Patient Global Assessment Scale Research Articles

Autologous Micrografts Containing Nanovesicles, Exosomes, and Follicle Stem Cells in Androgenetic Alopecia: In Vitro and In Vivo Analysis Through a Multicentric, Observational, Evaluator-Blinded Study.

The use of micrografts (MCGs) containing human follicle mesenchymal stem cells (HF-MSCs) is a hair loss (HL) treatment that needs to be standardized as seems to have promising effects on hair regrowth (HR-G) also thanks to the presence of extracellular vesicles (EVs). The study aims to report both the in vivo results, obtained in patients affected by androgenic alopecia (AGA) treated using MCGs, and in vitro analysis characterizing the EVs. A multicentric, retrospective, observational, evaluator-blinded study was conducted. Eighty-three AGA patients were initially enrolled [52 suffering from male pattern hair loss (MPHL) at stages I-III vertex by the Norwood-Hamilton scale and 31 suffering from female PHL (FPHL) at stages I-II by the Ludwig scale]. Sixty patients (20 females and 40 males) were treated and analyzed after exclusion and inclusion criteria assessment. The in vivo HR-G was evaluated through photography, physician's, and patient's global assessment scales, in addition to standardized photo-trichograms, during a follow-up for 1 year, while the in vitro analysis was performed through a quantitative, morphological, and dimensional characterization of the EVs population using transmission electron microscopy (TEM) and fluorescent microscopy. A hair density (HD) increase of 28 ± 4hairs/cm2 at T4 after 12 months in the targeted area (TA) of FPHL, compared with the baseline, was observed using computerized trichograms with a statistically significant difference (SSD) in hair regrowth (HR-G) (p = 0.0429). Regarding MPHL, an HD increase of 30 ± 5hairs/cm2 at T4 after 12 months in the TA was observed with an SSD in HR-G (p = 0.0012). The presence of EVs and their interaction with the surrounding cellular population were demonstrated. MCGs containing HF-MSCs and exosomes may fill in as a safe and viable alternative treatment against HL in mild and moderate degrees of AGA both in MPHL and in FPHL. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

Janus kinase inhibitors versus tumor necrosis factor inhibitors in rheumatoid arthritis: meta-analytical comparison of efficacy and safety.

Rheumatoid arthritis (RA) is a chronic systemic autoimmune disorder characterized by persistent inflammation leading to progressively worse disability. Janus kinase (JAK) inhibitors and tumor necrosis factor (TNF) inhibitors are pivotal in RA treatment, yet their comparative efficacy remains underexplored. This study aimed to compare the efficacy and safety of JAK inhibitors and TNF inhibitors in treating RA using data from randomized controlled trials (RCTs). A meta-analysis and outcomes analysis were based on results of the Health Assessment Questionnaire Disability Index (HAQ-DI), Clinical Disease Activity Index (CDAI), Visual Analogue Scale (VAS), and Patient Global Assessment Scale (PtGA) and other indices as incidences of venous thromboembolism (VTE) and malignancy. The JAK inhibitors caused a statistically significant improvement in the HAQ-DI score [MD = 0.08, 95% CI (0.03, 0.12), p = 0.0008] compared with the TNF inhibitors. However, no significant difference was observed between the two drug classes in the CDAI score [MD = -2.03, 95% CI (-9.27, 5.22), p = 0.58]. JAK inhibitors were associated with an increase in the VAS score [MD = 3.62, 95% CI (0.86, 6.38), p = 0.01], but there was no significant difference in the PtGA score [MD = 1.91, 95% CI (-3.25, 7.08), p = 0.47]. JAK inhibitors demonstrated superior efficacy in improving the functional status and reducing the disease activity in RA patients compared with TNF inhibitors. Both drug classes exhibited comparable safety profiles for VTE and malignancies, though JAK inhibitors had a higher risk for thromboembolism.

Efficacy and Safety of Autologous Serum Therapy in Chronic Spontaneous Urticaria in the Pediatric Population: A Prospective Pilot Study.

Chronic spontaneous urticaria (CSU) in children is mostly spontaneous in onset (57%). Treatment comprises long-term antihistaminic therapy without need for elaborate investigations. A subset of such patients don't respond to conventional treatment and novel therapies to help reduce pill burden is the need of the hour. To determine the efficacy and safety of autologous serum therapy (AST) in pediatric patients with chronic spontaneous urticaria. All pediatric patients, aged between 6-16 years, attended to our OPD from March 2019 to March 2020 were recruited. Clinico-demographic data and baseline investigations of all patients were performed. Two-weekly AST therapy was given for 8 visits with levocetrizine tablet 5mg on an on-demand basis. Urticaria activity score (UAS) sheet was provided to record and return every 2 weeks. Statistical analysis was done using the IBM SPSS 26 software package. Autologous serum skin test (ASST) was positive in 63% patients. Both the ASST positive and ASST negative group showed significant reduction in UAS7 score at week 14 compared to baseline. The reduction in mean UAS7 score was associated with a decreased pill burden and positive response in the patient and physician global assessment scale. No statistically significant difference between the two groups in terms of mean UAS7 reduction was found. This study has explored the efficacy and safety of autologous serum therapy in the pediatric CSU patients. Both ASST positive and ASST negative group respond to AST therapy.

