The effect of tenidap on the anti-hypertensive efficacy of thiazide diuretics in patients treated for mild to moderate hypertension.

1. This randomised, placebo-controlled, double-blind, parallel-group study was conducted to assess the effect of tenidap sodium 120 mg, a novel anti-arthritic cytokine modulating drug, on the hypotensive efficacy of the thiazide diuretics hydrochlorothiazide or bendrofluazide. 2. Twenty-three male and female patients, aged 41-78 years, with mild to moderate, uncomplicated, essential hypertension controlled with thiazide diuretic therapy, received either a single daily dose of tenidap sodium 120 mg or matched placebo for 22 days in addition to their diuretic therapy. Changes between baseline and endpoint in supine and standing systolic and diastolic pressures and pulse rate were compared between treatment groups. 3. Daily treatment with tenidap reduced the anti-hypertensive efficacy of the thiazide diuretics. Blood pressure tended to increase marginally and the increase in mean standing diastolic pressure observed with tenidap was significantly greater than the change in the placebo group. All pressures tended to decrease in the placebo group and all endpoint measurements were within 7 mm Hg of baseline in both groups. 4. Treatment-related side effects of mild to moderate severity were reported in two subjects receiving tenidap, but in neither case was treatment discontinued. Two subjects receiving placebo also experienced side effects considered to be treatment-related and both were withdrawn from the study. 5. The results of this study suggest that tenidap may be given to patients treated for mild to moderate essential hypertension controlled with thiazide therapy; however, the patient's blood pressure should be regularly monitored.

A comparison of the efficacy of two ear drop preparations ('Audax' and 'Earex') in the softening and removal of impacted ear wax.

Thirty-six patients with symptoms of impacted ear wax were recruited to an open, randomized, parallel group study of 'Audax' ear drops and 'Earex' ear drops. Patients had had their symptoms for several weeks and they were assessed on entry for the degree of impaction in each ear. After using the drops, morning and evening for 4 days, they were assessed on the fifth day for degree of impaction, ease of syringing, side-effects or discomfort, and the investigator's and patient's own global impression of efficacy of the ear drops. A trend was seen showing less impaction post-treatment in the 'Audax' group than in the 'Earex' group although the difference did not reach statistical significance. A significant difference was seen in favour of 'Audax' for the frequency and ease of syringing (p < 0.005). No patients in the 'Audax' group reported any side-effect or discomfort although 1 patient using 'Earex' reported slight irritation whilst another found the smell unacceptable. The results of the investigators' and patients' own global impression of efficacy were significantly in favour of 'Audax' ear drops (p < 0.01).

A comparison of mebeverine with high-fibre dietary advice and mebeverine plus ispaghula in the treatment of irritable bowel syndrome: an open, prospectively randomised, parallel group study.

OBJECTIVE To compare the efficacy and acceptability of mebeverine and high-fibre dietary advice versus mebeverine and ispaghula in fixed combination in the treatment of irritable bowel syndrome in adults. DESIGN Open, prospectively randomised, parallel group comparison of mebeverine/dietary advice and mebeverine/ispaghula during an eight-week study period. SETTING General practices in the UK. PATIENTS One hundred and eleven patients with irritable bowel syndrome diagnosed by symptom profile or negative investigations between the ages of 18 and 75 years were entered. All patients had a history of abdominal pain occurring at least once a week for a period of three months or more. INTERVENTION Dosage was 135 mg of mebeverine hydrochloride, three times daily before meals, together with advice on high-fibre dietary intake, or 135 mg of mebeverine hydrochloride plus 3.5 g of ispaghula husk twice or three times daily before meals. MEASUREMENTS AND RESULTS Details of abdominal pain severity and frequency, bowel frequency and stool consistency were recorded by means of clinicians' assessments and patient diaries. Pre-treatment assessments revealed no significant differences between the two groups with respect to any of the parameters. Both treatment groups demonstrated highly significant improvements in the numbers of pain attacks and their severity; no statistically significant differences between the two groups were demonstrated. Five patients in the mebeverine/dietary advice group reported five concurrent effects and nine patients in the mebeverine/ispaghula group reported 13 concurrent effects. All of the mebeverine/dietary advice group found their treatment acceptable but up to 28% of the mebeverine/ispaghula group found their treatment unpalatable. CONCLUSION Both treatments are effective in the treatment of irritable bowel syndrome in adults. The fixed combination of mebeverine/ispaghula, however, was found to be unpalatable by up to 28% of the patients in that group. There does not, therefore, appear to be any advantage in using fixed combination therapy in this condition.

Depression in general practice: a comparison of flupenthixol dihydrochloride and dothiepin hydrochloride.

A single-blind, parallel group, general practice study was carried out in 153 patients with mild to moderate depression to compare the efficacy and tolerability of flupenthixol dihydrochloride and dothiepin hydrochloride. Patients were allocated at random to receive single daily doses of either 1 mg flupenthixol in the morning or 75 mg dothiepin in the evening, and this dose could be doubled at the end of 2 weeks in the event of inadequate response. Assessments were made on entry and after 1, 2, 4 and 6 weeks of treatment using the Hamilton Depression Rating Scale, a 4-point severity scale and an unwanted symptoms checklist. The results showed that both treatments significantly improved the patients' condition over 6 weeks, and there was a significant difference in favour of flupenthixol at end-point. Both drugs were well tolerated, although persistence of anticholinergic side-effects in the dothiepin group resulted in a trend favouring flupenthixol. One patient in the flupenthixol group attempted suicide by overdose but made a complete recovery.

Astemizole suspension in the maintenance treatment of paediatric hay fever: a comparison with terfenadine suspension.

A study was carried out in general practice during the summer months of 1985 to compare the efficacy and tolerance of astemizole suspension with terfenadine suspension in the treatment of paediatric hay fever. The 65 patients who entered the study were all aged between 6 and 12 years and had suffered from hay fever in at least one previous season. Each child was randomly allocated to receive either 5 ml astemizole suspension (1 mg/ml) once daily or 5 ml terfenadine suspension (6 mg/ml) twice daily for a period of 8 weeks on a single-blind basis. Symptom scores assessed by the patient (or parent/guardian) on two visual analogue scales for ocular and nasal symptoms showed no significant difference between the treatment groups, neither did an analysis of visual analogue scores for runny nose, blocked nose, wheeze, sneezing or eye symptoms assessed by the investigator on entry or after 4 and 8 weeks. The global assessments made by the investigator at 4 weeks and the patient at 8 weeks, however, indicated significantly better overall symptom control in the astemizole group. Both treatments were well tolerated, side-effects being few and minor.