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Objective Lumbar spinal stenosis (LSS) patients suffer from significant pain and disability. To assess long-term safety and efficacy of laminectomy in LSS patients, a systematic review and meta-analysis study was conducted. Methods Literature review in MEDLINE, Embase, Scopus, Web of Science, and Cochrane Library databases was performed using a predefined search strategy. Articles were included if they met the following characteristics: human studies, LSS, and at least 5 years of follow-up. Outcome measures included patient satisfaction, pain, disability, claudication, reoperation rates, and complications. Results Twelve articles met the eligibility criteria for our study. Overall, there was low-quality evidence that patients undergoing laminectomy, with at least 5 years of follow-up, have significantly more satisfaction, and less pain and disability, compared with the preoperative baseline. Assessment of neurogenic intermittent claudication showed significant improvement in walking abilities. We also reviewed the postoperative complication and adverse events in the included studies. After meta-analysis was performed, the reoperation rate was found to be 14% (95% confidence interval: 13–16%). Conclusion Our study provides low-quality evidence suggesting that patients undergoing laminectomy for LSS have less disability and pain and can be more physically active postoperatively.

To investigate the predictive factors and the best predictive model for relapse in granulomatosis with polyangiitis (GPA) patients.All patients referred to our tertiary university hospital with confirmed diagnosis of GPA based on 1990-ACR criteria and/or revised Chapel Hill nomenclature, who were followed more than 24 months between 2012 and 2021 were included. Patients were classified into relapsing and non-relapsing groups. Disease activity was assessed based on Birmingham Vasculitis Activity Score (BVAS) and BVAS for GPA (BVAS-GPA). All demographic, clinical, laboratory, and radiologic parameters were compared between two groups.Data of 133 patients (male = 52 (39.1%); mean age = 46.5 ± 14.5 years) with a mean follow-up period of 49.4 ± 24.1 months were evaluated. Of those, 91 (68.4%) experienced at least one relapse episode. The mean duration of relapse-free-survival (RFS) was 12.5 months with 1-year, 3-year, and 5-year RFS rates of 46.6%, 34.6%, and 31.6%, respectively. The risk of relapse was higher if patients had higher BVAS or BVAS-GPA score (P-values 0.001), constitutional syndrome (P-value = 0.01), neutrophil-to-lymphocyte ratio (NLR) (P-value = 0.01), C-reactive-protein (P-value = 0.03), alanine transaminase 40 units/L (P-value = 0.04), and microscopic hematuria (P-value = 0.001). In backward logistic regression analysis, baseline BVAS score ≥ 12 (Ex(B) = 4.21, P-value = 0.03), and NLR 2.5 (Ex(B) = 12.00, P-value = 0.007) remained statistically significant at the last step of the model with 75.8% sensitivity, 76.9% specificity, and 76.3% accuracy in predicting the relapsing patients. The frequency of relapse episodes was significantly lower in treatment group of rituximab-rituximab (0.3 ± 0.6) compared to cyclophosphamide-methotrexate (1.2 ± 1.3) and cyclophosphamide-azathioprine (1.8 ± 1.5) treatment protocols (P-value = 0.002).High-risk patients according to proposed model should be prioritized for more intensive care, more aggressive treatment, and closer follow-ups.• During the mean follow-up period of 50 months, 68.4% experienced at least one relapse episode • Patients with baseline BVAS 12, renal involvement, and elevated NLR are more vulnerable to relapsing disease • Patients on rituximab for induction and maintenance less experienced relapse episodes compared to other treatment regimens.

