Are manual therapies effective at reducing chronic tension headache frequency in adults?

MAYBE. Among patients with chronic tension headaches, manual therapies may reduce headache frequency more than sham manual therapy, usual care, or exercise treatments-by 1.5 to 4.2 headaches or days with headache per week (strength of recommendation, B; preponderance of evidence from primarily small, heterogeneous randomized controlled trials [RCTs]).

Efficacy of acupuncture for tension-type headache prophylaxis: systematic review and meta-analysis with trial sequential analysis.

BACKGROUND: Acupuncture has been shown to reduce tension-type headache (TTH) frequency in previous studies. Nevertheless, repeated significance testing might inflate type I error. We aimed to verify the effectiveness and safety of acupuncture in reducing TTH frequency by meta-analysis and trial sequential analysis (TSA). METHODS: Ovid Medline, Embase, and Cochrane Library were searched until September 29, 2022. Randomized controlled trials comparing acupuncture with sham acupuncture, no acupuncture, or other active therapies in adults with TTH were included. The primary outcome was TTH frequency. The secondary outcomes were responder rate and adverse event. RESULTS: Fourteen studies involving 2795 participants were included. Acupuncture had more reduction than sham acupuncture in TTH frequency, both after treatment (standardized mean difference [SMD] - 0.80, 95% CI - 1.36 to - 0.24, P = 0.005) and at the follow-up period (SMD - 1.33, 95% CI - 2.18 to - 0.49, P = 0.002), while TSA showed the included sample size did not exceed required information size (RIS). Acupuncture was superior over no acupuncture after treatment (SMD - 0.52, 95% CI - 0.63 to - 0.41, P < 0.001), and cumulative sample size reached RIS. In terms of responder rate, acupuncture had a higher responder rate compared with sham acupuncture both after treatment (relative ratio [RR] 1.28, 95% CI 1.12 to 1.46, P = 0.0003) and the follow-up period (RR 1.37, 95% CI 1.19 to 1.58, P < 0.0001), but the sample size is inadequate. CONCLUSION: Acupuncture is an efficacious and safe treatment for TTH prevention, but this conclusion might be limited by the generally very low to low quality evidence. TSA suggested that high-quality trials are needed to verify the efficacy and safety of acupuncture compared to sham acupuncture.

An observational study of fixed-dose Tanacetum parthenium nutraceutical preparation for prophylaxis of pediatric headache.

BACKGROUND: Migraine is one of the most prevalent chronic pain manifestations of childhood. Despite the multitude of available treatments, parents are often concerned about chronic therapies and pediatricians have insufficient confidence in prescribing prophylactic drugs. Therefore, there is now growing interest for natural supplements used to control recurrent migraine headaches. Such approach may increase acceptance and adherence to long-term prophylaxis therapy in children. METHODS: This is an observational multicenter study performed in children (n = 91) with migraine, with (MO) or without aura (MA), or tension-type headache (TTH). A fixed-dose Andrographis paniculata, CoQ10, riboflavin, and magnesium, was administered for 16 weeks. Patients were evaluated at baseline (T0), at week 8 (T1) and at the end of treatment at week 16 (T2). A follow-up period occurred at week 20 (T3) and week 32 (T4). RESULTS: The herbal supplement significantly reduced the frequency of headaches in TTH patients during treatment period (T0: 11.97 + 1.92 vs T2: 5.13 + 1.93; p < 0.001) and the efficacy was maintained after 16 weeks of treatment withdrawal (T4: 4.46 + 1.75; p < 0.001 vs T0). The frequency of migraine attacks was also reduced in the MO group during treatment (T0: 9.70 + 0.96 vs T2: 4.03 + 0.75; p < 0.01) and after withdrawal (T4: 2.96 + 0.65; p < 0.01 vs T0). Conversely, MA patients showed reduction in migraine's frequency during treatment (T0: 8.74 + 1.91 vs T2: 3.78 + 2.02; p < 0.01) but not at the end of the study (T4: 5.57 + 3.31; p > 0.05 vs T0). TTH patients did not report significant improvement of pain intensity. A significant effect was observed in the MO group during treatment (T0: 3.06 + 0.11 vs T2: 2.14 + 0.19; p < 0.001) and after treatment withdrawal (T4: 2.20 + 0.21; p < 0.001 vs T0). Likewise, MA group showed a significant treatment effect (T0: 2.57 + 0.20 vs T2: 0.86 + 0.45; p < 0.001) and the efficacy persisted at the end of the study (T4: 1.00 + 0.58; p < 0.001 vs T0). CONCLUSION: This fixed-dose Tanacetum parthenium preparation improved headache frequency and pain intensity in children affected by TTH. Despite the main limits, this study supports the use of nutraceutical in pediatric headache/migraine.

