[Non-medical Approaches to Headache Prevention: What is the Evidence?] / "Nicht-medikamentöse Verfahren in der Kopfschmerzprophylaxe, was ist die Evidenz?".

Primary headaches can be prevented by medication, exercise, behavioral therapy, or lifestyle changes. It is important to note that if medication is used for prophylaxis, non-drug approaches should also be recommended as a complement. Patients often wish to address their headaches without medication. Except for cognitive behavioral therapy and biofeedback, the evidence for nonmedication approaches to headache management has not been definitively established. This article reviews the current literature on the evidence for endurance exercise, relaxation exercises, physical therapy, lifestyle factors, and complementary procedures. For tension-type headache, there is an increasing number of studies reporting positive results from physical therapy; long-term follow-up, however, are still pending. Aerobic endurance exercise has the best evidence as a measure for prevention of migraine. However, other methods can also be used.

Acupuncture versus tricyclic antidepressants in the prophylactic treatment of tension-type headaches: an indirect treatment comparison meta-analysis.

BACKGROUND: Acupuncture showed better improvement than sham acupuncture in reducing attack frequency of tension-type headache (TTH), but its effectiveness relative to first-line drugs for TTH is unknown, which impedes the recommendation of acupuncture for patients who are intolerant to drugs for TTH. We aimed to estimate the relative effectiveness between acupuncture and tricyclic antidepressants (TCAs) through indirect treatment comparison (ITC) meta-analysis. METHODS: We searched Ovid Medline, Embase, and Cochrane Library from database inception until April 13, 2023. Randomized controlled trials of TCAs or acupuncture in the prevention of TTH in adults were included. The primary outcome was headache frequency. The secondary outcomes were headache intensity, responder rate, and adverse event rate. Bayesian random-effect models were used to perform ITC meta-analysis, and confidence of evidence was evaluated by using the GRADE approach. RESULTS: A total of 34 trials involving 4426 participants were included. Acupuncture had similar effect with TCAs in decreasing TTH frequency (amitriptyline: mean difference [MD] -1.29, 95% CI -5.28 to 3.02; amitriptylinoxide: MD -0.05, 95% CI -6.86 to 7.06) and reducing TTH intensity (amitriptyline: MD 2.35, 95% CI -1.20 to 5.78; clomipramine: MD 1.83, 95% CI -4.23 to 8.20). Amitriptyline had a higher rate of adverse events than acupuncture (OR 4.73, 95% CI 1.42 to 14.23). CONCLUSION: Acupuncture had similar effect as TCAs in reducing headache frequency of TTH, and acupuncture had a lower adverse events rate than amitriptyline, as shown by very low certainty of evidence.

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.

[Migraine burden and clinical inertia: what can we do?] / Migren' i klinicheskaia inertsiia: chto my mozhem sdelat'?

AIM: To study the compliance of neurologists and headache specialists to chronic headache and chronic migraine (CM) diagnosis and treatment guidelines. MATERIAL AND METHODS: The survey included 634 neurologists from all regions of the Russian Federation. Mean age of respondents was 40.7±8.5 years, mean years of experience 14.2±7.8 years. RESULTS: Most doctors work in outpatient or hospital settings (49% and 24%, respectively), 7% were headache specialists. Tension-type headache (TTH) was diagnosed in 30% and CM in 17% of patients while 44% of patients were presumed to have a mixed headache disorder (TTH+CM). Only 10% of physicians do not use instrumental diagnostic methods in chronic headache. This study has shown sufficient attention to comorbid conditions and frequent prescription of headache preventative treatment. Botox prescription data is equivocal: 35% of physicians recommend such treatment, 27% do not, while other doctors prescribe it for off-label indications. CONCLUSION: To overcome clinical inertia, further education in chronic headaches and their optimal treatment is warranted.

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.

Variables Associated With the Use of Prophylactic Amitriptyline Treatment in Patients With Tension-type Headache.

