-
The Journal of Headache and Pain Sep 2023Intranasal agents may be ideal for the treatment of migraine patients. Many new acute intranasal-specific therapies have been developed, but few of them have been... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Intranasal agents may be ideal for the treatment of migraine patients. Many new acute intranasal-specific therapies have been developed, but few of them have been directly compared. The aim of this network meta-analysis (NMA) was to compare the efficacy and safety of various intranasal agents for the treatment of acute migraine in adult patients.
METHODS
The Cochrane Register of Controlled Trials, Embase, and PubMed were searched from inception to 15 August 2023. Randomized controlled trials (RCTs) using intranasal agents (no restrictions on dose, formulation, dosing regimen or timing of the first dose) to treat adult patients with acute migraine were included. The primary efficacy endpoint was pain freedom at 2 h, and the primary safety endpoint was adverse events (AEs). The analysis process followed the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines.
RESULTS
Nineteen studies (21 RCTs, 9738 participants) were included. Compared to the placebo, 5 mg of zolmitriptan using a conventional liquid nasal spray device was the most effective for pain freedom at 2 h [odds ratio (OR): 4.67, 95% confidence interval (CI): 3.43 to 6.43] and 24 h (OR: 5.49, 95% CI: 3.58 to 8.42) among all the interventions. Butorphanol nasal spray 1 mg was the most effective (OR: 8.62, 95% CI: 1.11 to 66.92) for pain freedom at 1 h, but with low-quality evidence. DFN-02 presented the highest freedom from nausea (OR: 4.95, 95% CI: 1.29 to 19.01) and phonophobia (OR: 5.36, 95% CI: 1.67 to 17.22) at 2 h, albeit with lower odds of achieving complete pain freedom. ROX-828 showed the highest improvement in freedom from photophobia at 2 h (OR: 4.03, 95% CI: 1.66 to 9.81). Dihydroergotamine nasal spray was significantly associated with the highest risk of AEs (OR: 9.65, 95% CI: 4.39 to 21.22) and was not recommended for routine use. Zavegepant nasal spray demonstrated the lowest risk of AEs (OR: 2.04, 95% CI: 1.37 to 3.03). The results of sensitivity analyses for the primary endpoints (pain freedom at 2 h and AEs) were generally consistent with those of the base case model.
CONCLUSIONS
Compared with other new intranasal-specific therapies in treating migraine attacks, zolmitriptan nasal spray 5 mg was the most effective agent for pain freedom at 2 h. Zavegepant nasal spray 10 mg had the fewest adverse side effects.
Topics: Adult; Humans; Nasal Sprays; Network Meta-Analysis; Migraine Disorders; Oxazolidinones
PubMed: 37723470
DOI: 10.1186/s10194-023-01662-6 -
The Cochrane Database of Systematic... Dec 2018Tinnitus affects 10% to 15% of the adult population, with about 20% of these experiencing symptoms that negatively affect quality of life. In England alone there are an... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Tinnitus affects 10% to 15% of the adult population, with about 20% of these experiencing symptoms that negatively affect quality of life. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression. Hearing aids, sound generators and combination devices (amplification and sound generation within one device) are a component of many tinnitus management programmes and together with information and advice are a first line of management in audiology departments for someone who has tinnitus.
OBJECTIVES
To assess the effects of sound therapy (using amplification devices and/or sound generators) for tinnitus in adults.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL, via the Cochrane Register of Studies); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 23 July 2018.
SELECTION CRITERIA
Randomised controlled trials (RCTs) recruiting adults with acute or chronic subjective idiopathic tinnitus. We included studies where the intervention involved hearing aids, sound generators or combination hearing aids and compared them to waiting list control, placebo or education/information only with no device. We also included studies comparing hearing aids to sound generators, combination hearing aids to hearing aids, and combination hearing aids to sound generators.