Tricyclic and Tetracyclic Antidepressants for the Prevention of Frequent Episodic or Chronic Tension-Type Headache in Adults: A Systematic Review and Meta-Analysis.

BACKGROUND: Tension-type headaches are a common source of pain and suffering. Our purpose was to assess the efficacy of tricyclic (TCA) and tetracyclic antidepressants in the prophylactic treatment of tension-type headache. METHODS: We searched the Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, the ISI Web of Science, and clinical trial registries through 11 March 2017 for randomized controlled studies of TCA or tetracyclic antidepressants in the prevention of tension-type headache in adults. Data were pooled using a random effects approach. KEY RESULTS: Among 22 randomized controlled trials, eight included a placebo comparison and 19 compared at least two active treatments. Eight studies compared TCAs to placebo, four compared TCAs to selective serotonin reuptake inhibitors (SSRIs), and two trials compared TCAs to behavioral therapies. Two trials compared tetracyclics to placebo. Single trials compared TCAs to tetracyclics, buspirone, spinal manipulation, transcutaneous electrical stimulation, massage, and intra-oral orthotics. High-quality evidence suggests that TCAs were superior to placebo in reducing headache frequency (weighted mean differences (WMD): -4.8 headaches/month, 95% CI: -6.63 to -2.95) and number of analgesic medications consumed (WMD: -21.0 doses/month, 95% CI: -38.2 to -3.8). TCAs were more effective than SSRIs. Low-quality studies suggest that TCAs are superior to buspirone, but equivalent to behavioral therapy, spinal manipulation, intra-oral orthotics, and massage. Tetracyclics were no better than placebo for chronic tension-type headache. CONCLUSIONS: Tricyclic antidepressants are modestly effective in reducing chronic tension-type headache and are superior to buspirone. In limited studies, tetracyclics appear to be ineffective in the prophylactic treatment of chronic tension-type headache.

Acupuncture for the Prevention of Tension-Type Headache (2016).

Linde K, Allais G, Brinkhaus B, et al. Acupuncture for the prevention of tension-type headache.Cochrane Database Syst Rev2016, Issue 48. Art No.: CD007587. DOI: 10.1002/14651858.CD007587.pub2. BACKGROUND: Acupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is (a) more effective than no prophylactic treatment/routine care only; (b) more effective than "sham" (placebo) acupuncture; and (c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE, and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomized trials with a post-randomization observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomization). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using Grading of Recommendations Assessment, Development and Evaluation (GRADE). MAIN RESULTS: Twelve trials (11 included in the previous version and one newly identified) with 2349 participants (median = 56, range: 10-1265) met the inclusion criteria. Acupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) = 2.5; 95% confidence interval (CI): 2.1-3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR = 11; 95% CI: 3.7-35). Long-term effects (beyond four months) were not investigated. Acupuncture was compared with sham acupuncture in seven trials of moderate- to high-quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR = 1.3; 95% CI: 1.09-1.5; four trials; moderate quality evidence). Results six months after randomization were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) = 1.3; 95% CI: 0.60-2.7; low quality evidence). Acupuncture was compared with physiotherapy, massage, or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favored the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects. Overall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes. AUTHORS׳ CONCLUSIONS: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials-particularly comparing acupuncture with other treatment options-are needed.

Efecto de la terapia manual en la cefalea tensional / The effect of manual therapy on tension headache

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Role of Acupuncture in the Treatment or Prevention of Migraine, Tension-Type Headache, or Chronic Headache Disorders.

