Quality Of Life Questionnaire Scores Research Articles

Outcome of Percutaneous Transforaminal Endoscopic Lumbar Decompression for Multisegment Lumbar Spinal Stenosis and the Effect on VAS Scores.

Purpose To investigate the efficacy of percutaneous transforaminal endoscopic lumbar decompression (PTED) in the treatment of multisegment lumbar spinal stenosis (LSS) and its effect on VAS scores. Methods 126 patients with multisegment LSS admitted between August 2017 and August 2021 were selected and divided into the PTED group and the traditional open surgery group (TOS group) according to the different treatment methods. There were 70 cases in the PTED group, treated with PTED, and 56 cases in the TOS group, treated with traditional open surgery. The clinical outcomes, the preoperative and postoperative pain visual analogue scale (VAS), the Oswestry disability index (ODI), the SF-36 quality of life questionnaire scores, the perioperative indicators (operative time, days in hospital, intraoperative blood loss), the postoperative complications, and imaging data were compared between the two groups. Results After the operation, the excellent and good rate in the PTED group (91.43%) was significantly higher than that in the TOS group (75.00%) (P < 0.05). At each time after the operation, the VAS and ODI scores of the two groups were lower than those before the operation, and the VAS scores of the PTED group at 1 day and 3 months after operation were lower than those of the TOS group, and the ODI scores of the PTED group at 3 months after operation were lower than those of the TOS group (P < 0.05). 3 months after the operation, the SF-36 scores in both groups were higher than those before the operation, and those in the PTED group were higher than those in the TOS group (P < 0.05). The operation time and days in hospital in the PTED group were shorter than those in the TOS group, and the intraoperative dominant blood loss and recessive blood loss were less than those in the TOS group (P < 0.05). The total incidence of complications in the PTED group (15.71%) was significantly lower than that in the TOS group (32.14%) (P < 0.05). Conclusion Both PTED and traditional open surgery are effective in treating patients with multisegmental LSS, and both show positive postoperative changes in all indicators, but the former has more promising near -term results in improving lumbar spine pain, function and quality of life than the latter, and has the advantages of less trauma, less bleeding, and fewer complications.

Pilot single-arm study to investigate the efficacy and safety of endovenous Microwave ablations for treatment of varicose veins in Singapore - one year results of the MAESTRO registry.

Aim was to report a prospective two-centre Singaporean experience using Endovenous Microwave Ablation (EMA) to treat symptomatic primary great saphenous vein reflux. We evaluated 1-year safety, efficacy and patient satisfaction. 50 patients (63 limbs; 29 females; mean age 58.0 ± 12.1years) were included. Patients were reviewed at 2-weeks, 3-, 6- and 12-months and underwent Duplex ultrasound assessment. Three quality of life (QoL) questionnaires were completed. The truncal closure rates at 2-weeks, 3-, 6- and 12-months were 63/63 (100%), 59/59 (100%), 58/58 (100%) and 59/60 (98.3%), respectively. There was 100% technical success and no serious adverse events. There were sustained improvement of QoL questionnaire scores from 2weeks to 12months. EMA is a safe and efficacious venous ablative technology at 12 months and is associated with a high rate of target vein occlusion and sustained QoL improvement.

Hailey-Hailey Disease Treated with Individualised Homoeopathy—An Evidence-Based Case Report

AbstractHailey-Hailey disease (HHD) is a rare autosomal dominant skin disorder presented as blistering dermatosis with recurrent erythematous plaques, leading to erosions, fissures and vegetations seen in the skin folds. Prevalence of this disease occurs in 1 to 4 per 100,000 affected between third and fourth decade, mostly either under-reported or misdiagnosed. Under standard conventional treatment, recurrence and remissions are typical. Therefore, it affects the quality of life compared with other skin disorders. However, with the individualised homoeopathic medicine, Psorinum, this rare case was treated without topicals; no recurrence of the complaints and adverse effects were observed in 1 year of follow-up. Furthermore, changes in the dermatology life quality of life questionnaire score from 20 (at baseline) to zero have been noticed; the modified Naranjo criteria for homeopathy total score was +9 out of +13, providing evidence attributed by the intervention. This case report reinforces that individualised homoeopathic intervention is beneficial in rare skin disorders like HHD, and pooling such data will develop future research concepts in this area.

Influence of sex, cigarette smoking and airway inflammation on treatable traits in CBIOPRED severe asthma.

Influence of sex, cigarette smoking and airway inflammation on treatable traits in CBIOPRED severe asthma.

