Despite declines in disease, the H1N1 pandemic flu is still in circulation and the “future is uncertain,” a CDC official said.

“We want and need to avoid complacency,” according to Anne Schuchat, MD, director of the agency’s national center for immunization and respiratory diseases.

Schuchat told reporters on Thursday that only four states are currently reporting widespread flu activity — Delaware, Maine, New Jersey, and Virginia — and laboratory-confirmed hospitalizations and deaths are dropping.

But she cited statistics from the 1957 flu pandemic, in which officials “essentially gave the all-clear whistle” in later December and early January after a fall peak in flu deaths tailed off.

“They had vaccines, but they didn’t encourage (their) use,” Schuchat said.

In that pandemic, deaths resurged in late January and February of 1958, reaching a peak of nearly 800 in March, Schuchat pointed out.

“This is really a reminder of why we are saying that we need to remain vigilant,” she said.

Schuchat said a cumulative total of 136 million does of vaccine have been available or ordered by the states, and an estimated 60 million people have had a shot against the pandemic strain.

She added that vaccine is now widely available across the U.S. “The vaccine should be easily available pretty much anywhere you live,” she said.

Schuchat said that flu activity nationwide continues to be above normal for this time of year, although it’s lower than in past weeks. She also said that only the H1N1 pandemic strain is currently circulating, with almost no evidence of the seasonal strains.

Molds thrive in damp places, such as around doors and windows, and on wet carpeting.

Some people can become sick from exposure to mold, while others show little or no reaction, the U.S. Centers for Disease Control and Prevention says.

The CDC mentions these common symptoms of mold exposure:

Nasal stuffiness and congestion.
Irritated throat.
Irritated eyes.
Wheezing or coughing.
Skin irritation.
Serious lung infections among some people with chronic lung disease.

ROCKVILLE, Md., March 8 — Although aspirin and other NSAIDs such as ibuprofen can prevent some colorectal cancer, the benefits are outweighed by the increased risk of gastrointestinal side effects, said the U.S. Preventive Services Task Force.

The task force recommendation against the routine use of NSAIDs for colorectal cancer chemoprevention emerged from two systematic risk-benefit analyses carried out by Catherine Dub?©, M.D., of the University of Calgary in Alberta, and colleagues.

The task force’s NSAID-colorectal cancer guidelines and the Canadian review results appeared in the March 6 issue of the Annals of Internal Medicine. Dr. Dub?© and colleagues conducted a systematic review of randomized controlled trials, case-control studies, and cohort studies of aspirin chemoprophylaxis.

“Cyclo-oxygenase-2 inhibitors and NSAIDs reduce the incidence of colonic adenomas,” the Canadian group concluded. “Nonsteroidal anti-inflammatory drugs also reduce the incidence of colorectal cancer. However, these agents are associated with important cardiovascular events and gastrointestinal harms. The balance of benefits to risk does not favor chemoprevention in average-risk individuals.”

The task force recommendation against NSAID colorectal-cancer chemoprophylaxis applies to asymptomatic adults at average risk for the malignancy, including those with a family history of it, but not to people with familial adenomatous polyposis, hereditary nonpolyposis colon cancer syndromes (Lynch I or II), or a personal history of colorectal cancer or adenomas.

Dr. Dub?© and colleagues found that regular use of aspirin modestly reduced the relative risk of adenomas of the colon in all three study designs. In randomized controlled trials, the relative risk for adenomas among aspirin users was 0.82 (95% confidence interval 0.7 to 0.95). In case-control studies, the relative risk was 0.87 (95% CI, 0.77 to 0.98), and in cohort studies it was 0.72 (95% CI, 0.61 to 0.85).

“In cohort studies, regular use of aspirin was associated with relative risk reductions of 22% for incidence of colorectal cancer,” they wrote. “Two randomized controlled trials of low-dose aspirin failed to show a protective effect. Data for colorectal cancer mortality were limited. Benefits from chemoprevention were more evident when aspirin was used at a high dose and for periods longer than 10 years.”

