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ASSESSMENT OF EFFICACY OF ACECLOFENAC VERSUS   TRAMADOL IN OSTEOARTHRITIS PATIENTS


A.Srinivasan*, T.Venkatachalam, G.Thamotharan, G.Sekar, N. Senthilkumar
Department of Pharmacy practice, JKKMMRF college of Pharmacy.The Tamilnadu Dr MGR Medical university, Erode, TamilNadu, INDIA

Abstract

Osteoarthritis (OA) is a common, slowly progressive disorder affecting primarily the weight-bearing diarthrodial joints of the peripheral and axial skeleton. This is an open label study conducted in both in patients and out patients to assess the aceclofenac and tramadol efficacy in osteoarthritis patients whom doctor decided to start with non-selective NSAIDs. The whole work is carried out in 126 patients for a period of 11 months from November 2011 to September 2012. Eligible patients were interviewed by asking questions from the standard WOMAC questionnaire and reviewed on three weeks basis. The patients were divided in to two class accordance with the drugs they have taken. The first follow up was taken after completing 3 week therapy.

The WOMAC questionnaire was asked to the patient and documented properly. The improvement score was noticed. The second follow up was taken after the completion of three week therapy after the first follow up with the same medicine, the improvement in score compare with the baseline therapy was documented. The total change in score in aceclofenac taking patients was 58.51(SD 6.61). In tramadol taking patients, the mean change in score was 42.0(SD 6.67). The decrease in score of stiffness, pain and function daily living was more pronounced with patients taking aceclofenac compared to patients taking tramadol.

Key words: OA, WOMAC, questionnaire, NSAIDs.

Introduction

Osteoarthritis (OA) is a common, slowly progressive disorder affecting primarily the weight-bearing diarthrodial joints of the peripheral and axial skeleton. It is characterized by progressive deterioration and loss of articular cartilage, resulting in osteophyte formation, limitation of motion, deformity, pain and progressive disability.1,4,5,6 Inflammation may or may not be present in the affected joints.10 Osteoarthritis (OA) is one of the most common disabilities from which the elderly population suffers.14,15 

Non-steroidal Anti-inflammatory Agents (NSAIDs): NSAIDs have been an important treatment for the symptoms of OA for a very long time. The mechanism by which NSAIDs exert their anti-inflammatory and analgesic effects is via inhibition of the prostaglandin-generating enzyme, cyclooxygenase (COX).2,3 Tramadol is non-NSAID/COX2 non-opioid pain medication, can be effective to manage pain symptoms alone, tramadol binds to receptors in the brain (narcotic or opioid receptors) that are important for transmitting the sensation of pain from throughout the body to the brain.11 

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a widely used measure of symptoms and physical disability originally developed for people with osteoarthritis (OA) of the hip and/or knee. Patients activities rated in each category according to the following scale of difficulty: 0 = None, 1 = Slight, 2 = Moderate, 3 = Very, 4 = Extremely, the measure was developed to evaluate clinically important, patient-relevant changes in health status as a result of treatment intervention.  More than 10 years ago, Bellamy and colleagues provided evidence of the reliability (test–retest), validity and responsiveness of the WOMAC in OA patients undergoing total knee or hip arthroplasty and in OA patients receiving non-steroidal anti-inflammatory drugs (NSAIDs)2,7,.

Materials and Methods

The ethics committee of MI hospital approved the study protocol and all patients gave informed written consent prior to their inclusion in the study. The inclusion criteria are Patients confirmed with osteoarthritis, WOMAC total score more than 30, Patients of either sex. The age >18 years suffering from arthritis were included. Literate patient who can complete the pain scale, both in-patients and out-patients. The exclusion criteria are patients with known allergic history with NSAIDs, WOMAC  total score less than 30, Pregnant and lactating women, patients with a proven history of peptic ulceration or gastrointestinal bleeding.

This is an open label study conducted in both in patients and out patients to assess the Aceclofenac and Tramadol efficacy in osteoarthritis patients whom doctor decided to start with non-selective NSAIDs. Total 126 patients were enrolled in this study. The whole work is planned to carry out for a period of 11 months from November 2011 to September 2012.