Efficacy and safety of house dust mite sublingual immunotherapy tablets in allergic rhinitis: A systematic review and meta-analysis

BackgroundHouse dust mite (HDM) sublingual immunotherapy (SLIT) tablets have been approved for the treatment of patients with allergic rhinitis (AR). However, the meta-analysis on the efficacy of HDM-SLIT tablets for HDM-induced AR patients remained limited. MethodsFive databases were searched including: PubMed/MEDLINE, EMBASE, Web of Science, the Cochrane Central Register of Controlled Trials, and CINAHL for randomized controlled trials (RCTs) that addressed the efficacy and safetyof HDM-SLIT tablets compared with placebo until January 2022. The primary outcome was a combined symptom and medication score (CSMS) after treatment. ResultsEight eligible RCTs were identified with a total of 3601 patients treated with HDM-SLIT tablets and 2783 patients who received a placebo. The CSMS was significantly lower in the HDM-SLIT tablet group compared with the placebo (standardized mean difference (SMD) −0.28 [95% CI: −0.32 to −0.23]). There was a significant reduction in rhinitis symptom scores, rhinitis medication scores, total combined conjunctivitis scores, and rhinoconjunctivitis quality of life questionnaire scores. The consistent efficacy compared to the placebo has been exhibited over the different kinds and doses of HDM tablets (6 SQ, 12 SQ, 300 IR, and 500 IR) and age groups (>5 years old, adolescents and adults) with low degrees of variability across the studies. There was no significant difference in proportions of participants who were injected with epinephrine between the treatment- and placebo groups. ConclusionsHDM-SLIT tablet is an effective treatment in reducing rhinitis symptoms and medication use in AR patients with favorable safety. They also improve quality of life and conjunctivitis symptoms.

Comparison between a dedicated venous stent and standard composite Wallstent–Z stent approach to iliofemoral venous stenting: Intermediate-term outcomes

ObjectiveDedicated venous stents have not been used in the management of symptomatic chronic iliofemoral venous obstruction (CIVO) until recently. The Bard Venovo stent (Becton, Dickinson, and Co, Franklin Lakes, NJ) is one such stent noted to have an increased chronic outward force and radial resistive force compared with the Wallstent (Boston Scientific, Marlborough, MA). In the present study, we evaluated the outcomes following the use of the Bard Venovo stent vs a matched cohort of limbs that had undergone stenting with the Wallstent–Zenith (Z) stent (Cook Medical Inc, Bloomington, IN) composite configuration. MethodsA review of contemporaneously entered electronic medical record data for 167 patients (167 limbs) with initial iliofemoral stents placed from 2019 to 2020 for quality of life (QOL)-impairing CIVO that had failed conservative therapy was performed. The visual analog scale for pain score (score, 0-10), grade of swelling (score, 0-4), venous clinical severity score (score, 0-27), and the 20-item chronic venous insufficiency quality of life questionnaire instrument for QOL were evaluated before and after intervention to assess the effects of stenting. A Kaplan-Meier analysis was used to examine primary, primary-assisted and secondary stent patency, and analysis of variance with repeated measures was used to compare clinical outcomes. ResultsA total of 167 limbs had undergone Bard Venovo stenting (56 men and 111 women). Their median age was 61 years. The laterality was right and left in 70 and 97 limbs, respectively. Post-thrombotic syndrome was seen in 84 limbs and nonthrombotic iliac vein lesions/May-Thurner syndrome in 83 limbs. At 6 months, the venous clinical severity score had improved from 7 to 4 in the limbs with a unilateral Venovo (UV) stent and from 5 to 4 in the composite Wallstent–Z stent group (P = .9). The grade of swelling had improved from 3 to 1 in the UV group and from 3 to 1 in the composite group (P = .6), and the visual analog scale for pain score had improved from 7 to 2 in the UV group and from 5 to 0 in the composite group (P = .007). At 12 months, ulcers had healed in 53% (8 of 15) of the UV group and 56% (5 of 9) of the composite group (P = .7). The global 20-item chronic venous insufficiency quality of life questionnaire scores had improved from 58 to 28 in the UV group and from 59 to 40 in the composite group (P = .6). The cumulative primary, primary-assisted, and secondary patency at 18 months was 81%, 97%, and 98% in the UV group and 87%, 98%, and 100% in the composite group, respectively (P > .4). No difference in the reintervention rates was noted between the two groups (P = .5). ConclusionsFor patients who had undergone stenting for QOL-impairing CIVO, the results with the Bard Venovo venous stent were comparable to those with the composite Wallstent–Z stent configuration for clinical outcomes, QOL improvement, and stent patency. Further study is, however, required to confirm this improvement in the long term.

The cumulative therapeutic effect of acupuncture in patients with migraine without aura: Evidence from dynamic alterations of intrinsic brain activity and effective connectivity.