Early perioperative versus postoperative meloxicam for pain control in patients undergoing orthopedic surgery: a systematic review and meta-analysis of randomized controlled trials

Objective Post-orthopaedic operative pain is a serious concern that often requires the administration of analgesics; however, the optimal time of analgesic administration is still inconclusive. Perioperative analgesia is administrating pre-emptive analgesia before and during the surgery followed by postoperative analgesia to decrease the procedure associated nociceptive response. We aim to assess perioperative meloxicam versus postoperative meloxicam for pain control after orthopaedic operations. Methods A systematic review and meta-analysis involving randomized controlled trials from PubMed, Embase, Scopus, WOS, and CENTAL until May 28th, 2022. We pooled dichotomous outcomes using risk ratio (RR) presented with a 95% confidence interval (CI) and continuous outcomes using mean difference (MD) with 95% CI. We registered our protocol in PROSPERO with ID: CRD42022336046. Results We included five RCTs with 964 patients. All the included trials showed high risk of performance and detection biases because of lack of blinding. Pooled analysis favored perioperative meloxicam in reducing pain score after six hours (MD: -0.42 with 95% CI [-0.63, -0.21], p = 0.0001), 12 hours (MD: -0.54 with 95% CI [-0.69, -0.39], p = 0.00001), and 24 hours (MD: -0.23 with 95% CI [-0.36, -0.10]. Pooled analysis favored perioperative meloxicam in improving patient global assessment scale after 12 hours (MD: -0.66 with 95% CI [-0.86, -0.46], p = 0.00001), 24 hours (MD: -0.30 with 95% CI [-0.49, -0.11, p = 0.002), and 48 hours (MD: -0.17 with 95% CI [-0.33, -0.01], p = 0.04). Pooled analysis favored perioperative meloxicam in reducing patient-controlled analgesia (MD: -4.25 with 95% CI [-5.96, -2.54], p = 0.00001). Conclusion Short-term pain management after orthopaedic procedures is better accomplished with perioperative meloxicam than postoperative meloxicam. Before recommending perioperative meloxicam for pain control following orthopaedic surgeries, further multicentre trials are still warranted to examine the impact of perioperative meloxicam in different orthopaedic procedures.

Open-Label Study to Evaluate the Response to Homeopathic Treatment of Psoriasis

Patients with psoriasis commonly opt for homeopathic treatment. However, no study has assessed the response to homeopathic treatment by using standardized disease-specific scales, and the findings are based on clinical assessments only. The objective of this study was to evaluate the response to the individualized homeopathic treatment of psoriasis with respect to changes in disease severity and quality of life based on Psoriasis Area and Severity Index (PASI) and Psoriasis Disability Index (PDI) scales, respectively. A multicentric study was conducted using a pragmatic model. The study participants were regularly followed up for 1 year. Subsequently, participants completing the 1-year follow-up were included in a long-term assessment for further 2 years. Three monthly assessments were made by using PASI, PDI, and Visual Analog scales for patient and physician general assessment. Data were analyzed to identify treatment effects and variables affecting treatment. In total, 384 patients were enrolled, out of whom 254 participants completed 1 year of treatment. Of these, 84 participants continued treatment for an additional 12 months. A significant reduction was observed in the scores of PASI (10.96 ± 10.67 at baseline to 4.24 ± 5.10 at 12 months, p = 0.000), PDI (10.19 ± 9.11 to 3.91 ± 4.44, p = 0.000), and patient and physician global assessment scales. Regarding PASI response at 12 and 24 months, PASI 75–89 was reported in 66 and 14 participants, whereas PASI 90–100 was reported in 29 and 17 participants, respectively. Baseline severity of psoriasis considerably affected treatment response, whereas age, gender, and duration of psoriasis did not. Furthermore, the severity of psoriasis and quality of life improved considerably with regular homeopathic treatment.

