Abstract
A prospective, randomized, placebo-controlled, double-blind clinical trial was performed on the efficacy and safety of a combination therapy of Macro Night and Vita Power in women inflicted with postmenopausal osteoporosis.
Objectives
The objective of this clinical study was to evaluate the efficacy and tolerability of Macro Night and Vita Power in women with postmenopausal osteoporosis and to study the potential and functional improvement offered by these products. Investigators tested the efficacy and safety of the combination therapy by assessing the following symptoms and physical findings: joint flexibility (range of motion), stiffness reduction, pain relief, cartilage support, blood flow, and inflammation.
Material & Methods
Sixty postmenopausal women aged 66.5+/-7.5 years with osteoporotic fractures were randomly divided into two groups to receive either the active investigational products (Macro Night with Vita Power) or a placebo with a non-active recipient. . The group that received the active investigational product ingested 1 tsp (3.79g) of Macro Night and two 800mg capsules of Vita Power per day for 6 months. The duration of the clinical trial was six months. Patients were screened to meet the inclusion and exclusion criteria for the study protocol. Thereafter, three follow-up visits were scheduled at week 4, week 8, and week 12 to ascertain the subjects’ symptoms and physical findings Serum alkaline phosphatase (ALP), bone alkaline phosphatase (bone ALP), serum C-terminal telopeptide of type I collagen (CTX) were measured at baseline, 3 months, and 6 months after treatment in the two groups.
Conclusion
A significant difference was noted in markers between women ingesting the active recipient and the placebo. After 3 months, bone ALP and CTX decreased 47.6% in the group ingesting the active ingredient compared to 8% in the placebo group. After 6 months study, bone ALP and CTX decreased respectively by 46.5% and 62.9% with statistically significant difference between study groups for bone markers. Our study found that treatment with Macro Night and Vita Power is able to decrease CTX and bone ALP bone markers in postmenopausal osteoporosis in women. No adverse events were found with either the placebo group or the active recipient group. This therapeutic protocol may provide a non-conventional treatment modality for patients inflicted with other forms of osteoporosis.
Study Investigators
Tony Nateem, Ph.D. Rehabilitation Medicine, Private Practice, St. Lapar County Hospital, San Diego, CA
Tony Lamam, MD, MS.Internal Medicine and Family Practice, Santa Rosa Medical Center, Santa Rosa, CA
Sonia Hamzy MD. Internal Medicine, University of Montreal, Canada.
Nasser Hajjar, MD. Internal Medicine, American University of Beirut, Beirut Lebanon
Jack Haddad, MD, MBA, Orthopedic Surgeon UCSF Medical Center, San Francisco, CA
Affiliated Hospitals
Sutter-Roseville Medical Center, Roseville, CA
San Francisco General Hospital, San Francisco, CA
San Jose Orthopedic Medical Group, San Jose, CA
Highland Hospital, Oakland, CA