Dossier n. 187/2009 [Abstract] Studies for the integration of complementary and alternative medicine. 2006-2008

According to the 1999-2001 Regional Healthcare Plan, in 2004 the Emilia-Romagna Regional Government established a regional Observatory for complementary and alternative medicine (OMNCER) and promoted the implementation of a regional experimental Programme to evaluate effectiveness, safety and the possibility to introduce CAM into the Regional Healthcare Service.

OMNCER’s aims and activities, the characteristics of the first regional Programme and the debate on these themes developed in the last years, as well as information and details on the second experimental Programme for the integration of CAM into the Regional Health Service of Emilia-Romagna, are presented in Dossier no. 186/2009 (dedicated web pages MNC). 

In the public call for bids, regional Health Trusts were invited to present project proposals for the integration of acupuncture, homeopathy and phytotherapy, to be co-funded.

Projects were evaluated on the basis of four groups of criteria:

• social relevance - ability to face one of the main health issues indicated by the Region (osteo-articular pain, menopause, headache, support to cancer patients, minor psychiatric disturbs, breech position) or to focus on particular relevant problems for more vulnerable population groups (elderly, children, migrants);
• scientific quality - competence level of research leader, adequacy of methodology, originality and dimension of the study, national and international collaborations;
• impact on healthcare processes - level of integration the healthcare processes of the Regional Healthcare Service, improvement of patient’s quality of life, cost reduction;
• participation in regional initiatives - participation in the activities of one regional group for the coordination of studies promoted by the OMNCER.

On the basis of OMNCER’s evaluations, the regional Government approved the first “Experimental programme for the integration of complementary and alternative medicine into the Regional Healthcare Service of Emilia-Romagna”. Thirty-seven projects were authorised for experimentation, out of 48 projects presented by the Health Trusts (10 sent by University Hospital Trusts).

These studies were mainly:

• focused on osteo-articular problems (osteo-articular pain treatment, lumbosciatalgia, post-herpetic neuralgia, rheumatic diseases), gynaecological problems (climacteric syndrome in women who cannot or do not want to undergo hormone replacement therapy, severe primary dysmenorrhea), obstetric problems (correction of breech presentation, analgesia during labor), neurological problems (headache),  oncologic problems (treatment of chemotherapy side effects), gastroenterological problems (dysfunction and inflammatory bowel diseases);
• mainly realised with acupunctural techniques (sometimes associated with moxibustion), seldom with use of phytotherapic and homeopathic products;
• implemented in obstetrics and gynaecology, oncology, rheumatology, antalgic therapy, neurology, gastroenterology.

In the volume, the final reports of the projects and studies of the first Programme - ended by the end of 2008 - are presented.

