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BMJ Clinical Evidence Feb 2010The revised International Headache Society (IHS) criteria for cluster headache are: attacks of severe or very severe, strictly unilateral pain, which is orbital,... (Review)
Review
INTRODUCTION
The revised International Headache Society (IHS) criteria for cluster headache are: attacks of severe or very severe, strictly unilateral pain, which is orbital, supraorbital, or temporal pain, lasting 15 to 180 minutes and occurring from once every other day to eight times daily.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical questions: What are the effects of interventions to abort cluster headache? What are the effects of interventions to prevent cluster headache? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2009 (Clinical Evidence reviews are updated periodically; please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations, such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA).
RESULTS
We found 23 systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions.
CONCLUSIONS
In this systematic review, we present information relating to the effectiveness and safety of the following interventions: baclofen (oral); botulinum toxin (intramuscular); capsaicin (intranasal); chlorpromazine; civamide (intranasal); clonidine (transdermal); corticosteroids; ergotamine and dihydroergotamine (oral or intranasal); gabapentin (oral); greater occipital nerve injections (betamethasone plus xylocaine); high-dose and high-flow-rate oxygen; hyperbaric oxygen; leuprolide; lidocaine (intranasal); lithium (oral); melatonin; methysergide (oral); octreotide (subcutaneous); pizotifen (oral); sodium valproate (oral); sumatriptan (oral, subcutaneous, and intranasal); topiramate (oral); tricyclic antidepressants (TCAs); verapamil; and zolmitriptan (oral and intranasal).
Topics: Adrenal Cortex Hormones; Betamethasone; Cluster Headache; Humans; Methysergide; Oxygen; Sumatriptan
PubMed: 21718584
DOI: No ID Found -
The Cochrane Database of Systematic... Jul 2008Somatostatin and its derivatives are sometimes used for emergency treatment of bleeding oesophageal varices in patients with cirrhosis of the liver. (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Somatostatin and its derivatives are sometimes used for emergency treatment of bleeding oesophageal varices in patients with cirrhosis of the liver.
OBJECTIVES
To study whether somatostatin or its analogues improve survival or reduce the need for blood transfusions in patients with bleeding oesophageal varices.
SEARCH STRATEGY
PubMed and The Cochrane Library were searched (November 2007). Reference lists of publications, contacts with authors.
SELECTION CRITERIA
All randomised trials comparing somatostatin or analogues with placebo or no treatment in patients suspected of acute or recent bleeding from oesophageal varices.
DATA COLLECTION AND ANALYSIS
The outcome measures extracted were: mortality, blood transfusions, use of balloon tamponade, initial haemostasis and rebleeding. Intention-to-treat analyses including all randomised patients were conducted if possible; a random-effects analysis was preferred if there was significant heterogeneity between the trials (P < 0.10). The trials were divided in two groups: trials with a low risk of bias, which had concealed allocation of patients and were double-blind, and other trials.
MAIN RESULTS
We included 21 trials (2588 patients). The drugs did not reduce mortality significantly (relative risk 0.97, 95% confidence interval (CI) 0.75 to 1.25, for the trials with a low risk of bias, and 0.80, 95% CI 0.63 to 1.01, for the other trials). Units of blood transfused were 0.7 (0.2 to 1.1) less with drugs in the trials with a low risk of bias and 1.5 (0.9 to 2.0) less in the other trials. Number of patients failing initial haemostasis was reduced, relative risk 0.68 (0.54 to 0.87). Number of patients with rebleeding was not significantly reduced for the trials with a low risk of bias, relative risk 0.84 (0.52 to 1.37) while it was substantially reduced in the other trials, relative risk 0.36 (0.19 to 0.68). Use of balloon tamponade was rarely reported.
AUTHORS' CONCLUSIONS
The need for blood transfusions corresponded to one half unit of blood saved per patient. It is doubtful whether this effect is worthwhile. The findings do not suggest a need for further placebo-controlled trials of the type reviewed here. A large placebo controlled trial enrolling thousands of patients is needed if one wishes to rule out the possibility that a worthwhile effect on mortality might have been overlooked.
