Pressure pain threshold and needle acupuncture in chronic tension-type headache--a double-blind placebo-controlled study

In order to examine the role of muscular mechanisms in chronic tension-type headache a study with needle acupuncture was performed. Needle acupuncture could be of therapeutic value because it has shown some positive effects in myofascial pain syndromes. We performed a double-blind, placebo-controlled study with 39 patients (mean age 49.0 years, SD=14.8) fulfilling the International Headache Society criteria for chronic tension-type headaches. Participants were randomly assigned to verum or placebo condition. Six weeks after end of treatment no significant differences between placebo and verum could be observed with respect to visual analogue scale and frequency of headache attacks. Nevertheless, pressure pain thresholds significantly increased for the verum group. The findings of our study support the hypothesis that peripheral mechanisms - such as increased muscle tenderness - only play a minor role in the pathogenesis of chronic tension-type headache.     

Chronic tension-type headache treated with acupuncture, physical training and relaxation training. Between-group differences

The aim of this study was to compare acupuncture, relaxation training and physical training in the treatment of chronic tension-type headache (CTTH). The study comprised 90 consecutive patients with CTTH who were randomly allocated to acupuncture, relaxation training or physical training. Headache intensity, headache-free days and headache-free periods were registered using a visual analogue scale and a headache diary. The measurements were made 4 weeks before, immediately after, and 3 and 6 months after the treatment period. Immediately after the last treatment, the number of headache-free periods and of headache-free days was higher in the relaxation group compared with the acupuncture group. There were no other significant differences between the groups at any time point. The clinical implications of our findings are that relaxation training induced the most pronounced effects directly after the treatment period, compared with acupuncture and physical training.     

Traditional Chinese acupuncture in tension-type headache: a controlled study.

Thirty patients with tension-type headache were randomly chosen to undergo a trial of traditional Chinese acupuncture and sham acupuncture. Five measures were used to assess symptom severity and treatment response: intensity, duration and frequency of headache pain episodes, headache index and analgesic intake. The five measures were assessed during a 4 week baseline period, after 4 and 8 weeks of treatment, and 1, 6 and 12 months thereafter. Before the start of the study, each patient was administered the MMPI. Split-plot ANOVAs showed that, compared to baseline, at 1 month after the end of treatment and for the 12 month follow-up, the frequency of headache episodes, analgesic consumption and the headache index (but not the duration or intensity of headache episodes) significantly decreased over time; however, no difference between acupuncture and placebo treatment was found. No single MMPI scale predicted the response to treatment, but the mean MMPI profile of acupuncture non-responders showed the presence of 'Conversion V'.     

Role of the needling per se in acupuncture as prophylaxis for menstrually related migraine: a randomized placebo-controlled study

The objectives were to introduce a new method for controlled trials of acupuncture in the field of headache research and to examine the role of needling per se. Women with menstrually related migraine were randomized to three months of treatment with verum or placebo needles. Three standard size casts were moulded to secure the placebo needles in the head. No significant differences were found between the verum group (n=15) and the placebo group (n=13) during treatment or follow up three and six months later, either in the attack frequency or in the number of days per month with migraine, headache intensity or drug-use. The casts held the needles exactly in place despite movements of the head, and are validated as practical, hygienic and extremely durable. This method is satisfactory for controlled studies of acupuncture in headache. It is possible that the positive results in earlier clinical trials on acupuncture in migraine are attributable to other mechanisms than needling of subcutaneous tissue.     

Low-dose ibuprofen in self-medication of mild to moderate headache: a comparison with acetylsalicylic acid and placebo

A double-blind, threefold crossover, double-dummy trial was performed, investigating the efficacy of 200 mg ibuprofen compared with 500 mg acetylsalicylic acid and placebo in patients who usually treated their headaches with over-the-counter drugs. Ninety-five patients suffering from mild to moderate migraine or episodic tension-type headache were included. Seventy-seven patients entered the intention-to-treat analysis and 65 completed all three treatments. For the main response criterion, a minimum 50% decrease of headache intensity on a visual analogue scale at I h after treatment, ibuprofen was significantly superior to acetylsalicylic acid and placebo. This was true for migraine attacks and tension-type headache episodes. Towards the end of the observation period (150 min), the differences between ibuprofen and acetylsalicylic acid were no longer significant. In conclusion, ibuprofen was at least equivalent to acetylsalicylic acid and superior to placebo.     

