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Minimizing risk of Postmenopausal Osteoporosis through Shatavari - A clinical study

Authors:
  • CVM University GJPIASR
  • G. J. Patel Institute of Ayurvedic Studies and Research

Abstract

The postmenopausal period is associated with significant increase in the incidence of age related medical conditions like cardiovascular diseases and osteoporosis. Postmenopausal Osteoporosis is a condition of major health importance because of its association with fractures. Bone loss is only partly reversible. Hence treatment is aimed at minimizing the bone loss after the age of 40. Postmenopausal osteoporosis is a disease of ageing. Rasayana can provide better alternative in increasing quality of life. Shatavari (Asparagus racemosus) is a well-known female rejuvenative. Its beneficial effect on women during fertile i.e. reproductive life is well established. In the present clinical study Shatavari was administered in perimenopausal and menopausal women; 6gms / day in two divided doses with milk for 10 weeks. At the end of the study it showed highly significant (P<0.001) changes in biochemical markers of bone formation and bone resorption.
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MINIMIZING RISK OF POSTMENOPAUSAL OSTEOPOROSIS
THROUGH SHATAVARI – A CLINICAL STUDY
*
Jasmine Ritesh ujarathi
1
, Ritesh Ashok Gujarathi
2
1
Dept. of Prasuti tantra & Stri roga, G. J. Patel Institute of Ayurvedic Studies & Research,
New Vallabh Vidyanagar, Anand, Gujarat, India.
2
Dept. of Basic principles, G. J. Patel Institute of Ayurvedic Studies & Research, New
Vallabh Vidyanagar, Anand, Gujarat, India.
ABSTRACT
The postmenopausal period is associated with significant increase in
the incidence of age related medical conditions like cardiovascular
diseases and osteoporosis. Postmenopausal Osteoporosis is a
condition of major health importance because of its association with
fractures. Bone loss is only partly reversible. Hence treatment is
aimed at minimizing the bone loss after the age of 40.
Postmenopausal osteoporosis is a disease of ageing. Rasayana can
provide better alternative in increasing quality of life. Shatavari
(Asparagus racemosus) is a well-known female rejuvenative. Its
beneficial effect on women during fertile i.e. reproductive life is well
established. In the present clinical study Shatavari was administered
in perimenopausal and menopausal women; 6gms / day in two
divided doses with milk for 10 weeks. At the end of the study it
showed highly significant (P<0.001) changes in biochemical markers
of bone formation and bone resorption.
Key words :- Postmenopausal osteoporosis, Bone loss, Rasayana, Shatavari.
INTRODUCTION
Old age is vulnerable time for both men and women - but for women it is even more so. The
aftermath of ageing strikes women twice, because in addition to process of senility, women
suffer simultaneously from the inevitable scars of menopause. Statistical data reveal that
osteoporotic fractures are four times more common than cardiovascular stroke and can lead to
Wo
rld Journal of Pharmaceutical research
Volume 2, Issue 1, 260-265. Research Article ISSN 2277 – 7105
Article
Received on
28 November 2012,
Revised on 16 December 2012,
Accepted on 29 December 2012
Author:
*Dr. Jasmine Ritesh ujarathi
Assistant Professor
Dept. of Prasuti tantra & Stri
roga, G. J. Patel Institute of
Ayurvedic Studies & Research.
New Vallabh Vidyanagar,
Anand, Gujarat. India.
jassyleo@gmail.com,
drritesh00@gmail.com,
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Jasmine et al. World Journal of Pharmaceutical Research
permanent disability and hence can even be life threatening, thus becoming a significant
cause of morbidity and mortality.
[1,2]s
World Health Organization defines osteoporosis as a “progressive systemic skeletal disease
characterized by low bone mass and micro architectural deterioration of bone tissue, with a
consequent increase in bone fragility and susceptibility to fracture”
[3].
Osteoporosis is a
metabolic disorder, where there is imbalance between bone formation and bone resorption.
Estrogen, during the reproductive phase, prevents bone loss by conserving calcium and
inhibiting activity of osteoclasts. Beginning at the age of 30 to 40, women lose about 10% of
their bone mass per decade; with age and reduced estrogen levels, there is an increased risk of
progressive loss of bone strength.