Topics: Acute Disease; Blood Transfusion; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Hemostatics; Humans; Liver Cirrhosis; Octreotide; Randomized Controlled Trials as Topic; Somatostatin
PubMed: 18677774
DOI: 10.1002/14651858.CD000193.pub3 -
Canadian Journal of Surgery. Journal... Dec 2007To assess the effectiveness of octreotide in preventing postoperative pancreatic fistula. Pancreatic fistula is one of the most common complications after elective... (Meta-Analysis)
Meta-Analysis Review
OBJECTIVE
To assess the effectiveness of octreotide in preventing postoperative pancreatic fistula. Pancreatic fistula is one of the most common complications after elective pancreatic surgery. Several clinical trials have evaluated the use of octreotide to prevent the development of pancreatic fistula after pancreatic surgery with conflicting recommendations.
METHODS
We undertook a meta-analysis of 7 identified randomized controlled trials, reporting comparisons between octreotide and a control. The primary outcome was the incidence of postoperative pancreatic fistula, and the secondary outcome was the postoperative mortality.
RESULTS
Seven studies, involving 1359 patients, met the inclusion criteria for this review. In these studies, sample sizes ranged from 75 to 252 patients. In total, 679 patients were given octreotide and 680 patients formed the control group. Perioperative octreotide is associated with a significant reduction in the incidence of pancreatic fistula after elective pancreatic surgery, with a relative risk of 0.59 (95% confidence interval 0.41-0.85, p = 0.004). However, this risk reduction was not associated with a significant difference in postoperative mortality (p > 0.05).
CONCLUSIONS
The review revealed that perioperative octreotide is associated with a significant reduction in the incidence of pancreatic fistula after elective pancreatic surgery. However, this risk reduction was not associated with a significant difference in postoperative mortality; further studies are warranted to confirm the results of this metaanalysis and to define which patient subgroups might benefit the most from prophylactic octreotide administration.
Topics: Aged; Elective Surgical Procedures; Gastrointestinal Agents; Humans; Middle Aged; Octreotide; Pancreatectomy; Pancreatic Fistula; Treatment Outcome
PubMed: 18053374
DOI: No ID Found -
Journal of Pain and Symptom Management Feb 2007The use of symptomatic agents has greatly improved the medical treatment of advanced cancer patients with inoperable bowel obstruction. A systematic review of studies of... (Review)
Review
The use of symptomatic agents has greatly improved the medical treatment of advanced cancer patients with inoperable bowel obstruction. A systematic review of studies of the most popular drugs used in the medical management of inoperable malignant bowel obstruction was performed to assess the effectiveness of these treatments and provide some lines of evidence. Randomized trials that involved patients with a clinical diagnosis of intestinal obstruction due to advanced cancer treated with these drugs were reviewed. Five reports fulfilled inclusion criteria. Three studies compared octreotide (OC) and hyoscine butylbromide (HB), and two studies compared corticosteroids (CSs) and placebo. Globally, 52 patients received OC, 51 patients received HB, 37 patients received CSs, 15 patients received placebo, and 37 patients received both placebo and CSs. On the basis of these few data, the superiority of OC over HB in relieving gastrointestinal symptoms was evidenced in a total of 103 patients. The latter studies had samples more defined in terms of stage and inoperability, and had a shorter survival in comparison with studies of CSs (less than 61 days, most of them less than 20 days). Data on CSs are less convincing, due to the methodological weakness of existing studies. This review confirms the difficulties in conducting randomized controlled trials in this population.
Topics: Adrenal Cortex Hormones; Butylscopolammonium Bromide; Gastrointestinal Agents; Humans; Intestinal Obstruction; Muscarinic Antagonists; Neoplasms; Octreotide
PubMed: 17280927
DOI: 10.1016/j.jpainsymman.2006.06.014 -
Alimentary Pharmacology & Therapeutics Jan 2003Controversy exists surrounding pharmacological therapy in acute variceal bleeding. (Review)
Review
BACKGROUND
Controversy exists surrounding pharmacological therapy in acute variceal bleeding.
AIM
To determine the efficacy and safety of terlipressin.
METHODS
Randomized trials were identified and duplicate, independent, review identified 20 randomized trials involving 1609 patients that compared terlipressin with placebo, balloon tamponade, endoscopic treatment, octreotide, somatostatin or vasopressin for treatment of acute oesophageal variceal haemorrhage.
