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Results for “randomized crossover trial”

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PubMed2002

Platelet transfusions in children: results of a randomized, prospective, crossover trial of plasma removal and a prospective audit of WBC reduction.

BACKGROUND: Febrile nonhemolytic transfusion reactions (FNHTRs) complicate 2 to 37 percent of platelet transfusions in adults, but the incidence of such reactions in children is not known. The effectiveness of plasma reduction after storage and WBC reduction of platelet concentrates before storage was studied in pediatric recipients of platelet transfusions. STUDY DESIGN AND METHODS: In the first study, a prospective randomized crossover design was used in which patients received either unmodified whole-blood-derived or apheresis platelets or platelets from which most of the plasma supernatant had been removed just before transfusion. The second study was a prospective audit of recipients of prestorage WBC-reduced platelets. Children between 3 months and 17 years of age were eligible for both studies. Patients were assessed for signs and symptoms that are characteristic of a reaction during, immediately after, and 2 hours following transfusion. RESULTS: There were 226 platelet transfusions administered to 66 children. One hundred and sixty transfusions were given to 35 children enrolled in the randomized study, and 66 transfusions were given to 33 children during the audit. In the randomized study, nine of the 75 transfusions of unmodified platelets (12%) and six of 85 transfusions of poststorage plasma-removed platelets (7%) were associated with an FNHTR (p=0.42). In the audit, three of 66 transfusions of prestorage WBC-reduced platelets (5%) were associated with an FNHTR. Allergic reactions occurred with 5 percent (4 of 75), 6 percent (5 of 85), and 6 percent (4 of 66) of platelet transfusions, respectively. CONCLUSION: FNHTRs appear to be less common among pediatric recipients of platelet transfusions than in adults. In our two studies, there was a trend toward a lower frequency of FNHTRs with poststorage plasma removal and prestorage WBC reduction than with standard platelets, but this was not significant.

Adolescent↗
PubMed2006

Comparing two methods of delivering high-flow gas therapy by nasal cannula following endotracheal extubation: a prospective, randomized, masked, crossover trial.

OBJECTIVE: We compared two methods of delivering high-flow gas therapy by nasal cannula, applied immediately after planned endotracheal extubations of NICU patients. STUDY DESIGN AND METHODS: Thirty NICU patients who were about to be extubated from mechanical ventilation were randomized into two groups; Group 1 received Vapotherm for the first 24 h after extubation, then standard high-flow nasal cannula for the next 24 h, and Group 2 received standard high-flow therapy for the first 24 h, then Vapotherm for the next 24 h. At 24 h after extubation and again 48 h after extubation, a neonatologist who was not aware which modality the patient had been receiving examined the nasal mucosa and applied a scoring system. A research nurse who was unaware of the modality abstracted respiratory rates and respiratory effort scores from a specific study-bedside record. The experimental design was such that a patient could 'fail' extubation either by reintubation for mechanical ventilation, or by rescue to the opposite modality before completing the 24-h test period. RESULTS: Fifteen patients were randomized to Group 1 and 15 to Group 2. No differences were apparent between the groups in birth weight, gestational age, age at study entry, gender or underlying pulmonary disorder. Respiratory rates were similar while on Vapotherm (52+/-13 breaths/min, mean+/-s.d.) and high-flow (54+/-14/min). At 24 h after starting the modality, those on Vapotherm had more normal examinations of the nasal mucosa (2.7+/-1.2 vs 7.8+/-1.7, P < 0.0005) and lower respiratory effort scores (1.2+/-0.6 vs 2.0+/-0.9, P < 0.05) than did those on high-flow. No patients failed while on Vapotherm, but seven failed while on high-flow (two reintubations and five rescue switches to Vapotherm, P < 0.005). CONCLUSIONS: Among NICU patients immediately following extubation, Vapotherm performed better than a standard high-flow nasal cannula in maintaining a normal appearing nasal mucosa, a lower respiratory effort score, and averting reintubation.

