Botulinum toxin type A as an effective prophylactic treatment in primary headache disorders

OBJECTIVE: To measure the effect of botulinum toxin type A (Botox, Allergan, Inc, Irvine, CA) treatment in 271 patients diagnosed with headache in accordance with International Headache Society (IHS) criteria. BACKGROUND: Botulinum toxin type A has shown promise for the treatment of headache in several clinical trials, but uncertainty remains as to how botulinum toxin type A optimally should be used for treating headache and which patients are best suited for this treatment. METHODS: This was a retrospective chart review of all patients who received botulinum toxin type A for the treatment of headache from January 1999 to February 2002. Patients were injected with an average dose of 63.2 U (SD, 14.5) of botulinum toxin type A on 2 or more visits, with treatments involving a "fixed-site" or a "follow-the-pain" (or a combination of both) approach. In the fixed-site approach, botulinum toxin type A was injected into the procerus, corrugator, frontalis, and temporalis muscles. In the follow-the-pain approach, botulinum toxin type A was injected into a combination of the procerus, corrugator, frontalis, temporalis, occipitalis, trapezius, and/or semispinalis capitis muscles. The primary outcomes for the trial were the reduction in headache days per month or headache intensity (0 to 3 scale) (or both) from baseline. Patients were diagnosed according to IHS criteria and subsequently classified into the following categories: chronic daily headache (more than 15 headache days per month), episodic tension-type headache, episodic migraine, and "mixed" HA (less than 15 headache days per month, combination of migraine and tension-type headache). RESULTS: Treatment period was an average of 8.6 months (SD, 6.4); patients received an average of 3.4 doses (SD, 1.6) 3 months apart. Of the 271 patients, 29 (10.7%) had episodic migraine, 17 (6.3%) had episodic tension-type headache, 71 (26.2%) had mixed headache, and 154 (56.8%) had chronic daily headache. Two-hundred fifty-six patients had data for the number of headache days per month, 117 had data for headache intensity, and all 271 had data for headache days or headache intensity. Botulinum toxin type A treatment significantly reduced the number of headache days per month from 18.9 (SD, 10.3) to 8.3 (SD, 8.9) (n=256, P<.001)--a 56% reduction. Headache intensity decreased from 2.4 points (SD, 0.6) to 1.8 points (SD, 0.8) (n=117, P<.001)--a 25% reduction. Of 263 patients surveyed, 225 (85.6%) reported improvement in headache frequency and intensity. There was no correlation of effect/lack of effect with reason for treatment, duration/number of treatments, injection technique, mean/total dose, age, gender, or comorbidity. Approximately 95% of patients did not experience medication side effects. CONCLUSION: These results suggest that botulinum toxin type A may be an effective and safe prophylactic treatment for a variety of moderate to severe chronic headache types.     

Botulinum toxin type A (BOTOX) for the prophylactic treatment of chronic daily headache: a randomized, double-blind, placebo-controlled trial

