Traditional Chinese medicines stall progression of diabetes

Traditional Chinese herbal medicines hold promise for slowing the progression from prediabetes to an official diabetes diagnosis, according to new research accepted for publication in the Endocrine Society's Journal of Clinical Endocrinology & Metabolism (JCEM).

19 jan2014--Prediabetes is diagnosed an individual has developed elevated blood sugar levels, but glucose levels have not yet risen to the point of developing type 2 diabetes. People who are prediabetic face a heightened risk of developing type 2 diabetesas well as heart disease and stroke. According to the Centers for Disease Control and Prevention, about 79 million American adults age 20 years or older have prediabetes.

"With diabetes evolving into a serious public health burden worldwide, it is crucial to take steps to stem the flood of cases," said one of the study's authors, Chun-Su Yuan, MD, PhD, of the University of Chicago. "Patients often struggle to make the necessary lifestyle changes to control blood sugar levels, and current medications have limitations and can have adverse gastrointestinal side effects. Traditional Chinese herbs may offer a new option for managing blood sugar levels, either alone or in combination with other treatments."

During the double-blind, randomized, placebo-controlled trial, 389 participants at 11 research sites in China were randomly assigned to take either a capsule containing a mixture of 10 Chinese herbal medicines or a placebo. For a year, subjects took capsules of either the Chinese herb mixture, called Tianqi, or the placebo three times a day before meals. All participants received a month of lifestyle education at the outset of the trial and met with nutritionists several times during the course of the study. Subjects' glucose tolerance was measured on a quarterly basis.

At the end of the trial, 36 participants in the Tianqi group and 56 in the placebo group had developed diabetes. The analysis found taking Tianqi reduced the risk of diabetes by 32.1 percent compared with the placebo, after adjusting for age and gender. The overall reduction in risk was comparable to that found in studies of diabetes medications acarbose and metformin, and study participants reported few side effects from the Tianqi herbs. Tianqi includes several herbs that have been shown to lower blood glucose levels and improve control of blood glucose levels after meals.

"Few controlled clinical trials have examined traditional Chinese medicine's impact on diabetes, and the findings from our study showed this approach can be very useful in slowing the disease's progression," said one of the study's lead authors, Xiaolin Tong, MD, PhD, of Guang'anmen Hospital in Beijing, China, said. "More research is needed to evaluate the role Chinese herbal medicine can play in preventing and controlling diabetes."

More information: The study, "Chinese Herbal Medicine Tianqi Reduces Progression from Impaired Glucose Tolerance to Diabetes: A Double-Blind, Randomized, Placebo-Controlled, Multicenter Trial," appears in the February issue of JCEM.

Provided by The Endocrine Society

Combo pill an option for diabetes-related nerve pain

26 oct 2009– A single pill containing the pain relievers tramadol and acetaminophen is as effective as the drug gabapentin for treating diabetes-related nerve pain, according to study findings presented Tuesday at the 20th World Diabetes Congress in Montreal.

Gabapentin is an anti-seizure drug frequently prescribed for epilepsy. The drug is also used to treat persistent neurological pain.

In general, gabapentin is regarded as a first-line therapy for "diabetic neuropathy" -- a painful condition that causes a range of symptoms from a tingling sensation or numbness in the toes and fingers to paralysis, lead researcher Dr. Bong Yun Cha, from the Catholic University of Korea, Seoul, told Reuters Health.

In the current study, Cha and colleagues compared gabapentin with the tramadol/acetaminophen (TA) combination pill in adults with painful diabetic neuropathy in the lower extremities. Sixty-six study subjects received TA and 73 received gabapentin.

The study was sponsored by JANSSEN KOREA, which markets the combination pill as Ultracet in the US.

Cha and colleagues report that the two groups experienced similar improvements in pain and related parameters over the 6-week study period.

Moreover, the rate of treatment-associated side events in the TA group was not significantly different from that in the gabapentin group: 50.6 percent vs. 36.9 percent.

The current findings, said Cha, support TA as a suitable alternative to gabapentin as a first-line therapy for painful diabetic neuropathy.

