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Results for “randomized crossover trial”

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PubMed1997

Acceptability and compliance with two forms of cholestyramine in the treatment of hypercholesterolemia in children: a randomized, crossover trial.

OBJECTIVE: To compare the acceptability, compliance, and effectiveness of two forms of cholestyramine resin in the treatment of hypercholesterolemia in children. STUDY DESIGN: Patients aged 10 to 18 years with familial hypercholesterolemia were enrolled in a randomized, crossover trial of two 8-week periods of either a pill or powder form of cholestyramine at a dose of 8 gm/day. RESULTS: Of 40 children enrolled, 38 completed both medication periods, with a median age of 13 years (range, 10 to 18). At the end of the study, 82% preferred the pill form, 16% the powder form and 2% neither form. Mean (+/-SD) compliance as assessed by the amount of medication taken was significantly greater for pills (61% +/- 31%) than powder (50% +/- 30%, p = 0.01). The form of the medication increased compliance by at least 25% for 16 patients (42%), 13 in favor of pills and 3 in favor of powder. Compliance was not associated with patient attitudes and perceptions of hypercholesterolemia, demographics, family history, previous experience with lipid-lowering medication, or lipid profile parameters. Significant mean reductions in low-density lipoprotein cholesterol concentrations were noted for both pills (-10% +/- 20%, p = 0.006) and powder (-15% +/- 17%, p = 0.0001), with no significant difference between forms (p = 0.16). CONCLUSIONS: A change in bile acid-binding resin formulation from powder to pills significantly increases acceptability and compliance in some children with hypercholesterolemia.

Adolescent↗

PubMed1986

[Randomized crossover trial of the antiemetic effects obtained with metoclopramide and droperidol versus those obtained with metoclopramide, droperidol and methylprednisolone in patients receiving cis-platinum chemotherapy].

Twenty-four patients with lung cancer receiving cis-platinum chemotherapy were entered in an antiemetic randomized crossover trial. The effects of high-dose metoclopramide and droperidol (regimen I) were compared with those obtained with a combination of high-dose metoclopramide, droperidol and methylprednisolone (regimen II). Three patients (12.5%) treated with regimen I and 10 (43.5%) treated with regimen II had no vomiting at all (p less than 0.05). Patient preference was significantly in favor of regimen II (p less than 0.05). No Severe side effects were observed. A further trial is necessary to determine the optimal dosage and scheduling of the available agents.

Aged↗

PubMed2005

A randomized crossover trial comparing three plateletpheresis machines.

BACKGROUND: The aim of the study was to compare three different apheresis machines with the same donors regarding the processing time required to obtain a 3.5 x 10(11) platelet (PLT) dose and acceptance by donors. STUDY DESIGN AND METHODS: A randomized crossover trial was performed to evaluate the differences between the Amicus Crescendo (Baxter Biotech Corp.), the MCS Plus (Haemonetics Corp.), and the Trima Accel (Gambro BCT). Donations from 51 donors were compared for time adjusted to obtain a standard 3.5 x 10(11) PLT dose (TSD3.5), efficiency, adverse reactions, yield, leukodepletion, machine accuracy, and donor preferences. Processing times were measured by chronometer. The same vein access was used during all three processes in each donor. In the statistical analysis, to take into account the nonindependence of several measurements from the same donor, generalized estimating equations were used with an autoregressive correlation matrix. RESULTS: The Accel produced a TSD3.5 (mean +/- SEM) of 47.9 +/- 1.0 min; the Amicus, 60.3 +/- 1.0 min; and the MCS Plus, 66.7 +/- 1.0 (p < 0.0001). The Amicus presented the greatest efficiency (87.5%; p < 0.0028). The MCS Plus demonstrated the highest capacity for leukodepletion (p < 0.0002) despite one process presenting more than 1 x 10(6) white blood cells per unit. The MCS Plus also measured the processing time with the greatest accuracy. No severe adverse effects were observed. The donors preferred the Accel (61%) followed by the Amicus (35%) and the MCS Plus (4%; p < 0.0001) and the processing speed was the most highly valued measure (55%). CONCLUSIONS: The Accel is the fastest and, because of this advantage, the machine preferred by donors. The Amicus was the most efficient and the MCS Plus was the only one not to underestimate the processing time.

