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Research Findings

 

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.