Sunday, September 27, 2009

Consensus Statement Updated on Management of Hyperglycemia in Type 2 Diabetes

From Medscape Medical News
Laurie Barclay, MD

Diabetologia. Published online October 22, 2008.

Clinical Context

Good glycemic control can significantly lower morbidity rates related to type 2 diabetes and is therefore a vitally important treatment goal. Lowering and keeping glucose levels as close to the normal range as possible has been shown to reduce microvascular complications of diabetes, including retinopathy, nephropathy, and neuropathy.

In August 2006, the ADA and EASD published a consensus algorithm for the medical management of type 2 diabetes. An update in January 2008 specifically highlighted safety concerns regarding the thiazolidinediones, whereas this current update focuses on new classes of medications for which more clinical data and wider experience are now available.

Study Highlights

In type 2 diabetes, an important therapeutic goal is to achieve and to maintain hemoglobin A1c levels of less than 7.0%.

For most patients with type 2 diabetes, the initial treatment approach (tier 1, step 1) with well-validated therapies should include lifestyle intervention and use of metformin, titrated to its maximally effective dose at 1 to 2 months.

Lifestyle changes should aim to improve glucose levels, blood pressure, lipid levels, and weight control.

When tier 1, step 1 fails to achieve or maintain target glycemic goals, other medications should be added rapidly, and new regimens should be started.

If target hemoglobin A1c level is not achieved with step 1, or if metformin is contraindicated or poorly tolerated, step 2 is to add another medication, either insulin or a sulfonylurea.
Insulin, typically a basal (intermediate- or long-acting) insulin, is preferred for patients who have a hemoglobin A1c level of more than 8.5% or hyperglycemic symptoms.
Insulin plus metformin is a particularly effective means to lower glycemia while limiting weight gain.
In step 3, insulin therapy is started or intensified by giving additional injections, usually a short- or rapid-acting insulin given before selected meals, to reduce postprandial glucose levels.
Once insulin injections are started, insulin secretagogues (sulfonylurea or glinides) should be discontinued, or tapered and then discontinued.
In selected clinical settings, the tier 2 algorithm, which consists of less well-validated therapies, may be considered.
For patients with hazardous jobs that would make hypoglycemia particularly dangerous, exenatide or pioglitazone may be added, but rosiglitazone is not recommended.
Exenatide may be considered for patients who need to lose weight and in whom hemoglobin A1c level is close to target (< 8.0%).
If these interventions do not achieve target hemoglobin A1c levels or are not tolerated, tier 2 interventions should be stopped and basal insulin started.
The amylin agonists, alpha-glucosidase inhibitors, glinides, and dipeptidyl peptidase 4 inhibitors may be appropriate for selected patients.
However, they are not included in the 2 tiers of preferred agents because their efficacy to lower glucose is less or equivalent vs the first- and second-tier agents, they are relatively expensive, and clinical data regarding their use are limited.
Selecting individual agents should be based on their efficacy to lower glucose and on other characteristics.
When adding second antihyperglycemic medications, the synergy of particular combinations and other drug interactions should be considered.
Antihyperglycemic drugs with different mechanisms of action typically have the greatest synergy.

Pearls for Practice

In type 2 diabetes, an important therapeutic goal is to achieve and to maintain hemoglobin A1c levels less than 7.0%. For most patients, step 1 is lifestyle intervention and metformin. When this fails to achieve or maintain target glycemic goals, other medications should be added rapidly, and new regimens should be started. Step 2 is to add another medication, either insulin or a sulfonylurea. In step 3, insulin therapy is started or intensified.

The tier 2 algorithm using less well-validated therapies may be considered in selected patients. For those in whom hypoglycemia would be particularly dangerous, exenatide or pioglitazone may be added, but rosiglitazone is not recommended. Exenatide may be considered for patients who need to lose weight and in whom hemoglobin A1c level is close to target (< 8.0%),

Rapid Flu Tests Miss Many Swine Flu Cases: CDC

From Reuters Health Information

By Julie Steenhuysen

CHICAGO (Reuters) Sep 24 - A study of rapid influenza tests found they miss many cases of swine flu and U.S. health experts said on Thursday they are not worth the trouble for this flu season.

A study looking at the effectiveness of a rapid flu test in the first few weeks of the H1N1 pandemic in May found it detected less than half of the cases later confirmed by more sophisticated tests.

The findings, which appeared in the U.S. Centers for Disease Control and Prevention's MMWR, confirm the CDC's current guidelines, which stress that people with flu-like symptoms should get quick treatment, before getting a flu test.

Health and Human Services Secretary Kathleen Sebelius told reporters at a briefing that doctors should simply treat symptoms and not bother with testing.

"The flu is the flu is the flu," she said.

In September, the CDC said doctors should not wait for laboratory confirmation of H1N1 because quick treatment is important, and because a negative rapid test does not rule out the flu.

The latest study, conducted by Dr. James Sabetta and colleagues at the Greenwich Hospital and the Greenwich Department of Health in Connecticut, shows why.

They collected data on patients from two school outbreaks of pandemic H1N1 flu in May. They did rapid flu diagnostic tests on 63 patients using the Xpect Flu A&B test by Remel, a unit of Thermo Fisher Scientific, and more sophisticated lab tests.

They found the rapid flu test detected just 47 percent of the pandemic flu cases later confirmed by the slower, but highly accurate real-time reverse transcription-polymerase chain reaction, or rRT-PCR.
The findings confirm an earlier study by the CDC that found quick flu tests caught just 40 to 69 percent of swine flu cases. That study, released in August, looked at three popular flu tests -- BinaxNow, made by Inverness Medical Innovations, Becton Dickinson's Directigen EZ Flu A+B test and Quidel's QuickVue.

The CDC said the findings confirm their current guidelines, and stress that treating flu -- whether seasonal or pandemic -- is more important than knowing what kind a person has.
"Almost everybody will almost certainly not know what kind of flu they had," Dr. Anne Schuchat of the CDC told the briefing.

Many companies are working on better rapid tests including GlaxoSmithKline and Enigma Diagnostics, Seegene, a company based in South Korea and Maryland, DxNA based in Utah, and Osmetech PLC, based in California.

