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24 articles

Efficacy and Safety of Pulsed Magnetic Therapy in Sleep related Disorders: A Remote, Randomized, Double-Blind, Placebo-Controlled Trial

Mar 2026 DOI 10.14302/issn.2574-4518.jsdr-26-6010
Marmann PeterCorresponding author

Background/Aim Sleep disturbances are common and are associated with impaired daytime functioning, reduced quality of life, and increased health risks. Non-pharmacological neuromodulatory interventions have gained interest as alternatives to hypnotic medication. Pulsed electromagnetic field (PEMF) therapy has been proposed as a non-invasive approach to improve sleep quality and recovery, but evidence from large, well-controlled trials remains limited. The objective of this study was to evaluate the efficacy and safety of pulsed magnetic field therapy (PMT) on sleep quality, sleep-related symptoms, daytime functioning, and well-being in adults with heterogeneous sleep complaints.  Materials and Methods In this remote, randomized, double-blind, placebo-controlled trial, 217 adults reporting non-restorative sleep, difficulties initiating sleep, or frequent nocturnal awakenings were assigned to active PMT using a PEMF device (Night Harmony Female/Male protocol) or a sham application for three weeks. Primary outcomes were changes in the Pittsburgh Sleep Quality Index (PSQI) global score and self-rated sleep satisfaction, restfulness, and sleep initiation difficulties. Secondary outcomes included sleep diary measures, daytime functioning, well-being (WHO-5), symptom burden (MYMOP), and daytime sleepiness (Epworth Sleepiness Scale). Analyses followed the intention-to-treat principle using ANCOVA with baseline values of the respective parameter as covariate.  Results Both groups showed significant improvements over time in global sleep quality and most secondary outcomes (p < 0.001). Between-group differences in PSQI global score were not significant (p = 0.314). However, active PMT resulted in significantly greater improvements in subjective sleep satisfaction (p = 0.02) and restfulness (p = 0.02), particularly among participants with moderate to severe baseline sleep disturbances (p < 0.001 for both). Sleep continuity measures improved similarly in both groups. No serious adverse events were reported.  Conclusions PMT produced modest but significant improvements in subjective restorative aspects of sleep beyond placebo effects and was well tolerated. Further studies using objective sleep measures and longer follow-up are warranted.

A 12-week, Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial Evaluating the Efficacy and Safety of DKB-131 in Knee Arthritis

Jun 2024 DOI 10.14302/issn.2379-7835.ijn-24-5117
Hoon Kim DoCorresponding author

In this study, the efficacy and safety of DKB-131 (extract of Siraitiagrosvenorii) in adults of both genders presenting mild symptoms of knee arthritis were evaluated in comparison to a placebo. This clinical trial was randomized, double-blind, multicenter, and lasted for 12 weeks. A total of 120 participants with Visual Analogue Scale (VAS) scores of 30 mm or higher in the knee area and Kellgren & Lawrence Grade I or II knee arthritis on X-ray were enrolled, with 60 subjects randomized to receive DKB-131 and 60 subjects receiving placebo. Following 12 weeks of consumption, the change in K-WOMAC total score assessed in the per protocol (PP) set revealed a reduction of 21.86±15.98 points in participants who received DKB-131 (p<0.0001), whereas those in the placebo group exhibited a reduction of 14.92±16.66 points (p<0.0001). This demonstrated a statistically significant difference between the test groups (p=0.0389). Additionally, significant differences were observed between the DKB-131 and placebo groups in the changes in K-WOMAC pain (p=0.0157) and physical function (p=0.0447). For the secondary efficacy endpoint, the change in Visual Analogue Scale (VAS) scores, analyzed in the PP set after 12 weeks of consumption, the test group showed a reduction of 17.82±13.80 mm (p<0.0001), while the control group exhibited a reduction of 11.81±13.99 mm (p<0.0001), indicating a statistically significant difference between the test groups (p=0.0359). Safety evaluations including hematological tests, biochemical tests, and urinalysis revealed no clinically significant differences between the consumption groups. Additionally, vital signs (pulse, blood pressure) and anthropometric measurements (body weight) did not exhibit clinically significant differences between the consumption groups, confirming the safety of DKB-131. We propose that the consumption of DKB-131 is safe for humans and may contribute to joint health. Trial registration (CRIS.NIH.go.Kr): KCT0008527

Evaluation of Cinnamon Supplementation on Insulin Resistance, BMI and Estradiol Levels in Women with Polycystic Ovary Syndrome: A Double-Blinded Randomized Controlled Clinical Trial

Oct 2022 DOI 10.14302/issn.2381-862X.jwrh-22-4315
Nazempour AnahitaCorresponding author OB/Gynecologist, fellowship of infertility and IVF, Sarem fertility and infertility research center (SAFIR), Sarem women’s hospital, Tehran, Iran.

