Ostolief Tablets showed efficacy for the treatment of Osteoarthritis

1. Clinical Study
Volume 17, Number 5 October 2006 Special Reprint
Evaluation of “Ostolief” (Polyherbal
Formulation) in the Management of
Osteoarthritis: A Double-blind, Randomized,
12-Week Comparative Study
DG Langade*
SRSinha** Osteoarthritis is a debilitating disease in
AA Hasamnis** geriatric age group.
SN Nawale †
AS Chandanwale ‡ among the elderly. Since the drug stiffness and immobility,
1
VY Deshpande § therapy of OA involves long-term characteristic of OA. One hundred
Abstract medication with drugs such as patients suffering from OA who
NSAIDs, it is fraught with unwanted needed drug therapy were divided
Osteoarthritis (OA), a
adverse effects. In this scenario, into two groups: one group received
degenerative form of arthritis, is a
plant-based formulations provide tablet Ostolief in a dose of one
disease that leads to considerable
a unique modality of treatment as tablet twice daily, while the other
disability, especially in the
they are safe and possibly have a group received tablet valdecoxib
geriatric group of patients. In fact,
disease-modifying action. The 10 mg twice daily for a period of
in certain populations, OA is now
present study was conducted to 12 weeks. A total of 94 patients
assuming epidemic proportions
evaluate the efficacy of completed the trial. In the Ostolief
a herbomineral formulation group, the average pain score at
*Lecturer,
**Resident, “Ostolief” in comparison with rest on visual analog scale
Department of Pharmacology, valdecoxib in reducing the pain, decreased from 49.56 ± 10.37 at
†
Resident,
‡
Professor and Head, Dep. of
Orthopedics and Traumatology,
§
Ex-Professor and Head,
With Best Compliments From
OCTOBER 2006
Department of Pharmacology,
Grant Medical College and Sir J.J. Group
of Hospitals, Byculla, Mumbai.
M/s. Charak Pharma Pvt. Ltd.
INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5

2. Clinical Study
baseline to 26.08 ± 9.77, while in OA has a particularly large novel treatment option of
the valdecoxib group, it fell from impact on the health of middle- Ostolief for OA. Ostolief is a
48.02 ± 13.66 to 26.02 ± 8.53. The aged and older women. Before the standardized, multi-ingredient
pain on joint use decreased from age 50, men have a higher herbal formulation, which not only
42.97 ± 12.09 to 24.02 ± 11.38 in prevalence of OA, but both the relieves the symptoms of
patients on Ostolief, while in prevalence and incidence are osteoarthritis , but is also postulated
patients in the valdecoxib group, higher in women after the age of to delay its progression. Ostolief
it decreased from 45.30 ± 13.70 to 50.1 The risk of knee, hip and hand contains Shallaki (Boswellia
25.51 ± 10.66. The reduction in OA in women increases s e r r a t a) a n d A s h w a g a n d h a
the Western Ontario and McMaster dramatically after menopause2-5. (Withania somnifera), which
(WOMAC) score in the Ostolief Older women are more likely to reduce the degradation of
group was from 14.13 ± 1.93 at report joint symptoms when glycosaminoglycan and delay the
baseline to 9.30 ± 2.83 at 12 weeks. radiographic OA is present, and progression of OA. Gokshur
The corresponding reduction in the hip OA atleast appears to progress (Tribulus terrestris) and Guduchi
valdecoxib group was 13.91 ± 2.10 more rapidly in older women (Tinospora cordifolia) are powerful
antioxidants and thus exhibit anti-
at baseline to 8.97 ± 2.99 at compared with older men6.
inflammatory action. Bala (Sida
12 weeks. Both the drugs were Numerous studies suggest that cordifolia) and Kupilu (Strychnos
well tolerated. It was concluded the prevalence of joint pain rises nux vomica) are potent anti-
that Ostolief showed a comparable markedly with age in the general inflammatory and analgesics.
efficacy vis-a-vis valdecoxib. On population, but for reasons not fully Moreover, Guduchi (T. cordifolia),
all evaluation parameters, Ostolief understood may decline somewhat Bala (S. cordifolia), Gokshur
and valdecoxib showed similar after the age of 75 or 80.7 Recent (T. terrestris) and Ashwagandha
results. Although patients on data from a variety of sources (W. somnifera) have anti-aging
valdecoxib showed slightly greater properties, which have a positive
2 reduction in pain scores, if the
across the globe suggest that
populations are now experiencing impact on preventing bone
safety aspect is considered, an epidemic of knee pain, with degeneration. In this study, we
Ostolief definitely has an edge one in 4 or one in 3 persons aged 55 compared the efficacy and
while having an equivalent and older having chronic knee tolerability of Ostolief with
efficacy. pain8,9. Most studies suggest that valdecoxib during a 12-week
knee pain is more common in older treatment in a randomized,
Introduction comparative, double-blind trial.
women than in older men.
OA is a degenerative arthritis
The basic pathology in OA is a
of chronic progression and is one
of the most debilitating diseases
thinning of the articular cartilage, Materials and
faced by an ever increasing
due to a decrease in the synthesis methods
of cartilage tissue, relative to the
geriatric population. It leads to One hundred patients (50 in
wear and tear. Currently available
chronic -sometimes severe - pain measures to manage OA include each group), diagnosed as
mostly in knees and lower back, NSAIDs, physiotherapy, supportive suffering from chronic OA, who
restricted mobility and a markedly belts, etc. Unfortunately, the drug needed drug therapy were
reduced quality-of-life. In many therapy of OA involves long-term enrolled after obtaining informed
cases, it interferes with normal medication with drugs such as written consent. Each patient
NSAIDs, and therefore, is fraught
OCTOBER 2006
daytime activities and the joint received either tablet Ostolief
pains may keep patients awake at with side effects. or tablet valdecoxib (10 mg).
night. In this study, we focus on a The two preparations looked
INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5