The 5-HT1-like agonist sumatriptan has a significant effect in chronic tension-type headache

Subcutaneous treatment of chronic tension-type headache with 2 mg and 4 mg sumatriptan, a selective 5-hydroxytryptamine1-like receptor agonist, was compared with placebo in a double-blind crossover study of 36 patients. The effect was evaluated using a 6-point verbal relief rating scale and by visual analog scale ratings of headache intensity before and for 2 h after treatment. Sumatriptan induced a modest but significantly greater headache relief than placebo, whereas no significant difference was found between the two doses of sumatriptan. Headache relief following sumatriptan was significant after 60 min and still seemed to be increasing after 120 min when the examination terminated. Three possible mechanisms of action of sumatriptan in tension-type headache are discussed.     

Treatment of chronic tension-type headache with botulinum toxin A: a randomized, double-blind, placebo-controlled multicenter study

A beneficial effect of botulinum toxin on tension-type headache was reported in open-label studies but scientifically rigorous clinical studies are lacking. Therefore we conducted a prospective, multicenter, randomized, double-blind, placebo-controlled trial. Multiple pericranial muscles of 112 patients with chronic tension-type headache were treated either with 500 mouse units of botulinum toxin (Dysport) or with placebo. The diagnoses were made strictly following the International Headache Society criteria. Co-existence of migraine was an exclusion criterion. Injections were made following a fixed scheme and not adjusted to the patient's symptoms. Patients kept a headache diary that was used to calculate the area under the headache curve of 6 weeks before and 12 weeks after the treatment as the main effect measure. Secondary effect measures were the number of days with headache, the number of days with intake of analgesics, the duration of the nocturnal sleep, and the Beck Depression Inventory score. There were no significant differences between the verum group and the placebo group in any of these variables. Seven patients of the verum group had transient weakness of the eyelids, the neck, or both, indicating that a higher dose than used in this study does not seem sensible for the treatment of headache. The statistical power of the study was high enough to warrant the conclusion that there is no clinically significant effect of botulinum toxin A on chronic tension-type headache.     

Needle acupuncture in chronic poststroke leg spasticity

OBJECTIVE: To determine whether needle acupuncture may be useful in the reduction of leg spasticity in a chronic state. DESIGN: Single-blind, randomized, placebo-controlled trial. SETTING: Neurologic outpatient department of a medical school in Germany. PARTICIPANTS: Twenty-five patients (14 women) suffering from chronic poststroke leg spasticity with pes equinovarus deformity (Modified Ashworth Scale [MAS] score, >/=1), aged 38 to 77 years (mean +/- standard deviation, 58.5+/-10.4 y), were enrolled in the study. The mean time from stroke to inclusion in the study was approximately 5 years (mean, 65.4+/-48.3 mo; range, 7-180 mo). INTERVENTIONS: Participants were randomly assigned to placebo treatment (n=12) by using a specially designed placebo needling procedure, or verum treatment (n=13). MAIN OUTCOME MEASURES: MAS score of the affected ankle, pain (visual analog scale), and walking speed. RESULTS: There was no demonstrated beneficial clinical effects from verum acupuncture. After 4 weeks of treatment, mean MAS score was 3.3+/-0.9 in the placebo group versus 3.3+/-1.1 in the verum group. The neurophysiologic measure of H-reflex indicated a significant increase of spinal motoneuron excitability after verum acupuncture (H-response/M-response ratio: placebo,.39+/-.19; verum,.68+/-.41; P<.05). CONCLUSIONS: This effect might be explained by afferent input of A delta and C fibers to the spinal motoneuron. The results from our study indicate that needle acupuncture may not be helpful to patients with chronic poststroke spasticity. However, there was neurophysiologic evidence for specific acupuncture effects on a spinal (segmental) level involving nociceptive reflex mechanisms.     

