title: [Effectiveness and safety of a homeopathic drug combination in the treatment of chronic low back pain. A double-blind, randomized, placebo-controlled clinical trial].
abstract: BACKGROUND
  The homeopathic drug combination Lymphdiaral Basistropfen is established in the treatment of edema and swellings. This is the first time the effectiveness and safety was investigated in the treatment of chronic low back pain.
  
  
  METHODS
  The study is a randomized, double-blind, placebo-controlled trial. From December 2003 to May 2007 248 patients aged 18 to 75 years were screened, 228 were randomized, 221 started therapy, in 192 the progress was measured (103 verum vs. 89 placebo), 137 completed the study (72 verum vs. 65 placebo). They received 10 drops of verum or placebo solution three times daily for 105 days additionally to an inpatient complex naturopathic treatment.
  
  
  RESULTS
  The hannover functional ability questionnaire score (primary outcome measure) tends to increase in the intention-to-treat-analysis (verum: 6.6 vs. placebo: 3.4; p = 0.11) and increases significantly in the per-protocol-analysis (verum: 9.4 vs. placebo: 4.1; p = 0.029). The treatment was well tolerated (92.9% vs. 95.4%). The incidence of adverse reactions and serious adverse reactions was similar in both treatment groups.
  
  
  CONCLUSIONS
  This first randomized, double-blind, placebo-controlled trial shows, that the homeopathic drug combination can improve the treatment of chronic low back pain.
authors: Klinik Blankenstein, Hattingen. andre.beer@klinik-blankenstein.de
authors: A M
authors: AM
authors: Beer
authors: S
authors: S
authors: Fey
authors: M
authors: M
authors: Zimmer
authors: W
authors: W
authors: Teske
authors: D
authors: D
authors: Schremmer
authors: K R
authors: KR
authors: Wiebelitz
mesh_terms: D000203:Activities of Daily Living / Q000145:classification; D000328:Adult; D000368:Aged; D000700:Analgesics / Q000627:therapeutic use; D003131:Combined Modality Therapy; D004185:Disability Evaluation; D004311:Double-Blind Method; D004338:Drug Combinations; D004359:Drug Therapy, Combination; D005260:Female; D005500:Follow-Up Studies; D006705:Homeopathy / Q000009:adverse effects; D006801:Humans; D007407:Interviews as Topic; D017116:Low Back Pain / Q000145:classification / Q000175:diagnosis / Q000188:drug therapy*; D008297:Male; D055118:Medication Adherence; D008875:Middle Aged; D009324:Naturopathy; D010147:Pain Measurement; D010343:Patient Admission; D010352:Patient Dropouts; D017060:Patient Satisfaction
chemical_list: D000700:Analgesics; D004338:Drug Combinations