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At least 19 recordsLinked to original sources
PubMed1981

Symptom relief and the placebo effect in the trial of an anti-peptic drug.

In order to determine some of the factors involved in the response of duodenal ulcers to placebo treatment, the following factors were studied prospectively during a double-blind, placebo-controlled trial: demographic data; duration of illness and effect of treatment; expectation of success or failure of the new drug; presence of psychiatric problems; and suggestibility. Healing (measured by endoscopy) occurred in 37 patients, 17 of whom were receiving placebo; relief of symptoms occurred in 35 patients, 16 of whom were receiving placebo. There was no significant difference between drug and placebo. Healing was significantly associated with relief of symptoms but with no other variable. Relief of symptoms was more common in male patients and in those from higher social classes, as well as in patients who expected a complete cure and those without evidence of psychiatric problems. the natural history of the disease may be different in these patients. Unexpectedly, suggestibility was not associated with healing or relief of symptoms in the patients receiving placebo.

Adult↗
PubMed2005

Novel measurement of rapid treatment success with ReQuest: first and sustained symptom relief as outcome parameters in patients with endoscopy-negative GERD receiving 20 mg pantoprazole or 20 mg esomeprazole.

BACKGROUND/AIMS: A prime concern for gastroesophageal reflux disease (GERD) patients is fast symptom control. Sparse valid information is available on the rapidity of the effect of proton pump inhibitors in provid ing symptom relief. The new reflux questionnaire ReQuest is validated for daily assessment of changes in GERD symptoms. Therefore, this study investigated the efficacy of 20 mg pantoprazole and 20 mg esomeprazole with regard to the time to symptom relief in patients with endoscopy-negative GERD (enGERD) using ReQuest. METHODS: 529 patients were treated with pantoprazole or esomeprazole over 4 weeks. ReQuest symptom scores were assessed daily. The mean and median times to first and sustained symptom relief were determined. RESULTS: Median time to first symptom relief was 2 days for both drugs (intention-to-treat population). The median time to sustained symptom relief was 3 days shorter with pantoprazole (10.0 vs. 13.0 days). The Hodges-Lehmann estimator for the difference in time to reach first and sustained symptom relief between both groups was 0.00 days. For both variables the one-sided 95% CI (Moses) was [0.00; infinity] documenting no significant differences between the treatment groups. CONCLUSIONS: The rapidity of symptom control can be evaluated by clinically significant parameters using ReQuest. Pantoprazole and esomeprazole are equally effective in the time to first and sustained symptom relief.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2005

Determination of ReQuest-based symptom thresholds to define symptom relief in GERD clinical studies.

BACKGROUND/AIMS: The growing importance of symptom assessment is evident from the numerous clinical studies on gastroesophageal reflux disease (GERD) assessing treatment-induced symptom relief. However, to date, the a priori selection of criteria defining symptom relief has been arbitrary. The present study was designed to prospectively identify GERD symptom thresholds for the broad spectrum of GERD-related symptoms assessed by the validated reflux questionnaire (ReQuest) and its subscales, ReQuest-GI (gastrointestinal symptoms) and ReQuest-WSO (general well-being, sleep disturbances, other complaints), in individuals without evidence of GERD. METHODS: In this 4-day evaluation in Germany, 385 individuals without evidence of GERD were included. On the first day, participants completed the ReQuest, the Gastrointestinal Symptom Rating Scale, and the Psychological General Well-Being scale. On the other days, participants filled in the ReQuest only. GERD symptom thresholds were calculated for ReQuest and its subscales, based on the respective 90th percentiles. RESULTS: GERD symptom thresholds were 3.37 for ReQuest, 0.95 for ReQuest-GI, and 2.46 for ReQuest-WSO. CONCLUSION: Even individuals without evidence of GERD may experience some mild symptoms that are commonly ascribed to GERD. GERD symptom thresholds derived in this study can be used to define the global symptom relief in patients with GERD.

Adult↗
PubMedDate not supplied

Short-term menopausal hormone therapy for symptom relief: an updated decision model.