Background Polycystic ovary syndrome (PCOS) is a serious multifactorial disorder. This study intended to assess the effect of cinnamon supplementation on estradiol level, and fasting- and two-hour (2 hpp) insulin and sugar levels in women with PCOS. Material and Methods This study was a double-blinded randomized clinical trial (RCT), conducted between January 2019 until December 2020, at Gynecology Clinic Sarem Women’s Hospital in Tehran, Iran. Patients with PCOS, 130 subjects (65 person/ group) were diagnosed using Rotterdam diagnostic criteria. All participants received daily treatment consisting of 1500 mg metformin and 1000 mg cinnamon per day for 12 weeks. An evaluation of serum AMH level was conducted before and after the completion of therapy. Results Cinnamon supplementation significantly reduced the estradiol, fasting glucose and 2hpp glucose, fasting insulin and 2 hpp insulin, BMI and weight levels after intervention. The highest reduction was observed in fasting glucose, 2 hpp insulin, and estradiol groups after intervention (P<0.05). There was a significant difference between the means of BMI (P<0.01), fasting sugar (P<0.01), and 2 hpp glucose (P<0.01) before and after intervention. Conclusion Cinnamon supplementation, as a safe herbal product, can be prescribed with metformin to improve the symptoms and complications of PCOS.

A Triple-Blind, Placebo-Controlled Randomized Trial of the Effect of Bilateral Alternating Somatosensory Stimulation on Reducing Stress-Related Cortisol and Anxiety During and After the Trier Social Stress Test

Jun 2019 DOI 10.14302/issn.2576-6694.jbbs-19-2784
Cesar Pinto Leal-Junior ErnestoCorresponding author Laboratory of Phototherapy and Innovative Technologies in Health, Nove de Julho University – UNINOVE, Sao Paulo, Brazil.

The aim of this clinical study was to determine the efficacy of bilateral alternating somatosensory stimulation for the management of stress and anxiety during and after the Trier Social Stress Test (TSST), a laboratory procedure for reliably inducing stress in human subjects. For this, a randomized, placebo-controlled, triple-blinded clinical trial of 80 qualified subjects was conducted. Subjects were randomized into two groups, a treatment group (n=40) and a control (placebo) group (n=40). Metrics of emotional stress assessed were a subjective rating of the level of emotional stress and salivary cortisol levels, both obtained at 3 timepoints: before treatment (baseline), immediately following completion of the TSST, and after 20 minutes of rest following completion of the TSST. Results showed that the treatment group had a statistically greater decrease in the subjective rating of stress relative to the control group both immediately following the TSST and 20 minutes after the TSST. Salivary cortisol levels in the treatment group were also lower than the control group at those same time points. These results suggest that bilateral alternating somatosensory stimulation may be effective in reducing subjective levels of stress and anxiety. It also may actively attenuate stress-related cortisol levels, which may reflect a mechanism for reducing cortisol-induced inflammation back to baseline after exposure to stressful situations.

Effect of Coenzyme Q 10 Supplementation on Statin-Induced Myalgia, A Randomized Double-Blind, Placebo-Controlled Study

Apr 2016 DOI 10.14302/issn.2474-3585.jpmc-15-704
Rott DavidCorresponding author Cardiac Rehabilitation Institute, Leviev Heart Center, The Chaim Sheba Medical Center, Tel Hashomer Israel

Objective: Statins are highly effective medications for reducing low-density lipoprotein cholesterol concentrations and cardiovascular events. Their most common side effects are a variety of myopathic complaints, possibly due to reduced circulating Coenzyme Q10 (CoQ10) levels. We sought to determine whether CoQ10 supplementation decreases the rate of myalgia in patients with statin-related myalgia. Methods: Patients treated with a statin for clinical indications who reported statin induced myalgia were eligible. Patients were randomized to treatment with CoQ10 120 mg/day (17 patients) or placebo (20 patients) in a double-blind manner. Treatment was continued for 12 weeks. All patients were instructed to continue taking their prescribed statin as usual. Myalgia score was assessed before intervention and then weekly, for 12 weeks of therapy, using a visual analogue scale (VAS). Results: Over 12 weeks of treatment, myalgia score gradually decreased in both the treatment group and placebo group to the same extent (from 6.2 to 3.3 in the treatment group and from 5.9 to 3.1 in the placebo group), without significant differences between the groups. No significant change was noted between the two groups in the number of patients tolerated statin therapy. Conclusions: CoQ10 does not appear to decrease the rate of myalgia when compared to placebo in patients with statin-related myalgia.

The Early Use of Blinding in Therapeutic Clinical Research of Neurological Disorders

Jan 2016 DOI 10.14302/issn.2470-5020.jnrt-15-803
B. Jensen MatthewCorresponding author University of Wisconsin Department of Neurology

We sought to identify early uses of blinding in therapeutic clinical trials of neurological disorders by multiple search methods. A 1784 report by Benjamin Franklin and others described the evaluation of the use of Mesmerism to treat neurological and other syndromes including headache and epilepsy, using blindfolds and screens. This report demonstrated the usefulness of blinding to reduce bias in clinical research, yet despite this early discovery, blinding was not widely accepted or routinely used until the 20th century. Blinded clinical trials began to be used for various neurological syndromes in the 1950s, sporadically at first and then increasing in frequency in subsequent years. The reason for this delay is unclear, but we propose several hypotheses.

