Crepinsek Maree A, Taylor Emily A, Michener Keryl, Stewart Fiona
Southern Cross University, Gold Coast, Australia.
School of Rural Medicine, University of New England, Main Beach, Australia.
Cochrane Database Syst Rev. 2020 Sep 29;9(9):CD007239. doi: 10.1002/14651858.CD007239.pub4.
Despite the health benefits of breastfeeding, initiation and duration rates continue to fall short of international guidelines. Many factors influence a woman's decision to wean; the main reason cited for weaning is associated with lactation complications, such as mastitis. Mastitis is an inflammation of the breast, with or without infection. It can be viewed as a continuum of disease, from non-infective inflammation of the breast to infection that may lead to abscess formation.
To assess the effectiveness of preventive strategies (for example, breastfeeding education, pharmacological treatments and alternative therapies) on the occurrence or recurrence of non-infective or infective mastitis in breastfeeding women post-childbirth.
We searched Cochrane Pregnancy and Childbirth's Trials Register, ClinicalTrials.gov, the WHO International Clinical Trials Registry Platform (ICTRP) (3 October 2019), and reference lists of retrieved studies.
We included randomised controlled trials of interventions for preventing mastitis in postpartum breastfeeding women. Quasi-randomised controlled trials and trials reported only in abstract form were eligible. We attempted to contact the authors to obtain any unpublished results, wherever possible. Interventions for preventing mastitis may include: probiotics, specialist breastfeeding advice and holistic approaches. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed trials for inclusion and risk of bias, extracted data and assessed the certainty of the evidence using GRADE.
We included 10 trials (3034 women). Nine trials (2395 women) contributed data. Generally, the trials were at low risk of bias in most domains but some were high risk for blinding, attrition bias, and selective reporting. Selection bias (allocation concealment) was generally unclear. The certainty of evidence was downgraded due to risk of bias and to imprecision (low numbers of women participating in the trials). Conflicts of interest on the part of trial authors, and the involvement of industry funders may also have had an impact on the certainty of the evidence. Most trials reported our primary outcome of incidence of mastitis but there were almost no data relating to adverse effects, breast pain, duration of breastfeeding, nipple damage, breast abscess or recurrence of mastitis. Probiotics versus placebo Probiotics may reduce the risk of mastitis more than placebo (risk ratio (RR) 0.51, 95% confidence interval (CI) 0.35 to 0.75; 2 trials; 399 women; low-certainty evidence). It is uncertain if probiotics reduce the risk of breast pain or nipple damage because the certainty of evidence is very low. Results for the biggest of these trials (639 women) are currently unavailable due to a contractual agreement between the probiotics supplier and the trialists. Adverse effects were reported in one trial, where no woman in either group experienced any adverse effects. Antibiotics versus placebo or usual care The risk of mastitis may be similar between antibiotics and usual care or placebo (RR 0.37, 95% CI 0.10 to 1.34; 3 trials; 429 women; low-certainty evidence). The risk of mastitis may be similar between antibiotics and fusidic acid ointment (RR 0.22, 95% CI 0.03 to 1.81; 1 trial; 36 women; low-certainty evidence) or mupirocin ointment (RR 0.44, 95% CI 0.05 to 3.89; 1 trial; 44 women; low-certainty evidence) but we are uncertain due to the wide CIs. None of the trials reported adverse effects. Topical treatments versus breastfeeding advice The risk of mastitis may be similar between fusidic acid ointment and breastfeeding advice (RR 0.77, 95% CI 0.27 to 2.22; 1 trial; 40 women; low-certainty evidence) and mupirocin ointment and breastfeeding advice (RR 0.39, 95% CI 0.12 to 1.35; 1 trial; 48 women; low-certainty evidence) but we are uncertain due to the wide CIs. One trial (42 women) compared topical treatments to each other. The risk of mastitis may be similar between fusidic acid and mupirocin (RR 0.51, 95% CI 0.13 to 2.00; low-certainty evidence) but we are uncertain due to the wide CIs. Adverse events were not reported. Specialist breastfeeding education versus usual care The risk of mastitis (RR 0.93, 95% CI 0.17 to 4.95; 1 trial; 203 women; low-certainty evidence) and breast pain (RR 0.93, 95% CI 0.36 to 2.37; 1 trial; 203 women; low-certainty evidence) may be similar but we are uncertain due to the wide CIs. Adverse events were not reported. Anti-secretory factor-inducing cereal versus standard cereal The risk of mastitis (RR 0.24, 95% CI 0.03 to 1.72; 1 trial; 29 women; low-certainty evidence) and recurrence of mastitis (RR 0.39, 95% CI 0.03 to 4.57; 1 trial; 7 women; low-certainty evidence) may be similar but we are uncertain due to the wide CIs. Adverse events were not reported. Acupoint massage versus routine care Acupoint massage probably reduces the risk of mastitis compared to routine care (RR 0.38, 95% CI 0.19 to 0.78;1 trial; 400 women; moderate-certainty evidence) and breast pain (RR 0.13, 95% CI 0.07 to 0.23; 1 trial; 400 women; moderate-certainty evidence). Adverse events were not reported. Breast massage and low frequency pulse treatment versus routine care Breast massage and low frequency pulse treatment may reduce risk of mastitis (RR 0.03, 95% CI 0.00 to 0.21; 1 trial; 300 women; low-certainty evidence). Adverse events were not reported.