We explored the dynamic alterations of intrinsic brain activity and effective connectivity after acupuncture treatment to investigate the underlying neurological mechanism of acupuncture treatment in patients with migraine without aura (MwoA). The Functional Magnetic Resonance Imaging (fMRI) scans were separately obtained at baseline, after the first and 12th acupuncture sessions in 40 patients with MwoA. Compared with the healthy controls (HCs), patients with MwoA mostly showed a decreased dynamic amplitude of low-frequency fluctuation (dALFF) variability in the rostral ventromedial medulla (RVM), superior lobe of left cerebellum (Cerebellum_Crus1_L), right precuneus (PCUN.R), and so on. The decreased dALFF variability of RVM, Cerebellum_Crus1_L, and PCUN.R progressively recovered after the first and 12th acupuncture treatment sessions as compared to the baseline. There was gradually increased dynamic effective connectivity (DEC) variability in RVM outflow to the right middle frontal gyrus, left insula, right precentral gyrus, and right supramarginal gyrus, and gradually enhanced DEC variability from the right fusiform gyrus inflow to RVM. Furthermore, the gradually increased DEC variability was found from Cerebellum_Crus1_L outflow to the left middle occipital gyrus and the left precentral gyrus, from PCUN.R outflow to the right thalamus. These dALFF variabilities were positively correlated with the frequency of migraine attacks and negatively correlated with disease duration at baseline. The dynamic Granger causality analysis (GCA) coefficients of this DEC variability were positively correlated with Migraine-Specific Quality of Life Questionnaire scores and negatively correlated with the frequency of migraine attacks and visual analog scale (VAS) scores after 12th acupuncture sessions. Our results were analyzed by a longitudinal fMRI in the absence of a sham acupuncture control group and provided insight into the dynamic alterations of brain activity and effective connectivity in patients with MwoA after acupuncture intervention. Acupuncture might relieve MwoA by increasing the effective connectivity of RVM, Cerebellum_Crus1_L, and PCUN.R to make up for the decreased dALFF variability in these brain areas.

Clinical and Quality of Life Outcomes Following Temperature-Controlled Radiofrequency Neurolysis of the Posterior Nasal Nerve (RhinAer) for Treatment of Chronic Rhinitis.

BackgroundTemperature-controlled radiofrequency (TCRF) neurolysis of the posterior nasal nerve (PNN; RhinAer) is a minimally invasive treatment option for patients with chronic rhinitis.ObjectiveTo determine clinical outcomes and quality of life (QoL) following TCRF neurolysis of the PNN.MethodsA prospective single-arm study of 129 patients with chronic rhinitis at 16 medical centers in the United States and Germany.ResultsThe mean 24-h reflective total nasal symptom score (rTNSS) improved from 7.8 (95% CI, 7.5-8.1) at baseline to 3.6 (95% CI, 3.2-4.0) at 3 months and continued to improve to 2.9 (95% CI, 2.5-3.3) at 6 months (p < .001 comparing follow-up to baseline and p = .002 comparing 3 and 6 months). This represents 53.8% improvement over baseline at 3 months and 62.8% improvement at 6 months. Rhinorrhea, congestion, sneezing, and itching subscores and postnasal drip and cough scores were all significantly improved over baseline at both timepoints. At 3 months, 76.2% (95% CI, 68.1%-82.8%) of patients achieved a minimal clinically important difference of ≥30% improvement in rTNSS over baseline and the percentage was higher at 6 months (83.5% [95% CI, 75.8%-89.0%]). At 3 months, 80.3% (95% CI, 72.6%-86.3%) reported a minimal clinically important difference of ≥0.4-point improvement in the mini rhinoconjunctivitis quality of life questionnaire score, and the percentage was higher at 6 months; 87.7% (95% CI, 80.7%-92.4%). There were no serious adverse events with a relationship to the device/procedure reported through 6 months.ConclusionIn this large, multicenter study, TCRF neurolysis of the PNN was safe and resulted in a significant reduction in rhinitis symptom burden at 3 months that was sustained/improved through 6 months. The majority of patients reported a clinically relevant improvement in QoL at 3 and 6 months postprocedure.

