Naturopathic Enzyme Therapy for Back Pain(Dr. Frank Düren (Orthopaedic surgeon), MEF e.V. 2014)

1. INTRODUCTION

Back pain is one of the most common health com-plaints. According to comprehensive surveys, 80% of Germans complain about back pain at least once a year. Nine out of ten patients con-cerned suffer from „unspecific back pain“ (Ras-pe, 2012). Experts describe such pain as unspeci-fic because they think of „soft motion elements“.It is surprising that the pathophysiology of unspecific back pain is still understudied. Since the patient complains about pain, the phy-sician treats him “according to the guidelines” (Clinical Guideline, 2010) by giving him analge-sics/NSAR. However, based on the motion seg-ment according to Junghanns, it makes more sense to start with tendons, ligaments, muscula-ture and also the autonomic nervous system in or-der to achieve integral treatment (Heine, 2007).Recently, conventional medicine has been follo-wing the concept of „multimodal pain treatment“, consisting of a medical, psycho and physiothera-peutic component. There are also new findings regarding the pathogenesis of chronic back pain: Firstly, increased serum levels can be measured by cytokines with a proinflammatory effect (Wang and Schiltenwolf, 2010). Secondly, the neurobio-logy of muscle pain shows a sensitisation of the “muscle nociceptor” by an increased producti-on of substance P (SP) and other vessel-dilating substances such as bradykinin (Mense, 2006).

Additionally, NO (nitrogen monoxide) activates nerve cells in the posterior horn area, so that an increased number of pain signals are directed into the brain. Apparently, that is caused by an increased level of oxidative and nitrosative stress which induces a chronic inflammation (here: neurogenic inflam-mation) with the cytokine patterns described abo-ve as well as an increased production and storage of SP and bradykinin (Black, 2002; Kersten,2009).These assumptions suggest applying the regulato-ry effective enzyme therapy. Older review articles (Miehlke and Inderst, 2004; Inderst, 1995), show that the application of regulatory effective proteases such as bromelain results in an astounding effect for all kinds of rheumatic pain. Moreover, comparative

studies with diclofenac vs. an enzyme combination product as well as cohort studies with more than 3,000 participants show an equivalency to NSAR when it comes to back pain with proteases being superior to NSAR regarding unwanted side effects. (Wittenborg et al., 2000; Klein and Kullich, 1999). Since the presence of enzymes such as brome-lain cause proinflammatory cytokines to be di-sposed of faster by Alpha 2 microglobulin and since also SP as well as bradykinin can be enzy-matically split, the result is an obvious longer-las-ting effect (Lauer et al., 200; Gaspani et al., 2002).Additional to regulatory effective enzymes, also other vital substances such as vitamins, bioflavon-oids and mineral nutrients help to relieve back pain. (Niestroj, 2000). Vitamins of the B complex reduce nitrosative stress and have an analgesic effect. Ascor-bic acid does not only have an antioxidant effect, it also influences regular collagen production. Seleni-um, vitamin E and bioflavonoids increase antioxidant capacity; zinc supports the formation and reformati-on of the extracellular matrix which is communica-ted through zincic enzymes produced naturally in the body. Not least does magnesium prevent mu-scle cramps and is also important in stress research. The question if a combination of proteases and such vital substances (innovazym®) constitutes an ideal tre-atment of patients suffering from unspecific back pain is the subject-matter of this placebo-controlled study. In order to find out about the impediments caused by back pain it was important to use a practicable but scientifically approved questi-onnaire. That was achieved by using the „Os-westry Disability Index“ (Mannion et al., 2006).

This excellent overall value results from verifiable, partly statistically significant improvements of the following individual parameters: pain, sitting, standing, lifting, traveling, personal hygiene, social and sexual life.

2. MATERIAL AND METHODS

The study group comprised 45 participants with complaints based on unspecific back pain. Using the internationally established Oswestry questionnaire, we determined the level of movement restrictions and what that means for the everyday life of the par-ticipants. Here, we collected a number of data, e.g. pain while walking, standing, lifting and sitting or restrictions when traveling, sleeping, etc. All partici-pants found themselves in a comparable situation.

Additionally, the participants completed the WHO-5 questionnaire about quality of life. The participants were asked to make no changes to their current dose

3. RESULTS

OSWESTRY QUESTIONNAIREThe many individual results have been summarised in the overall result „Oswestry Level of Restriction“.The Innovazym® group showed significantly better results than the placebo group.