OBJECTIVE: The objective of this study was to investigate differences in clinical, psychological, and psychophysical outcomes according to use of prophylactic medication (amitriptyline) in tension-type headache (TTH). METHODS: In total, 173 individuals with TTH participated. Headache features and symptomatic medication intake were collected with a 4-weeks headache diary at baseline and at 6-months. Burden of headache (Headache Disability Inventory-HDI), sleep quality (Pittsburgh Sleep Quality Index-PSQI), anxiety/depression (Hospital Anxiety and Depression Scale-HADS), and trait/state anxiety levels (State-Trait Anxiety Inventory-STAI) were also assessed at baseline. Pressure pain thresholds (PPT) were assessed over the temporalis, C5-C6 joint, second metacarpal, and tibialis anterior at baseline. Differences between participants taking or not taking prophylactic medication based on self-perceived effectiveness of the medication on headache characteristics were assessed. RESULTS: In total, 49 (28%) reported taking prophylactic medication for the headaches (amitriptyline: 100%). From these, 11 (23%) reported no effect, 25 (51%) reported moderate effect, and 13 (26%) reported positive effect with medication. Patients taking prophylactic medication had longer headache history, higher frequency of headaches (61% CTTH), higher headache burden, worse quality of sleep, and higher depression than those not taking medication. Prophylactic medication was less effective in patients with generalized pressure pain hyperalgesia. No other significant differences were found. CONCLUSIONS: Prophylactic medication is used by TTH patients with higher headache frequency, higher headache burden, worse sleep quality, and higher depression. Lower effectiveness of prophylactic amitriptyline was associated with widespread pain hyperalgesia.

Migraine and Tension-Type Headache.

Migraine and tension-type headache (TTH) are common primary disorders that carry significant morbidity and socioeconomic effect. In this article, we will review the epidemiology, presentation, and diagnosis of these disorders. First-line acute treatment for migraine consists of analgesics, triptans, and antiemetics, while nonsteroidal anti-inflammatory drugs are the mainstay treatment for TTH. Patients with frequent or chronic headaches warrant prophylactic therapy. For migraine, various classes of preventives can be used (ß-blockers, tricyclics, antiepileptics, botulinum toxin), with the choice of therapy tailored to the patient's risk factors and symptoms. For TTH, tricyclics have the most evidence as prophylactic therapy. A new class of medication, monoclonal antibodies to calcitonin gene receptor peptide or its receptor, became available in 2018, and is the first class of medication specifically designed to treat migraine. In addition to pharmacotherapy, we will also review nonpharmacologic interventions as well as neuromodulation for migraine.

Primary headache characters and coping strategies among medical students of Umm Al-Qura University in the Western Region of Saudi Arabia.

OBJECTIVE: To assess the headache patterns among medical students of Umm Al-Qura College of Medicine, Makkah, Kingdom of Saudi Arabia. Medical students represent a vulnerable group for primary headache disorders, as they are exposed to various physical and psychological stressors. METHODS: We carried an observational, cross-sectional study, and collected data during February, 2017 using electronic questionnaires. The international classification of headache disorders, third edition (ICHD-3) beta edition was used to classify headache into 10 types. RESULTS: A total of 623 responses (82.2%) were received out of 758 participants. The one-year headache prevalence was 558 (89.6%). The most common diagnosis among both genders was frequent tension-type headache (TTH) (n=173, 31.0%), followed by probable infrequent TTH (n=114, 20.4%) and probable frequent TTH (n=63, 11.3%). The greatest proportions of students who reported an impact of their academic level were found among the chronic TTH, migraine without and with aura (n=2, 40.0%; n=14, 34.4%; n=11, 33.3%). Migraine without aura was more prevalent among females (n=29, 10.5%) than males (n=10, 3.5%). Self-medication was common (62.5%-100.0%). Simple analgesics (67.4%-80.0%), sleeping (54.3%-80.0%) and caffeine intake (28.3%-60.0%) were the top 3 therapies that were practiced. CONCLUSION: The prevalence of headache among Umm Al-Qura university (UQU), Makkah, Kingdom of Saudi Arabia`s medical students appears higher than the prevalence among the general population. This may have a significant impact on academic performance and necessitates special attention. We recommend further studies on interventions to reduce the prevalence and impact of this prevalent problem.

