Clinical Briefs

By Louis Kuritzky, MD

Fluid Extract of Echinate Purpurea on the Incidence and Severity of Colds and Respiratory Infections

Up until the advent of antibiotics, Echinate was the most prominently sold American medical plant in the United States. Echinate-related products remain extremely popular in Europe, particularly in Germany. Echinate products have been used to treat chronic arthritis, cancer, Candida infection, chronic fatigue syndrome, and chronic pelvic infections. The current study examined the efficacy of Echinate purpurea fluid extract on colds and respiratory infections.

Adults (n = 109) were enrolled for an eight-week, placebo-controlled treatment period during which they received either 4 mL placebo juice twice daily or fluid extract of Echinate purpurea. Each subject had a history of at least four respiratory infections in the previous year. Primary outcome measures were the incidence and severity of colds and respiratory infections.

During the eight-week study period, there were no significant differences in incidence, severity, or duration of respiratory infections. Adverse events trended toward greater frequency in the Echinate group, as did treatment dropouts, but adversities were mild and reversible. So, the drug commission of German physicians recommends against the use of Echinate as an immunostimulator pending further data.

Grimm W, Muller H. Am J Med 1999; 106:138-143.

Long-term Maintenance of Weight Loss after a Low-Calorie Diet: A Randomized Blinded Trial of the Efficacy and Tolerability of Sibutramine

Although low-calorie diets (< 800 calories daily) have proven beneficial over the short term, maintenance of weight loss remains problematic. There have been few trials of pharmacotherapy combined with a low-calorie diet. The current study is a 12-month, double-blind trial of sibutramine in addition to a very low calorie diet for obesity.

Study subjects (n = 160) were required to have a baseline body mass index greater than 30. After a four-week, low-calorie diet, subjects were given sibutramine 10 mg daily, and their diet was changed to a reduced calorie intake calculated to be 20-30% less than their pre-study diet. Subjects were followed monthly for one year.

The placebo recipients gained an average of 0.5 kg over 12 months, compared with a 5.2 kg loss in recipients of sibutramine. Also, sibutramine treatment was associated with favorable changes in triglyceride and HDL levels when compared with placebo. Sibutramine treatment was associated with greater likelihood of maintaining more than 50% of initial weight loss than placebo. Withdrawal from treatment was infrequent (4%) but twice as common among placebo recipients. Apfelbaum and colleagues conclude that sibutramine is effective in maintaining, and even enhancing, weight loss after a low-calorie diet.

Apfelbaum M, et al. Am J Med 1999; 106:179-184.

Lack of Effectiveness of Bed Rest for Sciatica

Bed rest has been the tradition-al cornerstone of conservative therapy for sciatica, although mounting evidence against its efficacy has appeared in recent years. This randomized, controlled trial compared two weeks of bed rest, reportedly a commonplace recommendation for sciatica in the Netherlands, with up-and-about ad-lib advice, in patients referred by 50 general practitioners.

All patients (n = 183) suffered acute low back pain radiating below the gluteal fold, without evidence of progressive nerve damage or cauda equina syndrome. Outcomes measured included overall satisfaction with care, chief symptom control, degree of leg pain, and degree of back pain, as measured at two and 12 weeks.

There were no significant differences between the two groups at either 2 or 12 weeks for any of the outcome measures, even though the bed rest group maintained a supine position for an average of 21 hours daily throughout the study period. Even in the subgroup of patients with MRI-proven nerve root compression, no evidence of improved outcome with bed rest was seen. Vroomen and associates conclude that bed rest shows no advantage over watchful waiting with traditional activities as tolerated.

Vroomen PC, et al. N Engl J Med 1999;340:418-423.