Introduction: Traumatic spinal cord injury (TSCI) is a catastrophic event with a considerable health and economic burden on individuals and countries. This study was performed to update an earlier systematic review and meta-analysis of epidemiological properties of TSCI in developing countries published in 2013. Methods: Various search methods including online searching in database of EMBASE and PubMed, and hand searching were performed (2012 to May 2020). The keywords “Spinal cord injury,” “epidemiology,” “incidence,” and “prevalence” were used. Based on the definition of developing countries by the International Monetary Fund, studies related to developing countries were included. Data selection was according to PRISMA guidelines. The quality of included studies was evaluated by Joanna Briggs Institute Critical Appraisal Tools. Results of meta-analysis were presented as pooled frequency, and forest, funnel, and drapery plots. Results: We identified 47 studies from 23 developing countries. The pooled incidence of TSCI in developing countries was 22.55/million/year (95% CI: 13.52; 37.62/million/year). Males comprised 80.09% (95% CI: 78.29%; 81.83%) of TSCIs, and under 30 years patients were the most affected age group. Two leading etiologies of TSCIs were motor vehicle crashes (43.18% [95% CI: 37.80%; 48.63%]) and falls (34.24% [95% CI: 29.08%; 39.59%], respectively). The difference among the frequency of complete injury (49.47% [95% CI: 43.11%; 55.84%]) and incomplete injury (50.53% [95% CI: 44.16%; 56.89%]) was insignificant. The difference among frequency of tetraplegia (46.25% [95% CI: 37.78%; 54.83%]) and paraplegia (53.75% [95% CI: 45.17%; 62.22%]) was not statistically significant. The most prevalent level of TSCI was cervical injury (43.42% [95% CI: 37.38%; 49.55%]). Conclusion: In developing countries, TSCIs are more common in young adults and males. Motor vehicle crashes and falls are the main etiologies. Understanding epidemiological characteristics of TSCIs could lead to implant-appropriate cost-effective preventive strategies to decrease TSCI incidence and burden.

STUDY DESIGN: Systematic review. OBJECTIVES: This systematic review evaluates all randomized clinical trials (RCTs) conducted on assessing the efficacy and safety of pharmacologic therapies for the treatment of Spinal Cord Injury (SCI)-associated pain. METHODS: The PubMed/Medline, EMBASE, and Cochrane library online databases were searched from 1946 to May 2019 using specific search terms for SCI, pain, and RCTs meeting predetermined inclusion criteria. The efficacy outcome of interest was pain reduction, discontinuations, and adverse events (AEs). RESULTS: Of 2746 records identified through database searching, 703 duplicates were deleted. 1814 were excluded, the full text of the remaining 230 articles was reviewed, and finally, 28 papers were selected for drafting. The most studied medications were pregabalin, gabapentin, amitriptyline, and ketamine. Pregabalin, gabapentin, and amitriptyline reduced VAS by more than 30%, and ketamine reduced VAS by 40%. Oxcarbazepine, lamotrigine, alfentanil, tramadol, and morphine added to clonidine, baclofen, and botulinum toxin type A (BTA) significantly reduced pain compared with placebo. On the other hand, valproate, levetiracetam, trazodone, and duloxetine did not significantly alleviate SCI-associated pain compared to placebo. The risks of AEs and discontinuations in anticonvulsants were the least, while it was highest in analgesics. CONCLUSIONS: Studies of SCI-associated pain were few, small, heterogenic in measures and values, and did not allow quantitative comparisons of efficacy. However, available data suggested pregabalin and gabapentin led to a more marked reduction in SCI-associated pain with fewer AEs. Additional clinical studies are needed to assess the effect of established and novel management options.

