A widespread increase in the use of complementary alternative medicine (CAM) by patients with inflammatory bowel disease (IBD) has been recognized.
The aim of our study was to evaluate both the extent and the determinants of CAM use by outpatients with IBD.
METHODS:
Outpatients of the IBD centre at the University Hospital of Berne and patients of two gastroenterology private practices in Olten (Switzerland) completed a mailed self-administrated questionnaire regarding alternative medicine.
The questionnaire addressed the following topics: demographic variables; disease-related data; the use of 16 types of complementary medicine; comparison between attitudes towards alternative versus conventional medicine and out-of pocket expenses.
RESULTS:
Alternative medicine has been used by 47% of the patients. Diagnosis, duration and activity of disease, gender, age, previous surgery were not predictive for the use of CAM. The most commonly used CAM methods were: homeopathy, acupuncture and traditional Chinese medicine. Reasons cited for the use of CAM were: lack of satisfaction with and side effects of conventional therapy and the perceived safety of CAM. ***** Sixty-one percent ***** of patients noted that their IBD had improved with the use of CAM. By contrast, 16% noted a flare during CAM therapies. Forty-seven percent of patients paid more than Euro400 per year for CAM.
CONCLUSIONS:
Complementary medicine use is common in patients with IBD. Frequently cited reasons for the use of complementary therapies were safety of CAM; dissatisfaction with conventional therapies, including their side effects; and that CAM can be used in addition to conventional therapy.
Complementary alternative medicine in patients with inflammatory bowel disease: use and attitudes.
~~~~~~~~~~~~~~~~~~~~~~~~~~~~~Quattropani C, Ausfeld B, Straumann A, Heer P, Seibold F.
Inselspital Bern, Division of Gastroenterology, Bern, Switzerland.
Copied from Lee's Site ------ ibd.patientcommunity.com
Gene Linked to Autoimmune Diseases Found
NEW YORK (Reuters Health) - Scientists have identified a gene that may be involved in the development of severalautoimmune diseases, including type 1 diabetes, according to a new report.
Mutations in the gene, dubbed CTLA4, may increase susceptibility to a variety of autoimmune disorders, researchers reported in the advance online version of the journal Nature.
This gene normally serves as the "brakes" for the immune system, according to study co-author John A. Todd, a researcher with the Juvenile Diabetes Research Foundation/Wellcome Trust Diabetes and Inflammation Laboratory at the Cambridge Institute for Medical Research at the University of Cambridge in England.
"The normal function of CTLA4 is to inhibit the immune system," Todd said in an interview with Reuters Health. "The mutations that provide susceptibility to autoimmune diseases reduce the ability of CTLA4 to keep the immune system in check."
Todd and his colleagues looked at a chromosome previously associated with autoimmune diseases in 672 people with Graves' disease, 210 people related to those with Graves' and 228 people with autoimmune hypothyroidism to see if there was a common genetic signature. They compared these people to 462 others who had no history of any autoimmune disease.
The researchers identified several variations in the CTLA4 gene in people with autoimmune diseases. Similar variations in CTLA4 were also present in mice that had type 1 diabetes.
Autoimmune disorders affect about 5 percent of the population. These diseases cause the immune system to launch an attack against the body's own cells. The diseases are thought to be brought on by a combination of environmental and genetic factors.
Graves' disease, for example, often has its onset after stress, a viral infection or pregnancy. It occurs when antibodies attack the thyroid gland, causing it to grow and over-produce thyroid hormone. In type 1 diabetes, sometimes called juvenile diabetes, an autoimmune response destroys insulin-producing cells in the pancreas.
Mutations in CTLA4 may increase a person's risk of autoimmune diseases, but the genetic abnormalities most likely do not explain the whole picture, according to the researchers.
"The disease requires genes to develop in a person, but the effect of inherited versions of genes that predispose to Graves' is very dependent on mostly unknown environmental factors," Todd explained.
CTLA4 mutations may help explain genetic susceptibility to several autoimmune diseases.
That's because "CTLA4 has a general regulatory effect on the immune system and these diseases are diseases of the immune system, hence CTLA4 could well, and does, affect these and other diseases," Todd said.
SOURCE: Nature advance online edition 2003;10.1038/nature01621. Reuters Health By Linda Carroll Wednesday, April 30, 2003
FDA Approves REMICADE(R) (infliximab) For Long-Term Use in Fistulizing Crohn's Patients Using 8-Week Maintenance Dosing
"This indication further solidifies the important role REMICADE plays in the treatment of Crohn's disease, particularly among those struggling with fistulas," said Jerome A. Boscia, M.D., Vice President, Clinical Research & Development. "For many patients, REMICADE can reduce the number of fistulas, while potentially reducing the need for hospitalizations, and therefore, fills a significant unmet medical need. Centocor is delighted that the FDA's Center for Biologics Evaluation and Research was able to review and approve this important treatment option within the six-month priority review cycle."
In June 2002, the FDA approved REMICADE for use in inducing and maintaining clinical remission in patients with moderate-to-severe Crohn's disease using maintenance dosing every eight weeks.
REMICADE is a monoclonal antibody that specifically targets and irreversibly binds to TNF-alpha on the cell membrane and in the blood. Overproduction of TNF-alpha is believed to play a role in CD and RA, in addition to a wide range of Immune-Mediated Inflammatory Disorders (I.M.I.D.) in which REMICADE is currently being studied.
ACCENT II Trial
The approval was based on a priority review of 54-week data from the ACCENT II trial, the largest clinical trial in fistulizing CD, which was conducted at 45 sites in North America, Europe and Israel. The FDA grants priority review status to products that are considered to be a potential significant therapeutic advance over existing therapies. The objective of the study was to evaluate the safety and efficacy of REMICADE in maintaining fistula closure when administered every eight weeks.