BACKGROUND: Hormone therapy (HT) provides the most effective relief of menopausal symptoms. This therapy is associated with a decreased risk of osteoporosis and colorectal cancer but increased risks of cardiovascular disease (CVD), venous thrombosis, and breast cancer. Our objective was to identify which women should benefit from short-term HT by exploring the trade-off between symptom relief and risks of inducing disease. METHODS: A Markov model simulates the effect of short-term (2 years) estrogen and progestin HT on life expectancy and quality-adjusted life expectancy (QALE) among 50-year-old menopausal women with intact uteri, using findings from the Women's Health Initiative. Quality-of-life (QOL) utility scores were derived from the literature. We assumed HT-affected QOL only during perimenopause, when it reduced symptoms by 80%. RESULTS: Among asymptomatic women, short-term HT was associated with net losses in life expectancy and QALE of 1 to 3 months, depending on CVD risk. Women with mild or severe menopausal symptoms gained 3 to 4 months or 7 to 8 months of QALE, respectively. Among women at low risk for CVD, HT extended QALE if menopausal symptoms lowered QOL by as little as 4%. Among women at elevated CVD risk, HT extended QALE only if symptoms lowered QOL by at least 12%. CONCLUSIONS: Hormone therapy is associated with losses in survival but gains in QALE for women with menopausal symptoms. Women expected to benefit from short-term HT can be identified by the severity of their menopausal symptoms and CVD risk.

Black or African American↗
PubMed1996

Reflux symptom relief with omeprazole in patients without unequivocal oesophagitis.

BACKGROUND: As many as 50% of patients with reflux symptoms have no endoscopic evidence of oesophagitis. This multicentre study was designed to assess symptom relief after omeprazole 20 mg once daily in patients with symptoms typical of gastro-oesophageal reflux disease but without endoscopic evidence of oesophagitis. METHODS: Patients (n = 209) were randomized in a double-blind study to receive either omeprazole 20 mg once daily (n = 98) or placebo (n = 111) for 4 weeks. Symptoms were assessed at clinic visits and using daily diary cards, with patient-completed questionnaires providing additional data on symptoms and on psychological disturbance. RESULTS: On completion, symptom relief favoured omeprazole: 57% of patients on omeprazole were free of heartburn (vs. 19% on placebo), 75% were free of regurgitation (47%) and 43% were completely asymptomatic (14%), each with P < 0.0001. Fewer patients in the omeprazole group required alginate/antacid relief medication (P < 0.05). Symptom relief (time to first heartburn-free day) was more rapid with omeprazole (2 vs. 5 days on placebo; P < 0.01). A greater reduction in anxiety occurred in the omeprazole group (P < 0.05). CONCLUSION: Omeprazole 20 mg once daily is effective in providing relief of the symptoms typical of gastro-oesophageal reflux disease in patients with essentially normal oesophageal mucosa.

Adult↗
PubMed2002

Onset of symptom relief with rabeprazole: a community-based, open-label assessment of patients with erosive oesophagitis.