But they also found that aspirin use was associated with a dose-related increase in incidence of gastrointestinal complications. In controlled trials, the relative risk for GI bleeding among aspirin users compared with non-aspirin users ranged from 1.6 to 2.5-fold, with similar risks seen in both case-control and cohort studies. Aspirin was also associated with a near doubling or risk for other GI symptoms, such as nausea and dyspepsia.

“Aspirin appears to be effective at reducing the incidence of colonic adenoma and colorectal cancer, especially if used in high doses for more than 10 years,” the reviewer wrote. “However, the possible harms of such a practice require careful consideration. Further evaluation of the cost-effectiveness of chemoprevention compared with, and in combination with, a screening strategy is required.”

In the second review, the same authors looked at NSAIDs other than aspirin and at cyclo-oxygenase-2 (Cox-2) inhibitors (such as Celebrex) for the prevention of colorectal cancer and adenoma, using the same general research criteria for the aspirin review.

Although in one cohort study there was no evidence of an effect of non-aspirin NSAIDs on mortality, there was good evidence in other trials to show a positive effect on the incidence of colorectal cancer.

When they looked at cohort studies, the relative risk for developing colorectal cancer among NSAID users was 0.61 (95% CI, 0.48 to 0.77), and in case-control studies the relative risk was 0.70 (95% CI, 0.63 to 0.78). Colorectal adenoma incidence was also reduced by NSAIDs other than aspirin, with relative risk in cohort studies of 0.64 (95% CI, 0.48 to 0.85) and in case-control studies of 0.54 (95%CI, 0.4 to 0.74).

Cox-2 inhibitors, in randomized controlled trials, also reduced the relative risk for colorectal adenoma incidence, to 0.72 (95% CI, 0.68 to 0.77).

“The ulcer complication rate associated with non-aspirin NSAIDs is 1.5% per year,” the investigators wrote. “Compared with non-aspirin NSAIDs, Cox-2 inhibitors reduce this risk but, in multiyear use, have a higher ulcer complication rate than placebo.”

They also found that Cox-2 inhibitors and NSAIDs other than naproxen (Aleve and generics) increased the risk for serious cardiovascular events, with a relative risk for the Cox-2 inhibitors (versus placebo) of 1.86 (95% CI, 1.33 to 2.59).

The investigators noted that both reviews were limited by heterogeneity in the dose, duration and frequency of use of the various drugs, requiring careful grouping for analysis.

The reviews were funded by the CDC for the Agency for Healthcare Research and Quality and the U.S. Preventive Services Task Force. Co-author Alaa Rostom, M.D., is a consultant for and has received honoraria from Novartis. Dr. Dub?© and Dr. Rostom have received grants from AHRQ and the USPSTF.

Primary source: Annals of Internal Medicine

Source reference:

US Preventive Services Task Force. “Routine Aspirin or Nonsteroidal Anti-inflammatory Drugs for the Primary Prevention of Colorectal Cancer: U.S. Preventive Services Task Force Recommendation Statement.” Ann Intern Med. 2007;146:361-364.

Additional source: Annals of Internal Medicine

Source reference:

Dube C et al. “The Use of Aspirin for Primary Prevention of Colorectal Cancer: A Systematic Review Prepared for the U.S. Preventive Services Task Force.” Ann Intern Med. 2007;146:365-375.

Additional source: Annals of Internal Medicine

Source reference:

Rostom A et al. “Nonsteroidal Anti-inflammatory Drugs and Cyclooxygenase-2 Inhibitors for Primary Prevention of Colorectal Cancer: A Systematic Review Prepared for the U.S. Preventive Services Task Force.” Ann Intern Med. 2007;146:376-389.

LITTLE FALLS, N.J., June 12 — Children should be placed in rear-facing car seats until they reach the age of 4, two British researchers said.
A review of recent literature showed that injuries can be significantly reduced using this strategy, according to Elizabeth Watson, M.B.Ch.B., of Sunny Meed Surgery in Woking, England, and Michael Monteiro, M.B.Ch.B., of Royal Surrey County Hospital in Guildford, England.
In a report in BMJ, they said young children in forward-facing car seats are at risk for excessive stretching or transection of the spinal cord in a head-on collision because of their relatively large heads, as well as anatomical differences in the cervical spine.

