Medical therapy versus radiofrequency endometrial ablation in the initial treatment of heavy menstrual bleeding (iTOM Trial): A clinical and economic analysis

BackgroundRadiofrequency endometrial ablation (REA) is currently a second line treatment in women with heavy menstrual bleeding (MHB) if medical therapy (MTP) is contraindicated or unsatisfactory. Our objective is to compare the effectiveness and cost burden of MTP and REA in the initial treatment of HMB.MethodsWe performed a randomized trial at Mayo Clinic Rochester, Minnesota. The planned sample size was 60 patients per arm. A total of 67 women with HMB were randomly allocated to receive oral contraceptive pills (Nordette ®) or Naproxen (Naprosyn®) (n = 33) or REA (n = 34). Primary 12-month outcome measures included menstrual blood loss using pictorial blood loss assessment chart (PBLAC), patients’ satisfaction, and Menorrhagia Multi-Attribute Scale (MMAS). Secondary outcomes were total costs including direct medical and indirect costs associated with healthcare use, patient out-of-pocket costs, and lost work days and activity limitations over 12 months.ResultsCompared to MTP arm, women who received REA had a significantly lower PBLAC score (median [Interquartile range, IQR]: 0 [0–4] vs. 15 [0–131], p = 0.003), higher satisfaction rates (96.8%vs.63.2%, p = 0.003) and higher MMAS (median [IQR]: 100 [100–100] vs. 100 [87–100], p = 0.12) at 12 months. Direct medical costs were higher for REA ($5,331vs.$2,901, 95% confidence interval (CI) of mean difference:$727,$4,852), however, when indirect costs are included, the difference did not reach statistical significance ($5,469 vs. $3,869, 95% CI of mean difference:-$339, $4,089).ConclusionFor women with heavy menstrual bleeding, initial radiofrequency endometrial ablation compared to medical therapy offered superior reduction in menstrual blood loss and improvement in quality of life without significant differences in total costs of care.Clinical trial registrationNCT01165307.背景 射频子宫内膜消融术（Radiofrequency Endometrial Ablation, REA）目前是药物治疗（Medical Therapy, MTP）禁忌或疗效欠佳的月经过多（Heavy Menstrual Bleeding, MHB）女性患者的二线治疗方案。本研究旨在比较药物治疗与射频子宫内膜消融术用于月经过多初始治疗的有效性与成本负担。 方法 本研究于美国明尼苏达州罗切斯特市梅奥诊所开展随机对照试验。计划每组样本量为60例患者。最终共纳入67例月经过多女性，按随机分配原则分别接受口服避孕药（Nordette®）或萘普生（Naprosyn®）治疗（n=33），或行射频子宫内膜消融术（n=34）。主要12个月结局指标包括：采用图表月经失血量评估表（Pictorial Blood Loss Assessment Chart, PBLAC）评估的月经失血量、患者满意度，以及月经过多多属性量表（Menorrhagia Multi-Attribute Scale, MMAS）评分。次要结局指标包括12个月随访期内，与医疗服务利用相关的直接医疗成本与间接成本、患者自付费用、误工天数及活动受限情况。 结果 与药物治疗组相比，接受射频子宫内膜消融术的患者在12个月随访时的PBLAC评分显著更低[中位数（四分位距，IQR）：0（0~4）vs. 15（0~131），p=0.003]，患者满意度更高（96.8% vs. 63.2%，p=0.003），MMAS评分亦更高[中位数（四分位距，IQR）：100（100~100）vs. 100（87~100），p=0.12]。直接医疗成本方面，射频子宫内膜消融术组更高（5331美元 vs. 2901美元，均值差95%置信区间（CI）：727美元~4852美元）；但纳入间接成本后，两组总成本差异未达到统计学显著性（5469美元 vs. 3869美元，均值差95%置信区间（CI）：-339美元~4089美元）。 结论 对于月经过多女性患者，相较于药物治疗，初始采用射频子宫内膜消融术可更显著减少月经失血量、改善生活质量，且总医疗成本无显著差异。 临床试验注册 NCT01165307