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Total Symptom Score (total + symptom_score)
Selected AbstractsTreatment of symptomatic diabetic polyneuropathy with the antioxidant ,-lipoic acid: a meta-analysisDIABETIC MEDICINE, Issue 2 2004D. Ziegler Abstract Aims To determine the efficacy and safety of 600 mg of ,-lipoic acid given intravenously over 3 weeks in diabetic patients with symptomatic polyneuropathy. Methods We searched the database of VIATRIS GmbH, Frankfurt, Germany, for clinical trials of ,-lipoic acid according to the following prerequisites: randomized, double-masked, placebo-controlled, parallel-group trial using ,-lipoic acid infusions of 600 mg i.v. per day for 3 weeks, except for weekends, in diabetic patients with positive sensory symptoms of polyneuropathy which were scored by the Total Symptom Score (TSS) in the feet on a daily basis. Four trials (ALADIN I, ALADIN III, SYDNEY, NATHAN II) comprised n = 1258 patients (,-lipoic acid n = 716; placebo n = 542) met these eligibility criteria and were included in a meta-analysis based on the intention-to-treat principle. Primary analysis involved a comparison of the differences in TSS from baseline to the end of i.v. Treatment between the groups treated with ,-lipoic acid or placebo. Secondary analyses included daily changes in TSS, responder rates (, 50% improvement in TSS), individual TSS components, Neuropathy Impairment Score (NIS), NIS of the lower limbs (NIS-LL), individual NIS-LL components, and the rates of adverse events. Results After 3 weeks the relative difference in favour of ,-lipoic acid vs. placebo was 24.1% (13.5, 33.4) (geometric mean with 95% confidence interval) for TSS and 16.0% (5.7, 25.2) for NIS-LL. The responder rates were 52.7% in patients treated with ,-lipoic acid and 36.9% in those on placebo (P < 0.05). On a daily basis there was a continuous increase in the magnitude of TSS improvement in favour of ,-lipoic acid vs. placebo which was noted first after 8 days of treatment. Among the individual components of the TSS, pain, burning, and numbness decreased in favour of ,-lipoic acid compared with placebo, while among the NIS-LL components pin-prick and touch-pressure sensation as well as ankle reflexes were improved in favour of ,-lipoic acid after 3 weeks. The rates of adverse events did not differ between the groups. Conclusions The results of this meta-analysis provide evidence that treatment with ,-lipoic acid (600 mg/day i.v.) over 3 weeks is safe and significantly improves both positive neuropathic symptoms and neuropathic deficits to a clinically meaningful degree in diabetic patients with symptomatic polyneuropathy. Diabet. Med. 21, 114,121 (2004) [source] Agreement of efficacy assessments for five-grass pollen sublingual tablet immunotherapyALLERGY, Issue 1 2009A. Didier Background:, The optimal dose of five-grass pollen sublingual tablet immunotherapy (SLIT) was established recently by the primary criteria Rhinoconjunctivitis Total Symptom Score (RTSS) from the first treatment season. Secondary and exploratory criteria, such as RTSS at peak pollen season, exploratory combined symptom and rescue medication use score, quality of life and immunological markers are calculated and described in this analysis. Methods:, Six hundred and twenty-eight patients with grass pollen rhinoconjunctivitis (,2 years duration) were randomized in a double-blind, placebo-controlled trial conducted in Europe. Patients received once-daily SLIT (Stallergenes, Antony, France) of 100IR, 300IR, 500IR or placebo, starting 4 months before grass pollen season and throughout the 2005 season. Patients were instructed to take rescue medication only if symptoms were severe and record symptom severity on using the RTSS. Results:, Both 300IR and 500IR doses significantly reduced mean RTSS at pollen peak (P = 0.0005 and P = 0.0014, respectively) and the exploratory combined score (P = 0.0001 and P = 0.0026, respectively) compared with placebo. Compared with patients in the placebo group, those who were taking the 300IR and 500IR doses reported significantly improved quality of life using the mean Rhinoconjunctivitis Quality of Life Questionnaire scores during the peak of the pollen season (P < 0.0001) and at the end of the pollen season (P = 0.0031 and P , 0.0001, respectively). Specific immunoglobulin G4 increased significantly depending on the SLIT dose (P < 0.0001). Conclusions:, All secondary efficacy criteria, including efficacy at pollen peak, combined score, quality of life and immunological changes, indicate that 300IR tablets represent the optimal dose and suggest it is appropriate for use in clinical practice. [source] Laparoscopic Heller myotomy with Dor fundoplication for achalasia: long-term outcomes and effect on chest painDISEASES OF THE ESOPHAGUS, Issue 4 2010A. Sasaki SUMMARY The aim of the present study was to evaluate the long-term outcomes of laparoscopic Heller myotomy with Dor fundoplication (LHD) and its effect on chest pain. Between June 1995 and August 2009, a total of 35 patients with achalasia underwent an LHD. The symptom scores were calculated by combining the frequency and the severity. Pre- and postoperative evaluations included symptom