Phlogenzym in the treatment of a monoarticular painful gonarthritis
Efficacy and tolerance
Herrera E.G.
Hospital Aragon Avenida 506 entre Calle 521 y 519, Unidad San Juan de Aragon, Delegacion Gustavo A. Madero, Mexico D.F., C.P. 0792
Randomised double-blind study with parallel groups vs. diclofenac
Study Period: January 1997 - May 1997
Study No.: MU-696 416
Summary
A double-blind clinical study was performed to prove efficacy and tolerance
of Phlogenzym® for equivalence with the non-steroidal anti-inflammatory
drug diclofenac in monoarticular gonarthritis.
60 patients were planned, 59 patients with monoarticular gonarthritis
were included and randomised into two groups: 30 patients received the
enzyme preparation Phlogenzym® (enzyme group), and 29 patients diclofenac
(diclofenac group). The data of all patients was evaluable.
The principal investigator was Ernesto Garcia Herrera, M.D., Hospital
Aragon, Avenida 506 entre Calle 521 y 519, Unidad San Juan de Aragon,
Delegacion Gustavo A. Madero, Mexico D.F, C.P. 07920.
At baseline the patients were comparable with regard to age, sex, weight,
height, and symptoms (p > 0.05, Wilcoxon-Mann-Whitney-U-test).
As main endpoints for statistical evaluation the Lequesne index and
the sum score of the self-judgement (rest pain, pain on movement, restricted
movement assessed by the patients using a "visual analog scale" [Huskisson
score]) at of therapy were defined.
As secondary criteria the single self-judgements by the patients, the
result of the therapy, the motility of the knee without pain, the circumference
(cm) of the knee and the global judgements of efficacy by the physician
and by the patients were evaluated descriptively.
During monitoring visits it was noted that about 50% of the patients
did not meet the inclusion criterion "Lequesne index at baseline >
10.0". Nevertheless, it was decided to complete the study in the foregiven
period of time. The severity of the disease was therefore lower than
estimated; consequently, then the precalculated number of patients was
too low for statistical proof of equivalence.
The main endpoint "Lequesne index at end of therapy" was equivalent
in both groups: the Mann-Whitney statistics yielded a value of 0.4592
with a lower bound of the 95% confidence interval of 0.3387. As this
value is below 0.44, the equivalence could not be proven statistically.
The large range of the confidence interval verifies that the missed
significance is due to the low number of patients.
The second main endpoint, the sum score of the symptoms, showed similar
results: the groups were equivalent, but without statistical significance.
The Mann-Whitney estimator was 0.5287, with a lower bound of 0.4080,
again below the limit (0.44) for statistically proven equivalence.
The efficacy of the drug was judged in the enzyme group by the physician
as 2.2 ("good") and by the patients as 2.3 ("good" to "moderate"). In
the diclofenac group the physician judged the efficacy of the drug as
2.0 ("good") and the patients as 2.1 ("good"). The tolerance of the
drugs was judged in the enzyme group and in the diclofenac group by
the physician and by the patients as 1.6 ("very good" to "good").
Adverse events were documented in one patient in the enzyme group (gastralgia,
nausea, vomiting, headache), and in two patients in the diclofenac group
(gastralgia, nausea, vomiting, flatulence, diarrhea). They started after
10 days in the enzyme group and after 5.0 days in the diclofenac group.
The duration was 19 days in the enzyme group and on average 13.5 days
in the diclofenac group. They were judged in the enzyme and in the diclofenac
group as "moderate". They were in all patients without sequelae.
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