Overall level of restriction:In the innovazym® group, restrictions in daily life caused by back pain could be reduced by a signifi-cant 23% (p<0.05) within 4 weeks. This is shown by the fact that the overall level of restriction decreased. The placebo group showed a change for the worse. The movement restrictions increased by 12%.(Figure 1)

rate of analgesics or other treatment habits. Then, the group was divided at random: 24 people were gi-ven innovazym® by the company Innova Vital GmbH and 21 people were given placebo pills (free of ac-tive agents) filled with cellulose. After taking 6 pills a day (sober) over a four-week period, the partici-pants completed the Oswestry questionnaire about movement restrictions as well as the WHO-5 questi-onnaire about quality of life a second time.

The data of 34 participants could be evaluated (18 participants Verum, 16 participants placebo group).

Improvement by 23%

Deterioration by 12%

Figure 1

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AGAIN AS AN EXAMPLE FROM TWO INDIVIDAUL RESULTS:

Problems with standing:The excellent overall result goes along with a signi-ficant change for the better when it comes to stan-ding. The level of restriction decreased by 23% in the enzyme group while it increased by 26% in the placebo group (Fig. 2).

Figure 2

Sleeping:Taking innovazym® evidently results in better sleep. In the enzyme group sleeping problems decreased by 23% while they stayed the same in the placebo group (Fig. 3).

Figure 3

Figure 4WHO-5-QUESTIONNAIRE ABOUT QUALITY OF LIFE

Overall score:Well-being (mood, relaxation, ac-tivity, interesting everyday life) in-creased by a considerable 13.11% in the innovazym® group. The impro-vement in the placebo group (8.5%) is insignificant (Fig. 4).

Improvement by 23 %

Deterioration by 26 %

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WHO-5-QUESTIONNAIRE ABOUT QUALITY OF LIFE

Depression:A raw value below 13 points or a rating of 0 or 1 at one of the 5 WHO values can be interpreted as an indicator for depression and should be followed by a corresponding medical examination. At the begin-ning of the investigation, 77.8% of the innovazym® group (n=18) showed indicators for depression;After 4 weeks of enzyme treatment the percentage went down to 33.3. In the placebo group, 81.2% of the participants (n=16) showed indicators for depression in the beginning. After 4 weeks, the percentage was 56.25.

The number of participants suffering from depressi-on in the innovazym® decreased by 44.5% whereas it only decreased by 24.9% (Fig. 5) in the placebo group.

4. DISCUSSION

This is the first controlled study with German partici-pants that multicentrally compares innovazym® with placebo under practical conditions over a period of 4 weeks. It included 45 patients with unspecific back pain (URS) mostly lasting from 2 months to more than one year who either took Verum or a placebo similar in size, form and colour over a 4 week period in a dose rate of 6 pills/day.At the beginning, the participants of the Verum and the placebo collective showed no significant differences with regards to age, gender, previous treatments (mostly physiotherapy/physical) and the current severity of pain. Additional problems such as fatigue, inactivity, nausea, insomnia were equally common among both groups. URS distinguishes between an acute and a chronic phase: During the acute phase, which often lasts only a week, simple analgesics such as paracetamol or NSAR type diclofenac are recommended in accor-dance with the guideline due to heavy back pain. During the chronic phase, when the complaints last longer than 3-6 months, the multimodal treatment concept is preferred since at that point changes in social life start to increase (withdrawal from social life) and the quality of life starts to decrease.

Since the cohort observed can largely be attri-buted to the chronic phase, the focus was on the parameters regarding quality of life. Therefore, we not only used the established questionnaire “WHO-5 Wellbeing Index” (Spengler A et al., 2013) but also the Oswestry questionnaire. This test requires a self-assessment by the patient and then calculates the perceived impairment from it. 10 items with 6 response possibilities are given: pain intensity, personal hygiene, everyday activities, especially questions about sexual life, social activi-ties and travel possibilities. Score values from 0 to 5 are given; the higher the number the higher the impairment. Every participant can reach a maximum of 50 points. The level of impairment is calculated from the proportional value of the reached points compared to the maximally possible points. 0-20 % corresponds to a minimal level of impair-ment (B); 20-40% medium; 40-60 intense and higher percentages correspond to disablement.

In the Verum group, B. (%) was at 23.04 % in the beginning, and at 28.5 % (n.s.) in the placebo collective. This corresponds to medium impairment in both groups. At the end of the study, the values in the Verum group were at 17.73% and at 31.01% in

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5. SUMMARY

This placebo-controlled study showed that the administration of a dietetic product with natural ingredients (innovazym®) is able to significantly improve impairments in everyday life based on back pain. Partly considerable improvement could be achieved when it comes to sitting, standing, lifting, travelling, personal hygiene, in social and sexual life and the quality of life. Pain could be relieved considerably as well. Thereby, a scientific study has confirmed the positive results that have been known from practice: innovazym® offers an effective, natural possibility to treat back or movement pain.

