Study of the Safety of PM Joint Rescue for cases of Arthritis: a randomized, double-blinded, placebo-controlled trial
Breeana K. Saffell, Steven R. Frank, Mark J. McNamara, Rosia Warner, and Gary B. Clark, MD
Abstract
Background: Arthritis results in severe pain and inflammation in the affected joints and can be incredibly painful and disabling. The standard treatments involve anti-inflammatory agents to reduce the symptoms, but the condition is generally not reversible.
Methods: Subjects were randomly chosen to use either the test or the placebo for two weeks while their daily symptoms were assessed. The assessment phase was compared to baseline and return to baseline phases.
Results: Two test subjects reported side effects during the first week of assessment. The placebo group had 3 subjects that reported side effects during the first week of assessment and 1 subject continued to have side effects through the second week of assessment.
Conclusions: Peaceful Mountain Joint Rescue was found to be a safe topical therapy when used for 2 weeks.
Background
More than 40 million Americans suffer from inflammation of one or more joints1. This disease is known collectively as arthritis. Arthritis is associated with inflammation and degeneration of the joints and surrounding connective tissue. Symptoms include pain, swelling, and stiffness of the affected joint, and the discomfort can range from a dull ache to a crippling pain1, 2. Osteoarthritis, the most common form of the disease, is responsible for nearly half of the reported cases of arthritis and results from degeneration of cartilage due to wear and tear and ligament laxity. Rheumatoid arthritis, an extremely crippling form of the disease, accounts for 2.1 million of the reported arthritis cases and is associated with an autoimmune inflammation of the joint synovium1.
The standard of medical care for arthritis ranges from prescribing analgesics to anti-inflammatory agents1, 3. At the one end of the spectrum, analgesics such as acetaminophen may address the pain symptoms with minimal side effects4. However, acetaminophen has potential deleterious side effects4. At the other end of the spectrum are nonsteroidal and steroidal anti-inflammatory drugs (NSAIDS) and immune system suppressors, which address the cause of the disease3. The latter medications are generally more expensive and must be monitored closely to prevent very common and serious side effects. Clearly a more benign and efficacious treatment would be beneficial, especially for the more common and less complicated osteoarthritis cases.
The following is a protocol for testing the safety of Peaceful Mountain Joint Rescue, an herbal gel that is administered topically. This gel contains herbal based agents with analgesic, anti-inflammatory, antiviral, and regenerative properties.
Methods
Participants were recruited from local advertisements such as flyers and newspapers. Study visits were held at the Klearsen Corporation Clinical Research Department. Subjects were required to have a physician's diagnosis of arthritis, to be currently experiencing symptoms, and to be at least 18 years of age. The types of arthritis that was viewed in this study were osteoarthritis, rheumatoid arthritis, and one case of crohn's arthritis.
Following a comprehensive screening questionnaire and upon consented enrollment, subjects were randomly assigned to the placebo or the test groups. At the first clinic visit, each subject completed a side effect survey and was sent home with side effect surveys to complete daily. The subjects were required to attend weekly visits at the clinic. These weekly visits consisted of a verbal interview, the completion of a weekly side effect survey, and the weight assessment of the tube of gel. At the second visit, the subjects completed a survey and were given a tube of the gel that was randomly assigned to them. The subjects were instructed to liberally apply the gel to the affected joint 3 times daily. At the fourth visit, the subjects were instructed to discontinue use of the gel and to continue completing daily surveys for the final week. At the fifth and final visit, subjects completed a final weekly side effect survey and were told whether they had been given the placebo or the test.
Results
Variable
Test (n=11)
Placebo (n=11)
Age in years (± standard deviation)
58 (±15)
49 <±18)
Period of symptoms in years-median (range)
7 (2-17)
5 (1-40)
No. of women (%)
9 (81)
6 (55)
Type
Chron's - No. (%)
0 (0)
1 (9)
Osteoarthritis - No. (%)
6 (55)
6 (55)
Rheumatoid - No. (%)
0 (0)
1 (9)
Unknown - No. (%)
5 (45)
3 (27)
Location
Hands/wrists - No. (%)
5 (45)
6 (55)
Feet - No. (%)
1 (9)
0 (0)
Neck/back - No. (%)
2 (18)
2 (18)
Knees - No. (%)
1 (9)
3 (27)
Hips - No. (%)
2 (18)
0 (0)
Table 1 Baseline characteristics of participants. Values are averages unless otherwise stated.