3. Clinical Study
identical. Patients were provided to each patient leucocyte count, differential
randomized according to a for recording symptoms. Compliance leucocyte count, fasting blood
computer-generated randomization was checked at every visit. sugar, blood urea, creatinine,
bilirubin, alkaline phosphatase
chart. The drugs were packed in Evaluation of the patients
and X-ray of the affected joint was
sealed bottles with patient serial was performed every 3 weeks.
performed at baseline on
numbers on them. The patients were Patients, who were taking other
enrollment and at the end of
enrolled and assigned a serial number medications for OA, were given
12 weeks of study period.
in a chronological order. Both study a 15-day washout period,
treatments were administered in a following which the study drugs Results
dose of one tablet twice daily for a were administered. Of the 100 patients
period of 12 weeks. A diary was Hemoglobin, ESR, total enrolled in the study, 94 (46 in the
Table 1
Radiological findings in the two treatment groups
[number of patients]
Parameter Ostolief (n = 46) Valdecoxib (n = 48) χ 2-test
Marginal lipping 44 41
χ2 = 0.007; 3
Narrowing of joint space 41 47
d.f.
Sharpened articular 12
margins p = 0.999
(NS)
Sclerosis 34 45
Bone cysts 0 0 3
OCTOBER 2006
Figure 1. Pain on a 0-10 visual analog scale (VAS) during joint use/mobility in
two treatment groups at baseline and after 3, 6, 9 and 12 weeks of therapy.
INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5

4. Clinical Study
Table 2
Joint tenderness on a four-point rating scale in the two
treatment groups (Number of patients) at enrollment and
after 3, 6, 9 and 12 weeks
Ostolief (n = 46) Valdecoxib (n = 48) Mann-Whitney
Nil Mild Moderate Severe Nil Mild Moderate Severe ‘U’ test (p)
Baseline 14 29 3 0 24 17 7 0 p > 0.05 (NS)
3 weeks 15 29 2 0 27 14 7 0 p > 0.05 (NS)
6 weeks 19 27 0 0 27 14 7 0 p > 0.05 (NS)
9 weeks 25 21 0 0 37 8 3 0 p < 0.05 (Sig.)
12 weeks 34 12 0 0 36 6 3 0 p < 0.05 (Sig.)
p < 0.01 (Sig.) Kruskall-Wallis test p < 0.01 (Sig.) Kruskall-Wallis test -
Ostolief group and 48 in the
valdecoxib group) completed the
study as per the study protocol.
Marginal lipping and joint
space narrowing were the
prominent radiological findings
in both groups (Table 1).
4 The pain score on joint use
decreased from 42.97 ± 12.09 to
24.02 ± 11.38 in patients on
Ostolief after 12 weeks therapy,
while for patients in the valdecoxib
group, it decreased from 45.30 ±
Figure 2. Fall in pain score on 0-100 VAS in the two treatment 13.70 to 25.51 ± 10.66. Here again,
groups at 3, 6, 9 and 12 weeks of study period. the reduction in the pain score was
significant within both groups
(p < 0.0001), while there was no
difference in the reduction in pain
scores observed between the two
groups (Fig. 1).
Although the fall in the pain
scores were similar in both the
groups, the group receiving Ostolief
showed a greater fall in the pain
score at rest while the group receiving
OCTOBER 2006
valdecoxib showed a greater fall
Figure 3. Reduction in the mean WOMAC score in the two in the pain scores on joint use/
treatment. mobility (Fig. 2).
INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5