OBJECTIVE: The objective of this study was to evaluate the safety and efficacy of botulinum toxin type A (BoNT-A; BOTOX, Allergan, Inc.) for the prophylactic treatment of chronic daily headache (CDH). BACKGROUND: Several open-label and small controlled trials suggest that BoNT-A may be effective in the prophylactic treatment of headache. DESIGN AND METHODS: This was an 11-month, randomized double-blind, placebo-controlled study of BoNT-A for the treatment of patients aged 18 to 65 years old with 16 or more headache days per 30 days conducted at 13 North American study centers. Following a 30-day screening period and a 30-day, single-blind, placebo-response period to identify placebo responders, eligible patients from both the placebo responder and placebo nonresponder groups were injected with BoNT-A or placebo every 90 days and assessed every 30 days for 9 months, a period encompassing three treatment cycles. The primary efficacy measure was the change from baseline in the frequency of headache-free days in a 30-day period for the placebo nonresponder group at day 180, the chosen efficacy time point. The secondary efficacy measure was the proportion of patients with a decrease from baseline of 50% or more in the frequency of headache days per 30-day period for the placebo nonresponder group at day 180. The change from baseline in the frequency of headaches (per 30-day period), the proportion of patients with a decrease from baseline of 50% or greater in the frequency of headaches per 30-day period, acute medication use, and adverse events were also assessed. RESULTS: Of 571 patients assessed over the baseline period, 355 (mean age, 43.5 years; 300/355 [84.5%] female) were enrolled and randomized. At the end of the placebo run-in period, 279 patients (79%) were classified as placebo nonresponders and 76 patients (21%) as placebo responders. Subsequently, patients were randomized within each group to receive either BoNT-A or placebo. In the placebo nonresponder stratum, the mean number of headache-free days at baseline was 5.8 (+/-4.7) for BoNT-A- versus 5.5 (+/-4.7) for placebo-treated patients. At day 180, placebo nonresponders treated with BoNT-A had an improved mean change from baseline of 6.7 headache-free days per 30-day period compared to a mean change from baseline of 5.2 headache-free days for placebo-treated patients. The between-group difference of 1.5 headache-free days favored BoNT-A treatment, although the difference between the groups was not statistically significant. However, a statistically significant difference was observed at day 180 endpoint for the secondary efficacy measure. A significantly higher percentage of BoNT-A patients had a decrease from baseline of 50% or greater in the frequency of headache days per 30-day period at day 180 (32.7% vs. 15.0%, P=.027). Also, the mean change from baseline in the frequency of headaches per 30-day period at day 180 was -6.1 for BoNT-A patients vs. -3.1 for the placebo patients (P=.013). Only 4 of 173 BoNT-A patients (2.3%) discontinued the study due to adverse events. The majority of treatment-related adverse events were transient and mild to moderate in severity. CONCLUSIONS: BoNT-A treatment resulted in patients having, on average, approximately seven more (1 week) headache-free days compared to baseline. Although at the primary time point (day 180) the BoNT-A treatment resulted in a 1.5 between-group difference compared to placebo, this difference was not statistically significant. The treatment met secondary efficacy outcome measures, including the percentage of patients experiencing a 50% or more decrease in the frequency of headache days, in addition to statistically significant reductions in headache frequency. BoNT-A was also well tolerated in patients with CDH.     

Botulinum toxin injections for the treatment of frontal tension headache

Abstract We performed a randomized, double-blind, placebo-controlled trial to determine the efficacy of botulinum toxin type A (BOTOX; Allergan) in treating frontal tension-type headache (TTH). A total of 40 patients attending a headache treatment center were randomized to receive 50 U botulinum toxin type A or saline, injected at 10 sites of the forehead. Frequency and severity of headaches before and after injection were compared. The intensity of headaches in the botulinum toxin type A group, but not the placebo group, fell significantly from an average score of 5.19 to 4.65 (p<0.0001). Botulinum toxin type A patients and placebo patients experienced an average reduction in the number of headaches per month, but these reductions were not significantly different between groups. Botulinum toxin type A was well tolerated, with no significant adverse events. Botulinum toxin type A injections in the management of frontal TTH has been shown by this study to be both effective and well tolerated. It should be noted that the effect of botulinum toxin on intensity of headache, although statistically significant, was relatively small.     

A型肉毒毒素治疗紧张性头痛的临床研究

目的观察A型肉毒毒素治疗紧张性头痛的临床疗效和不良反应。方法选取31例紧张性头痛患者,应用A型肉毒毒素进行颅周肌肉注射治疗。问卷调查并记录每例紧张性头痛患者治疗前、后3个月紧张性头痛发作情况,比较紧张性头痛发作频率、持续时间、严重程度及使用止痛药物情况,观察不良反应。结果A型肉毒毒素治疗后第1个月,紧张性头痛发作频率、发作持续时间、发作严重程度均较治疗前明显下降(P<0.01),使用止痛药物较治疗前显著减少(P<0.01),疗效至少可维持3个月,且不良反应轻微、短暂。结论A型肉毒毒素颅周肌肉注射治疗紧张性头痛有一定疗效,不良反应轻微、短暂,值得进一步验证。     

Predictors of response to botulinum toxin type A (BoNTA) in chronic daily headache

