Introduction: The aim of this study was to investigate the clinical effectiveness, health related quality of life (HRQoL) and cost effectiveness of selective laser trabeculoplasty (SLT) compared to topical anti-glaucoma medications in step-up treatment of patients with primary open angle glaucoma (POAG). Methods: Seventeen POAG patients with suboptimal IOP control despite pre-existing topical medications were subjected to adjunct SLT (50 applications 180 degrees) or second line medical therapy. Current medications were continued, and patients were followed up for 6 months for degree of intraocular pressure (IOP) lowering. HRQoL was assessed using Glaucoma Quality of Life 36-item (GlauQoL-36), Assessment of Quality of Life-7D (AQoL-7D) and Vision related Quality of Life (VisQoL). Costs involved were calculated and compared to the effect (IOP reduction) achieved in each arm. Results: Ten patients were in the SLT group and 7 in the topical medication (MED) group. Mean baseline intraocular pressure (IOP) was 18.90±3.48mmHg in SLT group and 15.57±2.23mmHg in MED group. Mean reduction of IOP was 4.30±1.64mmHg in SLT group and 2.71±2.56 mmHg in MED group at 6 months which was not statistically significant (p=0.14) between two groups. All the HRQoL questionnaires did not show significant changes in the groups or between groups when compared baseline with 6-month post treatment (p-values ranging from 0.247 to 0.987). For every 1mmHg reduction in IOP, cost involved in MED group (RM53.61) was 165% of the cost involved in SLT group (RM32.56). Discussion and Conclusion: This study has shown that SLT was as effective clinically and tolerable as topical anti glaucoma medications and was possibly more cost effective in the step-up treatment of patients with POAG at 6 months follow- up.
selective laser traeculoplasty ; topical antiglaucoma, clinical effectiveness ; quality o0f life ; cost effectiveness ; primary open angle glaucoma ; prospective pilot cohort study

BACKGROUND: Recently, the prevalence of food allergies during childhood is increasing, with fruits being common allergens. However, data on allergens that cause fruit and vegetable allergies and pollen-food allergy syndrome (PFAS) in childhood are relatively few. This study aimed to examine the allergens in fruit and vegetable allergies in pediatric patients and to determine the association between fruit and vegetable allergies and PFAS.OBJECTIVE: This study aimed to examine the current status of fruit and vegetable allergies in Japanese children.METHODS: This was a multicenter case series observational study. The participants included children aged <15 years who developed allergic symptoms after eating fruits and vegetables and subsequently received treatment in the Pediatric Department of 6 hospitals in the Osaka Prefecture in Japan during the study period from August 2016 to July 2017. Participants' information was obtained using a questionnaire, and data were obtained by performing several types of allergy tests using blood samples.RESULTS: A total of 97 children (median age, 9 years; 56 males) were included in the study. Apple was the most common allergen, followed by peach, kiwi, cantaloupe, and watermelon. A total of 74 participants (76%) exhibited allergic symptoms due to PFAS; moreover, pathogenesis-related protein-10 (PR-10) was the most common allergen superfamily. On the contrary, in the group where neither PR-10 nor profilin was sensitized, kiwi and banana were the most common allergens, and the age of onset was lower than that in the PFAS group. Specific antibody titer was significantly associated with Birch for Bet v1 and latex for Bet v2 (r = 0.99 and r = 0.89).CONCLUSION: When we examine patients with fruit and vegetable allergies, we should first consider PFAS even in childhood specifically for children greater than 4 years old.
Age of Onset ; Allergens ; Asian Continental Ancestry Group ; Betula ; Child ; Citrullus ; Clinical Study ; Cucumis melo ; Eating ; Food Hypersensitivity ; Fruit ; Humans ; Hypersensitivity ; Japan ; Latex ; Musa ; Observational Study ; Prevalence ; Profilins ; Prunus persica ; Rhinitis ; Rhinitis, Allergic, Seasonal ; Vegetables

