Research demonstrates that the Wobenzym® PS formulation is effective therapy for shoulder tendonitis.
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.]
What the literature says about Systemic Enzyme Support and:
Naturopathic treatment of rotator cuff tendinitis among Canadian postal workers: a randomized controlled trial.Szczurko O, Cooley K, Mills EJ, Zhou Q, Perri D, Seely D. Naturopathic treatment of rotator cuff tendinitis among Canadian postal workers: a randomized controlled trial. Arthritis Rheum. 2009 Aug 15;61(8):1037-45.
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.
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
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.
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
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.