MMWR September 24, 2009.

Friday, September 25, 2009

Extended Physiotherapy, High-Dose Vitamin D Reduces Post-Hip Fracture Falls

From Medscape Medical News
Nancy A. Melville

September 22, 2009 (Denver, Colorado) — Extended physiotherapy, along with high-dose supplementation of vitamin D, after hip fracture can significantly improve the rate of falls and hospital readmissions for the elderly, according to a study presented here at the American Society for Bone and Mineral Research (ASBMR) 31st Annual Meeting.

High rates of post-hip-fracture morbidity and mortality are a heavy socioeconomic burden, yet there are no well-established guidelines for postfracture care among the elderly, said lead author Heike A. Bischoff-Ferrari, MD, professor of medicine at the University of Zurich in Switzerland. "Guidelines for postfracture care of elderly hip-fracture patients are not established, despite the fact that in the first 12 months after hip fracture, 5% to 10% of patients fracture their other hip, 30% are readmitted to acute care, 50% are left with permanent functional decline, 25% require long-term care, and 10% to 25% die," Dr. Bischoff-Ferrari said in an interview with Medscape Ob/Gyn & Women's Health.


To determine whether a strategy combining a home-based physiotherapy program and a vitamin D regimen could reduce some of the sequelae of hip fracture, the researchers enrolled 173 acute hip-fracture patients in their study; 79% were women with a mean age of 84 years and 77% were living in the community.

The researchers compared the effects of extended physiotherapy, which consisted of 1 hour of supervised physiotherapy per day during acute care plus an unsupervised home physiotherapy program, with those of standard physiotherapy, which consisted of 30 minutes of supervised physiotherapy per day during acute care and no home program.

The home-based physiotherapy involved basic exercises, such as getting in and out of a chair, balancing on 1 leg, walking up and down stairs, and a simple rubber-band exercise for upper-arm strength, Dr. Bischoff-Ferrari said.

The researchers also assessed the effects of 2000 IU of vitamin D3 per day, compared with 800 IU units per day, and the effect that the combined physiotherapy and vitamin D3 components had on the rate of falls and readmissions to the hospital.

Over the course of a 12-month follow-up, the researchers documented a total of 212 falls, with a rate of 1.43 falls per observed patient-year, and 74 hospital readmissions, with a rate of 0.5 per observed patient-year.

Falls among patients in the extended physiotherapy group were significantly reduced by 25%. Patients taking 2000 IU of vitamin D had a rate of hospital readmission that was 39% lower than those taking 800 IU of vitamin D per day.

The lower readmission rate could be explained by the 60% reduction in fall-related injuries and the 90% reduction in infections leading to inpatient care seen among the higher-dose vitamin D group, Dr. Bischoff-Ferrari said.

"Our study demonstrated that an extended physiotherapy program, together with 2000 IU of vitamin D, has complementary benefits for post-hip-fracture care, including a significant 25% reduction in falls and a 39% reduction in hospital readmission," she said. "This regimen could have an exceptional benefit on improving post-hip-fracture care for the elderly."

Jonathan D. Adachi, MD, professor of medicine at McMaster University in Hamilton, Ontario, said the study is particularly notable, not just for the improvements seen with the extended physiotherapy, but for the role of vitamin D.

"The study is very important because it demonstrates the benefit of both vitamin D and physiotherapy," said Dr. Adachi, who was not involved in the study.

"What is particularly important is the dose of vitamin D; most guidelines do not recommend this high a dose of vitamin D and many doctors do not recommend this dose of 2000 IU."

American Society for Bone and Mineral Research (ASBMR) 31st Annual Meeting: Abstract 1097. Presented September 12, 2009.

Monday, September 14, 2009

Depression Affects Survival in Cancer Patients

From Medscape Medical News
Roxanne Nelson

September 14, 2009 — The presence of depression might adversely affect outcomes in cancer patients. According to the findings of a meta-analysis, published online September 14 in Cancer, depression is a small but significant predictor of mortality in cancer patients.

Among patients experiencing depressive symptoms, mortality rates were up to 26% higher (unadjusted risk ratio [RR], 1.25; 95% confidence interval [CI], 1.12 - 1.40; P < .001) and among patients diagnosed with major or minor depression were up to 39% higher (unadjusted RR, 1.39; 95% CI, 1.10 - 1.89; P =.03) than those without these symptoms.

Conversely, depressive symptoms did not appear to significantly predict disease progression.

"Our meta-analysis did show an increased risk of risk of death in patients who report more depressive symptoms than others, and also in patients who have been diagnosed with a depressive disorder, compared with patients who have not," said first author Jillian R. Satin, MA, a doctoral student in clinical psychology at the University of British Columbia in Vancouver.

However, she emphasized that this study only shows that a link exists. "We cannot prove with this evidence that depression actually causes the increase in mortality," she told Medscape Oncology. "More research will be needed in order to potentially conclude this."

It is never too early in the course of cancer for patients to begin a dialogue with their physicians about mental-health issues.

A certain level of distress is expected after the diagnosis of cancer, Ms. Satin explained. "In our study, we restricted our analysis to studies that measure depression at least 1 month after diagnosis," she said. "Therefore, this is the time frame that our study makes conclusions about."

It can be difficult to define what a "normal" response to a cancer diagnosis looks like, Ms. Satin added, "but it is never too early in the course of cancer for patients to begin a dialogue with their physicians about mental-health issues."

Inconclusive Evidence Prompts Meta-Analysis

Depression has been widely studied in cancer patients, and is the most commonly studied psychological variable with respect to cancer progression and mortality in this population, the authors report. Depression is also the only psychological condition that is more commonly found in cancer patients than in the general population, and is the psychological problem most likely to persist throughout the illness trajectory.

The authors also point out that "a plausible model exists to link depression with cancer progression and mortality through both behavioral and biological pathways." An example is chronic activation of the hypothalamo-pituitary–adrenal axis, which has been implicated as a possible mediator of the effect of depression on disease progression in cancer. Depression has also been associated with inflammation, as previously reported by Medscape Oncology.

Although cancer patients and oncologists believe that psychological variables can influence the course of cancer, the evidence remains inconclusive. For this reason, Ms. Satin and colleagues conducted a meta-analysis to evaluate the extent to which depressive symptoms and major depressive disorder predict disease progression and mortality in cancer patients.