PURPOSE: In this study, we aimed to determine the role of extracorporeal shockwave therapy (ESWT) in the management of Peyronie's disease (PD). MATERIALS AND METHODS: A total of 325 patients suffering from PD were enrolled in this single-arm clinical study. All patients were received ESWT using a schedule of 1 treatment/wk. Penile curvature was measured by a goniometer after intracavernosal drug-induced erection using Alprostadil. Plaque size was measured with a ruler and sexual function assessed by the international index of erectile function (IIEF)-15 score. Severity of erectile dysfunction was classified as severe (IIEF-15 ≤10), moderate (IIEF-15 between 11 and 16), or mild (IIEF-15 between 17 and 25). Results were evaluated at baseline and 3 months after the treatment. RESULTS: All the patients completed the study protocol. Median age was 59.0 years (55.0–64.0 years). After treatment, the median (interquartile range, IQR) plaque size reduced from 1.78 cm2 (1.43–2.17 cm2) to 1.53 cm2 (1.31–1.96 cm2) (p<0.001); the median (IQR) penile length in erection increased from 13.0 cm (12.0–14.0 cm) to 14 cm (13.0–15.0 cm) (p<0.001) and the median (IQR) penile curvature from 30.4° (22.2°–35.4°) to 25.0° (20.2°–30.4°) (p<0.001). We also observed a decrease in pain assessed by visual analogue scale (7 vs. 3; p<0.001), an improvement in each of the IIEF sub-domains (p<0.001) and an improvement in all three PD questionnaire domains (p<0.001). CONCLUSIONS: Based on our findings, ESWT could be considered a safe and efficient minimally invasive option for the management of the patients suffering from PD.
Alprostadil ; Appointments and Schedules ; Clinical Study ; Erectile Dysfunction ; Humans ; Male ; Observational Study ; Penile Diseases ; Penile Induration ; Shock ; Treatment Outcome

BACKGROUND: Docetaxel is one of the standard treatments for advanced non-small cell lung cancer. Docetaxel is usually administered in a 3-week schedule, but there is significant toxicity. In this phase II clinical study, we investigated the efficacy and safety of a 4-weekly schedule of docetaxel monotherapy, as first-line chemotherapy for advanced squamous cell carcinoma in elderly lung cancer patients. METHODS: Patients with stage IIIB/ IV lung squamous-cell carcinoma age 70 or older, that had not undergone cytotoxic chemotherapy were enrolled. Patients received docetaxel 25 mg/m2 on days 1, 8, and 15, every 4 weeks. Primary endpoint was the objective response rate (ORR). Secondary endpoints were progression-free survival (PFS), overall survival (OS), and toxicity profiles. RESULTS: A total of 19 patients were enrolled. Among 19 patients, 17 were for evaluated efficacy and safety. In the intent-to-treat population, ORR and disease control rate (DCR) were 11.8% and 47.1%, respectively. In the response evaluable population, ORR was 16.7% and DCR was 66.7%. Median PFS and OS were 3.1 months and 3.3 months, respectively. There were three adverse grade 3/4 events. Grade 1 neutropenia was reported in one patient. CONCLUSION: Our data failed to demonstrate efficacy of a 4-weekly docetaxel regimen, in elderly patients with a poor performance status. However, incidence of side effects, including neutropenia, was lower than with a 3-week docetaxel regimen, as previously reported.
Aged ; Appointments and Schedules ; Carcinoma, Non-Small-Cell Lung ; Carcinoma, Squamous Cell ; Clinical Study ; Disease-Free Survival ; Drug Therapy ; Epithelial Cells ; Humans ; Incidence ; Lung Neoplasms ; Lung ; Neutropenia ; Treatment Outcome

