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.
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design.
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