Depression Linked to Mortality but Not Progression

To examine the effects of depression on survival, the researchers identified 27 observational studies (n = 9417), conducted from 1990 to 2009, which met all of their inclusion criteria. Of this group, 25 independent studies were based on measures of depressive symptoms, 3 were based on major or minor depression, 16 evaluated survival at less than 5 years postdiagnosis, and 11 examined survival at 5 years postdiagnosis or more.

"There is no evidence that the effect weakens when adjustments are made for other known risk factors, suggesting that depression may be an independent risk factor in cancer mortality, rather than merely correlating with biological factors associated with a poor prognosis," they write.

Only 3 studies were available for an analysis of the risk for depression on cancer progression, and depressive symptoms did not significantly predict disease progression (unadjusted RR,= 1.23; 95% CI, 0.85 - 1.77; P = .28).

The authors found it "surprising" that depression appeared to predict mortality but not disease recurrence, and postulated that the difference was primarily due to the limited number of studies in their analysis and the corresponding low power.

What Are the Latest Childhood Vaccine Recommendations?

From Medscape Nurses > Ask the Experts
Wendy L. Wright

Pediatric

All children aged 6 months to 18 years should be immunized against influenza. In the past, only high-risk children were immunized against seasonal influenza. Now, all children, regardless of risk, should receive this immunization. It is estimated that this recommendation means that approximately 50 million children will need the influenza vaccination this year. It is important, particularly in 2009, that clinicians begin to immunize against influenza as soon as the vaccines are received in the office. This will make way for the receipt of the H1N1 vaccine, which is anticipated in October or November of this year. Clinicians can be assured that although we will begin the immunization campaign in early September, much earlier than in the past, it will protect children throughout flu season.[1]

Patients aged 6 months to 24 years as well as those at high risk as a result of pulmonary or cardiac conditions should receive the H1N1 vaccination when it becomes available. At the time of this writing, this vaccination will probably be a series of 2 vaccinations, separated by 3 weeks. The first injection may be administered at the same time as the seasonal influenza vaccine, if it has not already been given. The vaccine will be purchased by the federal government and shipped to the states for distribution and administration. Each state is in charge of implementing the distribution and administration of the vaccine. While we are anticipating release of the vaccine in October, clinical trials for efficacy and safety are still under way.[1,2]

A combination vaccine named Pentacel is now available for infants. This combination vaccine provides protection against diphtheria, tetanus, and pertussis; polio; and Haemophilus influenzae type B. Depending on the state in which you practice and the vaccines to which you have access, this series may decrease the number of injections given to children by up to 7 shots. It consists of 4 injections administered at 2, 4, 6, and 15-18 months.[1]

The restrictions on H. influenzae type B vaccination have now been relaxed. Healthcare providers should attempt to "catch up" the children who missed dose number 4 of the series due to a lengthy shortage of the vaccine.[1]

There are currently 2 rotavirus vaccines available. RotaTeq is a series of 3 oral vaccinations given at 2, 4, and 6 months and Rotarix is a series of 2 oral vaccinations administered at 2 and 4 months. Providers must be aware of which vaccine product they are using to make certain that the correct schedule is followed

Adolescents

All adolescents age 11-18 years should receive the meningococcal (MCV4 or Menactra) vaccine. In the past, this vaccine was often recommended to be given just before a student went to college. However, the Advisory Committee on Immunization Practices now recommends that all children be immunized with MCV4 to provide protection against 4 strains of Neisseria meningitidis beginning at 11 years. It should be noted that children at high risk due to travel or immunosuppressive conditions may receive the vaccine as early as 2 years of age and may have it repeated, if high risk, 5 years after the initial vaccination.[1]

HPV (human papillomavirus) vaccine is recommended for all young women age 9-26 years as a 3-part series. The series is frequently initiated at 11 years of age but may be given as early as 9 years of age. It is administered according to the following schedule: day 0, 2 months after day 0, and 6 months after day 0. Healthcare providers should observe the recipient for 15 minutes following administration of the vaccine. In addition, the vaccinator may wish to place the child in a semirecumbent position during administration due to reports of syncope after vaccine administration.[1]

Tdap (combined tetanus, diphtheria, and pertussis) should be administered to all adolescents age 11 years and older. This additional pertussis protection should be given once to all adolescents and adults who have not received a pertussis booster.

Individuals 65 years of age and older should be given Td only, as the pertussis component has not been deemed safe or efficacious for this age cohort.

Saturday, September 12, 2009

New Review Endorses Cardiovascular Benefits of Fish Oil

From Heartwire
Lisa Nainggolan

August 10, 2009— A new review concludes that there is extensive evidence from three decades of research that fish oils, or more specifically the omega-3 polyunsaturated fatty acids (PUFAs) contained in them, are beneficial for everyone.

This includes healthy people as well as those with heart disease — including postmyocardial infarction (MI) patients and those with heart failure, atherosclerosis, or atrial fibrillation — say Dr Carl J Lavie (Ochsner Medical Center, New Orleans, LA) and colleagues in their paper published online August 3, 2009, in the Journal of the American College of Cardiology.

"We reviewed everything that was published on omega-3 that was clinically important, and the major finding is that there are a tremendous amount of data to support the benefits of omega-3, not just as a nutritional supplement — people have known that for years — but evidence that it prevents and treats many aspects of cardiovascular disease," Lavie told heartwire .

Lavie said he believes physicians are not as familiar with the omega-3 studies as they should be: "Clinicians know the findings of many statin trials even if they do not know all the details — they know that there are a ton of statin data. The omega-3 data may not be as impressive or as plentiful as this, but it should be 'promoted' to clinicians."

Omega-3 PUFA, says Lavie, "is a therapy that clinicians should be considering prescribing to their patients. Not just as something healthy but as something that may actually prevent the next event. In HF [heart failure], it may prevent death or hospitalization and the same thing post-MI." He and his colleagues reiterate the advice of the American Heart Association (AHA): that those with known coronary heart disease (CHD) or HF eat four or five oily-fish meals per week or take the equivalent in omega-3 supplements; healthy people should consume around two fatty-fish meals per week or the same in supplements.

