Improvement In Total Symptom Score Research Articles

A pre-seasonal birch/hazel sublingual immunotherapy can improve the outcome of grass pollen injective treatment in bisensitized individuals. A case-referent, two-year ontrolled study

BackgroundThe study tests the hypothesis of a reduction of priming due to tree allergy in patients sensitised to both birch/hazel and grass pollen undergoing an associated preseasonal Sublingual/Injective immunotherapy Methods36 out of 49 bisensitized candidates were pair-matched into 18 case-referent couples. During two years all patients were administered preseasonal grass-SIT and one patient in each couple received also birch/hazel-SLIT. Diary cards were fulfilled for three consecutive grass pollen seasons. Specific Nasal Provocation Test (NPT) for grass and aspecific bronchial challenge were done; sera were analyzed for specific IgE and IgG ResultsDuring the peak of the grass pollen season both groups showed a significant improvement in total symptom-score. Conjunctivitis and cough improved significantly more in patients with associated therapies. While antihistamine score decreased significantly in both groups, antiasthmatics did only in the SLIT-SIT group. The follow-up documented a significant increase in grass- and birch-specific IgG and a decrease in grass-specific IgE. Grass-NPT threshold was clearly higher in SLIT-SIT-group (p = 0.01) and only in this group PD20 methacholine improved significantly (p < 0.05) ConclusionsCombined birch/hazel-SLIT and grass-SIT are safe and improve clinical outcomes of SIT alone in young bisensitized patients. Priming reduction is supported by specific NPT and bronchial hyperresponsiveness

Finasteride in the treatment of clinical benign prostatic hyperplasia: a systematic review of randomised trials.

BackgroundBenign prostatic hyperplasia affects older men. This systematic review determined efficacy and adverse effects of finasteride.Review methodsPubMed, the Cochrane Library, reference lists of reports, and reviews were searched for randomised, double-blind trials of finasteride in benign prostatic hyperplasia. Outcomes included symptom score, urinary flow rate, prostate volume, discontinuation, and adverse effects. Relative risk and NNT or NNH were calculated for dichotomous data. Sensitivity analyses assessed influences of baseline symptom severity, initial prostate volume, a dominating trial, and previous interventions.ResultsThree trials had active controls and 19 had placebo. In placebo-controlled trials, 8820 patients received finasteride 5 mg and 5909 placebo over 3–48 months. Over 48 months finasteride produced greater improvements in total symptom score, maximum urinary flow rate, and prostate volume. Significantly more sexual dysfunction, impotence, ejaculation disorder and decreased libido occurred with finasteride at 12 months; the NNH for any sexual dysfunction at 12 months was 14. Significantly fewer men treated with finasteride experienced acute retention or had surgery at 24 or 48 months than with placebo; at 12 months the NNT was 49 (31 to 112) to avoid one acute urinary retention and 31 (21 to 61) to avoid one surgery. Sensitivity analyses showed benefit with finasteride 5 mg to be constant irrespective of the initial prostate volume.ConclusionsInformation from many patients in studies of high quality showed beneficial effects of finasteride in terms of symptoms, flow rate and prostate volume. More utility would result if patient centred outcomes were reported in dichotomous form.

Domperidone in the management of symptoms of diabetic gastroparesis: efficacy, tolerability, and quality-of-life outcomes in a multicenter controlled trial