score, radiology, manometry, and 24-hour pH manometry. Median total symptom score was significantly lower than the preoperative score (19 vs 4, P < 0.001) at a median follow-up of 94 months. Among the 35 patients, 18 (51%) had chest pain. The frequency of chest pain was similar for the pre- and postoperative scores, but the severity tended to be less. Median esophageal diameter (5.4 cm vs 3.5 cm, P < 0.001) and lower esophageal sphincter pressure (41 mmHg vs 8.9 mmHg, P < 0.001) were significantly reduced after surgery. Median age, duration of symptoms, esophageal diameter, and lower esophageal sphincter pressure were similar between patients with and without chest pain prior to surgery. No significant differences were observed between the two groups in terms of amplitude, duration, and frequency of contractions from the findings of postoperative 24-hour esophageal manometry. Chest pain resolved in three patients (17%) and improved in seven patients (39%) after surgery. LHD can durably relieve achalasic symptoms of both dysphagia and regurgitation, and it can be considered the surgical procedure of choice. However, achalasic chest pain does not always seem to be related with patient characteristics and manometric findings. [source] Menstrual cycle symptoms are associated with changes in low-grade inflammationEUROPEAN JOURNAL OF CLINICAL INVESTIGATION, Issue 1 2006J. J. Puder Abstract Background, A close link between mood, low-grade inflammation and obesity has been demonstrated even in healthy subjects. We investigated the relationship between changes in physical and psychological symptoms and inflammatory markers during the menstrual cycle both in normal weight and in overweight women. Materials and methods, Eight healthy normal weight (body mass index 21·6 ± 1·9 kg m,2) and seven overweight (body mass index 30 ± 2·4 kg m,2) young women with normal ovarian function and with no premenstrual syndrome were assessed 15 times throughout their menstrual cycle. At each time point fasting blood was drawn and symptoms were recorded using the Freeman Daily Symptom Record. Results, Independent of weight status, the serum concentrations of highly sensitive C-reactive protein (hs-CRP) and the total scores, in addition to the individual four factors (mood, behaviour, pain and physical symptoms), of the Daily Symptom Record varied significantly during the menstrual cycle (all P , 0·04) and paralleled each other. During the menstrual cycle, repeated hs-CRP serum concentrations correlated to the corresponding total symptom score and the factors mood, behaviour and physical symptoms, independent of both weight status and changes in circulating gonadal steroids (all P , 0·04). These associations were not observed for tumour necrosis factor-, serum levels. The mean hs-CRP concentrations were associated with the mean total symptom score, independent of weight status (r = 0·56, P = 0·04). Conclusion, Healthy young women showed psychological and physical symptoms during the menstrual cycle which changed in association with alterations in low-grade inflammation and which were independent of body weight or plasma levels of gonadal steroids. [source] Comparison of the efficacy and safety of bilastine 20 mg vs desloratadine 5 mg in seasonal allergic rhinitis patientsALLERGY, Issue 1 2009C. Bachert Background:, Bilastine is a novel, nonsedating H1 -antihistamine developed for symptomatic treatment of Allergic Rhinitis and Chronic Idiopathic Urticaria. The objective of this study was to compare the efficacy and safety of bilastine 20 mg vs placebo and desloratadine 5 mg in subjects with seasonal allergic rhinitis (SAR). Methods:, This randomized, double blind, placebo-controlled, parallel-group multicentre study evaluated the effect of 2 weeks' treatment with bilastine 20 mg, desloratadine 5 mg or matched placebo once daily, in 12,70 years old symptomatic SAR patients. All subjects assessed the severity of nasal (obstruction, rhinorrhoea, itching, and sneezing) and nonnasal (ocular itching, tearing, ocular redness, itching of ears and/or palate) symptoms on a predetermined scale to provide a total symptom score (TSS), composed of nasal and nonnasal symptom scores (NSS and NNSS, respectively). The primary efficacy measure was the area under the curve (AUC) for the TSS over the entire treatment period. Results:, Bilastine 20 mg significantly reduced the AUC of TSS to a greater degree from baseline compared to placebo (98.4 with bilastine vs 118.4 with placebo; P < 0.001), but not compared to desloratadine 5 mg (100.5). Bilastine 20 mg was not different from desloratadine 5 mg but significantly more effective than placebo in improving the NSS, NNSS, and rhinitis-associated discomfort scores (P < 0.05), and rhinoconjunctivitis quality of life questionnaire total (P < 0.005) and four out of seven individual domain (P < 0.05) scores. The incidence of treatment emergent adverse events was similar for bilastine (20.6%), desloratadine (19.8%), and placebo (18.8%). Conclusion:, Bilastine 20 mg once daily was efficacious, safe and not different from desloratadine 5 mg once daily in the treatment of SAR symptoms. [source] Use of Spinal Cord Stimulation in the Treatment of Phantom Limb Pain: