This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of episodic tension-type headache.
The aims of this placebo-controlled study were to determine whether single doses of diclofenac-K 12.5 and 25 mg effectively relieve episodic tension headache (ETH) in adults and to compare it to ibuprofen 400 mg. A single-dose, multicentre, randomized, double-blind, double-dummy, clinical trial was conducted at 22 primary care centres in Germany. All subjects had a history of ETH according to the classification of the International Headache Society. Of 684 subjects, 620 used the study drugs for an episode of tension headache occurring within one month after enrollment: diclofenac-K 12.5mg (160), diclofenac-K 25mg (156), ibuprofen 400mg (151) and placebo (153). The primary efficacy variable was total pain relief, calculated as the time-weighted sum of the pain relief assessments from baseline to the 3 hr evaluation time. Results of the study show that all active treatments were superior to placebo; no statistically significant difference between the three active treatments could be detected. The final conclusion drawn is that diclofenac-K, administered as single doses of 12.5 and 25 mg effectively relieves ETH and is comparable to ibuprofen 400 mg. (PsycInfo Database Record (c) 2021 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.
HINTERGRUND: Die Wirksamkeit von Coffein als Adjuvans zu Ibuprofen hat sich in Untersuchungen von akuten Schmerzen dokumentiert. Unsere Ziele waren, um diese Mittel bei der Behandlung von Spannungskopfschmerz zu bewerten und die klinische Studie Methoden für die Auswertung dieses Mittels im Vergleich zu verschiedenen Spannungskopfschmerz Behandlungen zu etablieren. Stoppuhr-Technologie wurde für die Messung verwendeten Techniken.
METHODEN: Eine randomisierte, doppel-blinde, parallele, multizentrische, Einzeldosis-, placebo-und aktiv-kontrollierte Studie umfasste 301 Patienten mit Spannungskopfschmerz diagnostiziert. Behandlungsgruppen waren Ibuprofen und Koffein, Ibuprofen allein, Koffein allein, oder Placebo. Probanden gemessen Beginn der Erleichterung (sowohl Zeit bis zum ersten spürbaren Entlastung und Zeit für sinnvolle Erleichterung) nach der Einnahme eines oralen Einzeldosis von den ihnen zugewiesenen Medikation. Schmerzintensität und Schmerzlinderung wurden über einen 6-Stunden-Zeitraum Studie bewertet. Gesamtbeurteilung wurde nach Abschluss aller anderen Bewertungen vorgenommen.
ERGEBNISSE: Ibuprofen und Koffein verabreicht zusammen vorausgesetzt signifikant größere analgetische Wirkung als Ibuprofen allein, Koffein allein, und Placebo. Ibuprofen und Koffein zusammen deutlich kürzere Zeiten verabreicht gezeigt, dass bedeutsame Verbesserung in der Linderung der Kopfschmerzen als Ibuprofen oder Placebo; deutlich höhere Summe Analgesie als Ibuprofen allein, Koffein allein oder Placebo, und deutlich größer als Höhepunkt Relief Ibuprofen allein, Koffein allein, oder Placebo. Signifikant mehr Patienten erhalten aussagekräftige Kopfschmerzen Relief mit Ibuprofen und Koffein zusammen als mit Ibuprofen allein oder Placebo verabreicht. Mehr Patienten berichteten komplette Linderung der Kopfschmerzen mit Ibuprofen und Koffein zusammen als mit Ibuprofen allein, Koffein allein, oder Placebo verabreicht. Ibuprofen und Koffein verabreicht wurde gemeinsam signifikant besser bewertet als von den Patienten entweder Ibuprofen allein, Koffein allein, oder Placebo. Keine Themen endete die Teilnahme an der Studie vorzeitig wegen unerwünschter Ereignisse ab.