Most Data on EPA and DHA

In their review, Lavie and colleagues explain that most of the data on omega-3 have been obtained in trials using docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA), the long-chain fatty acids in this family. The most compelling evidence for cardiovascular benefits comes from four controlled trials of almost 40,000 participants randomized to receive EPA with or without DHA in studies of primary prevention, after MI, and most recently with HF, they note.

They discuss the results for each specific cardiovascular condition in turn. For CHF, three large randomized trials — the Diet and Reinfarction Trial (DART), the Gruppo Italiano per lo Studio della Sopravvivenza nell' Infarto Miocardico (GISSI)-Prevenzione, and the Japan EPA Lipid Intervention Study (JELIS) — have indicated that omega-3 PUFAs lower CV risk in both the primary- and secondary-prevention settings, they note.

Lavie elaborated to heartwire : "The benefit is different in different studies but can be as much as 30%." The effects are seen on total mortality, sudden death, CHD mortality, and cardiovascular mortality.

But there are some studies that have not shown favorable results, although there are generally methodological reasons for this, they say. However, they do flag the most recent study of post-MI patients, OMEGA, which suggests there may not be additional short-term benefit of omega-3 PUFAs in low-risk patients already receiving optimal modern therapy.

There is also evidence of benefit in atherosclerosis and in a wide range of arrhythmias, with the most significant effect and potential benefit seen in "the current epidemic" of atrial fibrillation (AF), note the researchers. But more studies are needed to explore the effects of various doses of omega-3 PUFAs on the primary and secondary reduction of AF and to determine whether the benefits are caused by antiarrhythmic effects, benefits on autonomic tone, or even anti-inflammatory effects, they observe.

Benefit of Fish Oils Also Extend to HF

Recently, the potential benefits of omega-3 PUFAs "have been extended to the prevention and treatment of HF," say Lavie et al. Although the reduction in events was "only 8% to 9% in the recent GISSI-HF trial, which is not huge," Lavie admits, "when you think of HF, it's a very serious disorder, and in GISSI-HF, those patients were treated vigorously for their HF, so they were on good therapy, and adding just one [omega-3 PUFA] pill a day reduced deaths by between 8% and 9%, which is a pretty nice additional benefit."

But he and his colleagues say further studies are needed to determine the optimal dosing of omega-3 PUFA for different stages of HFand to investigate the underlying mechanisms for the benefits. However, in the meantime, omega-3 PUFA supplements "should join the short list of evidence-based life-prolonging therapies for HF."

They also discuss the data on omega-3 PUFAs in hyperlipidemia, noting that the FDA has approved one such supplement for the treatment of very high triglyceride levels.

And they note that more studies are needed to determine the optimal mix of DHA relative to EPA in various populations.

Finally, they state that this review does not focus on the plant-based precursor of EPA, alpha-linolenic acid (ALA), which is found in abundance in flaxseed and to a lesser extent in other plants. But they observe "the overall evidence is much weaker for ALA than for EPA and DHA."

Recommendations for Omega-3 Consumption

Mirroring recommendations from the AHA, European Society of Cardiology, and the World Health Organization (WHO), Lavie and colleagues recommend that healthy people consume at least 500 mg per day of EPA/DHA — equal to around two fatty-fish meals per week — and that those with known CHD or HF get 800 to 1000 mg per day EPA/DHA.

Asked by heartwire whether people should try to consume more fish or alternatively take supplements, Lavie says: "If somebody really were eating salmon and tuna and mackerel and sardines, and they were doing that several times a week, then they wouldn't need to be taking a supplement. But in the US, at least, very few people are going to eat the therapeutic doses of fatty fish."

Other good reasons to take supplements include the fact that they have usually had impurities, such as mercury, removed, he notes.

If people are trying to improve their consumption of oily fish, they could take supplements only on the days they were not eating such fish or every other day to try to get up to the recommended amount of omega-3 PUFAs, Lavie says.

But he warns that regimens that are too complex might result in underconsumption: "I would tend to think that most people are getting very little omega-3 PUFAs in the diet. There's no harm in taking extra — the only negative of extra is the calories. I don't think anyone thinks now that fish oil is doing any harm."

Thursday, September 10, 2009

Soluble Fiber May Be Effective for Symptoms of IBS

From Medscape Medical News CME
Laurie Barclay, MD & Charles P. Vega, MD

BMJ. 2009;339:b3154. Abstract

Clinical Context

IBS has a population-wide prevalence of approximately 10%, according to the authors of the current study. However, only a minority of individuals with IBS seek medical care for their symptoms. Most patients with IBS are women, and, although most cases of IBS are managed in primary care practices, few primary care clinicians use formal criteria to diagnose IBS.

Dietary advice and fiber supplements are considered mainstays of therapy for IBS. The current study compares a soluble fiber (psyllium) and insoluble fiber (bran) vs placebo in the treatment of IBS.


Study Highlights

Study participants included adults between the ages of 18 and 65 years who had been diagnosed with IBS in the previous 2 years. The study was conducted in primary care practices in the Netherlands. Diagnoses of IBS were identified through billing data, and researchers evaluated whether patients met formal diagnostic criteria for IBS as well.
Patients who had received fiber treatment in the past 4 weeks, who had a psychiatric disorder, or who had another diagnosis of organic bowel disease were excluded from study participation.
Participants were randomly assigned to receive 10 g of psyllium, 10 g of bran, or rice flour placebo in 2 daily dosages. Each study treatment was mixed with food, preferably yogurt. The treatment period was 3 months.

The main outcome of the study was adequate symptom relief for at least 2 weeks of the previous month, which was defined as response to treatment. Secondary outcomes included a measurement of IBS symptom severity, the severity of abdominal pain specifically, and disease-specific quality of life.
275 patients underwent randomization. 78% of participants were women, and 94% were white. The mean age of participants was 34.4 years.
Only 39% of participants fulfilled the Rome II diagnostic criteria for IBS. Most subjects had constipation-predominant IBS.
The mean intake of daily fiber before study treatment was 26.9 g/day, which was consistent with national average consumption in the Netherlands.