Double-Blind Randomized Trial on the Efficacy in a Short-Time Follow-Up of the “Quick Liberatory Rotation” Maneuver in Treating Posterior Canal BPPV

Nov 2014 DOI 10.14302/issn.2379-8572.joa-14-418
Califano LuigiCorresponding author Department of Audiology and Phoniatrics “G. Rummo” Hospital, Benevento, Italy

This double-blind randomized studyevaluates the efficiency of the Quick Liberatory Rotation maneuver (QLR) in solving signs and symptoms of Posterior Canal BPPV in a short time follow-up comparing the efficiency of QLR vs. a sham maneuver (“Fake QLR”).The study was performed at an input-output tertiary center for balance disorders.From January to September 2012, 200 patients with signs and symptoms of Posterior Canal BPPV respected the inclusion criteria in the study. The diagnosis was based on observation with binocular infrared videonystagmoscopy of the paroxysmal torsional and upbeat nystagmus evoked through the Dix-Hallpike test (DHT). Patients were divided in two groups, 100 in the group treated by QLR (Group 1) and 100 in the control group treated by “Fake QLR” (Group 2). Before the treatment, they self-evaluated a Visual Analogue Score on their vertiginous complaints (V-VAS). Patients were controlled one hour after the treatment by a blinded examiner about the first phase of the study through DHT, the Straight head-hanging positioning test and the Head Roll test in supine position and assessed again with V-VAS. Patients with a persisting positive Dix- Hallpike test were subsequently treated through QLR. The main outcome measure is the number of patients treated through QLR or “Fake QLR” with a negative DHT one hour after the first treatment. At the post-procedure check, 79 patients from Group 1 presented a negative DHT with little or no subjective symptoms, whereas all the patients of Group 2 presented persistence of a positive DHT. The presence of the secondary nystagmus during QLR (“liberatory” nystagmus) was significantly correlated with a negative DHT at the post-procedure control. In Group 1 pre- and post-treatment V-VAS differences were significant; post-treatment V-VAS differences were significant in Group 1 vs. Group 2. In a short time follow-up QLRis an effective treatmentfor Posterior Canal BPPV when compared to a sham maneuver.

Ophthalmic Science Open Access

Glaucoma Literacy in a Portuguese Population

Dec 2024 DOI 10.14302/issn.2470-0436.jos-24-5322
Pestana Aguiar CatarinaCorresponding author

Studies show that individuals with limited health literacy skills experience worse health outcomes in a multitude of chronic diseases including glaucoma. These patients have poorer compliance, worse disease understanding and greater disease progression. The main purpose of our study was to evaluate the knowledge about glaucoma basic concepts in patients with this disease. A 24 question survey was given to patients followed by the glaucoma department, by phone or in person. Epidemiological data and personal therapeutic regimens were collected as well as data concerning the pathophysiology, treatment and prognosis of the disease. Survey responses were obtained from 79 patients with a mean age of 72 years old. Most of the patients had a low education level. The majority of patients could not enumerate glaucoma risk factors (74.5%), their glaucoma type (94.9%) or the best glaucoma definition (57%). However, they were able to relate the disease to a high IOP (75.9%) and the possibility of it leading to blindness (96.2%). We believe that patients, when observed in their glaucoma appointments, tend to retain information related to the prognosis and consequences of the disease and not focus on the understanding of its pathophysiology, causes and mechanisms, which may reflect their concern about their own future. However, this may lead to some misconceptions about the definition of glaucoma and specially about what can cause this disease. Some investment should be done to improve health literacy in the glaucoma population, with appropriate language and handed material.

The Beneficial Effect of Two Nutraceuticals in Flea Allergy Dermatitis Itch Control: A Comparative Study

May 2024 DOI 10.14302/issn.2379-7835.ijn-24-5098
Cornegliani LuisaCorresponding author

This prospective randomized double-blinded multicentric study aimed to assess the efficacy of a new nutraceutical in controlling itch and skin lesions caused by flea allergy dermatitis (FAD) and compare it with another oral product of proven efficacy. Forty-three dogs, of different age, breed and sex, with FAD were included and divided into two groups: 24 received product A and 19 product B. Both groups received the same antiparasitic treatment. A modified canine atopic lesion index (mCADLI) and pruritus visual analogic scale (pVAS) were recorded at days 0, 30 and 60. pVAS was evaluated both by the examining veterinarian (vpVAS) and the owner (opVAS). Results obtained were compared between the two groups at each time point. In both groups of dogs, a significant decrease of mCADLI, vpVAS and opVAS at day 30 and 60, compared to day 0, was observed. At baseline, the mCADLI scores of Group B were significantly higher than Group A (95% CI: -4.0 to 0.0, p < 0.05), with no differences at D30 and D60 (not significant, p > 0.05). In Group B, significantly lower values of vpVAS were observed at D30 compared to Group A (95% CI: -2.5 to 0.0, p < 0.05), but not at D60 (not significant, p > 0.05). The median values of pVAS in Group B were lower compared to Group A at both D30 (95% CI: -2.5 to 0.4, p < 0.01) and D60 (95% CI: -3.0 to 0.3, p < 0.05). Both nutraceuticals can be useful to control discomfort, skin lesions and pruritus due to flea allergy dermatitis and can be a valuable replacement for antipruritic drugs antihistamines, steroids or Il-31 inhibitors.

