Caffeine as an analgesic adjuvant. A double-blind study comparing aspirin with caffeine to aspirin and placebo in patients with sore throat.

Despite its frequent clinical use in analgesic agents, caffeine has not been accepted unequivocally as an analgesic adjuvant. To evaluate this activity of caffeine, we used new study methods in a randomized controlled trial on patients with acute sore throat due to tonsillopharyngitis. Patients were randomly assigned to receive a single dose of one of three treatments: 800 mg of aspirin with 64 mg of caffeine (n = 70), 800 mg of aspirin (n = 68), or placebo (n = 69). Under double-blind conditions, during a 2-hour evaluation period, patients used different rating scales to assess pain intensity, change in pain, relief, and two qualities of throat pain, how swollen the throat felt, and difficulty swallowing. Aspirin with caffeine and aspirin alone were significantly more effective than placebo for all efficacy measurements from 30 minutes through 2 hours and overall. The aspirin-caffeine combination also showed evidence of activity at 15 minutes on the relief scale. Aspirin with caffeine was more effective than aspirin alone after 30 minutes and over the entire study period. For patients with fever, both active treatments were equally effective antipyretic agents. We conclude, therefore, that 800 mg of aspirin, given alone or with 64 mg of caffeine, is an effective analgesic and antipyretic agent. Because the aspirin-caffeine combination is significantly more effective than aspirin alone as an analgesic, we also conclude that 64 mg of caffeine is an analgesic adjuvant.

Role of hypnotic drugs in general practice.

General practice physicians commonly deal with patients who report experiencing insomnia. Advances in our understanding of insomnia should result in much more effective diagnosis and therapeutic intervention for insomnia patients at the primary care level. This presentation highlights the new knowledge of insomnia pertinent to general practice physicians and discusses the rational use of hypnotic medications in primary care.

Long-term treatment with transdermal clonidine in mild hypertension.

Long-term antihypertensive treatment by once-weekly application of transdermal clonidine patches, in doses equivalent to 0.1, 0.2, 0.3 mg of clonidine daily, was evaluated in an open trial of 41 patients with baseline seated diastolic blood pressures of 90 to 103 mmHg. In all the patients, seated diastolic blood pressure was reduced to less than 90 mmHg with transdermal clonidine alone at the end of a dose titration phase of two to six weeks. Thirty-two patients successfully completed at least 22 months of therapy; three patients withdrew because of lack of efficacy and six because of adverse events. In the second treatment year 14 patients required a concomitant diuretic. Mean reductions in seated diastolic blood pressure from baseline values were statistically significant (P less than 0.0001) at all study intervals. The incidence of patient withdrawals resulting from the development of contact dermatitis at the patch application site was 5%; skin irritation not requiring withdrawal occurred in 13 patients during the first year of treatment and in two during the second. The incidence of dry mouth (in 7%) and drowsiness (in 10%) was lower than has been reported during oral clonidine therapy (40% and 35%). The results suggest that transdermal clonidine may be beneficial for the maintenance therapy of many patients with mild hypertension.

Sore throat pain in the evaluation of mild analgesics.

A double-blind, single-dose parallel study was conducted to assess refinements of a previously tested model for evaluating treatment of sore throat pain. Patients with tonsillopharyngitis randomly received either 400 mg ibuprofen (n = 39), 1000 mg acetaminophen (n = 40), or placebo (n = 41). At hourly intervals for 6 hours the patients reported pain intensity and pain relief on conventional scales and two sensory qualities of throat pain ("swollen throat" and "difficulty swallowing") on two new visual analog scales. Both active agents were significantly more effective than placebo for all efficacy measurements (p less than 0.01). Ibuprofen, 400 mg, was more effective than acetaminophen, 1000 mg, on all rating scales, conventional and new, at all time points after 2 hours and overall (p less than 0.01). There were no side effects. We conclude that sore throat is a pain model that can be used to discriminate between active medication and placebo, as well as between two effective over-the-counter analgesics.

Guanfacine as monotherapy for systemic hypertension.

Three clinical studies examined the effects of guanfacine as monotherapy. Study 1 was a double-blind, randomized, parallel trial with a placebo control with 26 patients with mild essential hypertension treated with 1-mg guanfacine or matching placebo daily at bedtime for 8 weeks. Pretreatment and posttreatment determinations of plasma volume, plasma aldosterone and blood pressure (BP) were made in all 26 patients. There were no significant differences between guanfacine and placebo with regard to changes in plasma volume or plasma aldosterone, but a significant decrease (p = 0.001) in both diastolic and mean BPs was seen with the active drug. No side effects were reported. From this study, it was concluded that guanfacine monotherapy is an effective and well-tolerated initial treatment for mild essential hypertension with no effect on either plasma volume or plasma aldosterone. Study 2 was a double-blind, randomized, parallel clinical study with placebo control with 42 patients with mild essential hypertension treated with either guanfacine (1 mg/day) or matching placebo at bedtime for 8 weeks. Pretreatment and posttreatment evaluations of serum cholesterol, triglycerides, low density lipoproteins, very low density lipoproteins and high density lipoproteins revealed no significant differences between the treatment and the placebo groups. A statistically significant (p less than 0.0001) decrease in diastolic BP was seen in the guanfacine group compared with those patients who received placebo. Guanfacine monotherapy was again shown to be an effective initial treatment for mild essential hypertension with no adverse influence on serum lipids.(ABSTRACT TRUNCATED AT 250 WORDS)

Subjective and objective features of sore throat.

This study examines the relationship between the symptom of sore throat and the signs of pharyngitis. Patients seeking medical attention for sore throat were examined by their physician, who documented findings on a Tonsillopharyngitis Score (TPS) and obtained a throat culture. Each patient was then instructed by the physician's assistant to characterize the severity of throat pain on a Sore Throat Pain Intensity Scale (STPIS) and Sore Throat Questionnaire. A high positive correlation was found for the STPIS and TPS but not for these findings and the cause of pharyngitis. A similar association was found between the relative severity of throat pain and the words patients use to describe it. This new method objectively confirms the subjective rating of sore throat pain.

Double-blind evaluation of temazepam, flurazepam, and placebo in geriatric insomniacs.

The efficacy and safety of temazepam (30 mg) were compared with the efficacy and safety of flurazepam hydrochloride (30 mg) and placebo in a four-day, double-blind study in 75 geriatric convalescent-home patients with insomnia. The efficacy and safety profiles of the two active drugs were similar. Patients treated with temazepam, however, reported significantly less drug hangover both on awakening and during the entire day after each night of treatment than did patients receiving flurazepam or placebo. The difference between temazepam and flurazepam was probably due to the drugs' markedly different half-lives, temazepam's mean half-life being ten hours compared with 65.5 hours for the active metabolite of flurazepam. It is well recognized that the elderly may be especially sensitive to the adverse effects associated with the accumulation of the long-acting metabolite of flurazepam. Since temazepam has no active metabolites and minimal accumulation, it is a particularly appropriate hypnotic for use in geriatric patients.

Double-blind evaluation of the efficacy and safety of temazepam in outpatients with insomnia.

1 The efficacy and safety of temazepam 30 mg, compared with glutethimide 500 mg and placebo, were evaluated in double-blind conditions in a 4-day study in 75 outpatients with a history of insomnia. 2 Temazepam and glutethimide were rated by the patients as effective and significantly superior to placebo for general quality of sleep, time required to fall asleep, frequency of nocturnal and early morning awakenings, and duration of sleep. 3 Residual effects reported for temazepam and glutethimide immediately after awakening and during the day were similar to or less than those reported for placebo.