Timing of Surgery and Pre-operative Physiological Parameters as Clinical Predictors of Surgical Outcomes in Traumatic Subaxial Cervical Spine Fractures and Dislocations.

Objective To evaluate the risk factors and outcomes in patients surgically treated for subaxial cervical spine injuries with respect of the timing of surgery and preoperative physiological parameters of the patient. Methods 26 patients with sub-axial cervical spine fractures and dislocations were enrolled. Demographic data of patients, appropriate radiological investigation, and physiological parameters like respiratory rate, blood pressure, heart rate, PaO2 and ASIA impairment scale were documented. They were divided pre-operatively into 2 groups. Group U with patients having abnormal physiological parameters and Group S including patients having physiological parameters within normal range. They were further subdivided into early and late groups according to the timing of surgery as U early , U late, S early and S late . All the patients were called for follow-up at 1, 6 and 12 months. Results 56 percent of patients in Group S had neurological improvement by one ASIA grade and a good outcome irrespective of the timing of surgery. Patients in Group U having unstable physiological parameters and undergoing early surgical intervention had poor outcomes. Conclusion This study concludes that early surgical intervention in physiologically unstable patients had a strong association as a risk factor in the final outcome of the patients in terms of mortality and morbidity. Also, no positive association of improvement in physiologically stable patients with respect to the timing of surgery could be established.

Timing of Surgery and Pre-operative Physiological Parameters as Clinical Predictors of Surgical Outcomes in Traumatic Subaxial Cervical Spine Fractures and Dislocations / Momento da cirurgia e parâmetros fisiológicos pré-operatórios como fatores preditivos clínicos de desfechos cirúrgicos em fraturas e luxações traumáticas subaxiais da coluna cervical

Abstract Objective To evaluate the risk factors and outcomes in patients surgically treated for subaxial cervical spine injuries with respect of the timing of surgery and preoperative physiological parameters of the patient. Methods 26 patients with sub-axial cervical spine fractures and dislocations were enrolled. Demographic data of patients, appropriate radiological investigation, and physiological parameters like respiratory rate, blood pressure, heart rate, PaO2 and ASIA impairment scale were documented. They were divided pre-operatively into 2 groups. Group U with patients having abnormal physiological parameters and Group S including patients having physiological parameters within normal range. They were further subdivided into early and late groups according to the timing of surgery as Uearly, Ulate, Searly and Slate. All the patients were called for follow-up at 1, 6 and 12 months. Results 56 percent of patients in Group S had neurological improvement by one ASIA grade and a good outcome irrespective of the timing of surgery. Patients in Group U having unstable physiological parameters and undergoing early surgical intervention had poor outcomes. Conclusion This study concludes that early surgical intervention in physiologically unstable patients had a strong association as a risk factor in the final outcome of the patients in terms of mortality and morbidity. Also, no positive association of improvement in physiologically stable patients with respect to the timing of surgery could be established.

Resumo Objetivo Avaliar os fatores de risco e os desfechos em indivíduos submetidos ao tratamento cirúrgico de lesões subaxiais da coluna cervical em relação ao momento da cirurgia e aos parâmetros fisiológicos pré-operatórios dos pacientes. Métodos O estudo incluiu 26 pacientes com fraturas e luxações subaxiais da coluna cervical. Dados demográficos, investigação radiológica apropriada e parâmetros fisiológicos, como frequência respiratória, pressão arterial, frequência cardíaca, pressão parcial de oxigênio (PaO2) e escalas de disfunção da American Spine Injury Association (ASIA), foram documentados. No período pré-operatório, os pacientes foram divididos em dois grupos. O grupo instável (I) continha pacientes com parâmetros fisiológicos anormais e o grupo estável (E) era composto por pacientes com parâmetros fisiológicos dentro da faixa de normalidade. Os pacientes foram ainda subdivididos em grupos de tratamento precoce e tardio de acordo com o momento da cirurgia como Iprecoce, Itardio, Eprecoce e Etardio. Todos os pacientes foram chamados para consultas de acompanhamento em 1, 6 e 12 meses. Resultados Cinquenta e seis por cento dos pacientes do grupo E apresentaram melhora neurológica em um grau ASIA e desfecho bom independentemente do momento da cirurgia. Os desfechos em pacientes do grupo I com parâmetros fisiológicos instáveis e submetidos à intervenção cirúrgica precoce foram maus. Conclusão Este estudo conclui que a intervenção cirúrgica precoce em pacientes com instabilidade fisiológica teve forte associação como fator de risco no desfecho final em termos de mortalidade e morbidade. Além disso, não foi possível estabelecer nenhuma associação positiva de melhora em pacientes com estabilidade fisiológica em relação ao momento da cirurgia.