Thus, “healthcare professionals should advise that rear-facing seats are safer than forward-facing seats for children under 4 years,” Drs. Watson and Monteiro said.

The American Academy of Pediatrics recommends that children be placed in a rear-facing car seat until they are at least a year old and weigh at least 20 pounds.

But the 2002 policy statement the organization’s Committee on Injury, Violence, and Poison Prevention also states that if “a car safety seat accommodates children rear facing to higher weights, for optimal protection, the child should remain rear facing until reaching the maximum weight for the car safety seat, as long as the top of the head is below the top of the seat back.”

“Manufacturers should be encouraged to develop car safety seats that accommodate children rear facing to 4 years of age (45 pounds),” the statement continues.

Drs. Watson and Monteiro cited a retrospective U.S. study that looked at data from the National Highway Traffic Safety Administration’s vehicle crash database on 870 children younger than 2 — 352 were in rear-facing seats and 518 were in forward-facing seats.

The results, reported in 2007 in Injury Prevention, indicated that children facing front were 1.76 times (95% CI 1.40 to 2.20) more likely to be seriously injured in an accident.

For side impacts in particular, forward-facing children were 5.53 times (95% CI 3.74 to 8.18) more likely to suffer a serious injury.

The findings were similar in an analysis that included only children 12 to 23 months old.

Drs. Watson and Monteiro also pointed to a 1997 analysis of Volvo’s accident database, which included information on 421 children in rear-facing seats and 950 in forward-facing seats.

The Swedish researchers calculated the injury-reducing effect of rear-facing seats to be 96%, compared with 77% for forward-facing seats.

These studies using real-world accident data are supported by crash tests and numerical simulations, the researchers said.

Taken together, the findings indicate that “parents and guardians should be advised to keep young children in rear-facing car seats for as long as possible,” they said.

But they acknowledged some obstacles with changing the practice of turning children around at about a year.

“Many parents and healthcare providers may be unaware that it is safer to leave children in rear-facing seats for as long as possible or that rear-facing seats for toddlers exist,” they said.

In addition, there are no rear-facing seats available for children heavier than 35 pounds in North America, they said.

And finally, they said, parents might be concerned about motion sickness and leg room.

They said manufacturers and retailers should increase the availability of rear facing car seats for older and heavier children and update labeling to advise parents of the increased safety.

The authors reported no conflicts of interest.

Primary source: BMJ

Source reference:

Watson E, Monteiro M “Advise use of rear facing child car seats for children under 4 years old” BMJ 2009; DOI: 10.1136/bmj.b1994.

SAN FRANCISCO — Three-fourths of patients with advanced esophageal cancer had major responses when cetuximab (Erbitux) was added to chemoradiation, investigators reported here.

About 40% of patients had complete responses, and the overall response rate was similar in patients with squamous-cell carcinoma and adenocarcinoma, French oncologist Aimery de Gramont, MD, PhD, reported at the Gastrointestinal Cancers Symposium.

“This regimen exceeded the predefined threshold for efficacy of 50%,” said de Gramont, of Hôpital Saint-Antoine in Paris. “The overall response rate was greater than 75% in both squamous-cell and adenocarcinoma. On the basis of these results, this strategy should be evaluated in a phase III trial.”

For almost two decades, treatment with 5-fluorouracil and cisplatin plus radiation has been standard for patients with advanced carcinoma of the esophagus and gastroesophageal junction, or cardia. Recent studies have shown that replacing cisplatin with oxaliplatin could improve the regimen’s tolerability without sacrificing antitumor activity.

In other settings, cetuximab — a monoclonal antibody against the epidermal growth factor receptor — has boosted responses to both radiotherapy and platinum-based chemotherapy. De Gramont presented findings from a multicenter open-label study to evaluate the impact of adding the biologic drug to 5-FU/oxaliplatin (FOLFOX) chemoradiation for patients with advanced esophageal cancer.

The study involved 79 patients with stage III cardia or esophageal carcinoma and no prior exposure to thoracic radiotherapy or to chemotherapy. All patients were to receive five cycles of concurrent cetuximab and FOLFOX, and radiation therapy began with the third cycle of chemotherapy. The total planned radiation dose was 50.4 Gy.

