Official Title: “A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

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.

Key conclusions and implications for practice: If acupuncture treatment is acceptable to the mother, this, together with care interventions such as correction of breast-feeding position and babies’ attachment to the breast might be a more expedient and less invasive choice of treatment than the use of oxytocin nasal spray. Midwives, nurses or medical practitioners with specialist competence in breast feeding should be the primary care providers for mothers with inflammatory symptoms of the breast during lactation. The use of antibiotics for inflammatory symptoms of the breast should be closely monitored in order to help the global community reduce resistance development among bacterial pathogens.

Intervention(s) in this Clinical Trial

• Procedure: Acupuncture treatment
• Procedure: Administration of oxytocin nasal spray
• Procedure: Improved breast milk removal
• Procedure: Warmth applied to breasts
• Procedure: Breast massage
• Drug: Anti-pyretic medication, paracetamol
• Drug: cefadroxil
• Drug: penicillin
• Drug: flucloxacillin

Primary Measures

• 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

Secondary Measures

• 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

Inclusion Criteria:

• Lactating mothers with symptoms of breast inflammation
• Any mixture of increased breast tension, fever, breast erythema, lumps in the breast

Exclusion Criteria:

• Non-Swedish speaking
• Psychiatric illness
• Hemorrhagic disease
• Prosthetic heart valves
• Skin infections
• Hepatitis B
• HIV positive.

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: N/A

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Karlstad University

Overall Clinical Trial Officials and Contacts

Linda J Kvist, PhD Principal Investigator Karlstads University  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00405158

Study ID Number: 84839

ClinicalTrials.gov Identifier: NCT00405158

Health Authority: Sweden: Swedish National Council on Medical Ethics

Karlstad University Webb page