DATA COLLECTION AND ANALYSIS
We used the standard methodological procedures expected by Cochrane. Our primary outcomes were tinnitus symptom severity as measured as a global score on multi-item tinnitus questionnaire and significant adverse effects as indicated by an increase in self-reported tinnitus loudness. Our secondary outcomes were depressive symptoms, symptoms of generalised anxiety, health-related quality of life and adverse effects associated with wearing the device such as pain, discomfort, tenderness or skin irritation, or ear infections. We used GRADE to assess the quality of evidence for each outcome; this is indicated in italics.
MAIN RESULTS
This review included eight studies (with a total of 590 participants). Seven studies investigated the effects of hearing aids, four combination hearing aids and three sound generators. Seven studies were parallel-group RCTs and one had a cross-over design. In general, risk of bias was unclear due to lack of detail about sequence generation and allocation concealment. There was also little or no use of blinding.No data for our outcomes were available for any of our three main comparisons (comparing hearing aids, sound generators and combination devices with a waiting list control group, placebo or education/information only). Data for our additional comparisons (comparing these devices with each other) were also few, with limited potential for data pooling.Hearing aid only versus sound generator device onlyOne study compared patients fitted with sound generators versus those fitted with hearing aids and found no difference between them in their effects on our primary outcome, tinnitus symptom severity measured with the Tinnitus Handicap Inventory (THI) at 3, 6 or 12 months (low-quality evidence). The use of both types of device was associated with a clinically significant reduction in tinnitus symptom severity.Combination hearing aid versus hearing aid onlyThree studies compared combination hearing aids with hearing aids and measured tinnitus symptom severity using the THI or Tinnitus Functional Index. When we pooled the data we found no difference between them (standardised mean difference -0.15, 95% confidence interval -0.52 to 0.22; three studies; 114 participants) (low-quality evidence). The use of both types of device was again associated with a clinically significant reduction in tinnitus symptom severity.Adverse effects were not assessed in any of the included studies.None of the studies measured the secondary outcomes of depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life as measured by a validated instrument, nor the newly developed core outcomes tinnitus intrusiveness, ability to ignore, concentration, quality of sleep and sense of control.
AUTHORS' CONCLUSIONS
There is no evidence to support the superiority of sound therapy for tinnitus over waiting list control, placebo or education/information with no device. There is insufficient evidence to support the superiority or inferiority of any of the sound therapy options (hearing aid, sound generator or combination hearing aid) over each other. The quality of evidence for the reported outcomes, assessed using GRADE, was low. Using a combination device, hearing aid or sound generator might result in little or no difference in tinnitus symptom severity.Future research into the effectiveness of sound therapy in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.
Topics: Acoustic Stimulation; Adult; Hearing Aids; Humans; Randomized Controlled Trials as Topic; Sound; Tinnitus
PubMed: 30589445
DOI: 10.1002/14651858.CD013094.pub2 -
The Cochrane Database of Systematic... Nov 2022Tinnitus is a symptom defined as the perception of sound in the absence of an external source. In England alone there are an estimated ¾ million general practice... (Review)
Review
BACKGROUND
Tinnitus is a symptom defined as the perception of sound in the absence of an external source. In England alone there are an estimated ¾ million general practice consultations every year where the primary complaint is tinnitus, equating to a major burden on healthcare services. Clinical management strategies include education and advice, relaxation therapy, tinnitus retraining therapy (TRT), cognitive behavioural therapy (CBT), sound enrichment using ear-level sound generators or hearing aids, and drug therapies to manage co-morbid symptoms such as insomnia, anxiety or depression. OBJECTIVES: To assess the effects of Ginkgo biloba for tinnitus in adults and children.
SEARCH METHODS
The Cochrane ENT Information Specialist searched the Cochrane ENT Register; CENTRAL (2022, Issue 6); Ovid MEDLINE; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the search was 7 June 2022.