OBJECTIVE: To evaluate predictors of response to botulinum toxin type A (BoNTA; BOTOX, Allergan Inc., Irvine, CA, USA) in patients with chronic daily headache (CDH). BACKGROUND: Chronic migraine (CM) and chronic tension-type headache (CTTH) form the majority of CDH disorders. Controlled trials indicate that BoNTAis effective in reducing the frequency of headache and number of headache days in patients with CDH disorders. A recent migraine study found that patients with imploding or ocular types of headaches were responders to BoNTA, whereas those with exploding headaches were not. To date, there are no data on factors that might predict response to BoNTA in patients with CDH. METHODS: A total of 71 patients with CM and 11 patients with CTTH were treated with 100 units BoNTA. Every patient received at least 2 sets of injections at intervals of 12-15 weeks; fixed sites, fixed dose, and "follow-the-pain" approaches were used for the injections. A detailed medical history was taken for each patient in addition to recording Migraine Disability Assessment Scale (MIDAS) scores at baseline and every 3 months after each set of injections. Headache frequency was assessed throughout the study from baseline to weeks 24-27. Patients recorded the frequency, severity, and duration of headaches in Headache Diaries. Patients were divided into responders (> or = 50% reduction in both headache frequency and MIDAS scores compared with baseline) and nonresponders (< 50% reduction in either of the above variables). Variables analyzed for predictors of response include headache that is predominantly unilateral or bilateral in location, presence of cutaneous allodynia (scalp allodynia), and presence of pericranial muscle tenderness (also referred to as muscle allodynia). Chi-square analysis was used for parallel-group comparisons (proportion of CM responders vs proportion of CM nonresponders and proportion of CTTH responders vs proportion of CTTH nonresponders). RESULTS: In the CM group, 76.1% (54 /71) of patients were responders to BoNTA, of which 68.5% (37/54) had headache that was predominantly unilateral in location and the remaining 31.5% (17/54) had headache that was predominantly bilateral in location (both P < .01 vs CM nonresponders). Of the 23.9% (17/71) CM nonresponders, 76.5% (13/17) reported predominantly bilateral headache and in the remaining 23.5% (4/17) the headache was unilateral. In the CM responders group, 81.5% (44/54) had clinically detectable scalp allodynia, while pericranial muscle tenderness was present in 61.1% (33/54) (both P < .01 vs CM nonresponders). The presence of scalp allodynia and pericranial muscle tenderness in the CM nonresponders was 11.8% (2/17) and 17.6% (3/17), respectively. In the CTTH group where all patients (100%, 11/11) had bilateral headache, 36.4% (4/11) of patients were responders to BoNTA. All of those CTTH responders (100%, 4/4) had pericranial muscle tenderness (P < .05 vs CTTH nonresponders). None of the CTTH nonresponders had pericranial muscle tenderness. No clinically significant serious adverse events (AEs) were reported. Mild AEs, eg, injection-site pain that persisted for 1-9 days, were reported in 11 patients. One patient had transient brow ptosis. CONCLUSIONS: A greater percentage of patients with CM responded to BoNTA than patients with CTTH. Headaches that were predominantly unilateral in location, presence of scalp allodynia, and pericranial muscle tenderness appear to be predictors of response to BoNTA in CM, whereas in CTTH, pericranial muscle tenderness may be a predictor of response.     

Botulinum toxin type A as migraine preventive treatment in patients previously failing oral prophylactic treatment due to compliance issues