Correlations with Congenital Syphilis in the United States: A Cross-Sectional Study

Jul 2023 DOI 10.14302/issn.2994-6743.ijstd-23-4641
C. Hughes VirginiaCorresponding author

Syphilis is caused by the bacterium Treponema pallidum and is transmitted from human to human through sexual contact. Congenital syphilis (CS) occurs when the mother transmits the infection to the fetus. Clinical manifestations of CS include anemia, hepatosplenomegaly, blindness, deafness, meningitis, and deformities in bone structure. The number of cases of CS have increased over the past decade in the United States according to the CDC. A study was conducted correlating the number of Medicaid enrollees in 2020, the number of uninsured persons in 2020, and the number of cases of COVID-19 in 2020 to cases of CS in the United States in 2021. A Spearman rank correlation analysis was done using SPSS. Results were statistically significant for all three pairs of variables with positive correlations; Medicaid enrollment and CS cases (r = 0.735, P<.05), uninsured persons with CS cases (r = 0.713, P<.05), COVID-19 cases and CS cases (r = 0.689, P<.05). Reasons for the increase in CS cases are multifactorial, including variations in state laws regarding syphilis screening in the prenatal period, differences in provider processes for persons on Medicaid, persons uninsured, and restrictions to accessing healthcare providers during the COVID-19 pandemic. Future studies should include questionnaires and interviews with women on their experiences during prenatal visits in regards to syphilis screening, particularly women covered by Medicaid, and surveys completed by healthcare providers to gain insight and to identify factors that affect a woman not being tested for syphilis during her pregnancy.

Cross-Reactivity between COX-2 Inhibitors in Patients with Cross-Reactive Hypersensitivity to NSAIDs

Sep 2022 DOI 10.14302/issn.2641-4538.jphi-22-4238
Bavbek SevimCorresponding author Department of Chest Disease, Division of Allergy and Clinical Immunology, Ankara University, School of Medicine, Ankara, Turkey

The safety of cyclooxygenase (COX)-2 inhibitors has been tested in patients who had cross-reactive hypersensitivity reactions (HSRs) to nonsteroidal anti-inflammatory drugs (NSAIDs). However, these studies have been mainly done before the current classification of NSAID hypersensitivity and cross-reaction between COX-2 inhibitors has been rarely reported.We aimed to assess tolerability of COX-2 inhibitors and to evaluate the cross-reactivity between them in cross-reactive phenotype of NSAID hypersensitivity. The diagnosis was based on clinical features, reliable history of HSRs to at least two chemically different NSAIDs, and/or positive provocation tests with implicated NSAIDs in 151 patients. Single-blind, oral challenges with 1/4 and 3/4 divided doses of placebo, nimesulide, meloxicam, and celecoxib, as COX-2 inhibitors, were performed. The most common cross-reactive phenotype was NSAID-induced urticaria/angioedema (56.3%). Positive reactions to meloxicam, nimesulide, and celecoxib challenges were observed in 23/140 (16.4%), 7/33 (21.2%), and none of six patients, respectively. Overall, 24 patients were tested with two, one was tested with three COX-2 inhibitors. Six (31.6%) of 19 patients with meloxicam intolerance reacted to nimesulide provocation. Nimesulide, meloxicam, and celecoxib appeared safe alternatives in cross-reactive phenotypes of NSAID hypersensitivity. Although celecoxib has the most favorable tolerability, cross-reactivity among COX-2 inhibitors seems to be possible.

Use of a Partially Hydrolyzed 100% Whey-Based Infant Formula with Lactobacillus Reuteri in Infants with Caregiver-Perceived Intolerance

Nov 2019 DOI 10.14302/issn.2691-5014.jphn-19-3067
M. Czerkies LauraCorresponding author Nestlé Nutrition, Arlington, VA

This study evaluated the impact of switching exclusively formula-fed infants with caregiver-perceived formula intolerance to a reduced lactose, partially hydrolyzed 100% whey-based formula (PHF-W) with Lactobacillus reuteri and 2-fucosyllactose. Infants identified as ‘very’ or ‘extremely’ fussy by caregivers were eligible for this single-arm, single-blind study. Subjects switched their current formula to study formula for three weeks. Gastrointestinal tolerance was assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ) at baseline and end of the study. Caregivers ranked their infants’ fussiness (not at all, slightly, moderately, very, extremely) after the first three feedings of study formula and 24 hours after enrollment. A paired t-test was used to compare the change in IGSQ score, and a paired t-test and Wilcoxon signed rank test were used to compare post-feeding fussiness scores to baseline. Fifty infants (mean±std age 28.9±14.5 days) were enrolled; 41 completed the study per protocol. Mean (±std) baseline IGSQ score was 34.9±10.0, dropping to 22.1±7.5 after three weeks (p < 0.001). 48/50 (96%) caregivers stated their infants’ fussiness improved after 24 hours, and 2 (4%) remained the same. 42/46 (91%) caregivers stated their infants’ fussiness improved after the first feeding, and 4 (9%) remained the same. Caregiver-ranked fussiness significantly improved after the first, second, and third feedings and after 24 hours as compared to baseline (p < 0.001 for all). IGSQ scores significantly improved after three weeks of feeding with PHF-W containing Lactobacillus reuteri and 2-fucosyllactose in infants with caregiver-perceived intolerance, and improvements in fussiness were noted as quickly as after the first feeding.

