Hydrolyzed formulas, originally developed as an alternative to infant formulas containing cow's milk or soy proteins, have been used to treat food allergies in infants with moms who can't breastfeed. But do they help to reduce the risk of allergies in infants with a family history of allergies?

Researchers from the Johns Hopkins University School of Medicine examined 22 previously published studies that evaluated the effectiveness of hydrolyzed formulas in infants. The studies compared the allergy-preventing effectiveness of hydrolyzed formulas, compared to breastfeeding, cow's milk formulas, soy formulas, and combinations of these other formulas.

In general, children who consumed only hydrolyzed formula had a lower rate of allergies for up to 5 years after birth, compared to infants fed traditional cow's milk formulas. Researchers concluded that using hydrolyzed formulas reduced the risk of allergies among infants whose parents had allergies (having a family history of allergies puts an infant at high risk for developing them, too).

What This Means to You: According to the results of this study, babies at high risk may have a reduced risk of developing allergies if they are fed hydrolyzed formulas. Hydrolyzed formulas marketed in the United States include the brand names Nutramigen, Alimentum, Pregestimil, and Nestle Good Start Supreme. If your child has an increased risk of allergies because of a family history of the disease, you can reduce your child's risk by breastfeeding as long as possible. If breastfeeding isn't possible, discuss with your child's doctor the potential benefits of using a hydrolyzed formula.

SOMERSET, NJ -- May 11, 2005 -- A new head-to-head, peer-reviewed clinical trial demonstrated that Astelin® Nasal Spray™ (azelastine HCl), marketed by MedPointe Pharmaceuticals, provided 25 percent greater reduction in nasal symptoms than top-selling prescription antihistamine Zyrtec® (cetirizine HCl), marketed by Pfizer Inc. The new data, published in the May 2005 issue of Clinical Therapeutics, also showed that Astelin offered significantly greater improvements in allergy patients' quality of life, compared to Zyrtec.

"Patients with chronic allergies are often frustrated with allergy medications that do not work as well as they had hoped," said lead investigator, Jonathan Corren, MD, Allergy Research Foundation, Inc. "This study provided clear evidence that Astelin offered patients more relief from nasal symptoms than Zytrec and improved their overall quality of life."

The ACT I study (Azelastine Cetirizine Trial) directly compared the efficacy of Astelin versus Zyrtec in patients with moderate-to-severe allergic rhinitis in order to determine which prescription antihistamine was more effective in improving nasal symptoms of seasonal allergic rhinitis. The ACT I study examined the efficacy of Astelin or Zyrtec against common allergy symptoms, including runny nose, sneezing, nasal itching and nasal congestion.

These symptoms collectively were directly measured as the Total Nasal Symptom Score (TNSS). In the ACT I study, patients experienced improvements in TNSS while taking either Astelin or Zytrec; however, patients taking Astelin showed an overall greater improvement in TNSS compared to those taking Zyrtec. The average improvement in TNSS for Astelin was 5.56 (29.3%) compared with 4.32 (23.0%) with Zyrtec, which was significant (P =.015).

In the assessment of onset of action over four hours, the TNSS was significantly improved from baseline in both treatment groups 15 minutes after initial administration (P <.001). The difference between Astelin and Zyrtec was significant at 60 and 240 minutes (both, P =.040). At no time point during the four-hour observation period did the improvement in TNSS with Zyrtec exceed that with Astelin.

Using the Rhinitis Quality of Life Questionnaire (RQLQ), the standard tool of measurement, the ACT I study showed that Astelin offered statistically significant improvements (P = 0.049) in quality of life benefits compared with Zyrtec. "This study once again confirms the efficacy of Astelin and reaffirms the benefit of a topically administered antihistamine," said Paul Edick, President of MedPointe Pharmaceuticals.

Conducted during the 2004 fall allergy season at 20 investigational centers in major geographic regions throughout the U.S., the ACT I trial was a two-week, randomized, double-blind study involving 307 patients with moderate-to-severe allergic rhinitis. Participants were males and females 12 years of age and older with a two-year history of seasonal allergic rhinitis and a documented positive allergy skin test during the previous year. Following a one-week placebo lead-in period, patients were randomized to Astelin two sprays per nostril twice daily plus placebo tablets or Zyrtec 10-mg tablets once daily plus placebo (saline) nasal spray for the two-week, double-blind treatment period. Patients recorded symptoms twice daily in diary cards during the two-week treatment period.

Both Astelin and Zyrtec were well tolerated in the ACT I study. The most common adverse event, or side effect, experienced with Astelin was bitter taste (3.3 %). The most common side effect of Zyrtec was drowsiness (2.6%).

Allergic rhinitis is the fifth most prevalent chronic disease in the United States, affecting up to 40 million adults and children each year. Allergic rhinitis costs the nation approximately $5.3 billion in direct and indirect costs (including time lost from work and school) and accounts for about 10,000 absences from school.

Twenty percent of the U.S. population suffers from seasonal allergies, which are caused by pollen, spores, and other allergens. Millions of Americans suffering from seasonal allergies also may be sensitive to environmental triggers such as air pollution, cigarette smoke, and cleaning solutions. It is critical that patients seek proper diagnosis with physicians to determine which type of allergies they suffer from to determine the best treatment options.

Astelin, the only prescription antihistamine approved by the Food and Drug Administration to treat symptoms of seasonal allergic rhinitis and nonallergic vasomotor rhinitis, is the fastest-growing antihistamine in new prescriptions in the past year.

