Clinical trial
of Boswellia Serrata (Shallaki) in the treatment of
Osteoarthritis
Introduction:
Osteoarthritis of
the knee joint is a common problem presenting as pain and
progressive disability. Although arrest of degenerative changes
is difficult the treatment is aimed at making the patient
symptom free and mobile as far as possible. Drug treatment of
Osteoarthritis being prolonged, the drug selected should be free
of side effects.
Materials and method:
Patients complaining of
pain in the knee joints, stiffness and difficulty in walking and
or climbing were included in the trial. The diagnosis of
osteoarthritis was established from history, physical
examination and X Ray changes of the affected joint. The
patients selected were divided into two groups – one group of
patients received Shallaki tablets, while the other group of
patients were given paracetamol tablets.
Doses:
Shallaki 200mg twice a day
for 1st week, 200mg three times a day for 3 weeks.
Paracetamol 500mg three
times a day for 4 weeks.
Details of age, sex,
duration of illness and previous treatment received are as
follows:
|
Age in years
|
30 – 40
|
40 – 50
|
50 – 60
|
60 – 70
|
70 – 80
|
|
Shallaki
|
5
|
10
|
18
|
11
|
10
|
|
Paracetamol
|
4
|
20
|
22
|
3
|
1
|
|
Sex
|
Male
|
Female
|
|
Shallaki
|
21
|
33
|
|
Paracetamol
|
24
|
26
|
|
Duration of pain
|
Less than 1
month
|
1 – 6 months
|
6 months to 2
years
|
More than 2
years
|
|
Shallaki
|
8
|
25
|
18
|
3
|
|
Paracetamol
|
3
|
20
|
17
|
10
|
|
Previous
treatment taken
|
Nil
|
Oxyphen -
butazone
|
Aspirin
|
Oxyphen –
butazone + aspirin
|
Analgin
|
Ibupofen
|
Paracetamol
|
|
Shallaki
|
14
|
10
|
2
|
17
|
1
|
5
|
1
|
|
Paracetamol
|
6
|
32
|
1
|
11
|
-
|
-
|
-
|
Investigations:
All patients were subjected
to following investigations before and after treatment. RBC,
Haemoglobin, WBC, ESR, Platelet count, SGOT, SGPT, Stool, Urine
and X-Rays of the knee joints.
|
X Ray changes
|
Normal
|
Mild
|
Moderate
|
Severe
|
|
Shallaki
|
37
|
9
|
6
|
2
|
|
Paracetamol
|
38
|
11
|
1
|
-
|
Observations:
All patients were
clinically assesses regarding pain, tenderness, swelling, spasm
and range of movement.
Weekly observations noted
and tabulated.
Criteria for results
Excellent –
1.
Pain relieved within 1 week after starting treatment
2.
Complete relief of stiffness in 1 week
3.
Full range of movement
4.
75% relief of pain in 1st week
5.
no tenderness around joint after 1 week
Good –
1.
Pain relief in 2nd and 3rd week
2.
Stiffness decrease in 2nd or 3rd week
3.
50% to 75% relief of pain after 4 weeks
4.
no tenderness after 4 weeks
5.
full range of movement but terminal 5% slightly occasionally
painful
Fair –
1.
Pain relieved in last week with presence of tenderness or
morning stiffness
2.
25% to 50% relief of pain in 4 weeks
3.
acceptable increase in movement full range possible but painful
terminally
Poor –
1.
No relief at all after 4 weeks of treatment
2.
Those who were receiving Oxyphenbutazone or Aspirin before
complained more pain with increased joint stiffness and
restriction of movement
3.
All movements painful and limited
Relief of Pain
|
Duration in
weeks
|
Excellent
|
Good
|
Fair
|
Poor
|
|
1
|
4
|
1
|
-
|
-
|
|
2
|
2
|
6
|
-
|
-
|
|
3
|
1
|
17
|
4
|
2
|
|
4
|
-
|
2
|
2
|
2
|
|
No relief
|
-
|
-
|
2
|
9
|
Relief in stiffness
|
Duration in
weeks
|
Excellent
|
Good
|
Fair
|
Poor
|
|
1
|
2
|
-
|
-
|
-
|
|
2
|
1
|
4
|
-
|
-
|
|
3
|
1
|
13
|
3
|
1
|
|
4
|
-
|
1
|
-
|
1
|
|
No relief
|
-
|
5
|
-
|
6
|
|
Nil
|
3
|
3
|
5
|
6
|
Results of Shallaki and
Paracetamol after 4 weeks of trial –
|
Drug
|
Total no. of
patients
|
Excellent
|
Good
|
Fair
|
Poor
|
|
Shallaki
|
54
|
7
|
26
|
8
|
13
|
|
Paracetamol
|
50
|
0
|
2
|
12
|
36
|
The patients on paracetamol
did not show improvement in pain or stiffness in 4 weeks
Conclusion:
After 4 weeks of trial it
was observed that, 7 patients taking Shallaki showed excellent
response these cases were having short duration of complaints
(less than 6 months). They had no radiological changes.
26 cases showed good
response. In these patients duration of complaints was more than
6 months with minimal changes of osteoarthritis on X-Ray
examination. If treatment with Shallaki had continued for longer
period, patients would have shown excellent results.
|