Objective.— To examine the efficacy and safety of and satisfaction with botulinum toxin type A (BoNTA; BOTOX^®: Allergan, Inc., Irvine, CA) for prophylactic treatment of migraine headache in patients previously failing prophylaxis because of issues pertaining to compliance. Background.— Numerous factors (eg, adverse effects, tolerability, cost, frequency of dosage, hesitancy to take daily medication, failure to complete treatment) negatively influence compliance with the preventive pharmacology for migraine prophylaxis. BoNTA may offer benefit in improving compliance because of its long duration of action, injectable route of administration, and its tolerability (adverse event [AE]) profile. Methods.— This was a randomized, double‐blind, single‐center, placebo‐controlled study (months 1 to 3) of BoNTA with a cross‐over to open‐label BoNTA treatment (months 4 to 6). Criteria for enrollment included patients with disabling headache (International Headache Society, International Classification of Headache Disorders [ICHD‐I] diagnosis 1.1, 1.2, 1.7, or 2.2, and Headache Impact Test [HIT]‐6 scores ≥56) previously failing prophylaxis because of compliance, tolerability, or adherence issues. After baseline evaluation, subjects were randomized 2 : 1 to a single set of BoNTA (139 units [U] total; 17 sites/6 muscle groups) or placebo injections. After month 3, only placebo‐treated subjects were eligible to receive BoNTA in the open‐label continuation study. Treatment outcomes were evaluated by headache episodes and days and maximum headache severity. Headache impact was assessed by the HIT‐6, Migraine Disability Assessment (MIDAS) score, and Quality of Life (QoL) questionnaires. Treatment satisfaction was assessed with the Migraine Impact Questionnaire (MIQ), which included MIDAS and QoL. Results.— Of the 73 subjects screened, 61 (40 BoNTA; 21 placebo) with migraine headache diagnosis 1.1 and 1.2 who met all study criteria were enrolled in the 3‐month, blinded study, with 54 completing the study; 19 of 21 placebo‐treated subjects participated in the open‐label period (months 4 to 6), with 18 completing the study. Between‐group comparisons, demonstrated through analysis of the subjects' headache diaries, did not reach statistical significance at months 1 to 3 for the number of headache episodes or days (primary endpoint). At month 2, a decrease from baseline in the number of headache episodes (?0.99 ± 2.38; P = .0147 vs 0.42 ± 3.23; P = not significant [NS]) and headache days (?1.52 ± 3.84; P = .0194 vs 0.23 ± 4.67; P = NS) was noted in the BoNTA‐treated subjects but not in the placebo‐treated subjects, respectively. During the open‐label study, BoNTA‐treated subjects had a decrease in the number of headache episodes at months 5 and 6 (?1.58 ± 2.88 and ?1.58 ± 2.85, respectively; P < .05 vs baseline for both) and headache days at months 5 and 6 (?2.84 ± 4.47 and ?2.73 ± 4.86, respectively; P < .05 vs baseline for both). BoNTA did not affect maximum headache severity compared with baseline or placebo during the first 3 months of the study. A decrease in HIT‐6 scores was significantly greater for BoNTA‐treated subjects than for placebo‐treated subjects at month 3 (?7.77 vs ?3.58, P = .0466). Within‐group decreases in HIT‐6 scores were significant in BoNTA‐treated subjects during each month of the blinded trial (?5.10 ± 8.85, ?6.63 ± 7.49, ?7.77 ± 8.78 for months 1 to 3, respectively; P < .0001 for all vs baseline) and throughout the open‐label portion of the study (?7.89 ± 6.48, ?10.39 ± 10.81, ?9.00 ± 11.12 for months 4 to 6, respectively; P < .01 for all vs baseline). The within‐group decrease in placebo‐treated subjects was significant at months 1 and 3 (?3.35 ± 6.07 and ?3.58 ± 5.40, respectively; P < .05 for both). At 3 months, BoNTA was significantly better than placebo (P = .001) in the reduction of MIDAS total score. The change from baseline in the MIDAS total scores was significant in BoNTA‐treated subjects (?21.62 ± 38.70; P < .0001) but not in placebo recipients (4.76 ± 18.85; P = NS). BoNTA‐treated subjects showed improvement in 11 of 13 and 7 of 13 assessments of treatment satisfaction in MIQ at months 3 and 6, respectively, while the placebo group showed no improvement at any measured time interval in the study. At month 3 (blinded period), there were no treatment‐related AEs reported in both groups. However, there were 18 possible/probable occurrences of treatment‐related AEs in the BoNTA group. At month 6 (open‐label period), 4 treatment‐related AEs were reported, along with 2 possible occurrences. The majority of treatment‐related AEs were transient and mild to moderate in severity, with no subjects discontinuing the study because of AEs. Conclusions.— BoNTA‐treated subjects showed improvements from baseline in measures of headache frequency, and improvements from baseline and in comparison with placebo treatment in headache impact and treatment satisfaction at multiple time points in this study. However, BoNTA‐treated subjects did not differ from placebo‐treated subjects in measures of headache frequency and severity. BoNTA may be a useful treatment option for headache patients demonstrating poor compliance, adherence, or AE profile with oral prophylactic regimens.     

