Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back Pain
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 synerg...
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Frontiers Media S.A.
2019-06-01
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Online Access: | https://www.frontiersin.org/article/10.3389/fphar.2019.00607/full |
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doaj-88346b2ea1164b4fbac060c31ad46d00 |
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Article |
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DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Victor A. Voicu Victor A. Voicu Constantin Mircioiu Cristina Plesa Mariana Jinga Mariana Jinga Vasile Balaban Vasile Balaban Roxana Sandulovici Ana Maria Costache Valentina Anuta Ion Mircioiu |
spellingShingle |
Victor A. Voicu Victor A. Voicu Constantin Mircioiu Cristina Plesa Mariana Jinga Mariana Jinga Vasile Balaban Vasile Balaban Roxana Sandulovici Ana Maria Costache Valentina Anuta Ion Mircioiu Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back Pain Frontiers in Pharmacology low back pain synergistic combination lowest-dose pain relief Algopirin® safer drug use |
author_facet |
Victor A. Voicu Victor A. Voicu Constantin Mircioiu Cristina Plesa Mariana Jinga Mariana Jinga Vasile Balaban Vasile Balaban Roxana Sandulovici Ana Maria Costache Valentina Anuta Ion Mircioiu |
author_sort |
Victor A. Voicu |
title |
Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back Pain |
title_short |
Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back Pain |
title_full |
Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back Pain |
title_fullStr |
Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back Pain |
title_full_unstemmed |
Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back Pain |
title_sort |
effect of a new synergistic combination of low doses of acetylsalicylic acid, caffeine, acetaminophen, and chlorpheniramine in acute low back pain |
publisher |
Frontiers Media S.A. |
series |
Frontiers in Pharmacology |
issn |
1663-9812 |
publishDate |
2019-06-01 |
description |
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. |
topic |
low back pain synergistic combination lowest-dose pain relief Algopirin® safer drug use |
url |
https://www.frontiersin.org/article/10.3389/fphar.2019.00607/full |
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doaj-88346b2ea1164b4fbac060c31ad46d002020-11-24T22:15:13ZengFrontiers Media S.A.Frontiers in Pharmacology1663-98122019-06-011010.3389/fphar.2019.00607447929Effect of a New Synergistic Combination of Low Doses of Acetylsalicylic Acid, Caffeine, Acetaminophen, and Chlorpheniramine in Acute Low Back PainVictor A. Voicu0Victor A. Voicu1Constantin Mircioiu2Cristina Plesa3Mariana Jinga4Mariana Jinga5Vasile Balaban6Vasile Balaban7Roxana Sandulovici8Ana Maria Costache9Valentina Anuta10Ion Mircioiu11Department of Clinical Pharmacology, Toxicology and Psychopharmacology, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaDoctoral School, “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaDoctoral School, “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaDepartment of Neurology, “Dr. Carol Davila” Central Military Emergency University Hospital, Bucharest, RomaniaDepartment of Internal Medicine and Gastroenterology, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaInternal Medicine and Gastroenterology Clinic, “Dr. Carol Davila” Central Military Emergency University Hospital, Bucharest, RomaniaDepartment of Internal Medicine and Gastroenterology, Faculty of Medicine, “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaInternal Medicine and Gastroenterology Clinic, “Dr. Carol Davila” Central Military Emergency University Hospital, Bucharest, RomaniaDepartment of Applied Mathematics and Biostatistics, Titu Maiorescu University, Bucharest, RomaniaDepartment of Clinical Research, CEBIS International, Bucharest, RomaniaDepartment of Physical and Colloidal Chemistry, Faculty of Pharmacy, “Carol Davila” University of Medicine and Pharmacy, Bucharest, RomaniaDepartment of Biopharmacy and Pharmacokinetics, Titu Maiorescu University, Bucharest, RomaniaThe 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.https://www.frontiersin.org/article/10.3389/fphar.2019.00607/fulllow back painsynergistic combinationlowest-dose pain reliefAlgopirin®safer drug use |