Ultraviolet B Phototherapy Intervention in Patients with Multiple Sclerosis: A Prospective, Randomized Pilot Trial

Aug 2019 DOI 10.14302/issn.2470-5020.jnrt-19-2797
A Best-Popescu CatherineCorresponding author University of Illinois College of Medicine, Urbana-Champaign, Urbana, IL, USA (Barry J. Riskin, MD)

Background There is substantial evidence, from well-conducted epidemiological studies, that low vitamin D levels are correlated with increased risk for MS, and multiple case control studies have implicated the involvement of vitamin D deficiency in MS etiology. Narrow-band Ultraviolet B (NB-UVB; 300nm - 311 nm) induced vitamin D production has not previously been studied in a multiple sclerosis (MS) randomized placebo-controlled trial (RCT). Objectives To investigate NB-UVB induced vitamin D production, immunomodulation and MS symptomology following NB-UVB phototherapy in a MS cohort. Methods Using a blinded RCT study design, twelve individuals 18 years or older with MS were enrolled and assigned (1:1) into individualized NB-UVB dose (10-30kJ/m) phototherapy, or into placebo treatment, delivered 3 times per week, for 8-weeks. Serum vitamin D levels, walking performance, strength, cognitive function, mood and circulating progenitor cells (CPCs: CD34+CD45dim), monocyte populations (Intermediate CD14+CD16+, Classical CD14+CD16-), and T regulatory cell (CD4+/CD25+/FoxP3+Tregs) count were assesed. The data were analyzed by 2 x 3 mixed factor ANOVA.   Results A statistically significant condition by time interaction on vitamin D levels (F=7.14, p<.005, partial η2=.42) was identified. NB-UVB phototherapy may provide immunomodulation in a select group of MS individuals. Conclusion UVB phototherapy corrects vitamin D deficiency. This study adds to the growing research investigating UVB treatment in MS.

Effect of Oral Honey Consumption on Immune Function Following Ex-Vivo Lipopolysaccharide Stimulation in Healthy Humans

Mar 2019 DOI 10.14302/issn.2379-7835.ijn-19-2639
McCarthy OliviaCorresponding author Diabetes Research Group, Medical School, Swansea University, Swansea, UK

Nine healthy individuals with a mean ± SD BMI of 22.0 ± 0.7 kg/m² and age of 20 ± 0.2 years, participated in this single-blind randomised, crossover trial investigating the impact of ingesting two different honeys (1) Tropical Forest Honey (TFH) and (2) Manuka Honey; strength 12+ (MAN) on circulating levels of plasma interferon gamma following ex-vivo lipopolysaccharide (LPS) stimulation. Blood samples were prepared into duplicate aliquots of whole blood (800 μl) and 100 μg/l of LPS was added to samples to give a final volume of 1 ml. Levels of IFN-γ in plasma fractions were measured via commercially available sandwich ELISA and all comparisons were made with paired data using the Wilcoxon Signed Rank test taking a significance level of 5%. Whilst significant intra-and-interpersonal variation was observed, IFN-γ concentrations remained statistically unchanged 48 hours after the ingestion of either honey (p=0.15). Thus, in this instance the type of honey did not influence the IFN-γ response to plasma samples spiked with LPS.  

Effect of Neosaxitoxin on Epidural Anesthesia in Cats: a Promising Alternative to Conventional Anesthetics

Feb 2019 DOI 10.14302/issn.2578-8590.ipj-19-2623
Hinzpeter JaimeCorresponding author Department of Orthopaedic Surgery, Clinical Hospital, University of Chile, Santos Dumontt # 999, Independencia, Zip Code: 8380456, Santiago, Chile.

