Our aims were to determine the long-term clinical and manometric follow-up of 11 children with previously documented esophageal dysmotility, who had been breast-fed by mothers with silicone breast implants, their response to prokinetic agents, and to analyze changes in macrophage activation. Seven of 11 children had subjective clinical improvement. Weight/ height ratios remained the same or improved in 9/11. Biopsies at follow-up endoscopy were either normal or demonstrated mild esophagitis in 8/10. LES and UES pressures and percent propagation were not significantly different at follow-up, while wave amplitude significantly increased. Following intravenous metoclopramide, LES pressure, percent propagation, and wave amplitude significantly increased while UES pressure was unchanged. Urinary neopterin significantly decreased at follow-up, while urinary nitrates were unchanged. Esophageal dysmotility is chronic in this group of children, suggesting persistent autonomic nervous system dysfunction. Prokinetic agents may be useful in long-term management. The decreasing urinary neopterin levels suggest that, ultimately, there may be improvement in esophageal motility.
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Demographics, antibiotic use and admission diagnosis were similar amongst the three patients groups. Diarrhoea developed in 72 (40%) patients, 9.9 +/- 0.8 days after commencement of therapy, none of whom was positive for CD toxin or bacterial infection. Parasitic infections were found in four aboriginal men from an area endemic for these infections. Diarrhoea was most prevalent in patients who received combination therapy (49%) and was more common than in those who received erythromycin alone (30%) and metoclopramide alone (32%). Diarrhoea was short-lasting with a mean duration of 3.6 +/- 1.2 days.
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In the 0-1 h period after operation, there were no differences between the groups. In the 1-24 h period, dolasetron was significantly better than placebo (nausea 8 versus 24%; vomiting 4 versus 20%; total nausea and vomiting scores 16 versus 48%). Over the 0-24 h period, both dolasetron and ondansetron were significantly better than placebo (nausea 16 versus 26 versus 40%), vomiting (8 versus 16 versus 30%), and total nausea and vomiting scores (32 versus 48 versus 78%). There were no significant differences between dolasetron and ondansetron. There was no important methylene blue contamination, and little use of rescue metoclopramide. There were no important adverse events.
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The paper describes a model of motion sickness for dogs. The method is based on the simultaneous use of vertical and rotatory movement of the device with a continuously varying angular velocity of rotation to generate Coriolis acceleration. The exposure increases significantly the number of sick animals to be used in the selection of antimotion drugs. Diphenidol, marezine, tigane, bromotigane and metachloropromide were tested. Diphenidol and to a lesser extent marezine and metachloropromide proved effective. Tigane and bromotigane were ineffective against motion sickness.
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A survey (21 questions) designed to determine use of prokinetic agents was sent electronically to 112 ACVS Diplomates known to perform equine intestinal surgery. Several clinical scenarios were also described to determine which, if any, prokinetic agent respondents would select.
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High dose metoclopramide is an effective anti-emetic for use with cisplatin containing chemotherapy regimens but can cause extrapyramidal reactions. Lorazepam and dexamethasone are increasingly being used to alleviate chemotherapy induced emesis. This trial has assessed the contribution of high dose metoclopramide to anti-emetic control when given with dexamethasone and lorazepam. Eight-one patients receiving chemotherapy, mainly for gynaecological malignancy, entered a randomised double blind cross-over trial comparing dexamethasone and lorazepam with or without a 24 h metoclopramide infusion. This was followed by oral dexamethasone with or without oral metoclopramide for three further days depending on the initial randomisation. Sixty-one patients were fully evaluable. Fifty-five received cisplatin containing regimens and six non-cisplatin regimens. There was a significant reduction in the number of episodes of vomiting during the first 24 h in patients receiving the metoclopramide combination (P = 0.0001). On first exposure to chemotherapy 45% of patients receiving dexamethasone, lorazepam and high dose metoclopramide had no vomiting while 67% had two episodes or less ('major control'). This compared to 11% total control and 25% major control in those receiving dexamethasone, lorazepam and placebo. The control of nausea in the first 24 h was also improved (P = 0.0001). There was no difference in the degree of nausea or vomiting during the following three weeks between those receiving oral dexamethasone alone and those receiving dexamethasone and metoclopramide. Both groups showed a significant increase in nausea in the three weeks following the second course of treatment when compared to the first (P = 0.0007). Extrapyramidal reactions were recorded in 11.5% of patients receiving metoclopramide. More patients stated a preference for the metoclopramide combination although this was not statistically significant (chi 2(1) = 0.29, P = 0.59). In conclusion the combination of dexamethasone and lorazepam can give major control of emesis in 25% of patients receiving very emetogenic chemotherapy. The addition of metoclopramide increases this to 67% on first exposure to chemotherapy, but at the expense of extrapyramidal reactions in 11.5%.
