[Orthopaedics Today (2002): (IV), 4, 241-244]

Efficacy of OST-6, a polyherbal formulation in the management of

osteoporosis in postmenopausal women
Irshad Ahmed M.B.,B.S., D (Ortho), M.S. (Ortho)
Consultant Orthopedic Surgeon, Manipal Hospital & Ameena Medical Centre,
111, 18th Cross, Laxmipuram, Ulsoor, Bangalore, India,
Loknath Kumar, K.P., M.B.B.S., F.A.IM.S.,
Managing Director, Family Densitometry Centre, 3/3, Armugam Circle, (next to East School)
Basavanagudi, Bangalore, India,
Vijay Kumar, M.B.B.S.,
Assistant Manager,
And
Kala Suhas Kulkarni*, MD,
Medical Advisor
R&D Center, The Himalaya Drug Company, Makali, Bangalore, India.

ABSTRACT
A clinical study was conducted to study the safety and efficacy of a polyherbal preparation,
OST-6 in postmenopausal women with osteoporosis. Thirty seven women completed the 6month study. All the participants were on OST-6, an herbal anti-osteoporotic drug, at a dose
of 2 tablets twice daily. Bone densitometry studies using an ultrasound bone densitometer
were done to evaluate the percentage of bone loss before and after treatment. A complete
blood investigation was also done before and after treatment. On evaluation of the patients
following 6 months of treatment, the bone density was significantly increased when matched
to young adults, by 2.97% when matched to young adults and, by 3.13% when matched to
age. Bone loss was also reduced by 1%. The T score reduced by 0.263 and the Z score
reduced by 0.178. There was also an increase in the serum calcium and a decrease in serum
phosphorous and alkaline phosphatase levels. The biochemical parameters including kidney
function tests were normal before and after treatment. The study revealed that OST-6 is a
safe and effective therapy in postmenopausal women with osteoporosis.
INTRODUCTION
Osteoporosis affects all women during the perimenopausal period. Osteoporotic fractures are
more common in older postmenopausal women and account for significant morbidity and
mortality1. Although age is an independent risk factor for fractures, bone mineral density
(BMD) is one of the strongest predictors of fractures2,3.
Women often are unaware that they have osteoporosis until they experience an unexpected
and painful fracture, usually when they are in their postmenopausal period. The first
indication of osteoporosis may be a broken wrist or hip caused by a minor fall. Osteoporotic
fractures, particularly those of the hip and spine, often lead to significant pain and disability.
The fracture of the wrist often heals with little residual deformity. Studies have also shown
that women lose more trabecular bone at a higher rate than men.
Prevention of bone loss with hormone replacement therapy (HRT) has been shown to reduce
the incidence of vertebral and hip fractures4-6. However, HRT is associated with increased
risks of breast cancer, thrombo-embolism and hypertension, which are well documented.