BACKGROUND: In numerous clinical trials, proton pump inhibitors have demonstrated potent acid suppression and healing of erosive oesophagitis, as well as successful symptom relief for the entire spectrum of gastro-oesophageal reflux disease. AIM: The 'Future of Acid Suppression Therapy' (FAST) trial evaluated, in actual clinical practice, the timing of symptom relief, changes in symptom severity, health-related quality of life and safety in endoscopically confirmed erosive gastro-oesophageal reflux disease treated with rabeprazole. METHODS: This open-label, multicentre study enrolled 2579 patients to receive rabeprazole treatment using 20 mg once daily for 8 weeks. Between two clinical visits (at enrollment and week 8), patients used an interactive voice response system to rate gastro-oesophageal reflux disease symptoms. Subgroup analyses of efficacy were conducted for gender, age, Hetzel-Dent grade, presence of Barrett's oesophagus and for patients reporting previously ineffective symptom relief with omeprazole or lansoprazole. RESULTS: On day 1, rabeprazole significantly decreased daytime and night-time heartburn severity, regurgitation and belching. Complete relief of daytime and night-time heartburn was achieved in 64.0% and 69.2% of symptomatic patients, respectively, on day 1, and in 81.1% and 85.7% of patients, respectively, on day 7. Patients with moderate or severe heartburn symptoms at baseline achieved an even greater degree of satisfactory symptom relief (none or mild) from day 1 onwards. The median time to satisfactory heartburn relief was 2 days. Subgroup analyses showed no consistent differences in efficacy compared to the overall population treated. Health-related quality of life in patients was significantly lower than that of the US general population and improved significantly after 8 weeks of rabeprazole therapy. Rabeprazole was well tolerated, with headache as the most common adverse event, reported by less than 2% of the study population. CONCLUSIONS: In this large, open-label trial, rabeprazole rapidly and effectively relieved gastro-oesophageal reflux disease symptoms in most patients with erosive oesophagitis. Substantial symptom relief was noted on day 1; improvement continued over the first week and at week 4. By week 8, the health-related quality of life had also improved vs. baseline.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1997

Lansoprazole 15 and 30 mg daily in maintaining healing and symptom relief in patients with reflux oesophagitis.

BACKGROUND: In patients with reflux oesophagitis, endoscopic healing and symptom relief are considered important treatment goals in long-term care. AIM: To compare the effect of lansoprazole 15 and 30 mg daily on maintaining endoscopic healing and symptom relief in patients with moderate reflux oesophagitis. PATIENTS AND METHODS: In a single-centre, double-blind randomized clinical trial, 103 patients with grade 1 or 2 reflux oesophagitis who were endoscopically healed and asymptomatic after lansoprazole 30 mg daily for 12 weeks, were randomized to maintenance therapy with either lansoprazole 15 mg or 30 mg o.m. Endoscopy was repeated after 3, 6 and 12 months, and symptom relief assessed after 3, 6, 9 and 12 months. Relapse of oesophagitis or symptoms were considered end-points. RESULTS: After 12 months, 14/50 patients (28%) receiving lansoprazole 15 mg daily had suffered an endoscopic relapse compared to 8/53 patients (15%) treated with lansoprazole 30 mg daily. A life table analysis showed no statistically significant difference between the two groups (P = 0.086). Significantly more patients were kept in complete symptomatic remission in the 30 mg group (P < 0.01). In the 15 mg group, 23/50 (46%) had suffered either an endoscopic or symptomatic relapse on completion of the study, compared to 12/53 (23%) in the 30 mg group. A life table analysis showed this difference to be statistically significant (P = 0.010). Lansoprazole 15 and 30 mg daily were equally well tolerated. CONCLUSION: No statistically significant differences were found in endoscopic relapse rate or occurrence of adverse events, while lansoprazole 30 mg proved superior to 15 mg in maintaining patients in symptomatic relief and combined endoscopic and symptomatic remission.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed2004

Six-month trial of on-demand rabeprazole 10 mg maintains symptom relief in patients with non-erosive reflux disease.

BACKGROUND: Compliance studies have shown that patients with reflux symptoms generally take their medication only when experiencing these symptoms. AIM: To evaluate the efficacy of on-demand rabeprazole maintenance therapy in patients with non-erosive reflux disease. METHODS: This multicentre, randomized, double-blind, placebo-controlled, withdrawal study compared 6 months of on-demand treatment with rabeprazole 10 mg vs. placebo. Adults with a history of reflux symptoms, a negative endoscopy, and > or = 3 days of moderate to very severe heartburn in the 7 days before enrollment (N = 535) entered 4 weeks of open-label, acute treatment with rabeprazole 10 mg once daily. Patients with complete symptom relief then entered the on-demand phase. The primary end-point was discontinuation due to lack of heartburn control during the on-demand phase. RESULTS: Eighty-three percent (432 of 523) of patients reported complete symptom relief at the end of the acute phase. During on-demand treatment, rates of discontinuation because of inadequate heartburn control were 20% (28 of 139) for placebo vs. 6% (16 of 279) for rabeprazole (P < 0.00001). Antacid use was twofold higher in the placebo group vs. the rabeprazole group (P = 0.0009). CONCLUSIONS: Rabeprazole 10 mg once daily is highly effective in acute symptom relief and as on-demand long-term maintenance therapy in non-erosive reflux disease patients.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1999

Insulin treatment for poorly regulated diabetic patients in general practice. Better regulation and symptom relief?

