Frovatriptan 2.5 mg plus dexketoprofen (25 mg or 37.5 mg) in menstrually related migraine. Subanalysis from a double-blind, randomized trial.

PURPOSE: The purpose of this article is to investigate the efficacy and safety of frovatriptan plus dexketoprofen 25 or 37.5 mg (FroDex25 or FroDex37.5, respectively) compared to that of frovatriptan 2.5 mg (Frova) in menstrually related migraine (MRM). AIM: The aim of this article is to analyze a subgroup of 76 women who treated an MRM attack in this multicenter, randomized, double-blind, parallel-group study. METHODS: The primary end-point was the proportion of patients who were pain free (PF) at two hours. Secondary end-points included pain-relief (PR) at two hours and 48 hours sustained pain free (SPF). RESULTS: PF rates at two hours were 29% under Frova, 48% under FroDex25 and 64% under FroDex37.5 (p < 0.05). PR at two hours was Frova 52%, FroDex25 81% and FroDex37.5 88%, while 48 hours SPF was 18% under Frova, 30% under FroDex25 and 44% under FroDex37.5. CONCLUSION: Combining frovatriptan+dexketoprofen produced higher PF rates at two hours compared to Frova while maintaining efficacy at 48 hours. Tolerability profiles were comparable.

Migraine in perimenopausal women.

Hormonal changes during the reproductive cycle are thought to account for the variation in migraine occurrence and intensity. Although the majority of women and the specialists treating them do not consider migraine as a component of the climacteric syndrome, many women, in fact, do experience migraine during perimenopause. If a woman already suffers from migraine, the attacks often worsen during menopausal transition. Initial onset of the condition during this period is relatively rare. Women with the premenstrual syndrome (PMS) prior to entering menopause are more likely to experience, during late menopausal transition, an increased prevalence of migraine attacks. Hormone replacement therapy (HRT) can be initiated during the late premenopausal phase and the first years of postmenopause to relieve climacteric symptoms. The effect of HRT on migraine, either as a secondary effect of the therapy or as a preventive measure against perimenopausal migraine, has been variously investigated. HRT preparations should be administered continuously, without intervals, to prevent sudden estrogen deprivation and the migraine attacks that will ensue. Wide varieties of formulations, both systemic and topical, are available. Treatment with transdermal patches and estradiol-based gels is preferable to oral formulations as they maintain constant blood hormone levels. Natural menopause is associated with a lower incidence of migraine as compared with surgical menopause; data on the role of hysterectomy alone or associated with ovariectomy in changing the occurrence of migraine are till now unclear.

Migraine attacks in the pharmacy: a gender subanalysis on treatment preferences.

In 2014 our group published the results of a survey conducted in Piedmont, Italy, on the patterns of use and dispensing of drugs in patients requesting assistance from pharmacists for relief of a migraine attack. Epidemiological studies on migraine have consistently shown that migraine is far more common among women than men. This gender difference is also reflected in the higher percentage of women visiting a pharmacy to obtain treatment or advice for headache attacks. In this study, we further explored gender differences in healthcare-seeking behavior and use of migraine medications. The aim of the study was to determine whether women made better selective use of migraine medications and whether visiting a headache center for consultation and treatment reflected awareness of how best to manage their condition. Among the drugs usually taken for relieving head pain, there was no statistically significant difference between men and women in the routine use of NSAIDs (55.6 vs. 51.6 %) or ergot derivatives (8.7 vs. 9.3 %). Statistically significant differences emerged between men and women (27.9 vs. 35.4 %) in the use of triptans (p = 0.003; OR 1.41, 95 % CI 1.12-1.78) and in the use of combined medications (8.5 vs. 12.2 %) (p = 0.029; OR 1.49, 95 % CI 1.04-2.14) but not in the use of simple OTC non-NSAIDs. Less men than women sought professional medical care for managing migraine (65.7 vs. 72.4 %) (p = 0.003; OR 0.71, 95 % CI 0.57-0.89); more women than men sought treatment at a headache center (21.7 vs. 17.4 %) (p = 0.044; OR 1.31, 95 % CI 1.07-1.72).

Prevention, education and information: the role of the community pharmacist in the management of headaches.

