Doloteffin – clinically proven efficacy

Doloteffin versus synthetic Cox-II Inhibitor in patients with back pain 1

  • Prospective, randomized, monocentric, double-blind study of phase IV 1
  • Patients with acute*, non-specific back pain lasting for more than 8 weeks in the scope of chronic** back pain
  • Treatment duration of 6 weeks
  • 88 patients (44 patients per group)
  • 1-Year follow up study 2

*Visual analogue score > 5, **Lasting for at least 6 months

Number of pain-free patients

5 pain-free days per week without taking the rescue medication Tramadol

Relative improvement of ABPI* after 6 weeks

Relative improvement of the quality of life*


10 patients of the Doloteffin group and 5 patients of the synthetic cox-II inhibitor group were pain-free after 6 weeks of therapy. With regard to this primary target criterion there was a non-significant trend in favour of Doloteffin (p = 0.257, Fisher‘s exact test).


The general assessment of tolerance was similar in both groups. 31.8% of patients in both treatment groups presented with adverse events.


Doloteffin treatment is not inferior to synthetic cox-II inhibitor treatment with regard to the efficacy and tolerance.


Significant results of the 1-year follow-up study 2

  • Of 88 patients who had participated in the study 1 year before, 73 patients continued on for a subsequent 1-year follow-up. All follow-up patients received Doloteffin.
  • Former Doloteffin patients: n = 38
    Former synthetic Cox-II Inhibitor patients: n = 35

Pain assessment according to diary

Improvement of the “pain“ component of ABPI*

(median, per-protocol evaluation)

Relative change (intention to treat)

1. Chrubasik et al. Rheumatology 2003; 42:141–148.
2. Chrubasik et al. Phytomedicine 2005; 12:1–9.