RESULTS
Meta-analysis showed that compared to placebo, terlipressin reduced mortality (relative risk 0.66, 95% CI 0.49-0.88), failure of haemostasis (relative risk 0.63, 95% CI 0.45-0.89) and the number of emergency procedures per patient required for uncontrolled bleeding or rebleeding (relative risk 0.72, 95% CI 0.55-0.93). When used as an adjuvant to endoscopic sclerotherapy, terlipressin reduced failure of haemostasis (relative risk 0.75, 95% CI 0.58-0.96), and had an effect on reducing mortality that approached statistical significance (relative risk 0.74, 95% CI 0.53-1.04). No significant difference was demonstrated between terlipressin and endoscopic sclerotherapy, balloon tamponade, somatostatin or vasopressin. Haemostasis was achieved more frequently with octreotide compared to terlipressin (relative risk 1.62, 95% CI 1.05-2.50), but this result was based on unblinded studies. Adverse events were similar between terlipressin and the other comparison groups except for vasopressin, which caused more withdrawals due to adverse events.
CONCLUSIONS
Terlipressin is a safe and effective treatment for acute oesophageal variceal bleeding, with or without adjuvant endoscopic sclerotherapy. Terlipressin appears to reduce mortality in acute oesophageal variceal bleeding compared to placebo, and is the only pharmacological agent shown to do so. Future studies will be required to detect potential mortality differences between terlipressin and other therapeutic approaches.
Topics: Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Humans; Lypressin; Randomized Controlled Trials as Topic; Terlipressin; Vasoconstrictor Agents
PubMed: 12492732
DOI: 10.1046/j.1365-2036.2003.01356.x -
Arquivos de Gastroenterologia 2001Functional dyspepsia is defined by upper gastrointestinal symptoms without any evidence of structural abnormalities or organic disease. Current pharmacological treatment... (Review)
Review
BACKGROUND
Functional dyspepsia is defined by upper gastrointestinal symptoms without any evidence of structural abnormalities or organic disease. Current pharmacological treatment of functional dyspepsia is largely empirical and involves anti-secretory or prokinetic drugs.
AIMS
To review recent advances in the understanding of the mechanisms involved in symptom production in functional dyspepsia, as well as the development of new drugs that may interfere with these mechanisms, which may lead to more rational and effective treatment of this clinical condition.
METHOD
Systematic review of papers published in English for the last 10 years.
RESULTS
New drugs that increase propulsive gastroduodenal motor activity include new benzamides similar to cisapride, CCK-A blockers, agonists of opiate receptors and motilin agonists similar to erythromycin. A number of agents, including sumatriptan and buspirone, stimulates serotonin receptors in the myoenteric plexuses and have been shown to increase gastric accommodation to a meal. Finally, a number of new drugs that either increase thresholds for visceral perception or modify sensations is currently under investigation. This includes agents of several groups, such as octreotide, loxiglumide, ondansetron and other serotonin blockers, fedotozine and tricyclic antidepressant at low doses.
CONCLUSIONS
Although these new drugs may improve the pharmacological approach to the treatment of functional dyspepsia, there is a need for randomized, controlled trials to assess their efficacy. Moreover, difficulties related to the identification of the mechanisms underlying symptoms may limit the utilization of these new drugs.
Topics: Dyspepsia; Gastrointestinal Agents; Humans
PubMed: 11917722
DOI: 10.1590/s0004-28032001000300012 -
Alimentary Pharmacology & Therapeutics Dec 2001Somatostatin and octreotide have multiple effects which make them ideal for treating diarrhoea of different aetiologies. Their use in a variety of conditions with... (Review)
Review
BACKGROUND
Somatostatin and octreotide have multiple effects which make them ideal for treating diarrhoea of different aetiologies. Their use in a variety of conditions with refractory diarrhoea, however, is based on a limited number of studies.
AIM
We undertook a systematic review of the available English literature to maximize an evidence-based approach to the treatment of refractory diarrhoea. We tested the hypothesis that efficacy is independent of aetiology.
METHODS AND RESULTS
A Medline and individual article search from 1965 to 2000 was undertaken on the use of somatostatin and octreotide in diarrhoea. All reports containing at least five subjects were included. The percentage response in case series and randomized controlled trials was compared, and a meta-analysis of randomized controlled trials where patient level data were provided was carried out. There were 30 publications found (18 case series, 12 randomized controlled trials). The response percentage was 73% overall in case series and 64% in randomized controlled trials (not significant). A meta-analysis of nine randomized controlled trials revealed significant heterogeneity despite an overall relative risk of 0.5 (95% confidence interval, 0.27-0.91). Subgroup analysis of the largest aetiological groups showed that acquired immunodeficiency syndrome studies were homogeneous, but somatostatin and octreotide were less effective. Post-chemotherapy studies remained heterogeneous and somatostatin and octreotide were highly effective.