Cross-Over Studies↗

PubMed2004

Sevoflurane versus propofol for induction of anaesthesia for electroconvulsive therapy: a randomized crossover trial.

Propofol is often used to induce anaesthesia for electroconvulsive therapy. Some patients who receive propofol have fits of poor quality or inadequate duration despite increasing electroconvulsive therapy doses. Sevoflurane has been reported to exhibit pro-convulsant properties in some "at-risk" patients during anaesthesia for other procedures. The purpose of this study was to perform a randomized crossover trial in patients undergoing electroconvulsive therapy, comparing the effects on seizure parameters of propofol versus sevoflurane induction. Patients were randomly allocated to receive either sevoflurane or propofol for their first treatment. In the subsequent treatment the alternative agent was used. Patients in both treatment groups exhibited equally good fits, with those in the sevoflurane group having slightly better morphology, which is the most subjective of the parameters measured. The sevoflurane administrations were associated with slightly higher pulse rates and blood pressures. Sevoflurane provides a suitable alternative to propofol for anaesthesia in patients undergoing electroconvulsive therapy, although the slightly greater pulse rate rise and blood pressure rise should be considered in patients with ischaemic heart disease.

Anesthesia↗

PubMed1986

The protective effect of 2-mercapto-ethane sulfonate (MESNA) on hemorrhagic cystitis induced by high-dose ifosfamide treatment tested by a randomized crossover trial.

High-dose ifosfamide (one or two courses of 6 g/m2) with or without mesna was administered to 13 patients with advanced non-small cell lung cancer. The protective effect of 2-mercapto-ethane sulfonate (mesna) against the urotoxic side effects induced by ifosfamide was examined by a randomized crossover trial. A significant reduction in the incidence of hematuria was observed in the patients receiving mesna. Macroscopic hematuria was observed in only one patient who received treatment with mesna versus seven patients treated with ifosfamide alone. Other symptoms, such as frequency and dysuria, tended to be diminished in the patients receiving mesna, although the difference was not statistically significant. Our results suggest that mesna is effective in preventing or diminishing ifosfamide-induced hemorrhagic cystitis. Concomitant use of mesna should allow the administration of a high dose of ifosfamide although more extensive studies are needed to define the optimal dose and schedule of administration of mesna to prevent or attenuate the hemorrhagic cystitis.

Adult↗

PubMedDate not supplied

Ropinirole as a treatment of restless legs syndrome in patients on chronic hemodialysis: an open randomized crossover trial versus levodopa sustained release.

OBJECTIVE: Restless legs syndrome (RLS) is a common neurologic condition characterized by uncomfortable and unpleasant sensations in the legs, occurring primarily at rest, which are usually worse in the evening and are alleviated by movement. RLS is present in 20-40% of patients with renal failure. This study was a 14-week open, randomized, crossover trial of ropinirole vs. levodopa sustained release (SR) in 11 patients with RLS on chronic hemodialysis. METHODS: Eleven patients (7 men, 4 women) were enrolled in the study. They received either levodopa SR or ropinirole for 6 weeks, followed by a washout week, then the alternate treatment for 6 weeks. Patients rated the severity of RLS by means of a 6-item questionnaire developed by the International Restless Legs Study Group (6-item IRLS), by the Clinical Global Impression (CGI) scale, and by sleep diaries. RESULTS: Under treatment with levodopa SR, 1 patient presented severe vomiting, leading to study discontinuation. The 10 patients who completed the study reported a 33.5% improvement (from 16.7 +/- 3.2 to 11.1 +/- 4; P < 0.001) of the 6-item IRLS scores during levodopa SR treatment and a 73.5% improvement (from 16.6 +/- 2.8 to 4.4 +/- 3.8; P < 0.001) during ropinirole treatment. By the end of the study the mean levodopa SR dosage was 190 mg/d and the mean ropinirole dosage was 1.45 mg/d. Ropinirole was superior to levodopa SR in reducing 6-item IRLS scores (P < 0.001) and in increasing sleep time (P < 0.001). The patient CGI scale showed a significant difference favoring ropinirole (P < 0.01). There was no significant carryover or period effect for any outcome measure. Four patients reported a complete reversion of RLS symptoms during ropinirole treatment at doses ranging from 0.25-2 mg/d. CONCLUSIONS: These results suggest that ropinirole is more effective than levodopa SR in the treatment of RLS in patients on chronic hemodialysis.

