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 Phlogenzym^® in activated, inflammatory - degenerative spinal and joint diseases, fibromyalgias and other rheumatic soft - tissue diseases.

 A reference - controlled, multicentric, retrospective analysis of therapeutical data Summary and comments on the project
Hanisch J. Phlogenzym^® in activated, inflammatory - degenerative spinal and joint diseases, fibromyalgias and other rheumatic soft - tissue diseases. A reference - controlled, multicentric, retrospective analysis of therapeutical data Summary and comments on the project. IFAG Basel, November 1995 

 Results of the total sample analysis
- Data acquisition
Under observance of the guidelines laid down in the study protocol N = 379 physicians could be won for the study who made a total of N = 3028 analyzable case report forms available.
- Data collection and validation
N = 3028 plausible data sets (100%) were analyzed in the study, with N = 2137 (70.6%) making up the Phlogenzym - group and N = 891 (29.4%) being assigned to the NSAIDs group.
- Description of the physician - sample
The age distribution of the participating physicians largely corresponds to the respective demographic distribution in the western part of Germany, with the exception of a slightly increased representation of the age groups 30-41 years and 50-76 years and a somewhat lower representation of the 42-49 year olds. The participating physicians' gender and their distribution regarding the size of their respective home communities correspond to the demographic distribution in the western part of Germany.
While, regarding the states the participating physicians come from, Hessen and Bayern show an above average representation, NRW and Berlin are represented below the German average; the Saarland is not represented at all. However, these deviations do not have any real influence on the results. Among the participating physicians 71.6% were general practitioners and 28.4% were specialized either in internal medicine or in orthopedic surgery.
- Description of the patient - sample
A total of N = 3028 (100%) patients aged between 11 and 80 was included into the study with 56.4% of them being female and 43.6% being male.
In alteration of the study protocol, N = 13 patients (0.4%) were aged 11 - 17. Though generally all job groups were represented, the major part of the patients were employees/public servants (36.4%), workers/craftsmen (19.9%), pensioners (18.7%) and housewives (17.7%).
- Homogeneity of the sample
The Phlogenzym^® monotherapy and "Phlogenzym^® + NSAIDs" therapy was combined to one "Phlogenzym - group" and all therapy regimes with individual NSAIDs (mainly with diclofenac) were assigned to one "NSAIDs -group".
The diagnosis groups "fibromyalgias" and other "soft tissue rheumatic diseases" were merged into one group "rheumatic soft tissue diseases".
The therapy groups "Phlogenzym" and "NSAIDs" were comparable regarding their baseline values and therefore could be comparably assessed (hypotheses tests).

 In point of the duration of therapy, Phlogenzym^® was demonstrated to be clearly inferior to NSAIDs, i.e. a therapy with Phlogenzym^® needed more time to reach the documented results. (Effect size of inferiority minor to moderate).
   Example: While treating rheumatic soft tissue diseases with Phlogenzym^® took a median of 23 days, it took only   16 days with NSAIDs.

According to the results of this reference - controlled, multicentric, retrospective analysis of therapeutical data Phlogenzym^® turned out to be more effective than NSAIDs in the treatment of activated, inflammatory - degenerative spinal and joint diseases, fibromyalgias and other rheumatic soft tissue diseases (effect size "minor"). A therapy with Phlogenzym^® also showed to be accompanied with much less side effects than a therapy with NSAIDs was (effect size "major").
  E.g.: While treating the above diseases with Phlogenzym^® resulted in 2.8% - 7.7% of side effects, a treatment with NSAIDs caused in 27.4% - 42.3% unwanted drug reactions.
These advantages of Phlogenzym^® in efficacy and safety however have to be paid for by a distinctively longer duration of treatment (median difference 7-27 days)