CONCLUSIONS
While this review strengthens the consensus guidelines on the use of somatostatin and octreotide for refractory diarrhoea, evidence-based support requires additional studies.
Topics: Antidiarrheals; Case-Control Studies; Diarrhea; Evidence-Based Medicine; Humans; MEDLINE; Meta-Analysis as Topic; Octreotide; Randomized Controlled Trials as Topic; Somatostatin; Treatment Outcome
PubMed: 11736719
DOI: 10.1046/j.1365-2036.2001.01114.x -
The Cochrane Database of Systematic... 2001Terlipressin (triglycyl lysine vasopressin) is a synthetic analogue of vasopressin, which has been used in the treatment of acute variceal hemorrhage. In contrast to... (Review)
Review
BACKGROUND
Terlipressin (triglycyl lysine vasopressin) is a synthetic analogue of vasopressin, which has been used in the treatment of acute variceal hemorrhage. In contrast to vasopressin, terlipressin can be administered as intermittent injections instead of continuous intravenous infusion and it has a safer adverse reactions profile. However, its effectiveness remains uncertain.
OBJECTIVES
To determine if treatment with terlipressin improves outcome in acute esophageal variceal hemorrhage and is safe.
SEARCH STRATEGY
Randomized clinical trials were identified by searching the following databases: MEDLINE, EMBASE, the Cochrane Controlled Trials Register, the Cochrane Hepato-Biliary Group Controlled Trials Register, Biosis, and Current Contents. The bibliographies of identified publications were checked. Experts in the field and the manufacturers of terlipressin were contacted.
SELECTION CRITERIA
All randomized clinical trials which compared terlipressin with: (a) placebo or no treatment, (b) balloon tamponade, (c) endoscopic treatment, (d) octreotide, (e) somatostatin and (f) vasopressin, in the setting of acute variceal hemorrhage.
DATA COLLECTION AND ANALYSIS
Eligibility, trial quality assessment and data extraction were done independently by two reviewers. The primary outcome measure was mortality. Secondary outcomes were failure of initial hemostasis, rebleeding, procedures required for uncontrolled bleeding or rebleeding, transfusion requirements and length of hospitalization.
MAIN RESULTS
Twenty studies were identified for all the comparison groups, involving 1609 patients. There were seven studies (with 443 patients) comparing terlipressin to placebo, five of which were considered to be high quality studies based on the Jadad scale. The meta-analysis indicates that terlipressin was associated with a statistically significant reduction in all cause mortality compared to placebo (relative risk 0.66, 95% confidence interval 0.49 to 0.88). Three studies (with 302 patients) were identified comparing terlipressin to somatostatin, two of which were high quality studies; only one high quality study (219 patients) comparing terlipressin to endoscopic treatment was identified. Within the limited power provided by these small numbers of patients, no statistically significant difference was demonstrated between terlipressin and either somatostatin or endoscopic treatment in any of the outcomes. For the remaining comparison groups (terlipressin versus balloon tamponade, terlipressin versus octreotide and terlipressin versus vasopressin) only small, low quality studies were identified and no difference was demonstrated in any of the major outcomes. There was no difference between the terlipressin group and any of the comparison groups in the number of adverse events that caused death or withdrawal of medication.
REVIEWER'S CONCLUSIONS
On the basis of a 34% relative risk reduction in mortality, terlipressin should be considered to be effective in the treatment of acute variceal hemorrhage. Further, since no other vasoactive agent has been shown to reduce mortality in single studies or meta-analyses, terlipressin might be the vasoactive agent of choice in acute variceal bleeding.
Topics: Acute Disease; Catheterization; Esophageal and Gastric Varices; Gastrointestinal Hemorrhage; Humans; Lypressin; Portasystemic Shunt, Transjugular Intrahepatic; Randomized Controlled Trials as Topic; Sclerotherapy; Terlipressin; Vasoconstrictor Agents
PubMed: 11279753
DOI: 10.1002/14651858.CD002147