Exercise Self-Efficacy and patient global assessment were associated with 6-min walk test distance in persons with rheumatoid arthritis

IntroductionLow functional capacity is related to future loss of daily function and cardiovascular events. The present study explored the associations of patient-reported outcome measures (PROMs) and disease-specific measures with functional capacity as measured by the 6-min walk test (6MWT) in persons with rheumatoid arthritis (RA).MethodsSeventy-nine participants from rheumatology outpatient clinics were included. The distance walked during the 6MWT (6MWD) was the dependent variable in multivariable regression analyses. Model 1 included the independent variables sex, age (in tertiles to improve model fit), and body mass index (BMI). Building on Model 1, Model 2 added smoking, patient global assessment (PGA), Exercise Self-Efficacy, Hospital Anxiety and Depression Scale’s Depression score, and Cohen’s Perceived Stress Scale score, whereas Model 3 added smoking, disease duration, present use of glucocorticosteroids, seropositivity, Disease Activity Score 28—C-Reactive Protein (DAS28-CRP), and a comorbidity variable.ResultsMedian age was 65 years, 76% were female, and median 6MWD was 493 m. In Model 1, BMI and age were significantly associated with the 6MWD (R2 = 0.42). In Model 2, PGA and Exercise Self-Efficacy were also significantly associated with the 6MWD, with standardized regression coefficients of − 0.21 (p = 0.03) and 0.26 (p = 0.004) respectively (R2 = 0.54). The RA-specific variables in Model 3 were not significantly associated with the 6MWD (R2 = 0.49).ConclusionThe PROMs PGA and Exercise Self-Efficacy were significantly associated with functional capacity as measured by the 6MWT in persons with RA, whereas disease-specific measures such as DAS28-CRP and disease duration were not.Key Points• Functional capacity measured with the 6-minute walk test was significantly associated with body massindex, age, patient global assessment, and Exercise Self-Efficacy in persons with RA.• Patient-reported outcome measures explained more of the variation in functional capacity than objectiveor composite measures of disease and are relevant measures in clinical follow-up.• Techniques that enhance self-efficacy for exercise should be incorporated into clinical practice topromote physical activity.

Stress and Quality of Life in Psoriasis

Introduction Psoriasis is a common dermatological disorder characterized by silvery-white, scaly, and erythematous plaques with or without pruritus. It is an immensely stressful condition, hampering the quality of life with significant psychological morbidity. Objective To assess the level of stress and quality of life among the patients with psoriasis. Methods A nonexperimental descriptive study design was used. Sixty participants were enrolled from Dermatology OPD, PGIMER, Chandigarh, by a purposive sampling technique during October to January 2021. An interview schedule, comprising (a) sociodemographic and clinical profile, (b) Perceived Stress Scale (PSS), (c) Patient Health Questionnaire-4 to assess anxiety (PHQ-4), (d) Patient Health Questionnaire-9 to assess depression (PHQ-9), (e) Patient Global Assessment (PtGA) Scale to assess severity of illness (PtGA), and (f) Dermatology Life Quality Index (DLQI), was used for data collection. Data were collected by a telephonic interview as per the interview schedule. At the end of the interview, patients were asked to send the pictures of affected body parts, which were then assessed by the dermatologist using the Investigator’s Global Assessment (IGA) Scale. Data analysis was done with descriptive and inferential statistics using the Statistical Package for Social Sciences (SPSS version 23). Results Most of (86.7%) the participants reported a moderate level of stress (PSS) and 65% described moderate effect on the quality of life. The assessment of the severity of illness on IGA depicted that 36.7% of participants had mild, 28.3% had moderate, and 26.7% had severe psoriasis. Mild to moderate depression (PHQ-9) was screened in about 25% of the participants. A significant correlation was found between stress, quality of life, anxiety, and depression (<0.001). The severity of psoriasis was significantly correlated with quality of life, anxiety, and depression. Conclusion The study results concluded that the presence of a significant level of stress has a considerable effect on the quality of life among the patients with psoriasis. Thus, it is recommended to assess and address the psychological issues along with medical management for the comprehensive management of patients with psoriasis.

Effectiveness of brodalumab in achieving treatment satisfaction for patients with plaque psoriasis: The ProLOGUE study

