Effects of Human Placenta Extract Laennec on Quality of Life and Physical Performance in Patients with Chronic Fatigue Syndrome

Abstract

Objective: to evaluate the efficacy and safety of human placenta extract (HPE) Laennec infusions in treatment of patients with verified diagnosis “Chronic fatigue syndrome” (CFS). Material and methods: The study involved 38 patients with CFS, randomized into 2 groups: the experimental group (HPEL, 24 people) - patients were treated by 10 intravenous Laennec infusions, 4 ml each, 2 times/week, for 5 weeks and passive control group (CTRL, 14 pers.). Before, after, and 5 weeks follow-up treatment efficacy was evaluated by severity of chronic fatigue (Chronic Fatigue inventory), state anxiety and depression level (STAI and STDI) and Health related Quality of Life (HRQoL, questionnaire SF-36v2), exercise tolerance (cardiopulmonary exercise test with gas analysis), blood parameters. Results: The HPEL patients showed a significant reduction in index of chronic fatigue values, which was accompanied by significant decrease in situational depression, anxiety, improvements in subjective assessment of HRQoL, as well as a significant increase in exercise performance indicator values - maximum oxygen consumption, anaerobic threshold, exercise time to fatigue, normalization of the lipid “profile” after treatments and in 5 weeks follow-up. No changes in chronic fatigue index and other recorded indicators have been identified in CTRL. HPE Laennec did not cause adverse events, was well tolerated by all patients. Conclusion: The course of HPE Laennec therapy in patients with CFS reduces the severity of psychiatric symptoms experienced by chronic fatigue, decreases elevated anxiety and depression levels, improves the subjectively assessed HRQoL and objectively registered parameters of exercise performance, cardiorespiratory fitness.