Withdrawal bleeding together with increased risk factors limits the acceptability of long-term
(hormonal estrogen) treatment7,8.
Recent evidence suggests that the rate of bone loss and the degree of bone resorption may be
important factors in predicting future fractures9. In elderly women, bone resorption is
markedly increased10. This results in uncoupling of the bone-remodeling unit11.
OST-6 is a herbomineral formulation comprising of Terminalia arjuna, Withania somnifera,
Commiphora wightii, Sida cordifolia, Vanda roxburghii, Godanti bhasma and
Kukkutandatvak bhasma that are well known for their bone remineralization properties.
Terminalia arjuna is extensively used to treat osteoporosis and other bone related disorders
as it improves the synthesis and secretion of female hormones12. Withania somnifera is
considered a rejuvenator in Ayurveda. It helps in relieving pain associated with osteoporosis,
nervous exhaustion and muscular pains13. Commiphora wightii helps in remineralization of
the bones, thus reversing the process of osteoporosis14. Sida cordifolia has natural
phytosterol and phytoestrogens. Vanda roxburghii possesses anti-inflammatory properties
and relieves joint pains in osteoporosis. Godanti bhasma and Kukkutandatvak bhasma are
rich natural forms of calcium. Kukkutandatvak bhasma has an additional adaptogenic
property, which is useful in relieving general debility in postmenopausal women.
MATERIALS AND METHODS
Forty post-menopausal women who were 5 to 30 years post menopause were recruited in the
study. The minimum age was 48 and the maximum was 72 years. Women on estrogen
therapy were excluded from the trial. All of them were subjected to detailed physical
examination and laboratory baseline investigations. The laboratory investigations included
complete haemogram including haemoglobin, total and differential white cell count,
erythrocyte sedimentation rate, kidney function test (serum creatinine and BUN), serum
calcium, phosphorous and blood urea. All the patients were subjected for ultrasound bone
densitometry to assess the bone loss before starting drug therapy.
A written informed consent was obtained from all the women prior to trial drug
administration.
All women were recommended OST-6 twice daily for 6 months. Their daily dietary calcium
intake did not exceed 1 g, as demonstrated by a dietary questionnaire administered at
baseline. They were followed up every month for 6 months and subsequently re-examined at
one year. Participants were questioned about adverse events at each visit, which were
reported in the follow-up proforma.
Bone mineral density was measured at the calcaneum before treatment and after 6 months of
treatment with OST-6. The instrument used in the study was LUNAR ACHILLES EXPRESS
BONE ULTRASONOMETER.
The patients bone loss ranged from 5% to 57%. The T score ranged from 5.240 to -0.6310.
When these patients were compared and matched with a 25-year-old young adult there was
bone loss of 43% to 95%.

Statistical Analysis
Statistical analyses were done using repeated ANOVA measures using Graph Pad Prism 3.0
software.
RESULTS
Thirty-seven women completed 6
Fig. 1: Effect of OST-6 as assessed by bone
densitometry
months of treatment with OST-6, 3
patients however, did not complete the
trial due to unexplained reasons and
were dropped from the study. There
was excellent compliance to OST-6
and symptoms of bone pain was
significantly reduced, and the bone
densitometry result showed significant
improvement. The T score which
was 3.061 was reduced to 2.798
(p<0.0042), the Z score, which was
1.619 was reduced to 1.441
Fig. 2: Effect of OST-6 on bone loss
(p<0.0042) (Figure 1). There was
increase in the bone mineral density
by 1%. The mean bone loss before
treatment was 32.05% and after 6
months of treatment it was reduced to
31% (p<0.0024) (Figure 2). The bone
density of these post menopausal
women when compared to a young
adult female of 25 years increased by
2.97% (p<0.0031) and bone density
when matched to an adult female of
that age group increased by 3.13% (p<0.0037). The serum calcium, which was 9.24 mg%
before treatment increased to 9.549 mg% (p<0.0005). Serum phosphorous was 3.802 mg%
before treatment and was reduced to 3.519 mg% (p<0.0002) after treatment (Table 1). The
routine blood examination, kidney function tests and the blood sugar were not altered after
treatment, indicating that OST-6 is safe in women with postmenopausal osteoporosis.
Table 1: Hematological and Biochemical Parameters (Mean SD)
Parameters

Before treatment

After treatment

15.71 0.8591

15.68 0.7237

7611.00 854.80

7688.00 892.00

Random blood sugar (mg/dl)

94.24 22.85

111.8 29.78

Blood urea (mg/dl)

22.47 4.62

22.14 3.87

0.8326 0.09694

0.8334 0.09096

Serum calcium (mg/dl)

9.247 0.5323

9.549 0.5416

Serum phosphorous (mg/dl)

3.802 0.5369

3.519 0.5155

Hemoglobin (%)
Total cholesterol (cu.mm.)

