A prospective randomised controlled study of the use of ranitidine in patients with gastric cancer. Yorkshire GI Tumour Group.

BACKGROUND: Does the use of the histamine H2 receptor antagonist ranitidine improve the outcome of patients with gastric cancer? PATIENTS: A total of 222 patients with gastric cancer who had received radical or palliative resection or who were deemed inoperable at presentation. SETTING: Hospitals within Yorkshire, the participating clinicians being members of the Yorkshire GI Tumour Group. METHODS: A multicentre prospective randomised double blind trial comparing ranitidine 150 mg twice daily with placebo twice daily was undertaken. The principal outcome measures were survival and survival excluding those who died within 30 days of operation. RESULTS: The median survival (95% confidence intervals) was 331 (232 to 393) days for patients in the ranitidine group compared with 187 (143 to 269) for those in the placebo group. The difference in survival was not statistically significant (p = 0.225). When patients who died within 30 days of operation were excluded (21 in the placebo group, 15 in the ranitidine group), the difference in survival remained not significant (p = 0.358). No subgroup could be identified who significantly benefited from treatment, but for patients with stage VIa cancer the median survival was 134 days with placebo compared with 313 days with ranitidine (p = 0.073). CONCLUSION: This study does not show significant benefit from the use of ranitidine for gastric cancer but further larger studies may be indicated.

Efficacy and tolerability of diclofenac dispersible in elderly patients with osteoarthritis.

The efficacy and tolerability of a new dispersible formulation of diclofenac were evaluated in a randomized, double-blind, placebo-controlled, multi-centre study in patients aged 60 to 80 years suffering from osteoarthritis. A total of 314 elderly patients with a mean age of 68.9 years received either 50 mg diclofenac dispersible or placebo 3-times daily for a period of 4 weeks, with paracetamol being allowed as rescue analgesic for both treatment groups. The study consisted of a baseline evaluation and two follow-up visits after 14 and 28 days of treatment. The following clinical parameters were assessed: pain at rest, on movement and on local pressure; global severity of pain; effect of pain on daily activity; duration of stiffness after immobility; rescue analgesic consumption; overall opinion of the investigator on efficacy; and occurrence of adverse events. At either one or both post-treatment assessments, diclofenac dispersible was found to be significantly superior to placebo for almost all measures of efficacy (p less than or equal to 0.05). Thirty (14.4%) patients out of 208 assessed in the diclofenac group reported adverse events compared to 18 (17%) out of 106 who received placebo; therapy was discontinued prematurely due to poor tolerability in 4.8% and 5.7% of patients, respectively. The adverse events were predominantly related to the gastro-intestinal system and were mostly mild to moderate in severity. The results of this 4-week study thus demonstrate that diclofenac dispersible is not only effective in treating osteoarthritis in the elderly but also has an acceptable tolerability profile in a patient population which is especially vulnerable to adverse effects induced by non-steroidal anti-inflammatory drugs.

Comparison of the efficacy and tolerability of diclofenac gel (Voltarol Emulgel) and felbinac gel (Traxam) in the treatment of soft tissue injuries.

In an observer-blind, randomised study, the efficacy and tolerability of two topical NSAID preparations were assessed in 384 patients with acute soft tissue injuries. The patients were allocated to receive treatment with either diclofenac gel (Voltarol Emulgel) 4 g tds or felbinac gel (Traxam) 4 g tds for three or seven days, depending on the rate of recovery. In every parameter studied (pain at rest, pain on movement, pain on local pressure, swelling, range of movement, bruising, degree of recovery, requirement for rescue analgesics, daily pain levels), diclofenac was found to be more effective at day 3 and day 7, with the single exception of bruising at day 7. Treatment differences were statistically significant in favour of diclofenac for pain at rest (p = 0.03) and bruising on day 3 (p = 0.03), and pain on pressure at day 7 (p = 0.009). The difference in favour of diclofenac in reduction of daily pain level (as recorded on diary cards) did not quite reach significance (p = 0.06). Both preparations were well tolerated, with no significant treatment-related side-effects reported.

Joint pain and quality of life; results of a randomised trial.

1. Eight hundred and forty-six patients with pain in one or two joints of the hip, knee, ankle or wrist participated in a randomised double-blind trial to compare the efficacy, tolerability and effect on quality of life of diclofenac sodium slow release (DSR) 100 mg daily and a combination of dextropropoxyphene 180 mg and paracetamol 1.95 g daily (D&P). Health status or quality of life was measured using the Nottingham Health Profile (NHP) questionnaire. 2. Pain as measured by a visual analogue scale (VAS) showed 8% greater pain reduction with DSR as compared with D&P (P less than 0.05). Physical mobility as measured by the NHP improved by 13% more with DSR as compared with D&P (P less than 0.01). Energy, sleep, social isolation and emotional reactions did not differ significantly between the two treatment groups, but both treatment groups showed improvement during the trial. More D&P patients as compared with DSR patients reported problems with their job of work (P less than 0.05), and time lost from work (P less than 0.05). 3. Patients on D&P suffered an excess of tiredness or sleep disturbance (50 vs 21, P less than 0.01) whilst patients treated with DSR had an excess of abdominal or epigastric pain or indigestion (40 vs 18, P less than 0.01). 57 patients were withdrawn from DSR and 65 from D&P.