SELECTION CRITERIA
Randomised controlled trials (RCTs) recruiting adults and children with acute or chronic subjective tinnitus. We included studies where the intervention involved Ginkgo biloba and this was compared to placebo, no intervention, or education and information. Concurrent use of other medication or other treatment was acceptable if used equally in each group. Where an additional intervention was used equally in both groups, we analysed this as a separate comparison. The review included all courses of Ginkgo biloba, regardless of dose regimens or formulations, and for any duration of treatment.
DATA COLLECTION AND ANALYSIS
We used standard Cochrane methods. Our primary outcomes were tinnitus symptom severity measured as a global score on a multi-item tinnitus questionnaire and serious adverse effects (bleeding, seizures). Our secondary outcomes were tinnitus loudness (change in subjective perception), tinnitus intrusiveness, generalised depression, generalised anxiety, health-related quality of life and other adverse effects (gastrointestinal upset, headache, allergic reaction). We used GRADE to assess the certainty of the evidence for each outcome.
MAIN RESULTS
This review included 12 studies (with a total of 1915 participants). Eleven studies compared the effects of Ginkgo biloba with placebo and one study compared the effects of Ginkgo biloba with hearing aids to hearing aids alone. All included studies were parallel-group RCTs. In general, risk of bias was high or unclear due to selection bias and poor reporting of allocation concealment and blinding of participants, personnel and outcome assessments. Due to heterogeneity in the outcomes measured and measurement methods used, only limited data pooling was possible. Ginkgo biloba versus placebo When we pooled data from two studies for the primary outcome tinnitus symptom severity, we found that Ginkgo biloba may have little to no effect (Tinnitus Handicap Inventory scores) at three to six months compared to placebo, but the evidence is very uncertain (mean difference (MD) -1.35 (scale 0 to 100), 95% confidence interval (CI) -8.26 to 5.55; 2 studies; 85 participants) (very low-certainty). Ginkgo biloba may result in little to no difference in the risk of bleeding or seizures, with no serious adverse effects reported in either group (4 studies; 1154 participants; low-certainty). For the secondary outcomes, one study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on tinnitus loudness measured with audiometric loudness matching at 12 weeks, but the evidence is very uncertain (MD -4.00 (scale -10 to 140 dB), 95% CI -13.33 to 5.33; 1 study; 73 participants) (very low-certainty). One study found that there may be little to no difference between the effects of Ginkgo biloba and placebo on health-related quality of life measured with the Glasgow Health Status Inventory at three months (MD -0.58 (scale 0 to 100), 95% CI -4.67 to 3.51; 1 study; 60 participants) (low-certainty). Ginkgo biloba may not increase the frequency of other adverse effects (gastrointestinal upset, headache, allergic reaction) at three months compared to placebo (risk ratio 0.91, 95% CI 0.52 to 1.60; 4 studies; 1175 participants) (low-certainty). None of the studies reported the other secondary outcomes of tinnitus intrusiveness or changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety. Gingko biloba with concurrent intervention versus concurrent intervention only One study compared Ginkgo biloba with hearing aids to hearing aids only. It assessed the mean difference in the change in Tinnitus Handicap Inventory scores and tinnitus loudness using a 10-point visual analogue scale (VAS) at three months. The study did not report adverse effects, tinnitus intrusiveness, changes in depressive symptoms or depression, anxiety symptoms or generalised anxiety, or health-related quality of life. This was a single, very small study (22 participants) and for all outcomes the certainty of the evidence was very low. We were unable to draw meaningful conclusions from the numerical results.
AUTHORS' CONCLUSIONS
There is uncertainty about the benefits and harms of Ginkgo biloba for the treatment of tinnitus when compared to placebo. We were unable to draw meaningful conclusions regarding the benefits and harms of Ginkgo biloba when used with concurrent intervention (hearing aids). The certainty of the evidence for the reported outcomes, assessed using GRADE, ranged from low to very low. Future research into the effectiveness of Ginkgo biloba in patients with tinnitus should use rigorous methodology. Randomisation and blinding should be of the highest quality, given the subjective nature of tinnitus and the strong likelihood of a placebo response. The CONSORT statement should be used in the design and reporting of future studies. We also recommend the use of validated, patient-centred outcome measures for research in the field of tinnitus.
