N-Acetyl Cysteine as an Add-on Therapy is Useful in Treating Acute Lumbar Radiculopathy Caused by Disc Herniation: Results of a Randomized, Controlled Clinical Trial.
- 2023-11
- Reviews on recent clinical trials 18(4)
- Bijan Heidari
- Zeinab-Alsadat Seyedian
- Maryam Mehrpooya
- Davoud Ahmadimoghaddam
- Mahtabalsadat Mirjalili
- Masood Ghiasian
- PubMed: 37779397
- DOI: 10.2174/0115748871250545230919055109
Study Design
- Type
- Randomized Controlled Trial (RCT)
- Population
- Sixty-two patients diagnosed with acute lumbar radiculopathy associated with disc herniation
- Methods
- randomly allocated to the NAC or the placebo groups; besides naproxen at a dose of 500 mg twice a day, participants started with NAC or matched placebo at a dose of 600 mg twice a day for eight weeks
- Blinding
- Double-blind
- Duration
- eight weeks
Background
Available experimental and clinical evidence indicates that N-Acetyl cysteine (NAC) may have an analgesic role in specific pain conditions, particularly neuropathic pain. Thus, we hypothesized that NAC supplementation might be also helpful in decreasing pain and improving pain-related disability in patients with acute radiculopathy. We designed this study to investigate the potential use of NAC-adjunctive treatment to Nonsteroidal Anti- Inflammatory Drugs (NSAIDs) in patients with acute radiculopathy secondary to lumbar intervertebral disc herniation.Methods
Sixty-two patients diagnosed with acute lumbar radiculopathy associated with disc herniation were randomly allocated to the NAC or the placebo groups. Besides naproxen at a dose of 500 mg twice a day, participants based on their allocation group started with NAC or matched placebo at a dose of 600 mg twice a day for eight weeks. The pain severity, measured by the Visual Analog Scale (VAS), and pain-related disability measured by the Oswestry Disability Index (ODI) were measured at baseline and weeks 2, 4, and 8 of treatment. Global improvement of symptoms rated by Patient and Clinical Global Impressions of Change (PGIC and CGIC) was also recorded at the end of week 8. All analyses were conducted on an Intentionto- Treat (ITT) analysis data set.Results
A comparison of the VAS and ODI scores at weeks 2 and 4 of the treatment between the two groups did not show a significant difference. In contrast, from week 4 to week 8, we noticed a significantly greater reduction in the mean VAS and ODI scores in the NAC group compared to the placebo group (p-value <0.001 for both variables). In parallel with these results, also, more NAC-treated than placebo-treated patients achieved treatment success defined as ''very much'' or ''much improved'' on CGIC and PGIC scales, and these differences reached a significant level (p-value = .011 and p-value = .043).Conclusions
This study suggested that NAC might be a relevant candidate for adjunct therapy in managing acute lumbar radiculopathy. Additional clinical trials are needed to validate these findings.Research Insights
more NAC-treated than placebo-treated patients achieved treatment success defined as 'very much' or 'much improved' on CGIC ... scales, and these differences reached a significant level (p-value = .011)
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 600 mg twice a day
more NAC-treated than placebo-treated patients achieved treatment success defined as 'very much' or 'much improved' on ... PGIC scales, and these differences reached a significant level (p-value = .043)
- Effect
- Beneficial
- Effect size
- Moderate
- Dose
- 600 mg twice a day
A comparison of the VAS ... scores at weeks 2 and 4 of the treatment between the two groups did not show a significant difference
- Effect
- Neutral
- Effect size
- Small
- Dose
- 600 mg twice a day
A comparison of the ... ODI scores at weeks 2 and 4 of the treatment between the two groups did not show a significant difference
- Effect
- Neutral
- Effect size
- Small
- Dose
- 600 mg twice a day