Astelin is indicated for the treatment of the symptoms of seasonal allergic rhinitis (in patients 5 years of age and older) and nonallergic vasomotor rhinitis (in patients 12 years of age and older). Astelin is well tolerated and relieves the full range of rhinitis symptoms, including difficult-to-treat nasal congestion. The most commonly reported adverse events in seasonal allergic rhinitis and nonallergic vasomotor rhinitis patients 12 years of age and older were bitter taste, headache, somnolence, and nasal burning. The adverse event profile in seasonal allergic rhinitis patients 5 to 11 years of age was similar to that in the adult population.

Objective We evaluated whether phototherapy using a combination of UV-B (5%), UV-A (25%), and visible light (70%), referred to as mUV/VIS, is effective in treating allergic rhinitis.

Methods We conducted a randomized, double-blind study, in 49 patients with hay fever. The study was performed during the ragweed season. Each intranasal cavity was illuminated 3 times a week for 3 weeks with mUV/VIS or with low-intensity visible light. Symptom scores, inflammatory cells, and their mediators were assessed in nasal lavages. In vitro effects of mUV/VIS irradiation on T-cell and eosinophil apoptosis and its inhibitory effect on mediator release from basophils were examined.

Results Rhinophototherapy was tolerated well and resulted in a significant improvement of clinical symptoms for sneezing (P < .016), rhinorrhea (P < .007), nasal itching (P < .014), and total nasal score (P < .004). None of the scores improved significantly in the control group. Scores for nasal obstruction slightly improved after mUV/VIS treatment and significantly increased in the control group (P < .017). In the nasal lavage, phototherapy significantly reduced the number of eosinophils and the level of eosinophil cationic protein and IL-5. In vitro irradiation of T cells and eosinophils with mUV/VIS light dose-dependently induced apoptosis. Furthermore, mUV/VIS irradiation inhibited the mediator release from RBL-2H3 basophils.

Conclusion These results suggest that phototherapy is an effective modality to treat allergic rhinitis and offer new options for the treatment of immune-mediated mucosal diseases.

WEDNESDAY, Aug. 25 (HealthDayNews) -- An allergic inflammatory disease of the esophagus triggered by immune cells may be on the rise among U.S. children, a new study finds.

The chronic disorder, called eosinophilic esophagitis (EE), is characterized by irritation and inflammation of the esophagus, the tube that carries food from the throat to the stomach. As the esophagus narrows, children with EE suffer discomfort and difficulty when swallowing food, and vomiting is not uncommon.

Rates for the disease appear to be on the rise. The percentage of children affected with EE may now outrank those with better-known gastrointestinal ailments such as Crohn's disease or ulcerative colitis, according to the study.

"Our study found a considerable rise in cases, especially in the past few years," said lead researcher Dr. Marc E. Rothenberg, director of allergy and immunology at Cincinnati Children's Hospital Medical Hospital.

His team reviewed data from the hospital's pathology lab database dating back to 1991. The hospital is the single provider of pediatric gastroenterology care for the greater Cincinnati area, so a review of former patients would give the researchers a sense of any local changes in the incidence of EE.

They identified 315 cases of confirmed disease among pediatric patients, "with only 2.8 percent having been identified before 2000," Rothenberg said. Many of the cases were clustered in families, usually among siblings. This could point to "either genetic links or shared environment" as possible factors, he said.

By the end of 2003, more than four of every 10,000 children in the Cincinnati area were estimated to suffer from EE -- a number similar to that of more common chronic gastrointestinal ailments.

"What's new about this report about eosinophilic esophagitis is that it had been a previously under-appreciated syndrome," said Dr. Lanny J. Rosenwasser, professor of medicine and allergy at the National Jewish Medical and Research Center in Denver. "Its prevalence is really exploding now that it's being recognized, especially in the pediatric age group."

Rosenwasser said it's hard to figure out whether the condition is simply being detected more often or whether there has been a sharp increase in new cases, as has been the case with other allergic conditions, such as asthma. "Some of it may be that people haven't been aware of it," he said. "But it may be that allergic diseases in general are increasing in prevalence, too."

The disease isn't confined to children, either. "It's possible that many cases of GERD in adults are [undiagnosed] EE, that's been unexplored as of yet," Rosenwasser said.

EE is characterized by the abnormal proliferation in the esophagus of eosinophils, which are inflammatory immune cells. Because symptoms often mimic those of gastrointestinal esophageal reflux disorder (GERD), EE is often mistaken for pediatric GERD.

"It's probably misdiagnosed very easily," Rosenwasser said. "I don't know how many doctors are aware of it. It's probably not on the radar screen for many primary-care physicians."

In fact, Rothenberg said, "many patients wait for years before a correct diagnosis is made. Once a proper diagnosis is established, children are treated with antacids and proton pump inhibitor drugs (like Prilosec) to help ease gastrointestinal symptoms, and anti-allergy drugs to help fight the underlying cause of the disorder.

Rothenberg stressed that more study needs to be done to see if the sudden rise in EE is occurring elsewhere in the nation. "It could be something specific to this area," he said.

Scientists need to learn much more about the causes of this emerging threat, as well. "We have to find out why these eosinophils are collecting in the esophagus," Rosenwasser said, "to get a better understanding of their basic biology."