Topics: Adult; Child; Humans; Ginkgo biloba; Headache; Hypersensitivity; Seizures; Tinnitus; Randomized Controlled Trials as Topic
PubMed: 36383762
DOI: 10.1002/14651858.CD013514.pub2 -
BMJ Open Jun 2016To systematically review studies of the epidemiology of tinnitus and hyperacusis in children and young people, in order to determine the methodological differences... (Review)
Review
OBJECTIVES
To systematically review studies of the epidemiology of tinnitus and hyperacusis in children and young people, in order to determine the methodological differences implicated in the variability of prevalence estimates and the influence of population characteristics on childhood tinnitus and hyperacusis.
DATA SOURCES
Articles were retrieved from PubMed, EMBASE and Scopus databases and from the relevant reference lists using the methods described in the study protocol, which has previously been published. Reporting Items for Systematic Review (PRISMA) guidelines were followed.
ELIGIBILITY CRITERIA
Studies addressing childhood prevalence, for example, children and young people aged 5-19 years.
DATA SELECTION
2 reviewers independently assessed the studies for eligibility, extracted data and assessed study consistency. Owing to the heterogeneity in the methodologies among the reported studies, only narrative synthesis of the results was carried out.
RESULTS
Having identified 1032 publications, 131 articles were selected and 25 articles met the inclusion criteria and had sufficient methodological consistency to be included. Prevalence estimates of tinnitus range from 4.7% to 46% in the general paediatric population and among children with normal hearing, and from 23.5% to 62.2% of population of children with hearing loss. Reported prevalence ranged from 6% to 41.9% when children with hearing loss and normal hearing were both included. The prevalence of hyperacusis varied from 3.2% to 17.1%.
CONCLUSIONS
Data on prevalence vary considerably according to the study design, study population and the research question posed. The age range of children studied was varied and a marked degree of variation between definitions (tinnitus, hyperacusis) and measures (severity, perception, annoyance) was observed. The lack of consistency among studies indicates the necessity of examining the epidemiology of tinnitus and hyperacusis in children and adolescents with a set of standardised criteria.
TRIAL REGISTRATION NUMBER
CRD42014013456.
Topics: Adaptation, Psychological; Adolescent; Child; Comorbidity; Female; Humans; Hyperacusis; Male; Prevalence; Referral and Consultation; Research Design; Tinnitus
PubMed: 27259524
DOI: 10.1136/bmjopen-2015-010596 -
The Cochrane Database of Systematic... Feb 2012Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter (OTC) analgesics. Diclofenac is an established analgesic, and new formulations using the potassium or epolamine salts, which can be dissolved in water, have been developed for rapid absorption, which may be beneficial in acute migraine. Co-therapy with an antiemetic should help to reduce the nausea and vomiting commonly associated with migraine.
OBJECTIVES
To determine the efficacy and tolerability of diclofenac, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, the Oxford Pain Relief Database, ClinicalTrials.gov, and reference lists for studies through 27 September 2011.
SELECTION CRITERIA
We included randomised, double-blind, placebo- and/or active-controlled studies using self administered diclofenac to treat a migraine headache episode, with at least 10 participants per treatment arm.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.
MAIN RESULTS
Five studies (1356 participants) compared oral diclofenac with placebo, and one also compared it with sumatriptan; none combined diclofenac with a self administered antiemetic. Four studies treated attacks with single doses of medication, and two allowed an optional second dose for inadequate response. Only two studies, with three active treatment arms, provided data for pooled analysis of primary outcomes. For single doses of diclofenac potassium 50 mg versus placebo (two studies), the NNTs were 6.2, 8.9, and 9.5 for pain-free at two hours, headache relief at two hours, and pain-free responses at 24 hours, respectively.Associated symptoms of nausea, photophobia and phonophobia, and functional disability were reduced within two hours, and similar numbers of participants experienced adverse events, which were mostly mild and transient.There were insufficient data to evaluate other doses of oral diclofenac, or to compare different formulations or different dosing regimens; only one study compared oral diclofenac with an active comparator (oral sumatriptan 100 mg).