BackgroundReal-life evidence on the quality of treatment with brodalumab in patients with plaque psoriasis based on patient-reported outcomes remains limited. ObjectiveTo assess the effectiveness of brodalumab in achieving treatment satisfaction for real-life Japanese patients with psoriasis. MethodsAs part of a single-arm, open-label, multicenter, prospective study (ProLOGUE), Psoriasis Area and Severity Index (PASI) scores, body surface area (BSA), and Treatment Satisfaction Questionnaire for Medication-9 (TSQM-9) domain scores were assessed at baseline and Weeks 12 and 48 of brodalumab treatment. Patient Global Assessment (PtGA) scores were captured at Weeks 12 and 48. ResultsSeventy-five patients were enrolled, of whom 73 received brodalumab. PASI scores and BSA significantly reduced from baseline at Weeks 12 and 48 (all P < 0.0001). Most (90%) patients felt the treatment was effective on the PtGA scale at Weeks 12 and 48. TSQM-9 domain scores significantly improved at Weeks 12 and 48 (all P < 0.0001). A PASI score of ≤ 2 was suggested as a treatment goal for biologic treatment of psoriasis from a receiver operating characteristic curve analysis, although some of the TSQM-9 domain scores did not improve in patients achieving this goal. No new safety signals were observed. ConclusionTreatment with brodalumab was associated with improved objective symptoms and satisfaction in Japanese patients with psoriasis. A PASI score of ≤ 2 as a goal for biologic treatment of psoriasis may be feasible, although achieving this PASI goal alone may be insufficient to clearly improve long-term patient satisfaction (Japan Registry of Clinical Trials identifier: jRCTs031180037).

A split-face comparison of fractional erbium: YAG laser plus Kligman's formula vs. Kligman's formula monotherapy for facial melasma.

Melasma is a chronic hyperpigmentation disorder. Although several treatment methods are used for patients, it remains a challenging problem for physicians. Erbium-YAG laser is one of the laser treatment methods that proved its efficacy in melasma treatment. We aimed to compare the efficacy of combining the fractional Er: YAG laser and Kligman's formula with Kligman's formula alone in the treatment of melasma. Twenty female patients with bilateral melasma were randomly treated in a split-face controlled manner with a fractional Er: YAG laser followed by Kligman's formula on one side and Kligman's formula on the other side. All patients received three laser sessions with four-week intervals. The efficacy of treatments was determined through photographs, Visioface, and Melasma Area Severity Index (MASI) score, all performed at baseline and three months after the end of laser sessions. Fractional Er: YAG laser and Kligman's formula showed a significant decrease in MASI score than Kligman's formula alone (P = 0.005). There was a significant decrease in cheek Visioface score on Er: YAG laser and Kligman's formula vs Kligman's formula (P = 0.02). However, the Patient Global Assessment Scale of both sides was not statistically significant (P = 0.23). The combination of Fractional Er: YAG laser with Kligman's formula is an effective treatment method for melasma.

A PROSPECTIVE, OPEN-LABEL, OBSERVATIONAL STUDY OF SULPHUR IN CLINICAL PRACTICE.

Sulphur is such a complete Homoeopathic medicine that it is somewhat difcult to tell where to begin. Sulphur seems to contain a likeness of all the sickness of men and a beginner on reading over the proving of Sulphur might naturally think that he would need no other remedy, as the image of all sicknesses seems to be contained in Sulphur. Aim: To study the symptoms of Sulphur in clinical practice and identifying its true totality after obtaining results. Objectives: Ÿ To verify the symptoms of Sulphur in clinical practice. Ÿ To restore the health of the sick individual. Study design : Ÿ Prospective Ÿ Observational Ÿ Open-label Inclusion criteria : Ÿ Patients in all age group Ÿ Both gender Material &amp; Methods: In this study 30 cases were selected from the OPDs of Government Homoeopathic Medical College &amp; Hospital, Bhopal. Case taking was done for each case as instructed by Dr. Hahnemann. Medicine was selected after analysis/evaluation of symptoms and forming the prescribing totality. Help of computer repertorization was also taken by using RADAR-synthesis repertory. Follow-up was done as per the need in each case; three consecutive follow-ups are studied for further observation. For outcome assessment 'Patient Global assessment Scale' was used to get the data for analysis. Results: The results have shown that maximum number of cases has shown moderate improvement with the treatment that is 60%, and 27% of cases has shown marked improvement, only 4 cases were recorded as mild improvement. There is no case which has shown no signicant improvement. Conclusion : A group of mental generals, physical generals and particular symptoms of Sulphur have been emerged in this study, based on repetition in many patients.

Association of Patient Mental Health Status With the Level of Agreement Between Patient and Physician Ratings of Psoriasis Severity