Headaches are among the most common disorders of the nervous system. On a global level, it is estimated that the prevalence of headache disorder in adults is 47 %. A proper treatment of headaches requires training of health care personnel, careful diagnosis and recognition of the condition, appropriate treatment with cost-effective drugs, simple changements in lifestyle and patient education. Unfortunately, a large number of people suffering from headache disorders are not diagnosed and treated. The unsatisfied needs in migraine can be faced by involving the pharmacist in the management of the pathology. To really understand which are the activities and the potential of community pharmacies in the management of patients with headache or migraine we took into account studies conducted around the world during the last 5 years. Based on the data collected it is clear that the role of the community pharmacist may be crucial in managing patients with headache or migraine but only if he receives an adequate and continuous education both on the management of therapies and maintains a stable relationship with the medical doctor and/or patient. In Piedmont a specific study to identify migraine sufferers has involved the community pharmacies in the administration of a questionnaire, specially crafted by the Italian Headache Foundation (FICEF non-profit association).

Endonasal mucosal contact points in chronic migraine.

Some anatomo-functional alterations of the nose may be considered as possible causes of headache: deviations of the nasal septum, abnormal turbinates, especially middle or superior, with consequent areas of mucosal contact with the septum. This study was performed on 100 subjects, 27 chronic migraine (CM) sufferers and 73 subjects who never suffered from migraine as control group. In the CM group, a direct endoscopic assessment was carried out in order to search for mucosal points of contact. Following the endoscopy, the patients underwent a computerized tomography (CT) in order to confirm the mucosal contact and for a better evaluation of its localization. The control group (C group) consisted of subjects who underwent a CT of the skull for various reasons. In CM group, a mucosal contact was highlighted in 14 patients (51.8 %); it was unilateral in 50 % of cases. In C group, the contact was present in 27 cases (36.9 %); in 81.5 % of them (n = 22), it was unilateral. A single site of contact was present in 6 (22 %) patients in CM group and 20 (27.3 %) patients in C group; more sites, in 8 (29.6 %) CM group patients and in 7 (9.5 %) patients of the C group. The connection between subjects and the number of single or multiple contacts in the two groups was statistically significant (p = 0.049). Furthermore, the frequency of the septum-middle turbinate was significantly (p = 0.0013) more frequent in CM sufferers (13/14) compared with control subjects (11/27). This study suggests, although with extremely early data, the need to select carefully patients for a possible surgical approach, using various parameters: in particular, the site of the mucosal contact, favoring the cases with multiple areas of contact, mainly between septum-middle turbinate and septum-superior turbinate.

Migraine attacks in the pharmacy: a survey in Piedmont, Italy.

Headache patients often consult a pharmacist in an attempt to obtain momentary pain relief without having been given any previous expert advice. A specific questionnaire was distributed to the pharmacies in order to assess the patterns of use and dispensing of analgesic medications to the headache patient who turns to the pharmacist for relief of a painful attack. This study aimed at identifying migraine patients who self-medicated, with further end points including whether these patients shared any particular clinical characteristics, the most common type of analgesic medications used, and what, if anything, was recommended by the pharmacist; lastly, which health care professional, if any, routinely managed the patient's headaches. A total of 9,100 questionnaires were distributed to the pharmacies and the complete 3,065 were included in the database. The ID Migraine Screener Test was used to classify subjects into 4 groups: "Definite migraine" (3/3 positive answers: n = 1,042; 34 %), "Probable migraine" (2/3: n = 969; 31.6 %), "Unlikely migraine" (1/3: n = 630; 20.5 %), and "Other headaches" (0/3: n = 424; 13.8 %). Only Definite and Probable migraines (n = 2,011) are considered in this paper. Amongst the drugs usually taken by the patients, NSAIDs were more common in the Probable migraine group (60.7 %) than in the Definite migraine (44.7 %) group (p < 0.001). On the contrary, triptans were more commonly used by the Definite migraine group (42.9 %) than the Probable migraine (23.7 %) group (p < 0.001), and combination drugs were preferentially (p < 0.001) chosen by the Definite (13.8 %) rather than the Probable migraine group (8.7 %). A total of 29.2 % of respondents reported that for the management of their headaches, they did not avail themselves of any type of professional healthcare, such as their general practitioner, a headache specialist, or a Headache Center.

