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The Cochrane Database of Systematic... Sep 2014Around 16 million cases of whooping cough (pertussis) occur worldwide each year, mostly in low-income countries. Much of the morbidity of whooping cough in children and... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Around 16 million cases of whooping cough (pertussis) occur worldwide each year, mostly in low-income countries. Much of the morbidity of whooping cough in children and adults is due to the effects of the paroxysmal cough. Cough treatments proposed include corticosteroids, beta2-adrenergic agonists, pertussis-specific immunoglobulin, antihistamines and possibly leukotriene receptor antagonists (LTRAs).
OBJECTIVES
To assess the effectiveness and safety of interventions to reduce the severity of paroxysmal cough in whooping cough in children and adults.
SEARCH METHODS
We updated our searches of the Cochrane Central Register of Controlled Trials (CENTRAL, 2014, Issue 1), which contains the Cochrane Acute Respiratory Infections Group's Specialised Register, the Database of Abstracts of Reviews of Effects (DARE 2014, Issue 2), accessed from The Cochrane Library, MEDLINE (1950 to 30 January 2014), EMBASE (1980 to 30 January 2014), AMED (1985 to 30 January 2014), CINAHL (1980 to 30 January 2014) and LILACS (30 January 2014). We searched Current Controlled Trials to identify trials in progress.
SELECTION CRITERIA
We selected randomised controlled trials (RCTs) and quasi-RCTs of any intervention (excluding antibiotics and vaccines) to suppress the cough in whooping cough.
DATA COLLECTION AND ANALYSIS
Two review authors (SB, MT) independently selected trials, extracted data and assessed the quality of each trial for this review in 2009. Two review authors (SB, KW) independently reviewed additional studies identified by the updated searches in 2012 and 2014. The primary outcome was frequency of paroxysms of coughing. Secondary outcomes were frequency of vomiting, frequency of whoop, frequency of cyanosis (turning blue), development of serious complications, mortality from any cause, side effects due to medication, admission to hospital and duration of hospital stay.
MAIN RESULTS
We included 12 trials of varying sample sizes (N = 9 to 135), mainly from high-income countries, including a total of 578 participants. Ten trials recruited children (N = 448 participants). Two trials recruited adolescents and adults (N = 130 participants). We considered only three trials to be of high methodological quality (one trial each of diphenhydramine, pertussis immunoglobulin and montelukast). Included studies did not show a statistically significant benefit for any of the interventions. Only six trials, including a total of 196 participants, reported data in sufficient detail for analysis. Diphenhydramine did not change coughing episodes; the mean difference (MD) of coughing spells per 24 hours was 1.9; 95% confidence interval (CI) -4.7 to 8.5 (N = 49 participants from one trial). One trial on pertussis immunoglobulin reported a possible mean reduction of -3.1 whoops per 24 hours (95% CI -6.2 to 0.02, N = 47 participants) but no change in hospital stay (MD -0.7 days; 95% CI -3.8 to 2.4, N = 46 participants). Dexamethasone did not show a clear decrease in length of hospital stay (MD -3.5 days; 95% CI -15.3 to 8.4, N = 11 participants from one trial) and salbutamol showed no change in coughing paroxysms per day (MD -0.2; 95% CI -4.1 to 3.7, N = 42 participants from two trials). Only one trial comparing pertussis immunoglobulin versus placebo (N = 47 participants) reported data on adverse events: 4.3% in the treatment group (rash) versus 5.3% in the placebo group (loose stools, pain and swelling at injection site).
AUTHORS' CONCLUSIONS
There is insufficient evidence to draw conclusions about the effectiveness of interventions for the cough in whooping cough. More high-quality trials are needed to assess the effectiveness of potential antitussive treatments in patients with whooping cough.
Topics: Acetates; Adolescent; Adult; Albuterol; Anti-Inflammatory Agents; Bordetella pertussis; Child; Cough; Cyclopropanes; Dexamethasone; Diphenhydramine; Histamine H1 Antagonists; Humans; Immunoglobulins; Length of Stay; Quinolines; Randomized Controlled Trials as Topic; Sulfides; Whooping Cough
PubMed: 25243777
DOI: 10.1002/14651858.CD003257.pub5 -
Journal of Pediatric Oncology Nursing :... Jul 2014Transfusion-related reactions cause unwanted interruptions in blood-product administration and potential complications for patients. The most common reactions are... (Review)
Review
Effects of Leukoreduction and Premedication With Acetaminophen and Diphenhydramine in Minimizing Febrile Nonhemolytic Transfusion Reactions and Allergic Transfusion Reactions During and After Blood Product Administration: A Literature Review With Recommendations for Practice.
