Himalaya Reosto
Reosto Research and Clinical Studies
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Himalaya Reosto is an ayurvedic preparation. Each tablet contains 575mg of herbs and minerals. Reosto is a formulation that provides natural calcium and hormone regularizing phytoestrogens the combination of which is very useful in osteoporosis. It is also recommended for women age 35 and up when bone loss first starts to occur. Reosto has been subjected to various research and clinical studies some of which are listed below.
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Reosto Research and Clinical Studies:
Evaluation of the efficacy and safety of
Reosto in postmenopausal osteoporosis:
A prospective, randomized, placebo-
controlled, double blind, phase III
clinical trial
Jayashree Reddy, MD, DGO
Obstetrician & Gynecologist,
CDR Hospitals, Hyderabad
S.A. Kolhapure*, MD
Senior Medical Advisor
R&D Center
The Himalaya Drug Company
Bangalore
ABSTRACT
The available drugs for the
management of Postmenopausal osteoporosis/type I
osteoporosis are associated with
numerous adverse reactions, which
limit their long-term usage. Recently,
phytoestrogens have been shown to
be beneficial in the management of
Postmenopausal osteoporosis. Reosto is a polyherbal
formulation, which is a rich source of
phytoestrogens, a natural calcium
and this study was planned to
evaluate the efficacy and safety of
Reosto in the management of Postmenopausal osteoporosis.
The study was a prospective,
randomized, double blind, placebo-
controlled, phase-III clinical trial
conducted as per the GCP guidelines.
A total of 100 healthy women with
amenorrhea in the previous 6
months, and who had menopausal
blood hormonal profile, were
included in the study. All the enrolled
patients underwent a thorough
clinical examination, along with
routine and specific biochemical
investigations and hormonal analysis.
All the patients underwent at
baseline and at the end of 3 months
Bone Mineral Density examination of the total body
bones, using DEXA. All the patients
were categorized into the Reosto and
the placebo group, and both the
groups were advised to consume the
respective medications in a dose of 2
tablets twice daily, for 3 months. All
the patients were monitored at monthly intervals for 3 months, and a
detailed evaluation with Bone Mineral Density,
hematological and bone-specific
biochemical investigations were
repeated at the end of 3 months. All
the adverse events were recorded.
The predefined primary efficacy end-
points were improvement in the
Bone Mineral Density, T- and Z-scores, and bone-
specific biochemical parameters. The
predefined secondary safety end-
points were incidence of adverse
events and overall patient compliance
to the treatment. Statistical analysis
was done according to intent-to-treat
principles.
This study observed a highly
significant increase in Bone Mineral Density, T- and Z-
scores of the total body bones in the
Reosto group as compared to the
placebo group, at the end of the
study. There was a highly significant
increase in serum calcium, serum
phosphorus, and a significant
decrease in serum alkaline
phosphatase levels in the Reosto
group as compared to the placebo
group, at the end of the study. There
were no clinically significant changes
in any of the hematological
parameters. There were no clinically
significant adverse reactions and the
overall compliance to the treatment
was excellent. These beneficial effects
might be due to the synergistic
actions of the ingredients of Reosto.
Reosto probably inhibits bone
resorption and renormalizes the bone
formation (through its estrogenic,
antioxidant, anti-inflammatory,
adaptogenic properties, and
supplementation of organic calcium
carbonate). Therefore, it may be
concluded that Reosto is clinically
safe and effective in the management
of Postmenopausal osteoporosis
ABBREVIATIONS
BMD : Bone mineral density
CVD : Cardiovascular disease
DEXA : Dual energy X-ray absorptiometry
ER : Estrogen receptor
ERT : Estrogen replacement therapy
GCP : Good Clinical Practice
HRT : Hormone replacement therapy
HS : Highly significant
LDL : Low density lipoprotein
NO : Nitric oxide
NS : Nonsignificant
OP : Osteoporosis
PMO : Postmenopausal osteoporosis
PTH : Parathyroid hormone
ROS : Reactive oxygen species
S : Significant
SD : Standard deviation
SERM : Selective estrogen receptor modulator
Evaluation of efficacy and safety of Reosto in senile osteoporosis: A randomized, double-blind placebo-controlled clinical trial
Dr. Amit Shah, M.S. (Ortho) Consultant Orthopedic Surgeon, Assistant Professor & Head, Department of Orthopaedics, Medical College and S.S.G. Hospital, Baroda, India
Dr. S.A. Kolhapure, M.D.