Only 60% of participants attended the final visit at the end of the 3-month study period. Most patients who left the trial did not provide a reason for discontinuing their participation, but study discontinuation was most common among the bran group in the first study month. Most of these patients complained of a worsening of IBS symptoms.
Among patients who remained in the trial, adherence to study therapy was similar in the psyllium and bran groups, as were the consumption of dietary fiber and total fluids.

57% of participants receiving psyllium experienced a treatment response at 1 month vs 35% of participants receiving placebo. The respective response rates at month 2 were 59% and 41%, and psyllium was significantly superior to placebo in both months. The superiority of psyllium was lost in the third month of the trial.
Subgroup analysis focusing on patients who met Rome II criteria for IBS suggested that psyllium may be even more effective for these patients. Psyllium remained more effective than placebo in an analysis limited to participants with constipation-predominant IBS.
Bran was superior to placebo in the main study outcome only in the third month of the trial.
Psyllium was associated with a significant overall reduction in IBS symptoms vs placebo, whereas bran was not.
Neither psyllium nor bran relieved IBS abdominal pain or improved quality of life vs placebo.
The percentages of participants who remained in the study and reported adverse events were 74%, 64%, and 66% in the psyllium, bran, and placebo groups, respectively. Diarrhea and constipation were the most commonly reported adverse events and were common in all treatment groups.

Clinical Implications

The prevalence of IBS is approximately 10%, with a predilection for women. Most patients with IBS do not seek medical care for their symptoms, and most primary care physicians do not use formal criteria to diagnose IBS.
The current study suggests that psyllium may relieve IBS symptoms, whereas bran may worsen symptoms.

Glaucoma Patients Can Participate in Moderate Aerobic Exercise

From Reuters Health Information
By Michelle Rizzo

NEW YORK (Reuters Health) Sep 07 - Patients with glaucoma can exercise without fear of negatively affecting their intraocular pressure, according to a study in online BMC Ophthalmology published on August 13.

"As an increasing number of people are becoming active in aerobic physical exercise such as jogging and bicycling, it would be interesting to identify any limitations or precautions concerning the effect of exercise on intraocular pressure," Dr. Irene Asouhidou, of Aristotle University of Thessaloniki, Greece, and colleagues write. "Previous studies have shown a reduction in intraocular pressure following certain forms of exercise, ranging from walking to exhausting exercise, in healthy volunteers."

However, they add, there are few data as to the effect of exercise on intraocular pressure among individuals using antiglaucoma medication.

In the current study, the researchers examined how intraocular pressure is affected in athletes, non-athletes, and glaucoma patients who perform aerobic exercise with or without the instillation of various anti-glaucoma eye medications. The study included 100 healthy subjects and 45 primary open-angle glaucoma patients.

The participants were divided into seven groups: normotensive subjects who jogged or bicycled regularly (group A, n = 25); normotensives who had their right eye instilled with the beta blocker timolol maleate 0.5% (group B, n = 40); the prostaglandin analogue latanoprost 0.005% (group C, n = 20); or the alpha-agonist brimonidine tartrate 0.2% (group D, n = 15).

The remaining groups had primary glaucoma under monotherapy with timolol maleate (group E, n = 15), latanoprost (group F, n = 15), or combined anti-glaucoma treatment (group G, n = 15) instilled in both eyes.

The researchers measured the intraocular pressure of both eyes before and after exercise.

A significant decrease in intraocular pressure was observed after exercise. Moderate aerobic exercise reduced the intraocular pressure of healthy subjects. Intraocular pressure was also reduced after exercise following instillation of a beta-blocker, a prostaglandin analogue, or an alpha-agonist. A decrease in intraocular pressure was observed in glaucoma patients already under anti-glaucoma treatment.

"Regular moderate aerobic exercise (walking, jogging, bicycle, etc.) has been proven beneficial and should be encouraged for glaucoma patients," Dr. Asouhidou told Reuters Health in an email interview. "The next step of our research is to identify how other types of exercise affect the intraocular pressure, especially in patients who are under medication for glaucoma."

BMC Ophthalmol 2009;9:6

Wednesday, September 9, 2009

Hepatitis B slideshow

Hepatitis B is a disease caused by the hepatitis B virus (HBV), discovered in 1965 by Baruch Blumberg at the National Institutes of Health. Millions of people worldwide are infected through unprotected sexual contact, hematogenous spread, or maternal-fetal transmission. Without adequate diagnosis and treatment, these individuals may go on to develop liver failure, hepatocellular carcinoma, or die. Image courtesy of the US Centers for Disease Control and Prevention (CDC).

Hepatitis B is a worldwide healthcare problem. Roughly one third of the global population has been infected with HBV, and approximately 350 million are chronic carriers. However, due to aggressive vaccination plans, screening of blood products, and antiviral therapy, hepatitis B is now mainly a disease of the developing world. Epidemics still exist in parts of Asia and Africa. In high-prevalence areas without vaccination, perinatal transmission is the major mode of transmission. Image courtesy of the CDC

for rest of slides go to:

http://www.medscape.com/features/slideshow/hepatitis

Friday, September 4, 2009

ACIP Issues Guidelines for Use of Influenza A (H1N1) 2009 Monovalent Vaccine

From Medscape Medical News
Laurie Barclay, MD

August 24, 2009 — The US Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) has issued guidelines regarding the use of vaccine against infection with novel influenza A (H1N1) virus. The new recommendations were posted online August 21 in the Morbidity and Mortality Weekly Report.

"Because novel influenza A (H1N1) virus is continuing to cause illness in the United States and worldwide, the primary focus of vaccination efforts should be to vaccinate as many persons as possible in the recommended target groups as quickly as possible once vaccine becomes available," write Anne Schuchat, MD, and colleagues from the National Center for Immunization and Respiratory Diseases, CDC.

H1N1 Vaccine Use

"As vaccine availability increases, additional groups are recommended for vaccination.... These recommendations are intended to provide vaccination programs and providers with information to assist in planning and to alert providers and the public about target groups comprising an estimated 159 million persons who are recommended to be first to receive influenza A (H1N1) 2009 monovalent vaccine," write Dr. Schuchat and colleagues.