[4]
Thus post menopausal osteoporosis is one of the most
common and disabling disease affecting women.
During the past decade, it has increasingly been perceived as serious disabling disease
needing substantial involvement of all medical sciences to develop and assess potential
treatments.
The disease postmenopausal osteoporosis is a disease of Aging and prevailing specially in
women, drug Shatavari (Asparagus racemosus) was selected to analyze its role in decreasing
bone loss and hence minimizing the risk of postmenopausal osteoporosis.
AIMS AND OBJECTIVES
1. To study the disease postmenopausal osteoporosis as per Ayurveda and modern
concept.
2. To assess the effect of Shatavari in minimizing bone loss.
3. To see for any adverse effects of the same during the study.
4. To compare the efficacy of Shatavari with Kukkutanda twak bhasma.(bhasma prepared
from egg shell)
MATERIALS AND METHODS
Clinical Study
Patients : For clinical study, patients attending OPD and IPD of I. P. G. T & R.A. hospital
presenting risk factors for developing the disease were registered.
Drugs : Shatavari moola churna, Kukkutanda twak bhasma and placebo tablets (wheat flour)
were prepared in the pharmacy of Gujarat Ayurved Univeristy, Jamnagar.
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PLAN OF STUDY
CRITERIA OF SELECTION
1. Women of age group 40 -60 years (perimenopausal and postmenopausal age group)
2. Presenting one or more risk factors for developing osteoporosis.
CRITERIA OF EXCLUSION
1. Hyperparathyroidism 2. Chronic diseases
INVESTIGATIONS
Routine blood, urine and stool examinations.
Biochemical bone markers
Urine – 24 hour urine calcium , Urine creatinine
Serum – Serum calcium, Serum alkaline phosphatase, Serum acid phosphatase
X-ray spine
CRITERIA OF ASSESSMENT
Subjective criteria
Results of the treatment were assessed on the basis of relief in Asthikshayatmaka lakshana
(symptoms of Asthi Dhatu Kshaya) with the help of specific scoring pattern as recorded in
research proforma.
Objective criteria
To assess the effect of treatment on bone loss, biochemical bone markers were used before
treatment (BT) and after treatment (AT) to detect any change in rate of bone formation and
bone resorption.
Table I- Grouping
GROUP A GROUP B GROUP C
DRUG
Kukkutanda
Twak bhasma
Shatavari
Moola churna
Placebo
(Wheat flour)
DOSE
500 mg / day
in 2 divided doses
6 gm / day in
3 divided doses
6 gm / day in
3 divided doses
DURATION
10 Weeks 10 Weeks 10 Weeks
ANUPANA
Milk Milk Milk
No. of Patients
10 14 11
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Table II - Observations
Group No. Of Patients
Total Registered Lama Completed
A 14 04 10
B 15 01 14
C 14 03 11
TOTAL 43 08 35
1. Maximum no. of patients – 62.79% belonged to the age group of 40-45 years.
2. 55.81% of patients were postmenopausal, whereas 44.81% fell into perimenopausal age
group.
3. 83.72% of patients registered had natural menopause whereas 16.27% underwent
hysterectomy.
4. 34.88% of patients had age of menopause between 40-45 and 45-50 years.
5. 67.44% of patients did not perform any exercise in their daily routine.
6. Vata dominant Prakriti was found maximum number of patients with combination of
Pitta (58.13%) and Kapha (32.55%)
7. 95.34% of patients had low life time calcium intake as risk factor, 69.76% presented
small body frame as well as inactive life style whereas 48.83% were underweight and
34.88% of patients had early menopause as risk factor for developing osteoporosis.
8. Bone pain and low back pain was observed in 95.34%, extreme fatigue and cramps in
legs in 90.69%, difficulty in walking in 88.37%, premature graying of hair in 67.44% and
pain at symphysis pubis was observed in 60.46% of patients.
9. Radiological findings indicated established osteoporosis in 18.60% of patients. Loss of
normal lumber lordosis was found in 23.25% of patients.