Study Design
Two hundred and ninety-six patients with draining enterocutaneous fistula(s), and in some cases rectovaginal fistulas, were enrolled in the trial and received 5mg/kg REMICADE at weeks 0, 2 and 6. Patients in fistula response at both weeks 10 and 14 were randomized to receive a maintenance dose of either placebo or 5 mg/kg REMICADE at week 14 and then every eight weeks through week 46. The primary endpoint was time from randomization to loss of fistula response. Concurrent use of stable doses of immunosuppressive and antibiotic therapy was permitted.
Of 273 patients randomized at week 14, 87 percent had perianal fistulas, 14 percent had abdominal fistulas and eight percent had rectovaginal fistulas.
At week 14, 65 percent (177/273) of patients were in fistula response. Patients randomized to REMICADE maintenance had a significantly longer time to loss of fistula response compared to the placebo maintenance group (>40 weeks vs. 14 weeks, p=0.001). At week 54, 38 percent of REMICADE-treated patients had no draining fistulas compared with 22 percent of placebo-treated patients (p=0.02). Patients who had not achieved a response by week 14 were unlikely to respond to additional doses of REMICADE.
The ACCENT II study also evaluated the impact of REMICADE maintenance therapy on the number of hospitalizations per patient. Compared to placebo maintenance, patients on REMICADE maintenance had a trend toward fewer hospitalizations per patient.
The most common adverse events reported among all randomized patients were upper respiratory tract infection, abdominal pain and headache. Worsening of Crohn's disease was the most commonly reported serious adverse event, occurring at an incidence of 9.7 percent in the placebo group and 2.9 percent in the REMICADE group.
About REMICADE
REMICADE, in combination with methotrexate, is indicated for reducing signs and symptoms, inhibiting the progression of structural damage, and improving physical function in patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to methotrexate.
REMICADE is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in patients with moderately to severely active Crohn's disease who have had an inadequate response to conventional therapy. It is also indicated for reducing the number of draining enterocutaneous and rectovaginal fistulas and maintaining fistula closure in patients with fistulizing Crohn's disease.
Important Information
Many people with heart failure should not take REMICADE; so, prior to treatment, patients should discuss any heart condition with their doctor. Patients should tell their doctor right away if they develop new or worsening symptoms of heart failure (such as shortness of breath or swelling of their feet).
There are reports of serious infections, including tuberculosis (TB) and sepsis. Some of these infections have been fatal. Patients should tell their doctor if they have had recent or past exposure to people with TB. Their doctor will evaluate them for TB and perform a skin test. If a patient has latent (inactive) TB, his or her doctor should begin TB treatment before starting REMICADE. If a patient is prone to or has a history of infections, currently has one, or develops one while taking REMICADE, he or she should tell his or her doctor right away. Patients should also tell their doctor if they have lived in a region where histoplasmosis or coccidioidomycosis is common, or if they have or have had a disease that affects the nervous system, or if they experience any numbness, tingling, or visual disturbances.
There are also reports of serious infusion reactions with hives, difficulty breathing, and low blood pressure. In clinical studies, some people experienced the following common side effects: upper respiratory infections, headache, nausea, cough, sinusitis or mild reactions to the infusion such as rash or itchy skin. Please read important information about REMICADE, including full prescribing information, at www.remicade.com
The bowel disorder affects 100,000 Britons and can cause a variety of symptoms, ranging from a lack of appetite to chronic diarrhoea and abdominal pain.
Its cause is unknown, although one theory is that it can be passed to humans in milk, suggesting that it may be caused by a bacterium.
This discovery of a type of bacteria in patients with the disease will raise hopes of better treatments to fight the condition.
Professor John Hermon-Taylor and colleagues at St George's Hospital Medical School in London carried out tests on a group of patients with Crohn's disease.
They also carried out tests on another group without the condition.
However, they only found the bacteria in 26% of patients without the condition.
This has led the scientists to suggest that this bacteria may play a key role in causing the disease.
"The rate of detection of MAP in individuals with Crohn's disease is highly significant and implicates this pathogen in disease causation," said Professor Hermon-Taylor.
"The problems caused by the MAP bug are a public health tragedy," he said.
IBS clue
Professor Hermon-Taylor said an unexpected finding of the research showed that patients suffering from irritable bowel syndrome (IBS) may also be infected with MAP.
IBS is painful and can cause diarrhoea, or diarrhoea alternating with constipation.
Sufferers often desperately need to go to the toilet with little warning, which severely limits their lifestyle.
No-one knows what causes IBS, although it is suggested that stress can make it worse. More women are affected than men.
"In animals, MAP inflames the nerves of the gut," Professor Hermon-Taylor said.
"Recent work from Sweden shows that people with IBS also have inflamed gut nerves.
"There is a real chance that the MAP bug may be inflaming people's gut nerves and causing IBS."
The findings are published in the Journal of Clinical Microbiology. Professor Hermon-Taylor said he has sent a copy of the paper to Sir Liam Donaldson, chief medical officer for England.
The research was welcomed by the medical charity Action Research.
It said that previous studies have suggested that MAP is found in 2% of retail pasteurised milk cartons.
"The discovery that the MAP bug is present in the vast majority of Crohn's sufferers means it is almost certainly causing the intestinal inflammation," it said in a statement.
"Action Research does not recommend that anyone stops drinking milk.
"However, for those individuals with Crohn's disease or their close relatives who may feel particularly at risk, it may be sensible to start drinking UHT milk.
"As UHT involves higher pasteurisation temperatures, it is probable that MAP is destroyed," it said.
The charity called for Crohn's to be made a reportable disease, for more stringent milk pasteurisation, for tests for MAP in dairy herds, and procedures for reducing MAP infection on farms.
