Efficacy and Safety of Phospholipid Liposomes in the Treatment of Neuro-psychological Disorders Associated with the Menopause: A Double-blind, Randomised, Placebo-controlled Study

Abstract

SUMMARYA double-blind, randomised, placebo-controlled clinical trial was performed to evaluate the efficacy and safety of phospholipid liposomes (Liposom® Forte) administered parenterally in the treatment of anxiety and depression linked to the menopause.A total of 64 females aged 40-60 years were randomised to receive the active drug or placebo intramuscularly; 58 patients completed the study. Treatment lasted 60 consecutive days. One IM administration of 2 ml active drug or placebo every other day was carried out.Efficacy was evaluated by the Hamilton Anxiety Scale (HAMA) and the Climacteric Index. An intention-to-treat analysis was performed, defined as all patients administered with at least one dose of the study medications with at least one return visit.A highly significant (p < 0.001) decrease in) HAMA total score in both groups was noted. However, the decline in the HAMA score was significantly greater in patients administered phospholipid liposomes after 40 days (p = 0.006), 60 days of treatment (p < 0.001) and at the last follow-up visit (p < 0.001). Also, there were statistically significant differences between treatment groups after 60 days of therapy for individual items, such as anxious mood (p = 0.006), tension (p = 0.024) and fear (p = 0.009), with significantly less patients experiencing these symptoms in the phospholipid liposomes-treated group.When the Climacteric Index was evaluated, a highly significant (p < 0.001) decrease in the total score in both groups was noted. However, the decline was significantly greater in patients administered phospholipid liposomes after 40 days of treatment (p = 0.017), 60 days of treatment (p = 0.0013) and at the last follow-up visit (p = 0.0012). Significant differences between treatment groups were recorded after 60 days in asthenia (p = 0.05), dizziness (p = 0.024) and restlessness (p = 0.019) in favour of the active treatment.Twelve patients reported at least one adverse event, nine in the phospholipid liposomes groupand three in the placebo group (p = 0.062). The most commonly reported event was drowsiness with two reports in each group.These findings further demonstrate that phospholipid liposomes administered intramuscularly are active against mild anxiety and depressive symptoms in menopausal women.