Abstract：
BACKGROUND: Some mothers may seek lactation inhibition on personal, social, or medical grounds. The common drug used for lactation inhibition is cabergoline. Several adverse effects and contraindications are known for this drug. Its use is contraindicated for patients with hypertensive disorders and fibrotic, cardiac, or hepatic diseases. In addition, pyridoxine (vitamin B6) has been used for this indication, with no significant adverse effect, following studies that demonstrated its efficacy.
OBJECTIVE: This study aimed to compare the efficiency of cabergoline vs pyridoxine for lactation inhibition.
METHODS: A randomized controlled trial was conducted. Postpartum patients who requested lactation inhibition were randomly allocated to receive either cabergoline (1 mg once on postpartum day 1 or divided to 0.25 mg twice a day for 2 days thereafter, according to the departmental protocol, which is in line with the manufacturer recommendations) or pyridoxine (200 mg 3 times a day for 7 days). The patients enrolled were free of diseases in which contraindications to cabergoline are present. All patients completed a questionnaire for assessing breast engorgement, breast pain, and milk leakage on a scale of 0 (no symptom) to 5 (severe symptom) on days 0, 2, 7, and 14. The primary outcome was lactation inhibition success, defined as a score of 0 for both engorgement and pain on day 7. The secondary outcomes included the assessment of milk leakage, adverse effects, fever, mastitis, and treatment discontinuation or alteration.
RESULTS: Of note, 45 and 43 patients received cabergoline or pyridoxine, respectively, and were included in the analysis following the intention-to-treat principle. Cabergoline was superior to pyridoxine in inhibiting lactation at day 7 (78% vs 35%, respectively; P<.0001). Mild symptoms, defined as a score of 0 to 2 for breast engorgement and pain, at day 7 were 40 (89%) in the cabergoline group and 29 (67%) in the pyridoxine group (P=.01). The incidence of milk leakage was lower in the cabergoline group after 7 and 14 days than in the pyridoxine group (9% vs 42% [P=.0003] and 11% vs 31% [P=.02], respectively). Cabergoline had more adverse effects than pyridoxine (31% vs 9%, respectively; P=.01), but all adverse effects were mild. The rates of mastitis and fever that were related to engorgement were similar in the cabergoline and pyridoxine groups (4 [9%] vs 2 [5%], respectively; P=.67). Furthermore, 9 patients (21%) in the pyridoxine group switched to or added cabergoline because of treatment failure. Accordingly, on day 7, the pyridoxine success rate was reduced from 35% (15 women) to 28% (12 women) and from 67% (29 women) to 53% (23 women) for a score of 0 and 0 to 2 for both engorgement and pain, respectively.
CONCLUSIONS: Cabergoline was superior to pyridoxine in inhibiting lactation. Cabergoline had more adverse effects, but no major adverse effect was documented in either treatment group. As pyridoxine inhibited lactation successfully in previous studies and in 67% of patients in this study, its use should be considered in women with contraindications for cabergoline.
OBJECTIVE: This study aimed to compare the efficiency of cabergoline vs pyridoxine for lactation inhibition.
METHODS: A randomized controlled trial was conducted. Postpartum patients who requested lactation inhibition were randomly allocated to receive either cabergoline (1 mg once on postpartum day 1 or divided to 0.25 mg twice a day for 2 days thereafter, according to the departmental protocol, which is in line with the manufacturer recommendations) or pyridoxine (200 mg 3 times a day for 7 days). The patients enrolled were free of diseases in which contraindications to cabergoline are present. All patients completed a questionnaire for assessing breast engorgement, breast pain, and milk leakage on a scale of 0 (no symptom) to 5 (severe symptom) on days 0, 2, 7, and 14. The primary outcome was lactation inhibition success, defined as a score of 0 for both engorgement and pain on day 7. The secondary outcomes included the assessment of milk leakage, adverse effects, fever, mastitis, and treatment discontinuation or alteration.
RESULTS: Of note, 45 and 43 patients received cabergoline or pyridoxine, respectively, and were included in the analysis following the intention-to-treat principle. Cabergoline was superior to pyridoxine in inhibiting lactation at day 7 (78% vs 35%, respectively; P<.0001). Mild symptoms, defined as a score of 0 to 2 for breast engorgement and pain, at day 7 were 40 (89%) in the cabergoline group and 29 (67%) in the pyridoxine group (P=.01). The incidence of milk leakage was lower in the cabergoline group after 7 and 14 days than in the pyridoxine group (9% vs 42% [P=.0003] and 11% vs 31% [P=.02], respectively). Cabergoline had more adverse effects than pyridoxine (31% vs 9%, respectively; P=.01), but all adverse effects were mild. The rates of mastitis and fever that were related to engorgement were similar in the cabergoline and pyridoxine groups (4 [9%] vs 2 [5%], respectively; P=.67). Furthermore, 9 patients (21%) in the pyridoxine group switched to or added cabergoline because of treatment failure. Accordingly, on day 7, the pyridoxine success rate was reduced from 35% (15 women) to 28% (12 women) and from 67% (29 women) to 53% (23 women) for a score of 0 and 0 to 2 for both engorgement and pain, respectively.