急性颅脑损伤后紧张型头痛的综合治疗方法

目的探讨急性颅脑损伤后紧张型头痛的综合治疗效果。方法对14例轻度颅脑损伤后出现重度头痛、按照国际头痛协会诊断标准确定为紧张型头痛的患者,根据查体体征行神经及痛点阻滞,应用曲安奈德10mg配成利多卡因浓度为0.4%的消炎镇痛液,选择相应的压痛点每个点穿刺注射3ml,配合口服塞来昔布和乙哌立松,观察治疗前后头痛程度和持续时间的变化。结果治疗后,患者的头痛发作程度明显减轻,头痛持续时间明显缩短(P<0.01)。结论以神经阻滞为主的综合治疗方法对颅脑损伤后紧张型头痛有明显的疗效。     

Modified-release formulation of tizanidine in chronic tension-type headache

The efficacy of the modified-release formulation of tizanidine (Sirdalud) was compared with placebo in a randomized, double-blind, parallel-group study of 138 women and 47 men, aged 18 to 79 years, with a history of chronic tension-type headache (IHS categories 2.2 and 2.3). The treatment period was 6 weeks preceded by a 2-week prerandomization period. The patients were randomly assigned to receive 6-mg Sirdalud, 12-mg Sirdalud MR, or placebo. The study medication was taken once per day, orally in the evening. Efficacy was measured by visual analog scale, the number of headache-free days, the daily duration of headache, and the use of paracetamol. The primary end point was the severity of daily headache derived from visual analog scale scores covering the last 2 treatment weeks. One hundred sixty patients (56 in the 6-mg group, 49 in the 12-mg group, and 55 in the placebo group) completed the study. The severity of the headache decreased similarly in the treatment groups and the placebo group. The visual analog scale values decreased from the prerandomization values by 53% in the 6-mg group, 48% in the 12-mg group, and 52% in the placebo group. The modified-release formulation of tizanidine in doses up to 12 mg taken in the evening is not superior to placebo in the treatment of chronic tension-type headache. The placebo effect was unexpectedly strong in the present study, supporting the view that psychophysiological mechanisms are of considerable importance in sustaining chronic tension-type headache.     

Treatment of tension-type headache with botulinum toxin type A: a double-blind, placebo-controlled study

OBJECTIVE: To determine whether injections of botulinum toxin could be of therapeutic value in the treatment of tension-type headache. BACKGROUND: Botulinum toxin A is very effective at reducing muscle tenderness and pain in many diseases. Increased muscle tension may contribute to tension-type headache. METHODS: We performed a double-blind, placebo-controlled study with 21 patients fulfilling the International Headache Society criteria for tension-type headache. Participants were randomly assigned to treatment (pericranial injection of 10 x 20 mouse units botulinum toxin A) or placebo (injection of isotonic saline in the same manner). RESULTS: After 4, 8, and 12 weeks, no significant differences between placebo and treatment could be observed (with respect to visual analog scale, frequency and duration of headache attacks, consumption of analgesics, pressure pain threshold, total tenderness score, and quality-of-life parameters). CONCLUSIONS: The findings of our study strongly support the hypothesis that peripheral mechanisms, such as increased muscle tenderness, only play a minor role in the pathogenesis of tension-type headache.     

Ketoprofen, paracetamol and placebo in the treatment of episodic tension-type headache

The aim of the study was to assess the efficacy and tolerability of a single oral dose of ketoprofen 25 mg in comparison with single doses of ketoprofen 2 × 25 mg, paracetamol 500 mg and 1,000 mg, and placebo in the treatment of episodic tension-type headache. The study was conducted as a single centre, double-blind, randomized, placebo-controlled, five-period, within-patient comparative trial in outpatients with episodic tension-type headache according; to the International Headache Society's diagnostic criteria. Each patient had to treat five attacks of episodic tension-type headache with a single dose of each of the tested medications with a minimum interval o 72 h between two attacks. Details of the attack and response to treatment were recorded on a diary card Altogether 30 patients treated 5 attacks and 2, 3, 1 and 4 patients treated 4, 3, 2 and 1 attack, respectively, The primary variable was decrease in headache pain intensity from baseline to 2 h after intake, evaluated by means of a 100 mm visual analogue scale. Ketoprofen 50 mg was significantly better than placebo an paracetamol for this main criterion. Neither of the paracetamol groups differed from the placebo group, Only a few adverse events were reported, usually of mild or moderate severity, with no difference between the treatments. Ketoprofen 50 mg may be considered an effective and well tolerated analgesic in the treatment of episodic tension-type headache of moderate or severe intensity.     