Serum creatinine (mg/dl)

DISCUSSION
OST-6 addresses two factors associated with healthy bone architecture: adequate calcium
supplementation and appropriate hormonal balance. Earlier studies with OST-6 demonstrate a
dose-dependent increase in the bone mineral content and density. OST-6 treatment shows
desired effect on inhibitors on bone reabsorption and stimulators of bone formation in
experimental studies, thereby indicating a potential therapeutic usefulness as an antiosteoporotic agent15. It consists of Terminalia arjuna, Withania somnifera, Commiphora
wightii, Sida cordifolia, Vanda roxburghii, Godanti bhasma and Kukkutandatvak bhasma.
Godanti bhasma and Kukkutandatvak bhasma present in OST-6 are the rich natural sources
of calcium that are present in adequate levels required for the management of osteoporosis.
Sida cordifolia and Withania somnifera present in OST-6 contain phytoestrogens, which
influences bone mineral density. Phytoestrogens are naturally occurring compounds found in
many medicinal herbs with a historical use in conditions that are now treated by estrogens.
The majority of phytoestrogens found in plants can be classified into two major categories:
isoflavones and lignans. After consumption of the plant lignans and isoflavone precursors,
metabolic conversions occur in the gastrointestinal tract resulting in the formation of
heterocyclic phenols that are similar in structure to estrogens.16 Phytoestrogens have a
diphenolic ring in chemical structure that is very similar to endogenous estrogens, estradiol
and diethylstilbestrol, accounting for their weak estrogen-like effects. Most phytoestrogens
contain at least one aromatic ring with a hydroxyl group, similar to those of estrogens, and
have been found to bind to the two subtypes of estrogen receptors, but more strongly to the
beta-receptors.17
Phytoestrogens are therefore considered as natural selective estrogen receptor modulators, as
they appear to be estrogen agonists for the cardiovascular system, bone and brain, while
having either no agonist or, perhaps, antagonist effects for the mammary gland and uterus.18
As steroidal estrogens are of benefit in preventing osteoporosis, phytoestrogens also have a
protective effect in the postmenopausal woman.19
Recent studies conducted on phytoestrogen effect on bone mineral density in
hypercholesteriemic post menopausal women showed significant increase in bone mineral
density and bone mineral content in the lumbar spine.20 In vitro, isoflavone can stimulate
osteoblast-like cell formation and also suppress osteoclast formation and induce osteoclast
apoptosis.21 Isoflavone also slows bone reabsorption and stimulates collagen synthesis in
bone.22 There is evidence from animal studies that phytoestrogens preserve bone mineral
density.23 Studies conducted with isoflavone derivative ipriflavone have found that it reduces
bone loss in postmenopausal women.24
This study confirms the benefits of OST-6 in postmenopausal osteoporosis. There is evidence
from this study that OST-6 protects against fractures and slows or reverses bone loss. OST-6
provides benefits in women with associated risk of coronary heart disease. In this study it was
seen that the T score was reduced by 0.263 within 6 months of treatment. The Z score
also was reduced by 0.178. The total bone loss was reduced by 1%. The bone mineral
density when matched with that of a young adult of 25 years increased by 2.97% and when
matched for that particular age in healthy postmenopausal women there was an increase of
3.13%. There was also an increase in serum calcium and simultaneous decrease in serum

phosphorous and alkaline phosphatase. This showed that OST-6 prevents bone loss during
the menopausal period. The common symptoms such as backache and leg pain also reduced.
This may be attributable to Commiphora wightii, which has a potent anti-inflammatory
property. Additional natural forms of calcium, through Kukkutandatvak and Godanthi
bhasmas provide adequate calcium required to prevent osteoporosis.
CONCLUSION
We report that OST-6 prevents bone loss in postmenopausal women primarily by slowing
bone resorption. OST-6 provides 362.4 mg of calcium/tablet. Hence, administering 4
tablets/day provides 1449.6 mg calcium, which is in the range of recommended calcium for
the osteoporotic patients.
This is a short-term study on a small population of women, the efficacy of OST-6 can be
further evaluated in a larger population of women with a longer follow-up.
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