Antiparkinson Agents↗

PubMed2003

Comparison of neutropenia in a randomized, crossover trial of 3-, 6-, and 24-h infusions of paclitaxel.

OBJECTIVE: Paclitaxel is most commonly infused over 3 hs rather than the original schedule of 24 h as the briefer infusion duration results in greater convenience, similar efficacy, significantly less myelosuppression, and less cost. While differences in toxicity between 3- and 24-h infusions are well described, there is little information about the effect of modest prolongation of infusion duration, which is often employed in patients who develop hypersensitivity reactions. To assess whether prolonging a 3-h infusion significantly increases the degree of neutropenia, we reviewed our data from a randomized, crossover trial of 3-h versus 6-h versus 24-h regimens of paclitaxel. METHODS: Results from 12 patients who were randomized to receive one 3-h, one 6-h and one 24-h infusion of paclitaxel in varied sequences during their first three cycles of treatment were analysed. The blood counts were monitored closely throughout each cycle of treatment. RESULTS: Crossover trial methodology was used to assess the differences in the degree of neutropenia caused by the three different infusion regimens. The 24-h infusion regimen resulted in significantly worse neutropenia than the 3- or 6-h infusion regimens. There was no statistically significant difference between the 3- and 6-h infusion regimens with respect to all endpoints. The estimated mean difference in the duration of grade 3 or 4 neutropenia between the 3- and 6-h infusion regimens (6 h - 3-h) was 1.1 day (95% CI: -0.9, 3.2), and for grade 4 neutropenia, the estimated mean difference in the duration was 0.8 day (95% CI: -0.4, 2.0). CONCLUSIONS: Increasing the duration of paclitaxel infusions from 3 to 6 h does not result in a statistically significant increase in the degree of neutropenia. Any additional neutropenia is likely to be of brief duration.

Adult↗

PubMed2002

Randomized crossover trial of two treatments for sleep apnea/hypopnea syndrome: continuous positive airway pressure and mandibular repositioning splint.

Mandibular repositioning splints (MRSs) and continuous positive airway pressure (CPAP) are used to treat the sleep apnea/hypopnea syndrome (SAHS). There are some data suggesting that patients with milder symptoms prefer MRS, but there are few comparative data on outcomes. Therefore, we performed a randomized crossover trial of 8 weeks of CPAP and 8 weeks of MRS treatment in consecutive new outpatients diagnosed with SAHS (apnea/hypopnea index [AHI] >or= 5/hour, and >or= 2 symptoms including sleepiness). Assessments at the end of both limbs comprised home sleep study, subjective ratings of treatment value, sleepiness, symptoms, and well-being, and objective tests of sleepiness and cognition. Forty-eight of 51 recruited patients completed the trial (12 women; age [mean +/- SD], 46 +/- 9 years; Epworth 14 +/- 4; median AHI, 22/hour; interquartile ratio [IQR], 11-43/hour). Significant (p <or= 0.01) differences between MRS and CPAP were observed for 7 of 21 variables (effect sizes, 0.3-0.6 SDs), all favoring CPAP, including AHI (15 +/- 16 and 8 +/- 6/hour, respectively), effectiveness rating, symptoms, Epworth (12 +/- 5 and 8 +/- 5, respectively), functional outcomes of sleepiness questionnaire, short-form 36 health survey mental component, and health transition scores. Objective sleepiness, cognitive performance, and preference for treatments were not different. In patients experiencing a mild form of the syndrome (AHI < 15, n = 18), symptoms, treatment efficacy and satisfaction, and subjective sleepiness were also better with CPAP than with MRS (effect sizes, 0.7-1.1 SDs). These results do not support these MRS devices as first-line treatment for sleepy patients with SAHS.