1. Survey on the use of non conventional medicine products (survey with questionnaire, perspective study) 
   Piacenza Local Health Trust 
   Scientific coordinator: Thérèse Gregori 
   The study aimed to analyse the diffusion of the use of non conventional medicine products in the local population; patients’ perceived risk on the use of those products; the assessment of hospital doctors’ degree of knowledge on the effects and interaction risks from the use of those products and consequently the evaluation of training needs in this field.
2. Experimental not randomised study (before/ after) on the use of acupuncture to control the symptoms of climacteric syndrome, aimed at women in menopause who cannot or do not want to have hormone replacement therapy 
   Piacenza Local Health Trust 
   Scientific coordinator: Alberto Botti 
   The study aimed to evaluate acupuncture effectiveness in reducing the symptoms of climacteric syndrome, for women who cannot or do not want to undergo hormone replacement therapy; expectations, compliance and satisfaction degree of women who joined the study; cost-benefit relationship of the acupunctural treatment.
3. Survey on the use of some non conventional medicines by female population referring to the Women Health Area of Parma Local Health Trust (survey with questionnaire) 
   Parma Local Health Trust 
   Scientific coordinator: Maurizio Impallomeni 
   The study aimed to understand the health needs of women who use non conventional medicine (in the survey homeopathy, Chinese Traditional Medicine, acupuncture, phytotherapy, manual treatment, other therapies are considered) and to evaluate the possibility of controlled integration into health care processes.
4. Chinese traditional acupuncture as supportive care during systemic antiblastic chemioterapy (observational, monocentric, feasibility, one arm study) 
   Modena Local Health Trust 
   Scientific coordinator: Fabrizio Artioli, Laura Scaltriti 
   This study was aimed at evaluating acupuncture use to improve life quality and to reduce intensity and frequency of side effects in patients under chemotherapy treatment.
5. Acupuncture in the management of menopausal symptoms in women diagnosed with breast cancer (uncontrolled experimental pilot study) 
   Bologna Local Health Trust - Montebello outpatients’ department 
   Scientific coordinator: Grazia Lesi 
   The study aimed to acquire preliminary data on therapeutic usefulness and safety of an acupuncture cycle to treat menopausal symptoms and to improve life quality in women diagnosed with breast cancer, who could not undergo hormone replacement therapy.
6. Use of complementary and alternative medicine (CAM) by women experiencing menopausal symptoms in Bologna
   Bologna Local Health Trust - Family Planning Service
   Scientific coordinator: Grazia Lesi, Francesco Cardini
   The study describes the use and the perceived effectiveness of CAM treatments to reduce menopausal symptoms. Also communication between doctors and women about their use of CAM and factors associated to CAM use were investigated. 1,203 women aged 45-65 years referring to Family Planning Services and to Women’s Health or Menopause Centres in Bologna were invited to complete a voluntary, anonymous, self-administered questionnaire during the visit.
7. Vit. K acupuncture point injection San Yin Jiao (Sp 6) for severe primary dysmenorrhea (uncontrolled pilot study) 
   Bologna Local Health Trust - Montebello outpatients’ department 
   Scientific coordinator: Grazia Lesi 
   The study aimed to evaluate short term effects of Vit. K injection to reduce menstrual pain.
8. Survey about the use of acupuncture for the treatment of pain due to muscoloskeletical apparatus diseases (survey with questionnaire, perspective study) Bologna Local Health Trust - Pain therapy service at Bellaria outpatients’ department
   Scientific coordinator: Giancarlo Caruso 
   The study aimed at evaluating socio-demographic aspects and motivations
   of patients who choose to undergo acupuncture in hospital for the treatment of muscoloskeletical pain; analysis of patients’ expectations on the treatment.
9. Implementation of a public observatory for the surveillance of CAM use 
   Forlì Local Health Trust 
   Scientific coordinator: Lucio Bottini 
   The purpose of this action was to create a database in order to know the quali/quantitative local offer of CAM.
10. Use of soy isoflavones product for a total dosage of 75mg per day divided into two doses (observational study) 
    Ravenna Local Health Trust – Flaminia centre at Ravenna Civil Hospital  
    Scientific coordinator: Maurizio Morelli 
    The study aimed to assess the effectiveness of soy phythoestrogens use to reduce menopausal symptoms; to evaluate of life quality before and after the treatment to analyse possible side effects.
11. Evaluation of the effectiveness of acupuncture for pain treatment in rheumatic diseases (perspective observational study) 
    Ravenna Local Health Trust, Antalgic therapy Service 
    Scientific coordinator: Virgilio Ricci 
    The study aimed at analysing the use and effectiveness of acupuncture for pain reduction, and at evaluating the reduction of analgesic drugs and the improvement of life quality.
12. Evaluation of the use and effectiveness of acupuncture for the pain treatment due to post-herpetic nevritis (perspective observational study) 
    Ravenna Local Health Trust, Antalgic therapy Service 
    Scientific coordinator: Virgilio Ricci 
    The study aimed at analysing: the use and effectiveness of acupuncture for pain treatment due to post-herpetic nevritis; analgesic drug use reduction; improvement of life quality.