Efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine in the treatment of episodic tension‐type headache: a double‐blind, randomized, nimesulide‐controlled, parallel group, multicentre trial

Cerbo, R.; Centonze, Vincenzo; Grazioli, Irene; Tavolato, B.; Trenti, Tommaso; Uslenghi, C; Sternieri, E

doi:10.1111/j.1468-1331.2005.01056.x

Cited by 14 publications

(32 citation statements)

References 43 publications

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“…There were 40 included reports [6,8,11,[17][18][19][20][21][22][23][24][25]30,[35][36][37]39,[44][45][46][47]53,[55][56][57][59][60][61]64,[66][67][68][69][74][75][76][77]79,82,83]. Four reports included more than 1 trial.…”

Section: Searchingmentioning

confidence: 97%

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Evidence for efficacy of acute treatment of episodic tension-type headache: Methodological critique of randomised trials for oral treatments

Moore

Derry

Wiffen

et al. 2014

Pain

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The International Headache Society (IHS) provides guidance on the conduct of trials for acute treatment of episodic tension-type headache (TTH), a common disorder with considerable disability. Electronic and other searches identified randomised, double-blind trials of oral drugs treating episodic TTH with moderate or severe pain at baseline, or that tested drugs at first pain onset. The aims were to review methods, quality, and outcomes reported (in particular the IHS-recommended primary efficacy parameter pain-free after 2 hours), and to assess efficacy by meta-analysis. We identified 58 reports: 55 from previous reviews and searches, 2 unpublished reports, and 1 clinical trial report with results. We included 40 reports of 55 randomised trials involving 12,143 patients. Reporting quality was generally good, with potential risk of bias from incomplete outcome reporting and small size; the 23 largest trials involved 82% of patients. Few trials reported IHS outcomes. The number needed to treat values for being pain-free at 2 hours compared with placebo were 8.7 (95% confidence interval [CI] 6.2 to 15) for paracetamol 1000 mg, 8.9 (95% CI 5.9 to 18) for ibuprofen 400mg, and 9.8 (95% CI 5.1 to 146) for ketoprofen 25mg. Lower (better) number needed to treat values were calculated for outcomes of mild or no pain at 2 hours, and patient global assessment. These were similar to values for these drugs in migraine. No other drugs had evaluable results for these patient-centred outcomes. There was no evidence that any one outcome was better than others. The evidence available for treatment efficacy is small in comparison to the size of the clinical problem.

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Section: Searchingmentioning

confidence: 97%

“…Of the 40 reports, 34 had a placebo control, whereas 6 used an active comparator only [6,21,22,30,36,56]. Twenty-eight had a parallel design.…”

Section: Characteristics Of Included Trialsmentioning

confidence: 98%

Evidence for efficacy of acute treatment of episodic tension-type headache: Methodological critique of randomised trials for oral treatments

Moore

Derry

Wiffen

et al. 2014

Pain

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“…In a double-blind, double-dummy, randomised, parallel group, multicenter study, the fixed combination and sumatriptan (50 mg) did not significantly differ in the acute treatment of migraine attacks in terms of the primary efficacy endpoint [15]. In a similar study on the treatment of episodic tension-type headache, the fixed combination was significantly superior to the control substance nimesulide (a sulfonamide compound with antiinflammatory, analgesic and antipyretic effects) at 100 mg in the second headache episode, but not in the first episode examined [19]. …”

Section: Discussionmentioning

confidence: 99%

Combined analgesics in (headache) pain therapy: shotgun approach or precise multi-target therapeutics?