Schlussfolgerung: Die sensitive Methoden wurden eingeführt, um Unterschiede in der Analgesie unter Over-the-Counter-Analgetika bei der Linderung von Spannungskopfschmerz Schmerz zu beurteilen. Eine Doppelblind-Studie mit dieser Methode lässt vermuten, dass Ibuprofen und Koffein verabreicht gemeinsam größere analgetische Wirksamkeit als jede Komponente allein bietet.
1. The objective of this study was to investigate the efficacy of home-medicated non-steroidal anti-inflammatory (NSAID) analgesics, using an electronic patient diary. Single doses of ketoprofen 25 mg and ketoprofen 50 mg were compared with ibuprofen 200 mg and placebo in the treatment of a single occasion of episodic tension-type headache, using a double-blind, randomized, parallel group design. 2. A total of 166 patients with headache compatible with episodic tension-type headache and no refractory headaches or contraindications to NSAIDs were contacted by advertisements and selected by questionnaires. Patients performed the study at home, using an electronic diary for headache assessment, with a form to allow comments and corrections. Visual analogue scales (VAS 10 cm) of headache severity, five-item headache relief rating (HRR) scales, and time of intake of 'escape' analgesics were scored regularly, for 4 h following intake of trial medication. 3. VAS-scores (n = 1407) and HRRs (n = 452) were returned by 159 patients. Of these scores, 1.5% were inadvertently omitted from the electronic diary or modified on the comment forms. 4. Headache (VAS and HRR) improved more with all three NSAIDs than with placebo, although the effect of ibuprofen was significant for HRR only. After 2 and 4 h respectively, the reduction in VAS-ratios was 17 and 19% with placebo, 18 and 53% with ibuprofen 200 mg, 41 and 61% with ketoprofen 25 mg, and 47 and 59% with ketoprofen 50 mg. After 4 h, headache improved strongly (highest HRR) in 18% of patients on placebo, 39% on ibuprofen 200 mg, 62% on ketoprofen 25 mg, and 55% on ketoprofen 50 mg. Headache disappeared completely (VAS-score = 0) in one patient (3%) with placebo (after 180 min), 10% with ibuprofen 200 mg (average 211 min), 18% with ketoprofen 25 mg (159 min), and 28% with ketoprofen 50 mg (146 min). 5. The effects of ketoprofen 50 mg were more pronounced than those of ibuprofen 200 mg, which seemed to start later. Ketoprofen 25 mg and 50 mg were very similar, suggesting a maximal effect of the lower dose. Mild to moderate adverse events were reported by 9% of the patients, half of which occurred with ketoprofen 50 mg. Treatment of headache with ketoprofen can start with 25 mg, and possibly less. 6. Although a direct comparative study would be necessary to determine the relative benefits of the novel electronic patient diaries over traditional paper-and-pencil methods, this study has shown the usefulness of this newer technique to detect differences in efficacy between low doses of analgesics under ambulant conditions, with very limited loss of data. Electronic patient diaries appear to be an important new attribute for the efficacy assessment of self-medicated drugs.
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 safety and efficacy of treatment of tension-type headache with either ketoprofen or ibuprofen and naproxen sodium were evaluated in a prospective, randomized, double-blind parallel-group-study in 345 subjects. All patients were valid for evaluation of efficacy and safety. Headache pain intensity and pain relief were measured on categorical verbal scales 30, 45, 60, 120, 180 and 240 min after ingestion of a single dose of 12.5 mg or 25 mg ketoprofen, 200 mg ibuprofen and 275 mg naproxen sodium. At no time in four hours observation the efficacy of the four treatments differed, neither in pain intensity difference nor in the pain relief scale. A statistical comparison test was performed only once analysing the primary efficacy variable, the sum of pain intensity differences. There was no statistically significant difference among all treatments in this respect. The results of this clearly indicate that ketoprofen in a dosage of 12.5 or 25 mg, compared to 200 mg ibuprofen and 275 mg naproxen sodium, is an effective and safe treatment in tension-type headache.
This study will compare the ability of a single-dose of a novel ibuprofen formulation to relieve pain compared to placebo and standard ibuprofen in the treatment of tension-type headache