Dr. Frank Düren Dr. Ina Viebahn Dr. Rudolf Inderst

On behalf of

MEF e.V.Medizinischen Enzymforschungsgesellschaft

Mitterbachweg 483224 Grassauwww.enzymforschungsgesellschaft.de

the placebo group. This is a significant improvement among the Verum collective (beginning/end) as well as compared to the placebo group. A similar improvement could be found regarding the sexual life, better travel possibilities and a plea-sant social life. This result was confirmed by the WHO-5 questionnaire, e.g. at the item „Indicators for depression“ in %: Here, the initial value for Verum was 77.8% and the end value was 33.3%. For placebo, the initial values were at 81.2% (n.s.) and the end value was 56.25%. Consequently, the results of Verum were much better than those of the placebo.

A great part of scientific literature deals with multimodal treatment of back pain (an overview can be found with Kini B and Schiltenwolf M, 2009), but there is not much uabout naturopathic therapy for chronic back pain (overview Chrubasik S, 2014). A dissertation now compares conservative ortho-paedic with stationary naturopathic therapy on 150 patients with nearly identical criteria for inclusion (Wikening, 2011). It shows that there is no difference between the two types of therapy (5 classic methods are used – phytopharmaceuticals included). An explanation for the astounding effect of Verum can be the long-lasting influence on the cytokine net described in the introduction (especially the reduction of SP).

SP is especially often found in nociceptive nerve endings and can increase pain perception (Mense). Moreover, inflammatory cytokines are described with patients suffering from chronic back pain anddepressive symptomatology, thus a reduction caused by proteases (through eliminating alpha-2 M) is helpful.

The vital substances contained in the product such as zinc or magnesium are able to reduce the increased quantity of NO that is the consequence of nitrosative stress and therefore to positively influence the over-activated nerve cells. That will be a good support for practicing methods such as AT. An especially important characteristic of the proteases is the low number of side effects. The number of dropouts following the reduction in pills taken, big life changes and serious illnesses/injuries during the intervention period was the same in both groups.

In total, 6 participants dropped out of the study ahead of schedule in the Verum group and five in the placebo group. The number of participants may raise some criticism, but a considerable number of patients has been tested in partly unblinded or retrolective studies (Wittenborg et al.) for such products regarding the equivalence to NSAR and pain relief which showed equally good results.

6. LITERATURE LIST

Black PH: Stress and the inflammatory response: a review of neurogenic inflammation. Brain Behav Immun 16, 2002

Gaspani L et al.: In vivo and in vitro effects of Bromelain on PGE (2) and SP concentrations in inflammatory exsudate in rats.Pharmacology 65, 2002

Heine H: Lehrbuch der biologischen Medizin. Hippokrates Stuttgart 2007

Inderst R: Systemische Enzymtherapie: naturnahe Alternative bei rheumatischen Erkrankungen. Ärztezeitschrift für Naturheilverfahren 36,1995

Kersten W: Paradigmenwechsel im Verständnis chronischer Zivilisationskrankheiten. Komplement integr. Med 50, 2009

Klein G und W Kullich: Schmerzreduktion durch eine orale Enzymtherapie bei rheumatischen Erkrankungen. Wien. Med. Wschr. 149, 1999

Lauer D et al: Modulation of growth factor binding properties of alpha-2-macroglobulin by enzyme therapy.Cancer Chemother Pharmacol 47, 2001

Mannion AF et al: Development of a German version of the Oswestry Disability Index. Eur. Spine J 15, 2006

Mens eS: Neurobiologie des Muskelschmerzes. Deutsche Zeitschr. Für Sportmedizin 51, 2000

Miehlke K und R. Inderst: Moderne Proteasentherapie bei rheumatischen Beschwerden.Ärztezeitschrift für Naturheilverfahren 45, 2004

Niestroj I: Praxis der Orthomolekularen Medizin. Hippokrates 2000

NN: Programm für nationale Versorgungsleitlinien, Kreuzschmerz- Version 4 Herausgeber: Bundesärztekammer, KBV und AWMF 2010

Raspe H: Rückenschmerzen. Herausgeber: Robert Koch Institut . Gesundheitsberichterstattung des Bundes, Heft 53, Berlin 2012

Wang H und M Schiltenwolf: Zur Rolle der Zytokine bei Patienten mit Rückenschmerz und Fibromyalgie. Der Schmerz 24, 2010

Wittenborg A et al: Vergleichende epidemiologische Studie bei Erkrankungen des rheumatischen Formenkreises am Beispiel der Therapie mit nichtsteroidalen Antiphlogistika versus einem oralen Enzymkombinations-präparat. Arzneimittelforschung 50, 2000

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