To assess which population groups should first be targeted for vaccination, the ACIP reviewed epidemiologic and clinical data on July 29, 2009. The ACIP also evaluated the projected supply likely to be available when the vaccine first becomes available, as well as the anticipated increase in vaccine availability during the following 6 months. By mid-October 2009, it is anticipated that licensed H1N1 vaccine will be available.

The guidelines recommend that vaccination efforts begin as soon as the vaccine is available. In accordance with state and local conditions, state and local health officials and vaccination providers should make decisions concerning vaccine administration and distribution.

Vaccination and healthcare providers should be vigilant about following announcements and other information forthcoming from state and local health departments and the CDC regarding vaccination against H1N1 virus infection. The CDC's influenza Web site and state and local health departments may provide additional information.

ACIP H1N1 Vaccine Recommendations

Key points of the ACIP recommendations include the following 3 items.

First, 5 general population groups that should be targeted as an initial focus of vaccination efforts are pregnant women, household contacts or caregivers for infants younger than 6 months (such as parents, siblings, and daycare providers), healthcare and emergency medical services personnel, children and young adults 6 months to 24 years of age, and persons aged 25 to 64 years who are at greater risk for influenza-related complications because of underlying medical conditions. These medical conditions increasing risk for influenza-related complications include chronic pulmonary conditions, including asthma; cardiovascular conditions except for hypertension; renal, hepatic, cognitive, neurologic/neuromuscular, hematologic, or metabolic disorders, including diabetes mellitus; and immunosuppression caused by

Second, if initial vaccine availability is insufficient to meet demand, priority is established for a subset of persons within the initial target groups. These persons who are to receive priority for vaccination (order of target groups does not indicate priority) include pregnant women, household contacts or caregivers for infants younger than 6 months, healthcare and emergency medical services personnel in direct contact with patients or infectious material, children 6 months to 4 years of age, and children and adolescents aged 5 to 18 years who are at greater risk for influenza-related complications because of underlying medical conditions.

Third, as vaccine availability increases, other adult population groups should receive H1N1 vaccine in accordance with the guidelines recommendations.
In addition, ACIP made additional recommendations concerning the use of influenza A (H1N1) 2009 monovalent vaccine, as follows:

The number of doses of vaccine needed for immunization against H1N1 has not been determined. Vaccine should not be stockpiled for patients who already have received 1 dose but might require a second dose, because vaccine availability is expected to increase over time.
If different anatomic sites are used, inactivated vaccines against seasonal and H1N1 viruses may be administered simultaneously. However, ACIP does not recommend simultaneous administration of live, attenuated vaccines against seasonal and H1N1 virus.
All persons, including those older than 65 years of age, who are currently recommended for seasonal influenza vaccine should receive the seasonal vaccine as soon as it is available. Recommendations for use of the 2009 to 2010 seasonal influenza vaccine were previously published.
"The guiding principle of these recommendations is to vaccinate as many persons as possible as quickly as possible," the guidelines authors state. "ACIP will review new epidemiologic and clinical data as they become available and might revise these recommendations."

Morb Mortal Wkly Rep. Published online August 21, 2009.

Thursday, September 3, 2009

No Benefit in Lowering BP Below "Standard" 140/90 mm Hg

From Heartwire
Lisa Nainggolan

July 10, 2009 (San Pedro de Montes de Oca, Costa Rica) — A new review has found that lowering blood pressure below the "standard" target of 140/90 mm Hg is not beneficial in terms of reducing mortality or morbidity [1]. Dr Jose Agustin Arguedas (Universidad de Costa Rica, San Pedro de Montes de Oca) and colleagues report their findings online July 8, 2009 in the Cochrane Database of Systematic Reviews.

They explain that over the past five years, a trend toward lower targets has been recommended by hypertension experts who set treatment guidelines, "based on the assumption that the use of drugs to bring the BP lower than 140/90 mm Hg will reduce heart attack and stroke." But this approach "is not proven," they point out.

Arguedas told heartwire that they reviewed seven trials with more than 22 000 subjects comparing lower or standard diastolic BP targets, but they were unable to identify any studies comparing different systolic BP targets. "We found there is no evidence that reaching a target of below 90 mm Hg diastolic BP will provide additional clinical benefit, but we can't say whether lowering systolic BP below 140 mm Hg will be beneficial or not; there are no data."

Dr Franz Messerli (St Luke Roosevelt Hospital, New York, NY), who was not involved with this review, told heartwire that there is no question that the 140/90-mm-Hg BP limit is "absolutely arbitrary, and the benefits of antihypertensive medications are most obvious in patients with the highest BP. The closer we get to 'normotension,' the more difficult it becomes to show benefits of BP lowering.

"The Lewington meta-analysis of one million patients has convincingly shown that people fare better—ie, have fewer strokes and heart attacks—when their 'usual' BP is 115/70 mm Hg compared with those with a 'usual' BP of 130/80," Messerli adds. "However there are no data and probably never will be that lowering BP from 130/80 mm Hg to 115/70 mm Hg confers any benefits," he says.

Further Review Required in at-Risk Patients

Attempting to achieve lower BP targets has several consequences, the researchers note; "the most obvious is the need for large doses and increased number of antihypertensive drugs. This has inconvenience and economic costs to patients. More drugs and higher doses will also increase adverse drug effects, which if serious could negate any potential benefit associated with lower BP." There is also the potential that lowering BP too much may cause adverse cardiovascular events, the so-called "J-curve" phenomenon, they observe.

In their review, they included: the Modification of Diet in Renal Disease (MDRD) trial; the Hypertension Optimal Treatment (HOT) study; the BP Control in Diabetes (ABCD) trials H and N; the African American Study of Kidney Disease and Hypertension (AASK), and the Renoprotection in Patients With Nondiabetic Chronic Renal Disease (REIN-2) study.

They found that, despite a 4/3-mm-Hg-greater achieved reduction in systolic/diastolic BP (p<0.001), attempting to achieve "lower targets" instead of "standard targets" did not change:

"This strategy did not prolong survival or reduce stroke, heart attack, heart failure, or kidney failure," they note. "More trials are needed, but at present there is no evidence to support aiming for a blood-pressure target lower than 140/90 mm Hg in any hypertensive patient."