Is there Really a Lump in My Throat? The Incidence and Implication of Vocal fold Abnormalities in Patients Presenting with Globus

To identify the prevalence of vocal fold abnormalities in patients with a primary complaint of globus sensation. Secondly, to determine the relationship between globus, vocal fold abnormality, and patient-reported quality of life questionnaire score. Retrospective chart review. A retrospective chart review was performed to identify all new patients evaluated at a tertiary academic care laryngology practice between January 2018 and December 2018 presenting with a chief complaint of globus. Variables of interest include age, gender, laryngeal symptoms, self-reported quality-of-life questionnaire results, and laryngostroboscopy findings. Questionnaires selected for this investigation include the reflux symptom index (RSI), eating assessment tool-10 (EAT-10), and voice handicap index-10 (VHI-10). Two hundred twenty-eight subjects with an average age of 54 ±17 years, were categorized based on one of three laryngostroboscopic findings: absence of vocal fold abnormality, vocal fold paresis/paralysis (motion abnormality), or a vocal fold mass lesion. Fifty percent of patients reporting globus had a normal laryngeal exam, and 50% had a mass lesion or motion abnormality. Twenty five percent had vocal fold motion abnormality (paresis, paralysis, or supraglottic squeeze); 19% had a mass lesion; and 3% had both a lesion and motion abnormality. The average self-reported survey scores were compared among the three groups. Patients with dysphonia had a significantly higher VHI-10 (P=0.00), and a significantly higher RSI (P= 0.00) than those without dysphonia. Those patients with dysphagia had significantly higher EAT-10 (P=0.00) and RSI (P=0.02) scores than those who did not have dysphagia. Patients with vocal fold motion abnormality had significantly higher VHI-10 than those with normal vocal fold mobility (P=0.02) CONCLUSIONS: Identifying the etiology of globus presents a significant challenge to laryngologists. Data presented here suggest that vocal fold abnormalities may contribute to the sensation of globus and should therefore be considered in the differential when managing these patients.

Homeopathic Treatment of Nonbullous Impetigo

Impetigo is the most contagious skin infection affecting school-going children and is more prevalent during summer. Impetigo has two types, nonbullous Impetigo (NBI) and bullous Impetigo, of which NBI is the most typical variety caused by Staphylococcus aureus and Group A beta-haemolytic Streptococci or both. The diagnosis is mainly based on the clinical examination and the characteristic appearance of the honey crust formation. In addition, the culture of the pus or bullous fluid may be helpful for the identification of the pathogens. A 14-year-old girl presented with NBI even after taking 1-week conventional treatment for 1 week in vain. However, Mezereum was treated successfully without topicals, complications, or adverse effects. Further, changes in the Dermatology Life Quality of Life questionnaire score from 20 (at the beginning) to zero have been observed: the Modified Naranjo Criteria for Homoeopathy score was +9 out of +13, providing evidence attributed to the intervention. This case report reinforced that homeopathic intervention is beneficial in treating bacterial infections such as NBI, and future pragmatic research needs to strengthen the results.

Bipolar radiofrequency thermotherapy vs. transurethral resection of the prostate: Effect on nocturia as a result of benign prostatic obstruction.

The purpose of this study was to investigate and compare the effects of radiofrequency thermotherapy (RF) thermotherapy and transurethral resection of the prostate (TURP) on nocturia and associated quality of life in patients diagnosed with benign prostatic obstruction (BPO) under medical treatment who have complaints of persistent nocturia. The results of patients who underwent RF thermotherapy and TURP procedures between February 2019 and February 2022 were examined, and their three-month results were compared based on their uroflowmetry values, International Prostate Symptom Score (IPSS) values, nocturia frequency, and Nocturia Quality of Life Questionnaire scores. While the frequency of nocturia in the RF thermotherapy group that was 4.5±1.6 before the procedure decreased to 2.3±1.4 after the procedure (p=0.002), this value in the TURP group decreased from 5.1±2.42 to 3.9±2.1 (p=0.044). RF thermotherapy was found to be more effective than TURP (p<0.005). Significantly, more noticeable improvements were observed in most nocturia-related next-day complaints and nocturia-related concerns in the RF thermotherapy group than the TURP group. It was observed that RF thermotherapy had a more acceptable effect on obstructive complaints in comparison to TURP, and it could be more effective on nocturia and associated quality of life. RF ablation treatment may be offered as an appropriate option to treat nocturia complaints in suitable patients.

Tension-free vaginal mesh for patients with pelvic organ prolapse: mid-term functional outcomes.

ObjectiveWe aimed to evaluate the mid-term efficacy of tension-free vaginal mesh (TVM) for pelvic organ prolapse (POP), and observe the time course of lower urinary tract symptoms and sexual function.MethodsIn this retrospective study, we included 112 female patients who underwent TVM at a single center for stage 2 or higher POP, and replied to questionnaires before, and 2 and 4 years after TVM. We evaluated the anatomical cure rate, prolapse quality of life questionnaire scores, international prostate symptom scores, International Consultation on Incontinence Questionnaire-Short Form scores, and Female Sexual Function Index scores.ResultsThe anatomical cure rate at 4 years was 89%. Voiding and storage symptoms improved in patients after TVM. We found that 25/112 patients had sexual intercourse before TVM, and among them, 15/25 (60%) continued sexual intercourse after TVM. Additionally, of the 87 patients who had no sexual intercourse before TVM, 13 resumed sexual intercourse after TVM.ConclusionCases of TVM have decreased because of the Food and Drug Administration statements concerning mesh problems. However, this study showed relatively favorable mid-term results for lower urinary tract symptoms. Furthermore, sexual activity was restored in some patients, indicating the efficacy of TVM for sexual function.