The purpose of this clinical study was to determine the efficacy, tolerability, and impact on quality of life of domperidone—a specific peripherally acting dopamine antagonist—in the management of symptoms of gastroparesis, a common and potentially debilitating condition in patients with diabetes mellitus. In the first phase of this multicenter, two-phase withdrawal study, 287 diabetic patients with symptoms of gastroparesis of at least 6 months' duration received domperidone 20 mg QID in a single-masked fashion for 4 weeks. Efficacy was evaluated using a four-point rating scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) for each of the following symptoms: nausea, abdominal distention/bloating, early satiety, vomiting, and abdominal pain. At the end of the first phase, patients with sufficient improvement in their total symptom score (a score ≤6 and a decrease in score of ≥5 units from the baseline [selection] visit) were eligible for the 4-week, randomized, placebo-controlled, double-masked withdrawal phase of the study. The impact of domperidone on quality of life was determined using the Medical Outcomes Study Short Form-36 (SF-36). Of 269 patients with data from the single-masked phase, 208 (77%) qualified for entry into the double-masked phase based on a statistically significant improvement in total symptom score, from a mean score of 10.32 at baseline (initial visit) to 3.79 after 4 weeks of single-masked domperidone therapy. During the double-masked phase, patients in the placebo group had significantly greater deterioration in total symptom scores compared with patients in the domperidone group (mean changes of 1.84 and 0.85, respectively). Similar significant differences in favor of domperidone were seen in the secondary efficacy variables (ie, patients' diary scores and global assessments of symptoms). The tolerability profile of domperidone was similar to that of placebo. Patients who responded to domperidone experienced significant improvements in quality of life, as indicated by the SF-36 physical and mental component summary scores. During the double-masked phase, patients who were randomized to placebo experienced a significant deterioration in the physical component summary score compared with patients in the domperidone group. The results of this study suggest that domperidone 20 mg QID provides significant improvement in the upper gastrointestinal symptoms of diabetic gastroparesis and is well tolerated in patients with this condition.

Intranasal Fluticasone Once Daily Compared with Once-Daily Cetirizine in the Treatment of Seasonal Allergic Rhinitis

The efficacy and tolerability of fluticasone aqueous nasal spray, 200µg once daily for 21 days, was compared with cetirizine, 10mg once daily for 21 days, in a multicentre, randomised, double-blind, double-dummy, parallel group study. 237 evaluable patients aged 12 years and above, with seasonal allergic rhinitis (defined as having a positive skin test and a total symptom score of ≥ 6/15), received either fluticasone aqueous nasal spray (n = 119) or cetirizine (n = 118). Improvement in total symptom score was observed in patients from both treatment groups, with the improvement in the fluticasone treatment group being significantly greater (decrease in total symptom score from 9.23 to 2.13) than in the cetirizine treatment group (decrease in total symptom score from 9.36 to 4.31; p < 0.001). There was also a significantly greater improvement in the number of symptom-free days for all symptoms in favour of fluticasone aqueous nasal spray compared with cetirizine (p < 0.001). Furthermore, the percentage of days when patients did not require terfenadine as rescue therapy was significantly greater in the fluticasone group (87%) than in the cetirizine group (80%; p < 0.05). Five adverse events were reported during intranasal fluticasone treatment and 10 adverse events were reported during cetirizine therapy. There were no treatment-related withdrawals from therapy in the fluticasone group, but 5 treatment-related withdrawals were reported in the cetirizine group.This study demonstrated that fluticasone aqueous nasal spray, 200µg once daily, was significantly more effective than cetirizine, 10mg once daily, and had comparable (if not better) tolerability, in the treatment of seasonal allergic rhinitis.

Antihistamines and the common cold. A review and critique of the literature.

To determine if antihistamines provided clinically significant relief from the symptoms of the common cold. Structured literature review following standardized guidelines of primary studies published after 1975. Improvements in symptom scores for total symptoms and nasal symptoms over the first three days of a common cold. Three of five studies reporting on sneezing found a statistically significant improvement in the antihistamine group; similarly, three of seven studies reporting on nasal discharge found a statistically significant improvement with therapy. No study reported improvement in total symptom score at the level of p < .05. The validity of these findings was weakened by several flaws in the literature such as inattention to clinical significance and functional impact, inappropriate use of statistical tests, and poorly described methodology. The clinical significance of these improvements was not demonstrated. The primary literature offers little support for the use of antihistamines in the common cold.

