This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.
The main aim of this study was to confirm in an Italian population affected by tension-type headache (TTH) the good profile of safety and tolerability of the combination paracetamol 1,000 mg-caffeine 130 mg (PCF) observed in previous studies, by a comparison with naproxen sodium 550 mg (NAP) and placebo (PLA). A secondary objective was to assess the efficacy of PCF in the acute treatment of TTH. This was a multicentre, randomised, double-blind, double-dummy, crossover, placebo-controlled trial. Tolerability was assessed by recording adverse events by the patient in the 4-h post-dose treatment. To assess the efficacy, the sum of pain intensity differences (SPID) and the total pain relief (TOTPAR) were calculated. Comparing PCF and NAP and PCF and PLA for tolerability, the difference was nonsignificant but the result regarding noninferiority was inconclusive, whilst NAP was noninferior to PLA. As regards SPID and TOTPAR, both PCF and NAP were better than placebo (P < 0.05), but not significantly different from each other. In conclusion, PCF was well-tolerated and effective in the treatment of acute TTH.
The objective of this study was to evaluate and compare the efficacy and safety of single doses of acetaminophen (paracetamol) 1000 mg and naproxen 375 mg vs. placebo over a six-hour period in the treatment of tension-type headache. The treatments were compared in a randomized, double-blind, multicentre, placebo-controlled study. Efficacy was evaluated using four standard analgesic summary endpoints (the sum of pain intensity differences from baseline, the maximum pain intensity from baseline, the sum of the pain relief scores, and the maximum pain relief score). Both acetaminophen 1000 mg and naproxen 375 mg were significantly superior to placebo (<i>P</i> ≤ 0.009 and <i>P</i> ≤ 0.021, respectively) but not significantly different from each other (<i>P</i> ≥ 0.498) for these four endpoints. For example, the mean sum of pain intensity differences from baseline was 9.14 ± 0.34 for acetaminophen 1000 mg and 8.81 ± 0.35 for naproxen 375 mg compared with 7.42 ± 0.34 for placebo. Other efficacy endpoints (percentage of responders (pain reduced to none) at two hours, onset of meaningful relief, time to use of rescue medication and subject's overall impression of study medication) showed similar trends. A significantly larger mean pain intensity difference from baseline was observed for acetaminophen 1000 mg (1.13) than for naproxen 375 mg (0.95) (<i>P</i> = 0.036) at one hour after treatment. There was no significant difference among the treatment groups in the incidence of adverse events (<i>P</i> = 0.730). In summary, the results of this well-controlled, double-blind study demonstrate that over-the-counter acetaminophen 1000 mg and prescription naproxen 375 mg are effective and well tolerated in the treatment of tough (moderate-to-severe) tension-type headache. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
Objective.-To evaluate the relative efficacy of a new solubilized formulation of ibuprofen compared with acetaminophen caplets. Methods.-This double-blind, randomized, parallel group study evaluated 154 subjects taking a single dose of solubilized ibuprofen, 400 mg; acetaminophen, 1000 mg; or placebo for the relief of episodic tension-type headache. Time to relief was measured using a stopwatch, and overall efficacy was measured using traditional categorical pain and relief scales. Results.-Ibuprofen capsules (liquigel), 400 mg, were significantly faster than both acetaminophen, 1000 mg, and placebo for all time-to-relief measures. Ibuprofen liquigel had a median time to first perceptible pain relief of 39 minutes compared with 47 minutes for acetaminophen and 113 minutes for placebo. For median time to meaningful relief, ibuprofen liquigel had a time of 39 minutes compared with 53 minutes for acetaminophen and more than 180 minutes for placebo (P<=.02 for both measures). In addition, ibuprofen liquigels demonstrated significantly superior overall analgesic efficacy compared with acetaminophen, 1000 mg, for the relief of episodic tension-type headache. Both active treatments had a side effect profile similar to placebo. Conclusions.-Although several other studies have demonstrated the overall analgesic superiority of ibuprofen to acetaminophen, this study demonstrated that the liquigel formulation also provides a clinically relevant advantage for time to analgesic effects.
