OBJECTIVES:Fifty-five postmenopausal women with menopausal complaints were treated with the food supplement Melbrosia for 3 months. Menopausal symptom evaluation scales and psychological questionnaires were administered, and cardiovascular disease markers in blood were analyzed at the beginning and the end of the trial. SETTING: The perimenopausal care unit of Second Obstetrics and Gynecology Hospital, Sofia, Bulgaria. DESIGN: The study was an open, multicenter, uncontrolled, prospective observation study. The subjective symptoms questionnaires administered before Melbrosia treatment and after 3 months of treatment were Kupperman Score, Zerssen Symptom List, Zung Depression Score, and Frankfurt Self-concept Scale (self-assessment test, problem-solving test, self-esteem test, and irritability test). The blood levels of high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides (TG), total cholesterol (TC), vascular cell adhesion molecule-1 (VCAM-1), andC-reactive protein (CRP) levels were measured in a subgroup of patients. RESULTS: Treatment of postmenopausal women with Melbrosia led to a statistically significant reduction in the Kupperman score, Zerssen's Symptoms List, and Zung Depression Score. The Frankfurt Self-concept Scale revealed significant improvement in problem-solving, no change in self-assessment and self-esteem, and worsening of irritability. Treatment with Melbrosia significantly reduced TC and LDL and significantly elevated HDL and TG. There were nonsignificant changes of serum VCAM-1 and CRP levels in patients treated with Melbrosia. CONCLUSIONS: The presented data suggest that Melbrosia may offer a potential alternative to hormone therapy for the treatment of menopausal symptoms. However, because of this study's uncontrolled, open- label methodology, no cause-and-effect inferences can be drawn until a larger, longer-term, blinded, placebo-controlled, randomized clinical trial is performed.
RCT Entities:
OBJECTIVES: Fifty-five postmenopausal women with menopausal complaints were treated with the food supplement Melbrosia for 3 months. Menopausal symptom evaluation scales and psychological questionnaires were administered, and cardiovascular disease markers in blood were analyzed at the beginning and the end of the trial. SETTING: The perimenopausal care unit of Second Obstetrics and Gynecology Hospital, Sofia, Bulgaria. DESIGN: The study was an open, multicenter, uncontrolled, prospective observation study. The subjective symptoms questionnaires administered before Melbrosia treatment and after 3 months of treatment were Kupperman Score, Zerssen Symptom List, Zung Depression Score, and Frankfurt Self-concept Scale (self-assessment test, problem-solving test, self-esteem test, and irritability test). The blood levels of high-density lipoproteins (HDL), low-density lipoproteins (LDL), triglycerides (TG), total cholesterol (TC), vascular cell adhesion molecule-1 (VCAM-1), and C-reactive protein (CRP) levels were measured in a subgroup of patients. RESULTS: Treatment of postmenopausal women with Melbrosia led to a statistically significant reduction in the Kupperman score, Zerssen's Symptoms List, and Zung Depression Score. The Frankfurt Self-concept Scale revealed significant improvement in problem-solving, no change in self-assessment and self-esteem, and worsening of irritability. Treatment with Melbrosia significantly reduced TC and LDL and significantly elevated HDL and TG. There were nonsignificant changes of serum VCAM-1 and CRP levels in patients treated with Melbrosia. CONCLUSIONS: The presented data suggest that Melbrosia may offer a potential alternative to hormone therapy for the treatment of menopausal symptoms. However, because of this study's uncontrolled, open- label methodology, no cause-and-effect inferences can be drawn until a larger, longer-term, blinded, placebo-controlled, randomized clinical trial is performed.
Authors: M Cushman; C Legault; E Barrett-Connor; M L Stefanick; C Kessler; H L Judd; P A Sakkinen; R P Tracy Journal: Circulation Date: 1999-08-17 Impact factor: 29.690
Authors: R A Mulnard; C W Cotman; C Kawas; C H van Dyck; M Sano; R Doody; E Koss; E Pfeiffer; S Jin; A Gamst; M Grundman; R Thomas; L J Thal Journal: JAMA Date: 2000-02-23 Impact factor: 56.272
Authors: Stephen R Rapp; Mark A Espeland; Sally A Shumaker; Victor W Henderson; Robert L Brunner; JoAnn E Manson; Margery L S Gass; Marcia L Stefanick; Dorothy S Lane; Jennifer Hays; Karen C Johnson; Laura H Coker; Maggie Dailey; Deborah Bowen Journal: JAMA Date: 2003-05-28 Impact factor: 56.272
Authors: Deborah Grady; David Herrington; Vera Bittner; Roger Blumenthal; Michael Davidson; Mark Hlatky; Judith Hsia; Stephen Hulley; Alan Herd; Steven Khan; L Kristin Newby; David Waters; Eric Vittinghoff; Nanette Wenger Journal: JAMA Date: 2002-07-03 Impact factor: 56.272
Authors: Jacques E Rossouw; Garnet L Anderson; Ross L Prentice; Andrea Z LaCroix; Charles Kooperberg; Marcia L Stefanick; Rebecca D Jackson; Shirley A A Beresford; Barbara V Howard; Karen C Johnson; Jane Morley Kotchen; Judith Ockene Journal: JAMA Date: 2002-07-17 Impact factor: 56.272