Case Series and Review of the LiteraturePAIN PRACTICE, Issue 5 2010Ashwin Viswanathan MD Abstract Introduction: Despite technical advances in spinal cord stimulation (SCS), there is a paucity of recent literature regarding SCS for phantom limb pain. Methods: Between January 2003 and May 2008, four patients at M.D. Anderson Cancer Center underwent SCS for intractable phantom limb pain. A retrospective chart review was performed to assess outcomes and complications. A PubMed search was performed to review previously published series regarding the efficacy of SCS for phantom limb pain. Results: Postoperatively, all patients subjectively reported excellent pain relief (>80%). Patients were all followed with the Brief Pain Inventory. Patients 1 to 3 each reported a two-point decrease in their usual amount of pain using the numerical rating scale. Patient 4's numerical pain scale was unchanged. When using an 11-point scale to assess other symptomology along 10 dimensions, patients 1 to 3 demonstrated a decrease in their total symptom score by 13, 14, and 4 points, respectively. Patient 4 reported an increase by 5 points in his total symptom score. With regard to complications, patient 2 developed an allergic dermatitis to the generator requiring revision with a polyfluoroethylene (GorTex) pouch. Patient 3 developed a surgical site infection after an implantable pulse generator change. Patients 2 to 4 were very satisfied with their stimulator and would choose to undergo implantation again, with patient 1 having an equivocal response. Conclusions: For selected patients who have not obtained adequate relief with medical management, SCS for phantom limb pain can prove an effective intervention.,, [source] Safety and efficacy of oral fexofenadine in children with seasonal allergic rhinitis , a pooled analysis of three studiesPEDIATRIC ALLERGY AND IMMUNOLOGY, Issue 3 2004Eli O. Meltzer Allergic rhinitis is one of the most common clinical conditions in children; however, data regarding the safety of antihistamines in children with seasonal allergic rhinitis are limiting. To evaluate the safety and efficacy of fexofenadine in children with seasonal allergic rhinitis, data were pooled from three, double-blind, randomized, placebo-controlled, parallel-group, 2-week trials in children (6,11 year) with seasonal allergic rhinitis. All studies assessed fexofenadine HCl 30 mg b.i.d.; two studies included fexofenadine HCl at 15 and 60 mg b.i.d. Patients (and investigators) reported any adverse events during the trial. Physical examinations, including measurements of vital signs and laboratory tests, were performed. Efficacy assessments (total symptom score and individual symptom scores) were evaluated. Exposure to fexofenadine HCl 30 mg b.i.d. and to any fexofenadine dose exceeded 10,000 and 17,000 patient days, respectively. Incidences of adverse events, and discontinuations because of adverse events, were low and similar across treatment groups. In the placebo group, 24.4% of subjects reported adverse events compared with 24.1% for fexofenadine HCl 30 mg b.i.d., and 28.4% for all fexofenadine-treated groups. The most common adverse event overall was headache (4.3% placebo; 5.8% fexofenadine HCl 30 mg b.i.d.; and 7.2% any fexofenadine doses). Treatment-related adverse events were similar across treatment groups with no sedative effects. Fexofenadine HCl 30 mg b.i.d. was significantly superior to placebo in reducing the total symptom score and all individual seasonal allergic rhinitis symptoms, including nasal congestion (p < 0.05). Fexofenadine, at doses of up to 60 mg b.i.d., is safe and non-sedating, and fexofenadine HCl 30 mg b.i.d. effectively reduces all seasonal allergic rhinitis symptoms in children aged 6,11 years. [source] Rupatadine in the treatment of chronic idiopathic urticaria: a double-blind, randomized, placebo-controlled multicentre studyALLERGY, Issue 5 2007A. Gimenez-Arnau Background:, Chronic urticaria is one of the most common and disturbing cutaneous condition. The treatment of chronic idiopathic urticaria (CIU) is still a challenge. Antihistamines are recommended as first-line treatment. Rupatadine is a new potent nonsedative anti-H1. Objective:, To study rupatadine efficacy and safety for moderate to severe CIU treatment. Methods:, This randomized, double-blind, placebo-controlled, parallel-group, multicentre, study was designed to assess primarily mean pruritus score (MPS) reduction with rupatadine, 10 and 20 mg, administered once daily for 4 weeks. Three hundred and thirty-three patients with active episodes of moderate-to-severe CIU were included. Results:, A 57.5% (P < 0.005) and 63.3% (P = 0.0001) significative MPS reduction from baseline, was observed at week 4 with 10 and 20 mg rupatadine, respectively, compared with placebo (44.9%). Both doses of rupatadine were not significantly different at any time point, with respect to their effects on pruritus severity, number of wheals and total symptoms scores. Rupatadine 10 mg had an overall better adverse event profile. Conclusion:, Rupatadine 10 mg is a fast, long-acting, efficacious and safe treatment option for the management of patients with moderate-to-severe CIU. [source] | ||||||||||