Acupuncture in cluster headache: four cases and review of the literature.

Although cluster headache (CH) is the most disabling form of primary headache, little evidences regarding alternative and complementary therapies are available. Only few dated studies and some isolated cases are described. We describe four patients with CH treated with acupuncture as a preventive treatment, combined with verapamil or alone. All patients received acupuncture treatment twice/week for 2 weeks, then once/week for 8 weeks, and then once/alternate weeks for 2 weeks. According to Traditional Chinese Medicine the acupoints selected were: Ex HN-5 Taiyang, GB 14 Yangbai (both only on the affected side), GB 20 Fengchi (on both sides), LI 4 Hegu, LR 2 Xingjiang, SP 6 Sanyinjiao, ST 36 Zusanli (all on both sides). At each point, after the insertion of the needle, the feeling of "De Qi" was evoked; after obtaining this sensation the acupoints were not further stimulated for a period of 20 min, until their extraction. In all patients an interruption of cluster attacks was obtained. To our knowledge, this is the first report concerning acupuncture in CH patients which details the protocol approach, acupoints and duration of the treatment. Our results offer the opportunity to discuss the emerging role of acupuncture in the therapy of CH, assuming a possible influence on opioid system.

Effects of the acupoints PC 6 Neiguan and LR 3 Taichong on cerebral blood flow in normal subjects and in migraine patients.

Acupuncture has been proven to be effective in the treatment of various cardiovascular disorders; it acts both on the peripheral flow and on the cerebral flow. Our study aimed to evaluate the effects of the insertion of PC 6 Neiguan and LR 3 Taichong acupoints on the cerebral blood flow (CBF) in the middle cerebral artery (MCA). These effects were measured in a group of patients suffering from migraine without aura (Group M) and in a healthy control group (Group C). In the study, we included 16 patients suffering from migraine without aura, classified according to the criteria of the International Headache Society, and 14 healthy subjects as a control group. The subjects took part in the study on two different days, and on each day, the effect of a single acupoint was evaluated. Transcranial Doppler was used to measure the blood flow velocity (BFV) in the MCA. Our study showed that the stimulation of PC 6 Neiguan in both groups results in a significant and longlasting reduction in the average BFV in the MCA. After pricking LR 3 Taichong, instead, the average BFV undergoes a very sudden and marked increase; subsequently, it decreases and tends to stabilize at a slightly higher level compared with the baseline, recorded before needle insertion. Our data seem to suggest that these two acupoints have very different effects on CBF. The insertion of PC 6 Neiguan probably triggers a vasodilation in MCA, while the pricking of LR 3 Taichong determines a rapid and marked vasoconstriction.

Ear acupuncture and fMRI: a pilot study for assessing the specificity of auricular points.

In recent years research explored different acupuncture stimulation techniques but interest has focused primarily on somatic acupuncture and on a limited number of acupoints. As regards ear Acupuncture (EA) there is still some criticism about the clinical specificity of auricular points/areas representing organs or structures of the body. The aim of this study was to verify through (Functional magnetic resonance imaging) fMRI the hypothesis of EA point specificity using two auricular points having different topographical locations and clinical significance. Six healthy volunteers underwent two experimental fMRI sessions: the first was dedicated to the stimulation of Thumb Auricular Acupoint (TAA) and the second to the stimulation of Brain Stem Auricular Acupoint (BSAA). The stimulation of the needle placed in the TAA of the left ear produced an increase in activation bilaterally in the parietal operculum, region of the secondary somatosensory area SII. Stimulation of the needle placed in the BSAA of the left ear showed a pattern that largely overlapped regions belonging to the pain matrix, as shown to be involved in previous somatic acupuncture studies but with local differences in the left amygdala, anterior cingulate cortex, and cerebellum. The differences in activation patterns between TAA and BSAA stimulation support the specificity of the two acupoints. Moreover, the peculiarity of the regions involved in BSAA stimulation compared to those involved in the pain matrix, is in accordance with the therapeutic indications of this acupoint that include head pain, dizziness and vertigo. Our results provide preliminary evidence on the specificity of two auricular acupoints; further research is warranted by means of fMRI both in healthy volunteers and in patients carrying neurological/psychiatric syndromes.

