Dossier n. 186/2009 [Abstract] Non conventional medicines and Emilia-Romagna Regional Healthcare Service. An experimental approach

The so-called “non conventional medicines” (hereafter NCMs) - even though arousing remarkable interest among citizens and health professionals for different reasons - do not have in Italy an adequate regulatory framework that at least clearly identifies them, sets boundaries of usability and defines criteria to qualify health professionals entitled to practice each of them. Moreover, non conventional medicines are not included in the list of medical procedures generally offered by the National Healthcare Service.

This controversial situation prompted some Regions to develop own initiatives, in particular within the Healthcare Service. The Emilia-Romagna Region has been among the most active Italian Regions, by enacting specific laws, establishing an Observatory for non conventional medicines (Italian acronym: OMNCER) with qualified experts and promoting a research Programme aimed to evaluate the possibility of integrating NCMs in the Regional Healthcare Service (RHS).

OMNCER is a point of observation, promotion and dialogue. Besides researches, several support actions have been carried out aimed at creating good conditions in the RHS through: appointment of reference experts in the Health Trusts, training for healthcare professionals involved in research activities, improvement of information quality for citizens also with a dedicated web pages MNC , understanding of physicians’ attitudes, etc.

The OMNCER logo - also used in the website graphics - was chosen to underline the above mentioned approach and refers to the ancient Epidaurus theatre in classical Greece: it had a peculiar meaning as it lay in the area sacred to Aesculapius, the god of medicine, where sick persons used to go for healing and recovery.

In this volume the many-year experience developed with the contribution of several different subjects is described, as well as critical points and reflections tackled by OMNCER.

First, it is important to say that the approach adopted by the Emilia-Romagna Region is characterized by a particular attention to efficacy and safety assessment and to the possible integration of such medical practices in the healthcare processes provided by the public healthcare system. In other words, NCMs have been considered as potential innovation for the healthcare system. Moreover, even if in some cases these medicines have age-old origins, they have been tested with the same scientific method required for the integration of any other clinical innovation that is about to be introduced in the public healthcare system. Therefore, NCM use was proposed only within experimental studies, and the creation of separate healthcare contexts - for example ad hoc structures for NCM provision - was not allowed.

The reports of the studies developed in the framework of the first experimental regional Programme and that successfully came to an end by 2008 are presented in another volume of this Collection (Dossier n. 187/2009).
Nevertheless, the results of this peculiar approach cannot be measured only through the outcomes of the developed researches, but also through other important effects.
The definition of specific research protocols also allowed, for example, to better guarantee procedures quality and safety, by promoting a real selection of involved structures and healthcare professionals. Competence in these fields has no reference to recognised medical post-graduate specialisations nor to equivalent training qualifications; it is therefore sometimes really hard to assign professional responsibilities.

Moreover, in the conditions established by surveys, citizens interested in NCMs have been provided with an adequate clinical direction, thus overcoming insecurity and risks that can result from the supply of medical services not supported by an appropriate orientation.

The choice of adopting an experimental approach and a rigorous method to assess studies quality also allowed to share rules needed to start and maintain a profitable dialogue among experts in NCMs and in traditional medicine. It was not to be expected, and at the very beginning it seemed also very unlikely. Instead, that successful choice contributed to reduce preconceptions and to deepen themes that are becoming important in medical research debate, such as the role of comparative studies and the need to pay more attention to effectiveness.

In this context, the regional Observatory for non conventional medicines was responsible of promoting the dialogue - with researchers, clinicians and end users of research outcomes - on methodological and practical criticalities of the clinical research in NCM, in particular on:

• the integrity of non conventional treatments while respecting the best clinical practice and the optimal form of treatment, defined by field experts through adequate strategies of consensus building;
• the specificity of the therapeutic action and the placebo effect, considering the so-called aspecific effect of treatments as integral part of their efficacy;
• the research on effectiveness through pragmatic/comparative randomized trials with conventional therapeutic standards, that can guarantee the integrity of non conventional treatments and can be used in clinical practice;
• other studies besides randomized trials, such as outcome epidemiological studies, that observe treatment effects in clinical practice, and the so-called “qualitative researches”, that investigate the intervention meaning for the patient on the basis of his/her beliefs and expectations;
• the answer to patients’ needs by facing problems whose solution could orient clinical research in general.

As indicated in the Emilia-Romagna Regional Social and Healthcare 2008-2010 Plan, the Regional Council renewed the mandate to OMNCER and funded a new regional Programme. The general development lines were confirmed, both for the experimental approach and for the supporting regional actions.

The present context, however, is different from the pioneeristic one of the beginning. Attention on NCMs has increased, conditions to implement research projects are more favourable, methodological know how and the possibility of confrontation between experts have enlarged. The new experimental Programme for NCMs integration in healthcare processes is becoming an important element of the regional strategy for research and innovation within the Emilia-Romagna Healthcare Service.

To improve experimentation skills and studies designs, OMNCER has adopted a more interactive behaviour towards researchers, encouraging the proposal of multicenter projects to be funded with ad hoc funds and offering methodological counselling and workshops with experts also from Ethics Committees. These efforts resulted in the approval of four studies on particularly interesting themes:

• ACUMIGRAN - multicenter randomized controlled parallel group study on acupuncture use in migraine with or without aura;
• AcClimat - multicenter randomized study on the use of Chinese traditional acupuncture and self care, versus self care only, to reduce hot flushes and to improve life quality in women diagnosed with breast cancer;
• MEFA 2008 - explorative, prospective, multicenter, randomized three-arm study to compare clinical efficacy and safety of three therapeutic strategies (low dose estrogens, phytoestrogens, acupuncture) used to treat vasomotor disorders caused by physiological menopause;
• Head down! - prospective, observational, multicenter study to assess the frequency of spontaneous cephalic version in the last trimester pregnancy, related factors, characteristics of population undergoing treatments to induce cephalic version, frequency trend of version after such treatments.

Besides the multicenter studies actively promoted by OMNCER, the presentation of research proposals was stimulated through a call approved by the Regional Council in December 2008, and the selection was carried out.

This volume aims to describe the development on NCM issue in Emilia-Romagna in 2004-2009 period, tracing the path followed and the use of public resources in independent clinical research. The experience described can also represent an opportunity to underline the change from an attitude of mutual distrust between experts in different medical practices to an interesting wide confrontation on these themes.

Chapters deal with:

• the national institutional framework and the normative initiatives at different levels, mainly the regional one;
• Emilia-Romagna actions;
• the experimental Programme to integrate NCMs in the Regional Healthcare Service: general lines, criteria and tools adopted in the various phases;
• regional actions implemented to support the project, in particular for training and information;
• a study on the physician/patient relationship in the experimental contexts and on the informed consent, as an important verification of one of the most qualifying aspects of NCMs;
• an analysis of medical-legal aspects connected with the use of non conventional medicine that, mainly because of the inadequate normative framework, presents many uncertainties;
• the methodological debate within the regional Observatory in these years, also confronted in meetings with Ethics Committees, public workshops, conferences;
• some hints on future developments.

In the final part of the volume, the main laws and administrative acts on NCMs adopted by the Regional Council of Emilia-Romagna are reported.