AUTHORS' CONCLUSIONS
Oral diclofenac potassium 50 mg is an effective treatment for acute migraine, providing relief from pain and associated symptoms, although only a minority of patients experience pain-free responses. Adverse events are mostly mild and transient and occur at the same rate as with placebo.
Topics: Acute Disease; Adult; Analgesics; Antiemetics; Diclofenac; Drug Therapy, Combination; Humans; Hyperacusis; Migraine Disorders; Nausea; Photophobia; Sumatriptan
PubMed: 22336852
DOI: 10.1002/14651858.CD008783.pub2 -
International Journal of Environmental... Jun 2022Misophonia is a scarcely known disorder. This systematic review (1) offers a quantitative and qualitative analysis of the literature since 2001, (2) identifies the most... (Review)
Review
Misophonia is a scarcely known disorder. This systematic review (1) offers a quantitative and qualitative analysis of the literature since 2001, (2) identifies the most relevant aspects but also controversies, (3) identifies the theoretical and methodological approaches, and (4) highlights the outstanding advances until May 2022 as well as aspects that remain unknown and deserve future research efforts. Misophonia is characterized by strong physiological, emotional, and behavioral reactions to auditory, visual, and/or kinesthetic stimuli of different nature regardless of their physical characteristics. These misophonic responses include anger, general discomfort, disgust, anxiety, and avoidance and escape behaviors, and decrease the quality of life of the people with the disorder and their relatives. There is no consensus on the diagnostic criteria yet. High comorbidity between misophonia and other psychiatric and auditory disorders is reported. Importantly, the confusion with other disorders contributes to its underdiagnosis. In recent years, assessment systems with good psychometric properties have increased considerably, as have treatment proposals. Although misophonia is not yet included in international classification systems, it is an emerging field of growing scientific and clinical interest.
Topics: Anger; Anxiety Disorders; Emotions; Humans; Hyperacusis; Quality of Life
PubMed: 35682372
DOI: 10.3390/ijerph19116790 -
The Cochrane Database of Systematic... Feb 2012Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family.
OBJECTIVES
To determine the efficacy and tolerability of oral sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.
SEARCH METHODS
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.
SELECTION CRITERIA
We included randomised, double-blind, placebo- and/or active-controlled studies using oral sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.
MAIN RESULTS
Sixty-one studies (37,250 participants) compared oral sumatriptan with placebo or an active comparator. Most of the data were for the 50 mg and 100 mg doses. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 50 mg versus placebo the NNTs were 6.1, 7.5, and 4.0 for pain-free at two hours and headache relief at one and two hours, respectively. NNTs for sustained pain-free and sustained headache relief during the 24 hours postdose were 9.5 and 6.0, respectively. For sumatriptan 100 mg versus placebo the NNTs were 4.7, 6.8, 3.5, 6.5, and 5.2, respectively, for the same outcomes. Results for the 25 mg dose were similar to the 50 mg dose, while sumatriptan 100 mg was significantly better than 50 mg for pain-free and headache relief at two hours, and for sustained pain-free during 24 hours. Treating early, during the mild pain phase, gave significantly better NNTs for pain-free at two hours and sustained pain-free during 24 hours than did treating established attacks with moderate or severe pain intensity.Relief of associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than with placebo. For the most part, adverse events were transient and mild and were more common with the sumatriptan than with placebo, with a clear dose response relationship (25 mg to 100 mg).Sumatriptan was compared directly with a number of active treatments, including other triptans, paracetamol (acetaminophen), acetylsalicylic acid, non-steroidal anti-inflammatory drugs (NSAIDs), and ergotamine combinations.
AUTHORS' CONCLUSIONS
Oral sumatriptan is effective as an abortive treatment for migraine attacks, relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events.
