Rheumadol Real-World Testing
In order to test the effectiveness of Rheumadol a pre-clinical trial of this product was conducted on human. Very encouraging results of this study are described below.
The study was conducted on patients who reported to the clinics of three of privately practicing physicians for the treatment of their pains and aches. A total of 30 (22 female and 8 male) such patients agreed to participate in this study for 3 weeks without taking any other medications. Within a week 4 ( one male and 3 female) patients withdrew from this study since they had to revert back to some pain management treatment. Finally 26 of them participated.
As mentioned earlier that it is difficult to distinguish pains and aches due to arthritis and/or due to fibromyalgia. Callahan and Pincus (Arthritis and Rheumatism 1990;33:1317-1322), however, developed a questionnaire that includes difficulty in activity of daily living (D-ADL) and pain visual analog scale (P-VAS) in order to delineate between arthritis and fibromyalgia. The following questions were asked to estimate score for D-ADL.
- Are you able to dress yourself, including tying shoelaces and doing buttons?
- Are you able to get in and out of bed?
- Are you able to lift a full cup or glass to your mouth?
- Are you able to walk outdoors on flat ground?
- Are you able to wash and dry your entire body?
- Are you able to bend down?
- Are you able to turn water faucet?
- Are you able to get in and out of a car?
Each patient was asked, on a scale of 0 (worst) to 10 (maximum), to indicate severity of pain.. The average of the score the D-ADL was used to divide the score on P-VAS. If the number of P-VAS/D-ADL was less than 3, the patients were diagnosed for arthritis, while patients scored more than 5 were diagnosed for fibromyalgia. Seven patients were thus categorized as arthritic and the rest 19 of them as fibromyalgic.
Patients with arthritis were further examined for their joint pain and joint swelling by using the Lequesne Index (Lequesne M et al. Scand. J. Rheumatol. 1982;22:2290-2296). Fibromyalgic patients, however, were asked to score on their physical and mental health conditions as mentioned below:
- Any physical impairment (0-10)
- Days felt good in a week (1-7)
- Fatigue (0-10)
- Feeling tired upon awakening (0-10)
- Stiffness (0-10)
- Anxiety (0-10)
- Depression (0-10)
- Any numbness (0-10)
These patients were also examined for tender points on their body.
After having all the above score and examinations completed, each patient was given Rheumadol to ingest with their meals (2 tablets) in the morning and evening for three weeks. All the patients reported after completing this treatment regimen and once again the above health conditions were monitored. The results are presented in the following tables separately for arthritic and fibromyalgic patients.
TABLE 1: Clinical Efficacy of Rheumadol on Arthritic Patients
Number of patients (n)= 7 (male=4, female=3), Mean age= 47.8 years
Mean of disease duration= 8.6 years
| Conditions monitored |
Pre-treatment |
Post-treatment |
Clinical evaluations |
| Dress yourself, including tying shoelaces and doing buttons |
2.7±1.0 |
2.03±1.02 |
Good |
| Get in and out of bed |
2.04±0.9 |
1.2±0.63 |
Better |
| Lift a full cup or glass to your mouth |
2.3±1.03 |
1.9±0.72 |
Good |
| Walk outdoors on flat ground |
3.01±1.2 |
2.2±0.91 |
Better |
| Wash and dry your entire body |
2.8±1.0 |
2.02±0.8 |
Better |
| Bend down |
3.3±1.3 |
2.7±1.01 |
Much better |
| Get in and out of a car |
3.5±1.3 |
2.7±1.02 |
Much better |
| Pain on visual scale |
7.4±1.4 |
5.7±1.1 |
Better |
| Swelling of joints (Lequesne Index) |
7.5±2.5 |
6.3±2.2 |
Lower trend |
TABLE 2: Clinical Efficacy of Rheumadol on Fibromyalgia
Number of patients (n)=19 (male=3, female=16), Mean age=45.6 years
Mean disease duration= 6.6 years
|
Conditions monitored
|
Pre-treatment
|
Post-treatment
|
Clinical evaluations
|
|
Dress yourself, including tying
shoelaces and doing buttons
|
1.6±0.6
|
1.0±0.4
|
Much better
|
|
Get in and out of bed
|
1.5±0.5
|
1.02±0.2
|
Better
|
|
Lift a full cup or glass to your mouth
|
1.3±0.5
|
0.8±0.3
|
Better
|
|
Walk outdoors on flat ground
|
1.7±0.4
|
1.0±0.3
|
Better
|
|
Wash and dry your entire body
|
1.0±0.4
|
0.0±0.0
|
Better
|
|
Bend down
|
2.01±0.9
|
1.0±0.2
|
Much better
|
|
Get in and out of a car
|
0.7±0.02
|
0.0±0.0
|
Good
|
|
Pain on visual scale
|
9.0±1.0
|
1.5±0.8
|
Extremely well
|
|
Physical impairment
|
3.03±1.0
|
1.8±0.5
|
Much better
|
|
Days felt good
|
2.5±1.3
|
5.5±1.2
|
Much better
|
|
Fatigue
|
7.8±3.5
|
2.1±0.6
|
Relieved
|
|
Feeling tired upon awakening
|
6.9±4.4
|
1.9±0.8
|
Much better
|
|
Stiffness
|
4.3±2.1
|
1.7±0.4
|
Much better
|
|
Anxiety
|
3.2±2.8
|
1.6±1.1
|
Better
|
|
Depression
|
4.8±2.4
|
2.2±1.3
|
Better
|
|
Tender points (0-18)
|
11.7±4.2
|
5.3±1.9
|
Improved
|
A close review of the previous two tables indicates that all most all the patients were benefited by taking RHEUMADOL, just for 3 weeks only. Fibromyalgic patients have shown a greater improvement of their conditions compared to the arthritic patients. This may either be due to short duration of treatment and/or due to severity of their joint pains and swelling. Notice in Table 1 that the Lequense Index showed a lowering trend, not a significant change. A longer treatment time period is expected to bring desirable change in the joints. In the mean time, however, a 3 weeks treatment has already brought a greater relief from pains and aches due to arthritis and improved daily activity of all the patients.
Most significant efficacious outcomes were obtained with the fibromyalgic patients. Their pain threshold, in terms of pain visual analog scale, was significantly improved (from 9.0±1.0 to 1.5±0.8, see Table 2). Table 2 also shows that all most all patients had a significant improvement on their energy and quality of life. As assumed that fibromyalgia may be a neurological phenomenon, all such symptoms due to this condition have significantly improved. These findings, therefore, strongly suggest that RHEUMADOL is highly efficacious in treating fibromyalgia within a short period of time.
A careful comparison of Table 1 and 2 reveals that daily activity level of fibromyalgic patients was considerably higher than the patients with arthritis. In contrast, the pain threshold, i.e. the P-VAS, was significantly higher in fibromyalgia. These observations agree well with the previously reported observations.
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