et al. 2011

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BackgroundPain in general and headache in particular are characterized by a change in activity in brain areas involved in pain processing. The therapeutic challenge is to identify drugs with molecular targets that restore the healthy state, resulting in meaningful pain relief or even freedom from pain. Different aspects of pain perception, i.e. sensory and affective components, also explain why there is not just one single target structure for therapeutic approaches to pain. A network of brain areas ("pain matrix") are involved in pain perception and pain control. This diversification of the pain system explains why a wide range of molecularly different substances can be used in the treatment of different pain states and why in recent years more and more studies have described a superior efficacy of a precise multi-target combination therapy compared to therapy with monotherapeutics.DiscussionIn this article, we discuss the available literature on the effects of several fixed-dose combinations in the treatment of headaches and discuss the evidence in support of the role of combination therapy in the pharmacotherapy of pain, particularly of headaches. The scientific rationale behind multi-target combinations is the therapeutic benefit that could not be achieved by the individual constituents and that the single substances of the combinations act together additively or even multiplicatively and cooperate to achieve a completeness of the desired therapeutic effect.As an example the fixesd-dose combination of acetylsalicylic acid (ASA), paracetamol (acetaminophen) and caffeine is reviewed in detail. The major advantage of using such a fixed combination is that the active ingredients act on different but distinct molecular targets and thus are able to act on more signalling cascades involved in pain than most single analgesics without adding more side effects to the therapy.SummaryMultitarget therapeutics like combined analgesics broaden the array of therapeutic options, enable the completeness of the therapeutic effect, and allow doctors (and, in self-medication with OTC medications, the patients themselves) to customize treatment to the patient's specific needs. There is substantial clinical evidence that such a multi-component therapy is more effective than mono-component therapies.

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“…The fixed combination of indomethacin, prochlorperazine and caffeine (hereinafter Indoprocaf) is a drug of well-established use in Italy, with a recognized efficacy and a good level of safety both in the acute treatment of migraine [2, 3] and tension-type headache [4]. …”

Section: Introductionmentioning

confidence: 99%

The central analgesia induced by antimigraine drugs is independent from Gi proteins: superiority of a fixed combination of indomethacin, prochlorperazine and caffeine, compared to sumatriptan, in an in vivo model

et al. 2009

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A hypofunctionality of Gi proteins has been found in migraine patients. The fixed combination of indomethacin, prochlorperazine and caffeine (Indoprocaf) is a drug of well-established use in the acute treatment of migraine and tension-type headache. The aim of this study was to investigate if Indoprocaf was able to exert its central antinociceptive action when Gi proteins activity is abolished by pertussis toxin (PTX), compared to its single active ingredients and to sumatriptan. The mice model of abdominal constriction test induced by an i.p. injection of a 0.6% solution of acetic acid was used. The study showed that Indoprocaf (a fixed combination of indomethacin 1 mg/kg, prochlorperazine 1 mg/kg and caffeine 3 mg/kg, s.c.) and sumatriptan (20 mg/kg, s.c.) exert their central antinociceptive action independently from the Gi proteins. In addition, the antinociceptive efficacy of Indoprocaf in this study was statistically superior to that of sumatriptan. This study also showed that the single active ingredients of Indoprocaf, indomethacin (1 mg/kg, s.c.), prochlorperazine (1 mg/kg, s.c.) and caffeine (3 mg/kg, s.c.), were able to exert their central antinociceptive action independently from the Gi proteins. However, Indoprocaf at analgesic doses was able to abolish almost completely the abdominal constrictions, with a statistically higher efficacy compared to the single active ingredients, showing an important synergic effect of Indoprocaf. This synergic effect was evident not only when Gi proteins activity was abolished by PTX, but also under control condition, when Gi proteins were active. This study suggests that the central antinociceptive action induced by antimigraine drugs is independent from Gi proteins.

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Efficacy of a fixed combination of indomethacin, prochlorperazine, and caffeine in the treatment of episodic tension‐type headache: a double‐blind, randomized, nimesulide‐controlled, parallel group, multicentre trial

Cited by 14 publications

References 43 publications

Evidence for efficacy of acute treatment of episodic tension-type headache: Methodological critique of randomised trials for oral treatments

Evidence for efficacy of acute treatment of episodic tension-type headache: Methodological critique of randomised trials for oral treatments

Combined analgesics in (headache) pain therapy: shotgun approach or precise multi-target therapeutics?

The central analgesia induced by antimigraine drugs is independent from Gi proteins: superiority of a fixed combination of indomethacin, prochlorperazine and caffeine, compared to sumatriptan, in an in vivo model

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