Ignite Creation Date:
2024-05-05 @ 5:10 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00405158
Status:
COMPLETED
Last Update Posted:
2006-12-04
First Post:
2006-11-28
Brief Title:
Study of Acupuncture and Care Interventions for the Treatment of Breast Inflammation During Breastfeeding
Sponsor:
Karlstad University
Organization:
Karlstad University
Study Overview
Official Title:
A RCT in Sweden of Acupuncture and Care Interventions for the Relief of Inflammatory Symptoms of the Breast During Lactation
Status:
COMPLETED
Status Verified Date:
2006-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 womens 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 33 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 babys 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
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 babys 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None