OBJECTIVE: To summarize the current evidence that evaluates the effectiveness of acupuncture for the treatment or prevention of migraine, tension-type headache, and chronic headache disorders. METHODS: Findings from selected systematic reviews and meta-analyses are summarized. RESULTS: Recently published systematic reviews and meta-analyses demonstrate that acupuncture is associated with improved clinical outcomes compared to routine care only, medical management, and sham acupuncture 2 months after randomization. The evidence in support of acupuncture's comparative effectiveness at longer follow-up periods is mixed. Cost effectiveness analyses conducted in the United Kingdom and Germany suggest that acupuncture is a cost-effective treatment option in those countries. There are few or no cost-effectiveness studies of acupuncture in the United States. DISCUSSION: This brief review of the current, published evidence does not include a discussion of potential risks or adverse events associated with acupuncture. There is also the question of the extent to which placebo effects might contribute to acupuncture's clinical effectiveness. From a purely comparative effectiveness perspective, however, the evidence from clinical trials and meta-analyses makes a compelling case in support of a potentially important role for acupuncture as part of a treatment plan for patients with migraine, tension-type headache, and several different types of chronic headache disorders.

Acupuncture for the prevention of tension-type headache.

BACKGROUND: Acupuncture is often used for prevention of tension-type headache but its effectiveness is still controversial. This is an update of our Cochrane review originally published in Issue 1, 2009 of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in adults with episodic or chronic tension-type headache. SEARCH METHODS: We searched CENTRAL, MEDLINE, EMBASE and AMED to 19 January 2016. We searched the World Health Organization (WHO) International Clinical Trials Registry Platform to 10 February 2016 for ongoing and unpublished trials. SELECTION CRITERIA: We included randomised trials with a post-randomisation observation period of at least eight weeks, which compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another prophylactic intervention in adults with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two review authors checked eligibility; extracted information on participants, interventions, methods and results; and assessed study risk of bias and the quality of the acupuncture intervention. The main efficacy outcome measure was response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation). To assess safety/acceptability we extracted the number of participants dropping out due to adverse effects and the number of participants reporting adverse effects. We assessed the quality of the evidence using GRADE (Grading of Recommendations Assessment, Development and Evaluation). MAIN RESULTS: Twelve trials (11 included in the previous version and one newly identified) with 2349 participants (median 56, range 10 to 1265) met the inclusion criteria.Acupuncture was compared with routine care or treatment of acute headaches only in two large trials (1265 and 207 participants), but they had quite different baseline headache frequency and management in the control groups. Neither trial was blinded but trial quality was otherwise high (low risk of bias). While effect size estimates of the two trials differed considerably, the proportion of participants experiencing at least 50% reduction of headache frequency was much higher in groups receiving acupuncture than in control groups (moderate quality evidence; trial 1: 302/629 (48%) versus 121/636 (19%); risk ratio (RR) 2.5; 95% confidence interval (CI) 2.1 to 3.0; trial 2: 60/132 (45%) versus 3/75 (4%); RR 11; 95% CI 3.7 to 35). Long-term effects (beyond four months) were not investigated.Acupuncture was compared with sham acupuncture in seven trials of moderate to high quality (low risk of bias); five large studies provided data for one or more meta-analyses. Among participants receiving acupuncture, 205 of 391 (51%) had at least 50% reduction of headache frequency compared to 133 of 312 (43%) in the sham group after treatment (RR 1.3; 95% CI 1.09 to 1.5; four trials; moderate quality evidence). Results six months after randomisation were similar. Withdrawals were low: 1 of 420 participants receiving acupuncture dropped out due to adverse effects and 0 of 343 receiving sham (six trials; low quality evidence). Three trials reported the number of participants reporting adverse effects: 29 of 174 (17%) with acupuncture versus 12 of 103 with sham (12%; odds ratio (OR) 1.3; 95% CI 0.60 to 2.7; low quality evidence).Acupuncture was compared with physiotherapy, massage or exercise in four trials of low to moderate quality (high risk of bias); study findings were inadequately reported. No trial found a significant superiority of acupuncture and for some outcomes the results slightly favoured the comparison therapy. None of these trials reported the number of participants dropping out due to adverse effects or the number of participants reporting adverse effects.Overall, the quality of the evidence assessed using GRADE was moderate or low, downgraded mainly due to a lack of blinding and variable effect sizes. AUTHORS' CONCLUSIONS: The available results suggest that acupuncture is effective for treating frequent episodic or chronic tension-type headaches, but further trials - particularly comparing acupuncture with other treatment options - are needed.