Senior Medical Advisor, R&D Center, The Himalaya Drug Company, Makali, Bangalore, India.*Corresponding author
Osteoporosis is a commonly encountered entity in an orthopedic clinical practice. Osteoporosis is a metabolic bone disease characterized by low bone mass and microarchitectural deterioration leading to enhanced fragility and an increased risk of fractures1. Osteoporosis may be either primary or secondary. Primary osteoporosis is subdivided into type I (postmenopausal) and II (senile), and secondary OP is also referred as type III OP. Senile OP (Type II OP) occurs as a result of calcium deficiency and occurs in individuals over the age of 70 years, in a 2:1 ratio of women to men. Both trabecular and cortical bone are affected and a causal association with hip fractures has been observed.
The World Health Organization has recommended diagnosing OP based on BMD measurements of the hip and spine. Patients with BMD 1 to 2.5 SD below peak bone mass measurements are classified as osteopenic and patients with BMD >2.5 SD below peak bone mass measurements, are classified as osteoporotic3. For BMD measurements DEXA is the gold standard, due to its distinct advantages (low radiation dose, short scanning time and feasibility of scanning of both axial as well as appendicular sites).
The goal of OP treatment is the prevention of consequent complications. Balanced diet, weight-bearing exercises and vitamin D intake are important components of renormalizing peak bone mass.
Reosto is a herbomineral formulation indicated for OP and it contains the powders of Terminalia arjuna, Withania somnifera, Commiphora wightii, Sida cordifolia and Vanda roxburghi alongwith organic calcium (Godanti bhasma and Kukkutandatvak bhasma). Various experimental studies and clinical trials conducted with Reosto have reported the beneficial effect of Reosto in OP, as evidenced by improvements in bone density and remineralization alongwith symptomatic relief6. This study was planned to evaluate the efficacy and safety of Reosto in senile OP.
RESULTS
Out of 143 initially screened patients, 100 patients who fulfilled the inclusion criteria were enrolled in the study. Ten patients were lost to follow-up and 90 patients completed the study.
There was a female preponderance in the study population (57 females and 33 males) and a total of 52 (57.78%) patients were above 60 years of age. Of the 52 patients who were above 60 years, 24 were males and 28 were females. There were a total of 47 (52.22%) patients in the Reosto group and 43 (47.78%) patients in the placebo group.
There was a highly significant increase in the BMD , ‘T Score’ and ‘Z Score’ , in the patients from the Reosto group as compared to the patients from the placebo group, at the end of the study.
There was a highly significant increase in the serum calcium levels with a simultaneous highly significant decrease in serum phosphorous and alkaline phosphatase levels in the Reosto group patients, as compared to the patients from the placebo group at the end of the study.
There were no clinically significant adverse events; either reported or observed during the entire study period and the overall compliance to the study drug was excellent.
This study observed highly significant improvement in the BMD, ‘T’ score and ‘Z’ score, alongwith highly significant increase in the serum calcium levels with a simultaneous highly significant decrease in serum phosphorous and alkaline phosphatase levels in the patients from Reosto group. These results indicate that Reosto might be a useful therapy in patients who have either osteopenia or OP and it might prevent age-related bone loss. This finding may be linked with increased rate and extent of calcium absorption with Reosto , which provides 1449.6 mg of calcium per day, matching the recommended quantity for osteoporotic patients. This study also observed that Reosto alleviated common symptoms such as backache, joint swelling, joint pain and joint stiffness. Reosto also appeared to be safe for long-term usage, as there were no clinically significant adverse events recorded and this finding is important, as OP management demands drug therapy for longer periods of time. The beneficial effects of Reosto can be attributed to the potent anti-inflammatory, antioxidant, analgesic and bone remineralization activities of the ingredients alongwith the high bioavailability of natural organic calcium.
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