Associazione Medica per lo Studio dell'Agopuntura

Presidente: Dr. Carlo Di Stanislao

Scuola Italo-Cinese di Agopuntura di Roma

Direttore: Dr. Dante De Berardinis

Unamedicina

Presidente: Dr. Francesco Marcelli

UOC di Clinica Ostetrica e Ginecologia AUSL 04 L'Aquila

Direttore: Prof. Giulio Mascaretti

UOC di Oncologia Medica AUSL 04 L'Aquila

Direttore: Prof. Paolo Marchetti

UOC di Dermatologia e Centro Allergologico AUSL 04 L'Aquila

Direttore: Prof. Giovanni Bologna

 

 Temple oh Heaven

 

Reflections on Evidenced based Medicine,
and their effect in the creation of gold-standards in Acupuncture.

 

Carlo Di Stanislao, Giampiero Porzio, Patrizia Palermo, Dennis Konopacki

 

 

“to practice medicine without books is like sailing in uncharted waters, but to practice medicine without books and without patients is as if you are not sailing at all.”

W. Osler

 

 

 

Summary: In the moment in which there are various schools of Acupuncture, and different approaches to both the diagnosis and treatments in acupuncture, it is possible to imagine in light of what is today called Evidence Based Medicine, various studies which could be proposed on homogeneous group of patients, to determine the efficaciousness and efficiency of these various approaches. This research, which is anything but boring and academic exercises, would allow one to define a standard for the determination and treatment of different pathologies. We have carried out one such research program, but we are preparing similar studies in the fields of gynecology, rheumatology and oncology. These additional research programs can be used to create a practical reference and a gold standard for further clinical studies in which a comparison is made between these treatments and those of the consolidated conventional treatments.

 

Key Words: Evidence Based Medicine, EBM, Schools of Traditional Chinese Medicine

 