Birth Weight↗
PubMed2002

Dose response of almonds on coronary heart disease risk factors: blood lipids, oxidized low-density lipoproteins, lipoprotein(a), homocysteine, and pulmonary nitric oxide: a randomized, controlled, crossover trial.

BACKGROUND: Although recent studies have indicated that nut consumption may improve levels of blood lipids, nuts are not generally recommended as snacks for hyperlipidemic subjects because of their high fat content. Furthermore, the effective dose is still unknown. METHODS AND RESULTS: The dose-response effects of whole almonds, taken as snacks, were compared with low-saturated fat (<5% energy) whole-wheat muffins (control) in the therapeutic diets of hyperlipidemic subjects. In a randomized crossover study, 27 hyperlipidemic men and women consumed 3 isoenergetic (mean 423 kcal/d) supplements each for 1 month. Supplements provided 22.2% of energy and consisted of full-dose almonds (73+/-3 g/d), half-dose almonds plus half-dose muffins, and full-dose muffins. Fasting blood, expired air, blood pressure, and body weight measurements were obtained at weeks 0, 2, and 4. Mean body weights differed <300 g between treatments. The full-dose almonds produced the greatest reduction in levels of blood lipids. Significant reductions from baseline were seen on both half- and full-dose almonds for LDL cholesterol (4.4+/-1.7%, P=0.018, and 9.4+/-1.9%, P<0.001, respectively) and LDL:HDL cholesterol (7.8+/-2.2%, P=0.001, and 12.0+/-2.1%, P<0.001, respectively) and on full-dose almonds alone for lipoprotein(a) (7.8+/-3.5%, P=0.034) and oxidized LDL concentrations (14.0+/-3.8%, P<0.001), with no significant reductions on the control diet. No difference was seen in pulmonary nitric oxide between treatments. CONCLUSIONS: Almonds used as snacks in the diets of hyperlipidemic subjects significantly reduce coronary heart disease risk factors, probably in part because of the nonfat (protein and fiber) and monounsaturated fatty acid components of the nut.

Aged↗
PubMed2005

Randomized, controlled, crossover trial of methylphenidate in pervasive developmental disorders with hyperactivity.

CONTEXT: Hyperactivity and inattention are common symptoms in children with autistic disorder and related pervasive developmental disorders, but studies of stimulants in these conditions have been inconclusive. OBJECTIVES: To determine the efficacy and safety of methylphenidate hydrochloride in children with pervasive developmental disorders and hyperactivity. DESIGN: Double-blind, placebo-controlled, crossover trial followed by open-label continuation. SETTING: Five academic outpatient clinics. PARTICIPANTS: Seventy-two drug-free children, aged 5 to 14 years, with pervasive developmental disorders accompanied by moderate to severe hyperactivity. INTERVENTIONS: Prior to randomization, subjects entered a 1-week test-dose phase in which each subject received placebo for 1 day followed by increasing doses of methylphenidate (low, medium, and high doses) that were each given for 2 days. The low, medium, and high doses of methylphenidate hydrochloride were based on weight, and they ranged from 7.5 mg/d to 50.0 mg/d in divided doses. Subjects who tolerated the test dose (n = 66) were assigned to receive placebo for 1 week and then 3 methylphenidate doses in random order during a double-blind, crossover phase. Children responding to methylphenidate then entered 8 weeks of open-label treatment at the individually determined best dose. MAIN OUTCOME MEASURES: The primary outcome measure was the teacher-rated hyperactivity subscale of the Aberrant Behavior Checklist. Response was defined as "much improved" or "very much improved" on the Clinical Global Impressions Improvement item coupled with considerable reductions in the parent-rated and/or teacher-rated Aberrant Behavior Checklist hyperactivity subscale score. RESULTS: Methylphenidate was superior to placebo on the primary outcome measure, with effect sizes ranging from 0.20 to 0.54 depending on dose and rater. Thirty-five (49%) of 72 enrolled subjects were classified as methylphenidate responders. Adverse effects led to the discontinuation of study medication in 13 (18%) of 72 subjects. CONCLUSIONS: Methylphenidate was often efficacious in treating hyperactivity associated with pervasive developmental disorders, but the magnitude of response was less than that seen in typically developing children with attention-deficit/hyperactivity disorder. Adverse effects were more frequent.

