Background: The Azienda Sanitaria di Firenze includes the Department of Oncology, which includes the Units of Medical Oncology, Radiation Therapy, Psycho-Oncology and Palliative Care and the Center of TCM Fior di Prugna. Considering as a priority the development of an integrated methodology, an observational clinical study was created. Aim: The objective was to evaluate the efficacy and safety of traditional Chinese medicine (TCM) in oncology, specifically on cancer pain control and iatrogenic vasomotor disturbances. The secondary endpoint was to evaluate the improvement in health status perception. Methods: The study was a clinical observational prospective study. The patients were resident in Tuscany and being followed up by the Oncology Department, with good performance status (Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2), age ≥ 18 years, who accept treatment TCM in addition to conventional cancer treatment. Based on systematic reviews, meta-analysis, controlled trials and Society for Integrative Oncology (SIO) guidelines, three categories of patients were identified: patients with cancer pain of moderate or severe intensity (Numeric Rating Scale, NRS ≥ 5) despite conventional therapy (group A), or hormone therapy in patients with hot flashes (at least three episodes within 24 h) and breast cancer (group B) or prostate cancer (group C). A specific treatment protocol was applied to each category of patients (treatment schedule with specific techniques employed and the number of therapeutic sessions). The TCM treatments were a choice between acupuncture, moxibustion, gavel 'Fior di Prugna', auricular therapy and the treatment provided according to the 'diagnostic abdominal Nanjing'. Treatments were provided weekly at the San Felice a Ema Hospice, part of the Oncology Department, and at MTC Center Fior di Prugna. The safety assessment was on a weekly basis and included the annotation of any adverse event after a therapeutic session, while the efficacy of the treatment was evaluated after completion of the sessions. The assessment tools were NRS for pain, Hot Flash Score (HFS) for hot flashes and Short-Form Health Survey 12 items (SF12) for the state of health perception. For group A, a reduction of pain NRS ≤3 is considered efficacious; however, any pain reduction is registered. For groups B and C, the treatment effectiveness is based on HFS reduction.
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