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Based on the safety and efficacy of ondansetron, it may be used as a first-line agent for relief of nausea or vomiting for most patient populations in the ED.
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Aspiration pneumonitis is a syndrome resulting from the inhalation of gastric contents. The incidence in obstetric anaesthesia has fallen, largely due to improved anaesthetic techniques and the increased use of regional anaesthesia at caesarean section. However, aspiration pneumonitis is still a cause of maternal morbidity and mortality, and it is important to use effective prophylaxis.
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Alteration of the gastrointestinal motility following abdominal surgery is a well substantiated clinical observation. Clinical reports concerning the effect of drugs theoretically suitable for normalizing inhibited gastric emptying during the postoperative period have been conflicting, however. The effect of chlorpromazine, neostigmine and metoclopramide upon retarded gastric emptying following laparotomy was studied in experiments on rats. Metoclopramide (Primperan) considerably improved the emptying ability of the stomach as early as 24 hours after laparotomy. After 72 hours this effect was further accentuated. No improvement of postoperatively retarded motility resulted from treatment with chlorpromazine or with neostigmine during the first 3 postoperative days.
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The possible effect on the infant of dopamine antagonists used to promote lactation is cause for concern. Domperidone (Motilium) may be safer than other drugs in this group as it does not cross the blood-brain barrier. The mean serum level of prolactin 2 h after treatment with 20 mg of domperidone in the puerperium was 255 ng/ml compared with 150 ng/ml after a placebo. The mean domperidone level in all breast milk samples during treatment with 10 mg, three times daily, was 2.6 ng/ml. This was significantly more than levels after a single 20 mg dose sampled at 2 h (0.24 ng/ml) and at 4 h (1.1 ng/ml), and considerably less than values available for metoclopramide and sulpiride, relative to the therapeutic dosage. The effectiveness of domperidone to augment lactation requires further study.
The pre-, peri-, and postoperative variations in blood PRL concentrations were determined using assays conducted at 10-minute intervals. Of the 36 patients included in the study, 27 were considered cured (resumption of a normal menstrual cycle within 6 months, PRL concentration at 9 days [mean +/- standard deviation 2.5+/-2.1 ng/ml] and 12 months [4.5+/-2.2 ng/ml] after the operation < 10 ng/ml and normally stimulated by metoclopramide and thyrotropin-releasing hormone [TRH]). Nine patients were not cured (PRL 20+/-15.7 ng/ml at 9 days after surgery, with no response to metoclopramide and TRH). The kinetics of PRL decrease in definitively cured patients were characterized by the following: 1) the initial slope of the curve decreased by at least 11% within the first 10 minutes after resection, and 2) immediate postoperative PRL concentrations were 20 ng/ml or less.
