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Pathological findings and clinical outcomes study of 101 fibromyalgia patients treated by quadrant pain intervention.

A study of 101 consecutive FMS patients treated between March 2004 and June 2004 by Quadrant Pain Intervention (QPI) was recently completed.

Patient Data

Ninety-two of the 101 Fibromyalgia operated patients, with whom samplings were taken to the patho-histology examination, could be subjected the examination of the result-quality 3 months, 6 months and 12 months postoperative.

Of the patients, 82 were female and 10 were male, aged 51 [+ or -] 10 years. Females age were 52.6 [+ or -] 9.6 years, males 43.1 [+ or -] 11 years. All were physician diagnosed with fibromyalgia syndrome (73 of them by extern doctors) and all fully met the American College of Rheumatology classification criteria for FMS (ACR 1990). The mean chronicity for these patients was 15.9 [+ or -] 10.2 years.

All had complaints of generalised soft tissue pain, disturbed and non-restorative sleep, cognitive clouding, and persistent fatigue.

Other problems included (several answers were possible):

Upper quadrant: cervical spine and thoracic vertebral column pain (92), shoulder/arm pain (79), occiput pains (80), migraine (42), tinnitus (57), facial/ teeth/ jaw pain (80), radiant pain emittance into the fingers (83), strengthless hands (85), heart/lung [breathing complaints] (62), neurological symptoms [tingling, stinging] (89), orofacial syndrome/trigeminus (55), other complaints (3).

Lower quadrant: dorsum/sacral region pain (86), os coxae [hip] pain (66), knee complaints (75), restless legs (42), difficulties walking up the stairs (75), neurological symptoms [tingling, crampus syndrome] (77), inguen [groin] pain (47), meteorism [tympanites], irritable bowel syndrome (75), irritable bladder (66), high consumption of pain medicines (92), other complaints (1).

Intake Assessment

At intake all patients were seen for an intake and medical history interview (90 minutes) and all patients completed a self-report questionnaire and symptom check list. All patients were seen by the surgeon for an examination that included palpation of the ACR-defined 18 tender point locations as well of the acupuncture points all over the body as potential tender points. A map of tender points all over the body was performed for every patient.

All patients were provided with a complete rheumatological and neurological examination provided by other medical doctors before intake in our study.

On physical examination, all patients fully met the ACR (1990) classification criteria for FMS with a minimum of 11 positive tender points.

Therapy

All 101 patients underwent a quadrant intervention in the described manner

(1-6) at the right (53) or left (47) forearm and leg (2). During the operation the cover part compressing the nerves, arteries, and veins corresponding to the well known acupuncture points Li 6, 7, 8, 9, 10, 11 and Lu 5, 6 (upper quadrant) or Ki 3, 4, 5, 6, 7, 8, 9 and Spleen/Pancreas 6 (quadrant below) was taken off and stored in 5% formaline for histology.

Histological findings

The analysis of all 101 specimen were performed at the Institute for Pathology of the Clinic Munich-North (Schwabing) associated to the Medical School of the University of Munich.

Results

Typical specimen reports are shown in fig 1. and fig. 2

[FIGURE 1a OMITTED]

Formulation of questions:

* Is that a thesaurismosis?

* Is there any evidence of micro-traumata?

* Is that the case of a chronic progressive local-focal tissue alteration?

Number of examined samples:

Tissue samples from 101 patients were examined. The results are shown on Fig. 3 and Fig. 4. In the annex, pictures of histological preparations are presented.

[FIGURE 1b OMITTED]

Discussion with respect to the histopathological results

Neither thesaurismoses, nor micro-traumata could be found.

The changes exclusively affected tendon and muscle tissue as well as nerve fibers. This proves that the denomination 'fibro-my-algia' was chosen appropriately (Fig. 3).