Background: Individuals with moderate to severe traumatic brain injury (TBI) often have prolonged cognitive impairments, resulting in long-term problems with their real-life activities. Given the urgent need for evidence-based recommendations for neuropsychological management of Iranian TBI patients, the current work aimed to adapt eligible international guidelines for cognitive assessment and rehabilitation of the TBI patients in Iran. Methods: The project was led by an executive committee, under the supervision of the Iranian Ministry of Health and Medical Education (MOHME). Following a systematic literature search and selection process, four guidelines were included for adaptation. Clinical recommendations of the source guidelines were tabulated as possible clinical scenarios for 90 PICO clinical questions covering all relevant phases of care. After summing up the scenarios, our initial list of recommendations was drafted according to the Iranian patients’ conditions. The final decision-making, with the contribution of a national interdisciplinary panel of 37 experts from across the country, was conducted in two rounds using online and offline survey forms (Round 1), and face-to-face and telephone meetings (Round 2). Results: A total of 63 recommendations in six sections were included in the final list of recommendations, among which 24 were considered as key recommendations. In addition, some of the recommendations were identified as fundamental, meaning that proper implementation of the other recommendations is largely dependent on their implementation. Conclusion: Iranian health policy makers and rehabilitation program managers are recommended to address some fundamental issues to provide the necessary infrastructure to set up an efficient cognitive rehabilitation service system.

OBJECTIVEPredicting neurological recovery following traumatic spinal cord injury (TSCI) is a complex task considering the heterogeneous nature of injury and the inconsistency of individual studies. This study aims to summarize the current evidence on neurological recovery following TSCI by use of a meta-analytical approach, and to identify injury, treatment, and study variables with prognostic significance.METHODSA literature search in MEDLINE and EMBASE was performed, and studies reporting follow-up changes in American Spinal Injury Association (ASIA) Impairment Scale (AIS) or Frankel or ASIA motor score (AMS) scales were included in the meta-analysis. The proportion of patients with at least 1 grade of AIS/Frankel improvement, and point changes in AMS were calculated using random pooled effect analysis. The potential effect of severity, level and mechanism of injury, type of treatment, time and country of study, and follow-up duration were evaluated using meta-regression analysis.RESULTSA total of 114 studies were included, reporting AIS/Frankel changes in 19,913 patients and AMS changes in 6920 patients. Overall, the quality of evidence was poor. The AIS/Frankel conversion rate was 19.3% (95% CI 16.2–22.6) for patients with grade A, 73.8% (95% CI 69.0–78.4) for those with grade B, 87.3% (95% CI 77.9–94.8) for those with grade C, and 46.5% (95% CI 38.2–54.9) for those with grade D. Neurological recovery was significantly different between all grades of SCI severity in the following order: C > B > D > A. Level of injury was a significant predictor of recovery; recovery rates followed this pattern: lumbar > cervical and thoracolumbar > thoracic. Thoracic SCI and penetrating SCI were significantly more likely to result in complete injury. Penetrating TSCI had a significantly lower recovery rate compared to blunt injury (OR 0.76, 95% CI 0.62–0.92; p = 0.006). Recovery rate was positively correlated with longer follow-up duration (p = 0.001). Studies with follow-up durations of approximately 6 months or less reported significantly lower recovery rates for incomplete SCI compared to studies with long-term (3–5 years) follow-ups.CONCLUSIONSThe authors’ meta-analysis provides an overall quantitative description of neurological outcomes associated with TSCI. Moreover, they demonstrated how neurological recovery after TSCI is significantly dependent on injury factors (i.e., severity, level, and mechanism of injury), but is not associated with type of treatment or country of origin. Based on these results, a minimum follow-up of 12 months is recommended for TSCI studies that include patients with neurologically incomplete injury.

Background: Proper utilization of high-quality clinical practice guidelines (CPGs) eliminates the dependence of patients’ outcomes on the ability and knowledge of "individual" health care providers and reduces unwarranted variation in care. The aim of this study was to adapt/adopt two CPGs for pharmacologic management of acute spinal cord injury (SCI) using guideline adaptation methods. Methods: This study was conducted based on the ADAPTE process. Following establishment of an organizing committee and choosing the health topics, we appraised the quality of the CPGs using the Appraisal of Clinical Guidelines for Research & Evaluation II (AGREE II). Then, the authors extracted and categorized suggestions according to Population, Intervention, Professions, Outcomes and Health care setting (PIPOH). The decision-making process was based on systemic evaluation of each suggestion, utilizing a combination of AGREE II scores, the quality of supporting evidence for or against each suggestion and the triad of feasibility, acceptance and adoptability for the Iranian health-care context. Results: Two guidelines were included in the adaptation process. Based on high-quality of these guidelines and the feasibility and adoptability evaluation of the organizing committee, we decided to adopt the suggestion of both guidelines. Overall, seven suggestions were extracted from the source guidelines. Conclusion: This work provides a framework to apply guidelines for acute SCI to the developing regions of the world. Attempts should be made to implement these suggestions in order to improve the health outcomes of Iranian SCI patients.