5. Clinical Study
Figure 4. Global efficacy assessment by the physician.
Joint swelling and Morning stiffness such as hemogram and liver and
tenderness In the Ostolief group, only kidney function tests were
11 patients complained of morning performed in all the patients
Joint tenderness was also rated
on a four-point scale similar to stiffness at the end of the study,
compared to 28 at baseline.
before and after the therapy. Both
the medications were found to be
5
joint swelling. After 12 weeks of
However, in patients in the safe and did not lead to any
treatment, both the groups
valdecoxib group, 12 patients significant alteration in the liver
showed significant reduction in
complained of morning stiffness and kidney functions. Similarly,
the tenderness (Table 2).
after 12 weeks treatment, as both the medications were well
WOMAC score compared to 21 at baseline. tolerated by the patients.
The WOMAC score for OA Global efficacy Discussion
showed significant reduction, assessment by the Long-term use of NSAIDs
comparable in the two groups. The physician is a common practice in the
mean score in the Ostolief group management of mild-to-moderate
Overall, physicians rated the
reduced from 14.13 ± 1 . 9 3 OA. Patients suffering from OA
response as good in all the
at baseline to 9.30 ± 2.83 at 12 are also known to consume higher
46 patients in the Ostolief group
weeks. The corresponding doses of NSAIDs, and misuse of
after 12 weeks therapy. It was
reduction in the valdecoxib group NSAIDs is fairly common.
observed that as the duration of the
was 13.91 ± 2.10 at baseline to therapy increased, the response to Therefore, such patients are
8.97 ± 2.99. Thus, the reduction in therapy improved (Fig. 4). especially vulnerable to the
OCTOBER 2006
the mean WOMAC score was distressing side effects of NSAIDs.
comparable in both the groups Safety and tolerability The severity and morbidity caused
(Fig. 3). Laboratory investigations by the side effects of NSAIDs can
INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5

6. Clinical Study
assume grave proportions
especially in long-term users.
Conclusion
NSAID use is a very common From this trial, it can be concluded that the clinical
cause of upper gastrointestinal (GI) efficacy of Ostolief tablets is comparable to that of valdecoxib.
bleeding. Even cyclooxygenase Ostolief can be prescribed to patients with mild-to-moderate
(COX)-2 inhibitors, which are
OA. The patients in this trial reported no side effects of Ostolief.
believed to have lesser GI side effects
compared to other NSAIDs, have
been shown to produce gastric ulcers.
change the underlying disease Gokshur and Ashwagandha have
The recent findings of cardiac
process and protect the joint from been used in the Ayurvedic system
adverse events with the use of COX-
further structural damage. Recent of medicine as rasayanas that
2 inhibitors, especially rofecoxib,
studies which have been published have anti-aging properties. Herbs
have further highlighted the problem
in “The New England Journal of that act as r a s a y a n a s exert
of severe side effects that can force
Medicine” have demonstrated that their anti-aging effect through
discontinuation of therapy.
glucosamine and chondroitin rejuvenating/revitalizing all the
In addition to these sulfate alone or in combination body tissues (dhatus). Since bones
issues, NSAID therapy offers no are one of the seven dhatus (asthi),
are similar to placebo and do not
advantage in terms of reversing rasayanas also have a positive
reduce pain effectively in patients
the basic pathological mechanisms impact on preventing bone
with OA of the knee10. Therefore, it
in OA, namely destruction of intra- degeneration. Rasayanas are also
is very important to initiate therapy
articular cartilages and progressive powerful antioxidants and thus
with drugs that not only manage
loss of the articular surfaces of the exhibit anti-inflammatory action.
symptoms but also favorably
bones. In this study, it was found that
affect changes in joint structure
Therefore, in the management over long-term treatment periods the study medicine, Ostolief,
6 of OA, it is important to use a
therapeutic tool that provides relief
and thus slow or arrest disease
progression - the so-called
showed good efficacy in all the
evaluation parameters. The
from the disabling symptoms, does disease- or structure-modifying efficacy of Ostolief was
not cause distressing side effects treatments. comparable to that of valdecoxib-
and also arrests or reverses the Ostolief is one such multi- a COX-2 inhibitor. None of the
degenerative changes that ingredient formulation that patients reported any adverse
cause OA. contains ingredients like Shallaki effects with the formulation. The
(B. serrata), Ashwagandha (W. need for rescue medication was
A structure-modifying somnifera), Gokshur (T. terrestris), also low, indicating that patient
treatment for OA Guduchi (T. cordifolia), Bala satisfaction with this formulation
Nearly all treatments for OA (S . c o r d i f o l i a) a n d K u p i l u was high.
in the current therapeutic arsenal (Strychnos nux vomica). Owing to
can be considered symptom-
this unique combination of drugs References
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OCTOBER 2006
classification and reporting of
“arthritis cure” - may only primarily glycosaminoglycan and delays the osteoarthritis. Classification of
modify symptoms rather than progression of OA. Guduchi, Bala, osteoarthritis of the knee.
INDIAN JOURNAL OF CLINICAL PRACTICE Vol. 17, No. 5

7. Clinical Study
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7
Reprinted under permission from IJCP Group of Publications, Daryacha, 39, Hauz Khas Village, New Delhi - 110 016
from Indian Journal of Clinical Practice 2006 October-;17(5):21-26.
Published, Printed and Edited by Dr KK Aggarwal, on behalf of IJCP Academy of CME
OCTOBER 2006
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