The researchers say they were unable to fully assess the net health effect of lower targets due to lack of information regarding all total serious adverse events and withdrawals due to adverse effects in six of seven trials.

Trials Needed to Compare Lower With Standard Systolic Targets

Arguedas and his colleagues note that a lower BP target of 130/80 mm Hg is currently recommended for at-risk patients, and they did perform a sensitivity analysis in diabetic and kidney-disease patients, which did not show significant benefits for treating to targets of lower than 135/85 mm Hg. "However, in these two populations, the evidence for a lack of benefit is less robust," they note.

Arguedas told heartwire that properly conducted randomized controlled trials are needed comparing lower systolic BP targets with standard ones in the general population and also in specific subgroups of at-risk patients.

One such study is the ongoing Action to Control Cardiovascular Disease in Diabetes (ACCORD) blood-pressure trial—an unmasked, open-label, randomized trial with participants randomized to one of two groups with different treatment goals: systolic blood pressure <120 mm Hg for the more intensive goal, and systolic blood pressure <140 mm Hg for the less intensive goal [2].

The primary outcome measure is the first occurrence of a major CVD event, specifically nonfatal MI or stroke, or cardiovascular death during a follow-up period ranging from four to eight years. The results should provide some of the first definitive clinical-trial data on the possible benefit of treating to a more aggressive systolic blood-pressure goal.

In the meantime, says Arguedas, "We are doing another separate systematic review specifically in patients with diabetes and chronic kidney disease to see whether targets lower than 130/80 mm Hg change morbidity or mortality as compared with standard targets."

Adding an Antiviral to Corticosteroid May Heighten Benefit in Bell's Palsy

From Medscape Medical News
Allison Gandey

September 3, 2009 — Results from a systematic review suggest that adding an antiviral to corticosteroid therapy for Bell's palsy might increase efficacy. Antivirals as single agents have proven unsuccessful in activating the cranial nerve, so many doctors use them instead in combination with steroids. But the practice is mired in uncertainty and has prompted questions that investigators worked to answer in a meta-analysis published September 2 in the Journal of the American Medical Association.

"The most important point is that we found the use of steroids early in Bell's palsy is effective," study author Gordon Guyatt, MD, from McMaster University in Hamilton, Ontario, said during an interview.

In contrast to the primary trials, the new meta-analysis suggests that antivirals might be beneficial when combined with steroids. "Everyone had concluded that there is no place for antivirals, but our work suggests the possibility of an even bigger effect," Dr. Guyatt told Medscape Neurology. "Our study emphasizes the importance of comprehensive statistical reviews."

Although the results point to a possible incremental benefit, the investigators acknowledge that the relative risk of 0.75 did not reach statistical significance (P = .05). It is a problem that leaves much to clinical decision-making between doctors and patients until more studies are done.

Failed to Reach Statistical Significance

The results conflict with a small meta-analysis published in June (Arch Otolaryngol Head Neck Surg. 2009;135:558-564). In that study, investigators looked at just 4 studies and concluded that no treatment is established in Bell's palsy.

But after reviewing 18 randomized controlled trials of more than 2700 patients, Dr. Guyatt and his team, led by John de Almeida, MD, from Sunnybrook Hospital in Toronto, Ontario, disagree with that study. They report that corticosteroids were associated with a reduced risk for unsatisfactory recovery (relative risk, 0.69; 95% confidence interval, 0.55 to 0.87; P = .001). They found the number needed to treat to benefit 1 person is 11.

"This evidence is not likely to be contradicted by additional clinical trials," John Steiner, MD, from Kaiser Permanente Colorado in Denver, said in an accompanying editorial. "It has important implications for clinical practice."

"Corticosteroids are well established," Dr. Guyatt said.

Corticosteroids Standard, Antivirals Debatable

In their June paper, Drs. John Goudakos and Konstantinos Markou, from AHEPA University Hospital and Aristotle University of Thessaloniki in Greece, said that "treatment decisions regarding patients with Bell's palsy are doubtful and remain a common problem in medical practice."

Many questions remain when it comes to whether to experiment with combination therapy. "Given the possibility of marginal benefit and the absence of major harm with antiviral therapy, clinicians may convert uncertain knowledge into definitive action by adding an antiviral medication to a corticosteroid for their next patient with Bell's palsy," Dr. Steiner noted.

"Until the next generation of clinical trials is completed, clinicians and patients will have to deal with substantial uncertainty in deciding whether to add antiviral drugs to corticosteroids." But, he adds, the availability of generic low-cost antivirals, such as acyclovir, and the apparent absence of major adverse effects suggest that large clinical trials are warranted.

The authors agree that more trials are needed, but they disagree with Dr. Steiner on the issue of cost. At roughly $20 a day for acyclovir (4000 mg) and valacyclovir (3000 mg), the price is "not insignificant," they note — especially for an uncertain benefit.

Coauthor Ian Witterick, MD, from Mount Sinai Hospital in Toronto, Ontario, reports receiving funding from Schering, Abbott Laboratories, and Alcon Canada.

JAMA. 2009;302:985-993. Abstract

Tobacco Smoking May Increase Risk for Tuberculosis

From Medscape Medical News
Laurie Barclay, MD

September 1, 2009 — Tobacco smoking is associated with a 2-fold increased risk for active tuberculosis, according to the results of a prospective Taiwan cohort study reported in the September 1 issue of the American Journal of Respiratory and Critical Care Medicine.

"Previous case-control studies and a small number of cohort studies in high-risk populations have found an association between tobacco and active tuberculosis, but no cohort studies have been conducted in the general population on this association to date," write Hsien-Ho Lin, MD, ScD, from Harvard School of Public Health in Boston, Massachusetts, and colleagues.

The goal of the study was to evaluate the association between tobacco smoking and active tuberculosis in a general population cohort of 17,699 participants older than 12 years enrolled in the Taiwan National Health Interview Survey. An in-person interview at baseline determined smoking status and other covariates. During follow-up from 2001 to 2004, incident cases of active tuberculosis were identified with use of the National Health Insurance database. After adjustment for age, sex, alcohol intake, socioeconomic status, and other covariates, the association between smoking status and active tuberculosis was estimated with multivariate logistic regression.