Abdominal Massage in Functional Chronic Constipation: A Randomized Placebo-Controlled Trial.

The aim of this study was to investigate the effects of abdominal massage on the severity of constipation, bowel function, and quality of life (QoL) in patients with functional chronic constipation in a randomized placebo-controlled design. Seventy-four patients diagnosed with functional constipation according to the Rome IV diagnostic criteria were included. Patients were randomly assigned to the intervention group (abdominal massage plus lifestyle advice) or the control group (placebo therapeutic ultrasound plus lifestyle advice). Abdominal massage or placebo ultrasound was applied for 4weeks. The primary outcome measure was the Constipation Severity Instrument score. Bowel diary data and the Patient Assessment of Constipation Quality of Life Questionnaire score were used as secondary outcome measures. Differences in outcome measures within and between groups were analyzed by repeated-measures analysis of variance. Although constipation severity, bowel function indicators (defecation frequency and duration and stool consistency), and QoL were found to improve significantly over time in both groups, improvements in both primary and secondary outcomes were much more significant in the abdominal massage group. In addition, group × time interaction effects were found to be significant for constipation severity, bowel function findings, and QoL. There were approximately 70% and 28% reductions in constipation severity, 56% and 38% improvement rates in QoL, and 70% and 43% increases in defecation frequency in the intervention and placebo groups, respectively. Abdominal massage should be one of the first-line conservative approaches in the management of functional chronic constipation. Further randomized placebo-controlled studies with long-term follow-up are needed. For functional constipation, which is a common gastrointestinal problem, abdominal massage should be considered as an option in first-line therapy because of its effect beyond the placebo effect. If you have functional constipation, your physical therapist may be able to provide abdominal massage to help reduce your symptoms.

Total versus partial posterior fundoplication in the surgical repair of para-oesophageal hernias: randomized clinical trial.

BackgroundFundoplication is an essential step in para-oesophageal hernia (POH) repair, but which type minimizes postoperative mechanical complications is controversial.MethodsThis was a randomized, double-blind clinical trial conducted between May 2009 and October 2018. Patients with symptomatic POH were allocated to either a total (Nissen) or a posterior partial (Toupet) fundoplication after hernia reduction and crural repair. The primary outcome was dysphagia (Ogilvie dysphagia scores) at 6 months postoperatively. Secondary outcomes were peri- and postoperative complications, swallowing difficulties assessed by the Dakkak dysphagia score, gastro-oesophageal reflux, quality of life (QoL), and radiologically confirmed hernia recurrence.ResultsA total of 70 patients were randomized to a Nissen (n = 32) or a Toupet (n = 38) fundoplication. Compared with baseline, Ogilvie dysphagia scores were stable at the 3- and 6-month follow-up in the Nissen group (P = 0.075 and 0.084 respectively) but significantly improved in the Toupet group (from baseline mean (s.d.): 1.4 (1.1) to 0.5 ( 0.8) at 3 months, and 0.5 (0.6) at 6 months; P = 0.003 and P = 0.001 respectively). At 6 months, Dakkak dysphagia scores were significantly higher in the Nissen group than in the Toupet group (mean (s.d.): 10.4 (7.9) versus 5.1 (7.2); P = 0.003). QoL scores improved throughout the follow-up. However, at 3 and 6 months postoperatively, the absolute median improvement (⍙) from preoperative values in the mental component scores of the Short Form-36 QoL questionnaire was significantly higher in the Toupet group (median (i.q.r.): 7.1 (−0.6 to 15.2) versus 1.0 (−5.4 to 3.3) at 3 months, and 11.2 (1.4 to 18.3) versus 0.4 (−9.4 to 7.5) at 6 months; (P = 0.010 and 0.003 respectively)). At 6 months, radiologically confirmed POH recurrence occurred in 11 of 24 patients (46 per cent) of the Nissen group and in 15 of 32 patients (47 per cent) of the Toupet group (P = 1.001).ConclusionsA partial posterior wrap (Toupet fundoplication) showed reduced obstructive complications and improved QoL compared with a total (Nissen) fundoplication following POH repair.Registration number: NCT04436159 (http://www.clinicaltrials.gov)

