Himalaya Reosto is an ayurvedic preparation which has been subjected to various research and clinical studies some of which are listed below.

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

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

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Evaluation of the Efficacy and Safety of Reosto in Postmenopausal Osteoporosis: A Prospective, Randomized, Placebo-Controlled, Double Blind, Phase III Clinical Trial

Dr. Deepti Dongaonkar, MD, DGO Professor, Department of Obstetrics & Gynaecology, Dr. Rajeev Mehta, MD (Radiology) Hon. Professor, Department of Radiology Grant Medical College and Sir JJ Group of Hospital, Mumbai, India Dr. Kolhapure, S.A.* MD Senior Medical Advisor, R&D Center, The Himalaya Drug Company, Bangalore, India. [*Corresponding author] Obst. & Gynae. Today 2005; X(7), 362-367

ABSTRACT

The current management of postmenopausal osteoporosis (PMO) includes the use of estrogenic compounds, SERMs, bisphosphonates, calcitonin, and PTH; however, the associated adverse effects limit their long-term usage. Recently, phytoestrogens have been shown to be beneficial in the management of Postmenopausal osteoporosis. Reosto is a polyherbal formulation and is a rich source of phytoestrogens and 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 ethical guidelines of Good Clinical Practice. One hundred and five healthy women, with natural or surgical menopause, who had amenorrhea in the preceding 6 months were included in the study. All women who were consuming any drug, which is known to affect bone metabolism, those women suffering from endometrial polyps or hyperplasia or other estrogendependent tumors were excluded from the study. At the randomization visit, a detailed medical history was obtained from all the enrolled women. Subsequently, all women underwent a thorough systemic and gynecological examination, routine and bone-specific biochemical investigations. All women underwent a baseline Bone mineral density examination using DEXA. All women were randomized in Reosto and placebo groups, and both the groups were advised to consume the respective medications in dose of two tablets twice daily, orally, for 6 months. All the enrolled women were monitored at monthly intervals for 6 months, for any reported or observed adverse effects. The predefined primary efficacy end points were improvement in the Bone mineral density score and bone-specific biochemical parameters. The predefined secondary safety end points were incidence of short- and long-term adverse events, and overall patient compliance to the drug treatment. Statistical analysis was done according to intent-to-treat principles.

Out of the 105 enrolled women, 11 women had normal Bone mineral density, and 16 women were lost to follow-up and the data of 78 women (39 from each group) was considered for statistical analysis.

This study observed a significant increase in the T-score and Bone mineral density of lumbar spine, femur neck, and hip, in the Reosto group (which indicate the desirable remineralization of osteoporotic bones). There was also a significant increase in serum calcium and serum phosphorus, and a significant decrease in serum alkaline phosphatase levels, in the Reosto group (which indicates the beneficial changes in the biochemical bone markers). Also, there were no clinically significant changes in any of the hematological parameters, nor was there any clinically significant adverse reaction, and the overall compliance to the treatment was excellent (which reflects the short- and long-term safety of Reosto). Therefore it may be concluded that the treatment with Reosto is effective and safe 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

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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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References:

Himalaya Herbals Company

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