Effect of Combined Diclofenac and B Vitamins (Thiamine, Pyridoxine, and Cyanocobalamin) for Low Back Pain Management: Systematic Review and Meta-analysis

Abstract

Background: Cumulative evidence suggests an analgesic effect of thiamine, pyridoxine, and cyanocobalamin (TPC) in monotherapy, and also when combined with nonsteroidal anti-inflammatory drugs (NSAIDs), particularly diclofenac, in a synergistic manner. The aim of this review was to determine the effects of diclofenac combined with TPC compared with diclofenac monotherapy for low back pain (LBP) management.

Methods: We searched for randomized clinical trials on the MEDLINE, EMBASE, LILACS, and Cochrane databases of records of clinical trials, among other sources. We evaluated the risk of bias regarding randomization, allocation concealment, blinding, incomplete outcome data, selective reporting, and other biases. A random-effects meta-analysis to examine patients with acute LBP (N = 1,108 adults) was performed, along with a subsequent sensitivity analysis.

Results: Five studies in patients with LBP were included in the qualitative synthesis. Four of these studies in acute LBP were included in the first meta-analysis. A sensitivity test based on risk of bias (three moderate- to high-quality studies) found that the combination therapy of diclofenac plus TPC was associated with a significant reduction in the duration of treatment (around 50%) compared with diclofenac monotherapy (odds ratio = 2.23, 95% confidence interval = 1.59 to 3.13, P < 0.00001). We found no differences in the safety profile and patient satisfaction.

Conclusions: This meta-analysis demonstrated that combination therapy of diclofenac with TPC might have an analgesic superiority compared with diclofenac monotherapy in acute LBP. However, there is not enough evidence to recommend this therapy in other types of pain due to the scarcity of high-quality studies.

Keywords: B Vitamins; Back Pain; Diclofenac; Meta-analysis; Systematic Review.

Figure 1

Flowchart describing study selection.

Figure 2

Risk of bias summary in low back pain studies: “+”: low risk of bias, “?”: unclear risk of bias, “−”: high risk of bias.

Figure 3

Meta-analysis: early suspension of medication in patients with acute low back pain due to relief of symptoms, including the Brüggemann study. Forest plot of randomized controlled trials examining premature suspension of study medication due to complete pain relief (VAS ≤ 2). Study ID is the primary author’s last name.

Figure 4

Meta-analysis: gastrointestinal adverse events. Forest plot of randomized controlled trials examining the occurrence of gastrointestinal adverse events.

Figure 5

Meta-analysis: patient satisfaction Forest plot of randomized controlled trials examining patient satisfaction according to the number of patients who reported some grade of improvement and those who did not at their last visit in the study.

Figure 6

Meta-analysis: early suspension of medication in patients with acute low back pain due to relief of symptoms, without including the Brüggemann study. Forest plot of randomized controlled trials examining premature suspension of study medication due to complete pain relief (VAS ≤ 2), without including the Brüggemann study (sensitivity analysis). Study ID is the primary author's last name.