More Drug Trials Needed for Conditions Affecting Kids: Review

HealthDay – 6 mins ago WEDNESDAY, July 25 (HealthDay News) -- A new review finds that while children account for almost 60 percent of those with five common medical conditions, only 12 percent of clinical trials of drugs for those conditions examined their effects on pediatric patients.

Yet, the review authors noted, previous research has shown that off-label drugs, where the medicine has only been approved for adult use by the U.S. Food and Drug Administration, make up as much as 79 percent of the medications given to children in hospitals and up to 56 percent of drugs prescribed for kids in doctors' offices.

"We think this contrast is striking, and speaks to the under-representation of research on kids," said review author Dr. Florence Bourgeois, an assistant professor of pediatrics at Boston Children's Hospital and Harvard Medical School in Boston. "Understandably, whenever we see an adverse event the concern is, 'Could these drugs really be dangerous?' and we are left wondering."

The results were released online July 23 in advance of publication in the August print issue of the journal Pediatrics.

The FDA requires that clinical trials demonstrate a drug's safety and effectiveness for a condition before it approves the drug to treat that condition, but many drugs are only tested in adults. As a result, physicians are often left to rely on trial-and-error to decide how to use drugs off-label in children, the review noted.

Bourgeois and her team found that, while just over 21 percent of people in high-income countries who are afflicted by conditions such as depression, asthma, migraines, schizophrenia and bipolar disorder are children and adolescents, less than 10 percent of clinical trials studying these conditions included patients under the age of 18.

The gap was even wider for developing countries, where children and adolescents bear nearly 62 percent of the disease burden for conditions such as malaria, diarrhea, HIV and depression, but only about 12 percent of clinical trials of treatments for these diseases include pediatric patients.

A number of professional organizations, including the Institute of Medicine, the American Academy of Pediatrics and the Royal College of Paediatrics and Child Health in England, have all published statements on the importance of evaluating medical treatments for children using randomized, controlled trials. A randomized, controlled trial, in which study participants are randomly chosen to either receive a treatment or not, is the gold standard for medical research.

"In some instances, it may be fine to extrapolate adult

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Low vitamin B6 related to inflammatory Conditions in adults in the United States

Accumulated inflammation and wear and tear are the principal markers of the decline in health.  Many of us take a variety of nutrients to help reduce inflammation and repair of our body.  A new study highlights the fact that we should not forget basic nutrition as a key element of our efforts to anti-inflammatory drugs.  The researchers found that low levels of biologically active B6 (pyridoxal-5-phosphate) had the largest amount of inflammation.

The researchers are interested in this subject, because previous research had linked low B6 to a variety of inflammatory diseases, including cardiovascular disease, rheumatoid arthritis, inflammatory bowel disease and diabetes.

The researchers investigated the levels of blood of the B6 with 13 different inflammatory markers in 2 229 adults, with the average age of 62.  The relationship between a lack of B6 and an increase in inflammation was clear as Crystal.

A vitamin is called vitamin because it cannot be made by your body to something else.  You must consume vitamins in your diet or take as supplements.  The best form of vitamin B6 for supplementation is the biologically active form, pyridoxal-5-phosphate.  Cheap B6, pyridoxine HCL, called requires that your body a gift of energy for her to make it active, and some of the by-products of this metabolic process may be neurological irritation.

B vitamins are generally absent in the American diet due to the transformation of food which depletes the natural grain sources.  B6 is essential for the metabolism of proteins and is required by all neurotransmitters in the brain for optimal function.  Researchers have long sought to explain that the lack of vitamin c and B6 is intimately associated with cardiovascular disease.  This new study on the influence of vitamin B6 system B6 documents keep inflammation in check.

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Higher levels of vitamin B6 reduced the risk of lung cancer
Vitamin B6 protects against Inflammation
Low folic acid or vitamin B6 weaken bones
Vitamin B6 reduced the risk of heart attack in women

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HPV Vaccine May Prevent Recurrence of Precancerous Conditions

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HPV Vaccine May Help Women With Cervical Conditions

HealthDay – 39 mins ago TUESDAY, March 27 (HealthDay News) -- A new study finds that women diagnosed with pre-cancerous cervical conditions after they get the human papillomavirus (HPV) vaccine can still benefit from the shot because it cuts their risk of future HPV-related cervical disease.

"This study helps to clarify the effects of the HPV vaccine and further define its use," noted one expert, Dr. Elizabeth Poynor, a gynecologic oncologist and pelvic surgeon at Lenox Hill Hospital in New York City.

Poynor, who was not involved in the new research, said it "is the first to address the effect of the HPV vaccine in women who have undergone treatment for HPV-related disease."

The study was published online March 27 in the BMJ.

HPV remains the most common sexually transmitted infection in the United States and can cause health problems ranging from genital warts to cervical cancer, according to the U.S. Centers for Disease Control and Prevention. HPV infection is thought to be the leading cause of cervical cancer, and two HPV vaccines, Gardasil and Cervarix, have received U.S. Food and Drug Administration approval.