Harpagophytum-Extrakt LI 174 (Teufelskralle) bei der Behandlung unspezifischer Rückenschmerzen

PROBLEM: This randomised, double-blind, placebo controlled study was intended to investigate the effects of Harpagophytum procumbens (Devil's Claw) on sensory, motor and vascular mechanisms of muscle pain. In addition to clinical efficacy and tolerability, possible action mechanisms were analysed by means of experimental algesimetric methods. METHODOLOGY: The study was performed on patients with slight to moderate muscular tension or slight muscular pain of the back, shoulder and neck. On a double-blind randomised basis the verum group received 2x1 film tablets per day, i. e. 2x480 mg/day, of Harpagophytum extract LI 174 (Rivoltan(R)) at 8.00 a.m. and 8.00 p.m. over a certain period. The duration of the therapy was 4 weeks. Data recording at 14-day intervals was made using a visual analogue scale, pressure algometer test, recording of antinociceptive muscular reflexes, muscle stiffness test, EMG surface activity, muscular ischaemia test, clinical global score and subjective patient and physician ratings. RESULTS: A total of 31 patients in the verum group and 32 in the placebo group were treated. After four weeks of treatment there was found to be a clear clinical efficacy of the verum on the clinical global score and in the patient and physician ratings. Highly significant effects were found in the visual analogue scale, the pressure algometer test, the muscle stiffness test and the muscular ischaemia test. No difference from placebo was found in the recording of antinociceptive muscular reflexes or in the EMG surface activity. Tolerability was good; no serious adverse effects occurred. CONCLUSIONS: A highly significant clinical efficacy was achieved with a monotherapy of Harpagophytum dry extract LI 174 after four weeks' treatment at a dosage of 2x480 mg/day in cases of slight to moderate muscular pain. With regard to the action mechanisms investigated, it may be concluded that treatment with Harpagophytum extract LI 174 may be expected to have a significant influence on sensory and vascular muscular response and bring about a reduction in muscle stiffness. No central nervous effects were discovered.     

Cerebrovascular response in migraineurs during prophylactic treatment with acupuncture: a randomized controlled trial

Abstract Objectives: The study objective was to evaluate the effect of acupuncture on cerebrovascular response in migraineurs by transcranial Doppler ultrasound. Design: This study was a randomized, quasi double-blinded, placebo-controlled study. Subjects: Thirty-five (35) migraineurs were diagnosed according to the International Headache Society criteria. The stimulus paradigm was performed in 18 verum and 17 placebo acupuncture patients. Interventions: Participants were treated with acupuncture according to Traditional Chinese Medicine recommendations. All patients received one session of acupuncture each week for 8 weeks. Outcome measures: To evaluate the clinical effect of acupuncture treatment, headache frequency and intensity was monitored by a headache diary. Cerebral blood flow velocity data were analyzed with a validated technique based on automated stimulus-related averaging. Vasotonus was determined by systolic and mean flow velocities and pulsality index in right and left middle cerebral arteries during rest. Cerebrovascular response was evaluated by detecting the cerebrovascular Valsalva ratio by maximum end-diastolic flow velocity acceleration during the straining phase of a Valsalva maneuver. Additionally, the centroperipheral Valsalva ratio was determined by the quotient of the cerebrovascular ratio to the corresponding blood pressure acceleration. Results: Pre-/post-acupuncture treatment comparisons between verum- and placebo- acupuncture groups demonstrated a significant decrease of days with migraine headache in the verum group (-52.5%; p<0.001), whereas placebo-acupuncture patients profited to a smaller extent and the duration of headache attack (hours/month) did not decrease significantly. Pretreatment recordings showed increased vasotonus and exaggerated cerebrovascular response in migraineurs. Pre-/post-treatment comparisons demonstrated no significant differences in vasotonus between groups, while cerebrovascular response patterns to Valsalva stimulus were significantly (p<0.001) diminished in verum-acupuncture patients, but not in the placebo group. Conclusions: The findings indicate that prophylactic treatment of migraineurs by standardized acupuncture might positively influence the dysfunction of the cerebrovascular response to autonomic stimuli, but not the cerebral vasotonus during rest.     