In the forefront of all findings there is evidently fibrosis, which in its mostly marked expression appears under the form of cuffs. It is the sequel of a focal inflammation, which could be identified in a few cases. As the fibrosis proceeds, the inflammatory infiltration regresses. The inflammation heals forming a scar. It was surprising that in only two cases the presence of a ferrous pigment (haemosiderin deposits) could be found by the relevant special staining. Therefore, repeated micro-traumata may not play a role in the aetiology and pathogenesis of fibromyalgia.

The hyalinosis should be interpreted as degenerative change of collagen in which the collagenous fibres firmly conglutinate. This is a late sequel, just as mucoid degeneration.

[FIGURE 2a OMITTED]

Congophilic deposits would correspond to amyloid. It was searched for in all cases by Congo-red staining but it wasn't found. The inclusions of peripheral nerve fibres in the cicatricial tissue may very well be the cause of fibromyalgia development, and above all of its persistence. The identification of nerve fibers was done by means of immunohistological methods (see Annex).

[FIGURE 2b OMITTED]

Summarizing, fibromyalgia is initially an inflammatory process that heals developing an increasing cicatricial fibrosis. Taking the history, still other additional information regarding causative pathological implications can be detected (e.g. excessive stress at sports, physical stress, and great misfortunes).

These findings show that local damage to the nervous system may slowly develop far-reaching antiregulatory, in part also pathophysiological sequences of events.

This knowledge has not been utilized so far for the treatment of pain in nerve damage.

The present application of this knowledge to clinical observations regarding fibromyalgia led to the working hypothesis that damage in the periphery of the nociceptive axis is the cause of its poikilomorphic manifestations.

Conclusions of the histopathological findings: It's somatic!

Clinical outcomes all operated patients which were reached (n=92)

92 of the 101 because of Fibromyalgia operated patients, with whom samplings were taken to the patho-histology examination had a following (Fig. 5). The result quality 3 months, 6 months and 12 months after the intervention could be examined.

The number of 92 of 101 represents an excellent effectiveness of the study-organization. With such result-oriented studies, it is considered as good valid quota, if from 100 already treated patients 60 are reached.

Summary

The success of the operative treatment of fibromyalgia has been proven.

In severe cases (30% of all patients) it is necessary to operate more than once. However, among the patients operated upon up to now, it has been necessary in only 6% to operate four times, i.e. upon all four quadrants.

Conclusions

1. Acupuncture points are morphologically (anatomically) defined nerve exit points, or nerve transit channels.

2. They may be affected by local inflammation accompanied by the formation of fibrotic boards leading to the compression of nerves and to regulatory disorders manifesting themselves as somatic disorders.

3. It is possible to approach the diseased areas morphologically --surgically, and to restore normal anatomic conditions by operation.

4. With a delay of weeks, months, maybe a year (or even longer, depending on pain memory) the normalized anatomy is followed by normalization of functions, leading to regression of somatic disorders up to their lasting absence. (It must be reminded: In neurosurgery regarding peripheral nerves, restitution of damaged nerves lasts 4 to 30 months).

The sequentialities documented by histopathological findings lead to completely new views in medical teaching with respect to medicine of the Far East: The medicine of the Far East is placed upon the anatomic, morphologic basis of Western anatomy, and hereby becomes accessible to the medical teacher. Synthesis of East and West yields a new medical conception of the world.

[FIGURES 1-5 OMITTED]

