title: Efficacy and short-term safety of topical Dwarf Elder (Sambucus ebulus L.) versus diclofenac for knee osteoarthritis: A randomized, double-blind, active-controlled trial.
abstract: BACKGROUND
  Sambucus ebulus L. (S. ebulus) has had long-standing application in Traditional Persian Medicine for joint pain and for a variety of bone and joint disorders. According to traditional use of S. ebulus and its relevant pharmacologic properties, this study was designed to evaluate the efficacy and short-term safety of topical use of S. ebulus in patients with knee osteoarthritis (OA).
  
  
  METHODS
  Seventy nine patients with knee OA were randomly enrolled in 2 parallel arms of a pilot randomized, double-blind, active-controlled clinical trial. The patients were treated by topical S. ebulus gel or 1% diclofenac gel, three times a day, as much as a fingertip unit for 4 weeks. Patients were assessed prior to enrollment and, then, 2 and 4 weeks subsequent to the intervention, in terms of scores of visual analogue scale (VAS) for self-grading of their knee joint pain, and according to 3 different domains of Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) questionnaire. Any observed adverse effects were also scrutinized.
  
  
  RESULTS
  The mean values of WOMAC pain score, total WOMAC score and VAS score for pain of the S. ebulus group were significantly lower compared with the diclofenac group (P=0.004, P=0.04, and P<0.001, respectively). In addition, no serious adverse effect was reported.
  
  
  CONCLUSIONS
  This pilot study showed that topical treatment with S. ebulus gel can be recommended for alleviating symptoms of patients with knee OA. However, longer trials involving larger samples size, are needed for achieving a comprehensive understanding about the efficacy and safety of S. ebulus in knee OA.
authors.affiliation: Department of Traditional Medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran.
authors.forename: Marzie
authors.initials: M
authors.lastname: Jabbari
authors.affiliation: Department of Traditional Medicine, School of Medicine, Fasa University of Medical Sciences, Fasa, Iran; Essence of Parsiyan Wisdom Institute, Phytopharmaceutical and Traditional Medicine Incubator, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Mohammad Hashem
authors.initials: MH
authors.lastname: Hashempur
authors.affiliation: Brain and Spinal Cord Injury Research Center, Neuroscience Institute, Physical Medicine and Rehabilitation, Tehran University of Medical Sciences, Tehran, Iran.
authors.forename: Seyede Zahra Emami
authors.initials: SZ
authors.lastname: Razavi
authors.affiliation: Department of Biostatistics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran.
authors.forename: Hadi Raeisi
authors.initials: HR
authors.lastname: Shahraki
authors.affiliation: Department of Pharmaceutics, Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran. Electronic address: mkamalinejad@yahoo.com.
authors.forename: Mohammad
authors.initials: M
authors.lastname: Kamalinejad
authors.affiliation: Department of Traditional Medicine, Faculty of Iranian Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Ardakan, Yazd, Iran; The Research Center of The Iranian Traditional Medicine, Shahid Sadoughi University of Medical Sciences, Yazd, Iran. Electronic address: dr.emtiazy@ssu.ac.ir.
authors.forename: Majid
authors.initials: M
authors.lastname: Emtiazy
mesh_terms: D000279:Administration, Cutaneous; D000328:Adult; D000700:Analgesics / Q000008:administration & dosage / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D018771:Arthralgia / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D016861:Cyclooxygenase Inhibitors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D004008:Diclofenac / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D005782:Gels; D006801:Humans; D007492:Iran; D008297:Male; D008875:Middle Aged; D020370:Osteoarthritis, Knee / Q000175:diagnosis / Q000188:drug therapy* / Q000503:physiopathology; D010147:Pain Measurement; D008517:Phytotherapy; D010865:Pilot Projects; D010936:Plant Extracts / Q000008:administration & dosage / Q000009:adverse effects / Q000302:isolation & purification / Q000627:therapeutic use*; D010946:Plants, Medicinal; D027923:Sambucus / Q000737:chemistry*; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D000700:Analgesics; D016861:Cyclooxygenase Inhibitors; D005782:Gels; D010936:Plant Extracts; D004008:Diclofenac
keywords: Diclofenac; Dwarf elder; Herbal Medicine; Osteoarthritis; Sambucus ebulus L.; Traditional Persian Medicine