Data collection and measurements

At baseline, we collected data related to socio demographic parameters such as age, the number of pregnancies, the existence of previous knee/hip injuries and duration of disease. Patients data’s of Social history, habituation of patients like smoking and co morbid factor like presence of like ischemic heart disease, hypertension, diabetes mellitus, renal disease has enrolled. The body mass index (BMI) was calculated as body weight (kg) /height (m2).

Study procedure

Eligible patients were aged 18 years or older; had osteoarthritis of the knee or hip had experienced at least moderate pain in the worst affected knee/hip were interviewed by asking questions from the standard WOMAC questionnaire and reviewed on three weeks basis. The patients were divided in to two classes, accordance with the drugs they have taken .All the necessary data including Age, sex, type of arthritis, smoking habit, number of pregnancies, past medical history, category of drug prescribed, dose etc. were collected and documented in a suitably designed data collection form.

The first follow up was taken after completing 3 week therapy. The WOMAC questionnaire was asked to the patient and documented properly. The improvement of the score was noticed. The second follow up was taken after the completion of three week therapy after the first follow up with the same medicine; the improvement in score compare with the baseline therapy was documented.

Results and Discussion

Fig1: Sex wise distribution

Fig 1 shows sex wise distribution of the 126 patients. In aceclofenac taking patients, the male patients were 25(33.8%) and the female patients were 49(66.2%). In tramadol taking patents, male patients were 16(30.8%) and female patients were 36(69.2%). In both the groups, Female patients were more in number.

Fig 2: Age Wise Distribution, The majority of the patients lies in the age limit of (51-60) followed by (41-50) limit  

Table 1: BMI

 

BMI

Total patients
No.Patients %
< 18.5(underweight) 2 2.7
18.6 – 24.9(Normal weight) 46 36.8
25-29.9(Over weight) 69 55.2
30 & above(Obesity) 9 6.65
Total 126 100

Table 1 shows BMI wise distribution of total patients. The maximum number of patients (69) lies in over weightand 9 patients’ lies in obesity, Overall 78 patients suffers from overweight which is associated with knee arthritis.

Table 2: Baseline Scores

Baseline scores Aceclofenac taking patients Tramadol taking patients ‘p’ value
Mean SD Mean SD
Stiffness score 6.72 0.89 5.62 0.92 0.6012

Not significant

Pain score 26.22 2.41 18.25 1.91 0.651

Not Significant

Physical function daily living score 52.67 4.88 61.11 4.67 0.0001

Significant

Total score 85.88 5.89 85.4 5.64 0.701

Not Significant

Table 2 shows first follow up scores. In aceclofenac taking patients, the mean stiffness score was 6.72(SD 0.89). The mean pain score was 26.22(SD 2.41). The mean Physical function daily living score was 52.67(SD 4.88). The total mean score in the first follow up of aceclofenac taking patients was 85.88(SD 5.89)

In tramadol taking patients, the mean stiffness score was 5.62(SD 0.92). The mean pain score was 18.25(SD 1.91). The mean Physical function daily living score was 61.11(SD 4.67). The total mean score in the base line of aceclofenac group was 85.4(SD 5.64)

Table 3: First Follow Up Scores

First Follow up scores Aceclofenac taking patients Tramadol taking patients ‘p’ value
Mean SD Mean SD
Stiffness score 4.05 1.05 4.17 1.2 0.6012

Not significant

Pain score 15.8 2.84 13.52 2.49 0.001

Significant

Physical function daily living score 31.73 5.74 45.23 6.07 0.0001

Significant

Total score 51.57 6.85 62.92 7.24 0.0001

Significant

 

Table 3 shows first follow up scores. In aceclofenac taking patients, the mean stiffness score was 4.05(SD 1.05). The mean pain score was 15.8(SD 2.84). The mean Physical function daily living score was 31.73(SD 5.74). The total mean score in the first follow up of aceclofenac taking patients was 51.57(SD 6.85)

In tramadol taking patients, the mean stiffness score was 4.17(SD 1.2). The mean pain score was 13.52(SD 6.07). The mean Physical function daily living score was 45.23(SD 6.07). The total mean score in the base line of aceclofenac group was 62.92(SD 7.24)