A pilot study of botulinum toxin A for headache in cervical dystonia

OBJECTIVE: To evaluate the prevalence of associated headache (HA) pain with craniocervical dystonia and the therapeutic effect of BoNT-A injections on the HA component when injected for cervical dystonia. BACKGROUND: HA associated with craniocervical dystonia is a recent formally codified entity, but has not been systematically studied. METHODS: We identified 44 subjects from three movement disorder clinics who presented with craniocervical dystonia and concurrent HA pain. The subjects were injected with botulinum toxin type A (BoNT-A) and prospectively evaluated with the Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS), headache diaries, Headache Impact Test (HIT-6), and Migraine Disability Assessment Scale (MIDAS), along with HA pain anatomy and adverse events, at baseline, and at 4, 8, and 12 weeks post-injection. RESULTS: As expected, all aspects of the TWSTRS robustly improved. Headache diaries and the HIT-6 also improved at 4, 8, and 12 weeks post-injection. Sections of the MIDAS improved, and adverse events were minimal. CONCLUSION: BoNT-A safely improves headache associated with craniocervical dystonia when administered for the primary condition of craniocervical dystonia.     

Botulinum toxin type A in the management of headache: a review of the literature and personal experience

Abstract Botulinum toxin type A (BoNT-A) shows significant promise in the management of a variety of headache types including migraine, chronic daily headache, tension-type headache, and other head and neck pains. Confirmation of efficacy still awaits the report of well-controlled double-blind placebo-controlled trials; however, a mounting body of evidence suggests that BoNT-A is effective, well-tolerated and safe for the management of many headache disorders. In this paper, I review recent evidence on the efficacy of BoNT-A, and also report my personal experience with the treatment in over 600 headache patients.     

Botulinum toxin type a prophylactic treatment of episodic migraine: a randomized, double-blind, placebo-controlled exploratory study

OBJECTIVE: This exploratory trial evaluated the safety and efficacy of multiple treatments of botulinum toxin type A (BoNTA; BOTOX, Allergan, Inc., Irvine, CA, USA) as prophylactic treatment of episodic migraine headaches. DESIGN AND METHODS: This was an 11-month randomized, double-blind, placebo-controlled, exploratory study. Patients were screened during a 30-day baseline period, and eligible patients with 4 or more migraine episodes and < or =15 headache days entered a single-blind 30-day placebo run-in period. Patients were classified as placebo nonresponders (PNR) if they had at least 4 moderate-to-severe migraine episodes and did not experience at least a 50% decrease from baseline in the frequency of migraine episodes following their placebo treatment. All other subjects were classified as placebo responders (PR). Patients were randomized within each stratum (PNR, PR) to 3 treatments with BoNTA (110 to 260 U of BoNTA per treatment cycle) or placebo at 90-day intervals using a modified follow-the-pain treatment paradigm. The primary efficacy outcome measure was the mean change from baseline in the frequency of migraine episodes for the 30 days prior to day 180 in the PNR group. Secondary efficacy measures included the proportion of patients with a decrease from baseline of 50% or more migraine episodes per 30-day period. Patients were allowed to take concomitant acute and prophylactic headache medications. Adverse events were reported. RESULTS: A total of 809 patients were screened and 369 patients (89.2% female; mean age, 45 years; range, 20 to 65 years) entered the placebo run-in period and were subsequently randomized to BoNTA or placebo. The mean total dose of BoNTA was 190.5 units (U) (range, 110 U to 260 U). The predetermined primary efficacy endpoint was not met. Substantial mean improvements of 2.4 and 2.2 fewer migraine episodes per month at day 180 in the PNR stratum treated with BoNTA and placebo, respectively, were observed (P > .999). From day 180 through the end of the study (day 270) at least 50% of all patients in each treatment group had a decrease from baseline of 50% or more migraine episodes per 30-day period. However, in the group of patients with > or =12 headache days at baseline (and < or =15 headache days), BoNTA patients experienced a mean change from baseline of -4.0 headache episodes at day 180 compared with -1.9 headache episodes in the placebo group (P= .048). The majority of treatment-related adverse events were transient and mild to moderate in severity. Only 7 patients (1.9%) discontinued the study due to adverse events (6 BoNTA, 1 placebo). CONCLUSION: There were no statistically significant between-group differences in the mean change from baseline in the frequency of migraine episodes per 30-day period. There were substantial, sustained improvements during the course of the study in all groups. Multiple treatments with BoNTA were shown to be safe and well tolerated over an active treatment period lasting 9 months.     