The influence of ictal cutaneous allodynia on the response to occipital transcutaneous electrical stimulation in chronic migraine and chronic tension-type headache: a randomized, sham-controlled study.

OBJECTIVE: The objective of this article is to determine whether cutaneous allodynia (CA) influences the response to treatment with occipital transcutaneous electrical stimulation (OTES) in chronic migraine (CM) and chronic tension-type headache (CTTH). METHODS: One hundred and sixty consecutive patients with CM or CTTH were randomized to be treated with real or sham OTES stimulation three times a day for two consecutive weeks. All patients completed the validated 12-item allodynia symptom checklist for assessing the presence and the severity of CA during headache attack. Primary end-point was change (≥50%) in number of monthly headache-free days. RESULTS: There was a significant difference in the percentage of responders in the real OTES compared with sham OTES group (p <0.001). Importantly, there was not a significant change of monthly headache-free days in the allodynic patients with CM and CTTH treated both with real and sham OTES, while the number of headache-free days per month was significantly reduced in the real (86%) but not in the sham group (7%) of non-allodynic patients with CTTH and CM. CONCLUSIONS: Severe CA is associated with decreased response to treatment with OTES in patients with CM and CTTH.

[Therapeutic exercise as treatment for migraine and tension-type headaches: a systematic review of randomised clinical trials]. / Ejercicio terapéutico como tratamiento de las migrañas y cefaleas tensionales: revisión sistemática de ensayos clínicos aleatorizados.

AIM. To analyse the effectiveness of therapeutic exercise on migraines and tension-type headaches (TTH). MATERIALS AND METHODS. Electronic databases were used to search the literature for relevant articles. Eligibility criteria were: controlled randomised clinical trials (RCT), conducted on patients with migraine or TTH, in which the therapeutic intervention was based on therapeutic exercise, and the papers had been published in English and Spanish. Two independent reviewers performed the analysis of the methodological quality using the Delphi scale. RESULTS. Ten RCT were selected, seven of which offered good methodological quality. According to all the studies analysed, the intensity and frequency of pain diminished in comparison to the situation prior to establishing therapeutic exercise, and in five studies the effect was higher than in the control group. The qualitative analysis showed strong evidence of the absence of adverse events following the application of therapeutic exercise. Furthermore, strong evidence was also found of the effect of physiotherapeutic treatment, including therapeutic exercise, in lowering the intensity, frequency and duration of pain in patients with TTH. Limited evidence was also found of the effectiveness of aerobic exercise in patients with migraine, although it was not better than the effects derived from other forms of treatment. CONCLUSIONS. Results show that therapeutic exercise is a safe treatment that provides beneficial effects on migraines or TTH. Further RCT are required in the future with appropriate methodological designs to confirm these results.

TITLE: Ejercicio terapeutico como tratamiento de las migrañas y cefaleas tensionales: revision sistematica de ensayos clinicos aleatorizados.Objetivo. Analizar la efectividad que tiene el ejercicio terapeutico sobre las migrañas y las cefaleas de tipo tensional (CTT). Materiales y metodos. La busqueda de articulos se realizo utilizando bases de datos electronicas. Los criterios de inclusion fueron: estudios clinicos aleatorizados (ECA) controlados, realizados en pacientes con migrañas o CTT, donde la intervencion terapeutica se basara en ejercicio terapeutico y publicados en ingles y español. Dos revisores independientes realizaron el analisis de la calidad metodologica utilizando la escala Delphi. Resultados. Se seleccionaron 10 ECA, de los cuales siete presentaron una calidad metodologica buena. Segun todos los estudios analizados, el ejercicio terapeutico disminuyo la intensidad y frecuencia del dolor comparado con la situacion previa, y en cinco estudios el efecto fue mayor que en la comparativa con el grupo control. El analisis cualitativo muestra evidencia fuerte acerca de la ausencia de eventos adversos tras la aplicacion de ejercicio terapeutico. Ademas, se encontro evidencia fuerte acerca del efecto del tratamiento de fisioterapia, incluyendo el ejercicio terapeutico, para disminuir la intensidad, la frecuencia y la duracion del dolor en pacientes con CTT. Se observo evidencia limitada acerca de la efectividad del ejercicio aerobico sobre los pacientes con migraña sin ser superior el efecto al de otros tratamientos. Conclusiones. Los resultados muestran que el ejercicio terapeutico es un tratamiento seguro, que presenta efectos beneficiosos sobre las migrañas o las CTT. Es necesario que futuros ECA con diseños metodologicos adecuados confirmen estos resultados.