Therapies in current use for episodic tension-type headache (ETTH) are often unsatisfactory. Few trials have been conducted to demonstrate efficacy of any of them. This multicenter placebo-controlled randomized parallel-groups study compared the analgesic efficacy of single oral doses of ketoprofen 25 mg and acetaminophen 1000 mg as outpatient treatment of 1 attack of ETTH. Efficacy was assessed by patients as pain relief on a diary-entered 7-point categorical scale. A total of 457 patients treated 348 attacks, 330 of which were evaluable. There were no serious adverse events (AEs); gastrointestinal AEs were most common on all treatments. Total relief from pain after 2 h was recorded by 16% of patients on placebo, 28% on ketoprofen, and 22% on acetaminophen. Worthwhile effect or total relief (all other responses were regarded as treatment failures) were recorded by 36% on placebo, 70% on ketoprofen (<i>p</i> < 0.001), 61% on acetaminophen (<i>p</i> < 0.001). The difference between ketoprofen and acetaminophen was not significant (<i>p</i> = 0.24). Various secondary efficacy measures confirmed superiority of both active treatments over placebo, with some trends for slightly better outcome on ketoprofen than on acetaminophen This study demonstrates that ketoprofen is an effective alternative to standard therapy in ETTH. (PsycInfo Database Record (c) 2021 APA, all rights reserved)
A single-dose, double-blind, randomized clinical trial was conducted to examine the relative analgesic effectiveness of 400 mg of ibuprofen (n = 153), 1,000 mg of acetaminophen (n = 151), and placebo (n = 151) in volunteers with muscle contraction headache. At regular intervals during a 4-hour period, participants evaluated headache pain intensity on a 100-mm visual analog scale and headache pain relief on a six-category scale. Both active agents were significantly different from placebo at all time points and in reducing pain intensity and providing relief of headache overall. Similarly, ibuprofen at 400 mg differed significantly from acetaminophen at 1,000 mg on both rating scales. Participants receiving ibuprofen at 400 mg achieved complete relief of headache faster than those receiving acetaminophen at 1,000 mg or placebo, and more participants taking ibuprofen experienced complete relief of headache than those taking placebo or acetaminophen. Both ibuprofen at 400 mg and acetaminophen at 1,000 mg are efficacious analgesic agents for muscle contraction headache, and ibuprofen at 400 mg is significantly more effective than acetaminophen at 1,000 mg for treating this condition.
The effect of a locally applied peppermint oil preparation on tension-type headache was examined in the design of a randomized, placebo-controlled double-blind crossover study for the first time. The preparation was tested against both the reference substance acetaminophen and to the corresponding placebo. The liquid test preparation contained 10 g of peppermint oil and ethanol (90%) ad 100 (test preparation LI 170, Lichtwer Pharma, Berlin); the placebo was a 90% ethanol solution to which traces of peppermint oil were added for blinding purposes. The reference preparation contained 500 mg acetaminophen; the placebo tablet was identical to the verum in size and appearance. The study included the analysis of 164 headache attacks of 41 patients of both sexes ranging between 18 and 65 years of age, suffering from tension-type headache in accordance with the IHS classification. Four headache episodes per patient were treated in a double-blind, randomized crossover design. Each headache attack was treated by the application of 2 capsules of the oral medication (1,000 mg of acetaminophen or placebo) and the cutaneous application of the oil preparation (peppermint oil or placebo solution). The oil was spread largely across forehead and temples which was repeated after 15 and 30 minutes. Using a headache diary, the headache parameters were assessed after 15, 30, 45 and 60 minutes. Compared to the application of placebo, a 10% peppermint oil in ethanol solution significantly reduced the clinical headache intensity already after 15 minutes (p < 0.01). This significant clinical reduction of the pain intensity continued over the one hour observation period. Acetaminophen, too, proved to be efficient compared to placebo (p < 0.01). There was no significant difference between the efficacy of 1,000 mg of acetaminophen and 10% peppermint oil in ethanol solution. Simultaneous application of 1,000 mg of acetaminophen and 10% peppermint oil in ethanol solution leads to an additive effect which remains below the significance threshold, however. The patients reported no adverse events. This controlled study showed for the first time that a 10% peppermint oil in ethanol solution efficiently alleviates tension-type headache. Peppermint oil thus proves to be a well-tolerated and cost-effective alternative to usual therapies.
