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Abstract
The present paper continues a more complex research related to the increased synergism in terms of both anti-inflammatory and analgesic effect obtained by the addition of chlorpheniramine (CLF) to the common acetylsalicylic acid (ASA), acetaminophen (PAR), and caffeine (CAF) combination. This synergistic effect was previously highlighted both in vitro in rat models and in vivo in the treatment of migraine. The aim of the research was to further evaluate the analgesic effect of a synergistic low-dose ASA–PAR–CAF–CLF combination in the treatment of low back pain, in a parallel, multiple-dose, double-blind, active controlled clinical trial. A number of 89 patients with low back pain of at least moderate intensity were randomly assigned to receive Algopirin® (ALG), a combinational product containing 125 mg ASA, 75 mg PAR, 15 mg CAF, and 2 mg CLF, or PAR 500 mg, a drug recognized by American Pain Society as “safe and effective” in the treatment of low back pain. One tablet of the assigned product was administered three times a day for seven consecutive days. The patients evaluated their pain level using a Visual Analog Scale prior to administration, and at 1, 2, 4, and 6 h after the morning dose. Time course of effect was similar in structure and size for both treatments. Pain relief appeared rapidly and steadily increased over 4 h after drug administration. Differential pain curves of ALG and PAR were very similar and comparable with the previously determined ALG analgesia pattern in migraine. Differences between the daily mean pain scores were not statistically significant for the two treatments. Similar results were obtained for the Sum of Pain Intensity Differences (SPID) for 0–4 h and 0–6 h intervals as well as for the time course of the proportion of patients with at least 30% and at least 50% pain relief. In conclusion, in spite of very small doses of active components, ALG proved equally effective to the standard low back pain treatment and therefore a viable therapeutic alternative, mainly for patients with gastrointestinal and hepatic sensitivity. Trial Registration: www.ClinicalTrials.gov, identifier EudraCT No.: 2015–002314–74.
Highlights
Low back pain (LBP) affects a large number of people in developed countries and, following the associated disability, has important consequences on the health system and economy (Frymoyer, 1988; Liddle et al, 2007)
The present study aims to extend our research regarding the efficacy of the synergistic low-dose acetylsalicylic acid (ASA)–PAR–CAF–CLF combination in the treatment of acute LBP, in a parallel, multipledose, double-blind, active controlled clinical trial, for the purpose of offering a therapeutic alternative with comparable efficacy to PAR 500 mg
The study conformed with the Helsinki Declaration of 1964, as revised in 2013, with the International Conference on Harmonization (ICH) Good Clinical Practice regulations, as well as the Joint Clinical Practice Guideline from the American College of Physicians and the American Pain Society on the diagnosis and treatment of LBP (Chou et al, 2007)
Summary
Low back pain (LBP) affects a large number of people in developed countries and, following the associated disability, has important consequences on the health system and economy (Frymoyer, 1988; Liddle et al, 2007). LBP is the fifth most common reason for all visits to physicians for clinical diagnosis, treatment, and evaluation in the United States (Hart et al, 1995; Deyo et al, 2006). The common therapy to reduce pain, inflammation, and functional disability includes nonsteroidal anti-inflammatory drugs (NSAIDs), PAR, corticosteroids, and various opioids. Nonsteroidal Anti-Inflammatory Drugs NSAIDs are the most widely used drugs in the world and their use in the treatment of LBP makes no exception (Matsumo et al, 1991). A Joint Guideline of the American College of Physicians and the American Pain Society makes the recommendation that “for most patients, first-line medication options are acetaminophen or nonsteroidal anti-inflammatory drugs (NSAIDs)” (Chou et al, 2007)
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