Bone morphogenetic proteins (BMPs) have been commonly used as a graft substitute in spinal fusion. Although the U.S. Food and Drug Administration issued a warning on life-threatening complications of recombinant human BMPs (rhBMPs) in cervical spine fusion in 2008, their off-label use has been continued. This investigation aimed to review the evidence for the use of rhBMP-2 and rhBMP-7 in anterior cervical spine fusions.A comprehensive search was performed through Ovid (MEDLINE), PubMed, and Embase. The risk of bias assessment was according to the recommended criteria by the Cochrane Back and Neck group and MINORS (Methodological Index for Non-Randomized Studies). A wide array of radiographic and clinical outcomes including the adverse events were collated.Eighteen articles (1 randomized and 17 nonrandomized) were eligible for inclusion. The fusion rate was higher with use of rhBMP in most studies and our meta-analysis of the pooled data from 4782 patients confirmed this finding (odds ratio, 5.45; P0.00001). Altogether, the rhBMP and control groups were comparable in patient-reported outcomes. However, most studies tended to show a significantly higher incidence of overall complication rate, dysphagia/dysphonia, cervical swelling, readmission, wound complications, neurologic complications, and ossification.Application of rhBMPs in cervical spine fusion yields a significantly higher fusion rate with similar patient-reported outcomes, yet increased risk of life-threatening complications. Thus, we do not recommend the use of rhBMP in anterior cervical fusions.

Study Design: Systematic review. Objectives: Anterior cervical approach is associated with complications such as dysphagia and airway compromise. In this study, we aimed to systematically review the literature on the efficacy and safety of corticosteroid administration as a preventive measure of such complications in anterior cervical spine surgery with fusion. Methods: Following a systematic literature search of MEDLINE, Embase, and Cochrane databases in July 2016, all comparative human studies that evaluated the effect of steroids for prevention of complications in anterior cervical spine surgery with fusion were included, irrespective of number of levels and language. Risk of bias was assessed using MINORS (Methodological Index for Non-Randomized Studies) checklist and Cochrane Back and Neck group recommendations, for nonrandomized and randomized studies, respectively. Results: Our search yielded 556 articles, of which 9 studies (7 randomized controlled trials and 2 non–randomized controlled trials) were included in the final review. Dysphagia was the most commonly evaluated complication, and in most studies, its severity or incidence was significantly lower in the steroid group. Although prevertebral soft tissue swelling was less commonly assessed, the results were generally in favor of steroid use. The evidence for airway compromise and length of hospitalization was inconclusive. Steroid-related complications were rare, and in both studies that evaluated the fusion rate, it was comparable between steroid and control groups in long-term follow-up. Conclusions: Current literature supports the use of steroids for prevention of complications in anterior cervical spine surgery with fusion. However, evidence is limited by substantial risk of bias and small number of studies reporting key outcomes.