Neosaxitoxin (NeoSTX) is a specific high-affinity inhibitor of voltage-dependent sodium channels, which has shown excellent results as a local anesthetic in various pathologies and post-operative protocols, since it effect is long-lasting and have virtually no side effects.The aim of this study was to analyze the effect of NeoSTX as an epidural anesthetic in female cats, undergoing ovariohysterectomy, compared to Lidocaine in a randomized and double-blind study. Two groups of 11 female cats were randomly in the NeoSTX group and the lidocaine group. They were administered, respectively, a single dose of NeoSTX (0.5 μg / kg) or lidocaine (4 mg / kg, 2%) by epidural via. Using the UNESP-Botucatu pain assessment scale, which considers multiple behavioral and physiological factors, the epidural anesthetic effect of NeoSTX and lidocaine was evaluated, up to 240 min after the ovariohysterectomy procedure. NeoSTX no altered the peripheral blood pressure during the cut of uterine cervix, and generated lower values on the pain scale as compared to the lidocaine treatment. None of the cats anesthetized with NeoSTX required an extra dose of pain-relieving drugs (2 mg / kg of tramadol) during the first 150 min after surgery, whereas nine cats from the lidocaine group did need an extra dose of analgesic. NeoSTX is a powerful pain blocker, with a long-lasting anesthetic effect when administered by an epidural procedure. Therefore, NeoSTX emerges as a promising alternative to conventional anesthetics for the treatment of postoperative pain.

Ophthalmic Science Open Access

Accessibility and Barriers to Uptake of Ophthalmic Services among Rural Communities in the Upper Denkyira West District, Ghana

Jan 2019 DOI 10.14302/issn.2470-0436.jos-19-2602
Adaboh HayfordCorresponding author Department of Optometry and Visual Science, Kwame Nkrumah University of Science and Technology, Kumasi, Ghana

Vision impairment and blindness remain a challenge in developing countries, especially in rural communities. Notwithstanding, VISION 2020 global initiative seeks to eliminate avoidable blindness by 2020. This community-based cross-sectional study aimed at determining the accessibility of ophthalmic services and barriers to its utilization in rural communities in the Upper Denkyira West District, Ghana. One-hundred and seventy participants from 5 randomly chosen rural communities in the district were included. Participants were interviewed using a structured questionnaire. Socio-demographic information, information regarding accessibility, utilization, and barriers to eye care services were obtained. Descriptive statistics were carried out using SPSS version 23. The Chi-squared test was employed to determine associations. P-values less than 0.05 at a confidence interval of 95% were considered significant. Only 21.8% of participants had had eye examination within the past 3 years, with over half of the examinations undertaken at screening grounds and health centres. Significant associations were found between ophthalmic services utilization and increasing age (p = 0.004), female gender (p = 0.027) and those who had a past history of eye problem(s) (p = 0.0010. The study found gross inadequate utilization of ophthalmic services mainly due to unavailable ophthalmic services in the rural district. Public health education and eye care interventions should prioritize and target rural populations. Key Messages This study found gross inadequate utilization of ophthalmic services mainly due to unavailable ophthalmic services in the rural district. Rural dwellers were thus compelled to resort to harmful eye care practices. Public health education and eye care interventions should prioritize and target rural populations

Efficacy and Safety of Lycoprozen®, a Novel Tomato-Based Food Supplement in Patients with Benign Prostatic Hyperplasia

Dec 2018 DOI 10.14302/issn.2379-7835.ijn-18-2491
Iacobelli StefanoCorresponding author Janus Pharma S.r.l., Via Giacomo Peroni 386, 00131 Roma, Italy.

Objective: To evaluate the efficacy and safety of a novel tomato-based food supplement on the lower urinary tract symptoms (LUTS) of patients with benign prostatic hyperplasia (BPH). Methods: Twenty patients with BPH were enrolled in this observational study. They were assigned to consume daily a sachet of Lycoprozen® (5 grams) dissolved in water for two months. Results: All patients successfully completed the Lycoprozen scheduled regimen and the IPSS (International Prostatic Symptom Score) questionnaire before and after treatment. No side effects due to treatment were noticed. In this preliminary study, we have found that Lycoprozen® significantly reduced the LUTS severity (paired t-test, two-tailed p value < 0.0001). The IPSS mean values before and after the treatment were 16.95+6.0 SD (range 31-6) and 12.2+4.9 SD (range 20-2), respectively. Conclusions: Based on these data, Lycoprozen® may represent a suitable alternative option for the treatment of symptomatic BPH patients which worth of further testing in a phase 2 prospective randomized double blind placebo controlled study. The treatment was without side effects and acceptance among patients was high.

Bacterial Meningitis Associated with Pituitary Macroadenoma: Systematic Review

May 2017 DOI 10.14302/issn.2470-5020.jnrt-17-1503
TOUDOU DAOUDA MoussaCorresponding author Department of Neurology, Hassan II University Teaching Hospital, Sidi Harazem Road, PO Box 1835, Atlass, Fez, Morocco.