Omalizumab for severe atopic dermatitis in 4- to 19-year-olds: the ADAPT RCT

BackgroundEvidence for systemic treatments for severe childhood eczema is limited. Systemic immunosuppressants are unlicensed for use in children and are associated with unwanted side effects.ObjectiveTo examine the role of anti-immunoglobulin E (IgE) [omalizumab (Xolair®, Novartis Pharmaceuticals UK Ltd, Frimley, UK)] in children and young people with severe eczema.DesignA double-blind, placebo-controlled, parallel-arm randomised (1 : 1) trial.SettingA single specialist centre – Guy’s and St Thomas’ NHS Foundation Trust, London.ParticipantsAtopic children and young people (aged 4–19 years) with severe eczema.InterventionsTreatment with omalizumab or placebo for 24 weeks.Main outcome measuresThe primary outcome was eczema severity, measured using the objective SCORing Atopic Dermatitis (SCORAD) at 24 weeks. Secondary outcomes included validated measures of eczema severity, quality of life (QoL) and potent topical steroid use.ResultsSixty-two participants, with a median baseline total IgE level of 8373 kU/l, received treatment with omalizumab (n = 30) or placebo (n = 32). The unadjusted mean objective SCORAD score at week 24 was 43.1 [standard deviation (SD) 12.5] for participants in the omalizumab arm and 49.2 (SD 11.3) for participants in the placebo arm. After adjustment for baseline objective SCORAD score, age and IgE level, the mean difference between arms at 24 weeks was –6.9 [95% confidence interval (CI) –12.2 to –1.5;p = 0.013], in favour of omalizumab. The mean objective SCORAD scores improved by –12.4 and –5.1 in the omalizumab and placebo arms, respectively, by 24 weeks. Secondary outcome measure estimates were also in favour of omalizumab for eczema severity at 24 weeks: the adjusted mean treatment arm difference was –8.3 (95% CI –15.1 to –1.1;p = 0.024) for total combined objective and subjective SCORAD and –6.7 (95% CI –13.2 to –0.1;p = 0.046) for the Eczema Area and Severity Index, with less effect on the Patient-Oriented Eczema Measure (POEM; –1.1, 95% CI –4.6 to 2.4;p = 0.527). Treatment estimate precision was limited by the sample size. The QoL measures favoured omalizumab, with an improvement (reduction) in both (Children’s) Dermatology Life Quality Index [(C)DLQI] score (mean –3.5, 95% CI –6.4 to –0.5;p = 0.022) and Paediatric Allergic Disease Quality of Life Questionnaire score (mean –0.5, 95% CI –0.9 to 0.0;p = 0.050). The mean (C)DLQI score improved by 50%, from 17.0 (SD 5.6) at baseline to 8.5 (SD 5.9) at week 24, for patients treated with omalizumab. Improvements were seen despite lower potent topical steroid use in the omalizumab arm, with 48% more days of use than (109 days in the placebo arm vs. 161 days in the omalizumab arm) and twice the body surface area coverage of (15.5% in the placebo arm vs. 31.3% in the omalizumab arm) the placebo arm. There were fewer treatment failures and new systemic immunosuppression initiations in the omalizumab arm. There was no difference in the numbers of cases of infective eczema and eczema exacerbation. There was one suspected severe adverse reaction in the omalizumab arm. In each arm, six participants reported a total of seven severe adverse events that were unrelated to treatment. Non-serious respiratory and dermatological adverse event rates were higher in the placebo arm (incidence rate ratio 0.69, 95% CI 0.49 to 0.96).ConclusionsOmalizumab, in a highly atopic paediatric population with severe eczema, reduced eczema severity and improved QoL despite a reduction in potent steroid use and highly elevated total IgE levels. Omalizumab, with its favourable side effect profile, warrants further study as a treatment option for this difficult-to-manage population. Further studies are needed to clarify the role of omalizumab. Treatment benefit became more apparent towards 24 weeks and persisted after treatment stopped. The optimal duration of treatment needs to be determined.Trial registrationThis trial is registered as ISRCTN15090567, EudraCT 2010-020841-29 and ClinicalTrials.gov NCT02300701.FundingThis project was funded by the Efficacy and Mechanism Evaluation programme, a Medical Research Council and National Institute for Health and Care Research (NIHR) partnership. This will be published in full inEfficacy and Mechanism Evaluation; Vol. 9, No. 5. See the NIHR Journals Library website for further project information. A grant from the Guy’s and St Thomas’ Charity supported the Atopic Dermatitis Anti-IgE Paediatric Trial (ADAPT). Omalizumab and the placebo were supplied by Novartis Pharmaceuticals UK Ltd.