Optimization of transurethral hyperthermia: Number of treatments

Objective. The optimal number of transurethral microwave hyperthermia (TUHT) treatments in patients with moderate to severe symptoms of benign prostatic hyperplasia (BPH) is not known. This study was designed to compare TUHT efficacy with the use of three versus six treatments. Methods. In a Phase II prospective trial during a three-month period, 28 poor surgical risk patients with moderate to severe prostatism were randomized to receive three or six TUHT sessions. TUHT treatments were given on an outpatient basis without sedation or anesthesia for sixty minutes at 915 MHz with the temperature controlled on the urethral surface at 45°C. Results. Subjective improvement was obtained in 7 (50%) patients receiving three TUHT treatments and in 12 (86%) patients receiving six treatments. A greater degree of improvement in total symptom score (P = 0.01) and obstructive (P = 0.01) and irritative (P = 0.04) symptoms was also recorded in the 14 patients receiving six treatments compared to those treated with three TUHT sessions (P = 0.01). A posttreatment improvement in objective study parameters was recorded for both treatment groups. The 14 patients treated with six TUHT sessions, however, showed a better improvement in peak flow rates (51 % vs. 8.4%, P = 0.003) and postvoiding residual volume compared to the 14 patients treated with three TUHT sessions (P = 0.10). Treatments were very well tolerated and no clinically significant toxicity was recorded. Of the 9 study patients who failed to respond to treatment, 1 patient was successfully retreated with TURP while 8 patients required an indwelling catheter. Conclusions. In TUHT in poor surgical risk patients with BPH with the temperature controlled at 45°C, six treatments were superior to three treatments, based on a higher incidence of subjective and objective improvement.

Improvement in autonomic and gastric function following pancreas-kidney versus kidney-alone transplantation and the correlation with quality of life.

We conducted a series of studies to document changes in autonomic and gastrointestinal function following pancreas-kidney and kidney-alone transplantation, define how autonomic function is associated with quality of life, and identify how transplantation alters the quality of life of diabetic transplant recipients. Uremic type I diabetic patients receiving combined pancreas-kidney (n = 23) or kidney-alone (n = 16) transplants completed pre- and 12-month-posttransplant evaluation of vasomotor function (total capillary pulse amplitude, capillary vasoconstriction response to cold, capillary response to postural adjustments), cardiac function (R-R interval variation, valsalva ratio), overall autonomic function (total autonomic score, autonomic index), gastric function (cutaneous electrogastrography, gastric emptying, total gastrointestinal symptoms score), and quality of life (sickness impact profile). Kidney recipients experienced nonsignificant improvement in autonomic function with significant improvement in total symptom score. In contrast, pancreas-kidney recipients demonstrated significant improvement in postural adjustment ratio (P < or = .0085), valsalva ratio (P < or = .0348), electrogastography (P < or = .0159), and total symptom score (P < or = .0001). Improvement or stabilization of gastric function occurred for 12 of 23 pancreas-kidney patients (52%) versus 5 of 12 kidney-alone patients (41.7%). A path analysis of 56 diabetic patients having a wide range in diabetic autonomic neuropathy, found the sickness impact profile to correlate with valsalva ratio (r = .36, P < or = .0056), R-R interval (r = .27, P < or = .0396), and vasoconstriction (r = .24, P < or = .064). Together, autonomic function measures accounted for 15.2% of the total variance in the sickness impact profile. Sickness impact profile scores also significantly improved for both groups of transplant recipients.

Effect of Cisapride Therapy for Severe Dyspepsia on Gastrointestinal Symptoms and Quality of Life: General Discussion

Quality of life measures have received little attention in evaluation of therapy for dyspepsia. To examine the effect of cisapride on gastrointestinal symptoms and quality of life measures, we studied eight patients with chronic, severe dyspepsia, before and after therapy with cisapride (20 mg three times daily) for 12 months. Gastrointestinal (GI) Total Symptom Score (TSS), Overall Patient Assessment (OPA), and quality of life by both trait (Minnesota Multiphasic Personality Inventory (MMPI)) and physical function (Sickness Impact Profile (SIP)) were measured at base line and at month 12 of cisapride therapy. Results showed significant improvement in TSS, OPA, and the MMPI Depression and Anxiety scales (all, p < 0.05). Improvement in the SIP physical dimension score approached significance (p = 0.065). We conclude that, in this group of patients with severe dyspepsia, both GI symptoms and quality of life measures improved with 12 months of cisapride therapy. These quality of life measures may prove useful in evaluating the efficacy of drug treatment for dyspepsia.