Osteopatía en la cefalea tensional y la cervicalgia / Osteopathy for tension-type headache and cervical pains

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Abordajes terapéuticos no farmacológicos para el tratamiento de la cefalea tensional. Revisión bibliográfica / Non-pharmacological therapeutic approaches for the treatment of tension-type headache. Bibliographic review

Introducción: La cefalea tensional (CT) es la más prevalente dentro de las cefaleas primarias. Representa un impacto económico alto y una repercusión importante en la vida de los pacientes que las sufren y en el sistema público de salud. Objetivos: Conocer el número y fechas de publicación de los estudios realizados en el tratamiento de la CT. Material y Métodos: Se procedió a una búsqueda bibliográfica en PubMed recurriendo al uso de las palabras clave contenidas en dichas publicaciones referidas específicamente a CT y se realizó una búsqueda incluyendo los términos tension-type headache y manual therapy, manipulation therapy, physical therapy, vertebral manipulation, cervical manipulation, osteopathy, osteopathic treatment, osteopathic medicine, osteopathic manipulative treatment, osteopathic manipulative. Se encontraron y analizaron un total de 5 estudios que cumplieron los criterios de selección. Resultados: Los resultados encontrados tras la revisión mostraron que respecto a la cefalea tensional (Tension-type headache) existen 2.506 estudios desde 1947 hasta la actualidad. Los resultados mostraron hasta 15 estudios que comenzaron en 1977 hasta el 2009 cuando se asoció a osteopatía (osteopathy) como concepto general resultaron; con tratamiento osteopático (osteopathic treatment) 14 estudios desde 1993 hasta 2011; con medicina osteopática (osteopathic medicine) resultaron 8 estudios desde 1993 hasta 2009; con tratamiento osteopático manipulativo (osteopathic manipulative treatment) 11 estudios desde 1993 hasta 2009; y con osteopatía manipulativa (osteopathic manipulative) 8 estudios desde 1993 hasta 2011. Conclusiones: Existe escasez de estudios que relacionen la terapia osteopática y la CT. Respecto a la aplicación del tratamiento osteopático, junto y por separado, resulta eficaz, pero es necesario que los estudios tengan mayor calidad metodológica (AU)

Introduction: Tension-type headache (TTH) is the most predominant primary headache. It has a high economic impact and a significant consequence for patients whom suffer from it and for the public health system. Objectives: To know how many studies for treating the TTH were performed and when they were published. Material and methods: A bibliographical search was carried out in PubMed, using keywords included in these publications that strictly refer to TTH. This search included terms such as tension-type headache and manual therapy, manipulation therapy, physical therapy, vertebral manipulation, cervical manipulation, osteopathy, osteopathic treatment, osteopathic medicine, osteopathic manipulative treatment, osteopathic manipulative. Five studies were found and analysed that fulfilled the selection criteria. Results: Results that were found after the review showed that regarding the tension-type headache, there are 2,506 studies since 1947 until now. Results showed until 15 studies that started in 1977 until 2009, when osteopathy was associated as general concept; there were 14 studies of osteopathic treatment since 1993 until 2011; 8 studies of osteopathic medicine since 1993 until 2009; 11 studies of osteopathic manipulative treatment since 1993 until 2009 and 8 studies of osteopathic manipulative since 1993 until 2011. Conclusions: There is a lack of studies that link the osteopathic therapy with the TTH. As for the application of an osteopathic treatment, either singly or in conjunction, it is effective, but it is necessary to have more methodological quality in these studies (AU)

Taking care of the challenging tension headache patient.