Study Design: Narrative review. Objectives: Anterior cervical discectomy and fusion (ACDF) is a reliable procedure, commonly used for cervical degenerative disc disease. For interbody fusions, autograft was the gold standard for decades; however, limited availability and donor site morbidities have led to a constant search for new materials. Clinically, it has been shown that calcium phosphate ceramics, including hydroxyapatite (HA) and tricalcium phosphate (TCP), are effective as osteoconductive materials and bone grafts. In this review, we present the current findings regarding the use of ceramics in ACDF. Methods: A review of the relevant literature examining the clinical use of ceramics in anterior cervical discectomy and fusion procedures was conducted using PubMed, OVID and Cochrane. Result: HA, coralline HA, sandwiched HA, TCP, and biphasic calcium phosphate ceramics were used in combination with osteoinductive materials such as bone marrow aspirate and various cages composed of poly-ether-ether-ketone (PEEK), fiber carbon, and titanium. Stand-alone ceramic spacers have been associated with fracture and cracks. Metallic cages such as titanium endure the risk of subsidence and migration. PEEK cages in combination with ceramics were shown to be a suitable substitute for autograft. Conclusion: None of the discussed options has demonstrated clear superiority over others, although direct comparisons are often difficult due to discrepancies in data collection and study methodologies. Future randomized clinical trials are warranted before definitive conclusions can be drawn.

The infantile colic is one of the most common complaints in the infancy; however, limited therapeutic approaches are described in the literature. Recently probiotics have been suggested as a potential strategy in the treatment of infantile colic. We conducted this study to investigate the efficacy of probiotics in relieving colic symptoms in Iranian infants. This double-blind clinical trial was performed among 70 infants aged 3 to 16 weeks with the presumed diagnosis of infantile colic according to Wessel criteria who were breastfed or formula fed. They were assigned at random to receive Pedilact® (Bifidobacterium infantis, Lactobacillus reuteri, and Lactobacillus rhamnosus) (N=33) or placebo (N=32). Demographic data were recorded in the questionnaires at the beginning of the study. The number of daily episodes of crying and fussiness, number of weekly crying days, and duration of crying were separately analyzed on 7, 21, and 30th days of investigation. Baseline demographic data showed no statistically significant difference between intervention and placebo groups. Infants given Pedilact® showed a significant reduction in daily episodes of crying, duration of crying, and the weekly number of crying days at the end of the treatment period compared with those receiving placebo (P=0.000). On 21th day of the study, daily episodes of fuss and crying (P=0.032) and duration of crying reduced significantly in the intervention group in comparison to the placebo group (P=0.000). Administration of Pedilact® drop significantly improved colic symptoms by reducing crying and fussing times in breastfed or formula fed in Iranian infants with colic. © 2019 Tehran University of Medical Sciences. All rights reserved. Acta Med Iran 2019;57(7):405-411.

Anterior cervical discectomy and fusion (ACDF) is one of the most widely used procedures in cervical spine. Demineralized bone matrix (DBM) is one of the fusion options that has been used in treatment of the bone defects for years. The purpose of this review is to provide an evidence-based analysis on the current evidence for effectiveness of DBM in ACDF.A systematic search of the literature was conducted using MEDLINE, Scopus, and CENTRAL. The risk of bias was evaluated with the criteria recommended by the Cochrane Back and Neck group and the Methodological Index for Non-Randomized Studies (MINORS). The patient-reported outcome measures included the visual analog scale (VAS), Odom's criteria, Japanese Orthopaedic Association (JOA), and Neck Disability Index (NDI). Secondary outcome measures were fusion rate, non-union, subsidence, collapse, displacement, spinal alignment, and re-operation.Twelve studies met the eligibility criteria, of which three were randomized and nine were non-randomized. Patient-reported outcomes were non-inferior for DBM compared with the autograft and other bone substitute materials. The DBM had a fusion rate comparable with other graft materials, particularly in long term (88.8-100%, after 18 months follow-up). The majority of studies reported no collapse, subsidence or displacement with DBM. The revision surgery was mainly due to the symptomatic non-union in 4.1-8.3% of the DBM cases. Preservation of the angle of cervical lordosis was acceptable with DBM fusion.Most of the studies reported non-inferior results for DBM compared with autograft and other graft substitute materials in terms of patient-reported outcomes, fusion rate, and safety. However, the quantity and quality of evidence is very limited.