Clinical Review for Macro Night and Vita Power
Effects of Macro-Night and Vita Power On Bone Turnover Markers
in Osteoporotic Postmenopausal Women
This is a prospective, randomized, placebo-controlled, double-blind clinical trial on the efficacy and safety of a combination therapy of Macro Night and Vita Power in women inflicted with Postmenopausal osteoporosis. The manuscript has passed all revisions and is pending publication. The purpose of the clinical study was to test the potential and functional improvement offered by the ingestion of the products Macro Night and Vita Power on patients with Postmenopausal osteoporosis.
The objective of the study was to evaluate the efficacy and tolerability of Macro Night and Vita Power in women with osteoporosis. Investigators (Haddad et al) 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.
Materials and methods
Sixty patients underwent randomization and were 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 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. A randomized, double-blind, active-controlled study enrolled 60 postmenopausal women aged 66.5+/-7.5 years with osteoporotic fractures. 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. 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.
We noted a significant difference in markers between women ingesting the active recipient and placebo. After 3 months, bone ALP and CTX decreased 47.6% in the group ingesting the active ingredient and 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. We didn't find adverse events with either of the placebo group or active recipient. This therapeutic protocol may provide a non-conventional treatment modality for patients inflicted with other forms of osteoporosis.
Tony Nateem, Ph.D., Rehabilitation Medicine, Private Practice, San Diego, CA., 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, DPM, Orthopedic Surgery , Highland Hospital, Oakland, CA , San Jose Orthopedic Medical Group, San Jose, CA
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