Time to relief of episodic symptoms of gastro-oesophageal reflux disease. A crossover comparison of single doses of the effervescent and standard formulations of ranitidine.

BACKGROUND: The length of time until symptom relief and the consistency of response are important aspects of the management of episodes of gastro-oesophageal reflux disease (GORD). METHODS: In an open, randomized, crossover study 98 patients treated 3 episodes of GORD with ranitidine effervescent formulation and 3 with ranitidine standard formulation. The patients filled in a diary card during the 1st h after each study medication. Satisfaction with the formulations and the formulation of choice were determined at the end of the study. RESULTS: A higher percentage of episodes with acceptable symptom relief (82.4% versus 73.1% P=0.024) and a shorter time to acceptable symptom relief (27 min versus 36 min; P < 0.001) were achieved with the effervescent formulation. Sixty-five per cent preferred the effervescent formulation (P < 0.01). CONCLUSIONS: An increased consistency of response and a more rapid symptom relief were achieved with treatment with the ranitidine effervescent formulation, indicating it may be more appropriate for on-demand treatment in patients with episodes of GORD.

A multinational investigation of the impact of subcutaneous sumatriptan. I: Design, methods and clinical findings.

This report describes the design, methods and clinical results of a prospective sequential multinational (5 countries) study conducted to evaluate the effects of subcutaneous sumatriptan on health-related quality of life, workplace productivity, clinical parameters and patient satisfaction. Adult patients with moderate to severe migraine initially received customary therapy for migraine episodes for 12 weeks, followed by 24 weeks' treatment with self-administered subcutaneous sumatriptan 6 mg. Demographic, baseline, health-related quality of life and patient satisfaction rating data were collected during visits to the clinic. Data relating to migraine symptoms, migraine therapy, work productivity and non-work activity time were collected on diary cards filled out by the patients. 749 patients were recruited to the study and 637 received at least 1 dose of sumatriptan. Overall, 75.5% of migraines were successfully treated within 2 hours with sumatriptan compared with 31.9% with customary therapy; 36% of patients reported complete relief at 2 hours with sumatriptan treatment compared with 1% of patients receiving customary therapy. 69% of patients successfully treated 70% of their migraines with sumatriptan within 2 hours, compared with 12% of patients with customary therapy. No serious adverse events were reported; 50% of patients reported an adverse event during the 12-week customary therapy phase and 89% of patients during the 24-week sumatriptan phase. These clinical results, which are consistent with those reported in randomised blinded studies of subcutaneous sumatriptan, suggest that relief of migraine symptoms occurs more often, and in less time, in patients receiving subcutaneous sumatriptan rather than customary therapy as their primary medication.

A randomised placebo controlled study with ondansetron in patients undergoing fractionated radiotherapy.

BACKGROUND: There are few randomised studies comparing anti-emetic drugs for the prevention of nausea and vomiting in patients treated with fractionated radiotherapy. The aim of the study was to compare the anti-emetic efficacy of 8 mg dose ondansetron twice a day with placebo. MATERIALS AND METHODS: One hundred eleven patients who were to commence a course of 10 or more daily fractionated radiotherapy including the abdomen were included in the study. The patients recorded daily emesis, nausea and bowel habit and graded weekly symptoms of nausea, vomiting, diarrhoea and lack of appetite. The EORTC C30 questionnaire was completed. RESULTS: 67% of patients given ondansetron had complete control of emesis compared with 45% of patients with placebo (P < 0.05). The number of emetic episodes recorded on the worst day was 1.4 for the ondansetron group and 3.1 for the placebo group (P < 0.01). Patients given ondansetron had fewer days with emesis and nausea compared with placebo (P < 0.05). The mean sum score of patients weekly grading of symptoms showed that the ondansetron group had less inconvenience than the placebo group (P < 0.05). This difference persisted during the first three weeks, but not thereafter. Similarly, some quality of life measures showed significant differences in favour of the ondansetron group. More patients (n = 13) withdrew due to lack of efficacy in the placebo group compared with patients (n = 8) in the ondansetron group. CONCLUSIONS: The present study illustrates that prophylactic anti-emetic administration of ondansetron is effective in preventing nausea and vomiting in patients undergoing fractionated radiotherapy of the abdomen.

A controlled multicenter clinical study of citalopram and placebo in elderly depressed patients with and without concomitant dementia.

