title: Single-blind, randomized, pilot study combining shiatsu and amitriptyline in refractory primary headaches.
abstract: Complementary alternative medicine, such as shiatsu, can represent a suitable treatment for primary headaches. However, evidence-based data about the effect of combining shiatsu and pharmacological treatments are still not available. Therefore, we tested the efficacy and safety of combining shiatsu and amitriptyline to treat refractory primary headaches in a single-blind, randomized, pilot study. Subjects with a diagnosis of primary headache and who experienced lack of response to ≥2 different prophylactic drugs were randomized in a 1:1:1 ratio to receive shiatsu plus amitriptyline, shiatsu alone, or amitriptyline alone for 3 months. Primary endpoint was the proportion of patients experiencing ≥50%-reduction in headache days. Secondary endpoints were days with headache per month, visual analogue scale, and number of pain killers taken per month. After randomization, 37 subjects were allocated to shiatsu plus amitriptyline (n = 11), shiatsu alone (n = 13), and amitriptyline alone (n = 13). Randomization ensured well-balanced demographic and clinical characteristics at baseline. Although all the three groups improved in terms of headache frequency, visual analogue scale score, and number of pain killers (p < 0.05), there was no between-group difference in primary endpoint (p = ns). Shiatsu (alone or in combination) was superior to amitriptyline in reducing the number of pain killers taken per month (p < 0.05). Seven (19%) subjects reported adverse events, all attributable to amitriptyline, while no side effects were related with shiatsu treatment. Shiatsu is a safe and potentially useful alternative approach for refractory headache. However, there is no evidence of an additive or synergistic effect of combining shiatsu and amitriptyline. These findings are only preliminary and should be interpreted cautiously due to the small sample size of the population included in our study. Trial registration 81/2010 (Ethical Committee, S. Andrea Hospital, Sapienza University, Rome, Italy).
authors.affiliation: Neuro-Oncology Unit, Regina Elena National Cancer Institute, Via Elio Chianesi 30, 00144, Rome, Italy. veronicavillani79@gmail.com.
authors.forename: Veronica
authors.initials: V
authors.lastname: Villani
authors.affiliation: Department of Neurology and Psychiatry, Sapienza University, Rome, Italy.
authors.forename: Luca
authors.initials: L
authors.lastname: Prosperini
authors.affiliation: Italian Shiatsu Association, Rome, Italy.
authors.forename: Fulvio
authors.initials: F
authors.lastname: Palombini
authors.affiliation: Department of Neuroscience, Mental Health and Sensory Organs (NESMOS), Sapienza University, Rome, Italy.
authors.forename: Francesco
authors.initials: F
authors.lastname: Orzi
authors.affiliation: Department of Neuroscience, Mental Health and Sensory Organs (NESMOS), Sapienza University, Rome, Italy.
authors.forename: Giuliano
authors.initials: G
authors.lastname: Sette
mesh_terms: D019050:Acupressure; D000293:Adolescent; D000328:Adult; D000639:Amitriptyline / Q000009:adverse effects / Q000627:therapeutic use*; D018712:Analgesics, Non-Narcotic / Q000009:adverse effects / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D005260:Female; D005500:Follow-Up Studies; D051270:Headache Disorders, Primary / Q000628:therapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010147:Pain Measurement; D010865:Pilot Projects; D016037:Single-Blind Method; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D018712:Analgesics, Non-Narcotic; D000639:Amitriptyline
keywords: Amitriptyline; Complementary alternative medicine; Migraine; Primary headache; Shiatsu