Introduction Bacterial meningitis complicates rarely pituitary macroadenomas. The aim of our systematic review is to study the features of the association between bacterial meningitis and pituitary macroadenoma. Methods We conducted a literature search in both MedLine and Google Scholar database from 1967 to October 2016 and reviewed all cases described of the association between bacterial meningitis and pituitary macroadenoma apart from any surgical act and without pituitary apoplexy. Results We found 14 articles describing 16 patients aged of 22-69 years old with a male predominance (sex ratio 4.3). Two patients (12.5%) had a well-documented clinical history of pituitary macroadenoma prior to the diagnosis of bacterial meningitis. Rhinorrhea has been found as the most common symptom through six patients (37.5%). Through the CSF culture, bacterial meningitis among patients suffering of pituitary macroadenoma commonly was due to Streptococcus pneumoniae. The examination in 18.75% of cases revealed signs related to pituitary macroadenoma (ophthalmoplegia and blindness). Six patients (37.5%) had received a treatment by dopaminergic agonist alone and 4 patients (25%) were treated with dopaminergic agonist associated with surgical treatment. Surgical treatment consisted of closure of the osteomeningeal breach in 12.5% (2/16) and tumor resection in 31.25% (5/16). Three patients (18.75%) had benefited tumor resection without prior agonist treatment. The mortality was 12.5% (2/16). Conclusion Our systematic review shows that bacterial meningitis represents a rare initial symptom leading to the diagnosis of invasive pituitary macroadenoma.

Effects of Soy-Milk on Blood Lipids and Total Homocysteine Level in Postmenopausal Women of Bangladesh

Jan 2017 DOI 10.14302/issn.2379-7835.ijn-16-1411
Saleh FarzanaCorresponding author Department of Community Nutrition, Bangladesh University of Health Sciences, Dhaka, Bangladesh

Background: Isoflavones are phytoestrogens present in natural sources, and they resemble estradiol in structure and manner of action. The aim of the study was to assess the effects of soy-milk on serum tHcy levels and to assess the glycemic and lipidemic status of Bangladeshi postmenopausal women. Methods: Thirty-six women (aged 50 ±5.16 years, M ±SD) participated in a randomized, un-blinded, open-ended, crossover study design for 52 days. The soy-milk group consumed 350 mL of milk twice a day for 21- day; the milk contained ~30 mg of isoflavones. FBG, PPG, HbA1c, TC, TG, HDL-C, NEFA, and tHcy were measured on day 0, day 21, day 31, and day 52 with a 10- day washout period. Results: After the consumption of soy-milk, the level of HDL-C significantly (p=0.005) increased on day 21 in the subjects. No significant changes were observed between the groups. After crossover, significant changes in FBG (p=0.005) and TG (p=0.049) were observed on day 52 in the soy-milk group. Significant improvement in TG (p=0.001) and HDL-C (p=0.032) was also seen at the end-point. Conclusions: Soy isoflavones is to some extent favorable to reduce CVD risk factors among Bangladeshi postmenopausal women.

Obesity Management Open Access

A Pilot Study Assessing the Impact of a High Protein Supplementation Diet on Fat Mass in Obese Adolescents with and without Type 2 Diabetes

Sep 2016 DOI 10.14302/issn.2574-450X.jom-16-1062
Gudala MeghanaCorresponding author Division of Pediatric Endocrinology, Baystate Children’s Hospital, 50 Wason Avenue, Springfield, Massachusetts 01199

Background: Obese adults with Type 2 Diabetes (T2D) have shown differences in body composition and response to varying diets when compared to obese adults without T2D. This difference in body composition affects management options for obesity. Such studies have not been done on adolescents thus far. Objectives: To estimate differences in fat mass at baseline as well as following a two-week high protein liquid diet in obese adolescents with and without T2D. Methods: Thiswas a pilot study using a non-randomized, unblinded pre/post intervention design without a control group. We planned to recruit 40 subjects (20 per group, with and without T2D) from ages 10 – 19 years, with Body mass index (BMI) ≥ 95 percentile. Body fat mass was measured via the Bod Pod® at baseline and after two weeks of following the diet with Ensure High Protein shakes. Change in fat mass is presented as mean differences and 95% confidence intervals. Results: We recruited 28 subjects, 19 completed the study and 12 were compliant with the diet. The mean difference in fat mass percent from baseline in subjects who completed the study (n=19) and without T2D was 1.4 (95% confidence interval (CI): -2.1 to -0.8) and in subjects with T2D was 1.2 (95% CI: -3.6 to 1.24). Conclusion: We did not find any meaningful difference in fat mass at baseline or after following a two-week high protein diet between the groups. High dropout rate and noncompliance with the diet were major limitations.

Ophthalmic Science Open Access

Ocular Manifestations of Vitamin A Deficiency Among the Rural Pre-School Children of North India

Dec 2015 DOI 10.14302/issn.2470-0436.jos-15-818
Arlappa NimmathotaCorresponding author National Institute of Nutrition (Indian Council of Medical Research), Hyderabad, India.

