title: The efficacy of an association of palmitoylethanolamide and alpha-lipoic acid in patients with chronic prostatitis/chronic pelvic pain syndrome: A randomized clinical trial.
abstract: BACKGROUND
  Chronic prostatitis/chronic pelvic pain syndrome (CP/CPPS) is a complex condition, characterized by uncertain etiology and by limited response to therapy. The definition of CP/CPPS includes genitourinary pain with or without voiding symptoms in the absence of uropathogenic bacteria, as detected by standard microbiological methods, or another identifiable cause such as malignancy. The efficacy of various medical therapies, has been evaluated in clinical studies, but evidence is lacking or conflicting. We compared Serenoa Repens in monotherapy versus Palmitoylethanolamide (PEA) in combination with Alpha-lipoic acid (ALA) and evaluated the efficacy of these treatments in patients with CP/CPPS.
  
  
  METHODS
  We conducted a randomized, single-blind trial. 44 patients diagnosed with CP/CPPS (mean age 41.32 ± 1.686 years) were randomly assigned to treatment with Palmitoylethanolamide 300 mg plus Alpha-lipoic acid 300 mg (Peanase®), or Serenoa Repens at 320 mg. Three questionnaires (NIH-CPSI, IPSS and IIEF5) were administered at baseline and after 12 weeks of treatment in each group.
  
  
  RESULTS
  12 week treatment with Peanase significantly improved the IPSS score compared to the same period of treatment with Serenoa Repens, and significantly reduced NIH-CPSI score. Similar results were observed in the different NIH-CPSI subscores break down. However, the same treatment did not result in significant improvement of the IIEF5 score. Both treatments did not produce undesired effects.
  
  
  CONCLUSIONS
  The present results document the efficacy of an association of Palmitoylethanolamide (PEA) and Alpha-lipoic acid (ALA) administered for 12 weeks for treating patients with CP/CPPS, compared with Serenoa Repens monotherapy.
authors.affiliation: Policlinico Morgagni, Catania. bgiammusso@hotmail.it.
authors.forename: Bruno
authors.initials: B
authors.lastname: Giammusso
authors.forename: Rosaria
authors.initials: R
authors.lastname: Di Mauro
authors.forename: Renato
authors.initials: R
authors.lastname: Bernardini
mesh_terms: D000328:Adult; D000577:Amides; D002908:Chronic Disease; D059350:Chronic Pain / Q000188:drug therapy; D004983:Ethanolamines / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D008875:Middle Aged; D010169:Palmitic Acids / Q000008:administration & dosage*; D017699:Pelvic Pain / Q000188:drug therapy*; D010936:Plant Extracts / Q000008:administration & dosage*; D011472:Prostatitis / Q000188:drug therapy*; D028024:Serenoa / Q000737:chemistry; D016037:Single-Blind Method; D011795:Surveys and Questionnaires; D008063:Thioctic Acid / Q000008:administration & dosage*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000577:Amides; D004983:Ethanolamines; D010169:Palmitic Acids; D010936:Plant Extracts; C005958:palmidrol; D008063:Thioctic Acid