Tendonitis
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Research demonstrates that the
Wobenzym®
PS formulation is effective therapy for shoulder
tendonitis. |
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The efficacy of the formulation is due to increased
clearance of excessive cytokines. The inflammation in
tendinitis it mediated by cytokines, including elevated
levels of TGF-beta.
[Fu SC, Wang W, Pau HM, Wong YP, Chan KM, Rolf CG. Clin
Orthop Relat Res. 2002 Jul;(400):174-83.] |
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What the literature says about Systemic Enzyme Support and:
Naturopathic treatment of rotator cuff tendinitis among Canadian
postal workers: a randomized controlled trial.
Canadian College of Naturopathic Medicine, Toronto, Ontario, Canada.
Objective: To explore the effectiveness of naturopathic care (NC) on rotator cuff tendinitis using a prospective randomized clinical trial design.
Methods:
Canadian postal workers with rotator cuff tendinitis for a duration
of >6 weeks were randomized to receive NC (n = 43) or standardized
physical exercises (PEs; n = 42) over 12 weeks. Participants in the
NC group received dietary counseling, acupuncture, and Phlogenzym (2
tablets 3 times/day). The PE intervention group received passive,
active-assisted, and active range of motion exercises and matched
placebo. The primary outcome measure was the Shoulder Pain and
Disability Index (SPADI), and secondary outcomes were the pain
visual analog scale (VAS), Short Form 36 (SF-36), Measure Yourself
Medical Outcomes Profile (MYMOP), and shoulder maximal range of
motion. Participants and assessors were blinded to group and placebo
allocation.
Results: Seventy-seven
participants (87%) completed >or=8 weeks of the trial. Final total
SPADI scores decreased by 54.5% (P < 0.0001) in the NC group and by
18% (P = 0.0241) in the PE group. Between-group differences in
changes to SPADI scores showed statistically significant decreases
in shoulder pain and disability in the NC group compared with the PE
group (P < 0.0001). Significant differences between groups were also
observed in the pain VAS, MYMOP, SF-36, and shoulder extension,
flexion, and abduction, with the NC group showing superiority in
each outcome. No serious adverse reactions were observed.
Conclusion: NC and PE
provided significant improvements, with greater improvement in
shoulder function in the NC group compared with the PE group.
Statistically significant improvements in quality of life measures
were observed in the NC
group as compared with the PE group.
PubMed:
19644905
Phlogenzym® in the Treatment of Periarthritis
Humeroscapularis Tendopathica.
(MU-695419). Efficacy and Tolerance.Study No.: MU-695419. Randomised
double-blind study phase III with parallel groups vs. diclofenac
according to the guidelines of good clinical practice (GCP).
Integrated biometric-medical final report according to ICH E3
guidelines. Primary Investigator: Prim. Univ.-Prof. Gert Klein, M.D.
Rehabilitation Center for Rheumatic Diseases and Diseases of
the Cardiovascular Systém, Thorerstrasse 26, A-5760 Saalfelden,
Austria. Evaluation by: MUCOS Pharma GmbH & Co, Clinical Research
Dpt., Malvenweg 2, , D-82538 Geretsried. Report by: PharmaScript,
Primelweg 2, D-82538 Geretsried
Summary
This double-blind clinical trial could demonstrate that the
therapy of a periarthritis humeroscapularis tendopathica with the
proteolytic enzyme preparation Phlogenzym® is at least as successful
as with the non-steroidal antiinflammatory drug diclofenac. An even
moderate superiority of the enzymes was calculated by the
Mann-Whitney statistics.
40 patients with periarthritis were taken into this trial and
randomised into two groups. 20 patients received the enzymes (enzyme
group) and 20 patients diclofenac (diclofenac group). The data of
all patients was evaluable.
The principal investigator was Prof. Gert Klein, M.D.,
rehabilitation center of rheumatic diseases and diseases of the
cardiovascular system, Ludwig Boltzmann-Institut, Thorerstrasse 26,
A5760 Saalfelden, Austria.
As the study had to be performed in a "double-dummy" design,
all patients received 2 tablets t.i.d. (i.e. 6 tablets per day) of
"enzyme tablets" and 1 capsule b.i.d. (i.e. 2 capsules per day) of "antirheumatic
agent". Thus, the patients took either 6 tablets of active
Phlogenzym® or 100 mg diclofenac for 3 weeks, depending on the
group.
At baseline the patients were comparable with regard to age,
sex, weight, height, and the symptoms (p > 0.05, Wilcoxon-Mann-Whitney-U-test).
