Bofill Rodriguez Magdalena, Lethaby Anne, Farquhar Cindy, Duffy James Mn
Department of Obstetrics and Gynaecology, University of Auckland, Auckland, New Zealand.
King's Fertility, Fetal Medicine Research Institute, London, UK.
Cochrane Database Syst Rev. 2020 Jul 23;7(7):CD013651. doi: 10.1002/14651858.CD013651.pub2.
Within the context of heavy menstrual bleeding, pandemics impact upon women's assessment and treatment by healthcare providers.
To summarise the evidence from Cochrane Reviews evaluating interventions for heavy menstrual bleeding that are commonly available during pandemics.
We sought published Cochrane Reviews, evaluating interventions that can continue during pandemics for women with heavy menstrual bleeding with no known underlying cause. We identified Cochrane Reviews by searching the Cochrane Database of Systematic Reviews in June 2020. The primary outcome was menstrual bleeding. Secondary outcomes included quality of life, patient satisfaction, side effects, and serious adverse events. We undertook the selection of systematic reviews, data extraction, and quality assessment in duplicate. We resolved any disagreements by discussion. We assessed review quality using the Assessing the Methodological Quality of Systematic Reviews (AMSTAR) 2 tool, and the certainty of the evidence for each outcome using GRADE methods.
We included four Cochrane Reviews, with 11 comparisons, data from 44 randomised controlled trials (RCTs), and 3196 women. We assessed all the reviews to be high quality. Non-steroidal anti-inflammatory drugs (NSAIDs) NSAIDs may be more effective in reducing heavy menstrual bleeding than placebo (mean difference (MD) -124 mL per cycle, 95% confidence interval (CI) -186 to -62 mL per cycle; 1 RCT, 11 women; low-certainty evidence). Mefenamic acid may be similar to naproxen (MD 21 mL per cycle, 95% CI -6 to 48 mL per cycle; 2 RCTs, 61 women; low-certainty evidence), and NSAIDs may be similar to combined hormonal contraceptives for heavy menstrual bleeding (MD 25 mL per cycle, 95% CI -22 to 73 mL per cycle; 1 RCT, 26 women; low-certainty evidence). NSAIDs may be be less effective in reducing menstrual bleeding than antifibrinolytics (relative risk (RR) 0.70, 95% CI 0.58 to 0.85; 2 RCTs, 161 women; low-certainty evidence). We are uncertain whether NSAIDs reduce menstrual blood loss more than short-cycle progestogens (RR 0.80, 95% CI 0.49 to 1.32; 1 RCT 32 women; very low-certainty evidence). Antifibrinolytics Antifibrinolytics appear to be more effective in reducing heavy menstrual bleeding than placebo (MD -53 mL per cycle, 95% CI -63 to -44 mL per cycle; 4 RCTs, 565 women; moderate-certainty evidence). Antifibrinolytics may be similar to placebo on the incidence of side effects (RR 1.05, 95% CI 0.93 to 1.18; 1 RCT, 297 women; low-certainty evidence), and they are probably similar on the incidence of serious adverse events (thrombotic events; RR 0.10, 95% CI 0.00 to 2.46; 2 RCT, 468 women; moderate-certainty evidence). Antifibrinolytics may be more effective in reducing heavy menstrual bleeding than short-cycle progestogen (MD -111 mL per cycle, 95% CI -178 mL to -44 mL per cycle; 1 RCT, 46 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to short-cycle progestogens on quality of life (RR 1.67, 95% CI 0.76 to 3.64; 1 RCT, 44 women; very low-certainty evidence), patient satisfaction (RR 0.91, 95% CI 0.59 to 1.39; 1 RCT, 42 women; very low-certainty evidence), or side effects (RR 0.85, 95% CI 0.65 to 1.12; 3 RCTs, 211 women; very low-certainty evidence). We are uncertain whether antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with long-cycle progestogen (MD -9 points per cycle, 95% CI -30 to 12 points per cycle; 2 RCTs, 184 women; low-certainty evidence). Antifibrinolytics may increase self-reported improvement in menstrual bleeding when compared with long-cycle medroxyprogesterone acetate (RR 1.32, 95% CI 1.08 to 1.61; 1 RCT, 94 women; low-certainty evidence). Antifibrinolytics may be similar to long-cycle progestogens on quality of life (MD 5, 95% CI -2.49 to 12.49; 1 RCT, 90 women; low-certainty evidence). We are uncertain whether antifibrinolytics are similar to long-cycle progestogens on side effects (RR 0.58, 95% CI 0.33 to 1.00; 2 RCTs, 184 women; very low-certainty evidence). There were no trials comparing antifibrinolytics to combined hormonal contraceptives. Combined hormonal contraceptives Combined hormonal contraceptives appear to be more effective for heavy menstrual bleeding than placebo or no treatment (RR 13.25, 95% CI 2.94 to 59.64; 2 RCTs, 363 women; moderate-certainty evidence). Combined hormonal contraceptives are probably similar to placebo on the incidence of side effects (RR 1.53, 95% CI 0.90 to 2.60; 2 RCTs, 411 women; moderate-certainty evidence). Progestogens There were no trials comparing progestogens to placebo. Limitations in the evidence included risk of bias in the primary RCTs, inconsistency between the primary RCTs, and imprecision in effect estimates.
