Mojgan Mirghafourvand1, Sakineh Mohammad-Alizadeh-Charandabi2, Parivash Ahmadpour3, Yousef Javadzadeh4. 1. Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran. 2. Social Determinants of Health (SDH) Research Center, Midwifery Department, Tabriz University of Medical Sciences, Tabriz, Iran. 3. Student Research Committee, Tabriz University of Medical Sciences, Tabriz, Iran. Electronic address: parivash.ahmadpor@yahoo.com. 4. Department of Pharmacy, School of Pharmacy, Tabriz University of Medical Sciences, Tabriz, Iran.
Abstract
OBJECTIVES: Evidence on the effect of Vitex agnus and Flaxseed on cyclical mastalgia is not enough. This study aimed to assess the efficacy of V. agnus and Flaxseed on cyclical mastalgia. DESIGN AND SETTING: This randomized controlled trial was conducted on 159 women referred to health centers of Tabriz, Iran. Subjects were allocated into three groups (n=53 per group) using block randomization. INTERVENTIONS AND MAIN OUTCOME MEASURES: Group I received 25g daily Flaxseed powder and placebo of V. agnus; group II received daily 3.2-4.8mg V. agnus tablet and placebo of Flaxseed and control group received both placebo. Nominal day breast pain was applied at baseline, first, and second month after the intervention. Data was analyzed using general linear model. RESULTS: There was no statistical significant difference between the three groups in terms of socio-demographic characteristics and baseline values. The breast pain improved significantly in both intervention groups during the first and second month after intervention. Mean NDBP score was significantly lower than that in the control group at the first month after the intervention in the Flaxseed [adjusted mean difference: -3.1 (95% CI: -4.2 to -2.0)] and V. agnus groups [-3.3 (-4.3 to -2.2)] and the second month after the intervention in Flaxseed [-7.0 (-8.1 to -5.9)] and V. agnus groups [-6.4 (-7.5 to -5.3)]. CONCLUSION:Flaxseed and V. agnus are effective in short-term period in decreasing cyclical mastalgia. However, further studies are needed to examine the long-term effectiveness and sustainability of the effects after stopping the treatment in order to decide whether these alternative treatments are suitable to treat mastalgia or not.
RCT Entities:
OBJECTIVES: Evidence on the effect of Vitex agnus and Flaxseed on cyclical mastalgia is not enough. This study aimed to assess the efficacy of V. agnus and Flaxseed on cyclical mastalgia. DESIGN AND SETTING: This randomized controlled trial was conducted on 159 women referred to health centers of Tabriz, Iran. Subjects were allocated into three groups (n=53 per group) using block randomization. INTERVENTIONS AND MAIN OUTCOME MEASURES: Group I received 25g daily Flaxseed powder and placebo of V. agnus; group II received daily 3.2-4.8mg V. agnus tablet and placebo of Flaxseed and control group received both placebo. Nominal day breast pain was applied at baseline, first, and second month after the intervention. Data was analyzed using general linear model. RESULTS: There was no statistical significant difference between the three groups in terms of socio-demographic characteristics and baseline values. The breast pain improved significantly in both intervention groups during the first and second month after intervention. Mean NDBP score was significantly lower than that in the control group at the first month after the intervention in the Flaxseed [adjusted mean difference: -3.1 (95% CI: -4.2 to -2.0)] and V. agnus groups [-3.3 (-4.3 to -2.2)] and the second month after the intervention in Flaxseed [-7.0 (-8.1 to -5.9)] and V. agnus groups [-6.4 (-7.5 to -5.3)]. CONCLUSION: Flaxseed and V. agnus are effective in short-term period in decreasing cyclical mastalgia. However, further studies are needed to examine the long-term effectiveness and sustainability of the effects after stopping the treatment in order to decide whether these alternative treatments are suitable to treat mastalgia or not.