The effects of oral administration of curcumin-galactomannan complex on brain waves are consistent with brain penetration: a randomized, double-blinded, placebo-controlled pilot study.

OVERVIEW: A novel highly bioavailable curcumin-galactomannan (CGM) formulation was shown to have improved blood-brain-barrier (BBB) permeability of free curcuminoids in animal models; however, this has not been established in humans. The present study was conducted to determine the functional effects of CGM on brain waves in healthy individuals, owing to its BBB permeability. METHODS: A total of 18 healthy volunteers aged 35-65 were randomly assigned to consume 500 mg CGM, Unformulated curcumin (UC) or Placebo capsules twice daily for 30 days. Electroencephalogram (EEG) measurements, audio-visual reaction time tests and a working memory test were conducted at baseline and after 30 days. RESULTS: Supplementation of CGM resulted in a significant increase in α- and ß-waves (p < 0.05) as well as a significant reduction in α/ß ratio in comparison with unformulated curcumin and placebo groups. Furthermore, the CGM showed significant reduction in the audio-reaction time (29.8 %; p < 0.05) in comparison with placebo and 24.6% (p < 0.05) with unformulated curcumin. The choice-based visual-reaction time was also significantly decreased (36%) in CGM as compared to unformulated curcumin and placebo which produced 15.36% and 5.2% respectively. CONCLUSION: The observed increase in α and ß waves and reduction in α/ß ratio in the CGM group suggest that CGM can influence the brain waves in healthy subjects in a manner consistent with penetration of the blood-brain-barrier. The EEG results correlated with improved audio-visual and working memory tests which further support the role of CGM on memory improvements and fatigue reduction.

Resolution Pattern and Predictors of Outcome for Optic Disc Pit - Maculopathy Following Vitrectomy: An Optical Coherence Tomography Based Morphometric Analysis.

BACKGROUND: To characterize the resolution pattern and macular structure recovery of optic disc pit-maculopathy (ODP-M) following vitrectomy using spectral domain-optical coherence tomography (SD-OCT). METHODS: This is a single-center, retrospective, observational case series. Serial SD-OCT scans of all consecutive eyes of ODP-M undergoing vitrectomy were evaluated to analyze the sequence of maculopathy resolution. RESULTS: Subretinal fluid (SRF) resolved/reduced in 9 of 12 eyes over a mean of 6 months. For eyes showing resolution, we observed that the closure of the communication tract (CT) [1-3 months] preceded the closure of outer layer defect (OLD) [2-6 months], while SRF[1-12 months] and outer retinal fluid(ORF)[1-12 months] were the last to be resolved. Three eyes with residual SRF/macular fluid had a patent CT. CONCLUSION: Maculopathy resolved in a staged manner: closure of CT preceded the closure of OLD and absorption of SRF. Non-closure of CT was associated with the persistence of maculopathy. SYNOPSIS: Optic disc pit maculopathy following vitrectomy shows a staged resolution. The persistence of maculopathy is seen in eyes with non-closure of the communication tract. ABBREVIATION: Key CDVA: Corrected distance visual acuityCMT: Central macular thicknessCR: Complete restorationCT: Communication tractILM: Internal limiting membraneIRF: Inner retinal fluidIR: Incomplete restorationMLF: Multilayered fluidODP-M: Optic disc pit maculopathyOLD: Outer layer defectORF: Outer retinal fluidPPV: Pars plana vitrectomyPVD: Posterior vitreous detachmentSD-OCT: Spectral Domain-Optical Coherence TomographySRF: Subretinal fluid.