AUTHORS' CONCLUSIONS: There is moderate-certainty evidence that antifibrinolytics and combined hormonal contraceptives reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that NSAIDs reduce heavy menstrual bleeding compared with placebo. There is low-certainty evidence that antifibrinolytics are more effective in reducing heavy menstrual bleeding when compared with NSAIDs and short-cycle progestogens, but we are unable to draw conclusions about the effects of antifibrinolytics compared to long-cycle progestogens, on low-certainty evidence.
在月经过多的情况下,大流行会影响医疗保健提供者对女性的评估和治疗。
总结Cochrane系统评价中的证据,这些评价评估了大流行期间常用的月经过多干预措施。
我们查找已发表的Cochrane系统评价,评估可在大流行期间继续用于不明潜在病因的月经过多女性的干预措施。我们通过检索2020年6月的Cochrane系统评价数据库来识别Cochrane系统评价。主要结局是月经出血。次要结局包括生活质量、患者满意度、副作用和严重不良事件。我们对系统评价的选择、数据提取和质量评估进行了重复操作。我们通过讨论解决了任何分歧。我们使用系统评价方法学质量评估(AMSTAR)2工具评估评价质量,并使用GRADE方法评估每个结局的证据确定性。
我们纳入了四项Cochrane系统评价,包含11项比较、来自44项随机对照试验(RCT)的数据以及3196名女性。我们评估所有评价为高质量。非甾体抗炎药(NSAIDs)NSAIDs在减少月经过多方面可能比安慰剂更有效(平均差(MD)为每周期-124 mL,95%置信区间(CI)为每周期-186至-62 mL;1项RCT,11名女性;低确定性证据)。甲芬那酸可能与萘普生相似(MD为每周期21 mL,95%CI为每周期-6至48 mL;2项RCT,61名女性;低确定性证据),并且NSAIDs在减少月经过多方面可能与复方激素避孕药相似(MD为每周期25 mL,95%CI为每周期-22至73 mL;1项RCT,26名女性;低确定性证据)。NSAIDs在减少月经出血方面可能比抗纤溶药物效果更差(相对风险(RR)0.70,95%CI为0.58至0.85;2项RCT,161名女性;低确定性证据)。我们不确定NSAIDs在减少月经失血方面是否比短周期孕激素更有效(RR 0.80,95%CI为0.49至1.32;1项RCT,32名女性;极低确定性证据)。抗纤溶药物抗纤溶药物在减少月经过多方面似乎比安慰剂更有效(MD为每周期-53 mL,95%CI为每周期-63至-44 mL;4项RCT,565名女性;中等确定性证据)。抗纤溶药物在副作用发生率方面可能与安慰剂相似(RR 1.05,95%CI为0.93至1.18;1项RCT,297名女性;低确定性证据),并且它们在严重不良事件(血栓事件)发生率方面可能相似(RR 0.10,95%CI为0.00至2.46;2项RCT,468名女性;中等确定性证据)。抗纤溶药物在减少月经过多方面可能比短周期孕激素更有效(MD为每周期-111 mL,95%CI为每周期-178 mL至-44 mL;1项RCT,46名女性;低确定性证据)。我们不确定抗纤溶药物在生活质量(RR 1.67,95%CI为0.76至3.64;1项RCT,44名女性;极低确定性证据)、患者满意度(RR 0.91,95%CI为0.59至1.39;1项RCT,42名女性;极低确定性证据)或副作用(RR 0.85,95%CI为0.65至1.12;3项RCT,211名女性;极低确定性证据)方面是否与短周期孕激素相似。我们不确定与长周期孕激素相比,抗纤溶药物在减少月经过多方面是否更有效(MD为每周期-9分,95%CI为每周期-30至12分;2项RCT,184名女性;低确定性证据)。与长效醋酸甲羟孕酮相比,抗纤溶药物可能会增加自我报告的月经出血改善情况(RR 1.32,95%CI为1.08至1.61;1项RCT,94名女性;低确定性证据)。抗纤溶药物在生活质量方面可能与长周期孕激素相似(MD 5,95%CI为-2.49至12.49;1项RCT,90名女性;低确定性证据)。我们不确定抗纤溶药物在副作用方面是否与长周期孕激素相似(RR 0.58,95%CI为0.33至1.00;2项RCT,184名女性;极低确定性证据)。没有试验将抗纤溶药物与复方激素避孕药进行比较。复方激素避孕药复方激素避孕药在治疗月经过多方面似乎比安慰剂或不治疗更有效(RR 13.25,95%CI为2.94至59.64;2项RCT,363名女性;中等确定性证据)。复方激素避孕药在副作用发生率方面可能与安慰剂相似(RR 1.53,95%CI为0.90至2.60;2项RCT,411名女性;中等确定性证据)。孕激素没有试验将孕激素与安慰剂进行比较。证据的局限性包括主要RCT中的偏倚风险、主要RCT之间的不一致性以及效应估计的不精确性。
有中等确定性证据表明,与安慰剂相比,抗纤溶药物和复方激素避孕药可减少月经过多。有低确定性证据表明,与安慰剂相比,NSAIDs可减少月经过多。有低确定性证据表明,与NSAIDs和短周期孕激素相比,抗纤溶药物在减少月经过多方面更有效,但基于低确定性证据,我们无法就抗纤溶药物与长周期孕激素相比的效果得出结论。