[Preventive treatment of tension headache in children and adolescents]. / Profilakticheskaia terapiia golovnoi boli napriazheniia u detei i podrostkov.

AIM: To assess the efficacy of noophen (γ-amino-ß-phenylbutyric acid hydrochloride) in the preventive treatment of tension-type headache (TTH) in children and adolescents. MATERIAL AND METHODS: The study included 30 patients with TTH, aged from 8 to 16 years, treated with noophen in dose of 15-20 mg/kg per day (2-3 times perorally) during 2 month. Before and during the treatment characteristics of headache, its influence on daily activities were assessed with HIT-6 and PedMIDAS, anxiety disorders were assessed with SCAS, the dynamics of sleep disturbances in children were evaluated. RESULTS AND CONCLUSION: A significant decrease in the frequency, duration and intensity of TTH as well as positive changes in daily life activities and reduction of anxiety and sleep disorders manifestations, which are the risk factors for TTH, were demonstrated during the treatment with noophen. Starting from the first month of treatment, there was a significant decrease in the number of days completely lost because of headache and days with the reduced activity (a decrease in the productivity by >50%).

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.

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.

[Possibilities of preventive therapy in frequent episodic tension-type headache].

OBJECTIVE: To study the efficacy and safety of tenoten in the preventive treatment of frequent episodic tension-type headache (FETHA) compared to patients treated with pain relievers. MATERIAL AND METHODS: A study included 60 patients with FETHA. Patients of the main group (n=30) received tenoten in addition to standard treatment. The study comprised 3 visits: beginning of treatment, after one month and after three months. All patients underwent physical and clinical/neurological examinations. In each visit, treatment efficacy was assessed according the following parameters: VAS scores (0-10) for assessment of pain and tension in pericranial muscles in 6 standard points, mean frequency and duration of the headache episode, quality of life indices, Beck depression scores, Spilberger trait and state anxiety, autonomic symptom severity, parameters of sleep disorders, frequency of adverse effects, CGI scores (0-7). RESULTS AND CONCLUSION: Tenoten as a preventive medication reduced the frequency of headache episodes that allowed to diagnose patients with rare episodic tension-type headache in the end of treatment. At the same time, there was a significant reduction in headache intensity during the episode and decrease in amount of analgesics used by the patients.

Melatonin 4 mg as prophylactic therapy for primary headaches: a pilot study.

There is growing evidence that headaches are connected to melatonin secretion. Our aim was to assess the potential effectiveness of melatonin for primary headache prevention. Forty-nine patients (37 with migraine and 12 with chronic tension-type headache, TTH) were prescribed oral melatonin, 4 mg, 30 minutes before bedtime for six months. Forty-one (83.6%) of the 49 patients completed the study, while eight dropped out for personal reasons. A statistically significant reduction in headache frequency was found between baseline and final follow-up after six months of treatment (p=0.033 for TTH patients and p<0.001 for migraineurs). The Headache Impact Test score was significantly reduced in both groups of headache patients (p=0.002 and p<0.001, respectively). At baseline, melatonin levels, measured both during a headache attack and a pain-free period, did not differ between patients with TTH and migraineurs (p=0.539 and p=0.693, respectively), and no statistically significant differences in Hamilton Depression Rating Scale scores were found between the two groups. This pilot study shows promising results, in terms of headache frequency reduction and daily quality of life improvement, in both groups.

Selective serotonin reuptake inhibitors (SSRIs) and serotonin-norepinephrine reuptake inhibitors (SNRIs) for the prevention of tension-type headache in adults.