A total of 149 patients in 7 centers in Denmark, Norway and Sweden entered a 6-week double-blind trial intended to assess the antidepressant effect and safety of citalopram vs placebo in depressed elderly patients (65 years of age or older) who might also suffer from somatic disorders and/or senile dementia. Results of ratings on the Hamilton Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression Scale provided consistent evidence that the citalopram-treated patients improved more than the placebo-treated patients. Results of ratings on the Gottfries-Bråne-Steen dementia rating scale indicated that both cognitive and emotional functioning improved significantly more in the citalopram-treated subgroup of patients with dementia than in the placebo-treated subgroup.

Treatment of depression in elderly patients with and without dementia disorders.

In two inter-Nordic multicenter controlled studies the effect of Citalopram on elderly patients with depression and emotional disturbances has been studied. One investigation included 98 patients in whom Alzheimer type dementia (AD/SDAT) and vascular dementia (VD) had been diagnosed, many of whom also had emotional disturbances. After four weeks treatment with Citalopram (10-30 mg/daily) there was significant improvement in confusion, irritability, anxiety, depressed mood and restlessness. No effect was seen on the intellectual capacity or motor performance measured. In the other study, which was a six weeks trial comparing Citalopram and placebo, elderly patients with a treatment-requiring depression were treated. Demented as well as non-demented patients were included. The Hamilton Depression Scale, the Montgomery-Asberg Depression Rating Scale and The Clinical Global Impressions all recorded an effect of Citalopram superior to that of placebo. In both studies depressive symptoms as well as symptoms of agitation, anxiety, restlessness and irritability improved. Citalopram is therefore considered not only an antidepressive drug but also an emotional stabilizer. The drug was well tolerated by elderly often somatically ill patients. Side effects were few.

Effect of citalopram, a selective 5-HT reuptake blocker, in emotionally disturbed patients with dementia.

In patients with Alzheimer's disease and vascular dementia, there are symptoms not only of cognitive impairment but also of emotional disturbance. Postmortem human brain studies have shown a disturbed metabolism of serotonin and overactivity of neuroendocrine-controlling factors in the hypothalamus. Treatment with a selective 5-HT reuptake blocker, citalopram, causes a significant reduction in postdexamethasone cortisol levels. Citalopram in patients with dementia disorders produces no improvement in psychomotor and cognitive behavior, but symptoms of emotional disturbance are reduced. Citalopram does not have a pure antidepressant effect; rather, the drug is considered an emotional stabilizer.

The clinical efficacy of citalopram in treatment of emotional disturbances in dementia disorders. A Nordic multicentre study.

In this multicenter study, the clinical efficacy of citalopram was investigated in 98 patients with moderate AD/SDAT or VD using a combined double-blind and open technique with placebo and citalopram. Analyses were made for each diagnosis after four weeks of double-blind treatment. Patients with AD/SDAT treated with citalopram showed a significant improvement in emotional bluntness, confusion, irritability, anxiety, fear/panic, depressed mood and restlessness. Those improvements were not found after treatment with placebo. There were no significant improvements in patients with VD. No improvements were recorded in motor or cognitive impairment. Citalopram provoked few and comparatively mild side-effects. None of the changes observed during the double-blind withdrawal period were identified as withdrawal symptoms or rebound phenomena.

Effects of environmental stimulation on biochemical and psychological variables in dementia.

The nursing care of a group of moderately demented patients (n = 11) in a nursing home was improved as a result of an education of the staff. Thus the patients were subjected to an increased emotional and intellectual stimulation during the ordinary daily care and participated in group sessions twice a week. In order to evaluate the effects of the treatment, psychological parameters and cerebrospinal fluid (CSF) HVA (homovanillic acid), 5-HIAA (5-hydroxyindole acetic acid) and HMPG (4-hydroxy, 3-metoxyphenylglucol) were quantified before and after a 2-month treatment period. A group of similar patients (n = 13) in another nursing home constituted a control group. The ratings of concentration, absent mindedness and recent memory showed a more favorable development in the treatment group than in the control group where an intellectual deterioration was evident. Restlessness was rated higher in the treatment group after the treatment period, while the psychological testings showed no significant changes between the groups. CSF HVA concentrations increased in the treatment group and decreased in the control group (P less than 0.05). No change was evident in 5-HIAA or HMPG concentrations in either group. The results suggest that environmental factors influence biochemical markers of transmitter activity which thus possibly may be of etiological importance in dementia.