The emerging paradigm of treat-to-target in psoriasis requires accurate monitoring of treatment response. The commonly used physician global assessment tool does not capture the patient's perception of their disease. Patient assessments facilitate shared decision-making and foster patient-centered care; however, recent research reports a discordance between patient- and physician-reported psoriasis severity. Understanding the factors underlying this discordance may improve treatment satisfaction and disease outcomes. To evaluate the discordance between patient- and physician-reported measures of psoriasis severity and assess the association with patient mental health status. A cohort study using repeated cross-sectional analysis of real-world longitudinal data was conducted at a large specialist psoriasis service serving London and Southeast England. A total of 502 patients attending the psoriasis service between May 12, 2016, and November 1, 2018, were included. Data analysis was conducted July 22 to October 22, 2019. Psoriasis severity was assessed on each visit with identical 5-point physician and patient global assessment scales (clear/nearly clear, mild, moderate, severe, and very severe). Each patient completed validated self-report screens for depression and anxiety on each visit. Longitudinal data from 502 individuals with psoriasis (1985 total observations) were available. A total of 339 patients (68%) were men, 396 (79%) were White, mean (SD) age was 47 (13) years, and 197 patients (39%) had concurrent psoriatic arthritis, 43 (9%) screened positive for depression, and 49 (10%) screened positive for anxiety. There was discordance between physician and patient measures of disease severity in 768 of 1985 office appointments (39%); on 511 visits (26%) patients rated their psoriasis as less severe and on 257 visits (13%) patients rated their psoriasis as more severe compared with their physician. Individuals who screened positive for depression or anxiety were more likely to overestimate their psoriasis severity compared with their physician (relative risk ratio: depression, 2.7; 95% CI, 1.6-4.5; anxiety, 2.1; 95% CI, 1.3-3.4). These findings remained statistically significant after adjustment for age, ethnicity, sex, body mass index, smoking, number of comorbidities, treatment modality, and presence of psoriatic arthritis. The findings of this cohort study suggest that discordance between patient and physician assessments of psoriasis severity is associated with patients' mental health status. Recognition of anxiety and depression in individuals with psoriasis appears to be important when interpreting patient-reported outcome measures and informing appropriate treatment decisions.

Anakinra treatment in patients with familial Mediterranean fever: a single-centre experience.

Anakinra is proven to be effective in controlled trials in terms of attack frequency and subclinical inflammation in colchicine-resistant patients. The objective of this study was to review the patients followed in our single centre with FMF who received anakinra because of insufficient colchicine response. The study was conducted at a tertiary rheumatology centre experienced in autoinflammatory diseases. The patients were treated for at least 1 month with anakinra. Patients with amyloidosis and pregnancy were not included. Attack frequency, patient global assessment scales of disease severity and acute phase reactants were recorded before and throughout anakinra treatment. Criteria of treatment termination were side effects, disease remission, inadequate response, pregnancy plan and non-compliance. One hundred and six patients diagnosed with FMF were treated with anakinra; 45.92% of the patients had a homozygous M694V mutation; 83 of the 98 patients tested for MEFV carried at least one copy of M694V. Attack frequency decreased while on anakinra treatment; in fact, no attacks were observed in 75 patients. Visual analogue scale score decreased from 7.49 (2.03) to 3.08 (2.82) (P = 0.001). Currently, 71 patients are still on anakinra treatment. Treatment of 34 patients was discontinued (32%). Insufficient response and side effects were the most common reasons for treatment discontinuation. All of the side effects observed were reversible and the patients alleviated after treatment cessation. In four patients, leukopenia was observed. In patients who were refractory to colchicine, anti-IL-1 agent anakinra was shown to be effective and safe. The effectiveness of anakinra stems from preventing attacks and increasing the quality of life.

Clinico-demographic Profile of Undifferentiated Inflammatory Arthritis Patients.

Undifferentiated inflammatory arthritis is a group of inflammatory joint diseases that do not fulfil the classification criteria for any other rheumatic or connective tissue disorders. This study aims to describe the clinical, demographic and serological features of undifferentiated inflammatory arthritis cases presenting at a tertiary level rheumatology centre from Nepal. A descriptive cross-sectional study conducted at National Centre for Rheumatic Diseases, Kathmandu, Nepal which represents a midterm analysis of the undifferentiated inflammatory arthritis registry maintained at the centre. Patients more than 18 years of age, who consented for the study having least one swollen or tender joint were enrolled. Ethical approval was obtained from Nepal Health Research Council. A total of 1120 patients were enrolled in the study out of which 941 (84%) were females. The mean age at diagnosis was 46.0±12.8 years and most of them were in overweight range (mean BMI: 27.0±5.8) with 818 (73%) patients having BMI more than 24.0. Patients mostly had low disease activity at presentation (DAS 28 score of 2.5±0.8). Other markers of inflammation and patient reported outcome measures (health assessment questionnaire, patient global assessment and visual analogue scale) were also in the moderate range. Seropositivity for anti-citrullinated peptides and anti-nuclear antibodies was seen in 5 (0.45%) and 43 (3.8%) patients respectively. Majority of patients were non-smokers (77%). Inflammatory arthritis on musculoskeletal ultrasonography was seen in 638 (57%). Undifferentiated inflammatory arthritis was more common in overweight females. Serological markers and smoking status are not common features in these patients.

Risk Factors Associated with Methotrexate Intolerance in Rheumatoid Arthritis Patients.

