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Thursday, March 24, 2011

Salt's Effect On Blood Pressure Decreased By Physical Activity

Blood Pressure Decreased By Physical ActivityThe more physically active you are, the less your blood pressure rises in response to a high-salt diet, researchers reported at the American Heart Association's Nutrition, Physical Activity and Metabolism/Cardiovascular Disease Epidemiology and Prevention 2011 Scientific Sessions. 

"Patients should be advised to increase their physical activity and eat less sodium," said Casey M. Rebholz, M.P.H., lead author of the study and a medical student at the Tulane School of Medicine and doctoral student at the Tulane University School of Public Health & Tropical Medicine in New Orleans. "Restricting sodium is particularly important in lowering blood pressure among more sedentary people." 

Investigators compared study participants' blood pressure on two one-week diets, one low in sodium (3,000 mg/day) and the other high in sodium (18,000 mg/day). 

The American Heart Association recommends consuming less than 1,500 mg/day of sodium. 

If a person's average systolic blood pressure (the top number in the reading, measured when the heart is contracting) increased 5 percent or more from the low-sodium to the high-sodium regimen, the researchers labeled them as high salt-sensitive. 

Based on physical activity questionnaires, researchers divided participants into four groups ranging from very active to quite sedentary. 

The average increases in systolic blood pressure after switching from low to high sodium, adjusted for age and gender, were:
  • 5.27 mm Hg in the least active group
  • 5.07 mm Hg in the next-to-lowest activity group
  • 4.93 mm Hg in the next to highest activity group
  • 3.88 mm Hg in the most active group
Compared with the sedentary group, the odds of being salt-sensitive, adjusted for age and gender, fell:
  • 10 percent in the next-to-lowest activity group
  • 17 percent in the next-to-highest activity group
  • 38 percent in the most active group
"In all the analyses we found a dose-response relationship with the more activity, the better," Rebholz said. 

The participants were 1,906 Han Chinese adults (average age 38) in the Genetic Epidemiology Network of Salt Sensitivity (GenSalt), a large project to identify genetic and environmental factors contributing to salt sensitivity. Siblings and their parents were invited to become involved in GenSalt if at least one sibling had pre-hypertension (blood pressure between 120/80 and 139/89 mm Hg) or stage-1hypertension (between 140/90 and 159/99 mm Hg). No one was on blood pressure medication during the study. 

The GenSalt project is located in rural China because the homogeneous population makes it more likely that genes influential to blood pressure control will be identified. 

"The study needs to be repeated, but I suspect that the relationship between physical activity and salt-sensitivity will apply to other populations," Rebholz said. 

Notes: 

Co-authors are: Dongfeng Gu, Ph.D.; Jing Chen, M.D., M.S.; Jian-feng Huang, M.D.; Jie Cao, M.D., M.S.; Ji-chun Chen, M.D., M.S.; Jianxin Li, M.D.; Fanghong Lu, M.D.; Jianjun Mu, M.D.; Jixiang Ma, M.D.; Dongsheng Hu, M.D., M.S.; Xu Ji, M.D.; Lydia A. Bazzano, M.D., Ph.D.; Depei Liu, M.D., Ph.D.; and Jiang He, M.D., Ph.D.

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Acupuncture For Pain No Better Than Placebo And Not Without Harm

Acupuncture For Pain No Better Than Placebo And Not Without Harm
Although acupuncture is commonly used for pain control, doubts about its effectiveness and safety remain. Investigators from the Universities of Exeter & Plymouth (Exeter, UK) and the Korea Institute of Oriental Medicine (Daejeon, South Korea) critically evaluated systematic reviews of acupuncture as a treatment of pain in order to explore this question. Reporting in the April 2011 issue of PAIN®, they conclude that numerous systematic reviews have generated little truly convincing evidence that acupuncture is effective in reducing pain, and serious adverse effects continue to be reported. 

"Many systematic reviews of acupuncture for pain management are available, yet they only support few indications, and contradictions abound," commented lead investigator Professor Edzard Ernst, MD, PhD, Laing Chair in Complementary Medicine, Peninsula Medical School, Universities of Exeter & Plymouth, UK. "Acupuncture remains associated with serious adverse effects. One might argue that, in view of the popularity of acupuncture, the number of serious adverse effects is minute. We would counter, however, that even one avoidable adverse event is one too many. The key to making progress would be to train all acupuncturists to a high level of competency." 

Researchers carefully identified and critically examined systematic reviews of acupuncture studies for pain relief and case reviews reporting adverse effects. Reviews were defined as systematic if they included an explicit Methods section describing the search strategy and inclusion/exclusion criteria. Systematic reviews had to focus on the effectiveness of any type of acupuncture for pain. Of the 266 articles found, 56 were categorized as acceptable systematic reviews. 

The authors observe that recent results from high-quality randomized controlled trials have shown that various forms of acupuncture, including so-called "sham acupuncture," during which no needles actually penetrate the skin, are equally effective for chronic low back pain, and more effective than standard care. In these and other studies, the effects were attributed to such factors as therapist conviction, patient enthusiasm or the acupuncturist's communication style. 

