Clinical Health Updates

Bariatric surgery reduces all-cause mortality in morbidly obese

Clinical Question:
Does bariatric surgery reduce all-cause mortality?

Bottom Line:
This nonrandomized controlled trial showed that bariatric surgery results in sustained weight loss of 14% to 25% after 10 years and also reduces all-cause mortality.

Reference:
Sjostrom L, Narbro K, Sjostrom CD, et al, for the Swedish Obese Subjects Study. Effects of bariatric surgery on mortality in Swedish obese subjects. N Engl J Med 2007;357:741-752.

Study Design:
Non-randomized controlled trial

Synopsis:
Obesity is associated with increased mortality. Weight loss improves cardiovascular risk factors, but no prospective interventional studies have reported whether weight loss decreases overall mortality. In fact, many observational studies suggest that weight reduction is associated with increased mortality. They did a prospective, controlled Swedish Obese Subjects study involved 4047 obese subjects. Of these subjects, 2010 underwent bariatric surgery (surgery group) and 2037 received conventional treatment (matched control group). We report on overall mortality during an average of 10.9 years of follow-up. At the time of the analysis (November 1, 2005), vital status was known for all but three subjects (follow-up rate, 99.9%). The average weight change in control subjects was less than +/-2% during the period of up to 15 years during which weights were recorded. Maximum weight losses in the surgical subgroups were observed after 1 to 2 years: gastric bypass, 32%; vertical-banded gastroplasty, 25%; and banding, 20%. After 10 years, the weight losses from baseline were stabilized at 25%, 16%, and 14%, respectively. There were 129 deaths in the control group and 101 deaths in the surgery group. The unadjusted overall hazard ratio was 0.76 in the surgery group (P=0.04), as compared with the control group, and the hazard ratio adjusted for sex, age, and risk factors was 0.71 (P=0.01). The most common causes of death were myocardial infarction (control group, 25 subjects; surgery group, 13 subjects) and cancer (control group, 47; surgery group, 29).

High-protein, low-carb diet associated with increased mortality in women

Clinical Question:
Is a diet high in protein and low in carbohydrates beneficial to women’s health?

Bottom Line:
There is an association between women?s mortality risk and a diet that is low in carbohydrates, high in protein, or both. The strength of this association is reinforced by a dose-response gradient in the observations, as well as the additive effects of low carbohydrates and high protein.

Reference:
Lagiou P, Sandin S, Weiderpass E, et al. Low carbohydrate-high protein diet and mortality in a cohort of Swedish women. Journal of Internal Medicine 2007;261:366-374.

Study Design:
Cohort (prospective)

Synopsis:
The long-term health consequences of diets used for weight control are not established. They evaluated the association of the frequently recommended low carbohydrate diets – usually characterized by concomitant increase in protein intake – with long-term mortality. The Women’s Lifestyle and Health cohort study initiated in Sweden during 1991-1992, with a 12-year almost complete follow up. The study was done in The Uppsala Health Care Region. Included were 42,237 women, 30-49 years old at baseline, volunteers from a random sample, who completed an extensive questionnaire and were traced through linkages to national registries until 2003. They evaluated the association of mortality with: decreasing carbohydrate intake (in deciles); increasing protein intake (in deciles) and an additive combination of these variables (low carbohydrate-high protein score from 2 to 20), in Cox models controlling for energy intake, saturated fat intake and several nondietary covariates. Decreasing carbohydrate or increasing protein intake by one decile were associated with increase in total mortality by 6% (95% CI: 0-12%) and 2% (95% CI: -1 to 5%), respectively. For cardiovascular mortality, amongst women 40-49 years old at enrolment, the corresponding increases were, respectively, 13% (95% CI: -4 to 32%) and 16% (95% CI: 5-29%), with the additive score being even more predictive.

Communication between hospitalist and primary care physician suboptimal

Clinical Question:
At patient discharge, how frequently do deficits in communication and information transfer occur, and which interventions improve this process?