Adolescent↗
PubMed2002

Soluble fiber intake at a dose approved by the US Food and Drug Administration for a claim of health benefits: serum lipid risk factors for cardiovascular disease assessed in a randomized controlled crossover trial.

BACKGROUND: The US Food and Drug Administration (FDA) approved health claims for 2 dietary fibers, beta-glucan (0.75 g/serving) and psyllium (1.78 g/serving), on the assumption that 4 servings/d would reduce cardiovascular disease risk. OBJECTIVE: We assessed the efficacy of this dose of fibers in reducing serum lipid risk factors for cardiovascular disease. DESIGN: Sixty-eight hyperlipidemic adults consumed a test (high-fiber) and a control low-fat (25% of energy), low-cholesterol (<150 mg/d) diet for 1 mo each in a randomized crossover study. The high-fiber diet included 4 servings/d of foods containing beta-glucan or psyllium that delivered 8 g/d more soluble fiber than did similar, unsupplemented foods in the control diet. Fasting blood samples and blood pressure readings were obtained at baseline and weeks 2 and 4, and the subjects' weight was monitored weekly. RESULTS: Compared with the control diet, the high-fiber diet reduced total cholesterol (2.1 +/- 0.7%; P = 0.003), total:HDL cholesterol (2.9 +/- 0.8%; P = 0.001), LDL:HDL cholesterol (2.4 +/- 1.0%; P = 0.015), and apolipoprotein B:A-I (1.4 +/- 0.8%; P = 0.076). Applying the Framingham cardiovascular disease risk equation to the data confirmed a reduction in risk of 4.2 +/- 1.4% (P = 0.003). Small reductions in blood pressure were found after both diets. The subjects reported no significant differences in palatability or gastrointestinal symptoms between the diets. CONCLUSIONS: The reduction in serum lipid risk factors for cardiovascular disease supports the FDA's approval of a health claim for a dietary fiber intake of 4 servings/d. Although relatively small in terms of patient treatment, the reduction in cardiovascular disease risk is likely to be significant on a population basis.

Adult↗
PubMed1998

The human capsaicin model of allodynia and hyperalgesia: sources of variability and methods for reduction.

Intradermal and topical application of capsaicin have been used to study mechanisms of mechanical allodynia (MA) and pinprick hyperalgesia (PPH) and the efficacy of drugs in relieving these symptoms. However, it is associated with significant inter- and intra-subject variability. In order to improve the model's sensitivity, we examined several potential sources of variability of capsaicin-evoked MA and PPH in healthy volunteers, including skin temperature fluctuations, method (intradermal vs. topical) and site (volar forearm vs. foot dorsum) of administration. In study I, 12 subjects received, in a 6-session, randomized, crossover trial, 1) 250 micrograms of intradermal (ID) CAP to the volar forearm with skin temperature fixed at 36 degrees C (36 ID). 2) 250 micrograms ID CAP with varying skin temperature (VT ID), or 3) 250 microliters of l% CAP patch placed on the skin at 36 degrees C. The resulting MA and PPH areas observed with each method were measured. In study II, a 4-session, randomized crossover trial, 12 subjects were given 100 micrograms ID CAP in the volar forearm or foot dorsum and subsequent areas of MA and PPH recorded. In study I, 5/12 subjects had small MA areas (< or = 5 cm2) and one subject had small PPH areas in at least 4/6 sessions. The most consistent intra-subject responses were seen with the 36 ID method. Correlation coefficients for the two sessions using the same method of administration were: MA; 36 ID r = 0.83, VT ID = 0.19. Topical r = 0.81; PPH: 36 ID r = 0.93; VT ID r = 0.38, Topical r = 0.78. In study II, 4/12 subjects had little MA for both forearm and foot though all subjects developed PPH. However, greater intra-subject consistency (MA: foot: r = 0.84; arm: r = 0.49; PPH: r = 0.87; r = 0.39) and significantly larger areas of MA (15.8 +/- 4.2 vs 9.1 +/- 2.5, p < 0.05) were seen with the foot. (PPH: foot: 28.9 +/- 6.7; arm: 21.6 +/- 4.2, NS). Large variability exists among subjects receiving CAP, with some developing minimal MA. However, these subjects may be screened out prior to entry, increasing the sensitivity of the model, which may be further improved by clamping the skin temperature.