Appendix

Take a system that is able to display m results [x.sub.1], [x.sub.2], ..., [x.sub.m], for instance the numbers one through six of a dice. Suppose that an event is dependent on n single measurements on these results, where all the values [x.sub.1], [x.sub.2], ..., [x.sub.m] could have been registered one or several times, and where they have to be connected in a definite way. The system becomes subject of an additive "Gestaltungs"-principle if the final event is dependent on whether either a definite value [x.sub.j] or another definite value [x.sub.k] has been registered. For instance, by throwing always two dice at the same time, the event may happen only if either number three or number six has been thrown. Then the probability W(3,6) of getting an event, where three or six appear, is the sum of the probabilities of W(3) and W(6). For always two throws, W is then 1/6+1/6 = 1/3. As a result, after three times throwing, it is always likely to get the number three or six. In general: An additive regulatory principle follows the law W([x.sub.j],[x.sub.k], .., [x.sub.r]) = W([x.sub.j]) + W([x.sub.k]) +...+ W([x.sub.r]). On the other hand, the system becomes subject of a multiplicative "Gestaltungs"-principle if the event can take place only if as well a definite [x.sub.j] as a definite [x.sub.k] has been registered. For instance, by throwing two dice at the same time, the event may happen only if as well number three as number six has been thrown. Then the probability of getting this event is the product of W(3) and W(6). This means that W(3/6) is then 1/6 x 1/6 = 1/18. After 18 times throwing two dice, it gets likely to throw as well the number three as six at the same time. In general, we have then for a multiplicative regulatory principle W([x.sub.j]/[x.sub.k]/.../[x.sub.r]) = W([x.sub.j])x W([x.sub.k]) x ... x W([x.sub.r]). The sum of random variables is again a random variable. Thus, the probability distribution of a system that is subject of an additive "Gestaltungs-principle" follows a Gaussian (-Normal-) distribution. It is governed by completely random events. The probability of getting in n trials a deviation u = (hp) n from throwing N = np times a definite number, where n _ , is described by the well-known Gaussian distribution [P.sub.N](u) = [(2 Nq).sup.-1/2] exp ([-u.sup.2]/2Nq), where q = 1-p. Since, on the other hand, the logarithm of a product of m components is equal to the sum of the logarithms of all the components (i.e., log(A x B x C x ...x Z) = logA + logB + logC +...+ logZ), in case of the multiplicative "Gestaltungsprinciple", the logarithms of all the random variables now take the same role of random variables that are taken for a additive principle by the values themselves. Consequently, if instead of the original parameters the logarithms of the parameters follow

References:

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(2.) Schuermann, H. and Schirduan, M. (1948). Untersuchungen uber Fragen der Penicillindosierung. Wein Klin Wochenschr, 33/34: 526-8.

(3.) Gebelein, H. and Heite, H.J. (1950). Uber die Unsymmetrie biologischer Haufigkeitsverteilungen. Wein Klin Wochenschr, 28: 41-5.

(4.) Sachs, L. (1969). Statistische Auswertungsmethoden. Berlin: Springer.

(5.) Zhang, C.L. and Popp, F-A. (1994). "Log-Normal Distribution of Physiological Parameters and the Coherence of Biological Systems." Medical Hypotheses, 43:11-6.

(6.) Popp, F-A. (1998). "About the Coherence of Biophotons." In Sassaroli, E., Srivastava, Y., Swain, J., & Widom, A., (Eds). Macroscopic Quantum Coherence. Singapore, New Jersey, London: World Scientific. pp 130-50.

(7.) Popp, F-A., Chang ,J.J., Herzog, A., Yan, Z., and Yan, Y. (2002). "Evidence of Non-classical (squeezed) Light in Biological Systems." Phys.Lett. A, 293, 98-102.

(8.) Popp, F-A., Beloussov, L. (Eds). (2003). Integrative Biophysics. Dordrecht, London: Kluwer Academic Publishers.

(9.) Glauber, R.J. (1969). "Coherence and Quantum Detection." In: Quantum Optics. New York and London: Academic Press, pp.15-56 (in particular pp 22 and 23).

(10.) Klimek, W.(2004). "Die elektrische Hautleitfahigkeit als Spiegel des inneren Regulationszustandes." Erfahrungsheilkunde (EHK) 53, 419-422.

(11.) Patent DE 103 55 348 A1 2005.06.23, Application PYCO.

(12.) Mehlhardt, W. (1975). "Elektrophysikalische Grundgesetze der Elektroakupunkturpunkte." Theorie und Praxis 2, 51-65.

(13.) Kramer, F. (1990). Lehrbuch der Elektroakupunktur Bd.1, Heidelberg: Haug-Verlag.