AUTHORS' CONCLUSIONS: There is some evidence that acupoint massage is probably better than routine care, probiotics may be better than placebo, and breast massage and low frequency pulse treatment may be better than routine care for preventing mastitis. However, it is important to note that we are aware of at least one large trial investigating probiotics whose results have not been made public, therefore, the evidence presented here is incomplete. The available evidence regarding other interventions, including breastfeeding education, pharmacological treatments and alternative therapies, suggests these may be little better than routine care for preventing mastitis but our conclusions are uncertain due to the low certainty of the evidence. Future trials should recruit sufficiently large numbers of women in order to detect clinically important differences between interventions and results of future trials should be made publicly available.
尽管母乳喂养对健康有益,但开始母乳喂养的比例和持续时间仍未达到国际指南的要求。许多因素影响女性断奶的决定;断奶的主要原因与泌乳并发症有关,如乳腺炎。乳腺炎是乳腺的炎症,有无感染均可发生。它可被视为一种疾病的连续体,从乳腺的非感染性炎症到可能导致脓肿形成的感染。
评估预防策略(如母乳喂养教育、药物治疗和替代疗法)对产后母乳喂养女性非感染性或感染性乳腺炎发生或复发的有效性。
我们检索了Cochrane妊娠与分娩试验注册库、ClinicalTrials.gov、世界卫生组织国际临床试验注册平台(ICTRP)(2019年10月3日)以及检索到的研究的参考文献列表。
我们纳入了预防产后母乳喂养女性乳腺炎的干预措施的随机对照试验。半随机对照试验和仅以摘要形式报道的试验符合条件。我们尽可能尝试联系作者以获取任何未发表的结果。预防乳腺炎的干预措施可能包括:益生菌、专业母乳喂养建议和整体方法。
两位综述作者独立评估试验是否纳入以及偏倚风险,提取数据并使用GRADE评估证据的确定性。
我们纳入了10项试验(3034名女性)。9项试验(2395名女性)提供了数据。总体而言,试验在大多数领域的偏倚风险较低,但有些试验在盲法、失访偏倚和选择性报告方面存在高风险。选择偏倚(分配隐藏)通常不明确。由于偏倚风险和不精确性(参与试验的女性数量较少),证据的确定性被降低。试验作者的利益冲突以及行业资助者的参与也可能对证据的确定性产生了影响。大多数试验报告了我们的主要结局乳腺炎的发生率,但几乎没有关于不良反应、乳房疼痛、母乳喂养持续时间、乳头损伤、乳房脓肿或乳腺炎复发的数据。
益生菌可能比安慰剂更能降低乳腺炎的风险(风险比(RR)0.51,95%置信区间(CI)0.35至0.75;2项试验;399名女性;低确定性证据)。由于证据的确定性非常低,尚不确定益生菌是否能降低乳房疼痛或乳头损伤的风险。由于益生菌供应商与试验者之间的合同协议,目前这些试验中最大的一项(639名女性)的结果尚未公布。一项试验报告了不良反应,两组中均没有女性出现任何不良反应。
抗生素与常规护理或安慰剂之间乳腺炎的风险可能相似(RR 0.37,95%CI 0.10至1.34;3项试验;429名女性;低确定性证据)。抗生素与夫西地酸软膏(RR 0.22,95%CI 0.03至1.81;1项试验;36名女性;低确定性证据)或莫匹罗星软膏(RR 0.44,95%CI 0.05至3.89;1项试验;44名女性;低确定性证据)之间乳腺炎的风险可能相似,但由于置信区间较宽,我们尚不确定。没有试验报告不良反应。
夫西地酸软膏与母乳喂养建议(RR 0.77,95%CI 0.27至2.22;1项试验;40名女性;低确定性证据)以及莫匹罗星软膏与母乳喂养建议(RR 0.39,95%CI 0.12至1.35;1项试验;48名女性;低确定性证据)之间乳腺炎的风险可能相似,但由于置信区间较宽,我们尚不确定。一项试验(42名女性)比较了局部治疗之间的效果。夫西地酸与莫匹罗星之间乳腺炎的风险可能相似(RR 0.51,95%CI 0.13至2.00;低确定性证据),但由于置信区间较宽,我们尚不确定。未报告不良事件。
乳腺炎的风险(RR 0.93,95%CI 0.17至4.95;1项试验;203名女性;低确定性证据)和乳房疼痛的风险(RR 0.93,95%CI 0.36至2.37;1项试验;203名女性;低确定性证据)可能相似,但由于置信区间较宽,我们尚不确定。未报告不良事件。
乳腺炎的风险(RR 0.24,95%CI 0.03至1.72;1项试验;29名女性;低确定性证据)和乳腺炎复发的风险(RR 0.39,95%CI 0.03至4.57;1项试验;7名女性;低确定性证据)可能相似,但由于置信区间较宽,我们尚不确定。未报告不良事件。
与常规护理相比,穴位按摩可能降低乳腺炎的风险(RR 0.38,95%CI 0.19至0.78;1项试验;400名女性;中等确定性证据)和乳房疼痛的风险(RR 0.13,95%CI 0.07至0.23;1项试验;400名女性;中等确定性证据)。未报告不良事件。
乳房按摩和低频脉冲治疗可能降低乳腺炎的风险(RR 0.03,95%CI 0.00至0.21;1项试验;300名女性;低确定性证据)。未报告不良事件。
有一些证据表明,穴位按摩可能比常规护理更好,益生菌可能比安慰剂更好,乳房按摩和低频脉冲治疗可能比常规护理更能预防乳腺炎。然而,需要注意的是,我们知道至少有一项关于益生菌的大型试验结果尚未公开,因此,这里呈现的证据是不完整的。关于其他干预措施,包括母乳喂养教育、药物治疗和替代疗法的现有证据表明,这些措施在预防乳腺炎方面可能并不比常规护理好多少,但由于证据的确定性较低,我们的结论尚不确定。未来的试验应招募足够多的女性,以便检测不同干预措施之间临床上的重要差异,并且未来试验的结果应公开。