Adolescent↗

PubMed2004

Antihypertensive effects of long-acting calcium channel blockers on hemodialysis days--a randomized crossover trial between benidipine and nifedipine CR.

BACKGROUND/AIMS: Since antihypertensive effects of most calcium channel blockers largely depend on their plasma concentrations, a rapid increase in blood pressure may occur as circulating levels of such blockers decrease after hemodialysis. Thus, the effects of benidipine and nifedipine CR (extended-release coated tablets, Adalat CR), which are long-acting calcium channel blockers, on post-hemodialytic blood pressures were investigated. METHODS: A randomized crossover trial was carried out with 10 hypertensive patients on chronic maintenance hemodialysis. Patients were assigned to receive benidipine (4-8 mg/day) or nifedipine CR (20-40 mg/day), and after 4 weeks, 24-hour ambulatory blood pressure monitoring was performed on the day of hemodialysis and blood samples were obtained before and after hemodialysis to measure plasma concentrations of the blockers. The calcium channel blockers were then exchanged in each patient and the same protocol was repeated. RESULTS: The pattern of fluctuation of blood pressure differed markedly between the treatment with benidipine and nifedipine CR. Under treatment with nifedipine CR, rapid increase in blood pressure was observed after hemodialysis, while blood pressure remained at favorable levels with benidipine. Plasma concentrations of the blockers were significantly decreased by hemodialysis. CONCLUSION: Benidipine exerts more sustained antihypertensive effects than expected from its disposition in plasma. The stable depressor effects of benidipine even after hemodialysis may contribute to favorable control of blood pressure in this population.

Aged↗

PubMed2004

Dietary serine and cystine attenuate the homocysteine-raising effect of dietary methionine: a randomized crossover trial in humans.

BACKGROUND: A high plasma total homocysteine (tHcy) concentration is a risk factor for cardiovascular disease. The increase in tHcy induced by methionine, the sole dietary precursor of homocysteine, might be modulated by other amino acids present in dietary proteins. OBJECTIVES: Our objectives were to compare the postprandial effect of free and dietary methionine on plasma tHcy concentrations and to investigate whether serine and cystine modify the effect of free methionine on tHcy. DESIGN: We conducted a randomized crossover trial in 24 healthy men. Each subject ingested 4 meals on separate days, which were separated by 1 wk. tHcy concentrations were measured in the fasting state and at 2, 4, 6, 8, 10, and 24 h after meal ingestion. The meals were 1) a low-protein meal fortified with 30 mg methionine/kg body wt (reference, denoted by "Met"), 2) meal 1 additionally fortified with 60.6 mg serine/kg body wt (MetSer), 3) meal 1 additionally fortified with 12.3 mg cystine/kg body wt (MetCys), and 4) a protein-rich meal containing 30 mg methionine, 60.6 mg serine, and 12.3 mg cystine per kg body wt (Protein). RESULTS: The mean (+/-SD) fasting tHcy concentration was 9.1 +/- 2.7 micromol/L. Mean peak tHcy concentrations were 17.9 +/- 4.5, 14.3 +/- 3.3, 14.8 +/- 3.9, and 11.2 +/- 3.1 micromol/L after Met, MetSer, MetCys, and Protein, respectively. Compared with the mean 24-h area under the tHcy-by-time curve after Met, the mean curves after MetSer, MetCys, and Protein were 37%, 32%, and 77% smaller, respectively (all P < 0.0005). CONCLUSIONS: Dietary methionine increases tHcy much less than does free methionine. Serine and cystine attenuate the tHcy-raising effect of free methionine. Thus, dietary proteins with a high content of serine or cystine relative to methionine may lead to lower postprandial tHcy responses.

Adult↗

PubMed1988

Double-blind randomized, crossover trial of calcium supplementation in essential hypertension.