(14.) Hollischer, E., Mehlhardt, W., Popp, F-A. and Schmidt, H.G. (1979). "Statistische Analyse von Widerstandswerten an besonderen Hautstellen." Physikalische Medizin und Rehabilitation 9, 472-475

(15.) Rossmann, H. and Popp, F-A. (1986). Arztezeitschrift fur Naturheilverfahren 9, 623-630.

(16.) Siebenhuner, B. Frankfurt, personal communication.

(17.) Kostler, W. Vienna, personal communication.

Johann A. Bauer

Associate Professor for Surgery at the Ludwig-Maximillians-University, Munich

Falkenweg 1, CH-6340 Baar (ZG), Switzerland

Office@fms-bauer.ch
Fig. 3: Results graph

The review of all 101 specimens
& histological findings
Histological findings
(Prof. Dr. med. Karl-Heinz
Wurster)

The numbers related to the
amount of entries, 542 in all with
101 samples/patients.

Fibro 275
my 169
-algia 98

Fig. 4: Histological findings

Histological findings (Prof. Dr. med. Karl-Heinz Wurster)

Material to be examined

Patients operated upon for fibromyalgia, n = 101

One sample from each patient was examined using multiple staining.
The described changes are multiple entries.

Formulation of questions

* Is that a thesaurismosis?

* Is there any evidence of micro-traumata?

* Is it the case of a chronic progressive local-focal tissue
alteration?

Results
Amount of entries in n = 101 samples/patients

 n
Hyalinized tendon tissue 101
Reticular, peritendinous, perimysial fibrosis 85
Streaked mucoid degeneration 65
Isolated necroses 24
Connective tissue with plenty of fibres 3
 278

Striated muscle tissue 101
Vacancy lipomatosis 32
Fibrosis encroaching on muscle tissue 36
 169

Enclosures of peripheral nerve fibres
perineural mucoid degeneration 49
Focal chronic peritendinous inflammation,
peritendinous cuff-like fibrosis 22
Focal enhanced vascularization 14
Lymphocytic infiltration 13
 98

Acid mucopolysaccharides 3
Congophilic substances (amyloid) 0

Micro-traumata
Haemosiderin deposits 2

Short summary and evaluation

The presented samples show a focal, local inflammatory and degenerative
disease process in which structures like nerve, tendon, and muscle
fibres are cuff-like enclosed. The perineural inflammation is hereby
confirmed. Thesaurismoses and micro-traumata are excluded.

Fig. 5: The result quality 3 months, 6 months and 12 months after the
intervention

3 months pOP, amount of the operated upon n = 92

17
3 No complaints (Code 1-1.5) 20
61
3 Improvement (Code 2-2.5) 64
6
0 No improvement (Code 3-3.5) 6
2 Cannot say (4) 2

92 Total (n=absolute number) 92

 Code 1-1.5 in % 21.74%
 Code 2-2.5 in % 69.57%
 Code 3-3.5 in % 6.52%
 Code 4 in % 2.17%
 Total (in percents) 100.00%

6 months pOP, amount of the operated upon n = 92

19
3 No complaints (Code 1-1.5) 22
48
1 Improvement (Code 2-2.5) 49
20
1 No improvement (Code 3-3.5) 21
0 Cannot say (4) 0
92 Total (n=absolute number) 92
 Code 1-1.5 in % 23.91%
 Code 2-2.5 in % 53.26%
 Code 3-3.5 in % 22.83%
 Code 4 in % 0.00%
 Total (in percents) 100.00%

12 months pOP, amount of the operated upon n = 92

41
0 No complaints (Code 1-1.5) 41
41
1 Improvement (Code 2-2.5) 42
2
0 No improvement (Code 3-3.5) 2
7 Cannot say (4) 7
92 Total (n=absolute number) 92
 Code 1-1.5 in % 44.57%
 Code 2-2.5 in % 45.65%
 Code 3-3.5 in % 2.17%
 Code 4 in % 7.61%
 Total (in percents) 100.00%
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Author:Bauer, Johann A.
Publication:Frontier Perspectives
Article Type:Clinical report
Geographic Code:1USA
Date:Mar 22, 2007
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