Adult↗
PubMed2001

Therapeutic electrical stimulation in cerebral palsy: a randomized, controlled, crossover trial.

The aim of this study was to evaluate the effect of therapeutic electrical stimulation (TES) applied to antagonists of spastic leg muscles on gross motor function in children with spastic diplegic cerebral palsy. Twelve children between 5 and 12 years of age completed a 24-month crossover study in which six were randomly assigned to receive TES for the first 12 months and the remaining six for the last 12 months. Physiotherapy and a home training program were not altered. All were evaluated blindly in terms of tests of motor function and video recordings at the start and at 12 and 24 months. At the end of the study parents/carers gave a subjective assessment of the effect of TES. No significant effect of TES on motor or ambulatory function was found on the blinded evaluation, but parents of 11 of the 12 children stated that TES had a significant effect. We conclude that it is unlikely that TES has a significant effect on motor and ambulatory function in spastic diplegia.

Cerebral Palsy↗
PubMed2002

In-line versus pistol-grip handles in a laparoscopic simulators. A randomized controlled crossover trial.

BACKGROUND: Needleholders with in-line handles (ILH) and those with pistol-grip handles (PGH) were compared in terms of operative end-product quality (OEPQ), procedure effectiveness (PE), and surgeon forearm workload (SFWL) during suturing in a laparoscopic simulator. METHODS: A 90% power crossover design at alpha 0.05 required 46 surgeons. Block randomization generated ILH-PGH or PGH-ILH sequence allocation. The task involved suturing a perforated ulcer on a foam stomach in a simulator. In this study, OEPQ was measured by tissue damage, accuracy error, water leak; PE by operating time and motion analysis including goal-directed actions (GDA) and non-goal-directed actions (NGDA); and SFWL by electromyogram (EMG) of six forearm and thumb muscles. RESULTS: The 46 surgeons performed the tasks as allocated. All the variables but two were significantly different between the first and second tasks, ignoring the handle type. There was no evidence of an unequal carryover effect when the comparison was stratified by ILH-PGH or PGH-ILH sequence. As compared with ILH, PGH tissue damage (0.1 vs 0.2 mm; p = 0.06) and NGDA (1 vs 1 p = 0.09) were different, whereas accuracy error, leak rates, operating time, GDA, and EMG were not. CONCLUSIONS: As compared with ILH needleholders, the use of PGH needleholders led to increased tissue damage and non-goal-directed actions during a suturing task in a simulator.

Computer Simulation↗
PubMed1995

Role of rectal route in treating cancer pain: a randomized crossover clinical trial of oral versus rectal morphine administration in opioid-naive cancer patients with pain.