RESULTS
Table III – Subjective Parameters
Asthi
Kshayatmaka
Lakshana
GROUP A
Kukkutanda
twak bhasma
GROUP B
Shatavari
moola churna
GROUP
C
Placebo
Keshapatan 66.66% 85.29% 37.50%
Asthi vedana 57.69% 80% 36.36%
Shrama 50% 71.42% 33.33%
Sandhishoola 36.84% 70.37% 32.14%
Katishoola 33.33% 68.57% 30.43%
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Table IV – Objective Parameters
BIOCHEMICAL
BONE MARKERS
GROUP A GROUP B GROUP C
Bone Formation Non significant Highly significant
( P < 0.01)
Non significant
Bone resorption Significant
(P < 0.05)
Highly significant
( P < 0.01)
Highly significant
( P < 0.01)
TOTAL EFFECT OF THERAPY
In group A, marked improvement was found in 10% of patients, 30% of patients were
moderately improved and 60% patients showed mild improvement in lakshana of asthi
kshaya. No patient remained unchanged in this group.
In group B, marked improvement was found in 50% patients. 42.85% patients were
moderately improved, 7.14% showed mild improvement and none of the patient remained
unchanged.
In group C, 22.85% of patients presented marked improvement, 28.57% patients exhibited
moderate improvement, mild improvement was demonstrated in 54.54% patients and 36.26%
of patients remained unchanged after administration of therapy.
DISCUSSION
Reviewing all the available literatures related to Asthi Dhatu, the final diagnosis of the
disease was given as Asthi Saushirya.’ Anga bhanga- fractures can be considered as
Pratyatma lakshana of this disease. Gambhira dhatu, Svabhavabalapravritta Vyadhi and
Bhedawastha make this disease Asadhya. This disease can become Yapya by intervention at
proper level, following Pathyapathaya and Rasayana Therapy.
Maximum patients registered had early menopause and had less than 2 years as duration of
menopause which supports the fact that age of menopause is declining and that the bone loss
is accelerated in the first few years of menopause. Low life time calcium intake and inactive
life style were the risk factors found in maximum number of patients which serves as Nidana
(Etiological factors) of Asthi Saushirya.
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Effect of Shatavari on Asthi Ksayatmaka lakshana was better over that of KTB and placebo.
The effect of Shatavari on bone markers indicates that it enhances bone formation as well as
decreases bone resorption. Shatavari acts on both ways and balances bone remodeling and
hence can prevent bone loss and help in increasing bone mass. The mode of action of
Shatavari can also be explained with the help of its active chemical constituent Steroidal
Saponins which fall under Phytoestrogens. Phytoestrogens stimulate osteoblastosis and
suppress osteoclastosis and thus help in preventing bone loss.
CONCLUSION
Postmenopausal osteoporosis is a disabling disease which renders women a bedridden life.
Hormone replacement therapy- only known therapy in prevention and management of
postmenopausal osteoporosis has got major risks than benefits.
The effect of Shatavari on Asthi Kshayatmaka lakshana was better over Kukkutanda twak
bhasma and placebo. Shatavari provided encouraging results on bone metabolism by
preventing bone loss and enhancing bone formation.
Additional studies by combining Shatavari with calcium supplements and life style planning
are needed to improve the quality of life of postmenopausal women.
REFERENCES
1. Melton L J, Chrischilles E A, Cooper C, Lane A W, Riggs B L. How many women have
osteoporosis ? J Bone Miner Res; 7 : 1005-1010, 1992
2. Riggs BL, Melton LJ III. Involutional Osteoporosis. N Engl J Med ; 314:1676-86,1986.
3. World Health Organisation. Assessment of fracture risk and its application to screening
for postmenopausal osteoporosis. Geneva : WHO, 1994. (Technical report series 843)
4. Heaney RP, Recker RR, Savile PD. Menopausal changes in bone remodeling. J Lab Clin
Med; 92 : 964-70, 1978.
... [9] Shatavari Taila's (ST) mode of action involves enhancing bone formation, decreasing resorption, and balancing bone remodeling, with Withania somnifera contributing to anti-osteoporotic effects. [10] The full ingredients are seen in Table 8. VGG is suggested to alleviate pain and increase bone density through its anti-inflammatory and anti-arthritic properties, particularly driven by guggulsterone. ...
