TRIP

PEARL I & PEARL II: Diamonds in the EBM Rough

Now@NEJM, 2012

In 2005, she had a 66-pound fibroid removed by Dr Pushpanjali Malipatil and his team, earning both patient and surgeon a spot in the .
Although the majority of fibroids are only a fraction of the size of the record-setting tumor, they can still result in menorrhagia, iron-deficiency anemia, pelvic discomfort, and impaired fertility.
A number of treatment alternatives (see NEJM studies from and .) are available, but more effective and better-tolerated options are badly needed.
Jacques Donnez (Université Catholique de Louvain, Brussels, Belgium) and colleagues present two short-duration, double-blind, multi-center trials that examine the utility of ulipristal acetate (a progesterone receptor modulator) prior to planned surgery in pre-menopausal women with symptomatic uterine fibroids.
In , 237 women with fibroids, excessive uterine bleeding, and anemia were randomized to ulipristal 5mg daily, ulipristal 10mg daily, or placebo.
At the end of the 13-week trial, uterine bleeding was controlled for about 92% of ulipristal-treated women compared to only 19% of the placebo-treated group (p<0.001 vs.
The fibroid volume shrunk for the ulipristal groups (21% smaller in size for the 5mg group and 12% smaller for the 10mg group) to a greater extent than it did for the placebo group (3% larger in size; p<0.01 vs.
From this, the authors conclude that ulipristal is more effective than placebo for the medical treatment of symptomatic fibroids.
Run in a clinical setting similar to that of PEARL I, provides evidence that daily oral ulipristal is non-inferior to monthly intramuscular leuprolide acetate for the medical treatment of symptomatic fibroids prior to planned uterine surgery.
Notably, the ulipristal groups experienced significantly fewer hot flashes than the leuprolide acetate group, suggesting that ulipristal is the better-tolerated treatment.
Elizabeth Stewart (Mayo Clinic, Rochester, Minnesota) characterizes these studies as “an important step” toward effective medical therapy for fibroids.