BACKGROUND: This is an updated version of the Cochrane review published in 2005 on selective serotonin re-uptake inhibitors (SSRIs) for preventing migraine and tension-type headache. The original review has been split in two parts and this review now only regards tension-type headache prevention. Another updated review covers migraine. Tension-type headache is the second most common disorder worldwide and has high social and economic relevance. As serotonin and other neurotransmitters may have a role in pain mechanisms, SSRIs and serotonin-norepinephrine reuptake inhibitors (SNRIs) have been evaluated for the prevention of tension-type headache. OBJECTIVES: To determine the efficacy and tolerability of SSRIs and SNRIs compared to placebo and other active interventions in the prevention of episodic and chronic tension-type headache in adults. SEARCH METHODS: For the original review, we searched the Cochrane Central Register of Controlled Trials (CENTRAL 2003, Issue 4), MEDLINE (1966 to January 2004), EMBASE (1994 to May 2003), and Headache Quarterly (1990 to 2003). For this update, we revised the original search strategy to reflect the broader type of intervention (SSRIs and SNRIs). We searched CENTRAL (2014, Issue 10) on the Cochrane Library, MEDLINE (1946 to November 2014), EMBASE (1980 to November 2014), and PsycINFO (1987 to November 2014). We also checked the reference lists of retrieved articles and searched trial registries for ongoing trials. SELECTION CRITERIA: We included randomised controlled trials comparing SSRIs or SNRIs with any type of control intervention in participants 18 years and older, of either sex, with tension-type headache. DATA COLLECTION AND ANALYSIS: Two authors independently extracted data (headache frequency, index, intensity, and duration; use of symptomatic/analgesic medication; quality of life; and withdrawals) and assessed the risk of bias of trials. The primary outcome is tension-type headache frequency, measured by the number of headache attacks or the number of days with headache per evaluation period. MAIN RESULTS: The original review included six studies on tension-type headache. We now include eight studies with a total of 412 participants with chronic forms of tension-type headache. These studies evaluated five SSRIs (citalopram, sertraline, fluoxetine, paroxetine, fluvoxamine) and one SNRI (venlafaxine). The two new studies included in this update are placebo controlled trials, one evaluated sertraline and one venlafaxine. Six studies, already included in the previous version of this review, compared SSRIs to other antidepressants (amitriptyline, desipramine, sulpiride, mianserin). Most of the included studies had methodological and/or reporting shortcomings and lacked adequate power. Follow-up ranged between two and four months.Six studies explored the effect of SSRIs or SNRIs on tension-type headache frequency, the primary endpoint. At eight weeks of follow-up, we found no difference when compared to placebo (two studies, N = 127; mean difference (MD) -0.96, 95% confidence interval (CI) -3.95 to 2.03; I(2)= 0%) or amitriptyline (two studies, N = 152; MD 0.76, 95% CI -2.05 to 3.57; I(2)= 44%).When considering secondary outcomes, SSRIs reduce the symptomatic/analgesic medication use for acute headache attacks compared to placebo (two studies, N = 118; MD -1.87, 95% CI -2.09 to -1.65; I(2)= 0%). However, amitriptyline appeared to reduce the intake of analgesic more efficiently than SSRIs (MD 4.98, 95% CI 1.12 to 8.84; I(2)= 0%). The studies supporting these findings were considered at unclear risk of bias. We found no differences compared to placebo or other antidepressants in headache duration and intensity.SSRIs or SNRI were generally more tolerable than tricyclics. However, the two groups did not differ in terms of number of participants who withdrew due to adverse events or for other reasons (four studies, N = 257; odds ratio (OR) 1.04; 95% CI 0.41 to 2.60; I(2)= 25% and OR 1.55, 95% CI 0.71 to 3.38; I(2)= 0%).We did not find any study comparing SSRIs or SNRIs with pharmacological treatments other than antidepressants (e.g. botulinum toxin) or non-drug therapies (e.g. psycho-behavioural treatments, manual therapy, acupuncture). AUTHORS' CONCLUSIONS: Since the last version of this review, the new included studies have not added high quality evidence to support the use of SSRIs or venlafaxine (a SNRI) as preventive drugs for tension-type headache. Over two months of treatment, SSRIs or venlafaxine are no more effective than placebo or amitriptyline in reducing headache frequency in patients with chronic tension-type headache. SSRIs seem to be less effective than tricyclic antidepressants in terms of intake of analgesic medications. Tricyclic antidepressants are associated with more adverse events; however, this did not cause a greater number of withdrawals. No reliable information is available at longer follow-up. Our conclusion is that the use of SSRIs and venlafaxine for the prevention of chronic tension-type headache is not supported by evidence.