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The safety and efficacy of intravenous granisetron were compared with combinations of conventional antiemetics in two single-blind, parallel-group studies which have been reported previously. In this review updated data from both studies is presented. In both studies granisetron (40 micrograms/kg) was given as a single 5-min infusion before chemotherapy with two additional doses allowed to control subsequent nausea and vomiting. All patients were naive to chemotherapy. Patients due to receive cisplatin (greater than 49 mg/m2) were randomly assigned to receive either granisetron alone or metoclopramide (3 mg/kg) plus dexamethasone (12 mg) given prophylactically followed by an 8-h infusion of metoclopramide (4 mg/kg). In the 24 h after the start of chemotherapy 70% of granisetron-treated patients and 67% of comparator group were complete responders. In patients due to receive moderately emetogenic chemotherapy, granisetron was compared with chlorpromazine (up to 200 mg/24 h) plus dexamethasone (12 mg). Twenty-four hour efficacy was significantly higher in the granisetron group with complete response in 68% of patients compared to 47% in the comparator group (P less than 0.001). A subset of 40 patients in this study were crossed over to receive the alternative antiemetic on their next cycle of chemotherapy. A significant majority of patients (32/34; 94%) preferred granisetron (P less than 0.001). Around 80% of the granisetron-treated patients in both groups required only a single prophylactic dose of granisetron. Following the first additional dose of granisetron, around 87% of patients reported symptoms to be improved or resolved. Adverse experience reporting was higher in the comparator groups with somnolence and extrapyramidal reactions representing the most common events. Headache was the most commonly reported adverse experience in granisetron-treated patients. Granisetron has proved safe and effective in controlling chemotherapy-induced emesis and is more convenient to administer than conventional antiemetics.
The work purpose was to study the application of 5-methylpyrrolidinone chitosan (MPC) for preparing mucoadhesive microparticles for the nasal administration of drugs. Microspheres were produced by the spray-drying technique using MPC; metoclopramide hydrochloride (MC) was chosen as model drug. Chitosan microparticles were prepared as a comparison. The microparticles obtained were characterised (encapsulation efficiency, morphology, size and drug release behaviour). In-vitro mucoadhesive tests, swelling tests and ex-vivo studies using sheep nasal mucosa were performed. The hydrogel formation from microspheres was studied in different media and at different pHs. Microspheres are able to control the in-vitro MC release. MPC microparticles show good in-vitro mucoadhesive properties and ex-vivo controlled permeation profiles. The hydrogel formation is dependent mainly on the medium used: ionically crosslinked hydrogel was hypothesized. These in-vitro and ex-vivo preliminary results show that spray-dried microspheres based on MPC could be a suitable nasal delivery system for the administration of metoclopramide.
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Pain on injection (angialgia) is a common adverse effect of anesthetic medications, especially propofol and methohexital, which are both used for electroconvulsive therapy (ECT). In this review, the authors survey some general literature on angialgia incidence, mechanisms, and prevention efforts in non-ECT settings and follow this with a review of similar topics relevant to ECT. They review practical methods of angialgia prevention for ECT patients. The methods with the best research basis include the use of an antecubital vein for intravenous access as well as the local anesthetic lidocaine. Regarding the latter, concerns regarding shortening of seizure duration during ECT have been raised. If lidocaine is used for angialgia in ECT, low doses should be administered to avoid possible interference with ictal electroencephalogram expression. Other methods worth studying further for angialgia during ECT include use of the antiemetic agent metoclopramide and high-potency opiates.
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A definitive treatment for functional dyspepsia (FD), and the role of Helicobacter pylori eradication on the course of this disease are controversial.
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Early and intensive pharmacological treatment not only may reduce gastrointestinal symptoms but also reverse malignant bowel obstruction. Fifteen consecutive advanced cancer patients with inoperable bowel obstruction received a combination of drugs including metoclopramide, octreotide, dexamethasone and an initial bolus of amidotrizoato. Recovery of intestinal transit was reported within 1-5 days in fourteen patients, who continued this treatment without presenting symptoms of bowel obstruction until death. This case series establishes that the combination of propulsive and antisecretive agents can act synergistically to allow a fast recovery of bowel transit without inducing unpleasant colic. It suggests that the most important mechanism in these circumstances is functional and can be reversible, if an aggressive treatment is initiated early before fecal impaction and edema render bowel obstruction irreversible.