In a double-blind, randomized, placebo-controlled, crossover trial, 23 middle-aged patients with mild to moderate essential hypertension were given an oral calcium supplement (1 g/day) for 8 weeks. At the end of this period, eight patients continued with this treatment for an additional 2 weeks but were also given 0.5 micrograms/day of 1,25-(OH)2 vitamin D3. In the 21 patients who completed the study, arterial pressure during the calcium-supplemented phase was almost identical to that of the placebo phase. In eight patients, mean arterial pressure (MAP) had changed by greater than 5 mmHg at the end of the calcium-supplemented period, compared with the end of the placebo phase (six patients showed an increase in MAP and two a decrease). Changes in arterial pressure were unrelated to age, plasma ionized calcium, parathyroid hormone (PTH), plasma renin activity (PRA), plasma aldosterone, 24-h urinary calcium, sodium and potassium and were only weakly related to body weight. In the eight patients who continued with the treatment of calcium plus 1,25-(OH)2 vitamin D3 after the 8-week study period, arterial pressure changed very little and not significantly. These results do not support the suggestion that calcium supplements lower arterial pressure in middle-aged subjects with mild to moderate essential hypertension.

Adult↗

PubMed2006

'Facilitated tucking by parents' in pain management of preterm infants-a randomized crossover trial.

BACKGROUND: There is a need for a safe and effective non-pharmacological pain management method for preterm infants. The parents could be given an active role in the pain management which may help the parents to cope with the stress related to painful situations of the infant. AIMS: To examine the effectiveness of a method called 'facilitated tucking by parents' (a parent holds the infant in a flexed position) in pain management during endotracheal/pharyngeal suctioning of preterm infants. In addition, the parental perception of the method was studied. STUDY DESIGN: A randomized crossover trial. SUBJECTS: Twenty preterm infants with one of their parents participated in the study. Infants' gestational age ranged from 24 to 33 (median 28) weeks and postnatal age from 6 to 37 days (median 15 days). OUTCOME MEASURES: The primary outcome was the Neonatal Infant Pain Scale (NIPS) score. Heart rate and oxygen saturation were recorded. Parents completed a questionnaire about their perception of the procedure. RESULTS: The highest NIPS score was median 3 (range from 2 to 6) using 'facilitated tucking by parents' and median 5 (range from 2 to 7) without tucking during suctioning (p < 0.001). The infants calmed down more quickly after 'facilitated tucking by parents' (5 s vs. 17 s, p = 0.024). Nineteen out of twenty parents preferred facilitated tucking during suctioning compared to control care. CONCLUSIONS: Facilitated tucking by parents is an effective and safe pain management method during suctioning of preterm infants. This study shows that parents can be given an active role in the pain care of their preterm infants.

Adolescent↗

PubMed2005

Effects of electroacupuncture in reducing weight and waist circumference in obese women: a randomized crossover trial.

OBJECTIVE: To compare the effects of weight control on simple obese women between electroacupuncture and sit-up exercise. DESIGN: Randomized and crossover trial conducted from 1 January 2002 to 31 December 2002. The subjects were randomly divided into groups A and B. Group A received electroacupuncture treatment first while group B received sit-up exercise treatment first. After 6 weeks of treatment and 7 days of washout, group A switched to sit-up exercise treatment and group B received electroacupuncture treatment for another 6 weeks. PATIENTS: In total, 54 simple obese women, with waist circumference (WC)>90 cm and body mass index (BMI)>30 kg/m(2), and who had not received any other weight control maneuver within the last 3 months. MEASUREMENT: The measurements of body weight (BW), BMI and WC were performed at the beginning, 6, 8 and 13 weeks. The data at different time periods were compared and expressed as % reductions. RESULTS: Electroacupuncture (n=46) showed significant differences in the % reductions in BW (P=0.001), BMI (P=0.003) and WC (P=0.005) compared with sit-up exercise. At the end of 13 weeks, there were no significant difference between groups A (n=24) and B (n=22) in all the measurements. At the end of the study, groups A and B showed significant differences in the % reductions in BW (P=0.004; 0.001), BMI (P=0.003; 0.021) and WC (P< or =0.001; 0.001) compared with the initial values. CONCLUSIONS: Electroacupuncture treatment is more effective than sit-up exercise in reducing weight and WC, making it an alternative treatment option for weight and WC control on obese women.