PURPOSE: The use of nondepolarizing neuromuscular blocking agents (NMBAs) may affect intraoperative neuromonitoring (IONM) during anesthesia used during thyroid and parathyroid surgery. METHODS: The use of sugammadex was evaluated in a prospective clinical study during thyroid surgery. Between July 2018 and January 2019, 129 patients were prospectively randomized to either the sugammadex group (group B) or the control group (group A). Group A patients underwent standardized IONM during thyroidectomy, while group B patients used an NMBA-reversal protocol comprised of rocuronium (0.6 mg/kg) in anesthesia induction and sugammadex (2 mg/kg) after first vagal stimulation (V0). A peripheral nerve stimulator was used to monitor the neuromuscular transmission. RESULTS: In our clinical study, it took 26.07 ± 3.26 and 50.0 ± 8.46 minutes to reach 100% recovery of laryngeal electromyography at injection of the sugammadex group (2 mg/kg) and the control group, respectively (P < 0.001). The train-of-four ratio recovered from 0 to >0.9 within 4 minutes after administering 2 mg/kg of sugammadex at the beginning of resection. Surgery time was significantly shorter in group B than in group A (P < 0.001). Transient recurrent laryngeal nerve (RLN) paralysis was detected in 4 patients from group A and in 3 patients from group B (P = 0.681). There was no permanent RLN paralysis in the 2 groups. CONCLUSION: Our clinical study showed that sugammadex effectively and rapidly improved the inhibition of neuromuscular function induced by rocuronium. The implementation of the nondepolarizing neuromuscular block recovery protocol may lead to tracheal intubation as well as favorable conditions for IONM in thyroid surgery.
Anesthesia ; Clinical Study ; Electromyography ; Humans ; Intubation ; Neuromuscular Blockade ; Neuromuscular Blocking Agents ; Paralysis ; Peripheral Nerves ; Prospective Studies ; Recurrent Laryngeal Nerve ; Thyroid Gland ; Thyroidectomy

STUDY DESIGN: Prospective clinical study. PURPOSE: The present study aimed to examine the neurological recovery pattern in cervical spondylotic myelopathy (CSM) after anterior cervical decompression and compare it with the existing reports in the literature. OVERVIEW OF LITERATURE: Neurological recovery and regression of myelopathy symptoms is an important factor that determines the outcomes of surgical decompression. The present findings contribute to the literature on the pattern of neurological recovery and patient prognosis with respect to the resolution of myelopathy symptoms after surgery. METHODS: This prospective study was conducted in Government Medical College in Jammu, North India between November 2012 and October 2014, a total of 30 consecutive patients with CSM were included and treated with anterior decompression and stabilization. They were prospectively followed up for 1 year and were evaluated for their neurological recovery pattern. The postoperative outcome was evaluated using the modified Japanese Orthopaedic Association (mJOA) score. The recovery rate was calculated using Hirabayashi's method. The JOA score was assessed before the operation and postoperatively at 1 week, 2 weeks, 1 month, 3 months, 4 months, 6 months, and 1 year. RESULTS: The postoperative mJOA score was 0 in the 1st month, 12.90±3.57 in the 3rd month, 13.50±3.55 in the 4th month, 14.63±3.62 in the 6th month, and 14.9±3.24 at the final follow-up of 1 year. The average recovery rate during the 1st month follow-up was 0%, and that during the 3rd month follow-up was 12.91% with a range of 0%–50%. The average recovery rate during the 4th month was 32.5%, with a range of 0%–60%, while that during the 6th month was 72.83%, with a range of 0%–100%. The average recovery rate during the final follow-up of 1 year was 54.3%. CONCLUSIONS: Neurological recovery after surgical decompression starts from the 3rd postoperative month and progresses until the 6th postoperative month; thereafter, it gradually plateaus over the subsequent 6 months until it steadies. Symptom duration is an important factor that requires consideration while determining postoperative neurological recovery.
Asian Continental Ancestry Group ; Clinical Study ; Decompression ; Decompression, Surgical ; Follow-Up Studies ; Humans ; India ; Methods ; Prognosis ; Prospective Studies ; Spinal Cord Diseases