CONCLUSIONS: Cabergoline was superior to pyridoxine in inhibiting lactation. Cabergoline had more adverse effects, but no major adverse effect was documented in either treatment group. As pyridoxine inhibited lactation successfully in previous studies and in 67% of patients in this study, its use should be considered in women with contraindications for cabergoline.
摘要：
背景：一些母亲可能会寻求对个人的泌乳抑制，社会,或医疗理由。用于抑制泌乳的常见药物是卡麦角林。该药物已知有几种不良反应和禁忌症。它的使用是禁忌的高血压疾病和纤维化患者，心脏,或肝脏疾病。此外,吡哆醇（维生素B6）已用于该适应症，无明显不良反应,以下研究证明了它的功效。
目的：本研究旨在比较卡麦角林与吡哆醇抑制泌乳的效果。
方法：进行一项随机对照试验。要求抑制泌乳的产后患者被随机分配接受卡麦角林（产后第1天1毫克一次或分为0.25毫克，每天2天，根据部门规定,符合制造商的建议）或吡哆醇（200mg，每天3次，共7天）。入选的患者没有卡麦角林禁忌症的疾病。所有患者都填写了一份评估乳房充血的问卷，乳房疼痛,在第0、2、7和14天，牛奶泄漏的等级为0（无症状）至5（严重症状）。主要结果是泌乳抑制成功，定义为第7天的充血和疼痛得分为0。次要结果包括牛奶泄漏的评估，不利影响，发烧,乳腺炎,和治疗中断或改变。
结果：值得注意的是，45和43名患者接受了卡麦角林或吡哆醇，分别,按照意向治疗原则纳入分析.在第7天，卡麦角林在抑制泌乳方面优于吡哆醇（78％vs35％，分别；P<.0001）。轻度症状,定义为乳房充血和疼痛的0到2分，第7天,卡麦角林组40例(89%),吡哆醇组29例(67%)(P=.01).卡麦角林组在7天和14天后的牛奶泄漏发生率低于吡哆醇组（9％vs42％[P=.0003]和11％vs31％[P=.02]，分别)。卡麦角林比吡哆醇有更多的不良反应（31％vs9％，分别为；P=0.01)，但所有不良反应都很轻微.与充血相关的乳腺炎和发热的发生率在卡麦角林和吡哆醇组中相似(4[9%]vs2[5%],分别为；P=.67）。此外，由于治疗失败，吡哆醇组的9名患者（21％）改用或添加了卡麦角林。因此，在第7天，吡哆醇的成功率从35％（15名妇女）降低到28％（12名妇女），从67％（29名妇女）降低到53％（23名妇女），得分为0和0至2。分别。
结论：卡麦角林在抑制泌乳方面优于吡哆醇。卡麦角林的不良反应较多,但在任一治疗组中均未发现重大不良反应.因为吡哆醇在以前的研究中成功地抑制泌乳，并且在本研究中67%的患者中，在有卡麦角林禁忌症的女性中应考虑其使用。
目的：本研究旨在比较卡麦角林与吡哆醇抑制泌乳的效果。
方法：进行一项随机对照试验。要求抑制泌乳的产后患者被随机分配接受卡麦角林（产后第1天1毫克一次或分为0.25毫克，每天2天，根据部门规定,符合制造商的建议）或吡哆醇（200mg，每天3次，共7天）。入选的患者没有卡麦角林禁忌症的疾病。所有患者都填写了一份评估乳房充血的问卷，乳房疼痛,在第0、2、7和14天，牛奶泄漏的等级为0（无症状）至5（严重症状）。主要结果是泌乳抑制成功，定义为第7天的充血和疼痛得分为0。次要结果包括牛奶泄漏的评估，不利影响，发烧,乳腺炎,和治疗中断或改变。
结果：值得注意的是，45和43名患者接受了卡麦角林或吡哆醇，分别,按照意向治疗原则纳入分析.在第7天，卡麦角林在抑制泌乳方面优于吡哆醇（78％vs35％，分别；P<.0001）。轻度症状,定义为乳房充血和疼痛的0到2分，第7天,卡麦角林组40例(89%),吡哆醇组29例(67%)(P=.01).卡麦角林组在7天和14天后的牛奶泄漏发生率低于吡哆醇组（9％vs42％[P=.0003]和11％vs31％[P=.02]，分别)。卡麦角林比吡哆醇有更多的不良反应（31％vs9％，分别为；P=0.01)，但所有不良反应都很轻微.与充血相关的乳腺炎和发热的发生率在卡麦角林和吡哆醇组中相似(4[9%]vs2[5%],分别为；P=.67）。此外，由于治疗失败，吡哆醇组的9名患者（21％）改用或添加了卡麦角林。因此，在第7天，吡哆醇的成功率从35％（15名妇女）降低到28％（12名妇女），从67％（29名妇女）降低到53％（23名妇女），得分为0和0至2。分别。
结论：卡麦角林在抑制泌乳方面优于吡哆醇。卡麦角林的不良反应较多,但在任一治疗组中均未发现重大不良反应.因为吡哆醇在以前的研究中成功地抑制泌乳，并且在本研究中67%的患者中，在有卡麦角林禁忌症的女性中应考虑其使用。