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This study investigated the antiemetic activity of two different acute antiemesis regimens in patients receiving cisplatin-based chemotherapy. Seventy-four patients were treated with high-dose metoclopramide, dexamethasone and lorazepam (MDL) and 71 patients received high-dose alizapride, dexamethasone and lorazepam (ADL). Complete protection from vomiting was 50% in MDL-treated patients as compared with 30% in the ADL arm (p = 0.04). Incidence of delayed emesis was assessed in the first 82 patients accrued for the 120 h postcisplatin, being 69 and 60% in MDL and ADL, respectively.
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The gastric emptying study using Tc-99m triethylene tetramine polystyrene resin with or without metoclopramide hydrochloride was used in six patients with different disease entities: achalasia, gastric lymphoma, primary amyloidosis, Zollinger-Ellison syndrome, duodenal diverticulum, and short bowel syndrome. All patients had abnormally prolonged gastric emptying times. The patient with gastric lymphoma and the patient with Zollinger-Ellison syndrome had virtually no effect from metoclopramide. The patient with a duodenal diverticulum and the patient with short bowel syndrome had partial and good response to metoclopramide, respectively. Endoscopic and/or autopsy examinations in patients with achalasia, Zollinger-Ellison syndrome, primary amyloidosis, and duodenal diverticulum proved the patency of the pyloric canal. The patient with gastric lymphoma had a mass associated with marked pyloric narrowing and lymphoma cell infiltration of the gastric wall, to explain the abnormal gastric emptying. The gastric emptying study with or without metoclopramide may be used noninvasively to measure gastric function, to determine the nature of gastric outlet obstruction, and to evaluate therapy with metoclopramide.
The use of purging for bowel cleansing prior to small-bowel capsule endoscopy (SBCE) has now been established in clinical practice. Despite that, the number of incomplete SBCEs is still around 15-20%. To date, the use of prokinetics in SBCE - aiming to improve completion rate (CR) - remains a contentious issue resulting in lack of consensus among capsule experts.
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The objective of this research was to evaluate the effect of drug characteristics and polymer molecular weight (MW) on phase-inversion dynamics, depot morphology, and drug release in injectable in situ depot-forming drug delivery systems. Two poly(lactide-co-glycolide) (50:50) polymers with different MW (RG502 and RG504) and two drugs with different hydrophilicity (metoclopramide salt and metoclopramide base) were studied here. The drug release from injectable depots, the polymer MW changes, and the cross-sectional depot morphologies were investigated, respectively. The results show that the initial drug release from high-MW polymer RG504 was always faster than that from low-MW polymer RG502, regardless of the drug type. Interestingly, depot morphology shows the development of a hollow core for RG502, whereas RG504 forms a solid core. The relationship of the depot morphology to release kinetics is proposed based on these observations. The use of basic drug catalyzes polymer degradation, during processing and over time. These affect starting MW and subsequent MW, and the effect on release kinetics is consistent with the general effects of MW. This research suggests that the polymer MW is an important effect on the polymer phase inversion kinetics, and thus the resultant depot morphology.
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100 cycles (50 patients) are evaluable. In 39 cycles there was no nausea and vomiting, in 74 cycles acceptable control of emesis was reached (0-2 episodes of vomiting), without significant differences among the two arms. However, nausea was shorter in lorazepam arm (p < 0.01), and 80% of the patients preferred treatment with lorazepam (p < 0.003). Anxiety was reduced in the patients treated with lorazepam (p < 0.4).
Male rats (Wistar race) received a single tramadol dose separately (0.45 mg/kg) or tramadol with haloperidol (0.45 mg/kg), midazolam (0.3 mg/kg), levomepromazine (0.35 mg/kg), metoclopramide (1.0 mg/kg), hyoscine butylbromide (1.7 mg/kg) or ketamine (0.3 mg/kg) as a single subcutaneous injection. Analgesia was measured by a tail flick test after 15, 30, 60 and 90 min of drug administration.
Sixteen volunteers (eight men and eight women) received ethanol (0.225 g/kg body weight) orally and intravenously, and the areas under the ethanol concentration time curves were determined to calculate FPM of ethanol. In seven of these subjects, FPM of ethanol was measured after the intravenous administration of 10 mg metoclopramide (MCP) and 20 mg N-butylscopolamine (NBS) in separate experiments to either accelerate or delay GE. GE was monitored sonographically by integration of the antral area of the stomach every five minutes for 90 minutes after oral ethanol intake. In addition, gastric biopsy specimens were taken to determine ADH activity and phenotype, as well as to evaluate gastric histology. Blood was also drawn for ADH genotyping.