OBJECTIVE: To study the relationship between symptoms, metabolic control and insulin treatment in diabetes mellitus. DESIGN: A cross-sectional questionnaire study of diabetic patients, and a 1-year follow-up study of poorly regulated patients prescribed insulin. Regulation criteria were predefined and the patients acted as their own controls. SETTING: Five primary care practices in Nordland county, Norway. PATIENTS: 111 patients in the cross-sectional study, with 18 of them participating in the follow-up study. MAIN OUTCOME MEASURES: Symptom scores and sum scores, based on five general symptoms--dizziness, depression, fatigue, thirst and dry mouth--and on two urinary symptoms--urinary frequency and urination during the night. RESULTS: Poorly regulated diabetic patients had a higher sum score for general symptoms than better regulated patients (6.1 vs. 4.2, p = 0.078 with Wilcoxon two-sample rank sum test). With parametric analysis, the difference was significant, and remained so when adjusted for age and sex. Females reported more symptoms than males. Symptom relief with insulin was not statistically significant; however, there was a slight but consistent tendency towards less symptoms with better regulation. There was no correlation with HbA1 values at any time during the follow-up study. Only one patient wanted to stop taking insulin after 1 year. CONCLUSION: Better metabolic control and better general well-being seem to be achieved in many cases when poorly regulated patients with type 2 diabetes mellitus begin insulin treatment. The general practitioner should be cautious in promising relief of specific symptoms.

Adult↗
PubMed1993

Kinevac-assisted cholescintigraphy as an accurate predictor of chronic acalculus gallbladder disease and the likelihood of symptom relief with cholecystectomy.

Thirty patients with chronic upper abdominal pain and no evidence of cholelithiasis were entered into this study. All had negative ultrasonography of the gallbladder, and most had a host of other negative investigations. These patients were referred to a surgeon to evaluate the possibility of atypical biliary colic associated with chronic acalculous cholecystitis. All patients underwent cholecystokinin-stimulated cholescintigraphy and were offered cholecystectomy if the ejection fraction was less than 35 per cent. Of the 30 patients, 27 (90%) had pathologically abnormal gallbladders. Follow-up averaged over 1 year (13.2 mo), and relief of symptoms occurred in 28 (94%). The authors conclude that in appropriately selected patients with symptoms of biliary colic (typical or atypical) and no evidence of cholelithiasis, a cholecystokinin-stimulated cholescintigram is a significant help in predicting not only which patients have gallbladder disease, but also how likely cholecystectomy is to result in an improvement in their symptoms.

Adolescent↗
PubMed1993

Improved symptom relief and duodenal ulcer healing with lansoprazole, a new proton pump inhibitor, compared with ranitidine.

The purpose of this study was to compare duodenal ulcer healing, symptom relief, and safety of lansoprazole (a new proton pump inhibitor) given at doses of 30 mg and 60 mg, in the morning with ranitidine 300 mg at bedtime. Two hundred and eighty nine patients were enrolled over a 20 month period in a double blind randomised parallel group comparative study set in outpatient endoscopy units of six United Kingdom medical centres. Patients were randomised to receive lansoprazole 30 mg in the morning (n = 95), 60 mg in the morning (n = 96), or ranitidine 300 mg at bedtime (n = 98) for four weeks. Efficacy was assessed by gastroscopy at study entry and after two and four weeks of treatment. Symptom relief was monitored by patient diaries and physician review at two and four weeks. Both doses of lansoprazole resulted in significantly greater ulcer healing than ranitidine after two and four weeks. Respective healing rates on lansoprazole 30 mg, 60 mg, and ranitidine 300 mg were 78%, 80%, and 60% after two weeks and 93%, 97%, and 81% after four weeks. Patients on lansoprazole 30 mg (p = 0.002) and lansoprazole 60 mg (p = 0.026) also recorded greater relief of night time pain in the diary cards during the first seven days of treatment than those on ranitidine. Patients on lansoprazole 60 mg reported significantly better pain relief at their two week visit compared with those receiving ranitidine (p = 0.007). There were no differences between treatment groups in the occurrence or pattern of adverse drug reactions during the trial. It is concluded that for patients with duodenal ulcer, lansoprazole 30 mg or 60 mg is associated with faster ulcer healing and better symptom relief than ranitidine 300 mg at bedtime. There were no significant differences between lansoprazole 30 mg and 60 mg. These data indicate that lansoprazole should be used at a once daily dose of 30 mg for the treatment of duodenal ulcer.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1990