Evidence Based Medicine, (Richeldi et, al., 2002), currently constitutes one of the basis in which the methodology becomes enjoined with clinical practice in various medical specialties. Its roots go back to mid 19th century and it represents one of the current controversial issues that is debated between clinicians, epidemiologists and health administrators. In EBM the physician makes decisions concerning the care of a given patient based on the conscientious and explicit evaluation of the best scientific evidence currently available (AAVV, 2002). This technique has been subsequently been applied in the areas of preventive medicine and more generally in health politics (Zaglio, 2000). From a practical view point the application of evidence based medicine means to integrate ones own personal experience with the best clinical data globally available after having applied the criteria for a systematic revision process. The systematic revision process, which is a central and qualifying act of any discipline, consists in an analytical evaluation carried out by the application of standardized criteria of all data regarding a particular clinical topic, currently available to the worldwide scientific community. (Grilli et al., 2000) The systematic review process evidently makes up a crucial moment, which can directly influence the EBM (Richeldi et al., 2002; Grilli et al., 2000). In theory (AAVV, 2002) all published documents should be placed under peer review. This review should be done by both internally as well as by others that were not involved with the writing of the article in question. In more advanced stages, pilot testing can be carried out. Here for a period of approximately six months, the proposed guide lines are applied by a recognized clinical institute from which feed back can be obtained for eventual modifications or corrections (Varonen et al., 1997). One of the problems relative to the research on the efficacy of acupuncture is that there are no standards for the diagnosis nor for the eventual treatments (Helms, 1997; AAVV, 2000; Pizzorno et al., 2001). As a result, for the same medical condition one can obtain different energetic diagnoses and different proposed treatments (selection of different points). This, which on the one hand demonstrates the richness of this discipline, on the other makes clinical studies much more complex. This fact also can disorient the search for guidelines. (Unshuld, 1992; Caspani, 2000). According to a didactic differentiation, which is commonly accepted, there schools are divided into those that deal with reflexology and those that deal with the traditional medicine. This latter group can be further subdivided into the French, Vietnamese, Japanese and Chinese Schools (Di Stanislao, 1999; Pizzorno et al., 2001). Some traditional acupuncturists state that being the model most frequently followed in China is that of the Zang/Fu, and that most of the indexed works also rely on this same model, it is apparent that the Zang/Fu model should constitute the standard both in clinical studies as well as in the studies of the efficaciousness of the treatments (OMS, 1990; Minelli, 2000). These individuals however don not take into account a series of factors, which are anything but insignificant. Many papers, which are written in French, German and Italian, do not follow this model. Many of these works have excellent clinical and research value (AAVV, 2000). Even the Chinese clinicians recognize that even though the Zang/Fu model is very good, it cannot be applied in all cases, as is evidenced by those complex syndromes assigned to the Curious Meridians (AAVV, 1991; Leung, 1993). Such syndromes can be called into play in certain endocrinological, psychological, respiratory or digestive pathologies. Such a model unites very well acupuncture with phytotherapy, but does not take into account the fine energetic realities (i.e. psychosomatic disturbances) that in Europe and in the western world are quite frequent (Kespi, 1990; Yuen, 1997; McPherson et al., 2000). It is quite evident that the diagnoses and treatment plans that are based upon the 5 Movements, the Meridians and the specific Energy disturbances have been in a notable decline in the past twenty years. Notwithstanding this however, overall, these techniques make up a significant reality in the evolution, application and affirmation of acupuncture in the western world (Borsarello, 1997). In addition, it has already been shown that each type of technique (Semizzi, 2002) has its advantages and disadvantages and one adapts, at least in a general sense, to conditions that qre quite different. Some could object, stating that analysis of all the scientific material published on any particular topic in acupuncture is practically impossible, due to the fact many of these works have not been indexed and are not contained in an international data bank (Allais et al., 2000). Apart from Pubmed, other data banks are involved in the collection of the best acupuncture works published in either English or French and, in the preliminary reviews, they can not take into consideration all the papers that are presented but only those of the highest level and written by the authors which are most recognized. An example of this is the work published by AMSA on the raynaudian manifestations during the illness of Systemic Sclerosis. This study, carried out in 1998, took into consideration the Chinese, French, American and Vietnamese protocols and their effect on the number and the severity of angioneurotic crisis in a homogenous and randomized group of patients suffering from Scleroderma. The efficacy of each technique after a treatment period of 30 days was described along with a follow-up evaluation (Di Stanislao et al., 1999). These results take on even more value if compared with a prior study in which the acupuncture treatments were combined with a device that produces infrared emissions (Tinkl) for the treatment of Raynauds syndrome in sclerodermic patients. The same results, used as a sort of pilot testing, have enabled the development of protocol of proven efficacy, since 1999, for the angioneurotic forms of the disease by the Department of Dermatology AUSL 04 L’Aquila (Bologna et al., 2003). Along with this we would like to recall that during the period 2001-2002, we have used various protocols (traditional acupuncture and neuroreflexological with electric stimulation) for the treatment of both acute herpetic neuralgia and post-herpetic form in diabetic patients, demonstrating that the analgesic points of the neck (ST-10, ST 11) appear to be the most efficacious (Di Stanislao et al., 2002). Analogous attempts to make comparisons can be traced, even if in an indirect way, in two clinical observations made by AMSA: the first dealing with the sensitive-motor polyneuropathy that can occur during AIDS (Di Stanislao et al., 2002a); the second deals with fibrocystic mastopathy (De Berardinis et al., 2003).In these two last cases, under the form of historic case controls, results are compared between Chinese treatments and other treatment programs. Finally, it is worth emphasizing that the actual orientation of the Health Ministry (Ministero della Salute, 2003) indicates that clinical studies must exclude the use of placebo and comparisons must be made between the proposed therapy against those therapies that are proven and consolidated. In the case of acupuncture, it deals with evaluating the efficacy and efficiency of treatments with points and different rationales and therefore the use of a placebo (false acupuncture) does not result necessary (Pizzorno et al., 2001). It is further pointed out that once a gold standard for acupuncture is established, one could compare, in subsequent clinical studies, the action of acupuncture (even documented from a historic aspect) with the pharmaceutical therapies consolidated for a given pathology.