Influence of a low-dose supplementation of curcumagalactomannoside complex (CurQfen) in knee osteoarthritis: A randomized, open-labeled, active-controlled clinical trial.

A 6-week, randomized, open-label, active-controlled clinical trial was conducted to evaluate the influence of a low-dose curcumagalactomannosides (CGM) (400 mg once daily) in OA subjects. The treatment was compared with a standard combination of 500 mg glucosamine hydrochloride (GLN) and 415 mg chondroitin sulphate (CHN), supplied as a single oral dose twice a day. Out of 84 subjects randomized, 72 subjects who have completed the study were evaluated for the safety and efficacy of the treatments at baseline and subsequent visits (day 28 and 42), by measuring walking performance, VAS, KPS, and WOMAC scores. CGM exhibited 47.02, 21.43, and 206% improvement in VAS, KPS, and walking performance, respectively, compared to the baseline. Similarly, there was 31.17, 32.93, 36.44, and 35% improvement in the pain, stiffness, physical function, and total WOMAC scores. CGM also caused a substantial reduction in the serum inflammatory marker levels. The results indicate that a short-term supplementation of a low dosage CGM exerted superior beneficial effects than a high-dosage CHN-GLN combination in alleviating the pain and symptoms of OA subjects. Further clinical trials of extended duration in a larger population is required to substantiate the efficacy of CGM in the long-term management of OA.

Efficacy of a novel extract of fenugreek seeds in alleviating vasomotor symptoms and depression in perimenopausal women: A randomized, double-blinded, placebo-controlled study.

The present randomized, double-blinded, placebo-controlled study investigated the effect of a standardized fenugreek extract (FHE) on perimenopausal discomforts and its influence on hormonal balance and safety. Healthy women characterized with perimenopausal symptoms (n = 48), as assessed by MRS questionnaire, were randomized either to FHE (n = 24) or placebo (n = 24) and supplemented with 250 mg × 2/day for 42 days. Both inter and intra-group comparison revealed a significant improvement in somatic, psychological, and urogenital scores in FHE group, especially for hot flashes (25.9%), night sweats (26.5%), depression (31.8%), and insomnia (21.6%). Further hormone analysis revealed an enhancement in serum estradiol (18.9%), free testosterone (38.2%), and progesterone (19.9%) concentrations and a significant decrease in FSH (38.2%) and SHBG (21.1%) concentrations toward establishing a hormonal balance among FHE-group; without significant changes in other clinical safety parameters. Thus, FHE supplementation offered a significant reduction in vasomotor effects and depression in perimenopausal women, without any adverse effects PRACTICAL APPLICATIONS: Fenugreek is a popular kitchen spice and Ayurvedic medicine for a variety of health conditions including diabetes, hypercholesterolemia, hepatotoxicity, gastritis, and also for a variety of hormone-related health conditions such as sexual functions, lactation, osteoporosis, PCOS, and post/perimenopausal discomforts. Fenugreek is rich in alkaloids, steroidal saponins, flavonoids and 4-hydroxyisoleucine. The present randomized-controlled study investigated the plausible application of a standardized hydro-ethanolic extract of fenugreek seeds (FHE) having a unique 3:1 ratio for protodioscin to trigonelline in the management of perimenopausal discomforts. It was observed that FHE at a dosage of 250 mg × 2/day for 42 days significantly reduced the discomforts, especially vasomotor symptoms and depression, and helped to attain a hormonal balance without any adverse effects or deviations in clinical safety parameters. Thus, FHE could be a potential natural agent for the management of post and perimenopausal discomforts and has to be explored in future studies.