Previous research has shown that HPV vaccination does not prevent progression to cervical pre-cancers in women who have an HPV infection when they receive the vaccine.

However, this is the first study to examine if HPV vaccination can prevent future cervical disease in these women after they've been successfully treated for their current condition, the researchers pointed out in a journal news release.

The study involved an international team of researchers led by Dr. Elmar Joura of the Medical University of Vienna. The investigators analyzed data from 1,350 young women in 24 developed and developing countries who took part in two clinical trials in which they received either the HPV vaccine or an inactive placebo. The women were subsequently diagnosed with either a vulvar or vaginal disease (including genital warts) or had required cervical surgery.

Among women who required cervical surgery after taking part in the studies, the risk of getting a subsequent HPV-related disease was 6.6 cases per 100 women per year among those who received the HPV vaccine and 12.2 cases per 100 women per year among those who received the placebo. This translates into more than a 46 percent reduced risk for women who received the HPV vaccine, the authors noted.

The researchers also found that the risk of pre-cancerous changes of the cervix and other "high-grade" cervical disease was almost 65 percent lower in those who received the HPV vaccination than in those who received the placebo.

Among women who were diagnosed with and treated for vaginal or vulvar disease, the risk of any future HPV-related disease was about 35 percent lower among those who received the HPV vaccine than among those who received the placebo, the study authors reported.

Two other experts said the findings appear heartening.

"While questions remain on the design of the study, it offers another reassurance that the efficacy of the quadrivalent HPV vaccine as initial protection may extend to decreasing subsequent diseases after initial vaccination," said Dr. Linus Chuang, director of gynecologic oncology at Mount Sinai Medical Center in New York City.

And Dr. Stephanie Blank, director of the gynecologic oncology fellowship at NYU School of Medicine, agreed that the study "describes potential further benefits of the HPV vaccine. HPV causes cervical cancer but affects even more women by causing cervical dysplasia

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HPV Vaccine May Help Women With Cervical Conditions

HealthDay – 39 mins ago TUESDAY, March 27 (HealthDay News) -- A new study finds that women diagnosed with pre-cancerous cervical conditions after they get the human papillomavirus (HPV) vaccine can still benefit from the shot because it cuts their risk of future HPV-related cervical disease.

"This study helps to clarify the effects of the HPV vaccine and further define its use," noted one expert, Dr. Elizabeth Poynor, a gynecologic oncologist and pelvic surgeon at Lenox Hill Hospital in New York City.

Poynor, who was not involved in the new research, said it "is the first to address the effect of the HPV vaccine in women who have undergone treatment for HPV-related disease."

The study was published online March 27 in the BMJ.

HPV remains the most common sexually transmitted infection in the United States and can cause health problems ranging from genital warts to cervical cancer, according to the U.S. Centers for Disease Control and Prevention. HPV infection is thought to be the leading cause of cervical cancer, and two HPV vaccines, Gardasil and Cervarix, have received U.S. Food and Drug Administration approval.

Previous research has shown that HPV vaccination does not prevent progression to cervical pre-cancers in women who have an HPV infection when they receive the vaccine.

However, this is the first study to examine if HPV vaccination can prevent future cervical disease in these women after they've been successfully treated for their current condition, the researchers pointed out in a journal news release.

The study involved an international team of researchers led by Dr. Elmar Joura of the Medical University of Vienna. The investigators analyzed data from 1,350 young women in 24 developed and developing countries who took part in two clinical trials in which they received either the HPV vaccine or an inactive placebo. The women were subsequently diagnosed with either a vulvar or vaginal disease (including genital warts) or had required cervical surgery.

Among women who required cervical surgery after taking part in the studies, the risk of getting a subsequent HPV-related disease was 6.6 cases per 100 women per year among those who received the HPV vaccine and 12.2 cases per 100 women per year among those who received the placebo. This translates into more than a 46 percent reduced risk for women who received the HPV vaccine, the authors noted.

The researchers also found that the risk of pre-cancerous changes of the cervix and other "high-grade" cervical disease was almost 65 percent lower in those who received the HPV vaccination than in those who received the placebo.

Among women who were diagnosed with and treated for vaginal or vulvar disease, the risk of any future HPV-related disease was about 35 percent lower among those who received the HPV vaccine than among those who received the placebo, the study authors reported.

Two other experts said the findings appear heartening.

"While questions remain on the design of the study, it offers another reassurance that the efficacy of the quadrivalent HPV vaccine as initial protection may extend to decreasing subsequent diseases after initial vaccination," said Dr. Linus Chuang, director of gynecologic oncology at Mount Sinai Medical Center in New York City.

And Dr. Stephanie Blank, director of the gynecologic oncology fellowship at NYU School of Medicine, agreed that the study "describes potential further benefits of the HPV vaccine. HPV causes cervical cancer but affects even more women by causing cervical dysplasia

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