Frovatriptan vs. other triptans for the acute treatment of oral contraceptive-induced menstrual migraine: pooled analysis of three double-blind, randomized, crossover, multicenter studies.

Oral contraceptive-induced menstrual migraine (OCMM) is a particularly severe form of migraine triggered by the cyclic hormone withdrawal. To review the efficacy of frovatriptan vs. other triptans, in the acute treatment of OCMM through a pooled analysis of three individual randomized Italian studies. With or without aura migraineurs were randomized to frovatriptan 2.5 mg or rizatriptan 10 mg (study 1), frovatriptan 2.5 mg or zolmitriptan 2.5 mg (study 2), frovatriptan 2.5 mg or almotriptan 12.5 mg (study 3). All studies had a multicenter, randomized, double-blind, crossover design. After treating 1-3 episodes of migraine in 3 months with the first treatment, patients switched to the other treatment for the next 3 months. In this analysis, the subset of 35 of the 280 women of the intention-to-treat population taking combined oral contraceptives and experiencing a migraine attack during the withdrawal phase, were analyzed. The proportion of pain free and pain relief at 2 h were 25 and 51 % with frovatriptan and 28 and 48 % with comparators (p = NS). At 24 h, 71 and 83 % of frovatriptan-treated patients and 60 and 76 % of comparator-treated patients were pain free (p < 0.05 between treatments) and had pain relief (p = NS), respectively. Relapse at 24 and 48 h was significantly (p < 0.05) lower with frovatriptan (17 and 21 %) than with the comparators (27 and 31 %). Our results suggest that, due to its sustained antimigraine effect, frovatriptan may be particularly suitable for the management of OCMM than other triptans.

Efficacy of frovatriptan and other triptans in the treatment of acute migraine of hypertensive and normotensive subjects: a review of randomized studies.

Migraine might be associated with high blood pressure (BP), which can cause more severe and more difficult to treat forms of headache. To evaluate the efficacy of frovatriptan and other triptans in the acute treatment of migraine, in patients classified according to a history of arterial hypertension, enrolled in three randomized, double-blind, crossover, Italian studies. Migraineurs with or without aura were randomized to frovatriptan 2.5 mg or rizatriptan 10 mg (study 1), frovatriptan 2.5 mg or zolmitriptan 2.5 mg (study 2), frovatriptan 2.5 mg or almotriptan 12.5 mg (study 3). After treating up to three episodes of migraine in 3 months with the first treatment, patients switched to the alternate treatment for the next 3 months. The present analysis assessed triptan efficacy in 60 subjects with a history of treated or untreated essential arterial hypertension (HT) and in 286 normotensive (NT) subjects. During the study, migraine attacks with aura were significantly more prevalent in HT subjects (21 vs. 13 % NT, p < 0.001). The proportion of pain free at 2 h did not significantly differ between HTs and NTs for either frovatriptan (25 vs. 26 %) or the comparators (33 vs. 32 %). Pain relief was achieved in significantly (p < 0.05) fewer episodes in HT subjects for both frovatriptan (41 vs. 52 % NT) and the comparators (48 vs. 58 %). Relapses at 48 h were similarly low in HTs and NTs with frovatriptan (29 vs. 31 %), while they were significantly (p < 0.05) larger in HTs (62 %) than in NTs (44 %) with comparators. No BP or heart rate increment was observed during the study in HT subjects. No difference in tolerability was reported between HTs and NTs. In conclusion, HT individuals tend to be less responsive than NT migraineurs to triptan therapy. However, frovatriptan, in contrast to other triptans, seems to have a sustained antimigraine effect in both HT and NT patients.

Migraines with and without aura and their response to preventive therapy with topiramate.