Tension type headache (TTH) is the most common primary headache disorder, but it is a diagnosis for which patients infrequently present for evaluation in the outpatient setting. Performing a thorough evaluation and establishing the correct diagnosis is essential in formulating an effective treatment plan. There are many complex issues that, although not causative, may play an exacerbating role in TTH. This article reviews the epidemiology, diagnosis, and pharmacologic treatment of TTH. In addition, nonpharmacologic treatment approaches, sleep dysfunction, and temporomandibular dysfunction are reviewed.

Treating tension-type headache -- an expert opinion.

INTRODUCTION: Tension-type headache (TTH) is a highly prevalent disorder with enormous costs for the individual and the society. AREAS COVERED: Nonpharmacological and pharmacological treatments are reviewed. Electromyographic (EMG) biofeedback has a documented effect in TTH, while cognitive-behavioral therapy and relaxation training are most likely to be effective. Physical therapy and acupuncture may be valuable options for patients with frequent TTH. Simple analgesics and nonsteroidal anti-inflammatory drugs are recommended for treatment of episodic TTH. Combination analgesics containing caffeine are drugs of second choice. Triptans, muscle relaxants and opioids should not be used. It is crucial to avoid frequent and excessive use of analgesics to prevent the development of medication-overuse headache. The tricyclic antidepressant amitriptyline is the drug of first choice for the prophylactic treatment of chronic TTH. Mirtazapine and venlafaxine are second-choice drugs. EXPERT OPINION: There is an urgent need for more research in nonpharmacological as well as pharmacological treatment possibilities of TTH. Future studies should examine the relative efficacy of the various treatment modalities and clarify how treatment programs can be optimized and combined to best suit the individual patient. Frequent TTH may be difficult to treat, but an acceptable result can usually be obtained by a combination of nonpharmacological and pharmacological treatments.

A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial.

OBJECTIVES: Tension-type headache (TTH) is the most common headache experienced by adults in Western society. Only 2 clinical trials of spinal manipulation for adult tension-type headache have been reported, neither of which was fully controlled. In 1 trial, spinal manipulation was compared to amitriptyline. There is an urgent need for well-controlled studies of chiropractic spinal manipulation for TTH. This trial was stopped prematurely due to poor recruitment. The purposes of this report are (1) to describe the trial protocol, as it contained several novel features, (2) to report the limited data set obtained from our sample of completed subjects, and (3) to discuss the problems that were encountered in conducting this study. METHODS: A randomized clinical trial was conducted with a factorial design in which adult TTH sufferers with more than 10 headaches per month were randomly assigned to four groups: real cervical manipulation + real amitriptyline, real cervical manipulation + placebo amitriptyline, sham cervical manipulation + real amitriptyline, and sham cervical manipulation + placebo amitriptyline. A baseline period of four weeks was followed by a treatment period of 14 weeks. The primary outcome was headache frequency obtained from a headache diary in the last 28 days of the treatment period. RESULTS: Nineteen subjects completed the trial. In the unadjusted analysis, a statistically significant main effect of chiropractic treatment was obtained (-2.2 [-10.2 to 5.8], P = .03) which was just below the 3-day reduction set for clinical importance. As well, a clinically important [corrected] effect of the combined therapies was obtained (-9 [-20.8 [corrected] to 2.9], P = .13), but this did not achieve statistical significance. In the adjusted analysis, neither the main effects of chiropractic nor amitriptyline were statistically significant or clinically important; however, the effect of the combined treatments was -8.4 (-15.8 to -1.1) which was statistically significant (P = .03) and reached our criterion for clinical importance. CONCLUSION: Although the sample size was smaller than initially required, a statistically significant and clinically important effect was obtained for the combined treatment group. There are considerable difficulties with recruitment of subjects in such a trial. This trial should be replicated with a larger sample.

Correlations of headache diary parameters, quality of life and disability scales.

OBJECTIVE: We aimed to investigate (1) to which extent headache diary variables correlate among each other; (2) to which extent they correlate with generic measures of quality of life and disability; (3) and whether correlations vary over time. METHODS: We performed a secondary analysis of data from 301 patients suffering from migraine and 270 patients suffering from tension-type headache collected in 2 randomized trials of acupuncture. We calculated product-moment correlation coefficients. RESULTS: Correlations between diary parameters varied to a great extent. Attack frequency, a measure recommended by the International Headache Society as a primary outcome measure for migraine prophylaxis trials, correlated only moderately with other diary outcomes. At baseline the parameters measured in the headache diary correlated only weakly with the generic outcome measures. After 12 weeks these correlations had increased considerably. CONCLUSION: Our findings suggest that participants in headache trials "learn" to fill in diaries and generic instruments in a more consistent manner during the course of the study.