Tizanidine in Chronic Tension-Type Headache: A placebo controlled double-blind cross-over study

The efficacy of tizanidine in chronic tension-type headache was compared with placebo in a randomized, double-blind and cross-over study in 37 women aged 20 to 59 years with a history of headache for 7 months to 30 years (median 5 years). The treatment periods were 6 weeks with an intervening 2 week wash-out period. The treatment was started with 6 mg/day divided into three doses, and the daily dose could be increased to 18 mg/day depending on the treatment response. The effect of the treatment was measured by visual analogue scale, verbal rating scale, number of days free of headache, number of analgesics needed, and the dose of trial medication needed. In all these measurements, tizanidine was statistically significantly more effective than placebo. The pre-trial Beck Depression Inventory score did not predict the response to treatment, neither did the level of electromyographic activity of the trapezius muscle. Side-effects, drowsiness and dry mouth were significantly more common during tizanidine treatment but they were usually mild. The results of the present trial suggest that tizanidine is effective in the treatment of chronic tension-type headache in women.     

Acupuncture for chronic headaches--an epidemiological study

OBJECTIVE: To investigate the characteristics and outcomes of patients undergoing acupuncture treatment for chronic headaches under conditions of routine care provided within the framework of statutory health insurance in Germany. Furthermore, we investigated correlations between different outcomes. PATIENTS AND METHODS: Patients with migraine, episodic or chronic tension-type headache (TTH), or several other forms of chronic headache (cluster, vascular, drug-induced headache; other specific headaches) treated with acupuncture (mean number of sessions 8.6 +/- 3.0) were included into an observational study. Detailed questionnaires including questions on headache days and instruments measuring disability (Pain Disability Index) and quality of life (SF-36) were completed before treatment, after treatment, and at 6 months after inclusion. RESULTS: A total of 2,022 patients (732 with migraine, 351 with episodic and 440 with chronic TTHs, and 499 with other diagnoses) treated by 1,418 physicians were included in the main analysis. Sociodemographic and baseline characteristics differed considerably in the four diagnostic groups. Statistically highly significant and clinically relevant improvements were seen for all clinical outcome measures in all diagnostic groups. In 52.6% of patients headache frequency decreased by at least 50% compared to baseline. The comparison of headache frequency, pain intensity, and generic outcome measures showed that some of these outcomes correlate only weakly. CONCLUSIONS: In this epidemiological study, headache patients reported clinically relevant improvements after receiving acupuncture. Randomized trials performed in parallel to this study confirm the relevant overall effect, however, the effect may largely be due to potent unspecific needling and placebo effects.     

Acupuncture for Tension-Type Headache: A Meta-Analysis of Randomized,Controlled Trials

We investigated the efficacy and safety of acupuncture for the treatment of tension-type headache by conducting a systematic review and meta-analysis of randomized, controlled trials. The Cochrane Central Register of Controlled Trials, MEDLINE, EMBASE, CINAHL, and PsycINFO were searched from inception through August 2007. No search or language restrictions were applied. Eight randomized, controlled trials met our inclusion criteria. Pooled data from 5 studies were used for the meta-analysis. Our primary outcome was headache days per month. We assessed data from 2 time points: During treatment and at long-term follow-up (20–25 weeks). The weighted mean difference (WMD) between acupuncture and sham groups was used to determine effect size, and a validated scale was used to assess the methodological quality of included studies. During treatment, the acupuncture group averaged 8.95 headache days per month compared with 10.5 in the sham group (WMD, −2.93 [95% CI, −7.49 to 1.64]; 5 trials). At long-term follow-up, the acupuncture group reported an average of 8.21 headache days per month compared with 9.54 in the sham group (WMD, −1.83[95% CI, −3.01 to −0.64]; 4 trials). The most common adverse events reported were bruising, headache exacerbation, and dizziness.PerspectiveThis meta-analysis suggests that acupuncture compared with sham for tension-type headache has limited efficacy for the reduction of headache frequency. There exists a lack of standardization of acupuncture point selection and treatment course among randomized, controlled trials. More research is needed to investigate the treatment of specific tension-type headache subtypes.     