Bottom Line:
Deficits in communication and information transfer at hospital discharge are common and may adversely affect patient care. Interventions such as computer-generated summaries and standardized formats may facilitate more timely transfer of pertinent patient information to primary care physicians and make discharge summaries more consistently available during follow-up care.

Reference:
Kripalani S, LeFevre F, Phillips CO, Williams MV, Basaviah P, Baker DW. Deficits in communication and information transfer between hospital-based and primary care physicians: implications for patient safety and continuity. JAMA 2007;297:831-841. of care.

Study Design:
Meta-analysis (other)

Synopsis:
Delayed or inaccurate communication between hospital-based and primary care physicians at hospital discharge may negatively affect continuity of care and contribute to adverse events. The authors characterized the prevalence of deficits in communication and information transfer at hospital discharge and to identify interventions to improve this process. Data gathered from MEDLINE (through November 2006), Cochrane Database of Systematic Reviews, and hand search of article bibliographies. They selected only observational studies investigating communication and information transfer at hospital discharge (n = 55) and controlled studies evaluating the efficacy of interventions to improve information transfer (n = 18). Data from observational studies were extracted on the availability, timeliness, content, and format of discharge communications, as well as primary care physician satisfaction. Results of interventions were summarized by their effect on timeliness, accuracy, completeness, and overall quality of the information transfer. Direct communication between hospital physicians and primary care physicians occurred infrequently (3%-20%). The availability of a discharge summary at the first postdischarge visit was low (12%-34%) and remained poor at 4 weeks (51%-77%), affecting the quality of care in approximately 25% of follow-up visits and contributing to primary care physician dissatisfaction. Discharge summaries often lacked important information such as diagnostic test results (missing from 33%-63%), treatment or hospital course (7%-22%), discharge medications (2%-40%), test results pending at discharge (65%), patient or family counseling (90%-92%), and follow-up plans (2%-43%). Several interventions, including computer-generated discharge summaries and using patients as couriers, shortened the delivery time of discharge communications. Use of standardized formats to highlight the most pertinent information improved the perceived quality of documents.

Botulinum toxin A effective for axillary hyperhidrosis

Clinical Question:
Are botulinum toxin type A injections safe and effective in the management of adults with axillary hyperhidrosis?

Bottom Line:
Botulinum toxin type A (Botox) injections are safe and effective for the treatment of adults with axillary hyperhidrosis. The duration of effect in this study was approximately 200 days.

Reference:
Lowe NJ, Glaser DA, Eadie N, et al, for the North American Botox in Primary Axillary Hyperhidrosis Clinical Study Group. Botulinum toxin type A in the treatment of primary axillary hyperhidrosis: A 52-week multicenter double-blind, randomized, placebo-controlled study of efficacy and safety. J Am Acad Dermatol 2007;56:604-611.

Study Design:
Randomized controlled trial (double-blinded)

Synopsis:
The long-term effects of botulinum toxin type A (BoNTA) on the global impairment associated with severe primary axillary hyperhidrosis have not been comprehensively assessed relative to placebo. The authors assessed the efficacy and safety of 2 dosages of BoNTA compared with placebo in subjects with primary axillary hyperhidrosis. Subjects (N = 322) were randomized to the use of BoNTA (75 U or 50 U/axilla) or placebo in this 52-week, multicenter, double-blind study. BoNTA treatment significantly reduced daily activity limitations at 4 weeks after injection. A 2-point improvement on the 4-point Hyperhidrosis Disease Severity Scale (HDSS) was reported in 75% of subjects in the 75-U and 50-U BoNTA groups and in 25% of the placebo group (P < .001). Improvements in HDSS scores were corroborated by gravimetric results. The median duration of effect was 197 days, 205 days, and 96 days in the 75-U, 50-U, and placebo groups, respectively. BoNTA was well tolerated.
LIMITATIONS: The effect of total surface area involvement on treatment efficacy was not evaluated.