Clinical and Immunologic Changes due to Subcutaneous Immunotherapy With Cat and Dog Extracts Using an Ultrarush Up-Dosing Phase: AReal-Life Study.

We aimed to evaluate the efficacy of and immunologic changes caused by subcutaneous immunotherapy (SCIT) in patients with allergy to cat and dog. The study population comprised patients with rhinitis and/or asthma and allergy to cat or dog from a previous safety study. All patients had specific IgE to cat and/or dog. The SCIT maintenance dose was administered using an infusion pump over a single 4-hour session, followed by monthly administration over 6 months. Data were gathered on clinical outcomes, pulmonary function, FeNO, rhinitis and asthma symptoms, quality of life (QOL), and scores for the Asthma Control Test and symptom visual analog scale were recorded at baseline and then at 1, 3, and 6 months. Specific IgE and IgG antibody responses to cat and dog allergens were determined. The study population comprised 61 patients with a mean age of 35.6 (9.7) years, of whom 40 underwent SCIT for at allergy. A significant improvement was observed in rhinitis and asthma symptoms and in QOL, use of medication, visual analog scale score, and Asthma Control Test score at 1 month; these improvements persisted at month 6. The clinical improvement with cat extract was significantly more marked than with dog extract. Nearly half of the patients (49.09%) had an increase of >0.9 in the ESPRINT-15 QOL in allergic rhinitis questionnaire, and 58.18% had an increase of >0.5 in the Asthma Quality of Life Questionnaire score at month 6. Both differences represent the minimal clinical important difference. A significant increase was observed in specific IgG and IgE to different allergens at 3 and/or 6 months. Ultrarush SCIT with cat and dog extracts has substantial clinical value for many patients.

Efficacy of Endoscopic and Surgical Treatments for Gastroesophageal Reflux Disease: A Systematic Review and Network Meta-Analysis.

Although various endoscopic and surgical procedures are available for the treatment of gastroesophageal reflux disease (GERD), the comparative efficacy of these treatments has not been fully elucidated. This study aimed to comprehensively evaluate the efficacy of various endoscopic and surgical treatments for GERD. All relevant randomized controlled trials published through August 2021 that compared the efficacy of endoscopic and surgical GERD treatments, including radiofrequency energy delivery, endoscopic plication, reinforcement of the lower esophageal sphincter (LES), and surgical fundoplication, were searched. A network meta-analysis was performed to analyze treatment outcomes, including the requirement of proton pump inhibitor (PPI) continuation and GERD-health-related quality of life questionnaire score (GERD-HRQL). As such, 25 studies with 2854 patients were included in the analysis. Endoscopic plication, reinforcement of the LES, and surgical fundoplication were effective in reducing the requirement of PPI continuation compared to PPI therapy (pooled risk ratio (RR) (95% confidence interval [CI]): endoscopic plication, 0.34 (0.21–0.56); reinforcement of LES, 0.32 (0.16–0.63), and surgical fundoplication, 0.16 (0.06–0.42)). Radiofrequency energy delivery tended to reduce the requirement of PPI continuation compared to PPI therapy (RR (95% CI): 0.55 (0.25–1.18)). In terms of GERD-HRQL, all endoscopic and surgical treatments were superior to PPI therapy. In conclusion, all endoscopic or surgical treatments, except radiofrequency energy delivery, were effective for discontinuation of PPI medication, especially surgical fundoplication. Quality of life, measured by GERD-HRQL, also improved in patients who underwent endoscopic or surgical treatment compared to those who received PPI therapy.

Inhibition of Prekallikrein for Hereditary Angioedema

BackgroundHereditary angioedema is characterized by recurrent and unpredictable swellings that are disabling and potentially fatal. Selective inhibition of plasma prekallikrein production by antisense oligonucleotide treatment (donidalorsen) may reduce the frequency of attacks and the burden of disease.MethodsIn this phase 2 trial, we randomly assigned, in a 2:1 ratio, patients with hereditary angioedema with C1 inhibitor deficiency to receive four subcutaneous doses of either donidalorsen (80 mg) or placebo, with one dose administered every 4 weeks. The primary end point was the time-normalized number of investigator-confirmed angioedema attacks per month (attack rate) between week 1 (baseline) and week 17. Secondary end points included quality of life, as measured with the Angioedema Quality of Life Questionnaire (scores range from 0 to 100, with higher scores indicating worse quality of life), and safety.ResultsA total of 20 patients were enrolled, of whom 14 were randomly assigned to receive donidalorsen and 6 to receive placebo. The mean monthly rate of investigator-confirmed angioedema attacks was 0.23 (95% confidence interval [CI], 0.08 to 0.39) among patients receiving donidalorsen and 2.21 (95% CI, 0.58 to 3.85) among patients receiving placebo (mean difference, −90%; 95% CI, −96 to −76; P<0.001). The mean change from baseline to week 17 in the Angioedema Quality of Life Questionnaire score was −26.8 points in the donidalorsen group and −6.2 points in the placebo group (mean difference, −20.7 points; 95% CI, −32.7 to −8.7). The incidence of mild-to-moderate adverse events was 71% among patients receiving donidalorsen and 83% among those receiving placebo.ConclusionsAmong patients with hereditary angioedema, donidalorsen treatment resulted in a significantly lower rate of angioedema attacks than placebo in this small, phase 2 trial. (Funded by Ionis Pharmaceuticals; ISIS 721744-CS2 ClinicalTrials.gov number, NCT04030598.)

