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Heavy menstrual bleeds given new treatment
Abstract & Commentary
By Frank W. Ling, MD, Clinical Professor, Department of Obstetrics and Gynecology, Vanderbilt University School of Medicine, Nashville, TN. Ling is associate editor for OB/GYN Clinical Alert.
Synopsis: In a double-blind, randomized, placebo-controlled trial, oral tranexamic acid was well tolerated and improved quality of life and menstrual blood flow in patients with heavy menstrual bleeding.
Source: Lukes AS, Moore KA, Muse KN, et al. Tranexamic acid treatment for heavy menstrual bleeding: A randomized controlled trial. Obstet Gynecol 2010;116:865-875.
After two pretreatment cycles, 196 patients with menorrhagia were randomized to tranexamic acid or placebo. Ultimately, after accounting for patients lost to follow-up, adverse events, and protocol violations, there were 117 evaluable patients in the tranexamic acid group and 72 in the placebo group who received up to five days of either study drug or placebo for each of six cycles. The primary endpoint was reduction in menstrual blood flow. This was defined as overall blood loss compared to predetermined significant amount (36 mL) and meaningful reduction perceived by the patient. Quality of life factors also were measured in terms of limitations of activities and work in and outside of home. The tranexamic acid successfully exceeded the benefits of placebo in terms of clinical and quality-of-life measurements, while having a comparable side effects profile.
How can you argue with a multicenter, randomized, placebo-controlled trial? Don't be cynical just because it was sponsored by a drug company. The findings can be useful for your patients. I know it already has helped some of my patients.
Tranexamic acid is a competitive plasminogen inhibitor that has been used overseas for reduction of menstrual blood loss. Gastrointestinal side effects have been minimized with a new formulation, sold as Lysteda. Showing efficacy when compared to placebo would seem to be a "given" since this is a Phase 3 trial. Having already passed the scrutiny of the Food and Drug Administration, the drug must do what it claims to do. It's important, however, to note that this study prohibited the concomitant use of oral contraceptives and nonsteroidal anti-inflammatory drugs. In real life, many patients potentially could use one or both of these agents, so further studies could address how the drug performs in those settings.
So the drug is out there on your sample shelf already. You've likely been "detailed" on it by your friendly, neighborhood pharmaceutical representative. Why do I include this study? Because early in this same issue, there is a study comparing two second-generation endometrial ablation techniques (bipolar radiofrequency endometrial ablation and hydrothermablation, with the former being shown to be superior to the latter).1 Here we have medical and surgical interventions being studied and reported on in the same issue of our most prestigious of journals.
I am hopeful that the significance of the juxtaposition of the two articles is not lost of any of us. Hopefully, nobody who has access to offering surgical/procedural interventions for menorrhagia is performing them without appropriate consideration of both old and new nonsurgical treatment options. Indeed, every patient might have preconceived notions of medical and surgical options and the appropriateness thereof. It is our job as women's health care advocates to make sure that each patient is given every opportunity to make a truly informed decision at each step. After all, as Yogi Berra said, "When you reach a fork in the road, take it." That advice reflects what each patient decision is: a choice. It needs to be supported by the best information that we can provide.