Acupuncture for tension-type headache.

BACKGROUND: Acupuncture is often used for tension-type headache prophylaxis but its effectiveness is still controversial. This review (along with a companion review on 'Acupuncture for migraine prophylaxis') represents an updated version of a Cochrane review originally published in Issue 1, 2001, of The Cochrane Library. OBJECTIVES: To investigate whether acupuncture is a) more effective than no prophylactic treatment/routine care only; b) more effective than 'sham' (placebo) acupuncture; and c) as effective as other interventions in reducing headache frequency in patients with episodic or chronic tension-type headache. SEARCH STRATEGY: The Cochrane Pain, Palliative & Supportive Care Trials Register, CENTRAL, MEDLINE, EMBASE and the Cochrane Complementary Medicine Field Trials Register were searched to January 2008. SELECTION CRITERIA: We included randomized trials with a post-randomization observation period of at least 8 weeks that compared the clinical effects of an acupuncture intervention with a control (treatment of acute headaches only or routine care), a sham acupuncture intervention or another intervention in patients with episodic or chronic tension-type headache. DATA COLLECTION AND ANALYSIS: Two reviewers checked eligibility; extracted information on patients, interventions, methods and results; and assessed risk of bias and quality of the acupuncture intervention. Outcomes extracted included response (at least 50% reduction of headache frequency; outcome of primary interest), headache days, pain intensity and analgesic use. MAIN RESULTS: Eleven trials with 2317 participants (median 62, range 10 to 1265) met the inclusion criteria. Two large trials compared acupuncture to treatment of acute headaches or routine care only. Both found statistically significant and clinically relevant short-term (up to 3 months) benefits of acupuncture over control for response, number of headache days and pain intensity. Long-term effects (beyond 3 months) were not investigated. Six trials compared acupuncture with a sham acupuncture intervention, and five of the six provided data for meta-analyses. Small but statistically significant benefits of acupuncture over sham were found for response as well as for several other outcomes. Three of the four trials comparing acupuncture with physiotherapy, massage or relaxation had important methodological or reporting shortcomings. Their findings are difficult to interpret, but collectively suggest slightly better results for some outcomes in the control groups. AUTHORS' CONCLUSIONS: In the previous version of this review, evidence in support of acupuncture for tension-type headache was considered insufficient. Now, with six additional trials, the authors conclude that acupuncture could be a valuable non-pharmacological tool in patients with frequent episodic or chronic tension-type headaches.

Acupuncture for tension-type headache: a multicentre, sham-controlled, patient-and observer-blinded, randomised trial.

Acupuncture treatment is frequently sought for tension-type headache (TTH), but there is conflicting evidence as to its effectiveness. This randomised, controlled, multicentre, patient-and observer-blinded trial was carried out in 122 outpatient practices in Germany on 409 patients with TTH, defined as > or =10 headache days per month of which < or =1 included migraine symptoms. Interventions were verum acupuncture according to the practice of traditional Chinese medicine or sham acupuncture consisting of superficial needling at nonacupuncture points. Acupuncture was administered by physicians with specialist acupuncture training. Ten 30-min sessions were given over a six-week period, with additional sessions available for partial response. Response was defined as >50% reduction in headache days/month at six months and no use of excluded concomitant medication or other therapies. In the intent-to-treat analysis (all 409 patients), 33% of verum patients and 27% of sham controls (p=0.18) were classed as responders. Verum was superior to sham for most secondary endpoints, including headache days (1.8 fewer; 95% CI 0.6, 3.0; p=0.004) and the International Headache Society response criterion (66% vs. 55% response, risk difference 12%, 95% CI: 2%-21%; p=0.024).). The relative risk on the primary and secondary response criterion was very similar ( approximately 0.8); the difference in statistical significance may be due to differences in event rate. TTH improves after acupuncture treatment. However, the degree to which treatment benefits depend on psychological compared to physiological effects and the degree to which any physiological effects depend on needle placement and insertion depth are unclear.