Effect of six weeks of treatment with cisapride in gastroparesis and intestinal pseudoobstruction

We have investigated the effect of oral cisapride (10 mg t.i.d.) in a double-blind, placebo-controlled trial in 26 patients with upper gut dysmotility: 11 with gastroparesis (8 diabetic, 3 idiopathic) and 15 with chronic idiopathic intestinal pseudoobstruction. Patients were evaluated at entry and at the end of the 6-wk study by upper gastrointestinal manometry, scintigraphic evaluation of gastric emptying of solids and liquids, measurement of body weight, and scoring of the following symptoms: abdominal pain, nausea, vomiting, early satiety, bloating, and distention. Cisapride and placebo groups were strictly comparable for all parameters assessed. Cisapride resulted in a significant increase in the gastric emptying of solids (p < 0.05) compared with placebo; cisapride also tended to increase the postcibal antral motility and normalize the abnormal manometric features in the patients with intestinal dysmotility, particularly the characteristics of fasting interdigestive motor complexes and the fed motor pattern. Both cisapride and placebo groups showed an improvement in total symptom scores and there was no significant difference in overall symptom response between the two groups. However, the change in abdominal pain was greater with cisapride (p = 0.07). Cisapride facilitates gastric emptying in patients with upper gut dysmotility. The overall symptomatic benefit during a 6-wk trial of cisapride, 10 mg t.i.d., was not greater than that of placebo, and dose-response as well as longer term trials are necessary to determine the clinical efficacy of this medication.

Effect of Six Weeks of Treatment With Cisapride in Gastroparesis and Intestinal Pseudo obstruction

We have investigated the effect of oral cisapride (10 mg t.i.d.) in a double-blind, placebo-controlled trial in 26 patients with upper gut dysmotility: 11 with gastroparesis (8 diabetic, 3 idiopathic) and 15 with chronic idiopathic intestinal pseudoobstruction. Patients were evaluated at entry and at the end of the 6-wk study by upper gastrointestinal manometry, scintigraphic evaluation of gastric emptying of solids and liquids, measurement of body weight, and scoring of the following symptoms: abdominal pain, nausea, vomiting, early satiety, bloating, and distention. Cisapride and placebo groups were strictly comparable for all parameters assessed. Cisapride resulted in a significant increase in the gastric emptying of solids (p less than 0.05) compared with placebo; cisapride also tended to increase the postcibal antral motility and normalize the abnormal manometric features in the patients with intestinal dysmotility, particularly the characteristics of fasting interdigestive motor complexes and the fed motor pattern. Both cisapride and placebo groups showed an improvement in total symptom scores and there was no significant difference in overall symptom response between the two groups. However, the change in abdominal pain was greater with cisapride (p = 0.07). Cisapride facilitates gastric emptying in patients with upper gut dysmotility. The overall symptomatic benefit during a 6-wk trial of cisapride, 10 mg t.i.d., was not greater than that of placebo, and dose-response as well as longer term trials are necessary to determine the clinical efficacy of this medication.

A comparison of the therapeutic and toxic effects of thioridazine and chlorpromazine in chronic schizophrenic patients

Summary Two groups, each composed of 71 chronic schizophrenic female patients, were treated for 13 weeks with thioridazine or chlorpromazine. The two groups were similar with respect to age, duration of hospitalization, 17 of 18 symptoms rated by a pair of physicians, and nine items of ward behavior rated by nursing personnel. Evaluations were made just prior to start of medication and again at the end of the 13th week. Reliability of the two physician-raters and paired nursing personnel was established prior to initiation of the project. Analysis of mean daily dosage actually administered to the two groups revealed no significant difference throughout the study. Medication was administered by a double-blind procedure with a maximum daily dose of 800 mg. for each drug. A daily record of side effects was maintained for all patients by the same physician. Both drug groups showed a significant and similar degree of improvement in total symptom scores obtained by physicians and in total ward behavior scores recorded by nurses. Examination of individual symptom and ward behavior response within each group and between groups further emphasized the similarity of the effects of the two drugs. Significant improvement occurred in both groups, and in general to a comparable degree, in the areas of motor behavior, affect, and speech. Delusions and hallucinations in these chronically ill patients were not significantly reduced by either drug. Side effects, including extrapyramidal symptoms, occurred in both groups. Parkinsonism was slightly more frequent, and tended to be more severe, among patients receiving chlorpromazine; this group required more than three times as much procyclidine for control of extrapyramidal symptoms than did the thioridazine group. Two patients receiving thioridazine had grand mal seizures, though it is not certain that these were due to effects of the medication. Among the patients studied in this investigation, there was a marked similarity in the action of the two drugs on the symptoms and behavior which were evaluated. Side effects were also similar for the two drugs, though there was a tendency for chlorpromazine to be associated with more severe extrapyramidal symptoms than was thioridazine.