A prospective, open-label, long-term study of the efficacy and tolerability of topiramate in the prophylaxis of chronic tension-type headache

This open study evaluates the effectiveness and safety of topiramate for the prophylaxis of chronic tension-type headache. Fifty-one patients were enrolled, of whom 46 completed 24 weeks of treatment with topiramate. Daily dosing was titrated from 25 mg to 100 mg by treatment week 4. The primary efficacy parameter was headache frequency at weeks 13-24 compared with baseline. Headache frequency declined from 23.50 +/- 5.32 days (baseline, mean, SD) to 12.58 +/- 6.28 days at weeks 13-24 (P < 0.0001), with frequency of severe headaches dropping from 8.18 to 3.14 days (P < 0.0001). The average headache intensity dropped from 6.13 to 2.07 on the visual analogue scale (P < 0.0001). These parameters were not significantly reduced at weeks 5-12. A 50% reduction in headache frequency was achieved in 73% of patients at weeks 13-24. Also improved were mood, sleep, quality of life (all parameters, P < 0.0001) as well as the Beck Depression Inventory-II (P < 0.0001). In addition, a highly significant weight loss of 2.14 kg (mean) was observed between baseline (71.64 +/- 10.65 kg) and week 24 [69.50 +/- 10.04 kg (SD)] (P < 0.0001). There were only few side-effects, none of these rated severe. The results provide preliminary confirmation of the efficacy and tolerability of topiramate in the prophylaxis of chronic tension-type headache.     

Designing an acupuncture study: the nationwide, randomized, controlled, German acupuncture trials on migraine and tension-type headache

BACKGROUND: In the nationwide German Acupuncture Trials (GERAC) verum acupuncture, based on Traditional Chinese Medicine (TCM), was to be tested against sham acupuncture for the entities classified in the West as "migraine" (MIG) and "tension-type headache" (TTH). However, there were no generally accepted guidelines on how to perform a consistent verum or sham treatment. OBJECTIVE: To design broadly consensual verum and sham acupuncture treatment protocols for MIG and TTH for the GERAC. METHODOLOGY: Extensive literature study and consultation with acupuncture experts. Personal interviews, both free and structured, e-mail discussions, and phone conferences were used. RESULTS: Broadly consensual acupuncture protocols for MIG and TTH for verum and sham acupuncture were developed. They included semi-standardized point combinations with clearly described point selection rules based on TCM acupuncture diagnoses. A procedure was developed to help ensure homogenous treatment quality in a large multicenter trial. CONCLUSIONS: The GERAC study design allowed acupuncture to be tested in a naturalistic environment. The rigorous study design and the large number of physician investigators guaranteed a high external validity for the results. The results will help determine the significance of Chinese acupuncture in the context of Western medicine for the treatment of MIG and TTH.     

Treating chronic tension-type headache not responding to amitriptyline hydrochloride with paroxetine hydrochloride: a pilot evaluation

CONTEXT: In some individuals, chronic tension-type headache fails to respond to tricyclic antidepressant medications that often serve as first-line therapy. OBJECTIVE: To evaluate the clinical efficacy of paroxetine hydrochloride for chronic tension-type headache not responding to amitriptyline hydrochloride. DESIGN AND SETTING: Open-label trial of paroxetine conducted at 2 outpatient sites in Ohio. PARTICIPANTS AND INTERVENTION: Thirty-one adults (mean age, 37 years; 20 women) with chronic tension-type headache (mean, 25 headache days per month) who had failed to respond (less than 30% improvement) to treatment with either amitriptyline (n = 13) or matched placebo (n = 18). All participants were treated with paroxetine (up to 40 mg per day) in a 9-month protocol. OUTCOME MEASURES: Monthly headache index calculated as the mean of pain ratings (0 to 10 scale) recorded by participants in a diary 4 times per day, number of days per month with at least moderate pain (pain rating of 5 or greater), and analgesic medication use. RESULTS: In patients who had not responded to amitriptyline, paroxetine failed to reduce chronic tension-type headaches or analgesic medication use. In patients who had not responded to placebo, paroxetine produced modest reductions in chronic tension-type headaches and analgesic use. CONCLUSIONS: We found no evidence that chronic tension-type headaches that failed to respond to tricyclic antidepressant therapy with amitriptyline improved when subsequently treated with paroxetine. More support was found for the efficacy of paroxetine in patients with chronic tension-type headaches who had failed to respond to placebo.