Curcumagalactomannoside/Glucosamine Combination Improved Joint Health Among Osteoarthritic Subjects as Compared to Chondroitin Sulfate/Glucosamine: Double-Blinded, Randomized Controlled Study.

Objective: A combination of curcumagalactomannosides (CGM) (400 mg) with glucosamine hydrochloride (GLN) (500 mg) was evaluated against a standard dietary supplement combination chondroitin sulfate (CHN) (415 mg)/GLN (500 mg) for their effectiveness in alleviating the pain and symptoms among osteoarthritic subjects. Design: Randomized, double-blinded and active-controlled study. Settings/Location: The study was conducted in a hospital-based research center in Vadodara, Gujarat, India. Subjects: Eighty subjects (38 males and 42 females), with confirmed osteoarthritis (OA) (Class I-III), were randomized into two parallel groups designated as Group I (CGM-GLN) and Group II (CHN-GLN). Interventions: All the study subjects were supplemented with their corresponding intervention capsules (ether CGM along with GLN or CHN along with GLN), as a single oral dose twice a day, once in the morning 10-15 min before breakfast and again in the evening before dinner, for 84 days. Outcome measures: A validated treadmill uphill walking protocol was used for the study, and the efficiency of supplementation was evaluated using visual analogue scale (VAS) score, Karnofsky Performance Scale (KPS) score, and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire at the baseline, 28th, and 84th day following the treatment. Mechanism of action of CGM-GLN combination was analyzed by measuring the levels of serum inflammatory markers interleukin 1 beta (IL-1ß), interleukin 6 (IL-6), and soluble vascular cell adhesion molecule-1 (sVCAM) at the baseline and 84th day. Results: CGM-GLN was found to offer significant beneficial effects to pain, stiffness, and physical function of OA subjects compared with CHN-GLN, which was evident from the improvement in walking performance, VAS score, KPS score, and WOMAC score. The efficiency of CGM-GLN was almost double compared with the CHN-GLN by the end of the study (84th day). A significant reduction of inflammatory serum marker levels was observed among CGM-GLN subjects compared with CHN-GLN subjects. Compared with the baseline, CGM-GLN produced 54.52%, 59.08%, and 22.03% reduction in IL-1ß, IL-6, and sVCAM levels, respectively. Whereas CHN-GLN group of subjects expressed only 23.17%, 21.38%, and 6.82% reduction in IL-1ß, IL-6, and sVCAM levels, respectively. Conclusions: In conclusion, the present study demonstrated the potential benefits of CGM-GLN supplements in alleviating the symptoms and function of OA subjects compared with the standard CHN-GLN treatment. The augmented efficacy of CGM-GLN combination could be attributed to the enhanced anti-inflammatory effect of CGM.

New instrumentations in the operating room for sinus surgery.

PURPOSE OF REVIEW: The article reviews the advancements in instrumentation in the operating room that augment the speed, safety or outcomes of endoscopic sinus surgery (ESS). The article aims to update the Rhinologist on recent perioperative instruments that may benefit their practice. RECENT FINDINGS: The greatest advancements in the recent years have been in the field of visualization and optics. The introduction of high definition and ultra high definition 4K camera and screens supported by improvements with three-dimensional and variable angled endoscopes have greatly enhanced the quality and range of the visual information available to the sinus surgeon. This is closely supported by flexibility and enhanced functionality of the powered instrumentation with bipolar, monopolar and malleable blades and ever increasing more powerful burs. SUMMARY: Recent years have seen notable developments in the areas of optics, cameras and powered instruments to support the sinus surgeon. This article summarizes these developments and highlights the major benefits of these developments.

Safety, tolerability, pharmacokinetics, and pharmacodynamics of compound SFDAC by intranasal administration of multiple escalating dose in healthy male subjects.