Adult↗

PubMed2006

Average volume-assured pressure support in obesity hypoventilation: A randomized crossover trial.

BACKGROUND: Average volume-assured pressure support (AVAPS) has been introduced as a new additional mode for a bilevel pressure ventilation (BPV) device (BiPAP; Respironics; Murrysville, PA), but studies on the physiologic and clinical effects have not yet been performed. There is a particular need to better define the most efficient ventilatory treatment modality for patients with obesity hypoventilation syndrome (OHS). METHODS: In OHS patients who did not respond to therapy with continuous positive airway pressure, the effects of BPV with the spontaneous/timed (S/T) ventilation mode with and without AVAPS over 6 weeks on ventilation pattern, gas exchange, sleep quality, and health-related quality of life (HRQL) assessed by the severe respiratory insufficiency questionnaire (SRI) were prospectively investigated in a randomized crossover trial. RESULTS: Ten patients (mean [+/- SD] age, 53.5 +/- 11.7 years; mean body mass index, 41.6 +/- 12.1 kg/m2; mean FEV1/FVC ratio, 79.4 +/- 6.5%; mean transcutaneous P(CO2) [PtcCO2], 58 +/- 12 mm Hg) were studied. PtcCO2 nonsignificantly decreased during nocturnal BPV-S/T by -5.6 +/- 11.8 mm Hg (95% confidence interval [CI], -14.7 to 3.4 mm Hg; p = 0.188), but significantly decreased during BPV-S/T-AVAPS by -12.6 +/- 12.2 mm Hg (95% CI, -22.0 to -3.2 mm Hg; p = 0.015). Pneumotachographic measurements revealed a higher individual variance of peak inspiratory pressure (p < 0.001) and a trend for lower leak volumes but also for higher tidal volumes during BPV-S/T-AVAPS. The SRI summary scale score improved from 63 +/- 15 to 78 +/- 14 during BPV-S/T (p = 0.004) and to 76 +/- 16 during BPV-S/T-AVAPS (p = 0.014). Sleep quality and oxygen saturation also comparably improved following BPV-S/T and BPV-S/T-AVAPS. CONCLUSION: BPV-S/T substantially improved oxygenation, sleep quality, and HRQL in patients with OHS. AVAPS provided additional benefits on ventilation quality, thus resulting in a more efficient decrease of PtcCO2. However, this did not provide further clinical benefits regarding sleep quality and HRQL.

Adult↗

PubMed1997

Pergolide: treatment of choice in restless legs syndrome (RLS) and nocturnal myoclonus syndrome (NMS). A double-blind randomized crossover trial of pergolide versus L-Dopa.

A double-blind randomized crossover study of 0.125 mg Pergolide (Lilly) at bedtime versus 250mg L-Dopa + Carbidopa (Roche) was conducted in 16-day phases in 11 patients with idiopathic restless legs syndrome. Two patients reported a partial and 9 patients a complete relieve of motor restlessness while receiving Pergolide. Only 1 patient experienced an improvement of restlessness after L-Dopa. The patients showed polysomnographically a mean decrease in NMS cluster disturbed time by 45% from control on L-Dopa (p < 0.025) and by 79% from control on Pergolide (p < 0.001). In addition, Pergolide increased the total sleep time compared to L-Dopa (p < 0.05). In conclusion, the dopamine agonist Pergolide is superior to L-Dopa in the treatment of RLS and NMS.

Aged↗

PubMed1987

Plasma pharmacokinetics of cyclophosphamide and its cytotoxic metabolites after intravenous versus oral administration in a randomized, crossover trial.

Since cyclophosphamide is used by both oral and i.v. routes in the treatment of hematological and solid malignancies, we designed a randomized, crossover clinical trial to evaluate the pharmacokinetics of this anticancer agent after either administration route. Plasma levels of cyclophosphamide and its two cytotoxic metabolites, 4-hydroxycyclophosphamide and phosphoramide mustard, were determined in seven cancer patients randomly assigned to treatment initially with either orally or i.v. administered cyclophosphamide with a 30-day interim between alternate therapy courses. Oral treatment was used initially in five patients and i.v. treatment in two patients, and the pharmacokinetic parameter, area under the plasma disappearance curve, was determined for each metabolite in each patient for both routes of drug administration. Statistical comparison of area under the plasma disappearance curve values for this set of patients indicated no significant differences for either metabolite for oral versus i.v. drug treatment, suggesting equal efficacy for these two routes of cyclophosphamide administration.

