DETROIT - Pregabalin, FDA-approved for neuropathic pain (pain caused by shingles and peripheral neuropathy), effectively reduced abdominal pain and improved sleep in women with adhesions, according to a Henry Ford study.
Adhesion pain, a common complication after abdominal or pelvic surgery, currently lacks effective therapy. Adhesions can also form after infections in the bowel such as diverticulitis.
"Many patients in the study went from debilitating pain to complete resolution of pain on pregabalin," says Ann Silverman, M.D., senior staff gastroenterologist at Henry Ford Hospital and lead author of the study.
Study results will be presented Oct. 26 at the American College of Gastroenterology's Annual Scientific Meeting in San Diego.
"Aside from the use of analgesics, additional surgery is the only treatment option for abdominal pain from adhesions but repeat surgery can lead to more adhesions," says Dr. Silverman.
The estimates of abdominal adhesion formation following surgery have been found to be as high as 100 percent in certain studies. Surgery is only recommended for bowel obstruction.
The randomized Henry Ford study looked at 18 women who received the drug or a look-alike placebo. All patients had previous abdominal surgery and were similar in age. The first eight weeks was a randomized placebo controlled trial of pregabalin followed by a four-week open label study in which all patients received the active study drug.
The primary objective was to demonstrate a significant reduction in pain scores.
The pain score result from the blinded phase indicated that the amount of decrease was significantly greater in the drug group (p-value = 0.024) compared with those on placebo, while the pain score resulted from the open label setting indicated that the amount of decrease was significantly greater in the placebo group (p-value = 0.043). This would be expected since those on active drug continued to take active drug and patients who had received the look-alike placebo received the active drug only during this phase of the study.
EDITOR'S NOTE: Dr. Ann Silverman is available for interviews.
EMBARGOED FOR RELEASE 11 a.m., EST, Monday, Oct. 26, 2009