Vincenzo Rocco - Last April the 30th the Patients Rights Court and the Chronic Patients Associations have contributed to the actual discussion on the regulation of Non Conventional Medicines (NCMs), presently in discussion at the Italian Senate XII Commission. The associations left a written note we wish to comment.

In synthesis the note assesses the debate on NCMs, exposes some principles and propose some integration to the law proposals.
The most important questions concern the cost of the treatments, the need for treatment transparency and medical education.
From our standpoint the document appears quite interesting; it represents a way of thinking on NCMs which essentially found our agreement. However the document shows how, thanks to the fact that since their birth NCMs have never been regulated at the education level, and the information on the topic is fragmentary, in the public perception there is confusion regarding the scopes and methods of each of those NCMs. Moreover this confusion concerns even the health personnel.

For example, at the level of expenses for NC therapies, the note indicates that the costs might be very high. The problem of the therapies cost is very relevant for the patient. It is therefore necessary to distinguish, for example, among the very high cost of therapies like homeopathic polypharmacy, homotoxicology, phytotheraphy or integrated treatments (allopathic- NC) and the cost of the Hahnemann Homeopathic treatment that has been shown to be much less expensive than the conventional one several times (see also 1-6).

A second question concerns homeopathic medicine safety and production. The association ask: are homeopathic medicines submitted to the same controls as the conventional ones? Are they safe?
It is quite curious that this kind of question is very often asked by patients associations, and this, for us, is due to the confusing overlap of different unconventional therapies and medicines. Homeopathic medicines production is systematically controlled by AIFA (the Italian Agency for medicines). Production sites are inspected by AIFA personnel each 2 years. We presently know that AIFA is actively working in defining common protocols for Homeopathic medicines registration. Therefore, the good manufacturing rules (GMP) are essentially the same for homeopathic and allopathic medicines. To show this fact – I just remember this from an speech of an AIFA inspector seminar– the 47 homeopathic medicine productions sites existing in 1997 have been reduced to about 20 nowadays, due to non compliance to GMPs. The remaining production sites are all regularly inspected and authorized.

Safety, adverse reactions. Concerning this topic we wish to quote a paper from the Italian Institute of Health (ISS) on the spontaneous reporting of Adverse Reactions (ADR) to give a measure of the degree of safety of the homeopathic remedies used by the Hahnemannian Homeopathic method. The paper (7) reports 27 ADRs due to homeopathic preparations in a period spanning from 2002 to 2007. Of these 27 reports, 19 were from homeopathic preparations containing mix of remedies (complexes) and 8 from single homeopathic remedies, these last used in Hahnemannian Homeopathy. In synthesis less than 2 reports per year during 5 years. If we compare these data with those coming from herbal-phytotherapy and homeopathic complexes and with conventional medicines (in Italy 9000 reports in 2007) it seems clear that homeopathic single remedies are quite safe for the user. If we add the study from Endrizzi et al. (8), it appears that in Homeopathic medicine there are adverse reactions but they are not severe, very rare, and seem dependent on diagnostic-prescription mistakes (unwanted provings...). Unfortunately also this chapter, concerning the very high safety of the homeopathic remedy, is systematically darkened by the paraphernalia of "natural", "alternative" medicines often associated to the homeopathic remedy.

The associations note quotes some reports of patients signaling the substitutive and non-complementary use of homeopathic remedies with the conventional ones, endangering patients. This is a chapter to be attentively commented and it seems to us necessary to analyze this statement step by step. First of all, if the Hahnemann homeopathic methodology is used together with an allopathic treatment it is possible that the homeopathic treatment will not act (it is however not even the case) because the allopathic medicine may inactivate the homeopathic one. Secondly, when two or more medicines are used at the same time it is quite difficult to establish which may have the positive or negative effects (actually there is not much information on the effects of combination of several allopathic medicines). On the other side the suspension of an allopathic treatment may certainly create a reaction on the organism. This may especially occur in chronic cases where the person receives very long treatments to whom the body get accustomed. We believe that the physician has to learn how to afford these situations case by case, evaluating with his patient the consequences and possibilities of different strategies, and form an alliance with the patient to afford the route to healing. The problem is therefore very serious and has to be faced essentially at the level of medical education and at the level of the physician ability to interact empathically with the patient, to reach the awareness of the best of the routes, and to monitor it constantly. But it is only the correct scientific humanistic and ethic medical education able to guarantee the reduction of medical mistakes and damages. Concerning Homeopathic Hahnemann Medicine, it seems to us that when the associations state that the physician has to " avoid the citizen to be taken away from specific treatments of proved efficacy, pursuing illusory healing hopes" , they have a false perception of the reasons moving a patient to a Homeopathic medical examination (at least in Italy). From researches realized on 7000 LUIMO clinical files it appears that 93% of the patients come with already a diagnosis and a conventional treatment (the other 7% are patients coming for prevention). These patients come to Homeopathy because they are not satisfied for the treatment or the treatment is not or was not effective. If the conventional treatments were effective, most probably the patient would not think about homeopathy. It is therefore correct to say that the patient has not to be taken away from specific treatments of proved efficacy, but these cases seem to be rare. From the mentioned LUIMO research, in general this case concern surgery.