More proof needed on costly diabetes drugs

By Julie Steenhuysen
CHICAGO , 30 oct 2008– U.S. doctors are using a wider array of newer, more costly drugs to treat diabetes with little long-term proof that they work better than older, cheaper medications, U.S. researchers said on Monday.
They said newer treatments boosted the average cost of a diabetes prescription by nearly 40 percent in six years.
A separate team that combed through clinical trial data found only the drug metformin cut the risk of heart problems in people with type 2 diabetes, the most common form in which the body gradually loses its ability to respond to insulin.
Taken together, the studies make the case for more long-term data on diabetes drugs as Americans' poor diet and rising rates of obesity are expected to swell the number of diabetics to 29 million by 2050, up from 21 million.
"Diabetes is common and costly. More than one in every 10 healthcare dollars goes to treating diabetes or its complications," said Dr. Caleb Alexander of the University of Chicago, whose study appears in Archives of Internal Medicine.
Alexander and colleagues analyzed prescription data from U.S. patients 35 and older with type 2 diabetes who visited a physician's office between 1994 and 2007. Information about medication costs was available from 2001 to 2007.
They found the annual cost of diabetes drugs rose to $12.5 billion in 2007 from $6.7 billion in 2001.
Alexander said more diabetics using more and newer drugs fueled the rise. Yearly patient visits for diabetes rose to 36 million in 2007 from 25 million in 1994, and the average number of drugs per patient rose to 1.63 from 1.14. The average cost per prescription rose to $76 in 2007 from $56 in 2001.
LESS OLD, MORE OF THE NEW
During this time, prescriptions for older and cheaper sulfonylurea drugs fell to 34 percent from 67 percent of treatment visits, while those for drugs such as metformin and glitazones, such as Takeda Pharmaceutical Co Ltd Actos or pioglitazone and GlaxoSmithKline's Avandia or rosiglitazone, increased.
Newer forms of insulin helped drive costs, as did new drugs such as Merck & Co Inc's Januvia or sitagliptin, which made up eight percent of prescriptions in 2007, and Eli Lilly and Co and Amylin Pharmaceuticals Inc's Byetta or exenatide, prescribed four percent of the time in 2007.
"Some of these drugs may represent valuable pharmaceutical innovation, but I think the need for greater evidence regarding their safety and effectiveness is important since they cost eight to 10 times more than some of the older, more time-tested alternatives," Alexander said in a telephone interview.
Elizabeth Selvin of Johns Hopkins in Baltimore and colleagues analyzed data on heart problems in 40 clinical trials of diabetes drugs published on or before January 2006. Twenty seven of the studies lasted less than one year.
Only metformin cut the risk of death or other heart problems. And only Avandia appeared to raise the risk of death or problems such as a heart attack or stroke, but that did not reach statistical significance, the researchers said.
They said poor quality and inconsistent reporting of heart data, along with the lack of long-term studies, make it hard to draw firm conclusions about diabetes medications.

FDA Advisers Call for Cardiovascular-Safety Assessment of New Diabetes Drugs

By Peggy Peck
ROCKVILLE, Md., 5 july2008 -- Type 2 diabetes drugs aiming to pass FDA muster should be required to consider long-term cardiovascular safety as part of the approval mix, according to agency advisers. The Endocrinologic and Metabolic Drugs Advisory Committee voted 14-2 to recommend that the FDA add long-term cardiovascular-safety trials to the regulatory burden. Most of the advisers said the risk assessment should be completed prior to drug approval, but the panel did not issue a clear-cut recommendation on that question. Currently, type 2 diabetes drugs are approved on the basis of a surrogate -- the ability to lower hemoglobin A1c, because it was believed that lowering glucose would translate into clinical benefit.
This notion has been challenged over the past year, first by a series of meta-analyses of rosiglitazone (Avandia), a drug that demonstrated significant efficacy in lowering glucose.
But beginning with a meta-analysis of published trial data by Steven Nissen, M.D., of the Cleveland Clinic and colleagues in May 2007, which revealed an increased risk of myocardial infarction among patients treated with rosiglitazone, a number of studies has linked the drug to increased risk of MI. As a result, the FDA added additional warnings to the rosiglitazone label. Pioglitazoane (Actos), a drug in the same class, already carried boxed warnings about congestive heart failure.
More recently, three trials reported at the American Diabetes Association meeting last month -- ACCORD, ADVANCE, and VADT -- found that aggressive glucose lowering did not reduce cardiovascular events.At a press briefing following the FDA advisory panel meeting, John Jenkins M.D., director of the FDA's Office of New Drugs, said the agency will consider several options for cardiovascular-risk assessment, including asking drug makers to continue patients as randomized for up to 18 months.
As it stands now, a typical trial design collects randomized data for a limited period -- 12 weeks is common -- to assess efficacy, and then crosses patients over to the investigational agent to gain long-term data.
Other possibilities would to require companies to include a single prospective cardiovascular-risk assessment trial as part of the NDA application process, or to permit a pooling of data from ongoing clinical trials.
But pooling was probably not a viable option for drugs in the approval pipeline because companies are not currently adjudicating cardiovascular risk, said Mary Parks, M.D., director of the agency's Division of Metabolism and Endocrinology Products.
Robert Temple, M.D., director of the FDA's Office of Medical Policy, said the same cardiovascular-risk assessment approach might be used to assess other drugs that are currently evaluated on the basis of a surrogate marker, such as hyperlipidemia agents and NSAIDs.
The panel considered, but rejected, the concept that a diabetes drug should be required to show cardiovascular benefit.