Effect of Bifidobacterium longum 35624 on disease severity and quality of life in patients with irritable bowel syndrome.

BACKGROUND Bifidobacterium longum 35624 has shown efficacy in improving irritable bowel syndrome (IBS) symptoms compared with placebo in double-blind randomized studies. However, few data are available from real-life clinical practice or from studies that used Rome IV criteria to diagnose IBS.AIMTo assess the effect of B. longum 35624 on IBS severity and quality of life in a real-life setting. METHODSFrom November 2018 to January 2020, 278 patients with IBS (according to Rome IV criteria) were enrolled in a prospective, open-label, multicenter observational study by private practice gastroenterologists to received one capsule of B. longum 35624 (109 colony-forming units) per day for 30 d. Participation in the study was independently proposed to patients during spontaneous consultations. Disease severity (assessed by the IBS severity scoring system) and patient quality of life (assessed by the IBS quality of life questionnaire) were compared between the inclusion visit (baseline) and the visit at the end of 30 d of treatment. The characteristics of patients were described at baseline. Continuous variables comparisons between inclusion and end-of-treatment visits were performed using the t-test and Kruskal-Wallis test. Categorical variables comparisons were performed using the χ2 test.RESULTSA total of 233 patients, with a mean age of 51.4 years and composed of 71.2% women, were included in the study. Of these patients, 48.1% had moderate IBS and 46.4% had severe IBS. After a 30-d treatment period with one B. longum 35624 capsule per day, a significant decrease in IBS severity was observed compared to baseline (mean ± SD, IBS severity scoring system scores: 208 ± 104 vs 303 ± 81, P < 0.001) and 57% of patients moved to lower severity categories or achieved remission. The quality of life of patients was also improved by the treatment (IBS Quality of Life questionnaire score: 68.8 ± 20.9 vs 60.2 ± 20.5; P < 0.001) and 63.8% of patients were satisfied with the treatment.CONCLUSIONThirty days of treatment with B. longum 35624 reduces disease severity and improves the quality of life of patients with IBS, particularly those with the most severe forms of IBS.

Efficacy and safety of acupuncture on oligomenorrhea due to polycystic ovary syndrome: An international multicenter, pilot randomized controlled trial.

Background:Polycystic ovary syndrome (PCOS) is one of the most common disorders of reproductive endocrinology affecting women of reproductive age. Our study aims to explore the feasibility of a full-scale trial to evaluate the efficacy and safety of acupuncture for PCOS.Methods:This study is a two-armed, parallel, multi-country, multi-center, pilot randomized controlled trial (RCT) for PCOS with oligomenorrhea. We will recruit 60 women aged 20 to 40 years with oligomenorrhea due to PCOS. The participants will be randomly assigned to acupuncture and control groups. The acupuncture group will undergo a total of 40 sessions for 16 weeks with usual care. The control group will be managed with usual care (regular meals, sufficient sleep, and appropriate exercise) only. The primary clinical outcome is mean change in menstrual frequency from baseline to 16 weeks and 32 weeks (follow-up) after the start of the trial. The secondary outcomes are menstrual period, levels of estradiol, luteinizing hormone (LH), follicle-stimulating hormone (FSH), and total testosterone, LH/FSH ratio, antral follicle count and ovarian volume, body mass index, waist hip ratio, acne severity, and health-related quality of life questionnaire scores at 16 and 32 weeks after the start of the trial.Discussion:This is the first protocol for multi-country, multi-center RCTs for PCOS in Korea and China. The control group in this study will be subjected to usual care (regular meals, enough sleep, and appropriate exercise). The results of this study will provide evidence for future clinical decisions and guidelines.This trial has been registered at ClinicalTrials.gov (Identifier: NCT04509817).