Patients without progressive disease at the end of treatment could receive additional cetuximab-FOLFOX chemotherapy, undergo surgery to the primary tumor, or have no additional therapy. Options for progressive disease were second-line therapy and best supportive care.

De Gramont reported that 53 of the 79 patients had squamous-cell histology, 25 had adenocarcinoma, and one had unknown histology. Tumor localization was in the esophagus in 74 patients and cardia in the remaining five.

At baseline, 24 patients had no dysphagia, 28 patients limited dysphagia, 20 could consume only semisolid food, five were on a liquid diet, and two patients had aphagia.

About three-fourths of the patients received ≥90% of the planned doses of cetuximab, oxaliplatin, and 5-FU, and almost 90% received the full course of radiation.

Upon completion of chemoradiation, 70 (88.6%) of patients had no evidence of disease progression. De Gramont said 33 patients received no further therapy, 20 received an additional four cycles of concurrent cetuximab and FOLFOX, and 17 had surgery.

Evaluation of tumor response showed that 32 of 79 (40.5%) had complete responses, and 29 patients had partial responses, resulting in an overall response rate of 77.2% in the intention-to-treat analysis. Patients with squamous-cell histology had an overall response rate of 75.5%, and those with adenocarcinoma had an 80% response rate.

Six patients had stable disease, and nine (11.4%) had progressive disease.

With a median follow-up of 19.4 months, the 79 patients had a median progression-free survival time of 14 months.

The regimen was generally well tolerated, said de Gramont. The most common grade 3-4 toxicities were neutropenia (28.4%), dysphagia/esophagitis (12.1%), and rash (10.5%).

Invited discussant Peter Enzinger, MD, of Dana-Farber Cancer Institute in Boston, said the data suggest the regimen is active and well tolerated, but he cited several limitations. First, the FOLFOX regimen remains unproven in this setting and will remain so until the completion of ongoing trials comparing it to conventional cisplatin-infusional 5-FU regimens.

The varied strategies employed upon completion of primary therapy will make long-term assessment difficult and preclude comparison of the final results to those of other trials, Enzinger said.

The results do not prove that cetuximab is active in this setting, he continued. However, other studies have provided “tantalizing hints” of activity.

“Overall, we can say that this study is one of the largest conducted to evaluate cetuximab with radiation,” said Enzinger. “But I would also like to point out that the RTOG 04-36 trial [a U.S. cooperative-group study] has had significant toxicity, and in the United States, at least, has raised significant concerns about using cetuximab with radiation therapy in this arena.”

Enzinger also disagreed with the conclusion that the regimen is ready for evaluation in a phase III trial.

“I would argue that there is no clear signal as yet from the data available,” he said. “The RTOG study in the United States should raise some flags of caution.

“I think that one could certainly proceed with cetuximab if the ongoing phase III studies are encouraging and positive, but as yet, we don’t know the results of those trials.”

De Gramont disclosed relationships with Merck-Serono and Sanofi-Aventis.

NEW YORK, Jan. 3 – Terri Schiavo’s final weeks of life on a feeding tube, which riveted the nation and reignited the debate over the right to die, was voted the top medical news story of the year by the readers of MedPage Today.

The Schiavo case was argued in state courts for more than seven years. It gained worldwide attention when Congress and President Bush tried an 11th hour move to override a Florida judge’s order to remove Ms. Schiavo’s feeding tube.

But while politicians debated, neurologists generally agreed that the woman was in a persistent vegetative state and had been for many years.

Climax in Tug-of-War Over Schiavo Feeding Tube
/Neurology/GeneralNeurology/tb2/742

Schiavo Feels No Pain
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Schiavo Neurologist Calls Frist a Fool and Shameful
/Neurology/GeneralNeurology/tb2/779

Schiavo Brain Only 615 Grams at Autopsy
/Neurology/GeneralNeurology/tb2/1198

Avian flu was a close second to Schiavo in the readers’ poll. MedPage Today published 30 articles on Avian flu in 2005.

