Published and not fully published doubleblind ra

Authors: Peer Carsten TfeltHansen

Publish Date: 2011/08

Volume: 12, Issue: 4, Pages: 399-

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Abstract

Naratriptan 25 mg is now an overthecounter drug in Germany This should increase the interest in drug The GSK Trial Register was searched for published and unpublished doubleblind randomised controlled trials RCTs concerning the use of naratriptan in migraine Only 7 of 17 RCTs are published in full Naratriptan 25 mg is superior to placebo for acute migraine treatment in 6 RCTs but inferior to sumatriptan 100 mg and rizatriptan 10 mg in one RCT each This dose of naratriptan has no more adverse events than placebo Naratriptan 1 mg bid has some effect in the shortterm prophylactic treatment of menstruationassociated migraine in 3 RCTs In 2 RCTs naratriptan 25 mg was equivalent to naproxen sodium 375 mg for migrainerelated quality of life Naratriptan 25 mg 34 preference was superior to naproxen sodium 500 mg 25 preference Naratriptan 25 mg is better than placebo in the acute treatment of migraine The adverse effect profile of naratriptan 25 mg is similar to that of placebo The efficacy of naratriptan 25 mg versus NSAIDs is not sufficiently investigated Naratriptan when available OTC is a reasonable second or third choice on the step care ladder in the acute treatment of migraineIn Germany the 5hydroxytryptamine 5HT1B/1D receptor agonist naratriptan is an overthecounter OTC drug most likely because of its excellent tolerability 1–3 The time to maximum blood concentration is 2 h for oral naratriptan and 15 h for oral sumatriptan 2 4 The oral bioavailability of naratriptan is 74 and much higher than the 14 availability of sumatriptan 4 The elimination halflives of naratriptan and sumatriptan are 55 and 2 h respectively 4 Naratriptan 25 mg tablets have a placebolike tolerability profile and are associated with a low incidence of headache recurrence 5 Thus the 25mg dose offers some advantages over other 5HT1B/1D agonists and naratriptan has been called the “gentle triptan” 5In 1998 the Ethics Subcommittee of the International Headache Society 6 stated that the “responsibility for publication cannot be separated from the ethical responsibility of the investigator” The Subcommittee agreed that “scientists have an ethical obligation to submit creditable research results for publication and should not enter into agreements that interfere with their control over the decision to publish” As a general rule every methodologically sound randomised controlled trial should be published to allow an evaluation of the results publication solely as an abstract or in nonpeerreviewed supplements is unacceptable 6Recently I reported on six unpublished randomised controlled trials RCTs with sumatriptan 7 These RCTs were found in the GlaxoSmithKline GSK Trial Register and I became aware of unpublished RCT with naratriptan Because naratriptan is now becoming an OTC drug in some countries a review of all RCTs is relevant In the present review of 17 doubleblind randomised controlled trials RCTs in the naratriptan part of the GSK Trial Register it was remarkable that less than half of these RCTs were fully published in peerreviewed journals

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