PURPOSE: The aim of this double-blind, double-dummy, crossover study was to compare the efficacy, tolerability, and time of onset of analgesia after the administration of 10 mg of morphine hydrochloride via the oral and rectal routes in opioid-naive cancer patients with pain. PATIENTS AND METHODS: Thirty-four patients with cancer pain and no previous opioid treatment were randomized to receive morphine hydrochloride 10 mg orally or rectally (in the form of a microenema) for 2 days. During days 3 and 4, a crossover took place. The scores of pain, nausea, and sedation (visual analog scale of 0 to 100) calculated as the percentage change from baseline (before opioid administration) were assessed at different intervals up to 240 minutes. The number of vomiting episodes was recorded. Parity tests and analysis of variance (ANOVA) were performed to compare the two administration routes. RESULTS: A significant difference in pain intensity was achieved 10 minutes after rectal administration compared with 60 minutes after oral administration. There was still a significant reduction in pain via the rectal route after 180 minutes versus via the oral route after 120 minutes. No significant difference was observed in the intensity of sedation, nausea, or number of vomiting episodes between the oral and rectal routes. CONCLUSION: A liquid solution of morphine is well absorbed via the rectal route. Rectal morphine is safe, effective, easy to manage, and inexpensive, with a rapid onset of action. Rectal morphine can be considered a valid alternative route for opioid administration and may also be used when rescue doses of morphine are required in patients regularly treated with oral or parenteral opioids.

Administration, Oral↗
PubMed2004

Effect of propranolol on heart rate variability in patients with end-stage renal disease: a double-blind, placebo-controlled, randomized crossover pilot trial.

BACKGROUND: Low heart rate variability (HRV) is an independent risk factor of cardiac mortality in patients with end-stage renal disease (ESRD). It has been explained by uremic parasympathetic neuropathy. Sympathetic overactivity can also reduce HRV. Our aim was to determine whether there is vagal activity in ESRD patients that is masked by sympathetic activity. METHODS: The effect of propranolol on HRV was examined in 13 patients with ESRD, aged 20.1 +/- 7.6 years without diabetes. All patients were given intravenous propranolol (0.05 mg/kg) once and placebo once in a randomized, double-blind way, with an interval of 6.6 days (mean, range: 2-9). Propranolol was administered before hemodialysis treatment, after 40 minutes supine resting period. HRV was registered for 10 minutes, during supine, before and after the injection. Patients' HRV data were compared to that of 29 age-matched healthy controls. RESULTS: Initially, both high-(HFV) and low-frequency (LFV) bands of heart rate variability were lower in ESRD patients compared to controls (p < 0.001 for both). Propranolol resulted in a significant increase of HFV (propranolol: AlgHFV = 0.182 (0.027 - 0.337), placebo: deltalgHFV = -0.029 (-0.128 - +0.070); p = 0.032). Elevation of LFV was not significant. Six patients had an elevated plasma norepinephrine and/or epinephrine level. Plasma dopamine level was elevated in all but 1 patient (mean: 432 pmol/l, 95% CI: 320-543) and showed an inverse relationship with the increase of IgHFV secondary to propranolol (r = -0.66, p = 0.014). CONCLUSIONS: Low HFV of ESRD patients can be improved by beta-adrenergic blockade. It demonstrates that there is some vagal activity in ESRD that is masked by sympathetic activity. Therefore, altered sympathovagal balance of ESRD patients should be taken into consideration in the assessment of vagal uremic neuropathy.

Adolescent↗
PubMed2000

A randomized, controlled crossover trial of two oral appliances for sleep apnea treatment.

Our purpose was to compare the effectiveness and side effects of a novel, single-piece mandibular advancement device (OSA-Monobloc) for sleep apnea therapy with those of a two-piece appliance with lateral Herbst attachments (OSA-Herbst) as used in previous studies. An OSA-Monobloc and an OSA-Herbst with equal protrusion were fitted in 24 obstructive sleep apnea patients unable to use continuous positive airway pressure (CPAP) therapy. After an adaptation period of 156 +/- 14 d (mean +/- SE), patients used the OSA-Monobloc, the OSA-Herbst, and no appliance in random order, using each appliance for 1 wk. Symptom scores were recorded and sleep studies were done at the end of each week. Several symptom scores were significantly improved with both appliances, but to a greater degree with the OSA-Monobloc. Epworth Sleepiness Scale scores were 8.8 +/- 0.7 with the OSA-Herbst, and 8.6 +/- 0.8 with the OSA-Monobloc devices, and 13.1 +/- 0.9 without therapy (p < 0.05 versus both appliances). The apnea/hypopnea index was 8.7 +/- 1.5/h with the OSA-Herbst and 7.9 +/- 1.6/h with the OSA-Monobloc device, and 22.6 +/- 3.1/h without therapy (p < 0.05 versus both appliances). Side effects were mild and of equal prevalence with both appliances. Fifteen patients preferred the OSA-Monobloc, eight patients had no preference, and one patient preferred the OSA-Herbst device (p < 0.008 versus OSA-Monobloc). We conclude that both the OSA-Herbst and the OSA-Monobloc are effective therapeutic devices for sleep apnea. The OSA-Monobloc relieved symptoms to a greater extent than the OSA-Herbst, and was preferred by the majority of patients on the basis of its simple application.