Thesis
Full-text available
Background: Osteopenia and osteoporosis are linked disorders, as their names suggest. Both have different degrees of bone loss as assessed by low bone mineral density (LBMD), which is a metric that indicates how strong a bone is and how likely it is to break. Normal bone mineral density tops the scale, osteopenia somewhere in the middle, and osteoporosis at the bottom. The bone conditions mentioned in Ayurvedic classics, such as Asthi-Kshaya (decrease in bone tissue) and Asthi Saushirya (porous bones), have some clinical resemblance to LBMD or osteoporosis. Aim To compare the efficacy of Vrishyamuladi Taila Matra Basti (VTMB, oil enema) and Shatavari Taila Matra Basti (STMB, oil enema) in the management of Asthi-Majja-Kshaya (osteoporosis or LBMD). Materials and Methods A total of 44 patients were screened, of which 34 suffered from Asthi-Majja-Kshaya , that is, LBMD; they were randomly selected and randomly divided into Group A and Group B, with 17 patients in each group. Group A patients were given VTMB for 16 days, followed by Vyoshadhya Gutika Guggulu (VGG) tablets, with a dose of 1g twice a day orally with lukewarm water for 30 days after Basti was completed. Group B patients were given STMB for 16 days, followed by VGG, with a dose of 1g twice a day orally with lukewarm water for 30 days after Basti (medicated enema) was completed. Results It was observed that both groups showed improvement in parameters of Asthishoola (bone pain), Asthitoda (pricking pain of bones), Nakhabhanga (splitting of nails), Raukshya (dryness of skin), Aswapna (loss of sleep), and Satataruka (continuous pain). There is no significant difference in any of the parameters tested in both Group A and Group B comparisons. Conclusion Both Groups A and B were effective in managing Asthi-Majja-Kshaya (LBMD).
... Studies on Shatavari containing saponins classified under phytoestrogens has shown encouraging results in minimizing bone loss. [33,34] Further evaluation of these herbs is needed on cardiovascular functions, osteoporosis with minimizing the risk of developing breast carcinoma and endometrial carcinoma. ...
Article
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Ageing affects differently to man and woman. The risks of cardiovascular disease and osteoporosis in women are doubled after menopause. Estrogen which is acting as prevention against these diseases throughout reproductive period is deficient during postmenopausal time and which makes women more vulnerable towards these diseases. Longer life expectancy of women has resulted in rise in their health needs. Tremendous amount of researches have been done on phytoestrogens which are plant derived compounds and are proving to be an effective alternative to Hormone replacement therapy. These plant derived compounds can reduce the risk of these conditions along with reducing financial burden and major side effects of hormone replacement therapy. Many sources of phytoestrogens in herbs are still unexplored. Protective effect of Soy which is rich in phytoestrogen is already studied. Herbs with phytoestrogenic effects can be studied in women with risk factors of developing these grave conditions. Clinical data for relieving menopausal symptoms through such herbs are sufficiently available. Further research is needed to study the same herbs for maintaining hormone homeostasis and preventing these challenging conditions.
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Introduction: Kukkutand twak bhasma is the ayurvedic medicine advised to treat calcium deficiency and leucorrhea like disease conditions. In preparation of KTB variations are found in usage of herbal drugs and pattern of temperature for incineration. Objectives: Thus the attempt was made to formulate KTB samples with different herbal combinations and temperature ranges on Kukkutand twak [KT]. Physico- chemical analysis and safety data of KTB is generated. Material and methodology: Purified KT was processed in Kumari Swaras and incinerated in Gajaputa to prepare four samples of KTB. While KT was triturated with Kumari Swaras, Nimbu Swaras and Gulab Jala, processed in Laghu Puta to prepare three samples of KTB. Analysis of KTB samples was done in laboratory. One sample of KTB was tested for toxicity through acute and subacute studies. Results and conclusions: KTB prepared in seven and three Gajaputa revealed white colour but little bit burning sensation. KTB-M-7GP showed high percentage of calcium than other KTB-GP samples. KT incinerated in three cycles of Laghuputa showed grayish colour with no burning sensation and estimated quantitative concentration of calcium. In acute toxicity study, animals didn’t show any mortality and morbidity. In subacute study, sample of KTB didn’t show any abnormal change in ileum and bone; insignificant inflammatory lesions are observed in liver and kidney. Present study has demonstrated different preparation methods and analytical data for KTB samples processed in Gajaputa and Laghu puta. Acute and subacute toxicity study records have been illustrated for KTB sample processed with Kumari Swaras in Gajaputa.
