To our knowledge, this is the only study utilizing CFAs for axial discogenic low back pain. This study found that supplementation with 4 weeks of CFAs reduced disability and improved function as measured by a statistically significant reduction in ODI scores. Pain from axial discogenic low back pain was also reduced as shown in the statistically significant reduction of NPRS best, worst, and current scores. NPRS best, worst, and current scores were all taken to attempt to address the critique that NPRS does not address the complexity and changing nature of chronic low back pain. While 48% of patients were responders using MCID for ODI scores, we must consider that axial discogenic low back pain is a complex condition, and this response rate is significant to an issue as difficult to treat. Based on these findings, CFAS could be an alternative for other substances utilized for pain and disability management in axial discogenic low back pain that come with extensive side effects.
It is important to frame the results of our study on CFAs in the scope of the other treatments available. Non-steroidal anti-inflammatory drugs (NSAIDs) and opiates are the most common pharmaceutical options for treating axial discogenic low back pain, with NSAIDs currently as the first line analgesic option [4, 5]. An extensive 2011 Cochrane review meta-analysis on NSAID use for low back pain concluded that NSAIDs have only shown a small impact for treatment of chronic low back pain [4, 5]. When compared to placebo, the pool weighted mean difference was − 12.40 (95% CI: -15.53 to-9.26) in favor of NSAIDs [5]. Overall, NSAIDs were slightly better than placebo at improving pain and disability from chronic low back pain. However, NSAIDs come with significant gastrointestinal side effects; 15–30% of patients on chronic NSAIDs will develop erosions or ulcers according to endoscopy studies [5, 20]. NSAIDs have also shown significant renal toxic and cardio toxic effects at lower rates than gastrointestinal side effects [20].
In comparison, opiates have shown evidence for analgesic effect in short term usage for chronic low back pain [21]. Data on function improvements and long-term effectiveness are unknown [21, 22]. The average pain relief encompassing chronic pain in general was 30%; however, data on long term usage and chronic back pain specifically is still unknown [21]. Use of opioids must be highly regulated as prescriptions for chronic pain are the main contributor to the opioid epidemic [22]. Opiates have high rates of development of abuse and/or dependence, and negative psychological changes including depression and anxiety, and hyperalgesia [22].
Similar to NSAIDs and opiates, there was an improvement in pain and disability in the short term in this study using CFAs. The ODI scores and NPRS of all measures decreased in a statistically significant manner. Around half of patients who received CFAs were considered responders, which was a significant number of patients in comparison. We do not have long term data to compare since our supplementation period was 4 weeks. However, since our study is not a randomized controlled trial, we are not able to make direct comparisons in success between NSAIDs, opiates, and CFAs. Patients in our study did not have the significant side effects of opiates and NSAIDs. In our study, around 10% of patients experienced adverse events, none of which were life threatening. One patient experienced shortness of breath. The patient pursued a cardiac stress test which was negative. We are unsure if this was a result of CFA supplementation or other conditions of the patient. Prior studies utilizing CFAs have supported limited side effects. In comparison with pharmaceutical options, the side effects noted for CFAs are minor. CFAs show strong capabilities as a no harm first line treatment for patients with axial discogenic low back pain.
We are aware that this study has some limitations. First is the lack of a control group with subjects receiving a placebo. A comparison between CFA and placebo was not within the aim of this study, although a placebo arm would have allowed to obtain clearer results and should be pursued in future studies. Similarly, the study did not have blinding of physicians or patients which could impact the results and should be studied. This study was conducted at a single center which cannot be representative of the entire population. Finally, the length of follow up is a limitation. Prior analysis of NSAID usage showed studies utilizing periods ranging from < 2 weeks to > 12 months [4]. While this range is variable, our supplementation for 4 weeks would be considered short-term. A longer term follow up would help to draw conclusions regarding the use of CFAs in the chronic pain and disability resulting from axial discogenic low back pain.
In conclusion, the supplementation of CFA in oral formulation for 4 consecutive weeks in patients with axial discogenic low back reduced disability and pain with minimal adverse effects. Oral CFA supplementation could be a promising solution to improve disability and pain in patients with axial discogenic low back pain as a first line treatment, though further studies need to be conducted.