|Date: 06-30-2015||HC# 121414-523|
Re: Topical Curcumin Treatment Improves Symptoms of Lactational Mastitis
Afshariani R, Farhadi P, Ghaffarpasand F, Roozbeh J. Effectiveness of topical curcumin for treatment of mastitis in breastfeeding women: a randomized, double-blind, placebo-controlled clinical trial. Oman Med J.2014;29(5):330-334.
Lactational mastitis is a painful inflammatory condition that affects up to 33% of women who are breastfeeding. The anti-inflammatory effects of oral curcumin, a bioactive constituent of turmeric (Curcuma longa, Zingiberaceae) rhizomes, are well established. The aim of this randomized, double-blind, placebo-controlled, clinical trial was to determine the efficacy of topical curcumin treatment for reducing the symptoms of lactational mastitis in breastfeeding women.
This study was conducted at the Maternal Healthcare Center at Hafez hospital in affiliation with Shiraz University of Medical Sciences, in Shiraz, Iran. Women between the ages of 21 and 35 years who were referred to the clinic with the impression of lactational mastitis were screened for eligibility. Patients were included if they had lactational mastitis (defined as the presence of at least 2 of the following symptoms: breast erythema, increased breast tension not relieved by breastfeeding, pain in the breast, flu-like symptoms, and lumps in the breast tissue) and a score of 8-14 on the lactational severity index. Patients were excluded if they had severe or recurrent lactational mastitis, a milk staphylococcal count ˃104 colony-forming units (CFU)/ml and a milk leukocyte count˃106 CFU/ml, conditions that can mimic clinical symptoms of mastitis such as breast abscess or engorgement, recent breast trauma or surgery, or consumed antibiotics in the last 2 months. To achieve 90% power to detect significant differences in efficacy, the statistical power calculation indicated that 28 patients were required in each study group (P˂0.05).
Out of the 64 patients eligible for the study, 32 patients were randomly assigned to apply 1 pump (200 mg) of a topical curcumin cream (Neurobiologix; Austin, Texas) every 8 hours for 3 days, and the other 32 patients were assigned to apply 1 pump of a topical moisturizing cream (placebo treatment) every 8 hours for 3 days. No other information regarding the composition of the curcumin cream was provided. A nurse assessed the inflammation severity index of the patients at baseline and 24, 48, and 72 hours after treatment was initiated. At baseline, there were no significant differences between the 2 study groups in terms of demographics or symptom severity.
In comparison to baseline, there were significant score reductions in the group treated with curcumin cream for breast tension after 24 hours of treatment (P<0.001), breast pain after 48 hours of treatment (P<0.001), and erythema after 72 hours of treatment (P=0.002). In the placebo group, the only significant reduction compared to baseline was in pain score after 72 hours of treatment (P=0.043).
In comparison to the placebo group, patients that were treated with curcumin cream had significantly lower scores for breast tension (P<0.001), pain (P<0.001), and erythema (P<0.001) after 72 hours of treatment. One patient in the placebo group was excluded from the analysis due to failed blinding. No adverse effects were reported.The authors conclude that a topical preparation of curcumin significantly improved symptoms of lactational mastitis after 72 hours of treatment without adverse effects. However, they acknowledge that the study had several limitations which may be summarized as follows: (1) the efficacy of topical curcumin has not been compared to standard treatment with non-steroidal anti-inflammatory drugs (NSAIDs), (2) the efficacy of oral curcumin may be superior to topical curcumin, (3) although the study was sufficiently powered to detect significant differences in efficacy, the sample size was still relatively small, (4) enrollment was restricted to patients with moderate mastitis; those with more or less severe inflammation may respond differently, and (5) although lactational mastitis comprises a spectrum of conditions ranging from non-infectious to infectious inflammation, only patients with non-detectable infections were included in the study. Considering the favorable safety profile of curcumin observed in numerous clinical trials, the authors suggest that topical curcumin "could be safely administered to those suffering from lactational mastitis after excluding infectious etiologies." These results suggest that further studies evaluating the efficacy of topical curcumin in comparison to NSAIDs and oral curcumin are warranted.
—Laura M. Bystrom, PhD