Cross-Over Studies↗
PubMed2003

Low-dose methadone has an analgesic effect in neuropathic pain: a double-blind randomized controlled crossover trial.

The analgesic effectiveness and adverse effect incidence of a daily dose of 10 or 20 mg of oral methadone were evaluated in 18 patients with a diverse range of chronic neuropathic pain syndromes, who had all responded poorly to traditional analgesic regimens. Analgesia was seen after each dose of methadone. As compared with placebo, the 20 mg daily dose (given as 10 mg bd) resulted in statistically significant (P = 0.013-0.020) improvements in patient Visual Analogue Scale ratings of maximum pain intensity, average pain intensity and pain relief, recorded at the same time daily. The analgesic effects extended over 48 hours, as shown by statistically significant (P = 0.013-0.020) improvements in all three outcomes on the rest days instituted between each daily dose. Analgesic effects (lowered maximum pain intensity and increased pain relief, on the day of dosing only) were also seen when the lower daily dose of 10 mg methadone (given as 5 mg bd) was used, but these failed to reach statistical significance (P = 0.064 and 0.065, respectively). Interpatient analysis showed that the analgesic effects were not restricted to any particular type of neuropathic pain. Patient compliance was high throughout the trial. One patient withdrew during the 10 mg and six during the 20 mg methadone treatment periods. This is the first double-blind randomized controlled trial to demonstrate that methadone has an analgesic effect in neuropathic pain.

Adult↗
PubMed1993

Reactivity of leg alignment to articular pressure testing: evaluation of a diagnostic test using a randomized crossover clinical trial approach.

OBJECTIVE: A study was undertaken to assess the reliability of detecting leg alignment changes (reactivity) and to determine if the observed leg alignment reactivity can be attributed to a rotatory articular pressure challenge. DESIGN: Prospective double-blind crossover trial of a diagnostic test. SETTING: Laboratory: Center for Technique Research. PARTICIPANTS: Forty-two chiropractic college students, faculty and staff. INTERVENTIONS: A standardized force of 2 or 3 kg was applied with a 1 cm2 rubber-tipped pressure algometer on the lateral aspect of the T3-T7 spinous processes and the posterior aspect of the lateral masses of C1. MAIN OUTCOME MEASURES: Leg alignment reactivity: an increase in leg alignment discrepancy (yes or no) following a diagnostic intervention. RESULTS: The reliability for detecting leg alignment reactivity was poor: on average, Kappa = 0.05 in the thoracics and 0.06 at C1. On average, the attributable risk of leg alignment reactivity (pressure test risk--sham test risk) was less than 4%. In many cases, the sham rate was greater than the pressure test rate. CONCLUSIONS: For the population investigated, leg alignment reactivity to rotatory pressure testing can, in the majority of cases, be attributable to background noise. This procedure was not found to be viable for identifying vertebrae for adjustment. Further research with different subject populations, regions of investigation, leg alignment measurement techniques and vertebral challenge techniques are indicated.

Adult↗
PubMed1990

A controlled crossover trial of fenfluramine in autism.

