Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding
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|ClinicalTrials.gov Identifier: NCT00405158|
Recruitment Status : Completed
First Posted : November 29, 2006
Last Update Posted : December 4, 2006
|Condition or disease||Intervention/treatment|
|Mastitis||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|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation|
|Study Start Date :||January 2002|
|Estimated Study Completion Date :||March 2004|
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00405158
|Dept Obstetrics & Gynecology, Helsingborg Hospital|
|Helsingborg, Skane, Sweden, 25187|
|Principal Investigator:||Linda J Kvist, PhD||Karlstads University|
|Study Director:||Bodil Wilde Larsson, PhD||Karlstad University|