BackgroundMethotrexate (MTX) Intolerance Severity Score (MISS) has been previously validated in the Arabic language and has helped to detect high levels of intolerance in rheumatoid arthritis (RA) patients. The aim of the current study was to evaluate patient and disease characteristics associated with a high risk of MTX intolerance.Materials and MethodsA cross-sectional interview-based survey was conducted using adult RA patients as a study group, who were visiting a specialized rheumatology clinic at King Saud University Medical City. The Arabic MISS was used in this survey. Statistical analyses were performed to understand associations between MTX-intolerant and MTX-tolerant patients.ResultsA total of 117 patients were involved in this study. Of those, 101 (86.3%) were females with a mean (SD) disease duration of 6.6 (5.7) years. The median (interquartile range (IQR)) Disease Activity Score-28 (DAS28) was 3.6 (3.6–4.1). MTX intolerance was observed in 55 (47%) patients. The most predominant component in patients with a positive test was the behavioral component. Intolerant patients had a higher median of pain (47.3 vs. 50.0; P = 0.010) and patient global assessment (50.0 vs. 60.0; P = 0.004) scales compared to those in tolerant patients. Additionally, MTX intolerance was associated with the female gender (adjusted odds ratio (AOR) 6.724; 95% CI 1.420, 31.843, P = 0.016), marital status (AOR 2.549; 95% CI 1.037, 6.270, P = 0.042) and DAS28 (AOR 1.612; 95% CI 1.032, 2.517, P = 0.036). There was no significant difference between the two groups in the remaining disease activity parameters, background therapies, seropositivity, and smoking status (P > 0.05).ConclusionPatient characteristics, rather than disease activity, significantly impact MTX intolerance. Behavioral component is the main driver of intolerance. Intolerant patients have higher patient-reported outcomes. Qualitative studies are needed to explore causes and potential solutions to MTX intolerance.

Indicators of Quality of Life and Functional Status of Patients with Arterial Hypertension and Gout

The objective: to evaluate the quality of life (QOL) and functional status of patients with arterial hypertension (AH) and gout, to determine the factors influencing the QOL in this category of patients.Materials and methods. The study included 61 patients with AH, mean age (SD) of 54,25±10,29 years, which were divided into 2 groups: group 1 (n=36, main) –patients with AH and gout, group 2 (n=25, comparison) – patients with AH. The control group included 10 patients. The QOL was evaluated using the Short Form Medical Outcomes Study (SF-36) questionnaire, the Health Assessment Questionnaire (HAQ-DI) and the 10-point Patient Global Assessment (PGA).Results. Patients with AH and gout were more likely to have lowered their physical health indicators and the role-emotional. The average value of the HAQ-DI questionnaire was significantly lower in the main group, and on the PGA scale, in the main and comparison group.Conclusion. QOL of patients with AH and gout has been reduced to a greater extent in comparison with patients without gout due to chronic pain syndrome, functional constraints, psychological problems. Factors affecting the lung in this category of patients are the clinical manifestations of AH and gout: age, number of exacerbations of AH per year, total cardiovascular risk (TCVR), total number of affected joints, severity of gout, comorbidity.

Effects of intravenous home dobutamine in palliative end‐stage heart failure on quality of life, heart failure hospitalization, and cost expenditure

AimsIn patients with palliative end‐stage heart failure, interventions that could provide symptomatic relief and prevent hospital admissions are important. Ambulatory continuous intravenous inotropes have been advocated by guidelines for such a purpose. We sought to determine the effect of intravenous dobutamine on symptomatic status, hospital stay, mortality, and cost expenditure.Methods and resultsAll consecutive end‐stage heart failure patients not amenable for advanced therapies and discharged with continuous intravenous home dobutamine from a single tertiary centre between April 2011 and January 2017 were retrospectively analysed. Dobutamine (fixed dose) was infused through a single‐lumen central venous catheter with a small pump that was refilled by a nurse on a daily basis. Symptomatic status was longitudinally assessed as the change in New York Heart Association class and patient global assessment scale. Antecedent and incident heart failure hospitalizations were determined in a paired fashion, and cost impact was assessed. A total of 21 patients (age 77 ± 9 years) were followed up for 869 ± 647 days. At first follow‐up (6 ± 1 weeks) after the initiation of dobutamine, patients had a significant improvement in New York Heart Association class (−1.29 ± 0.64; P < 0.001), global assessment scale (<0.001), and N‐terminal pro‐brain natriuretic peptide (6247 vs. 2543 pg/mL; P = 0.033). Incident heart failure hospitalizations assessed at 3, 6, and 12 months were significantly reduced (P < 0.001 for all) in comparison with antecedent heart failure hospitalizations over the same time period. Cost expenditure was significantly lower at 3 (P < 0.001), 6 (P = 0.005), and 12 months (P = 0.001) after initiation of dobutamine. Mortality rate at 1 year was 48% with 9/12 (75%) patients dying at home, most often from progressive pump failure.ConclusionsContinuous intravenous home dobutamine in patients with palliative end‐stage heart failure is feasible and associated with improved symptomatic status, heart failure hospitalizations, and health‐care‐related costs. Nevertheless, results should be interpreted in the context of the small and retrospective design. Larger studies are necessary to evaluate the effect of dobutamine in palliative end‐stage heart failure.