Topics: Acute Disease; Administration, Oral; Adult; Analgesics; Humans; Migraine Disorders; Randomized Controlled Trials as Topic; Serotonin 5-HT1 Receptor Agonists; Sumatriptan; Time Factors; Treatment Outcome
PubMed: 22336849
DOI: 10.1002/14651858.CD008615.pub2 -
The Cochrane Database of Systematic... Apr 2010Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Migraine is a common, disabling condition and a burden for the individual, health services and society. Many sufferers choose not to, or are unable to, seek professional help and rely on over-the-counter analgesics. Co-therapy with an antiemetic should help to reduce nausea and vomiting commonly associated with migraine headaches.
OBJECTIVES
To determine the efficacy and tolerability of aspirin, alone or in combination with an antiemetic, compared to placebo and other active interventions in the treatment of acute migraine headaches in adults.
SEARCH STRATEGY
We searched Cochrane CENTRAL, MEDLINE, EMBASE and the Oxford Pain Relief Database for studies through 10 March 2010.
SELECTION CRITERIA
We included randomised, double-blind, placebo- or active-controlled studies using aspirin to treat a discrete migraine headache episode, with at least 10 participants per treatment arm.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. Numbers of participants achieving each outcome were used to calculate relative risk and numbers needed to treat (NNT) or harm (NNH) compared to placebo or other active treatment.
MAIN RESULTS
Thirteen studies (4222 participants) compared aspirin 900 mg or 1000 mg, alone or in combination with metoclopramide 10 mg, with placebo or other active comparators, mainly sumatriptan 50 mg or 100 mg. For all efficacy outcomes, all active treatments were superior to placebo, with NNTs of 8.1, 4.9 and 6.6 for 2-hour pain-free, 2-hour headache relief, and 24-hour headache relief with aspirin alone versus placebo, and 8.8, 3.3 and 6.2 with aspirin plus metoclopramide versus placebo. Sumatriptan 50 mg did not differ from aspirin alone for 2-hour pain-free and headache relief, while sumatriptan 100 mg was better than the combination of aspirin plus metoclopramide for 2-hour pain-free, but not headache relief; there were no data for 24-hour headache relief.Associated symptoms of nausea, vomiting, photophobia and phonophobia were reduced with aspirin compared with placebo, with additional metoclopramide significantly reducing nausea (P < 0.00006) and vomiting (P = 0.002) compared with aspirin alone.Fewer participants needed rescue medication with aspirin than with placebo. Adverse events were mostly mild and transient, occurring slightly more often with aspirin than placebo.
AUTHORS' CONCLUSIONS
Aspirin 1000 mg is an effective treatment for acute migraine headaches, similar to sumatriptan 50 mg or 100 mg. Addition of metoclopramide 10 mg improves relief of nausea and vomiting. Adverse events were mainly mild and transient, and were slightly more common with aspirin than placebo, but less common than with sumatriptan 100 mg.
Topics: Adult; Anti-Inflammatory Agents, Non-Steroidal; Antiemetics; Aspirin; Drug Therapy, Combination; Humans; Metoclopramide; Migraine Disorders; Nausea; Photophobia; Randomized Controlled Trials as Topic; Sumatriptan; Vomiting
PubMed: 20393963
DOI: 10.1002/14651858.CD008041.pub2 -
The Cochrane Database of Systematic... Feb 2012Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family. Subcutaneous administration may be preferable to oral for individuals experiencing nausea and/or vomiting
OBJECTIVES
To determine the efficacy and tolerability of subcutaneous sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.
SEARCH METHODS
We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.
SELECTION CRITERIA
We included randomised, double-blind, placebo- and/or active-controlled studies using subcutaneous sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.
