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Key Words:
Enzimic-German research product
Introduction
Between 1987 and 2000, 1019 patients with
painful arthritic hips, knees, shoulders, elbows, and ankles
were treated with enzimic solutions. The mean period of
fallow-up was 48 months.
Nearly 80% had good and fair results; 20% had
poor relief from pain by the objective criteria of the
Markandeya’s performance score. 205 have required arthroplasty
at a mean of 12 months with good and satisfactory results.
The rate of success when the procedure was
performed for inflammatory arthritis, post-traumatic arthritis
and arthrosis. It is rarely indicated in the presence of
generalized inflammatory arthritis, but may be value in those
patients in whom the disease is limited primarily knees,
shoulders, and hips.
The strategy to restore the joint has revolved a basic formula
and the aim is to describe the broad principle of the
conservation of the joint with the non-surgical treatment for
the relief of pain and prolongation of the joint-life. Average
estimated cost of the procedure is around € 225 and may vary
from country to country about 10%. In a country like India it
will be around Rs.5,000 to 10,000.
J.Orthopaedics 2005;2(6)e2
Patients and Methods
Between
1987 and 1999, we treated 1019 patients joint-pain which is the
main cause for human misery, and time lost from work in terms of
sick leave. Though various surgical treatment methods are
developed in the past decades, still, none of them is very
successful in all aspects. An alternative treatment is to inject
enzyme-solutions directly in the joint-cavity which dissolve
damaged cartilage and improve lubrication between the
joint-surface, and to regenerate the cartilage. It is known as a
fact, that the capacity to repair joint-cartilage is limited. It
is presumed ulcerated cartilage is a troublesome thing, and when
degenerated it cannot be recovered. There has been acceptance of
the common and random degeneration of the joints with aging.
Belief that degeneration may be arrested, repaired, and reversed
have often been disregarded or viewed with cynicism. After all ,
if it gets bad enough, it can be replaced with a prosthetic ,
is the attitude of many surgeons.
Cartilage
defects on the articular-surface do not heal spontaneous and
generally progress to more widespread degeneration. With time,
although fibro-cartilage fills and covers the surface defects,
with temporary relief of pain, unlike hyaline cartilage, it will
resist pressure but not compression which is needed to withstand
longterm loading and shearing force and allow smooth
articulation. This is also helped by the low coefficient of
friction of hyaline cartilage.
To select a
treatment , is to remove degenerated articular-cartilage from
the articular surface and induce cartilage cell proliferation.
Regeneration of the cartilage described here with the formation
of an entirely new joint-surface, to duplicate the original
articular-surface. This has proved to some as possible, with
variable results and good prognosis.
The
treatment of arthrosis and arthritis by means of medical plants,
as described in the article by Th.Weilmayer, that was published
in the periodical “Fortschritte der. Medizin".4, discloses a
number of therapeutic approaches such as physiotherapy through
the aid of low temperatures, by means of a diet of raw
vegetables, an exclusive diet of juices or even through
biological product therapy by means of extracts from arnica,
hot pepper, camphor with essential oils and a number of
biological-pharmaceuticals such as the use of vegetable
solutions.
Enzymic
solutions were introduced 1 for the treatment of joints. It is
a solution purified from the herbs and fruits. The initial
report demonstrated with video-prints in 1992 and 1997. Apart
from the unusual appearance of the joint-space widening, the
joint-pain was disappeared and, the stiffness in the joint had
decreased within four weeks.
Table 1 : Hip joint
comparative study
|
Comparative
study after 10 injections A + B solutions and the drug
Xylocoin 1% (Blind controlled, study) |
|
No. Of persons
treated in 1994 |
A + B drug 5ml |
Xylocoin 1% 5mlml |
|
6 patients |
6 patients |
|
10 injections twice a
week |
10 injections twice a
week |
|
Duration of period
after the last injection |
6 weeks |
6 weeks |
|
Good
Fair
Poor |
4 ( 66. 6%)
1 (16,6%)
1 (16,6%) |
0
0
6 (100%) |
The effect
of Xylocoin is restricted to, only a few hours of pain relief.
After 10 moreinjections the patient showed no signs of pain
relief or improvement.
The pain
relief after the first injection with the combination of drug
A+B lasted for four days. After 10 following injections the
patients were relieved of pain and the movements in the
hip-joint improved. In 1999 two patients turned up to show their
hip-joints. The clinical results were excellent.
Table 2:
Knee-joint comparative study
|
Comparative study after
10 injections, solution (Enzimic) |
5 ml Enzimic 10
patients |
Xylocoin 1% 5 ml
10 patients |
|
Twice a week for 5
weeks |
Left knee 5, right
knee 5 |
Left knee 5, right
knee 5 |
|
Control study after 12
weeks |
Good 7 70%
Fair 1 10%
Poor 2 20%
|
0
0
0 |
|
Control study after 24
weeks |
Good 6 60%
Fair 3 30%
Poor 1 10% |
Poor 10 (100%) |
Good-normal
activity, joint free from pain for 24 months.