Data from the Prolonged Migraine Prevention (PROMPT) with Topiramate trial were evaluated post hoc to determine whether topiramate could prevent migraine auras, and whether its efficacy in preventing migraine headaches was similar in patients with (MA; n = 269) and without (MoA; n = 542) aura. Migraines and auras were recorded during prospective baseline, 6-month open-label (OL) topiramate and 6-month double-blind (DB), placebo-controlled phases. In the last 28 OL days, migraines without aura and migraine auras decreased by 43.1% and 54.1%, respectively, in MA patients. MoA patients experienced a 44.3% reduction in migraines. In the DB phase, increases in migraines with placebo vs. topiramate were similar to the full study, but were generally not statistically significant, probably due to lack of power in the subgroup analysis. Similarly, there were no statistically significant changes in number of auras between groups. Thus, topiramate appears to reduce migraine auras in parallel with headache reductions, which are similar in patients with and without aura.

Clinical review of headache in pregnancy.

Headache is a common disorder in the general population. Among women, the primary headache form that is more heavily affected by the physiologic hormonal variations occurring through a woman's lifetime is migraine. Migraine without aura (MO) and migraine with aura (MA) show a different clinical pattern during pregnancy. MO improves or disappears while it is not infrequent for women to have their first attack of MA during this period; usually, during pregnancy MA do not improve. In MO women who continue to suffer from migraine during pregnancy, clinical observation and the few data currently available from the literature suggest that in the gestational period their attacks are nonetheless less disabling than those occurring outside this period. Even though the duration of the attacks is unchanged, their severity tends to be mild or moderate. Treatment of migraine during pregnancy is discussed.

Migraine is a risk factor for hypertensive disorders in pregnancy: a prospective cohort study.

The aim was to assess whether women suffering from migraine are at higher risk of developing hypertensive disorders in pregnancy. In a prospective cohort study, performed at antenatal clinics in three maternity units in Northern Italy, 702 normotensive women with singleton pregnancy at 11-16 weeks' gestation were enrolled. Women with a history of hypertensive disorders in pregnancy or presenting chronic hypertension were excluded. The presence of migraine was investigated according to International Headache Society criteria. The main outcome measure was the onset of hypertension in pregnancy, defined as the occurrence of either gestational hypertension or preeclampsia. Two hundred and seventy women (38.5%) were diagnosed with migraine. The majority (68.1%) suffered from migraine without aura. The risk of developing hypertensive disorders in pregnancy was higher in migraineurs (9.1%) compared with non-migraineurs (3.1%) [odds ratio (OR) adjusted for age, family history of hypertension and smoking 2.85, 95% confidence interval (CI) 1.40, 5.81]. Women with migraine also showed a trend to increased risk for low birth weight infants with respect to women without migraine (OR 1.97, 95% CI 0.98, 3.98). Women with migraine are to be considered at increased risk of developing hypertensive disorders in pregnancy. The diagnosis of primary headaches should be taken into account at antenatal examination.

Menstrual migraine: a review of current and developing pharmacotherapies for women.

INTRODUCTION: Migraine is one of the most common neurological disorders in the general population. It affects 18% of women and 6% of men. In more than 50% of women migraineurs the occurrence of migraine attacks correlates strongly with the perimenstrual period. Menstrual migraine is highly debilitating, less responsive to therapy, and attacks are longer than those not correlated with menses. Menstrual migraine requires accurate evaluation and targeted therapy, that we aim to recommend in this review. AREAS COVERED: This review of the literature provides an overview of currently available pharmacological therapies (especially with triptans, anti-inflammatory drugs, hormonal strategies) and drugs in development (in particular those acting on calcitonin gene-related peptide) for the treatment of acute migraine attacks and the prophylaxis of menstrual migraine. The studies reviewed here were retrieved from the Medline database as of June 2017. EXPERT OPINION: The treatment of menstrual migraine is highly complex. Accurate evaluation of its characteristics is prerequisite to selecting appropriate therapy. An integrated approach involving neurologists and gynecologists is essential for patient management and for continuous updating on new therapies under development.

Transcranial Doppler for monitoring the cerebral blood flow dynamics: normal ranges in the Italian female population.