SPECIAL REPORT 2005: Who’s Afraid Of Avian Flu?
/InfectiousDisease/URItheFlu/tb2/2392

The report that French surgeons have performed a partial face transplant-a news story that grabbed headlines late in 2005-came in third in the voting.

Face Transplant Draws Admiration and Caution
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New York Surgeon Rejects Criticism of French Face Transplant
/Surgery/PlasticSurgery/tb2/2257

The medical response to Hurricane Katrina ranked fourth in the voting followed by Medicare Part D, the prescription drug coverage plan that remains mired in controversy and confusion.

Hurricane Katrina Perspectives Detail Personal Drama and Public Tragedy
/PublicHealthPolicy/PublicHealth/tb2/1925

Hospitals Evacuate in Wake of Rising Waters From Katrina
/PublicHealthPolicy/PublicHealth/tb2/1633

Aftermath of Hurricane Katrina Poses Major Public Health Threat
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A Dispatch From the Katrina Refugee Frontlines at the Astrodome
/Psychiatry/AnxietyStress/tb2/1671

After the Deluge Come Mental Health Problems
/Psychiatry/GeneralPsychiatry/tb2/1662

Medicare Prescription Drug Organizations Release Marketing Blitz
/PublicHealthPolicy/MedicaidMedicare/tb2/1866

Rounding out the rest of the top 10 stories of 2005, according the readers, were:
Controversy continues to rock FDA on approving drugs too quickly or too slowly
Tight glucose control reduces strokes and heart attacks 10 years later
Digital mammography trumps film mammography for detection of lesions in young women
FDA’s delay on a decision for OTC approval of Plan B
Aromatase inhibitors replacing tamoxifen as adjuvant breast cancer therapy

VANCOUVER, British Columbia, Nov. 3 — Previous infection with hepatitis C virus (HCV) and spontaneous clearance of the virus appear to confer protection against re-infection, reported researchers here.

Among more than 3,500 inner-city residents, primarily injectable drug users, those who had been infected with HCV and had spontaneous virological clearance but were at high-risk for re-infection had half the rate of new HCV infections as similar people who had never been infected, reported Jason Grebely, M.D., and colleagues from the University of British Columbia here.

“Our data lend support to the hypothesis that previous exposure to HCV may be protective, possibly on an immunologic basis, despite repeated exposure to HCV,” the authors wrote in the November issue of Hepatology.

There is evidence in both chimpanzees and in humans to suggest that previous infection with HCV may confer resistance to new infections.

To see whether this was true, the investigators conducted a large community-based cohort study of 3,553 residents of Vancouver’s Downtown Eastside neighborhood. They looked at those who had been infected with HCV and had documented virological clearance, and compared their rates of re-infection with first-time infection rates in members of the same cohort.

They identified from among the cohort 926 HCV-uninfected, and 658 HCV-infected viremic participants at baseline. In all, 152 of the 658 viremic participants (23.1%) had spontaneous clearance of the virus over a median follow-up of 5.2 years (interquartile range 2.8-7.4).

The cohort members who cleared HCV were significantly more likely at baseline to have co-infection with HIV (P<0.001) and to use illegal drugs frequently (P<0.004) than those who were not infected at baseline.

The authors found that despite having the same risks of exposure to HCV, HCV infection rates were lower among those who had been previously infected compared with those who were never infected. Among previously infected participants, 14 of 152 (9.2%), had new infections. In contrast, 172 of 926 (18.6%) of those with no evidence of infection at baseline became infected with HCV during follow-up.

The incidence rate for new infections among previously infected cohort members was 1.8/100 person-years (95% confidence interval, 0.9-3.0/100). The incidence rate of new infections for previously uninfected cohort members was 8.1 (95% CI, 6.9-9.4/100).

When the authors performed a logistic regression analysis using previous HCV infection as a covariate with other potential confounding variables (such as age, gender, ethnicity, HIV infection, housing status, and use of illegal and injectable drugs), they saw that participants with previous HCV infection who cleared the virus had a 77% lower risk for infection compared with others experiencing first-time infections (adjusted odds ratio, 0.23; 95% CI, 0.10-0.51, P<0.001).