Fair-normal activity, free from pain but
night discomfort. Not bad enough to open surgery. Poor-severe
pain, no improvement, later open-surgery.
Number of
patients treated 1019.
Table 3:
Comparison and distribution, in different age
groups, and different joints.
|
Age group |
Hip-joint |
Knee-joint |
Shoulder-joint |
Elbow-joint |
Ankle-joint |
|
20-30 |
0 |
18 |
|
4 |
8 |
|
31-40 |
5 |
21 |
31 |
11 |
12 |
|
41-60 |
218 |
52 |
44 |
8 |
7 |
|
61-65 |
224 |
16 |
10 |
6 |
7 |
|
66-70 |
258 |
14 |
7 |
|
|
|
71-75 |
9 |
11 |
15 |
|
|
|
76-80 |
3 |
0 |
|
|
|
|
Total |
717 |
132 |
107 |
29 |
34 |
Joints treated from 1987
till 1997
Hip-joints
717
70.3%
Knee-joints 132
12.9%
Shoulder-joints 107
10.5%
Elbow joints 29
2.8%
Ankle-joints 34
3.3%
The
amount of Enzimic solution needed for one joint:
In small joints the amount can be reduced accordingly. When
less-amount was used, the rest can be applied for some other
patient. Quantity used for each joint at a time. Equal amount of
A and B enzimic mixed before injecting. Ten injections are
needed for one joint.
Enzimic
A solution:
Fruct. Symphoricapi, Herb. Euphorbiae,Gold tetrachlorric.
Enzimic B solution:
Arnica D2, calendula, chamomilla, symphytum, millefolium,
belladonna, aconitum, bellis perennis, hypericum, echinacea,
herpar sulfuris.
Table 4
|
From 1987 to 1999.
|
Hip joints 4- 5 ml |
Knee joints
3-4 ml |
Shoulder joints 3 ml |
Elbow joints 2 ml |
Ankle joints 2 ml |
Total number of patients
1019
Mean values, for function,
without pain, and range of movement for each group at each
fallow-up intervals according Adusumalli
Table- 5:
( Hip-Knee- shoulder- and other joints )
Results after
12 months 24 months 36 months
48 months
Hip joints treatment
Good .
555
466 65
Fair . 83
10
4
Poor . 79
84
34
Control number (717)
(560) (104)
Knee joints
Good
112
31
38
Fair 18
11
8
Poor 2
33
16
Control number (132)
(75)
(66)
Shoulder joint
Good
87
63 64
Fair 15
13 12
Poor 5
13 6
Control number (107) (89)
(82)
Results -
12
months. 48 months
Good
56.3% ----20.8%
41.7%---33.3%
Fair 12.5% -----37.7%
16.6% ---22.2%
Poor 37.2% ----41.7%
41.7% ---44.5%
Control number 29 34
13 16
Controlled study of Enzimic
solution in four different ways (Stability study)
Stability of the drug after
mixing A+B solution and kept at room-temperature 20o C for 12
months and 36 months.(after mixing) the solution, is named
Enzimic).
Table 6
|
Time period 1996-97 |
A+B sol. |
Enzimic |
Enzimic |
Enzimic |
|
Solution used |
A+B separately injected |
A+B injected after
mixing |
A+B mixed,stored 12
months
Injected. |
A+B mixed,stored 36
months
Injected. |
|
No:persons treated |
6 |
6 |
6 |
6 |
|
after six weeks
Good
Fair
Poor |
5 (83.3%
1 (16.6%
0 |
6 (100%)
0
0 |
6 (100%)
0
0 |
6 (100%)
0
0 |
|
after six months
Good
Fair
Poor |
5 (83.3%)
1 (16.6%) |
6 (100%)
0 |
6 (100%)
0 |
6 (100%)
0 |
Comments :
Not much
difference was observed between the three combinations, except
injecting one after another.
The
treatment can be carried out with one injection, instead of
mixing before injecting. It saves time, and reduces the
production cost.
Three
individual orthopedic surgeons have carried-out, the above
treatment independently for the stability and effectiveness of
the solution.
Figure : 1 Fig 1 a
Fig 1 b
67 year old
women with osteoarthritis of the right hip-joint. a)Before
treatment a dye was injected to show the degenerated cartilage.
b) after 10 injections the joint was cleaned, after 24 months.
The patient is free from pain and free movements in the joint.