MAIN RESULTS
Thirty-five studies (9365 participants) compared subcutaneous sumatriptan with placebo or an active comparator. Most of the data were for the 6 mg dose. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 6 mg versus placebo the NNTs were 2.9, 2.3, 2.2, and 2.1 for pain-free at one and two hours, and headache relief at one and two hours, respectively, and 6.1 for sustained pain-free at 24 hours. Results for the 4 mg and 8 mg doses were similar to the 6 mg dose, with 6 mg significantly better than 4 mg only for pain-free at one hour, and 8 mg significantly better than 6 mg only for headache relief at one hour. There was no evidence of increased migraine relief if a second dose of sumatriptan 6 mg was given after an inadequate response to the first.Relief of headache-associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than placebo. For the most part, adverse events were transient and mild and were more common with sumatriptan than placebo.Sumatriptan was compared directly with a number of active treatments, including other triptans, acetylsalicylic acid plus metoclopramide, and dihydroergotamine, but there were insufficient data for any pooled analyses.
AUTHORS' CONCLUSIONS
Subcutaneous sumatriptan is effective as an abortive treatment for acute migraine attacks, quickly relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events.
Topics: Acute Disease; Adult; Humans; Injections, Subcutaneous; Migraine Disorders; Pain Management; Randomized Controlled Trials as Topic; Serotonin 5-HT1 Receptor Agonists; Sumatriptan; Time Factors
PubMed: 22336869
DOI: 10.1002/14651858.CD009665 -
The Cochrane Database of Systematic... Feb 2012Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Migraine is a highly disabling condition for the individual and also has wide-reaching implications for society, healthcare services, and the economy. Sumatriptan is an abortive medication for migraine attacks, belonging to the triptan family. Intranasal administration may be preferable to oral for individuals experiencing nausea and/or vomiting, although it is primarily absorbed in the gut, not the nasal mucosa.
OBJECTIVES
To determine the efficacy and tolerability of intranasal sumatriptan compared to placebo and other active interventions in the treatment of acute migraine attacks in adults.
SEARCH METHODS
We searched Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, EMBASE, online databases, and reference lists for studies through 13 October 2011.
SELECTION CRITERIA
We included randomised, double-blind, placebo- and/or active-controlled studies using intranasal sumatriptan to treat a migraine headache episode, with at least 10 participants per treatment arm.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed trial quality and extracted data. We used numbers of participants achieving each outcome to calculate relative risk (or 'risk ratio') and numbers needed to treat to benefit (NNT) or harm (NNH) compared to placebo or a different active treatment.
MAIN RESULTS
Twelve studies (4755 participants) compared intranasal sumatriptan with placebo or an active comparator. Most of the data were for the 10 mg and 20 mg doses. Sumatriptan surpassed placebo for all efficacy outcomes. For sumatriptan 10 mg versus placebo the NNTs were 7.3, 7.4, and 5.5 for pain-free at two hours, and headache relief at one and two hours, respectively. For sumatriptan 20 mg versus placebo the NNTs were 4.7, 4.9, and 3.5, respectively, for the same outcomes. The 20 mg dose was significantly better than the 10 mg dose for each of these three primary efficacy outcomes.Relief of headache-associated symptoms, including nausea, photophobia, and phonophobia, was greater with sumatriptan than with placebo, and use of rescue medication was lower with sumatriptan than placebo. For the most part, adverse events were transient and mild and were more common with sumatriptan than placebo.Direct comparison of sumatriptan with active treatments was limited to two studies, one comparing sumatriptan 20 mg and dihydroergotamine (DHE) 1 mg, and one comparing sumatriptan 20 mg with rizatriptan 10 mg.
AUTHORS' CONCLUSIONS
Intranasal sumatriptan is effective as an abortive treatment for acute migraine attacks, relieving pain, nausea, photophobia, phonophobia, and functional disability, but is associated with increased adverse events compared with placebo.
Topics: Acute Disease; Administration, Intranasal; Adult; Dihydroergotamine; Female; Humans; Male; Migraine Disorders; Pain Management; Randomized Controlled Trials as Topic; Serotonin 5-HT1 Receptor Agonists; Sumatriptan; Triazoles; Tryptamines
PubMed: 22336867
DOI: 10.1002/14651858.CD009663