Clinical Briefs in Primary Care
Source: Kaczorowski M, Kaczorowski J. BMJ. 2002;325:1445-1446.
Ice cream headache (ICH) is a commonplace phenomenon induced by ingestion of cold substances, of which ice cream is but one of many potential precipitants. The limited literature on this topic had suggested that ICH only occurs in hot weather, as if the contrast between hot ambience and cold palatal or pharyngeal stimulation might foster ICH. Kaczorowski and Kaczorowski, "in order to fill this important knowledge gap . . . " as they so state in their publication, carried out a winter-time randomized trial (n = 145) amongst high-school students to determine whether, indeed, ICH is an experience only attained in hot weather. Additionally, subjects were divided into 2 different ingestion modes, one "accelerated" (eating 3 ounces of ice cream within 5 seconds) the other "cautious" (3 ounces within 30 seconds). There were no refusals, dropouts, or subjects lost to follow-up.
Overall previous experience with ICH was 79% amongst participants. In this trial, cautious eaters reported less than half the incidence of ICH than accelerated eaters (13% vs 27%). ICH is readily precipitated in cold weather, as demonstrated in this trial. Kaczorowski and Kaczorowski graciously acknowledge that the funding of the study was supported "by an unrestricted grant from mum and dad."
Treatment of Antidepressant-Associated Sexual Dysfunction with Sildenafil
Source: Nurnberg HG, et al. JAMA. 2003;289:56-64.
Sexual dysfunction (SXD), weight gain, and sleep disturbance comprise as much as 75% of the adverse events that ultimately lead to antidepressant medication discontinuation. Of course, premature medication discontinuation is associated with a substantial risk of depression relapse, with its attendant morbidity and mortality.
Between 30-70% of persons who take SSRIs experience sexual dysfunction and will subsequently prematurely discontinue medication. The favorable retrospectively observed results of providing sildenafil to persons suffering SSRI-induced SXD prompted this prospective, randomized, placebo-controlled trial (n = 90).
Inclusion criteria required at least 6 weeks stable dosing of SSRI, and at least 4 weeks duration of SXD. Subjects were randomized to sildenafil 50-100 mg or placebo, and instructed to attempt intercourse at least twice weekly. Sildenafil recipients showed significant improvements in erectile function, orgasm, intercourse satisfaction, and overall satisfaction compared with placebo. No serious adverse events attributable to sildenafil were seen. Overall, sildenafil allowed more than 55% of recipients to experience "much/very much improved" sexual function, as compared to 4-6% in the placebo group.
Prophylactic Treatment of Migraine with an Angiotensin II Receptor Blocker
Source: Tronvik E, et al. JAMA. 2003;289:65-69.
Despite the very favorable effect of triptans upon migraine morbidity, a substantial population of persons either does not respond to, or chooses not to use, these agents. Expert advice has suggested that prophylaxis be considered predicated upon headache frequency, typically 2-4 headaches per month providing sufficient burden to merit a preventive pharmacotherapeutic agent. Recently lisinopril has been found to be an effective agent for migraine prophylaxis. Similarities in neurohumoral modulation of ACE inhibitors, when compared with angiotensin I receptor blockers (ARBs), would suggest that the latter might also be of benefit. Indeed, clinical trials in hypertension patients have consistently found a lower frequency of headache amongst ARB-treated patients than with placebo.
This randomized, double-blind placebo-controlled crossover study (n = 60) compared candesartan (CAN) 16 mg/d with placebo, in 2 12-week periods of observation (after a 4-week placebo run-in to verify attack frequency). Study subjects were normotensive throughout the trial, but did experience a 11/7 decline in BP. CAN was found to produce a statistically significant reduction in number of days with headache (13.6 vs 18.5), headache severity index, and level of disability. ARBs may be a new tool for prevention of migraine, especially because of their very favorable tolerability profile.
Syncope, Driving Recommendations, and Clinical Reality: Survey of Patients
Source: Maas R, et al. BMJ. 2003; 326:21.
