Guidelines for Controlled Trials of Prophylactic Treatment of Chronic Migraine in Adults

Silberstein, Stephen D.; Tfelt‐Hansen, Peer; Dodick, David W.; Limmroth, Volker; Lipton, Richard B.; Pascual, Julio; Wang, S. J.

doi:10.1111/j.1468-2982.2008.01555.x

Cited by 277 publications

(342 citation statements)

References 36 publications

(30 reference statements)

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“…The study design adhered to the recommendations for pharmacological RCTs as given by the IHS and CONSORT 1, 15, 16. Manual‐therapy RCTs have three major obstacles as compared with pharmacological RCTs.…”

Section: Discussionmentioning

confidence: 99%

“…The design of the study conformed to the recommendations of the International Headache Society (IHS) and CONSORT (Appendix S1) 1, 15, 16. The Norwegian Regional Committee for Medical Research Ethics and the Norwegian Social Science Data Services approved the project.…”

Section: Methodsmentioning

confidence: 99%

“…The primary and secondary end‐points were chosen based on the Task Force of the IHS Clinical Trial Subcommittee's clinical trial guidelines 1, 15. Based on previous reviews on migraine, a 25% reduction was considered to be a conservative estimate 12, 13.…”

Section: Methodsmentioning

confidence: 99%

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Chiropractic spinal manipulative therapy for migraine: a three‐armed, single‐blinded, placebo, randomized controlled trial

Chaibi

Benth

Tuchin

et al. 2016

Euro J of Neurology

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Background and purposeTo investigate the efficacy of chiropractic spinal manipulative therapy (CSMT) for migraineurs.MethodsThis was a prospective three‐armed, single‐blinded, placebo, randomized controlled trial (RCT) of 17 months duration including 104 migraineurs with at least one migraine attack per month. The RCT was conducted at Akershus University Hospital, Oslo, Norway. Active treatment consisted of CSMT, whereas placebo was a sham push manoeuvre of the lateral edge of the scapula and/or the gluteal region. The control group continued their usual pharmacological management. The RCT consisted of a 1‐month run‐in, 3 months intervention and outcome measures at the end of the intervention and at 3, 6 and 12 months follow‐up. The primary end‐point was the number of migraine days per month, whereas secondary end‐points were migraine duration, migraine intensity and headache index, and medicine consumption.ResultsMigraine days were significantly reduced within all three groups from baseline to post‐treatment (P < 0.001). The effect continued in the CSMT and placebo group at all follow‐up time points, whereas the control group returned to baseline. The reduction in migraine days was not significantly different between the groups (P > 0.025 for interaction). Migraine duration and headache index were reduced significantly more in the CSMT than the control group towards the end of follow‐up (P = 0.02 and P = 0.04 for interaction, respectively). Adverse events were few, mild and transient. Blinding was strongly sustained throughout the RCT.ConclusionsIt is possible to conduct a manual‐therapy RCT with concealed placebo. The effect of CSMT observed in our study is probably due to a placebo response.

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Section: Discussionmentioning

confidence: 99%

Section: Methodsmentioning

confidence: 99%

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Chiropractic spinal manipulative therapy for migraine: a three‐armed, single‐blinded, placebo, randomized controlled trial

Chaibi

Benth

Tuchin

et al. 2016

Euro J of Neurology

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“…21,22 In clinical practice, physicians and patients choose preventive treatments based primarily on FDA approval and drug tolerability. 9,18,19,[23][24][25] Systematic reviews and meta-analyses with consistent and transparent appraisal of study quality and strength of evidence are essential for arriving at evidence-based migraine preventive treatment and policy decisions. 26 Previously published systematic reviews focused on the efficacy of specific drugs rather than comparative effectiveness and tolerability of all pharmacologic options.…”

Section: Introductionmentioning

confidence: 99%

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

et al. 2013

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ELIGIBILITY CRITERIA: English-language randomized controlled trials (RCTs) of preventive drugs compared to placebo or active treatments examining rates of ≥50 % reduction in monthly migraine frequency or improvement in quality of life. STUDY APPRAISAL AND SYNTHESIS METHODS:We assessed risk of bias and strength of evidence and conducted random effects meta-analyses of absolute risk differences and Bayesian network meta-analysis. RESULTS: Of 5,244 retrieved references, 215 publications of RCTs provided mostly low-strength evidence because of the risk of bias and imprecision. RCTs examined 59 drugs from 14 drug classes. All approved drugs, including topiramate (9 RCTs), divalproex (3 RCTs), timolol (3 RCTs), and propranolol (4 RCTs); offlabel beta blockers metoprolol (4 RCTs), atenolol (1 RCT), nadolol (1 RCT), and acebutolol (1 RCT); angiotensin-converting enzyme inhibitors captopril (1 RCT) and lisinopril (1 RCT); and angiotensin II receptor blocker candesartan (1 RCT), outperformed placebo in reducing monthly migraine frequency by ≥50 % in 200-400 patients per 1,000 treated. Adverse effects leading to treatment discontinuation (68 RCTs) were greater with topiramate, off-label antiepileptics, and antidepressants than with placebo. Limited direct evidence as well as frequentist and exploratory network Bayesian meta-analysis showed no statistically significant differences in benefits between approved drugs. Off-label angiotensin-inhibiting drugs and beta-blockers were most effective and tolerable for episodic migraine prevention. LIMITATIONS:We did not quantify reporting bias or contact principal investigators regarding unpublished trials. CONCLUSIONS: Approved drugs prevented episodic migraine frequency by ≥50 % with no statistically significant difference between them. Exploratory network meta-analysis suggested that off-label angiotensin-inhibiting drugs and beta-blockers had favorable benefit-to-harm ratios. Evidence is lacking for longterm effects of drug treatments (i.e., trials of more than 3 months duration), especially for quality of life.KEY WORDS: migraine; evidence based medicine; adverse drug effects.

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“…Этот по-казатель традиционно используется также при оцен-ке эффективности лечения эпизодической мигрени. Однако ввиду значительно более высокой устойчиво-сти ХМ к лечению по сравнению с эпизодической мигренью, а также более выраженного нарушения качества жизни при этой форме ГБ в настоящее вре-мя критерием эффективности лечения ХМ предло-жено считать урежение ГБ на 30 % от исходного уровня [30].…”

Section: когда можно прекратить терапию ботоксом?unclassified

Practical issues of management of patients with chronic migraine. Recommendations from Russian experts

Latysheva¹,

Филатова²,

Tabeeva³

et al. 2015

Neuromuscular Diseases

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Контакты: Нина Владимировна Латышева ninalat@gmail.com В последние годы достигнуты значительные успехи мировой медицины в понимании причин и механизмов развития, а также в уточнении диагностических критериев и изучении терапевтических подходов при хронической мигрени (ХМ).

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Guidelines for Controlled Trials of Prophylactic Treatment of Chronic Migraine in Adults

Cited by 277 publications

References 36 publications

Chiropractic spinal manipulative therapy for migraine: a three‐armed, single‐blinded, placebo, randomized controlled trial

Chiropractic spinal manipulative therapy for migraine: a three‐armed, single‐blinded, placebo, randomized controlled trial

Preventive Pharmacologic Treatments for Episodic Migraine in Adults

Practical issues of management of patients with chronic migraine. Recommendations from Russian experts

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