By William C. Haas, III, MD, MBA
Carolinas Medical Center, Department of Family Medicine, Charlotte, NC
Dr. Haas reports no financial relationships relative to this field of study.
Synopsis: In comparison to placebo, topical curcumin improves markers of lactational mastitis within 72 hours of administration.
Source: Afshariani R, et al. Effectiveness of topical curcumin for treatment of mastitis in breastfeeding women: A randomized, double-blind, placebo-controlled clinical trial. Oman Med J 2014;29:330-334.
Summary Points
- Topical curcumin can successfully treat moderate lactation mastitis within a 72-hour period.
- Breast pain and tension are the first symptoms to improve with topical curcumin application, with erythema resolving later.
- The formulation used was a cream delivering 200 mg of curcumin per pump.
Through a randomized, double-blind, placebo-controlled clinical trial, the authors set-out to assess the anti-inflammatory effects of topical curcumin in patients with lactational mastitis. The authors identified topical curcumin as a possible treatment for this diagnosis given its ease of use early in the development of symptoms, in addition to its perceived benign side effect profile, especially compared to non-steroidal anti-inflammatory drugs.
Given the wide spectrum of symptoms among women suffering from lactational mastitis, an inflammation severity index was used to screen patients for inclusion. An initial criterion for mastitis was defined as meeting any two of the following: breast erythema, increased breast tension not relieved by breastfeeding, pain in the breast, flu-like symptoms (including fever > 39° C) and lumps in the breast tissues. Only those patients with moderate mastitis were included in the study, as determined by a scoring system grading the severity of erythema, breast tension, and breast pain. Exclusion criteria included: milk staphylococcal count higher than 104 CFU/mL, milk leukocyte count higher than 106 CFU/mL, breast abscess, breast engorgement, breast filling defect, blocked duct, galactocele, previous history of mastitis or recurrent mastitis, recent trauma to the affected breast, previous breast surgery, inflammatory skin diseases, and/or mothers exposed to systemic antibiotics within the last 2 months.
Patients were randomized to treatment consisting of either topical curcumin cream (standardized to 200 mg curcumin per pump) or topical moisturizer cream to be applied every 8 hours for 72 hours. Prior to randomization, all subjects were taught effective techniques for breast milk removal. Symptom severity, as discussed above, was assessed by the same staff nurse every 24 hours during the 72-hour treatment period.
Based on their power analysis, the authors enrolled 70 participants, 64 of whom were randomly assigned to either the treatment or placebo group (four did not meet inclusion criteria and two declined participation). Blinding reportedly failed for one participant, resulting in 32 patients in the curcumin group and 31 patients in the placebo group. No significant differences were reported between the two study groups regarding baseline characteristics; however, only age and duration of lactation (months) were discussed with no supporting table illustrating other demographic characteristics. No dropouts were reported.
After the 72-hour intervention period, 72% of patients in the curcumin group experienced complete resolution of the predetermined signs/symptoms of mastitis compared to 39% of patients in the placebo group (P < 0.001). Moreover, although both groups experienced significant reductions in pain scores, the curcumin group reported significantly lower scores for pain compared to the placebo group, 0.47 vs 3.13, respectively (P < 0.001). The authors also reported that curcumin application improved scores of breast tension and pain within the first 48 hours of treatment, while significant improvements in erythema typically occurred during the last 24 hours of treatment. No adverse events were reported for either the treatment or placebo group.
Commentary
Curcumin, one of a family of compounds isolated from turmeric rhizome (Curcuma longa), has garnered a growing interest in the treatment of a variety of inflammatory conditions, including dermatological conditions such as scleroderma and psoriasis.1 The authors of this study insightfully sought to determine the efficacy of topical curcumin in the treatment of an important inflammatory skin disorder among breastfeeding mothers, lactational mastitis. Through the use of a randomized, double-blind, placebo-controlled study, the authors provide compelling evidence about the utility of topical curcumin for treating moderate mastitis. Interestingly, the authors limited their study to moderate mastitis and excluded those patients with mild classification. Agreeably, it was prudent to exclude those with severe mastitis in lieu of conventional treatment. However, including those with mild mastitis might have enhanced the generalizability of the study, especially as participants were recruited after referral to a specialty maternal/child health care center, presumably from another physician such as a primary care provider. Perhaps treatment of mild mastitis with topical curcumin could have prevented progression to more advanced stages of mastitis? Nonetheless, the present study supports the use of topical curcumin for wound healing and illustrates some of its known healing properties, such as the induction of a large infiltration of immunological cells (macrophages, neutrophils and fibroblasts), and the production of a strong anti-inflammatory effect.2
A few other points should be considered before recommending topical curcumin to breastfeeding mothers. Limited baseline demographic information was provided, as mentioned above. The number of prior pregnancies or prior breastfeeding experiences would have been helpful to assess differences between the two groups. A mother with prior breastfeeding experience would likely be able to circumvent the development or progression of mastitis, which would have been an important variable for consideration. On another note, during treatment, blinding reportedly failed for one participant without further mention of the circumstances surrounding the incident. Further information would have been helpful to dispel any questions regarding the reliability of blinding among other subjects. Along a similar vein, some discussion regarding funding or acquisition of topical preparations would have been important to note. The company providing the topical curcumin preparation offers the product online for approximately $30 per bottle, arguably above many mothers’ prescription copays. Finally, despite the relative safety of high-dose curcumin therapy,3 the study did not evaluate the side effects of the topical treatment. Presumably the side effects of topical application to breastfeeding mothers would have been minimal; however, considerations should be given to the infants ingesting the curcumin, although application of the topical curcumin direct after feeding times would eliminate this concern.
References
- Thangapazham RL, et al. Beneficial role of curcumin in skin diseases. Adv Exp Med Biol 2007;595:343-357.
- Jacob A, et al. Mechanism of the anti-inflammatory effect of curcumin: PPAR-gamma activation. PPAR Res 2007;2007:89369.
- Nguyen TA, Friedman AJ. Curcumin: A novel treatment for skin-related disorders. J Drugs Dermatol 2013;12:1131-1137.
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