Botulinum might be more effective than nitroglycerine in anal fissure

Clinical Question:
Is type A botulinum toxin more effective than nitroglycerine ointment in treating chronic anal fissure?

Bottom Line:
In this study, botulinum toxin (Botox, Dysport) appeared slightly more effective than topical nitroglycerine in managing chronic anal fissures.

Reference:
Brisinda G, Cadeddu F, Brandara F, Marniga G, Maria G. Randomized clinical trial comparing botulinum toxin injections with 0.2 per cent nitroglycerin ointment for chronic anal fissure. Br J Surg 2007;94:162-167.

Study Design:
Randomized controlled trial (single-blinded)

Synopsis:
In recent years treatment of chronic anal fissure has shifted from surgical to medical. These authors compared the ability of two non-surgical treatments-botulinum toxin injections and nitroglycerin ointment-to induce healing in patients with idiopathic anal fissure. One hundred adults were assigned randomly to receive treatment with either type A botulinum toxin (30 units Botox or 90 units Dysport) injected into the internal anal sphincter or 0.2 per cent nitroglycerin ointment applied three times daily for 8 weeks. After 2 months, the fissures were healed in 46 (92 per cent) of 50 patients in the botulinum toxin group and in 35 (70 per cent) of 50 in the nitroglycerin group (P=0.009). Three patients in the botulinum toxin group and 17 in the nitroglycerin group reported adverse effects (P<0.001). Those treated with botulinum toxin had mild incontinence to flatus that lasted 3 weeks after treatment but disappeared spontaneously, whereas nitroglycerin treatment was associated with transient, moderate-to-severe headaches. Nineteen patients who did not have a response to the assigned treatment crossed over to the other therapy.

History of fall and gait/balance problem confer high risk for falls

Clinical Question:
What clinical factors predict a high risk for falls in the elderly?

Bottom Line:
Screening for risk of falling during the clinical examination begins with determining if the patient has fallen in the past year. For patients who have not previously fallen, screening consists of an assessment of gait and balance. Patients who have fallen or who have a gait or balance problem are at higher risk of future falls.

Reference:
Ganz DA, Bao Y, Shekelle PG, Rubenstein LA. Will my patient fall? JAMA 2007;297:77-86.

Study Design:
Decision rule (development only)

Synopsis:
Effective multifactorial interventions reduce the frequent falling rate of older patients by 30% to 40%. However, clinical consensus suggests reserving these interventions for high-risk patients. Limiting fall prevention programs to high-risk patients implies that clinicians must recognize features that predict future falls. The authors identified the prognostic value of risk factors for future falls among older patients. Search of MEDLINE (1966-September 2004), CINAHL (1982-September 2004), and authors’ own files to identify prospective cohort studies of risk factors for falls that performed a multivariate analysis of such factors. Two reviewers independently determined inclusion of articles and assessed study quality. Disagreements were resolved by consensus. Included studies were those identifying the prognostic value of risk factors for future falls among community-dwelling persons 65 years and older. Clinically identifiable risk factors were identified across 6 domains: orthostatic hypotension, visual impairment, impairment of gait or balance, medication use, limitations in basic or instrumental activities of daily living, and cognitive impairment. Eighteen studies met inclusion criteria and provided a multivariate analysis including at least 1 of the risk factor domains. The estimated pretest probability of falling at least once in any given year for individuals 65 years and older was 27% (95% confidence interval, 19%-36%). Patients who have fallen in the past year are more likely to fall again [likelihood ratio range, 2.3-2.8]. The most consistent predictors of future falls are clinically detected abnormalities of gait or balance (likelihood ratio range, 1.7-2.4). Visual impairment, medication variables, decreased activities of daily living, and impaired cognition did not consistently predict falls across studies. Orthostatic hypotension did not predict falls after controlling for other factors.