A one-year retrospective economic evaluation of botulinum toxin type A treatment of chronic tension headache

Abstract The objective was to measure the impact of botulinum toxin type A (BTX-A) treatment on symptoms and medication utilisation patterns in patients with chronic tension-type headache. A retrospective chart analysis was completed in the Day Hospital of the Regional Referral Headache Centre at SantAndrea Hospital in Rome. Clinical charts were randomly selected for 100 patients treated from February 2002 to January 2003. Patients were treated with 100 U of BTX-A every three months for one year by using the Fixed Doses Fixed Sites procedure. Treatment outcome ranged from complete resolution of headache symptoms to a worsening of symptoms resulting in discontinuation. Headache medication use before and after treatment was analysed. After BTX-A treatment, 85% of patients experienced at least some degree of pain relief and reduced their use of analgesics. The reduced percentages of patients using a variety of headache medications after BTX-A treatment results from a reduction in their headache symptoms.     

Botulinum toxin type a for the prophylaxis of chronic daily headache: subgroup analysis of patients not receiving other prophylactic medications: a randomized double-blind, placebo-controlled study

OBJECTIVE: To assess the efficacy and safety of botulinum toxin type A (BoNT-A; BOTOX, Allergan, Inc., Irvine, CA) for the prophylaxis of headaches in patients with chronic daily headache (CDH) without the confounding factor of concurrent prophylactic medications. BACKGROUND: Several open-label studies and an 11-month, randomized, double-blind, placebo-controlled study suggest that BoNT-A may be an effective therapy for the prophylaxis of headaches in patients with CDH. DESIGN AND METHODS: This was a subgroup analysis of an 11-month, randomized double-blind, placebo-controlled study of BoNT-A for the treatment of adult patients with 16 or more headache days per 30-day periods conducted at 13 North American study centers. All patients had a history of migraine or probable migraine. This analysis involved data for patients who were not receiving concomitant prophylactic headache medication and who constituted 64% of the full study population. Following a 30-day screening period and a 30-day single-blind, placebo injection, eligible patients were injected with BoNT-A or placebo and assessed every 30 days for 9 months The following efficacy measures were analyzed per 30-day periods: change from baseline in number of headache-free days; change from baseline in headache frequency; proportion of patients with at least 30% or at least 50% decrease from baseline in headache frequency; and change from baseline in mean headache severity. Acute medication use was assessed, and adverse events were recorded at each study visit. RESULTS: Of the 355 patients randomized in the study, 228 (64%) were not taking prophylactic medication and were included in this analysis (117 received BoNT-A, 111 received placebo injections). Mean age was 42.4+/-10.90 years; the mean frequency of headaches per 30 days at baseline was 14.1 for the BoNT-A group and 12.9 for the placebo group (P=.205). After two injection sessions, the maximum change in the mean frequency of headaches per 30 days was -7.8 in the BoNT-A group compared with only -4.5 in the placebo group (P=.032), a statistically significant between-group difference of 3.3 headaches. The between-group difference favoring BoNT-A treatment continued to improve to 4.2 headaches after a third injection session (P=.023). In addition, BoNT-A treatment at least halved the frequency of baseline headaches in over 50% of patients after three injection sessions compared to baseline. Statistically significant differences between BoNT-A and placebo were evident for the change from baseline in headache frequency and headache severity for most time points from day 180 through day 270. Only 5 patients (4 patients receiving BoNT-A treatment; 1 patient receiving placebo) discontinued the study due to adverse events and most treatment-related events were transient and mild to moderate in severity. CONCLUSIONS: BoNT-A is an effective and well-tolerated prophylactic treatment in migraine patients with CDH who are not using other prophylactic medications.     