Purpose: Vitamin A deficiency (VAD) is still a major nutritional problem of public health importance among the rural pre-school children in India, even after the implementation national vitamin A prophylaxis programme for prevention of nutritional blindness and ICDS have been in operation for more than three decades. The purpose of this communication is to assess the prevalence of ocular manifestations of vitamin A deficiency among rural pre-school children of north India. Methods: A community based cross-section study; adopting multi-stage random sampling procedure was carried out by NNMB among rural pre-school children of four north Indian states viz. Maharashtra, Madhya Pradesh, Orissa and West Bengal. A total of 36,111 rural pre-school children of 1-5years (Boys: 18408; Girls: 17703) were covered for this study. Results: The prevalence of conjunctival xerosis (2.5%), the first ocular sign of VAD and Bitot’s spot (0.9%), an objective ocular sign of VAD was higher than the cut-off values suggestive of public health nutritional problem among the rural children. While, the prevalence of night blindness, the first symptom VAD was reported among 0.5% of rural children. Similarly, the proportion of rural pre-school children with sub-clinical VAD was 64%, suggestive of severe public health importance. Conclusion: The prevalence of ocular manifestation and sub-clinical vitamin A deficiency was high among the rural children of north India. Therefore, rural communities are encouraged to consume diets rich in vitamin A and administer massive dose vitamin A solution to the children of under five for the prevention and control of vitamin A deficiency and its adverse impact on child morbidity and mortality.

Antioxidant Activity Open Access

Anti-Oxidant Phytochemicals as Potential Treatments for Age-Related Macular Degeneration

Jun 2015 DOI 10.14302/issn.2471-2140.jaa-14-616
Milward E.A.Corresponding author School of Biomedical Sciences and Pharmacy, The University of Newcastle, Australia

Age-related macular degeneration (AMD) is responsible for a substantial proportion of severe visual impairment and blindness in people over 50 years of age. Current treatments for AMD are not effective in all patients and a proportion of patients who respond well to the treatment will still eventually develop central visual impairment. Despite all efforts to develop safe and efficient medications for AMD, as yet pharmacological approaches have failed to provide fully effective treatments for this condition. Various lines of evidence attest to the contributions of oxidative stress in the etiology of AMD. Anti-oxidant nutrients may be valuable preventive or therapeutic agents however complementary therapies can become widely adopted without sufficient knowledge of the real advantages and liabilities. This review considers the interventional potential of some common phytochemicals for treating AMD, primarily focusing on clinical and epidemiological evidence of potential public health relevance.

Ophthalmic Science Open Access

Superior Sclera Versus Temporal Corneal on Steep Axis Incision to Correct Pre-Existing Corneal Astigmatism Less Than 1.5 D

Jan 2015 DOI 10.14302/issn.2470-0436.jos-14-572
KavitaBhatnagarCorresponding author Dr D Y Patil Medical College, Hospital & Research Center, Pune, India

Purpose: Cataract is the leading cause of blindness worldwide. Even in an uneventful cataract surgery, surgically induced astigmatism remains the major hurdle in attaining good unaided visual acuity post surgery. If pre-existing corneal astigmatism is not corrected at the time of surgery, it will result in more postoperative astigmatism; therefore, it is important to correct pre-existing corneal astigmatism. Material & Methods In this prospective study, 100 eyes of 100 age and sex matched patient’s with comparable preoperative astigmatism and visual acuity were divided in two groups according to pre operative corneal astigmatism. SIG (superior scleral incision group) included 50 eyes with steeper vertical axis and TIG (temporal corneal incision group) included 50 eyes with steeper horizontal axis. SIG and TIG were subjected to superior scleral tunnel and temporal corneal tunnel incisions respectively. Corneal astigmatism was measured preoperatively and at 1, 2 and 6 weeks postoperatively. Results: The mean postoperative astigmatism in SIG and TIG after 6 weeks was 0.545 ± 0.51D and 0.59 ± 0.48 D in comparison to preoperative astigmatism of 1.105 ± 0.54 D and 1.120 ± 0.49 D respectively. The difference was statistically significant in both the groups with P< 0.001 for both groups. The difference in surgically induced astigmatism between the two groups was not significant at any point of time after surgery (p>0.05). Conclusion: Incision site on steeper axis helps in reduction of pre-existing corneal astigmatism in cataract surgery. Both superior scleral and temporal corneal incisions help in neutralization of approx. 0.4-0.7 D of astigmatism.

Bioinformatics of Metabolomics in Diabetes Mellitus Type 2

Oct 2014 DOI 10.14302/issn.2374-9431.jbd-13-212
Ahmad Sliem HamdyCorresponding author Biochemistry and internal Medicine*, Basic oral and medical sciences, College of dentistry, Qassim University, Saudi Arabia

Diabetes mellitus type 2 (DMT2) is a complex polygenic disorder. DMT2 is a result of insulin resistance and destruction of pancreatic β-cell or dysfunction. Therefore, glucose builds up in the bloodstream, leading to nerve damage, blindness, organ failures and sometimes death. Recently, some recently discovered genes play a key role in regulating the sensitivity to insulin. Scientists have long known that the disease often runs in families, and other genetic links. Human genetic discoveries will keep improving our knowledge about diabetes for many years to come. Varieties of prospective diabetic researches were developed to diagnose and control DMT2. Researchers spent thousands of millions of dollars to address DMT2. Pioneers of advanced biotechnology developed bioinformatics tools that changed the course of research about the role of metabolomics in DMT2. It will facilitate the identification of possible causes of DMT2 in genome studies. The present article aimed at reviewing the research studies per training to metabolomics and bioinformatics in genome studies in relation to DMT2.  

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