If even sham acupuncture is as good as or better than standard care, then what is the harm? The answer lies in the adverse effect case studies. These studies were grouped into three categories: Infection (38 cases), trauma (42 cases) and other adverse effects (13 cases). Many of these adverse side effects are not intrinsic to acupuncture, but rather result from malpractice of acupuncturists. The most frequently reported complications included pneumothorax, (penetration of the thorax) and bacterial and viral infections. Five patients died after their treatment. 

In an accompanying commentary, Harriet Hall, MD, states her position forcefully: "Importantly, when a treatment is truly effective, studies tend to produce more convincing results as time passes and the weight of evidence accumulates. When a treatment is extensively studied for decades and the evidence continues to be inconsistent, it becomes more and more likely that the treatment is not truly effective. This appears to be the case for acupuncture. In fact, taken as a whole, the published (and scientifically rigorous) evidence leads to the conclusion that acupuncture is no more effective than placebo." 

The article is "Acupuncture: Does it alleviate pain and are there serious risks? A review of reviews" by E. Ernst, Myeong Soo Lee and Tae-Young Choi (DOI: 10.1016/j.pain.2010.11.004). The accompanying commentary is "Acupuncture's claims punctured: Not proven effective for pain, not harmless" by Harriet Hall, MD (DOI: 10.1016/j.pain.2011.01.039). Both appear in PAIN®, Volume 152, Issue 4 (April 2011) published by Elsevier.


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Gilead Trials Challenge Merck Replication HIV Inhibitor, Shares Up

Gilead Trials Challenge Merck Replication HIV Inhibitor, Shares UpThe battle against HIV rages on, and also does the competition fighting to produce the best drugs to treat it. Gilead has produced a new drug trucking through clinical trials, elvitegravir, which is as effective as its Merck counterpart, with only one dose daily compared to two. 

Elvitegravir is also being studied as part of Gilead's investigational fixed-dose, single-tablet "Quad" regimen. The Quad contains four Gilead compounds in a fixed-dose, single-tablet: elvitegravir; cobicistat, a pharmacoenhancing or "boosting" agent that increases blood levels of certain HIV medicines; and Truvada (emtricitabine/tenofovir disoproxil fumarate). The Quad is currently in Phase III testing. In addition, cobicistat is being evaluated as a stand-alone boosting agent for other antiretrovirals, in particular, protease inhibitors. 

Gilead licensed elvitegravir from Japan Tobacco Inc in March 2005. Gilead has exclusive rights to develop and commercialize the drug everywhere except Japan. Gilead's shares rose 2.7% to $41.53 this week in light of the recent reports. 

AIDS was first reported in the United States in 1981 and has since become a major worldwide epidemic. AIDS is caused by the human immunodeficiency virus, or HIV. By killing or damaging cells of the body's immune system, HIV progressively destroys the body's ability to fight infections and certain cancers. People diagnosed with AIDS may get life-threatening diseases called opportunistic infections. These infections are caused by microbes such as viruses or bacteria that usually do not make healthy people sick. 
  • Elvitegravir is designed to block the ability of the HIV virus to integrate into the genetic material of human cells which replicates the organisms' own DNA in the steps listed below:
  • Fusion of the HIV cell to the host cell surface.
  • HIV RNA, reverse transcriptase, integrase, and other viral proteins enter the host cell.
  • Viral DNA is formed by reverse transcription.
  • Viral DNA is transported across the nucleus and integrates into the host DNA.
  • New viral RNA is used as genomic RNA and to make viral proteins.
  • New viral RNA and proteins move to cell surface and a new, immature, HIV virus forms.
The virus matures by protease releasing individual HIV proteins.Click HERE for a full diagram illustration that shows how this process develops. 

On January 10, 2011, Gilead announced an amendment to the design of this clinical trial, extending the blinded, randomized period of the study to up to 96 weeks to obtain longer term safety and efficacy data than originally planned. Based on the achievement of the non-inferiority endpoint, patients will continue to receive the regimen to which they were randomized in a blinded fashion. 

Norbert Bischofberger, PhD, Executive Vice President, Research and Development and Chief Scientific Officer, Gilead Sciences states: 


"We are very pleased to have achieved the primary endpoint in this clinical trial, as data from this study will support regulatory filings for elvitegravir as well as Gilead's investigational Quad pill. By analyzing these data now we will be in a better position to advance filings as quickly as possible once data from subsequent Phase III clinical trials in our Quad development program become available later this year."

Since 1981, more than 980,000 cases of AIDS have been reported in the United States to the Centers for Disease Control and Prevention (CDC). According to CDC, more than 1,000,000 Americans may be infected with HIV, one-quarter of who are unaware of their infection. The epidemic is growing most rapidly among minority populations and is a leading killer of African-American males ages 25 to 44. 

In addition, AIDS affects nearly seven times more African Americans and three times more Hispanics than whites. In recent years, an increasing number of African-American women and children are being affected by HIV/AIDS.


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