There are 3 observations from the note we share plenty. From patient associations observations it result that a) in many cases there is no clinical documentation of the medical intervention, b) there is not informed consent, c) there is a large fragmentation in the legal status of NCMs at the regional level.
For LUIMO physicians clinical documentation and informed consent are normal activities. Since its birth in 1976, through the realization of the biopathographic protocol, LUIMO has promoted and developed any form of communication to convince Homeopathic and allopathic physicians to trace the clinical history of the patient and its follow-up. There is no science nor art able to be transmitted and ameliorated without any trace of its activity, it does not exist any serenity in the cure without adequate patient information and consent.
Presently clinical files and informed consent are an obligation for the physician and therefore also for the homeopathic physician. The cases in which these procedures are not effective have to be corrected definitively.

Concerning the legal status of different NCMs at the regional level it is so much diversified that indicates preferences or pressure groups on NCMs, and does not guarantee the same rights to all Italian citizens. But this rights disparity, unfortunately, it is quite spread in Italy.......

The principles on whom the associations agree: 1) interaction not integration between NCM and dominant medicine: for the first time we see patients to realize that to integrate without prior verification may be dangerous, and this cheer up us; 2) the need to realize post-degree education for professional in the NCMs. We are on the same wavelength, but we wish the associations to share the need to rigorously separate each one of the NCMs, because in this way more transparency towards patients is guaranteed; 3) Medicine exercise has to be reserved to health professionals. We perfectly share this statement, at least till the moment in which a complete Homeopathic Medicine Course will be possible in Italy, equivalent to the standard medicine degree.

For the moment Private Institutions and Universities have to realize a complete post-degree education and not only a partial information to students, if they want to create a physician conscious of the possibilities and limits of the therapies he uses!

1. Jain A. Does homeopathy reduce the cost of conventional drug prescribing? A study of comparative prescribing costs in general practice. Homeopathy 2003 Apr;92(2):71-6
2. van Wassenhoven M, Ives G. An observational study of patients receiving homeopathic treatment. Homeopathy 2004 January,93:3-11.
3. Taïeb C, Myon E. Chronic allergic rhinitis, usefulness of the homeopathic treatment. International Society of Pharmaco economics & Outcomes Research. 8th Annual International Meeting May 18-21,2003.
4. Rossi E, Crudeli L, Endrizzi C, Garibaldi D. Cost-effectiveness evaluation of homeopathic vs conventional therapy in respiratory diseases. Improving the Success of Homeopathy 5: January 2006.
5. Sevar R. Audit of outcome in 455 consecutive patients treated with homeopathic medicines. Homeopathy 2005;94:215-221.
6. Witt C. Effectiveness of homeopathy, an example of systematic research in children with atopic eczema. Proceedings of 63rd LMHI congress. May 20-24, 2008.
7. Menniti-Ippolito F, Mazzanti G, Santuccio C, Angela Moro P, Calapai G, Firenzuoli F, Valeri A, Raschetti R. Surveillance of suspected adverse reactions to natural health products in Italy Pharmacoepidemiol Drug Saf. 2008 Jun;17(6):626-35...
8. Harm in homeopathy: Aggravations, adverse drug events or medication errors? C Endrizzi, E Rossi,L Crudel and D Garibaldi. Homeopathy (2005) 94, 233–240