Cholecystectomy provides long-term symptom relief in patients with acalculous gallbladders.

Elective cholecystectomy was performed in 60 patients with biliary colic and acalculous gallbladders during a 5-year period. Gallbladder wall disease was significantly more common (p less than 0.01) in patients with acalculous gallbladders than in a similar symptomatic group with calculous gallbladders. Thirty-four of 43 patients (77%) available for long-term follow-up reported complete symptom relief after cholecystectomy. Preoperative ultrasonography, biliary scintigraphy, oral cholecystography, upper gastrointestinal series, and pathologic features of the gallbladder were equivocal in predicting long-term symptom relief. In patients with acalculous biliary colic, the best predictor of complete symptom relief is an adequate history of true biliary colic.

Adult↗
PubMedDate not supplied

pH, healing rate, and symptom relief in patients with GERD.

Gastroesophageal reflux symptoms are common and occur in all of us from time to time. In others, reflux may be associated with ulcerative esophagitis. The symptoms may be aggravated by large meals, coffee, smoking and position. Physiological and pathological reflux can be separated by the frequency and duration of the exposure of the lower esophagus to acid. Pathological reflux results in symptoms and also esophagitis and ulceration in some patients. Although gastroesophageal reflux disease (GERD) is considered to result from a disorder of motility in the esophagus, gastric acid and peptic activity are deemed pivotal to the initiation and continuation of the esophageal damage and the development of symptoms. Acid exposure in the esophagus is normally less than 4 percent of the 24 hours with a pH below 4. An increase over 4 percent of the time with a pH less than 4 is considered pathological. Hence, antisecretory drugs have become the principle approach to the treatment of reflux symptoms and esophagitis since they reduce the acidity, of gastric juice and the activity of pepsin. Importantly, they also reduce the volume of gastric juice available for reflux into the esophagus. There is a clear relationship between the degree and duration of acid suppression and the relief of heartburn and healing of esophagitis. Pharmacodynamic studies with different dose regimens of the H2-receptor antagonists and the proton pump inhibitors show a difference in the degree and duration of the antisecretory effect, and this correlates closely with the results of clinical trials with respect to the healing of esophagitis and the relief of symptoms. Proton pump inhibitors achieve healing rates by week four, which are not achieved by H2-receptor antagonists even after 12 weeks of treatment. The advantage of proton pump inhibitors over H2-receptor antagonists is due to the greater degree, longer duration of effect and more complete inhibition of acid secretion that maintains intragastric pH above 4 for a maximal duration. Although there is no significant difference between proton pump inhibitors with respect to healing of esophagitis, symptom relief occurs earlier with lansoprazole than omeprazole, and this is probably due to the greater oral bioavailability and faster onset of action of lansoprazole when compared to omeprazole.

2-Pyridinylmethylsulfinylbenzimidazoles↗
PubMed1999

Fundoplication provides effective and durable symptom relief in patients with Barrett's esophagus.