As main endpoint for statistical evaluation the sumscore of
the various kinds of pain and dysfunction was defined. As secondary
criteria the various kinds of pain, the restricted movement, the
amount of analgesic drugs taken and the global judgements by the
physician and the patients were evaluated descriptively.
Both the main endpoint (sum score) and the secondary criteria
showed statistical equivalence. The Mann-Whitney statistics for the
main endpoint has even proven a "moderate" superiority of the
enzymes: MW statistics = 0.6405, 90% Cl 0.4675 - 0.8136.
The various kinds of pain and the sum score showed also a
better improvement in the patients of the enzyme group than of the
diclofenac group.
The global judgement of the efficacy of the drug by the
physician in the enzyme group was 1.4 ("very good" to "good") and by
the patients 1.5 ("very good" to "good"). In the diclofenac group
the physician judged the efficacy of the drug as 1.7 ("very good" to
"good") and the patients as 1.9 ("good"). The
differences between the groups were not significant (p > 0.05).
The tolerance of the drugs was judged by the physician in the
enzyme group and in the placebo group as
1.2 ("very good") and by the patients as 1.3 ("very good" to
"good"). There were no significant differences between the groups (p
> 0.05).
Adverse events were documented in three patients in the
enzyme group (nausea and vomiting, exanthema of the face, allergic
exanthema of both upper arms) and in two patients in the diclofenac
group (exanthema of the diclofenac group (exanthema of the face).
They started on average after 2.7 days in the enzyme group and after
9.0 days in the diclofenac group. The duration was on average 4.3
days in the enzyme group and 4.0 days in the diclofenac group. They
were judged as "mild" to "moderate". In the enzyme group two
patients were without sequelae and one patient had moderate sequelae
and was in need of ambulatory treatment and in the diclofenac group
both patients remained without sequelae. In all cases the patient's
outcome was without damage. The frequency of adverse events did not
differ significantly (p = 1.000).
Treatment with oral enzymes in painful osteoarthritis of the knee
and periarthritis of the shoulder
Kullich W.*, Klein G.**. Treatment with oral enzymes in painful
osteoarthritis of the knee and periarthritis of the shoulder.
Reumatologia 1998, Suppl Vol. XXXVI, Warsaw 1998, Lectures No. 213,
pp 111-114. ISSN 0034-6233. 619 KA (19-09-2)
* Ludwig Boltzmann Institute for Rehabilitation of Internal
Diseases, Saalfelden, Austria. ** Rehabilitation Centre for
Rheumatic and Cardiovascular Diseases, Saalfelden, Austria. 2nd
Central European Congress of Rheumatology, 13-16 May, 1998, Warsaw,
Poland
40 patients with periarthropathia tendopathica simplex, aged between
38 and 68 years, were observed. The patients took double-blind
randomized the non-steroidal antiinflammatory drug diclofenac in a
dosage of 2 x 50 mg daily or oral enzymes (Phlogenzym®;
Mucos Pharma GesmbH., Germany) in a dosage of 3 x 2 enteric coated
tablets daily, consisting of 90 mg bromelain, 48 mg trypsin and 100
mg of the flavonoid rutosid which normalizes pathologically
increased vessel permeability without inhibiting the endogenous
defensive power.
The randomization resulted in a patients' group with enzyme
treatment of 12 men and 8 women with an average age of 54.5 years
and a group with diclofenac treatment of 12 men and 8 women with an
average age of 51.9 years.
Examinations were made at the beginning and after 1, 2 and 3 weeks
of therapy.
For judgement of efficacy, a sum score of four different types of
pain (pain on rest, pain on motion, pain on pressure, night pain)
and functional impairment was compared.
In our second study 73 patients (36 male, 37 female; 52,0 + 9,1
years of age) with symptomatic OA of the knee and radiographic
evidence of joint space narrowing and osteophyte were recruited. A
patients sum score of the Lequesne's index > 10 was demanded.
The study was performed double-blind randomized with a three weeks
medication.
Due to the "double blind" method, 37 patients were treated with 50
mg diclofenac sodium 3 times daily.
(TID) during the first week, followed by a dosage of 50 mg
diclofenac sodium twice a day (BID) during week 2 and 3, in order to
improve the gastroduodenal tolerance. Those patients additionally
got "enzyme placebo" tablets. 36 patients were treated with 2 enzyme
tablets TID during the whole period. These tablets were an enteric
coated enzyme preparation as mentioned in the former presented study
of . The "double blind" method required an additional application of
"diclofenac placebo" in this group. In both groups the therapy was
continued with 2 enzyme tablets TID during the weeks 4-7.