A novel corticosteroid compound (short form of IUPAC name: SFDAC) has been discovered by Sun Pharma Advanced Research Company (SPARC) Ltd. A randomized, observer-blind, active-controlled, parallel-groups, intranasal multiple escalating dose study was conducted in healthy male subjects to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of compound SFDAC formulated as an aqueous suspension for intranasal administration. Intranasal sprays of SFDAC, active control fluticasone propionate (FP) and placebo were administered once in a day for 14 days as per randomization. Various clinical evaluations including 24-hour serum cortisol and urinary free cortisol (UFC) profiles were carried out. Blood samples were collected at pre-defined time-points and analyzed using a validated chromatographic method for estimation of SFDAC and its metabolite. The results of the study indicate that multiple dose of SFDAC intranasal spray upto 3,200 µg is safe and tolerated. Clinically significant suppression of hypothalamic pituitary adrenal (HPA) axis was not observed. The plasma concentration of SFDAC was found to be below the lower limit of quantification (LLQ) at most time-points for all subjects. SFDAC M1 metabolite was detected only at picogram level in plasma. The safety and pharmacokinetic characteristics of SFDAC observed in this study support further clinical development of the SFDAC nasal spray.

Pattern of ocular manifestations in patients with sarcoidosis in developing countries.

PURPOSE: Sarcoidosis is increasingly diagnosed in developing countries, although it was earlier thought to be uncommon. We describe the pattern of ocular manifestations in sarcoidosis in India. METHODS: A total of 48 consecutive patients with histologically confirmed sarcoidosis, referred to a teaching university hospital, underwent a detailed ophthalmological examination, irrespective of whether they had eye symptoms or not. RESULTS: Ocular involvement was seen in 14 (29%) patients. The mean age at presentation was 50 years, and neither two peaks of incidence nor a female preponderance could be demonstrated. The majority of patients had chronic disease. Posterior uveitis was distinctly more common (12/14) than anterior (5/14) uveitis. Conjunctival involvement was uncommon. These findings differ from those reported in the Western literature. CONCLUSIONS: Eye involvement is common in sarcoidosis in India and may occur without ocular symptoms. Posterior segment involvement is more common than has been reported. Ophthalmologists need to be aware of ocular involvement in this disease as untreated disease can have significant visual consequences.

Filling-in along horizontal and vertical meridians.

PURPOSE: Filling-in is not homogeneous across the visual field; rather, fading time (FT) varies with eccentricity and polar angle. The reasons for this are unclear. The authors investigated FT along horizontal and vertical meridians in central and peripheral visual fields for luminance-defined targets, comparing Weber contrast sensitivity (CSw). They also compared cone-mediated and rod-mediated filling-in with previously described photoreceptor densities. This represents the first investigation into rod-mediated filling-in. METHODS: Fading times were recorded in nine volunteers using luminance-defined stimuli at eccentricities of 0 degrees , 2.5 degrees , 5 degrees , 10 degrees , and 20 degrees for high-contrast stimuli and 0 degrees , 1.25 degrees , 2.5 degrees , 3.75 degrees , and 5 degrees for low-contrast stimuli and were compared with CSw at each location. Fading times were also recorded at 0 degrees , 2.5 degrees , 5 degrees , 10 degrees , and 20 degrees using red-green stimuli and at 5 degrees , 10 degrees , and 20 degrees under dark-adapted conditions and compared with cone and rod densities in the nasal, temporal, superior, and inferior hemimeridians. RESULTS: Consistent anisotropy was evident in central and peripheral fields for luminance-defined targets and for chromatic targets, with horizontal meridians taking longer to fill in. The same pattern was observed in CSw and the previously described cone density. Log FT and CSw were correlated irrespective of visual field location. The ratio of rod-mediated FT to rod density decreased with eccentricity. CONCLUSIONS: Anisotropy between horizontal and vertical meridians for FT is consistent in central and peripheral fields, reflecting patterns in CSw and cone density. This is discussed in the context of cortical processes underlying filling-in. For rod-mediated filling-in, more peripheral eccentricities are characterized by reduced FTs in relation to rod density.