BACKGROUND: Columnar-lined esophagus with intestinal metaplasia (IM), also called Barrett's esophagus, is a manifestation of severe gastroesophageal reflux (GER) and may predict poor symptom relief and high failure rate after fundoplication. We compared symptom scores and reoperation rates in GER patients with and without Barrett's esophagus. METHODS: Between July 1992 and July 1997, 646 patients underwent fundoplication (626 laparoscopic). Of 150 endoscopic biopsies of suspected columnar-lined esophagus, 80 confirmed IM, 50 identified cardiac or fundic epithelium, and 20 revealed only esophagitis. Typical GER symptoms were scored by patients preoperatively and postoperatively (0 to 4 scale). We compared symptom response (Wilcoxon rank sum test) and failure rates (t test) in patients with IM and GER controls without IM. Preoperative data were available for 74 IM patients and 496 controls. One-year follow-up was available in 45 IM patients and 301 controls. Intermediate follow-up (2 to 5 years) was available in 20 IM patients and 99 controls. RESULTS: Preoperatively and postoperatively, patients with IM reported heartburn, regurgitation, and dysphagia scores similar to controls. Procedure failure, requiring redo fundoplication, appeared more likely in IM patients than controls (6.3% versus 2.5%), but this difference did not reach statistical significance (P = 0.061). CONCLUSION: Fundoplication provides equivalent symptom relief for patients with and without IM.

Barrett Esophagus↗
PubMed2005

Time to symptom relief for uncomplicated urinary tract infection treated with extended-release ciprofloxacin: a prospective, open-label, uncontrolled primary care study.

OBJECTIVE: Few studies have investigated symptom relief in urinary tract infections. This innovative exploratory trial aimed to measure the time to improvement of the signs and symptoms of uncomplicated urinary tract infection (UTI) in women receiving extended-release ciprofloxacin. Time to return to normal daily activities was also evaluated. RESEARCH DESIGN AND METHODS: An open-label, multicenter US study in adult female outpatients with uncomplicated UTI. Patients completed serial questionnaires: the Urinary tract infection Symptom Assessment [USA], tracking time to symptom improvement, and the Activity Impairment Assessment [AIA], measuring the time to return to normal daily activities, using hand-held electronic diaries. Severity on the USA questionnaire was categorized using a 4-point Likert-type scale, with improvement defined as a reduction of at least one degree of symptom severity. All patients received once-daily extended-release ciprofloxacin 500 mg tablets for 3 days. RESULTS: Of 276 female patients aged 18-78 years who enrolled at 28 sites, 273 (99%) were safety-valid, 264 (96%) completed at least 24 h of questionnaires and were valid for symptom relief analysis, and 170 (62%) had pre-therapy pathogen(s) > or = 10(3) CFU/mL and were valid for efficacy analysis. Six hours after the first dose of study drug, 50% of patients reported symptom improvement; 87% by 24 h and 91% by 48 h. At study entry, 54% of patients reported considerably decreased time at work or other activities; reduced to 23% by Day 2 and 10% by Day 3. At the test-of-cure visit (5-11 days post-therapy), 96% (163/170) of patients were clinical cures. Drug-related adverse events were reported by 18 (7%) patients and were consistent with previous extended-release ciprofloxacin studies (e.g., gastrointestinal disturbance, fungal superinfections). There were no serious adverse events or discontinuations due to adverse events. CONCLUSION: This open-label, non-comparative trial in adult women demonstrated a rapid improvement in uncomplicated UTI symptom severity (6-24 h) and the ability to return to work within 24 h following extended-release ciprofloxacin treatment. Clinical cure rate and tolerability profile were similar to results of previous extended-release ciprofloxacin studies.

Acute Disease↗
PubMed2006

Estimation of the Bath Ankylosing Spondylitis Disease Activity Index cutoff for perceived symptom relief in patients with spondyloarthropathies.