Minimally important change, measurement error, and responsiveness for the Self-Reported Foot and Ankle Score

Background and purpose — Patient-reported outcome measures (PROMs) are increasingly used to evaluate results in orthopedic surgery. To enhance good responsiveness with a PROM, the minimally important change (MIC) should be established. MIC reflects the smallest measured change in score that is perceived as being relevant by the patients. We assessed MIC for the Self-reported Foot and Ankle Score (SEFAS) used in Swedish national registries.Patients and methods — Patients with forefoot disorders (n = 83) or hindfoot/ankle disorders (n = 80) completed the SEFAS before surgery and 6 months after surgery. At 6 months also, a patient global assessment (PGA) scale—as external criterion—was completed. Measurement error was expressed as the standard error of a single determination. MIC was calculated by (1) median change scores in improved patients on the PGA scale, and (2) the best cutoff point (BCP) and area under the curve (AUC) using analysis of receiver operating characteristic curves (ROCs).Results — The change in mean summary score was the same, 9 (SD 9), in patients with forefoot disorders and in patients with hindfoot/ankle disorders. MIC for SEFAS in the total sample was 5 score points (IQR: 2–8) and the measurement error was 2.4. BCP was 5 and AUC was 0.8 (95% CI: 0.7–0.9).Interpretation — As previously shown, SEFAS has good responsiveness. The score change in SEFAS 6 months after surgery should exceed 5 score points in both forefoot patients and hindfoot/ankle patients to be considered as being clinically relevant.

An Open Label Efficacy Study of Amrita Guggulu and Pinda Taila in the Management of Hyperuricemia in Gout (Vatarakta) Patients

ABSTRACT Background Vatarakta vis-à-vis gout is a common condition in both primary care and specialist practice. Gout is a systemic disease characterized by manifestations of chronic under­lying hyperuricemia, resulting in the deposition of monosodium urate crystals in various tissues. Gout is the most common of the crystal induced arthritis due to disturbed uric acid metabolism and precipitation of urate crystals in extracellular space of joints, periarticular tissue, bones, and other organs. Aim and objective To explore the therapeutic efficacy and safety of Amrita Guggulu and Pinda Taila in the management of hyperuricemia in gout (Vatarakta) patients. Materials and methods A total of 100 cases (25–65 years) of primary gouty arthritis fulfilling the diagnostic criteria as recommended by the American College of Rheumatology were selected for the present study from outpatient department of the Central Ayurveda Research Institute for Respiratory Disorders Patiala and Regional Ayurveda Research Institute for Urinary Disorders, Jammu, India, irrespective of their sex, religion, and socioeconomic status. Only those patients who presented themselves with at least 6 of 12 criteria of American College of Rheumatology (1977) were selected for the clinical trial. Amrita Guggulu was given 1000 mg twice daily orally and Pinda Taila was applied locally 10 mL twice daily for 84 days. Results The trial therapy was assessed based on the improvement in clinical features, Visual Analog Scale (VAS) score, Patient's Global Assessment Scale score, Physician's Global Assessment Scale Score, SF-36 Health Survey Score for quality of life (QOL), and biochemical parameters. Each patient was subjected to routine blood test, serum uric acid, liver function tests, and renal function tests before treatment, after 28 days of treatment, and after 84 days of treatment. The trial combination showed statistically significant improvement in the clinical manifestations, QOL as well as reduction in marker of hyperuricemia, i.e., serum uric acid; the mean serum uric acid at the baseline was 7.76 mg/dL, which was reduced to 6.50 mg/dL after the trial period of 84 days. There was also decrease in the level of VAS score, Patient's Global Assessment Scale score, and Physician's Global Assessment Scale score. There were no impairment in liver function test and renal function test, indicating the good safety profile of trial therapy. Conclusion Hence, Amrita Guggulu and Pinda Taila drug combination is an effective and safe remedy for gouty arthritis (Vatarakta) patients. How to cite this article Singh H, Sannd R, Bhurke LW, Kumari K, Singh R, Vedi SK, Kumar A, Bharti, Rana R, Singhal R, Srikanth N, Padhi MM, Dhiman KS. An Open Label Efficacy Study of Amrita Guggulu and Pinda Taila in the Management of Hyperuricemia in Gout (Vatarakta) Patients. J Res Ayurvedic Sci 2017;1(1):25-33.