AIM: This study was aimed at recording, by means of a transcranial Doppler (TCD) device, the values of blood flow velocities (BFV) in the middle cerebral artery (MCA) in physiological conditions, in a population of healthy women in various ages of their life, in order to establish normative data in an Italian female population. METHODS: Our sample consisted of 100 healthy women (mean age 38 +/-15.14 years, range 12-78) that underwent an investigation of the intracranial circulation by means of TCD. Patients were subdivided into 4 age groups: less than 20 years; 20-34 years; 35-50 years; more than 50 years. RESULTS: No statistically significant differences were present between the mean BFV in the left and right MCAs of the subjects considered as a unique population (left MCA 68.06+/-9.22 cm/s; right MCA 66.71+/-8.79 cm/s). The BFVs tended to significantly decrease with the increasing of age. In fact, they were so distributed: left MCA 82.55+/-6.85 cm/s and right MCA 80.27+/-4.13 cm/s in the younger group; left MCA 72.15+/-6.37 cm/s and right MCA 70.68+/-6.79 cm/s in women aged 20-34; left MCA 63.85+/-7.08 cm/s and right MCA 63.06+/-7.29 cm/s in women aged 35-50; left MCA 60.67+/-6.85 cm/s and right MCA 59.10+/-5.36 cm/s in the last group. CONCLUSIONS: The present study defined a normal age-related range of variations in MCA BFVs, useful for future comparisons in studies involving pathological female subjects.

The relationship between headache and preeclampsia: a case-control study.

OBJECTIVE: Pregnancy-induced hypertension with proteinuria (preeclampsia-PE) is linked to increased vascular reactivity, increased vasoconstrictors, endothelial damage and platelet hyperaggregation, which are also typical features of migraine patients. Thus, we investigated the association between headache and PE. METHODS: In a case-control study, we evaluated the occurrence of primary headache forms in 75 women with a recent history of PE. Seventy-five controls were selected from women having uneventful pregnancy at term. Both groups were matched for age and parity. Subjects' headache history was evaluated by using an ad hoc structured questionnaire. The International Headache Society criteria for primary headaches were applied to diagnose the specific form of headache. RESULTS: In PE cases, gestational age at parturition was 34.2+/-3.8 weeks and birthweight was 1820+/-746 g, whereas in controls they were 39.3+/-1.5 weeks and 3365+/-437 g, respectively (P < 0.01). Sixty-six (44%) subjects suffered from headache. Headache was significantly more frequent in PE (47/75) than in controls (19/75), OR 4.95 (95% CI, 2.47-9.92). Migraine without aura was more frequently present in cases than in controls while episodic tension-type headache was equally distributed among groups. Fifty-two patients met the criteria of severe PE. The number of patients suffering from headache was significantly higher in severe patients (39 cases, 75%) than in those with moderate PE (8 cases, 34.8%), OR = 5.63 (95% CI, 1.97-16.03). With respect to controls, PE patients reported a more frequent onset at menarche, more menstrually related attacks and an increased rate of improvement during pregnancy. CONCLUSION: This study shows that there is a strong association between migraine history and PE development, namely with the severe form of PE.

Acupuncture versus pharmacological approach to reduce Hyperemesis gravidarum discomfort.

AIM: Several reports have suggested the use of acupuncture as a useful treatment for hyperemesis gravidarum (HG), in particular the effects on nausea intensity was underlined. The aim of this study was to compare the efficacy of acupuncture sessions plus acupressure with a metoclopramide/vitamin B12 treatment. METHODS: In this study we randomized 88 pregnant patients suffering from HG to receive either acupuncture sessions plus acupressure (acupuncture group) or metoclopramide infusion (metoclopramide group) supplemented by vitamin B12 complex. Somatic symptoms and the ability to achieve the daily routine activity (functioning) were evaluated. Acupuncture sessions were performed at the hospital twice a week for 2 weeks according to the traditional Chinese medicine criteria. Acupression was applied for 6-8 h/day. In the metoclopramide group, patients received at hospital metoclopramide infusion (20 mg/500 mL saline for 60 min) twice a week for 2 weeks. An oral supplementation with vitamin B12 complex (30 mg/day) was also prescribed. RESULTS: Both treatments reduced vomiting episodes and then nausea intensity with a consequent improvement in the rate of food intake. The effect of acupuncture seems to be progressive, increasing at the end of treatment whereas pharmacological approach has a prompt effect in responders remaining stable thereafter. Moreover, acupuncture was significantly more effective than drugs in improving functioning. CONCLUSIONS: In our study for the first time acupuncture, applied accordingly to Chinese formula, was compared to drugs demonstrating the same effect of both treatments on HG symptoms. Interestingly, functioning was significantly improved just by acupuncture. Even if the effect of acupuncture on HG discomfort remains to be confirmed, the reports on the effect of acupuncture on psychosocial variables could represent a further advantage of acupuncture application and provide an incentive to widen the base of the research.