The authors noted that their finding could possibly be explained by the presence of genetic polymorphisms that favor viral clearance and resistance to infection among those who were infected with the virus previously.

Alternatively, previously infected participants may have changed some of their high-risk behaviors, such as needle sharing, after their first bout with HCV, they speculated.

“However, given the higher rate of HIV infection in those with previous clearance, it is more likely that those with HCV clearance remain at higher risk of acquiring HCV infection over time,” they wrote.

Primary source: Hepatology

Source reference:
Grebely J et al. “Hepatitis C Virus Reinfection in Injection Drug Users.” Hepatology 2006;44:1139-1145.

BETHESDA, Md. — A Food and Drug Administration (FDA) panel today is considering approval of the nation’s first cell-based influenza vaccine — an alternative to vaccines produced by the traditional, time-consuming method of growing the virus in eggs.

A company called Protein Sciences Corporation is seeking approval for its trivalent seasonal influenza vaccine, FluBlok, for active immunization of adults ages 18 years and older against influenza virus subtypes A and type B.

Protein Sciences makes the vaccine by injecting the flu virus into a cell of a virus that grows on a species of moth larvae called armyworms. The three recombinant hemagglutinin influenza proteins are then extracted from the insect cells and purified.

The process takes two months from growth to manufacture, according to briefing documents from Protein Sciences posted on the FDA’s Web site, which is considerably faster than the egg culture method.

Proponents say that over the long term, cell culture vaccines offer another advantage in that production can be scaled up quickly. Egg culture requires specially produced eggs that must be ordered in advance.

The request comes at a critical time, with government officials being criticized for delivering less of the pandemic H1N1 vaccine than promised.

The Departments of Health and Humans Services and Homeland Security have blamed the problem on the discovery that the H1N1 virus grows more slowly in eggs than manufacturers expected.

The FluBlok vaccine is designed to protect against seasonal flu, not H1N1. However, its cell-growing technologies could be applied to pandemic flu.

Also, the cell-based alternative could be a good option for people who can’t receive traditional vaccines because of egg allergies.

“There appears to be a substantial unmet medical need for an alternative, egg protein-free influenza vaccine,” said a Protein Sciences researcher in briefing documents posted in advance of the hearing. Protein Sciences estimates that 2.5 million youngsters and five million adults have egg allergies.

There are currently five FDA-approved trivalent, inactivated flu vaccines, all of which are manufactured in chicken eggs. If the FDA approved FluBlok, it would be the first cell-based flu vaccine in the U.S.

Licensed vaccines for hepatitis B and human papillomavirus rely on recombinant DNA techniques to express proteins in cell culture. There are also several cell-based flu vaccines licensed in Europe.

Documents released by the FDA ahead of today’s panel hearing asserted that the vaccine was as safe and effective as other flu vaccines in four human trials of 3,231 adults ages 18 and older.

In Protein Science’s one Phase III clinical trial, the vaccine — which contains no adjuvants — was 44.8% effective at protecting against influenza illness caused by any flu virus strain.

That percentage isn’t higher because the virus strain wasn’t matched to the actual virus that was circulating at the time of the trial, officials said. That matching occurs every year after a panel of experts decides which strains are most likely to strike. The FDA has approved other vaccines based on comparable efficacy rates.

Although about one-third of the patients in the trials were over 65, FDA staff concluded that “the number of cases was too small to draw meaningful conclusions regarding the relative risk of influenza among older adult recipients of FluBlok relative to the licensed comparators.”

Protein Sciences is seeking “accelerated approval” from the FDA, which bases approval on “adequate and well-controlled” trials that show the biological product had an effect on a surrogate endpoint.

The frequency of adverse events was similar to those reported with use of other trivalent influenza vaccines.

CHICAGO, Dec. 2 — Positron emission mammography, which brings the precision imaging of PET scans to mammography, may be the next big thing in breast cancer imaging, according to participants in this exclusive MedPage Today roundtable discussion.

Joseph Tashjian, M.D., president of Saint Paul Radiology in Saint Paul, Minn., said the data on positron emission mammography were scarce, but promising.