Efficacy, Safety, and Tolerability of Fulranumab as an Adjunctive Therapy in Patients With Inadequately Controlled, Moderate-to-Severe Chronic Low Back Pain: A Randomized, Double-blind, Placebo-controlled, Dose-ranging, Dose-loading Phase II Study

PurposeFulranumab is an investigational, fully human recombinant monoclonal antibody (IgG2) that neutralizes the biological actions of human nerve growth factor. Low back pain is a common cause of noncancer chronic pain and represents one of the most significant socioeconomic health-related problems in developed countries. This randomized, double-blind, placebo-controlled study was conducted to evaluate the analgesic effect of fulranumab in patients with moderate-to-severe chronic low back pain. MethodsPatients (aged 18–80 years) were randomized to receive subcutaneous injections every 4 weeks in 1 of 5 parallel treatment groups: placebo or fulranumab 1mg (1mgQ4wk), 3mg (3mgQ4wk), 3mg after a 6mg loading dose (6mgLD+3mgQ4wk), or 10mg (10mgQ4wk) every 4 weeks. FindingsA total of 385 patients (median age, 53 years; women, 54%) received at least 1 injection of study medication. No statistically significant differences were observed in improvement of pain intensity scores between the fulranumab treatment regimens and the placebo group at week 12 (primary end point; mean [SD], placebo: −2.0 [2.17], 1mgQ4wk: −1.9 [2.14], 3mgQ4wk: −2.2 [1.89], 6mgLD+3mgQ4wk: −2.0 [1.72] and 10mgQ4wk: −2.1 [2.18]). Results for secondary efficacy parameters (change in the Oswestry Disability Index, Brief Pain Inventory–Short Form, and Patient Global Assessment scales) were consistent with the primary outcome. A placebo effect was observed; the overall percentage of patients with treatment-emergent adverse events (TEAEs) was similar between the placebo (76%) and fulranumab treatment groups (77%–90%). Across all phases, the most common TEAEs in at least 10% of patients (combined fulranumab group vs placebo) were arthralgia (15% vs 12%), back pain (15% vs 18%), upper respiratory tract infection (15% vs 8%), paresthesia (14% vs 8%), diarrhea (12% vs 4%), headache (12% vs 8%), hypoesthesia (11% vs 5%), pain in extremity (11% vs 8%), sinusitis (10% vs 5%), and nasopharyngitis (10% vs 9%). Across all phases, neurologic TEAEs were less frequent in the placebo group (14%) versus the fulranumab treatment groups (25%). In the posttreatment phase, 8 patients had joint replacement operations, which were considered a result of normal progression of osteoarthritis. One case in the 10-mg group was determined to be rapid progession of osteoarthritis and was considered to be possibly related to study drug. ImplicationsFulranumab did not demonstrate efficacy compared with placebo in patients with chronic low back pain but was generally well-tolerated. ClinicalTrials.gov identifier: NCT00973024.

Sexual dysfunctions and lower urinary tract symptoms in ankylosing spondylitis

To determine sexual dysfunctions and urinary symptoms in male ankylosing spondylitis (AS) patients and their association with various disease and patient factors. In this prospective case control study conducted at a tertiary care teaching institution, 100 males with AS were compared to 100 controls using International Index of Erectile Function-15 (IIEF), International Prostate Symptom Score (IPSS), Hospital Anxiety and Depression Scale (HADS) and a global question for overall relationship with their partners. Bath AS Functional Index (BASFI), visual analogue scale pain scores, patient global assessment scale and Bath AS Disease Activity Index were also assessed in the AS group. Chi-square test, unpaired t-test and univariate and multivariate binary logistic regression analyses were used to analyze the data. Anxiety, depression, erectile dysfunction (ED), orgasmic dysfunction, intercourse dissatisfaction, overall sexual dissatisfaction, altered overall relationship with partner and lower urinary tract symptoms (LUTS) were significantly (P < 0.05) higher in the AS group as compared to controls. Sexual desire, severe LUTS and bothersome LUTS (quality of life score > 2) were not different (P = 0.76, 0.82 and 0.30 respectively) between the two groups. ED was associated with anxiety, depression, longer disease duration, higher BASFI and higher age in AS patients (P = 0.02, 0.001, 0.02, 0.003 and 0.001 respectively). AS is associated with higher incidence of sexual dysfunction in male patients. ED is associated with anxiety, depression, longer duration of disease, higher BASFI score and higher age in AS patients.