Botulinum toxin type A in the prophylactic treatment of chronic tension-type headache: a multicentre, double-blind, randomized, placebo-controlled, parallel-group study

We studied the safety and efficacy of 0 U, 50 U, 100 U, 150 U (five sites), 86 Usub and 100 Usub (three sites) botulinum toxin type A (BoNTA; BOTOX); Allergan, Inc., Irvine, CA, USA) for the prophylaxis of chronic tension-type headache (CTTH). Three hundred patients (62.3% female; mean age 42.6 years) enrolled. For the primary endpoint, the mean change from baseline in the number of TTH-free days per month, there was no statistically significant difference between placebo and four BoNTA groups, but a significant difference favouring placebo vs. BoNTA 150 was observed (4.5 vs. 2.8 tension headache-free days/month; P = 0.007). All treatment groups improved at day 60. Although efficacy was not demonstrated for the primary endpoint, at day 90, more patients in three BoNTA groups had >or=50% decrease in tension headache days than did placebo (P 相似文献   

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.     

A one-year prospective costing study of botulinum toxin type A treatment of chronic tension headache

Abstract The objective was to measure the cost of botulinum toxin type A (BTX-A) treatment of chronic tension-type headache. A prospective pharmaceutical costing analysis was completed in the Day Hospital of the Regional Referral Headache Centre at SantAndrea Hospital in Rome, chronic tension-type headache patients were treated from February 2003 to January 2004. Patients were treated with 100 U of BTX-A every three months for one year by using the Fixed Doses Fixed Sites procedure. The cost of treatment was based on drug acquisition costs, supplies and professional time needed to administer treatment. The average cost of conventional headache medications was € 853.43 before BTX-A treatment, and € 450.47 after. The cost of BTX-A treatment was € 642.00. Adding the cost of adjunctive conventional medications brought the total cost of BTX-A treatment to € 1092.47. BTX-A treatment reduced use of conventional headache medications and expenditures although the net cost of treatment increased with BTX-A use.     

Bifocal nummular headache: a series of 6 new cases

(Headache 2011;51:1161‐1166) Objective.— We aimed to report 6 new cases of bifocal nummular headache (NH), showing their clinical characteristics and comparing them with those formerly described. Background.— NH is a focal head pain felt in a small, well‐circumscribed, coin‐shaped area. Among all the reported cases (over 200), 6 patients localized their pain in 2 or more separate areas. Methods.— We reviewed all patients diagnosed with NH at the headache clinics of 2 tertiary hospitals, searching for cases with head pain in 2 different areas. Results.— Six patients (4 female, 2 male; age at onset 40.8 ± 19.1, range 24‐69 years) presented with bifocal NH. The shape and size of both painful areas were identical in each patient. They were located at symmetrical points of either side in 3 patients, while 2 patients had both symptomatic areas on the same side of the head. The chronological pattern was synchronous in 2 patients, and the other 4 showed an additive pattern with onset intervals between the 2 areas ranging from 2 months to 30 years. Pain intensity was slightly different in each area in 4 of the cases. Four patients were treated with a preventive (gabapentin or carbamazepine) with good clinical response. Conclusion.— Although not frequently found, some patients may have bifocal or multifocal NH.     

肉毒毒素A治疗颈源性头痛的双盲研究

目的:颈部骨骼肌源性头痛目前尚无治疗的有效方法,观察肉毒毒素A治疗颈部骨骼肌源性头痛的疗效。方法:采用双盲原则,将40例颈源性头痛患者随机分为治疗组和对照组,分别接受浓度为50 u/ml肉毒毒素A溶液和生理盐水颈部多个肌筋膜扳机点注射。结果:头痛情况采用头痛月天数和头痛指数进行评估,治疗组在治疗后两周、四周时头痛月天数(2.0±2.4,2.2±2.6)和头痛指数(2.5±3.5,3.5±3.6)明显减低,和对照组(14.6±5.2,16.1±5.2和24.2±14.1,26.3±11.2)及治疗前(14.7±5.8和32.6±19.6)差异均有显著性意义(P<0.01)。结论:肉毒毒素A颈部肌筋膜扳机点注射是治疗颈部骨骼肌源性头痛的有效方法。