measured simultaneously.Analyses of interrater reliabilities, convergent validities according to anti-Dsg titers, correlation between the distribution and types of lesions with disease activity, predictors of higher titers of antibody (multiple regression analysis), and cutoff values of measures for 2 titers of anti-Dsg with optimal area under the curve, sensitivity, and specificity were performed.The interrater reliabilities were highest for the PDAI, followed by the ABSIS and the PVAS (intraclass correlation coefficients of 0.98 [95% CI, 0.97-0.98], 0.97 [95% CI, 0.96-0.98], and 0.93 [95% CI, 0.90-0.95], respectively). The convergent validity was highest for the PDAI, followed by the PVAS and the ABSIS (Spearman ρ = 0.67, 0.52, and 0.33, respectively). Head, neck, and trunk involvement were predictors of higher titers of anti-Dsg1.Among the 3 studied indexes, the PDAI had the highest validity and is recommended for use in multicenter studies for rare diseases, such as pemphigus vulgaris.

Visceral leishmaniasis (VL) is a vector-borne disease affecting humans and domestic animals that constitutes a serious public health problem in many countries. Although many antigens have been examined so far as protein- or DNA-based vaccines, none of them conferred complete long-term protection. The use of the lizard non-pathogenic to humans Leishmania (L.) tarentolae species as a live vaccine vector to deliver specific Leishmania antigens is a recent approach that needs to be explored further. In this study, we evaluated the effectiveness of live vaccination in protecting BALB/c mice against L. infantum infection using prime-boost regimens, namely Live/Live and DNA/Live. As a live vaccine, we used recombinant L. tarentolae expressing the L. donovani A2 antigen along with cysteine proteinases (CPA and CPB without its unusual C-terminal extension (CPB-CTE)) as a tri-fusion gene. For DNA priming, the tri-fusion gene was encoded in pcDNA formulated with cationic solid lipid nanoparticles (cSLN) acting as an adjuvant. At different time points post-challenge, parasite burden and histopathological changes as well as humoral and cellular immune responses were assessed. Our results showed that immunization with both prime-boost A2-CPA-CPB-CTE-recombinant L. tarentolae protects BALB/c mice against L. infantum challenge. This protective immunity is associated with a Th1-type immune response due to high levels of IFN-γ production prior and after challenge and with lower levels of IL-10 production after challenge, leading to a significantly higher IFN-γ/IL-10 ratio compared to the control groups. Moreover, this immunization elicited high IgG1 and IgG2a humoral immune responses. Protection in mice was also correlated with a high nitric oxide production and low parasite burden. Altogether, these results indicate the promise of the A2-CPA-CPB-CTE-recombinant L. tarentolae as a safe live vaccine candidate against VL., Author Summary Visceral leishmaniasis (VL) is the most severe form of leishmaniasis and has emerged as an opportunistic infection in HIV-1 infected patients in many parts of the world. Drug-resistant forms have developed so emergence and increased the need for advanced preventive strategies. Using live avirulent organisms as a vaccine has been proven to be more effective than other regimens. The lizard protozoan parasite Leishmania tarentolae is considered as nonpathogenic to humans. In our previous work, a recombinant L. tarentolae strain expressing the amastigote-specific L. donovani A2 antigen as a vaccine candidate elicited protection against L. infantum challenge in mice. Furthermore, combinations of CPA/CPB cysteine proteinases were more protective against visceral and cutaneous Leishmania infections than the individual forms. Herein, we used DNA/Live and Live/Live prime-boost vaccination strategies against visceral leishmaniasis in BALB/c mice consisting of the A2-CPA-CPB-CTE tri-fusion genes formulated with cationic solid lipid nanoparticles and a recombinant L. tarentolae expressing the tri-fusion. Assessments of cytokine production, humoral responses, parasite burden and histopathological studies support that the recombinant L. tarentolae A2-CPA-CPB-CTE candidate vaccine elicits a protective response against visceral leishmaniasis in mice and represents an important step forward in the development of new vaccine combinations against Leishmania infections.