Philip O. Alderson, M.D., dean of the School of Medicine at Saint Louis University, was a bit more skeptical, noting that MRI has been shown to do much of what positron emission tomography claims to accomplish, and possibly at a more reasonable cost.

Cost, however, was not an issue in a study from Israeli researchers who said that adding a digital image of a patient’s face to his file influenced the way in which radiologists read image scans.

Peggy Peck, executive editor of MedPage Today, moderated the discussion.

ATLANTA, Sept. 18 — A relaxation instruction audio accompanied by the soft sounds of waves lapping on a beach may ease stress hypertension in older adults even better than a soothing Mozart serenade, researchers said here.

Audio of a relaxation training program dropped nursing home residents’ systolic blood pressure by about three points and diastolic pressure by 1.5 points compared with Mozart’s music, Hsin-Yi Tang, Ph.D., A.R.N.P., of Seattle University, and colleagues, reported at the American Heart Association’s Council for High Blood Pressure Research conference here.

The advantage with guided relaxation recordings in the small randomized trial was statistically significant but both would likely have the same degree of impact on clinical outcomes, Dr. Tang said.

Based on the findings, guided relaxation training could “provide a supplemental method for lowering blood pressure in older adults,” the researchers suggested.

Similar programs have been used for years to train athletes and help patients with temporomandibular joint problems, chronic pain, and cancer, the researchers said.

The relaxation therapy was designed to soothe the parasympathetic nervous system, which relieves stress and relaxes the blood vessels.

For the program used in the study, a man’s voice guided listeners to relax from head to toe and do deep abdominal breathing while hearing the gentle sound of ocean waves in the background.

The ocean wave sounds incorporated a calming kind of stereophonic sound with two tones of different frequencies to regulate brain waves to the alpha range, Dr. Tang’s group noted.

For the study, a 12-minute CD of this program was compared with listening to Mozart — the andante from Symphony 13 in F Major, K 112, and the andante from the Serenade in D Major, K 250.

The effect on blood pressure from three weekly listening sessions over a period of four weeks was monitored among 41 mentally competent adults living at three retirement facilities who were on standard antihypertensive medications.

Assistants blinded to treatment randomization measured blood pressure and heart rate with an automated machine before and after the interventions.

The average for these post-session measurements was significantly lower after 11 of the 12 guided therapy sessions for systolic pressure, four of the sessions for diastolic pressure, and eight sessions for heart rate.

Mozart listeners had lower averages after six of the 12 sessions for systolic pressure, two sessions for diastolic pressure, and 10 sessions for heart rate compared with pre-session values.

The pooled effect of all 12 sessions showed a significantly greater systolic blood pressure benefit for guided relaxation (change 8.9 versus 6.0 mm Hg, P=0.015).

Systolic blood pressure fell 6.4% from 141 to 132 mm Hg with relaxation training compared with about a 5% drop from 141 to 134 mm Hg with classical music.

Both types of relaxation therapy exceeded the 3% to 5% threshold for a clinically meaningful change in blood pressure, the researchers said.

In prior studies, a 5 mm Hg reduction in systolic blood pressure has been estimated to reduce coronary heart disease-related death by 9% and stroke-related death by 14%, they noted.

Dr. Tang’s group also showed a trend for greater diastolic blood pressure reduction with relaxation training (73 to 70 versus 71 to 69, P=0.06).

Heart rate fell equally for both groups after the interventions compared with pre-session rates without a significant difference between groups (73 to 70 versus 69 to 66, P=0.923).

Interestingly, some participants in the guided therapy group didn’t like the program and wanted to switch to the music group but still had a reduction in blood pressure with the intervention, Dr. Tang said.

She noted that the findings would likely generalize to other relaxation training programs available on the market for patients and to other types of soothing classical music, although the majority of the literature has looked at Mozart’s pieces.

The researchers reported no conflicts of interest.

Primary source: Conference of the Council for High Blood Pressure Research

Source reference:
Tang H-Y, et al “A Randomized Trial of Music versus Audio-Guided Relaxation Training to Decrease Blood Pressure in an Elderly Population” AHA-BP 2008; Abstract P037.