OBJECTIVE: To estimate the best Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) cutoff based on patients' perceptions of symptom relief collected in a large population of patients with spondyloarthropathies (SpA), in comparison to the BASDAI cutoff determined by experts. METHODS: A survey of patient perceptions about current disease control was conducted among the members of Spondylis, one of the main not-for-profit SpA patient organizations in France. BASDAI was among data collected by the questionnaire. To estimate the best BASDAI cutoff for discriminating between poor and well perceived controlled groups, we plotted the receiver operating characteristic (ROC) curve. We also determined the cutoff separately in male and female patients. RESULTS: Of the 1000 mailed questionnaires, 485 were returned without any missing data regarding perceived disease control and the BASDAI. Of these patients, 55.3% perceived inadequate control of their disease. The mean BASDAI in the overall population was 43.5 +/- 22.9, 30.4 +/- 19.9 in the well controlled group and 54 +/- 19.4 in the poorly controlled group (p < 0.001). The best BASDAI cutoff for discriminating between patients in the 2 groups was 39 (sensitivity 74.6% and specificity 72.4%). According to gender, the best cutoff was 44 for women and 36 for men. CONCLUSION: The best BASDAI cutoff of 39 based on patients' perceptions was very similar to that selected by international experts, i.e., 40. Gender affected the cutoff for perceived symptom relief in our study. These results need to be confirmed by further studies collecting the opinions of both patients and physicians.

Antirheumatic Agents↗
PubMed2001

Oral cimetidine gives effective symptom relief in painful bladder disease: a prospective, randomized, double-blind placebo-controlled trial.

OBJECTIVE: To evaluate the efficacy of oral cimetidine as a treatment for painful bladder disease (PBD, variously described as a 'symptom complex' of suprapubic pain, frequency, dysuria and nocturia in the absence of overt urine infection) by assessing symptom relief and histological changes in the bladder wall tissue components, compared with placebo. PATIENTS AND METHODS: The study comprised 36 patients with PBD enrolled into a double-blind clinical study with two treatment arms, i.e. oral cimetidine or placebo, for a 3-month trial. Patients were asked to complete a symptom questionnaire (maximum score 35), and underwent cystoscopy and bladder biopsy before treatment allocation. On completing treatment the patients were re-evaluated by the questionnaire and biopsy. The symptom scores and bladder mucosal histology were compared before and after treatment, and the results analysed statistically to assess the efficacy of cimetidine. RESULTS: Of the 36 patients recruited, 34 (94%) completed the study. Those receiving cimetidine had a significant improvement in symptoms, with median symptom scores decreasing from 19 to 11 (P < 0.001). Suprapubic pain and nocturia decreased markedly (P = 0.009 and 0.006, respectively). However, histologically the bladder mucosa showed no qualitative change in the glycosaminoglycan layer or basement membrane, or in muscle collagen deposition, in either group. The T cell infiltrate was marginally decreased in the cimetidine group (median 203 before and 193 after) and increased in the placebo group (median 243 and 250, P > 0.3 and > 0.2, respectively). Angiogenesis remained relatively unchanged. The incidence of mast cells and B cells was sporadic in both groups. CONCLUSIONS: Oral cimetidine is very effective in relieving symptoms in patients with PBD but there is no apparent histological change in the bladder mucosa after treatment; the mechanism of symptom relief remains to be elucidated.

Administration, Oral↗
PubMed2002

Evidence-based symptom relief of intermittent claudication: efficacy and safety of cilostazol.

Intermittent claudication (IC) is a common, debilitating symptom of atherosclerotic peripheral arterial disease. There are two therapeutic objectives in patients with IC: relief of symptoms and secondary prevention of acute thrombotic complications. Among patients with Fontaine stage II disease, surgical revascularization for symptom relief is reserved for those in whom exercise/lifestyle modification and medical therapy has failed. To improve exercise tolerance in IC requires favourable alteration in the oxygen supply/demand relationship in the lower limb. Following the largest ever clinical trials programme in patients with IC, cilostazol, a phosophodiesterase III inhibitor, has been licensed for symptom relief in the UK. In double-blind, randomized, placebo-controlled trials involving over 2000 patients, cilostazol 100 mg b.d. produced significant and sustained improvements in pain-free and maximal walking distances as well as improved subjective assessments of quality of life. In particular, comparative studies with pentoxifylline (oxpentifylline) showed that cilostazol had significantly greater effects on functional outcome and exhibited good patient tolerance.

Cilostazol↗