The aim of the study was to assess the efficacy and tolerability of a single oral dose of ketoprofen 25 mg in comparison with single doses of ketoprofen 2 × 25 mg, paracetamol 500 mg and 1,000 mg, and placebo in the treatment of episodic tension-type headache. The study was conducted as a single centre, double-blind, randomized, placebo-controlled, five-period, within-patient comparative trial in outpatients with episodic tension-type headache according; to the International Headache Society's diagnostic criteria. Each patient had to treat five attacks of episodic tension-type headache with a single dose of each of the tested medications with a minimum interval o 72 h between two attacks. Details of the attack and response to treatment were recorded on a diary card Altogether 30 patients treated 5 attacks and 2, 3, 1 and 4 patients treated 4, 3, 2 and 1 attack, respectively, The primary variable was decrease in headache pain intensity from baseline to 2 h after intake, evaluated by means of a 100 mm visual analogue scale. Ketoprofen 50 mg was significantly better than placebo an paracetamol for this main criterion. Neither of the paracetamol groups differed from the placebo group, Only a few adverse events were reported, usually of mild or moderate severity, with no difference between the treatments. Ketoprofen 50 mg may be considered an effective and well tolerated analgesic in the treatment of episodic tension-type headache of moderate or severe intensity. (PsycInfo Database Record (c) 2022 APA, all rights reserved)
Sechs randomisierte, doppel-blinde, Zwei-Perioden-Crossover-Studien, die unter ähnlichen Protokollen durchgeführt, verglich die Wirksamkeit von zwei analgetische Kombinationen mit Koffein mit einem Paracetamol 1000 mg-Steuerung und mit einem Placebo bei ambulanten Patienten mit episodischen Spannungskopfschmerzen. In vier Studien, umfassend 1900 Patienten, bestand die koffeinhaltige analgetische aus einer Kombination von 500 mg Paracetamol, 500 mg Aspirin und 130 mg Koffein (APAP / ASA / CAF). In beiden Studien, umfassend 911 Patienten bestand die koffeinhaltige analgetische aus einer Kombination von 1000 mg Paracetamol und 130 mg Koffein (APAP / CAF). Die Patienten selbst Arzneimittel für mittelschwere oder schwere Kopfschmerzen, und mit einer Selbst-Rating Rekord sie schätzten sie ihre Schmerzen und ihre Linderung stündlich für 4 Stunden. In allen sechs Studien waren die koffeinhaltige Schmerzmittel signifikant überlegen sowohl mit Placebo und bis 1000 mg Paracetamol, Paracetamol und war dem Placebo signifikant überlegen. Der signifikante analgetische adjuvante Wirkung von Koffein war unabhängig von Patienten üblichen Koffein Nutzung oder ihre Koffein-Konsum in den 4 Stunden vor der Medikation. Für jede Behandlung wurden die gepoolten analgetischen Wirkungen für die vier Studien APAP / ASA / CAF nahezu deckungsgleich zu den Antworten in den beiden APAP / CAF Studien. Die Kombinationen produzierten mehr Magenbeschwerden, Nervosität, Schwindel und als Paracetamol oder Placebo.
This study will compare a fast-absorbing paracetamol plus caffeine formula with placebo and an over-the-counter dose of paracetamol and ibuprofen to treat episodic tension headache.