 

Work in progress

 

Research will be carried out in conjunction with the Gynecology University Department of the AUSL of L’Aquila, regarding the treatment of dysmenorrhea. Dysmenorrhea responds to acupuncture treatment and a wide review of this topic has been the object of a recent publication in this same journal (Di Stanislao, 2002). The treatment plans are diversified, as are the authors and the results, at least apparently, are very satisfying. In our study will include at least 20 women, in the age range of 18 – 35, all of which suffer from persistent dysmenorrhea, which is not due to either an inflammatory, neoplastic or degenerative process of the genital region. (a complete preliminary screening by a specialist along with colposcopy, pap-test and echography will be performed). The groups will be divided in a randomized manner: one group will be according to the teachings of the French Association of Acupuncture (Sciarretta, 1984), and the second group will treated according to the principle of Organs and Viscera (Maciocia, 2002). In the first case the diagnosis will be made on the basis of emptiness, fullness or stagnation of the Yin or Yang in the pelvic region. In those cases in which it is not possible to apply the “8“ rules (ba gang), the extraordinary meridians will be used for their effect on the equilibrium Qi/Xie in the pelvic region. (AAVV, 2002a). In particular we will treat:

 

In cases in which the disturbance does not follow the “8” rules:

For what deals with treatments based on the Organs & Viscera we recall (Gatto, 2002):

- Stasis of Liver Qi

- Stasis of the Blood

- Disturbances of the Spleen with accumulation of humidity

- Emptiness of the Blood

- Emptiness of the Liver and Kidney Yin

 

Treatments will be performed, independently of the menstrual cycle, on a weekly basis for three months and will be a follow-up after three months. The intensity of the pain, the number of days with pain, the amount of pain medications required (allowed nimesulid or paracetamole), the affect on sleep and the variations in the quality of life (in those days in which the patient was able to carry out recreational activities due to algomenorrhea) will be evaluated.

 

Another study that will be carried out with the Division of Palliative Therapies of the Department of Oncology of the AUSL4 of L’Aquila, will deal with asthenia in patients with advanced forms of cancer (solid tumors). Anemic patients will be excluded. Participants will be of both sexes of various ages and the severity of the asthenia will also vary. This condition, which frequently falls into the category of fatigue, can be ascribed to various different energetic interpretations (Di Stanislao et al., 2001). The patients will be randomly divided into three groups.

 

A third study will deal with psoriatic arthrodynia, which is a rheumatic condition, which appears from prior observations to be responsive to acupuncture (Corbellini et al., 1998; Galluzzo et al., 2003). This is considered to be both inflammatory as well as immunologic in nature. According to the current Chinese point of view, all rheumatic forms are classified as falling under the class of bizheng and the characteristics of psoriatic arthrodynia would enter in the forms of rebi. (Navarra et al., 2002). According to some studies, psoriatic arthrodynia could be treated as a stasis of blood (Galluzzo et al., 2003) while others treat it as an autoimmune disorder thru the use of the Distinct Meridians (jingbie) (AAVV, 2002a; Yuen, 1997). For this reason the patients will be divided into three subgroups and the following parameters will be evaluated: spontaneous pain, pain with movement, pain to pressure, morning stiffness, Sedimentation Rate, C reactive protein, use of pain medications (Tylenol + codeine) and an evaluation of the results obtained with the various treatment plans. Only those patients who are not treated anti-inflammatory nor immunosuppressive medications and do not have osteolysis will be included in this study. The treatments will be given twice weekly for two months and a follow-up after three months

 

With these three studies we wish to furnish valid examples on the internal comparison in the area of traditional acupuncture treatments, without commenting on validation guide lines, an argument with witch other groups have already dealt with extensively. In all three studies there will be evaluated the subjective satisfaction and it’s effect on the quality of life, as determined by the SAT- P model (Satisfaction Profile). This model consists in a questionnaire made up of 32 questions that deal with the various aspects of daily life. The participants, both those that were treated by conventional medicine and those treated with acupuncture, will be asked to answer this survey. (Majiani et al., 1997; AAVV, 1998). In fact the Health Related Quality of Life survey constitutes one of the central aspects in the evaluation of clinical studies (Avis et al., 1996). The models used must be simple, not require a long period of time to perform, not require an elevated cultural background, be focused on 5 to 6 factors and finally be able to discern a subjective response from an objective one. (AAVV, 1998). Analyzing the relative results to treatments, will enable to define the patient – type profile for the non conventional therapies (Majani et al., 1997).

 

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Address for clarifications:

Carlo Di Stanislao

PO S. Salvatore

Via Vetoio 6

67100 L'Aquila

Tel. 0862368642-729

Fax 0862319905

E-mail: amsaaq@tin.it; dermoaq@libero.it