Outcome
Week 1
Two test subjects reported side effects during the first week of assessment. One subject stated that the gel burned the cuts where the gel was applied. Another subject reported increased stiffness in the joints being treated. Three placebo subjects reported side effects. Each subject reported a different side effect including dry mouth, increased pain in the joints where the gel was applied, and a warming sensation in the area where the gel was applied.
Week 2
Only 1 placebo subject reported side effects during the second week of assessment. The subject continued to have the warming sensation where the gel was applied through both assessment weeks. All side effects stopped when application was discontinued.
The number of side effects in the test and placebo group and each week they were experienced.
Side Effect
Number of Subjects Experienced
Week Experienced
Test
Burning of Cuts
1
Week 1
Increased Stiffness
1
Week 1
Placebo
More acute pain
1
Week 1
Dry mouth
1
Week 1
Warming sensation
1
Week 1 and 2
Table 2 The type of side effect experienced and the number of subjects that experienced it.
Discussion
Common treatments for arthritis can have severe side effects. NSAIDs can cause gastrointestinal bleeding, destruction of renal and hepatic function, and dyspepsia8. During the two week assessment period for Peaceful Mountain Joint Rescue there were only two subjects that reported side effects suggesting that the gel is safe when used for a short period of time. Three placebo subjects reported side effects in the first week of assessment and one subject continued to experience side effects through assessment week 2. These results suggest that the test gel was as safe if not safer than the placebo gel.References
- Arthritis Pain. http://www.arthritis-symptom.com/arthritis-pain/pain.g\htm
- Loeser, Richard F., Najia Shakoor, N. (2003). Aging or osteoarthritis: Which is the problem? Rheumatic Disease Clinics Of North America. 29, 653-673.
- Raffa, Robert B., (2003). Mechanism of action of analgesics used to treat osteoarthritis pain. Rheumatic Disease Clinics Of North America. 29, 733-745.
- Goldkind, L., and Simon, L. S. Patients, their doctors, nonsteroidal anti-inflammatory drugs and the perception of risk. Arthritis Research and Therapy. 8(2), 1-4.
- Cibere, J., Deng, Z., Lin, Y, Ou, R., He, Y., Wang, Z, Thorne, A., Lehman, Allen J., Tsang, Ian K., &Esdaile, John M. (2003). A randomized double blind, placebo controlled trial of topical tripterygium wilfordii in rheumatoid arthritis: reanalysis using logistic regression analysis. Journal of Rheumatology. 30(3), 465-7.
- Deal, Chad L., Schnitzer, Thomas J., Lipstein, E., Seibold, James R., Stevens, Randall M., Levy, Moise D., Albert, D., & Renolds, F. (1991). Treatment of arthritis with topical capsaicin: a double-blind trial. Clinical Therapeutics. 13(3), 383-95.
- Galeazzi, M., Marcolongo, R. (1993). A placebo-controlled study of the efficacy and tolerability of a nonsteroidal anti-inflammatory drug, DHEP plaster, in inflammatory peri- and extra-articular rheumatological diseases. Drugs Under Experimental and Clinical Research. 19(3), 111-9.
- McCarthy, Geraldine M., McCarty, Daniel J. (1992). Effect of topical capsaicin in the therapy of painful osteoarthritis of the hands. The Journal of Rheumatology. 19(4), 604-7.
- O’Duffy, E. k., Clunie, G. P. R., Lui, D., Edwards, J. C. W., Ell, P. J. (1999). Double blind glucocorticoid controlled trial of samarium-153 particulate hydroxyapatite radiation synovectomy for chronic knee synovitis. Annals of the Rheumatic Diseases. 58, 554-8.