OTC product may ease urinary urge incontinence. (Milk of Magnesia Beats Placebo in Trial).
A randomized, double-blind, placebo-controlled study of 60 women with urinary urge incontinence showed significantly greater decreases in the mean number of urge incontinence episodes, nocturia, and the frequency of micturition in women who received 350 mg of magnesium hydroxide twice daily, compared with those on placebo, said Dr. Chesson, professor of gynecologic surgery at Louisiana State University; New Orleans.
He presented the findings on behalf of the study's lead investigator, Dr. F. A. Ganj of Iran University; Tehran, who was unable to attend the meeting.
Magnesium hydroxide is available in inexpensive over-the-counter preparations such as milk of magnesia. "This is only a teaspoon [of such products] twice a day to get this effect, which to me was surprising. It would be interesting to do a trial of [magnesium hydroxide] vs. imipramine, maybe using a little higher dose" of magnesium hydroxide, he said.
Twelve of 30 patients in the magnesium hydroxide group reported improvements in urinary incontinence after 1 month, compared with 5 of 30 patients taking placebo.
Patients compiled 24-hour bladder diaries before and after treatment and were interviewed before, during, and after the 4-week trial. Patients who had not improved after 2 weeks of treatment increased their doses of drug or placebo.
Urodynamic studies before and after treatment found no significant differences between patients in the drug and placebo groups. Patients in both groups who improved showed changes in detrusor pressure rise when the bladder was filled and in their first desire to void.
In general, people consume products like milk of magnesia to treat constipation. One physician at the meeting questioned whether the study truly was blinded, given the drug's effects on bowel movements. "I suspect there was some un-blinding" because of this, said Dr. Chesson, who emphasized again that this was a very small dose of magnesium hydroxide.
The drug was well tolerated; no one discontinued therapy during the trial. Other more common medications used to treat urge incontinence typically cause anticholinergic side effects such as dry mouth or constipation, Dr. Chesson noted.
In a separate presentation on the treatment of urinary urge incontinence, Dr. C. Willy Davila reported that rates of anticholinergic side effects from an investigational transdermal form of oxybutynin (Ditropan) were similar to rates with placebo and "substantially" lower than with immediate-release oral oxybutynin in a study of 542 patients and 303 healthy controls.
In the retrospective study; investigators combined data from all phase I, II, and III clinical trials of transdermal oxybutynin and data from comparisons of immediate-release oxybutynin and placebo. Among 201 participants in controlled studies, 9% using transdermal oxybutynin reported dry mouth, compared with 8% on placebo and 58% on immediate-release oxybutynin, said Dr. Davila, head of urogynecology and chairman of ob.gyn. at the Cleveland Clinic Florida, Weston.
Dr. Davila is a paid consultant to Watson Pharmaceuticals, which makes oxybutynin and which funded the study. The study did not compare data on extendedrelease oral oxybutynin, which has been reported to cause fewer anticholinergic side effects than does the immediate-release formulation.
In the current study, data from controlled trials showed overall rates of adverse events of 63% with transdermal oxybutynin, 62% with placebo, and 79% with immediate-release oxybutynin. More than half of patients using transdermal oxybutynin developed mild or moderate skin reactions where the patch was applied.
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|Publication:||OB GYN News|
|Date:||Jan 15, 2003|
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