Table 4: Second Follow Up Scores

Second Follow up scores Aceclofenac taking patients Tramadol taking patients ‘p’ value
Mean SD Mean SD
Stiffness score 2.16 1.04 3.62 1.07 0.0001

Significant

Pain score 6.85 1.6 10.63 1.53 0.0001

Significant

Physical function daily living score 16.28 4.05 32.08 6.34 0.0001
Significant
Total score 27.36 4.95 43.4 6.65 0.0001

Significant

Table 4 shows second follow up scores. In aceclofenac taking patients, the mean stiffness score was 2.16(SD 1.04). The mean pain score was 6.85(SD 1.6). The mean Physical function daily living score was 16.28(SD 4.04). The total mean score in the first follow up of aceclofenac taking patients was 27.36(SD 4.95)

In tramadol taking patients, the mean stiffness score was 3.62(SD 1.07). The mean pain score was 10.63(SD 1.53). The mean Physical function daily living score was 32.08(SD 6.34). The total mean score in the base line of aceclofenac taking patients was 43.4(SD 6.65)

Table 5: Improvement Scores In Different Parameter

 

Change in scores

Aceclofenac taking patients Tramadol taking patients ‘p’ value
Mean SD Mean SD
Stiffness score 2.74 1.41 1.42 1.43 0.001

Significant

Pain score 19.16 3.58 14.92 3.11 0.001

Significant

Physical function daily living score 38.5 5.13 28.94 5.83 0.001

Significant

Total score 58.51 6.61 42.0 6.67 0.001

Significant

 Table 5 shows change in score. In aceclofenac taking patients, the mean stiffness score was 2.74(SD 1.41). In tramadol taking patients, the mean stiffness score was 1.42(SD 1.43), the mean change in pain score was 19.16(SD 3.58). In tramadol taking patients, the mean pain score change was 14.92(SD 3.11), the change in function living score in aceclofenac taking patients was 38.5(SD 5.13), in tramadol taking patients, the mean change in Physical function daily living score was 28.94(SD 5.83). The total change in score in aceclofenac taking patients was 58.51(SD 6.61). In tramadol taking patients, the mean change in score was 42.0(SD 6.67)

Table 6: Improvement In Total Scores

 

Total scores

Aceclofenac taking patients Tramadol taking patients ‘p’ value
Mean SD Mean SD
Baseline 85.88 5.89 85.4 5.64 0.5748

Not significant

First follow up 51.57 6.85 62.92 7.24 0.001

Significant

Second follow up 27.36 4.95 43.4 6.65 0.001

Significant

Change 58.51 6.61 42.0 6.67 0.001

Significant

% of change 68.09 5.78 49.16 7.19 0.001

Significant

 

Table no 6 shows improvement in total scores. In aceclofenac taking patients, the total mean baseline score was 85.88(SD 5.89). At the first line follow up, the total score was 51.57(SD 6.85). At the second line follow up, the total score was 27.36(SD 4.95). The total change from the base line to the second line follow up was 58.51(SD 6.61). The percentage of change was 68.09(SD 5.78)

In tramadol taking patients, the total mean baseline score was 85.4(SD 5.64). At the first line follow up, the total score was 62.92(SD 7.24). At the second line follow up, the total score was 43.4(SD 6.65). The total change from the base line to the second line follow up was 42.0(SD 6.67). The percentage of change was 49.16(SD 7.19)

Conclusion

The present study was undertaken with the aim of comparing the efficacy of Aceclofenac Vs Tramadol in patients diagnosed for osteoarthritis. The severity of pain was recorded after the drug administration using WOMAC scale. The decrease in score of stiffness, pain and function daily living was more pronounced with patients taking aceclofenac compared to patients taking tramadol. Thus we can conclude that aceclofenac is more effective in improve the quality of life of the patient compare with tramadol in osteoarthritis patients.

The risk factors such as Age, Sex, BMI, were monitored and identified that these risk factors leads to disease progressiveness. The quality of life of patient were increased at the end of the study

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