Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Mastitis

Intervention / Treatment
-----------------
* 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


Participation Criteria
=================
Eligibility Criteria
-----------------
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.
Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lactation mastitis, Breast inflammation, Breastfeeding, Care interventions, Acupuncture treatment, Antibiotic therapy