There are different reasons for mergers among higher education institutes. In October 2010 the Iran University of Medical Sciences (IUMS) merged with two other medical universities in Tehran. In this study, we aim to review the literature on academic integrations and university mergers to call the attention to challenges and reasons for the success or failure of university mergers.We searched for studies that pertained to university or college mergers, amalgamation, dissolution, or acquisition in the following databases: PubMed, Emerald, Web of Science, Scopus, and Ovid, without any limitations on country, language, or publication date. Two reviewers selected the search results in a joint meeting. We used content analysis methodology and held three sessions for consensus building on incompatibilities.We reviewed a total of 32 documents. The "merger" phenomenon attracted considerable attention worldwide from the 1970s until the 1990s. The most important reasons for merging were to boost efficiency and effectiveness, deal with organizational fragmentation, broaden student access and implement equity strategies, increase government control on higher education systems, decentralization, and to establish larger organizations. Cultural incompatibility, different academic standards, and geographical distance may prevent a merger. In some countries, geographical distance has caused an increase in existing cultural, social, and academic tensions.The decision and process of a merger is a broad, multi-dimensional change for an academic organization. Managers who are unaware of the fact that mergers are an evolutionary process with different stages may cause challenges and problems during organizational changes. Socio-cultural integration acts as an important stage in the post-merger process. It is possible for newly-formed schools, departments, and research centers to be evaluated as case studies in future research.

Background Low-back pain (LBP) and related disabilities are major public health problems and a major cause of medical expenses, absenteeism and disablement. Low level laser therapy (LLLT) can be used as a therapeutic intervention for musculoskeletal disorders such as back pain. Objectives To assess the effects of LLLT in patients with non-specific low-back pain and to explore the most effective method of administering LLLT for this disorder. Search strategy We searched CENTRAL (The Cochrane Library 2005, Issue 2), MEDLINE and CINAHL from their start to January 2007 and EMBASE, AMED and PEDro from their start to 2005 with no language restrictions. We screened references in the included studies and in reviews of the literature and conducted citation tracking of identified RCTs and reviews using Science Citation Index. We also contacted content experts. Selection criteria Only randomised controlled clinical trials (RCTs) investigating low level laser therapy as a light source treatment for non-specific low-back pain were included. Data collection and analysis Two authors independently assessed methodological quality using the criteria recommended by the Cochrane Back Review Group and extracted data. Consensus was used to resolve disagreements. Clinically and statistically homogeneous studies were pooled using the fixed-effect model; clinically homogeneous and statistically heterogeneous studies were pooled using the random-effects model. Main results Six RCTs with reasonable quality were included in the review. All of them were published in English. Because of clinical heterogeneity in study populations, interventions used and reported outcomes, meta-analysis was not possible to determine an overall effect for pain, disability and range of motion. Three studies (n=168) separately showed a significant pain relief effect of LLLT compared to sham therapy for sub-acute and chronic low-back pain. These effects were only observed at short-term and intermediate-term follow-ups. Long-term follow-ups were not reported. There was insufficient evidence to investigate the difference between LLLT and comparison groups for pain-related disability. There is insufficient evidence to determine the effectiveness of LLLT on anterior-posterior lumbar range of motion compared to control group in short-term follow-up. The relapse rate in the LLLT group was significantly lower than in the control group at six months follow-up period according to the findings of two trials. One study (n=50) reported a significant improvement in pain in LLLT group versus exercise therapy. Authors' conclusions No side effects were reported. However, we conclude that there are insufficient data to draw firm conclusions. There is a need for further methodologically rigorous RCTs to evaluate the effects of LLLT compared to other treatments, different lengths of treatment, different wavelengths and different dosages. Comparison of different LLLT treatments will be more reasonable if dose calculation methods are harmonized.

Background The objective of this study was to compare concept mapping with lecture-based method in teaching of evidence based educated topic to medical students. Methods This randomized controlled trial was carried out on medical students during sixth year of 7-year MD curriculum clerkship phase. Cluster randomization was used to divide students into intervention and control groups. Both groups, at the beginning, were taught “Diabetic Ketoacidosis” (DKA) using evidence-based tool named Critically Appraised Topics (CAT). Students of intervention group were taught construction of concept maps on DKA and in the control group students had a lecture and a group discussion about what they had been taught on DKA. In the end, all of the students had an exam that they had to answer to 7 questions following to two clinical scenarios. The questions addressed physiopathology, diagnosis and treatment of patients with DKA and were scored separately. Sum of these scores was considered as total score. Scores were compared between intervention and control groups. Results Seventy six medical students (28 male, 48 female) were participated in this study. Total score among intervention group was higher than control group (78.2% vs. 72.5%, p