STUDY DESIGN: Prospective clinical study. PURPOSE: To investigate the effect of percutaneous transforaminal endoscopic surgery (PTES) for lateral recess stenosis (LRS)(LRS) in elderly patients and to assess patients’ health-related quality of life (HRQoL). OVERVIEW OF LITERATURE: PTES is an increasingly used surgical approach, primarily employed for lumbar disc herniation treatment. However, indications for PTES have been increasing in recent years. PTES has been recommended as a beneficial alternative to open decompression surgery in specific LRS cases; PTES is termed as percutaneous endoscopic ventral facetectomy (PEVF) in such cases. METHODS: In total, 65 elderly patients with LRS were prospectively studied. Patients presented severe comorbidities (coronary insufficiency, heart failure, diabetes mellitus, and respiratory failure); thus, general anesthesia administration would potentially cause considerable hazards. All the patients underwent successful PEVF in 2015–2016. The patients were assessed preoperatively and at 6 weeks; 3, 6, and 12 months; and 2 years postoperatively. Patients’ objective assessment was conducted according to specific clinical scales; the Visual Analog Scale (VAS) was separately used for leg and low-back pain (VAS-LP and VAS-BP, respectively), whereas the Short Form 36 Health Survey Questionnaire was used for the HRQoL evaluation. RESULTS: All studied parameters presented maximal improvement at 6 weeks postoperatively, with less enhancement at 3 and 6 months with subsequent stabilization. Statistical significance was found in all follow-up intervals for all parameters (p<0.05). Parameters with maximal absolute amelioration were VAS-LP, bodily pain, and role limitations due to physical health problems. In contrast, VAS-BP, general health, and mental health were comparatively less enhanced. CONCLUSIONS: PEVF was associated with remarkably enhanced HRQoL 2 years postoperatively. PEVF is thus a safe and effective alternative for LRS surgical management in elderly patients with severe comorbidities.
Aged ; Anesthesia, General ; Clinical Study ; Comorbidity ; Constriction, Pathologic ; Decompression ; Diabetes Mellitus ; Follow-Up Studies ; Health Surveys ; Heart Failure ; Humans ; Leg ; Mental Health ; Prospective Studies ; Quality of Life ; Visual Analog Scale ; Weights and Measures

STUDY DESIGN: Prospective clinical study. PURPOSE: We evaluated the challenges faced during diagnosis and management of patients with subacute pyogenic discitis and discussed various clues in clinical history, radiologic and hematologic parameters of these patients that helped in establishing their diagnosis. OVERVIEW OF LITERATURE: Present literature available shows that in patients with subacute spondylodiscitis and infection with less virulent organisms, the clinical picture often is confusing and the initial radiologic and hematologic studies do not contribute much toward establishing the diagnosis. METHODS: Demographic pattern, predisposing factors, clinical presentation, comorbidities, microbiology, treatment, neurologic recovery, and complications of 11 patients were prospectively reviewed regarding their contribution toward the conformation of diagnosis of subacute pyogenic discitis. RESULTS: Mean age at presentation was 46.0 years with average preoperative Oswestry Disability Index and Visual Analog Scale scores of 83.4 and 7.18, respectively. Mean follow-up duration was 12.0 months. The most common site of infection was the lumbar spine, followed by the thoracic spine (n=1). Infective organisms were isolated in only 45% of cases. Staphylococcus aureus was the most common causative organism isolated. CONCLUSIONS: Diagnosing subacute spondylodiscitis in a patient presenting with subacute low backache poses a diagnostic challenge. Clinical and radiologic picture are deceiving, and bacteriologic results often are negative, further complicating the picture. A detailed medical history along with clinical, radiologic, and biochemical parameters prevents missing the diagnosis. Serial serum C-reactive protein and alkaline phosphatases were more reliable blood parameters in cases of subacute presentation.
Alkaline Phosphatase ; C-Reactive Protein ; Causality ; Clinical Study ; Comorbidity ; Diagnosis ; Discitis ; Follow-Up Studies ; Humans ; Low Back Pain ; Lumbar Vertebrae ; Phosphoric Monoester Hydrolases ; Prospective Studies ; Spine ; Staphylococcal Infections ; Staphylococcus aureus ; Tertiary Care Centers ; Tertiary Healthcare ; Visual Analog Scale