Administration, Oral↗

PubMedDate not supplied

Calcium supplementation in premenstrual syndrome: a randomized crossover trial.

OBJECTIVE: To determine the efficacy of calcium supplementation in women with premenstrual syndrome (PMS). DESIGN: Randomized, double-blind crossover trial. SETTING: Outpatient medical clinic of a large city hospital. PARTICIPANTS: Seventy-eight women were initially screened. Trial selection was based on a history of recurrent PMS symptoms and on the results of a prospective assessment of daily symptom scores. Only women with symptom scores during the late luteal phase that were at least 50% greater than those during the intermenstrual phase were selected. Thirty-three women completed the trial. INTERVENTION: A preliminary evaluation included physical examination, routine laboratory tests, dietary assessment, and psychiatric evaluation. Each participant received six months of treatment involving three months of daily calcium supplementation (1,000 mg of calcium carbonate) and three months of placebo. MEASUREMENTS: Efficacy was assessed prospectively by changes in daily symptom scores over a six-month period and retrospectively by an overall global assessment. Multivariate repeated measures analysis of variance on symptom ratings derived from daily PMS symptom scores demonstrated a reduction in symptoms on calcium treatment during both the luteal (p = 0.011) and the menstrual phases (p = 0.032) of the reproductive cycle. Calcium supplementation had no effect during the intermenstrual phase. Retrospective assessment of overall symptoms confirmed this reduction: 73% of the women reported fewer symptoms during the treatment phase on calcium, 15% preferred placebo, and 12% had no clear preference. Three premenstrual factors (negative affect [p = 0.045]; water retention [p = 0.003]; pain [p = 0.036]) and one menstrual factor (pain [p = 0.02]) were significantly alleviated by calcium. CONCLUSION: Calcium supplementation is a simple and effective treatment for premenstrual syndrome, but further studies will be needed to determine its precise role in PMS.

Adult↗

PubMed1985

Randomized crossover trial of isosorbide mononitrate (Elantan 20) and slow-release glyceryl trinitrate in the treatment of angina pectoris.

An open, randomized, comparative crossover clinical trial was carried out to compare the clinical efficacy of 20 mg isosorbide mononitrate 3-times daily and 6.4 mg sustained-release glyceryl trinitrate 3-times daily in the treatment of angina pectoris. Fifty patients entered the trial and 48 patients completed. Each treatment was given for 12 weeks followed by crossover to the alternative drug. Both treatments resulted in marked significant improvements relative to the pre-trial baseline, but isosorbide mononitrate was shown to be significantly (p less than 0.001) more efficacious than sustained-release glyceryl trinitrate in the reduction of the number of angina attacks and sub-lingual glyceryl trinitrate consumption. Angina frequency was lower with isosorbide mononitrate than with sustained-release glyceryl trinitrate in 33 (69%) of the patients, but lower with sustained-release glyceryl trinitrate than with isosorbide mononitrate in only 3 (6%) patients (p less than 0.001). Sub-lingual glyceryl trinitrate consumption was lower with isosorbide mononitrate than with sustained-release glyceryl trinitrate in 36 (75%) patients, but lower with sustained-release glyceryl trinitrate than with isosorbide mononitrate in only 5 (10%) patients. Examination of the effect of changing from isosorbide mononitrate to sustained-release glyceryl trinitrate therapy or vice versa confirmed the clinical superiority of isosorbide mononitrate. Physical exercise capacity was reported as improved in 20 (60%) patients with isosorbide mononitrate but in only 12 (25%) patients with sustained-release glyceryl trinitrate (p less than 0.02). Neither treatment showed any tendency for a reduction in effect during 12-weeks' continuous therapy.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Oral↗