Acupuncture for idiopathic headache.

BACKGROUND: Acupuncture is widely used for the treatment of headache, but its effectiveness is controversial. OBJECTIVES: To determine whether acupuncture is: - more effective than no treatment - more effective than 'sham' (placebo) acupuncture - as effective as other interventions used to treat idiopathic (primary) headaches. SEARCH STRATEGY: Electronic searches were performed in MEDLINE, EMBASE, the Cochrane Controlled Trials Register, and the database of the Cochrane Field for Complementary Medicine. We also contacted researchers in the field and checked the bibliographies of all articles obtained. SELECTION CRITERIA: Randomized or quasi-randomized clinical trials comparing acupuncture with any type of control intervention for the treatment of idiopathic (primary) headaches were included. DATA COLLECTION AND ANALYSIS: Information on patients, interventions, methods, and results was extracted by at least two independent reviewers using a pre-tested standard form. Results on headache frequency and intensity were summarized descriptively. Responder rate ratios (responder rate in treatment group/responder rate in control group) were calculated as a crude indicator of results for sham-acupuncture-controlled trials. Quantitative meta-analysis was not possible due to trial heterogeneity and insufficient reporting. MAIN RESULTS: Twenty-six trials including a total of 1151 patients (median, 37; range, 10-150) met the inclusion criteria. Sixteen trials were conducted among patients with migraine, six among patients with tension-type headache, and four among patients with various types of headaches. The majority of trials had methodological and/or reporting shortcomings. In eight of the 16 trials comparing true and sham (placebo) acupuncture in migraine and tension-type headache patients, true acupuncture was reported to be significantly superior; in four trials there was a trend in favor of true acupuncture; and in two trials there was no difference between the two interventions. (Two trials were uninterpretable.) The 10 trials comparing acupuncture with other forms of treatment yielded contradictory results. REVIEWER'S CONCLUSIONS: Overall, the existing evidence supports the value of acupuncture for the treatment of idiopathic headaches. However, the quality and amount of evidence are not fully convincing. There is an urgent need for well-planned, large-scale studies to assess the effectiveness and cost-effectiveness of acupuncture under real-life conditions.

Acupuncture plus moxibustion to resolve breech presentation: a randomized controlled study.

OBJECTIVE: In many Western countries breech presentation is an indication for elective Cesarean section. In order to correct fetal presentation, the stimulation of the acupoint BL67 by moxibustion, acupuncture or both has been proposed. Since no studies had previously been carried out on Western populations, pregnant Italian women at 33-35 weeks gestational age carrying a fetus in breech presentation were enrolled in a randomized, controlled trial involving an active BL67 point stimulation and an observation group. METHODS: A total of 240 women at 33-35 weeks of gestation carrying a fetus in breech presentation were randomized to receive active treatment (acupuncture plus moxibustion) or to be assigned to the observation group. Bilateral acupuncture plus moxibustion was applied at the BL67 acupoint (Zhiyin). The primary outcome of the study was fetal presentation at delivery. RESULTS: Fourteen cases dropped out. The final analysis was thus made on 226 cases, 114 randomized to observation and 112 to acupuncture plus moxibustion. At delivery, the proportion of cephalic version was lower in the observation group (36.7%) than in the active-treatment group (53.6 %) (p = 0.01). Hence, the proportion of Cesarean sections indicated for breech presentation was significantly lower in the treatment group than in the observation group (52.3% vs. 66.7%, p = 0.03). CONCLUSIONS: Acupuncture plus moxibustion is more effective than observation in revolving fetuses in breech presentation. Such a method appears to be a valid option for women willing to experience a natural birth.