OBJECTIVE: The aims of this study were to investigate the effects of daily low-dose tadalafil on cognitive function and to examine whether there was a change in cerebral blood flow (CBF) in patients with erectile dysfunction (ED) and mild cognitive impairment. METHODS: Male patients aged 50 to 75 years with at least three months of ED (International Index of Erectile Function [IIEF]-5 score ≤ 21) and mild cognitive impairment (Montreal Cognitive Assessment [MoCA] score ≤ 22) were included in the study. The subjects were prescribed a low-dose PDE5 inhibitor (tadalafil 5 mg) to be taken once daily for eight weeks. Changes in MoCA score and single-photon emission computed tomography (SPECT) study between the two time-points were assessed by paired t tests. RESULTS: Overall, 30 male patients were assigned to the treatment group in this study and 25 patients completed the eight-week treatment course. Five patients were withdrawn due to adverse events such as myalgia and dizziness. Mean baseline IIEF and MoCA scores were 7.52 ± 4.84 and 18.92 ± 1.78. After the eight-week treatment, mean IIEF and MoCA scores were increased to 12.92 ± 7.27 (p < 0.05) and 21.8 ± 1.71 (p < 0.05), respectively. Patients showed increased relative regional CBF in the postcentral gyrus, precuneus, and brainstem after tadalafil administration versus at baseline (p < 0.001). CONCLUSION: The results of this prospective clinical study suggest that daily use of tadalafil 5 mg increases some regional CBF and improves cognitive function in patients with ED and mild cognitive impairment.
Brain Stem ; Cerebrovascular Circulation ; Clinical Study ; Cognition ; Dizziness ; Erectile Dysfunction ; Humans ; Male ; Methylenebis(chloroaniline) ; Mild Cognitive Impairment ; Myalgia ; Parietal Lobe ; Perfusion ; Phosphodiesterase Inhibitors ; Prospective Studies ; Somatosensory Cortex ; Tadalafil ; Tomography, Emission-Computed

BACKGROUND/AIMS: Bicarbonate-containing alginate formulations are reported to be effective for controlling reflux symptoms. However, the efficacy of Lamina G alginate without gas production has not been reported. The aim is to evaluate the efficacy of a non-bicarbonate alginate in individuals with reflux symptoms without reflux esophagitis. METHODS: Participants who had experienced heartburn or regurgitation for 7 consecutive days were randomized to one of the following treatment groups: proton pump inhibitors (PPI) plus alginate (combination) or PPI plus placebo (PPI only). In addition, as a reference group, patients received placebo plus alginate (alginate only). The primary endpoint compared the percentage of patients with complete resolution of symptoms for the final 7 days of the treatment. Secondary endpoints compared changes in symptom score, symptom-free days during the treatment period, the Reflux Disease Questionnaire, Patient Assessment of Upper Gastrointestinal Disorders (PAGI)-Quality of Life and PAGI-Symptoms Severity Index scores, the investigator's assessment of symptoms, and incidence of adverse events. RESULTS: Complete resolution of heartburn or regurgitation was not significantly different between the combination and PPI only groups (58.7% vs 57.5%, p=0.903). The secondary endpoints were not significantly different between the two groups. Complete resolution of heartburn or regurgitation, did not differ between the alginate only reference group and the PPI only group (75.0% vs 57.5%, p=0.146). CONCLUSIONS: The addition of non-bicarbonate alginate to PPI was no more effective than PPI alone in controlling reflux symptoms.
Alginates ; Clinical Study ; Esophagitis, Peptic ; Gastroesophageal Reflux ; Heartburn ; Humans ; Incidence ; Proton Pump Inhibitors ; Treatment Outcome