Figure:2 fig 2 a
Fig 2 b
69 year
old woman osteoarthritis of the left knee a) Before the
treatment- an anteroposterior plain vidio showing extensive loss
of cartilage tissue b) after 36 months. The patient was free
from pain and able to do her house work. Cartilage tissue
regenerated.
Cost of the
drug ,when manufactured in that country 2004 for the treatment
of one joint ( Hip or Knee)
Table 7:
Cost of the drug to treat one joint 10
injections. 2003
|
East Europian |
US |
GB |
France |
Germany
|
India |
|
€ 110. |
$ 365.00
|
€ 140. |
€ 250. |
€ 250. |
Rs 5,000 |
Discussion:
According
to WHO ( 2003) nearly 5 to 10% of the population need
joint-treatment. In India over 50 million people. The cost of
endoprosthetic replacement in India is around Rs.150,000, where
as enzimic treatment Rs. 10,000 for one patient.
There is
still uncertainty as to choose initial–arthroplasty or to try
non-surgical treatment. At present, there is little to chose
between the two. In our series the rate of success of 80 to 82%
even after 4 years.(Table 5) The aforementioned treatment has
one common denominator, for the joints. The aim is to decrease
the joint pressure sufficiently by removing the damaged,
degenerated tissues and widening the joint space. With that, the
joint-cartilage may regenerate to some extent and pain
disappears.( Fig. 1,Fig 2 )
It is
important to stress that not all the commercially available
joint-replacement will satisfy all the patients with the
joint-pain. Enzimic inter-articular treatment was found to be
very effective alternative means of providing relief of pain due
to joint diseases, like osteoarthritis, rheumatoid-arthritis,
and arthroses. The success of Enzimic therapy is in achieving
prolonged pain-free joint for the patient, more than 4 years in
average after the initial course, and the patients showed 80 to
82% (Table 5 )free from pain in hip-, knee-, and
shoulder-joints. Of these patients changes the pattern of work
in an Orthopedic and surgical units considerably, while patients
admitted in joint-replacement operation might otherwise have
occupied a bed for average 3-4 weeks, now they occupy no bed,
the workload and economic aspects enormously decrease.
Demands on
the physio-therapy are also changed with decrease in the need
for inpatient physiotherapy and a corresponding drop in
out-patient requirements.
My series
had encompassed the most difficult patients; the active, elderly
and young. Perhaps the most far-reaching effect of Enzimic
treatment on the general practice, is the pattern of referable.
It appears from clinical evidence that it may be safely injected
in the joint. It is unquestionable benefit when used for
joint-disease. There is enough satisfactory evidence from this
intra-articular treatment, which can reduce the cost of joint
replacement as an economical aspect, and at the same time
improves the condition of the joint to the patient’s
satisfaction. The risk of loosening or infection does not exist.
We have demonstrated that Enzimic inter-articular treatment can
achieve results comparable to those of conventional
joint-replacement in terms of pain relief, walking, function,
and range of motion. Further, their own stability and
practically no risk of sepsis.
It was
noteworthy that the improvement in the joint was mostly due to
cartilage regeneration in the joint ( Fig 1,and Fig 3). It is
important in terms of function without pain. In terms of
radiological analysis there appears to be enlarged joint-cavity
with considerable improvement in the joint and stability.
The future
role of non-surgical treatment is a subject of debate and
contravention. The present indication, instead total joint
replacement to restore the joint as far as possible, a life
saving of the joint. In time, it is to be hoped that many
doctors with an interest of joint restoration will adopt the use
of an Enzimic treatment. It may well be that the non-surgical
treatment will prove to have the same effect on surgery. There
is no doubt that the intra-articular treatment of joints with
enzimie will bring a change in the position of joint surgery,
only time will confirm what that change will be.
The author
wishes to thank WHO,at Geneva for their help with the
statistical data regarding health around the world.
No benefits
in any form have been received or will be received from a
commercial party related directly or indirectly to the subject
of this article.
References:
1.Adusumalli
C.,Hip joint restoration (Non surgical treatment of joint).I
Journal of Orthopaedics 2002,36-4, 274-5
2. Akamatsu Y, Koshipo T, Saito T, Wada
J. Changes in osteosclerosis of osteoarthritic knee after high
tibial osteotomy. Clin Orthop 1997; 334:207-14
3. Buckwalter JA, Mankin HJ. Articular
cartilage:part 1. Tissue design and chondrocytematrix
interactions. Part 11. Degeneration and osteoarthrosis repair
and regeneration and transplantation J Bone Joint Surg(Am) 1997;
79-A:600-32
4. Briggs AH,etc.Pulling
cost-effectiveness analysis up by its bootstraps:a non
parametric approach to confidence interval estimation. Health
Econ 1997;6:327-40
5. Briggs AH, Sculpher MJ. Sensitivity
analysis in economic evaluation: a review of published study
.Health econ 1995;4:355-71
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