The present study was to evaluate the efficacy of ondansetron, 5-HT3 receptor antagonist, versus placebo in the prevention of postoperative nausea and vomiting (PONV) in a homogenous group of female patients undergoing breast reduction surgery under general anaesthesia. Approximately one hour before skin closure, 70 patients were randomly divided into two groups of 35 each. In a double blind manner each group of patients received either intravenous ondansetron (4mg) or a matching placebo. The overall incidences of PONV during first 24-hour were 60% and 20% in placebo and ondansetron group respectively (p<0.05). However, there was no significant difference after 24-hour postoperatively. In placebo group 42.9% of patients received rescue anti-emetic (metoclopramide) for the treatment of severe PONV (ie, 2 or more episodes of PONV), whereas, only 8.6% patients were administered such intervention in the ondansetron group (p<0.05). It is, therefore, concluded that prophylactic administration of intravenous ondansetron (4mg) one hour before skin closure is safe and effective in preventing PONV in female patients undergoing breast surgery and routine use of ondansetron in the patient population is recommended.
To compare the clinical benefits of 3 strategies: stratified care, step care within attacks, and step care across attacks, among patients with migraine.
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Metoclopramide is an antiemetic drug; the effects on CNS (acute dystonic reaction, tardive dyskinesia, parkinsonism) occur in only 1 of 500 patients treated. Acute dystonic reactions are not apparently dose-dependent and suggest individual sensitivity to the drug (idiosyncrasia). We report 4 cases in 2 families (grandmother-grandchild; brother-sister). We feel that, if there is a case of dystonic reaction to metoclopramide, this drug should not be administered to other members of the same family.
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This is a retrospective analysis of 10 mg metoclopramide, 25 mg diphenhydramine, and 4 mg dexamethasone given intravenous piggyback every 6 hours for nausea or vomiting. Outcome measures were rapidity of symptom relief based on the self-report of the patient and nursing documentation of relief from symptoms of nausea or vomiting. Seven hundred and ninety seven patients were admitted to the inpatient hospice unit during a 2-year period. Sixty-three patients developed nausea or vomiting requiring the cocktail. Fifty-seven patients (90%) had objective response as reflected in nursing notes. Symptom relief was usually noted within 2 days with improvement in oral intake and enjoyment in activities, such as parties and family interactions. Partial relief was noted in patients with gastrointestinal malignancies and peritoneal carcinomatosis even with the addition of other antiemetics to the cocktail.
Capsule endoscopy (CE) is limited by incomplete small-bowel transit and poor view quality in the distal bowel. Currently, there is no consensus regarding the use of bowel purgatives or prokinetics in CE.
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The alkylating agent cyclophosphamide (CP) is a prodrug requiring cytochrome P-450-mediated bioactivation to form the active 4-hydroxycyclophosphamide (4OHCP). Modifications in the rate of CP bioactivation may have implications for the effectiveness of CP therapy, especially in high-dose regimens. In this study, agents frequently co-administered with CP in high-dose chemotherapy regimens were tested for their possible inhibition of the bioactivation of CP in human liver microsomes. The Km and Vmax values for the conversion of CP to 4OHCP were 93 microM and 4.3 nmol/h.mg, respectively. No inhibition was observed for aciclovir, carboplatin, ciprofloxacine, granisetron, mesna, metoclopramide, ranitidine, roxitromycin and temazepam. Inhibition was observed for amphotericin B, dexamethasone, fluconazole, itraconazole, lorazepam, ondansetron and thiotepa, with IC50 values of 50, >100, >50, 5, 15, >100 and 1.25 microM, respectively. For all but thiotepa, these IC50 values were higher than the therapeutic drug levels and thus considered of no clinical relevance. We conclude that of the tested co-medicated agents, only thiotepa inhibited metabolism of CP to 4OHCP at clinically relevant concentrations, and may thereby influence therapeutic and toxic responses of CP therapy.