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Osteoporosis is widely viewed as a major public health concern, but the exact magnitude of the problem is uncertain and likely to depend on how the condition is defined. Noninvasive bone mineral measurements can be used to define a state of heightened fracture risk (osteopenia), or the ultimate clinical manifestation of fracture can be assessed (established osteoporosis). If bone mineral measurements more than 2 standard deviations below the mean of young normal women represent osteopenia, then 45% of white women aged 50 years and over have the condition at one or more sites in the hip, spine, or forearm on the basis of population-based data from Rochester, Minnesota. A smaller proportion is affected at each specific skeletal site: 32% have bone mineral values this low in the lumbar spine, 29% in either of two regions in the proximal femur, and 26% in the midradius. Although this overall estimate is substantial, some other serious chronic diseases are almost as common. More importantly, low bone mass is associated with adverse health outcomes, especially fractures. The lifetime risk of any fracture of the hip, spine, or distal forearm is almost 40% in white women and 13% in white men from age 50 years onward. If the enormous costs associated with these fractures are to be reduced, increased attention must be given to the design and implementation of control programs directed at this major health problem.
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Bone remodeling was measured by a calcium-kinetic method in 151 normal perimenopausal women, and the effect of estrogen status on remodeling level and skeletal balance was determined. Premenopausal women exhibited remodeling rates of 0.337 gm/day Ca for mineral accretion and 0.358 gm/day Ca for mineral resorption. The difference between the two rates (computed skeletal balance) was -0.021 gm/day Ca. Postmenopausal women treated with estrogen in a mean dose of 0.0188 mg equivalents of ethinyl estradiol exhibited values for accretion and resorption (0.332 and 0.351 gm/day Ca), essentially identical with those of the premenopausal group. However, untreated postmenopausal women exhibited remodeling rates of 0.387 gm/day Ca for accretion and 0.425 gm/day Ca for resorption, with a computed skeletal balance of -0.038 gm/day Ca. These values were significantly higher than those of either the premenopausal or treated postmenopausal groups. Paired studies across menopause in 15 of the women demonstrated a rise in remodeling rates virtually identical to that estimated from the differences between groups. Estrogen loss at menopause is thus associated with an apparent partial release from an inhibition of skeletal resorption, and this release is, in whole or part, responsible for the negative skeletal balance shift associated with the postmenopausal years.
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This article has no abstract; the first 100 words appear below. OSTEOPOROSIS is an enormous public health problem, responsible for at least 1.2 million fractures in the United States each year. The sites of these fractures are the vertebrae in 538,000 cases, the hip in 227,000, the distal forearm (Colles' fracture) in 172,000, and other limb sites in 283,0001 (and Melton LJ, Riggs BL: unpublished data). One third of women over 65 will have vertebral fractures (Melton LJ, Riggs BL: unpublished data). By extreme old age, one of every three women and one of every six men will have had a hip fracture.² This catastrophic type of fracture is fatal in . . . Supported by grants (AM-27065, AM-30582, and AG-04875) from the National Institutes of Health, U.S. Public Health Service. Source Information From the Endocrine Research Unit, Division of Endocrinology, Metabolism, and Internal Medicine, and the Department of Medical Statistics and Epidemiology, Mayo Clinic and Mayo Foundation, Rochester, Minn. Address reprint requests to Dr. Riggs, Division of Endocrinology and Internal Medicine, Mayo Clinic, Rochester, MN 55905.
World Health Organisation. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis
World Health Organisation. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis. Geneva : WHO, 1994. (Technical report series 843)