Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of low back pain

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SCIENCE
Efficacy and safety of nicoboxil/nonivamide ointment for the treatment of low back pain
Key Take-Away: 
  • Nicoboxil/nonivamide ointment is an effective, tolerable and safe treatment option for low back pain.
  • At 8 h, pain intensity decreased statistically significantly more in the nicoboxil/nonivamide group {adjusted mean patient intensity difference (PID) = - 2.410} than in nicoboxil group (- 1.428); p < 0.0001 and placebo group (- 1.049); p < 0.0001 but there was no statistically significant difference between the nonivamide group (-2.252); p = 0.4171 and nicoboxil/nonivamide group.

Low back pain is a major health and socio-economic problem in many countries and prevalence of up to 82% in 1 year has been reported. Low back pain is a self-limiting disorder and approximately 90% of patients experience remission within 6 weeks. Paracetamol is usually recommended as first-line therapy and NSAIDs as second-line therapy, when paracetamol is not sufficient.

ABSTRACT: 
Background: 

Low back pain is a major health and socio-economic problem in many countries and prevalence of up to 82% in 1 year has been reported. Low back pain is a self-limiting disorder and approximately 90% of patients experience remission within 6 weeks. Paracetamol is usually recommended as first-line therapy and NSAIDs as second-line therapy, when paracetamol is not sufficient.

Opioids, muscle relaxants, steroids, antidepressants or anticonvulsive medication are also recommended by some guidelines. Overall, clinical data for low back pain treatment with these medications is limited, and there is still need for new treatment options. Topical nicoboxil/nonivamide ointment has been used since 1950s to treat discomfort of the musculoskeletal system but its effects for the treatment of acute low back pain have not been investigated in a randomized controlled trial.

  • Rationale behind research
  • Clinically proven & effective treatment options are sparse for low back pain and this generates the need to examine the efficacy of nicoboxil/nonivamide ointment
  • Objective

To examine the efficacy, tolerability and safety of nicoboxil 2.5%/nonivamide 0.4% ointment in the treatment of adults with acute low back pain 

Methods: 

 

Study outcomes

  • Primary outcome: Pain intensity difference (PID) between baseline (pre-dose) and 8 h after first application
  • Secondary outcomes:
  • PID between baseline (pre-dose) and 4 h after the first application (PID4h)
  • Average PID versus baseline on the last individual treatment day (APIDLID)
  • Patient assessment of efficacy on the last individual treatment day [on a 4-point verbal rating scale (VRS) with the categories, ‘poor’, ‘fair’, ‘good’, ‘very good’].
  • Other outcomes: Assessment of APID from baseline to Day 4, time to onset of pain relief, mobility score and number of patients taking rescue medication.
  • Time-points
  • Efficacy: Baseline, Day 1 and up to Day 4
  • Side effects: Baseline, Day 1 and up to Day 4
Results: 

 

Baseline: The two treatment groups were well balanced at baseline

  • Primary outcomes
    • At 8 h, pain intensity decreased statistically significantly more in the nicoboxil/nonivamide group (adjusted mean PID [95% CI] = - 2.410) than in nicoboxil group (- 1.428); p < 0.0001 and in placebo group (- 1.049); p < 0.0001 but there was no statistically significant difference between the nonivamide group (-2.252); p = 0.4171 and nicoboxil/nonivamide group
    • Compared with placebo, the combination reduced pain intensity 8 h after the onset of treatment by 1.362 points more

Secondary outcomes

  • At 4 h, pain intensity decreased significantly more in the nicoboxil/nonivamide group -1.699 than in nicoboxil group - 0.968 ( p < 0.0001) and placebo group - 0.650 but there was no significant difference between nonivamide and nicoboxil/nonivamide group. Compared with placebo, pain intensity was reduced by 1.049 points more in the combination group
  • On day 4, API decreased significantly from baseline more in the nicoboxil/nonivamide group compared with the three other treatments.
  • The proportion of patients who assessed efficacy on their last individual treatment day as ‘very good’ or ‘good’ was highest in the nicoboxil/nonivamide group (~68%), followed by nonivamide group (~60%), nicoboxil group (~43%) and placebo group (~27%).

Other outcomes

  • Time to onset of pain relief was assessed using a 7-point VRS (using a Kaplan–Meier analysis). Within the first 8 h, the combination of nicoboxil and nonivamide had an earlier onset of pain relief than the other three treatment groups.
  • In nicoboxil/nonivamide group, patients assessed the improvement of their mobility as better than nicoboxil (p < 0.01) and placebo (p < 0.0001) on all four treatment days and compared with nonivamide on Day 1 (p = 0.0435)
  • The proportion of patients taking rescue medication was numerically highest in the placebo group (25.5%), followed by nicoboxil group (22.4%), nicoboxil/nonivamide group (18.3%) and nonivamide group (17.7%).
Conclusion: 

Nicoboxil/nonivamide ointment was found to be effective, tolerable and safe treatment for acute low back pain.

Although paracetamol is recommended as first line treatment by majority of guidelines, a recent clinical trial showed that this analgesic was not superior to placebo. In such conditions, the combination nicoboxil/nonivamide ointment adds a promising option for the treatment of acute low back pain.

Eur J Pain. 2015
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