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The cohort comprised patients with radiologically confirmed OA of the hip or knee (meeting the American College of Rheumatology criteria) requiring joint replacement and with moderate-to-severe pain that had been inadequately controlled by weak opioids. The patients were randomized to receive TDF or placebo for 6 weeks after a 1-week pretreatment run-in phase. During study treatment, previously prescribed NSAIDs and simple analgesics were continued, but weak opioids were discontinued. All patients had access to paracetamol and metoclopramide. Pain was recorded on a visual analog scale (VAS), and function was assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC).
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Metoclopramide (MCP), a derivative of procainamide was compared with exercise, arginine, insulin and thyrotropin releasing hormone (TRH) as a prolactin (PRL) releaser in children. The peak response of plasma PRL after oral administration of MCP was greater than that after strenuous exercise and after i.v. administration of pharmacodynamic agents. Normal PRL and TSH responses were observed after TRH administration in all subjects. Variable PRL responses were seen after exercise and after i.v. administration of arginine and insulin, despite significant growth hormone (GH) release following the administration of these agents. MCP produced no increase in plasma TSH. Metoclopramide may be useful for dynamic testing of PRL release in children. It can be taken orally and is free of side-effects.
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90 patients scheduled for ESWL of renal stones received 1 hour prior to ESWL ketorolac 30 mg, butylscopolamine 20 mg or placebo intramusculary. 10 mg of metoclopramide and 6.6 microg/kg of alfentanil were given intravenously at the beginning of ESWL (Philips/Dornier MFL 5000). Intravenous PCA was started (demand dose: 0.25 mg of alfentanil, lockout time: 1 minute). Pain intensity (NRS 0-100), sedation score (VRS 0-4), respiratory rate (min(-1)) and partial oxygen saturation (SO(2)) were measured every 5 minutes. Statistical analysis included ANOVA and Chi-square-test (p<0,05).
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The pharmacokinetics and endocrinological effects of metoclopramide were investigated in 5 mothers with deficient lactation and in their children soon after delivery. In addition, the transfer of metoclopramide into breast milk was evaluated in 18 mothers during the 8th to 12th puerperal weeks. Metoclopramide was detected in all the milk samples studied, generally at a higher concentration than in maternal plasma. Metoclopramide was found in plasma from only 1 of the 5 neonates studied. Exposure of the child to metoclopramide, estimated by multiplying the daily breast milk volume by the concentration of metoclopramide in the milk, ranged from 6 to 24 micrograms/kg/day for the 5 children in the early puerperium to 1 to 13 micrograms/kg/day for the 18 children during the late puerperium. These quantities are considerably less than the therapeutic dose of 500 micrograms/kg/day recommended for children. However, the plasma concentration of prolactin in 4 out of 7 neonates sampled taken during administration of metoclopramide to the mother were higher than the highest plasma prolactin level in children of same age of untreated mothers. The plasma concentration of thyrotrophin in the newborns remained within the normal range.
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Recent Food and Drug Administration-mandated and company-initiated withdrawals of drug products from the marketplace have had an impact on utilization in related drug classes.
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Blinded, placebo-controlled clinical trials of 2 pharmaceutical galactagogues (domperidone and metoclopramide) and 5 popular herbal galactagogues (shatavari, fenugreek, silymarin, garlic, and malunggay) were identified. All of the studies identified for domperidone showed a significant difference in milk production between the treatment and placebo groups. Of the 6 trials of metoclopramide, only 1 study showed a significant difference in milk production compared to placebo. Results of the clinical trials on herbal galactagogues were mixed. Our review of the evidence for the efficacy of popular pharmaceutical and herbal galactagogues revealed a dearth of high-quality clinical trials and mixed results.
Information on the significance of an elevated urinary dopamine is limited and can lead to misinterpretation of the cause of such a finding. This laboratory-based study examines the associations with elevated dopamine gathered from a significant number of patients.