Open-Label Three Arm Trial Comparing Ormeloxifene, Gamma Linolenic Acid With Methylcobalamine + Vitamin C and Placebo in Mastalgia.

Abstract

Objective: We evaluated the beneficial effect of Ormeloxifene (Centchroman) versus a combination of Gamma Linolenic acid (GLA), methylcobalamine and vitamin C on mastalgia in a three-arm, open-label, placebo-controlled trial.

Materials and methods: Patients aged above 18 years with mastalgia were recruited between January 2019 and July 2021. Patients were divided in three arms: Ormeloxifene arm, GLA arm and Placebo arm. Response was evaluated using visual analogue scale (VAS) and score below 3/10 was defined as complete relief.

Results: A total of 113 consecutive women with mastalgia were randomized to the GLA group (Group 1, n = 39 women), Ormeloxifene (Group 2, n = 36) and Placebo (Group 3, n = 38). Complete response was observed in 94% patient in Group 1, 96% in Group 2 and 87% in Group 3 at the end of 12 weeks and it was not significant (p = 0.49). Adverse events were reported by eleven patients taking Ormeloxifene, compared to none in the other two groups.

Conclusion: In this study Ormeloxifene and GLA were not superior to placebo for pain relief in mastalgia. Furthermore, there were concerning side effects associated with Ormeloxifene therapy. The role of Ormeloxifene in mastalgia needs further evaluation before recommending it as preferred therapy.