We report a 12 month double-blind randomized crossover trial of fenfluramine in 20 children with the syndrome of autism. On active drug most of the children lost weight and blood serotonin levels fell by an average of 60%. There was a fall in urinary dopamine (DA) and noradrenaline (NA) levels and increased excretion of homovanillic acid (HVA). Some of the children showed improvement in tests of cognitive and language function, although the results did not achieve overall statistical significance. Event-related brain potentials (ERPs) were obtained in seven subjects on an auditory choice reaction time task. Side effects of the drug included irritability and lethargy. Fenfluramine may have a limited place in the management of some patients with autistic disorder.

Adolescent↗
PubMed2006

Factors that influence the applicability of sham needle in acupuncture trials: two randomized, single-blind, crossover trials with acupuncture-experienced subjects.

OBJECTIVES: In recent years the retractable type of sham needle has been anticipated to be a possible solution for masking patients in acupuncture research. However, this needle has been intended mainly for acupuncture-naïve subjects. The authors' goal in this study was to assess the validity of the retractable type of sham needle. METHODS: The authors conducted two randomized, single-blind, crossover trials with acupuncture-experienced subjects. Different acupuncture points were used in each trial (a LI-4 trial and a BL-23 trial). The subjects received two sessions of different stimulations in each trial. A Park Sham Needle was used in one session, a genuine acupuncture needle in the other. RESULTS: In the LI-4 trial, all of the 21 subjects (100%) felt penetration with the genuine needle, but only 7 of the 20 subjects (35%) felt a similar sensation with the sham needle (P=0.0002). Fifteen of the 21 subjects (71%) felt a dull sensation with the genuine needle, but only 4 of the 20 subjects (20%) felt a similar sensation with the sham needle (P=0.01). In the BL-23 trial, 14 of the 20 subjects (70%) felt penetration with the genuine needle and 10 of the 20 subjects (50%) felt "penetration" with the sham needle (P=0.39). Eight of the 20 subjects (40%) felt a dull sensation with the genuine needle and 2 of the 20 subjects (10%) did with the sham needle (P=0.109). CONCLUSIONS: Potential factors that influence the applicability of "placebo" needling include not only inter-tester variability but also the patient's knowledge and experience of acupuncture, acupuncture point selection, the visual impact of needling, and so on.

Acupuncture Therapy↗
PubMed2006

Effect of food intake on the bioavailability of almotriptan, an antimigraine compound, in healthy volunteers: an open, randomized, crossover, single-dose clinical trial.

This open, randomized, crossover, single-dose clinical trial evaluated the possible pharmacokinetic interaction between a single oral dose of almotriptan 25 mg, a 5-HT1B/1D receptor agonist for the acute treatment of migraine, and food intake in healthy volunteers. The influence of food intake in the rate and extent of almotriptan absorption was evaluated by bioequivalence criteria. Tolerability and safety of treatment were also assessed. 16 healthy volunteers (8 men and 8 women, aged 19-27 years) received a crossed single oral dose of almotriptan 25 mg under fasting and fed conditions, separated by a 7-day washout period. The treatment given under fasting condition was considered as reference. Plasma levels of almotriptan were analyzed using high-performance liquid chromatography (HPLC) and UV detection at 227 nm. The 90% confidence intervals (CI) for the logarithmically transformed Cmax and AUC0-infinity, values of almotriptan under fasting and fed conditions (97.8 - 124% and 102.9 - 108.2%, respectively) fell into the predetermined accepted range of 80 - 125%. No statistically significant differences in Cmax, tmax, AUC0-infinity, MRT and t1/2 were observed under fasting and fed conditions between men and women. Tolerability of treatments was good throughout the whole study period. In conclusion, administration of almotriptan 25 mg is bioequivalent under fasting and fed conditions in healthy men and women. Therefore, it is unlikely that concomitant food intake would produce clinially relevant differences in therapeutic effect with almotriptan at the dose studied here.

Administration, Oral↗