A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Proportion of women with lowest possible scores for symptom severity on days 3,4 and 5 in the three groups
研究概览
简要总结
The objective of the study was to test the hypothesis that acupuncture treatment hastens recovery time from inflammatory symptoms of the breast during breastfeeding. 205 mothers with 210 cases of breast inflammation (commonly called "mastitis") during breastfeeding were randomly assigned to one of three treatment groups. There were two groups where acupuncture was used and one without acupuncture. The mothers symptoms were recorded at the onset of health care contact and daily until recovery. All care interventions given, including antibiotic therapy, were monitored. Women who participated were asked to leave a breast milk sample to test for bacterial growth. It was found that acupuncture did not shorten the women's contacts with health care services but did improve their symptoms on contact days 3 and 4. It was seen in this study that only 15 % of women were prescribed antibiotics which was a very low rate of prescription compared to USA, Canada, Australia, Turkey and New Zealand where up to 100% are given antibiotics. Seven women (3.3% of those in the study) developed a breast boil and this is a similar number to a study in Australia where many more were treated by antibiotics. This could mean that many women throughout the world are given antibiotics when in fact they may recover without them. This is an important finding in relation to the fight against antibiotic resistant bacteria.
详细描述
Objectives: to further compare acupuncture treatment and care interventions for the relief of inflammatory symptoms of the breast during lactation and to investigate the relationship between bacteria in the breast milk and clinical signs and symptoms.
Design: randomised, non-blinded, controlled trial of acupuncture and care interventions.
Setting: a midwife-led breast-feeding clinic in Sweden.
Participants: 205 mothers with 210 cases of inflammatory symptoms of the breast during lactation agreed to participate. The mothers were randomly assigned to one of three treatment groups, two of which included acupuncture amongst the care interventions and one without acupuncture. All groups were given essential care. Protocols, which included scales for erythema, breast tension and pain, were maintained for each day of contact with the breast-feeding clinic. A Severity Index (SI) for each mother and each day was created by adding together the scores on the erythema, breast tension and pain scales. The range of the SI was 0 (least severe) to 19 (most severe).
Findings: There was no significant difference in numbers of mothers in the treatment groups with the lowest possible score for severity of symptoms on contact days 3, 4 or 5. There were no statistically significant differences between the treatment groups for number of contact days needed until the mother felt well enough to discontinue contact with the breast-feeding clinic or for number of mothers prescribed antibiotics. There were significant differences in the mean SI scores on contact days 3 and 4 between the non-acupuncture group and the two acupuncture groups. Mothers with less favourable outcomes (≥ 6 contact days, n = 61) were, at first contact with the midwife more often given advice on correction of the baby's attachment to the breast. An obstetrician was called to examine 20 % of the mothers and antibiotic therapy was prescribed for 15 % of the study population. The presence of Group B streptococci in the breast milk was related to less favourable outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Lactating mothers with symptoms of breast inflammation
- •Any mixture of increased breast tension, fever, breast erythema, lumps in the breast
排除标准
- •Non-Swedish speaking
- •Psychiatric illness
- •Hemorrhagic disease
- •Prosthetic heart valves
- •Skin infections
- •Hepatitis B
- •HIV positive.
结局指标
主要结局
Proportion of women with lowest possible scores for symptom severity on days 3,4 and 5 in the three groups
Comparison of the three groups for mean scores for symptom severity on days 3,4 and 5
Comparison of the three treatment groups for number of contact days with health care services until recovery
Proportion of mothers in the three groups with less favourable outcomes (6 or more contact days to recovery)
Comparison of the three groups for proportions of women prescribed antibiotics
Comparison of the three groups for proportions of mothers who developed breast abscess
Proportions of women in the three groups who experienced residual symptoms within 6 weeks which required renewed health care contact
Comparison of the three groups for care interventions used
次要结局
- Amounts of bacteria in the breast milk and correlated to erythema, increased breast tension and pain at first contact
- Type of bacteria in breast milk related to favourable outcomes (5 or less contact days) and less favorable outcomes (6 or more contact days)
- Differences in care interventions used in relation to favourable/less favourable outcomes
- Relationship between the occurrence of residual symptoms and the use of antibiotics