During the 3.3 years of follow-up, there were 57 new cases of active tuberculosis. Current smoking was linked to an increased risk for active tuberculosis (adjusted odds ratio [OR], 1.94; 95% confidence interval, 1.01 - 3.73). Compared with patients older than 65 years, those younger than 65 years showed a stronger association between current smoking and the risk for active tuberculosis (adjusted OR, 3.04 vs 0.78; P for interaction = .036). There were significant dose-response associations for cigarettes per day (P for trend = .0036), years of smoking (P for trend = 0.023), and pack-years (P for trend = .0023).

"Tobacco smoking was associated with a twofold increased risk of active tuberculosis in a representative cohort of Taiwan's population," the study authors write. "The finding that smoking increases the risk of tuberculosis suggests that tobacco control be considered as an important component in the global effort to eliminate tuberculosis."

Limitations of this study include deaths not recorded in the National Health Insurance database, short duration of follow-up, and lack of data from bacteriologic studies for the diagnosis of tuberculosis.

"Based on the results from our and other observational studies, policy makers and public health personnel should consider addressing tobacco cessation as part of TB [tuberculosis] control," the study authors conclude. "Recent studies suggest that introducing brief tobacco cessation advice may be feasible among TB patients, and an integrated approach has been proposed to monitor smoking cessation in TB care. From the perspective of prevention, the target of smoking cessation should aim beyond TB patients to reach high-risk populations who are likely to benefit most from cessation."

This study was supported by a grant from the World Bank through the International Union against Tuberculosis and Lung Disease and a fellowship from the Taiwan American Foundation of Boston. Some of the study authors have disclosed various financial relationships with Abt Associates, Bristol-Myers Squibb, and/or Pulmatrix.

Am J Respir Crit Care Med. 2009;180:475-480. Abstract

Wednesday, September 2, 2009

H1N1: 10 Things You Should Know

Tuesday, September 01, 2009

from: U.S. Centers for Disease Control and Prevention, New York City Department of Health and Mental Hygiene.

Since it first emerged in April, the global swine flu epidemic has sickened more than 1 million Americans and killed about 500. It's also spread around the world, infecting tens of thousands and killing nearly 2,000.

This summer, the virus has been surprisingly tenacious in the U.S., refusing to fade away as flu viruses usually do. And health officials predict a surge of cases this fall, perhaps very soon as schools reopen.

A White House report from an expert panel suggests that from 30 percent to half the population could catch swine flu during the course of this pandemic and that from 30,000 to 90,000 could die.

So how worried should you be and how do you prepare? The Associated Press has tried to boil down the mass of information into 10 things you should know to be flu-savvy.

1. No cause for panic.

So far, swine flu isn't much more threatening than regular seasonal flu.

During the few months of this new flu's existence, hospitalizations and deaths from it seem to be lower than the average seen for seasonal flu, and the virus hasn't dramatically mutated. That's what health officials have observed in the Southern Hemisphere where flu season is now winding down.

Still, more people are susceptible to swine flu and U.S. health officials are worried because it hung in so firmly here during the summer — a time of year the flu usually goes away.

2. Virus tougher on some.

Swine flu is more of a threat to certain groups — children under 2, pregnant women, people with health problems like asthma, diabetes and heart disease. Teens and young adults are also more vulnerable to swine flu.

Ordinary, seasonal flu hits older people the hardest, but not swine flu. Scientists think older people may have some immunity from exposure years earlier to viruses similar to swine flu.

3. Wash your hands often and long.

Like seasonal flu, swine flu spreads through the coughs and sneezes of people who are sick. Emphasize to children that they should wash with soap and water long enough to finish singing the alphabet song, "Now I know my ABC's..." Also use alcohol-based hand sanitizers.

4. Get the kids vaccinated.

These groups should be first in line for swine flu shots, especially if vaccine supplies are limited — people 6 months to 24 years old, pregnant women, health care workers.

Also a priority: Parents and caregivers of infants, people with those high-risk medical conditions previously noted.

5. Get your shots early.

Millions of swine flu shots should be available by October. If you are in one of the priority groups, try to get your shot as early as possible.

Check with your doctor or local or state health department about where to do this. Many children should be able to get vaccinated at school. Permission forms will be sent home in advance.

6. Immunity takes awhile.

Even those first in line for shots won't have immunity until around Thanksgiving.

That's because it's likely to take two shots, given three weeks apart, to provide protection. And it takes a week or two after the last shot for the vaccine to take full effect.

The regular seasonal flu shot should be widely available in September. People over 50 are urged to be among the first to get that shot.

7. Vaccines are being tested.

Health officials presume the swine flu vaccine is safe and effective, but they're testing it to make sure.

The federal government has begun studies in eight cities across the country to assess its effectiveness and figure out the best dose. Vaccine makers are doing their own tests as well.

8. Help! Surrounded by swine flu.

If an outbreak of swine flu hits your area before you're vaccinated, be extra cautious.

Stay away from public gathering places like malls, sports events and churches. Try to keep your distance from people in general. Keep washing those hands and keep your hands away from your eyes, nose and mouth.

9. What if you get sick?

If you have other health problems or are pregnant and develop flu-like symptoms, call your doctor right away. You may be prescribed Tamiflu or Relenza. These drugs can reduce the severity of swine flu if taken right after symptoms start.

If you develop breathing problems (rapid breathing for kids), pain in your chest, constant vomiting or a fever that keeps rising, go to an emergency room.

Most people, though, should just stay home and rest. Cough into your elbow or shoulder. Stay home for at least 24 hours after your fever breaks. Fluids and pain relievers like Tylenol can help with achiness and fever. Always check with a doctor before giving children any medicines. Adult cold and flu remedies are not for them.

10. No swine flu from barbecue.

You can't catch swine flu from pork — or poultry either (even though it recently turned up in turkeys in Chile). Swine flu is not spread by handling meat, whether it's raw or cooked.

On the Net:

CDC swine flu basics: http://www.cdc.gov/H1N1flu/qa.htm

New York City Department of Health and Mental Hygiene's FAQ's:

http://www.nyc.gov/html/doh/downloads/pdf/cd/h1n1(underscore)flu(underscore)basic(underscore)faq.pdf