Patients who suffer syncope disorders, similarly to those who have seizures, are at increased risk for themselves and others when driving. Detailed guidance has been devised for clinicians to assist patients in making decisions about the appropriateness of driving when seizure-free, and some countries have provided recommendations about driving for persons with syncope. For instance, the European task force guidelines state " . . . a person with recurrent syncope should be advised not to drive until a cause has been identified and symptoms are controlled." Whether patients choose to follow health professional guidance on such matters has been little studied.
Maas and colleagues studied patients (n = 104) from their cardiology practice who had been referred for consultation about syncope for a 28-month period. Patients were advised about driving in accordance with the European task force guideline, and were followed for 1 year. At contact 6 months after the initial consultation, the great majority of patients (78%) recalled receiving advice about driving. Remarkably, all (100%) of the patients who had been counseled not to drive had nonetheless continued to do so, unless they had already stopped driving prior to their arrival at the cardiologists’ office (n = 7). A substantial minority of patients (18%) did suffer recurrence of syncope during the study period, one incurring injury, and another suffering a driving misadventure that did not culminate in injury.
Adherence to clinician recommendations about driving appears inadequate, and new measures for enhancing compliance merit investigation.
ACE + ARB for Diabetic and Hypersensitive Neuropathy
Source: Nakao N, et al. Lancet. 2003;361:117-124.
Angiotensin-converting-enzyme inhibitors (ACE) and angiotensin-II receptor blockers (ARB) have been demonstrated to provide significant benefits for persons with both diabetic and hypertensive nephropathy. Whether ACE + ARB will provide greater renal protection than either agent alone is an area of intensive study, with initial data suggesting that combination therapies will provide greater benefit.
Nakao and colleagues prospectively studied patients (n = 263) with nondiabetic nephropathy, with at least 300 mg/24 hr microalbuminuria. Patients were randomly assigned to ARB (losartan 100 mg/d), ACE (trandolapril 6 mg/d), or ACE + ARB. The primary end point was the combination of doubling of serum creatinine or end stage renal disease; secondary end points were changes in blood pressure, proteinuria, and adverse effects.
At 3 years’ follow-up, the combination therapy had performed substantially better than either monotherapy: primary end point was reached by 11% (ACE + ARB), 23% (ARB), and 23% (ACE). Similar benefits were seen in patients whether they were at the stage of microalbuminuria or had progressed to overt proteinuria. No severe adverse reactions were seen. Nakao et al have demonstrated substantial efficacy enhancement of ACE + ARB over either agent alone.
Action and Efficacy of a Combination of Calcipotriene and Betamethasone Dipropionate in the Treatment of Psoriasis
Source: Papp K, et al. J Am Acad Dermatol. 2003;48:48-54.
Both calcipotriene (Dovonex®) and topical steroids (STR) have been proven effective in management of psoriasis. Calcipotriene (CPT) has been demonstrated to be more effective than steroids, and safe over long-term use (up to 1 year). The currently available delivery systems for topical CPT and topical steroids are not compatible. Since CPT and STR appear to work by different, potentially complementary mechanisms, the concept of combination therapy is appealing. Papp and colleagues assessed the efficacy of a new formulation containing both agents administered simultaneously.
This prospective, randomized, double-blind trial (n = 1028) compared CPT + STR vs CPT alone, STR alone, or vehicle alone. Subjects were followed for 4 weeks and assessed by the Psoriasis Area and Severity Index.
CPT + STR was statistically significantly more effective than either agent alone or vehicle. Additionally, onset of benefit was seen sooner with combination therapy. There was no increase in adverse events noted with application of the combination agent vs individual components. A combination CPT + STR product will be a welcome addition to psoriasis therapy.
Ice Cream-Evoked Headaches Study: A Randomized Trial of Accelerated vs Cautious Eating; Treatment of Antidepressant-Associated Sexual Dysfunction with Sildenafil; Prophylactic Treatment of Migraine with an Angiotensin II Receptor Blocker; Syncope, Driving Recommendations, and Clinical Reality: Survey of Patients; ACE + ARB for Diabetic and Hypersensitive Neuropathy; Action and Efficacy of a Combination of Calcipotriene and Betamethasone Dipropionate in the Treatment of Psoriasis
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