Transfusion-related reactions cause unwanted interruptions in blood-product administration and potential complications for patients. The most common reactions are febrile nonhemolytic transfusion reactions (FNHTRs) and allergic transfusion reactions (ATRs). The presence of leukocytes in blood products has been associated with these reactions, and efficacy of leukoreduction in minimizing FNHTRs and ATRs has recently been investigated. In addition, premedication with acetaminophen and diphenhydramine is the most widely used practice in minimizing FNHTRs and ATRs, yet the benefit of this is not supported by research. The aim of this systematic literature review was to evaluate the potential benefits of both of these interventions in minimizing FNHTRs and ATRs and provide recommendations for practice. We found moderate quality evidence with strong recommendations for the practice of leukoreduction in minimizing FNHTRs but not ATRs. We did not find evidence to support the use of premedications in minimizing transfusion-related reactions, and we question the need for this practice in settings where leukoreduction is used.
Topics: Acetaminophen; Diphenhydramine; Drug Administration Schedule; Erythrocyte Transfusion; Evidence-Based Nursing; Fever; Humans; Hypersensitivity; Nursing Process; Premedication; Transfusion Reaction
PubMed: 24794886
DOI: 10.1177/1043454214532029 -
The Clinical Journal of Pain Jan 2016Opioid-induced pruritus is a common side effect of opioid treatment in patients with acute pain associated with surgery or childbirth. There are several options... (Review)
Review
OBJECTIVES
Opioid-induced pruritus is a common side effect of opioid treatment in patients with acute pain associated with surgery or childbirth. There are several options available to treat opioid-induced pruritus, including nalbuphine. However, it is not known whether nalbuphine offers greater efficacy in treating pruritus without attenuation of analgesia and an increase in the incidence of adverse outcomes.
METHODS
A systematic search of studies assessing treatment efficacy of nalbuphine was conducted through Medline, PubMed, Cochrane Library, CINAHL, and ProQuest databases. The primary outcome was reduction of pruritus, whereas the secondary outcomes included analgesia and adverse outcomes.
RESULTS
Ten studies that met all inclusion criteria were identified, 9 of which were randomized controlled trials and 1 case report. The incidence of pruritus was higher among patients receiving neuraxial opioids than those with the intravenous route. Nalbuphine provided greater efficacy in treating opioid-induced pruritus when compared with placebo, control, or other pharmacologic agents such as diphenhydramine, naloxone, and propofol. There was no attenuation of analgesia or increase in sedation with low-dose nalbuphine treatment—25% to 50% of the dose to treat pain, that is, 2.5 to 5 mg versus 10 mg intravenously. Further, nalbuphine was associated with reduction of nausea or vomiting, and reversal of respiratory depression.
CONCLUSIONS
Nalbuphine is superior in treating opioid-induced pruritus when compared with placebo, control, diphenhydramine, naloxone, or propofol in patients receiving neuraxial opioids for acute pain related to surgery or childbirth. Therefore, it is recommended that nalbuphine should be used as a first-line treatment of opioid-induced pruritus.
Topics: Acute Pain; Analgesics, Opioid; Humans; Nalbuphine; Pruritus; Randomized Controlled Trials as Topic
PubMed: 26650717
DOI: 10.1097/AJP.0000000000000211 -
Headache Feb 2014Tension-type headache is highly prevalent in the general population and is a consistent if not frequent cause of visits to acute care settings. Analgesics such as... (Review)
Review
BACKGROUND
Tension-type headache is highly prevalent in the general population and is a consistent if not frequent cause of visits to acute care settings. Analgesics such as nonsteroidal anti-inflammatory drugs, acetaminophen, and salicylates are considered first-line therapy for treatment of tension-type headache. For patients who present to an acute care setting with persistent tension-type headache despite analgesic therapy, it is not clear which parenteral agent should be administered. We performed a systematic review of the medical literature to determine whether parenteral therapies other than salicylates or nonsteroidals are efficacious for acute tension-type headache.
METHODS
We performed a systematic review of Medline, EMBASE, CINAHL, Google scholar, and the Cochrane Central Registry of Controlled Trials from inception through August, 2012 using the search terms "tension-type headache" and "parenteral or subcutaneous or intramuscular or intravenous." Our goal was to identify randomized trials in which one parenteral treatment was compared to another active comparator or to placebo for the acute relief of tension-type headache. Parenteral was defined as intravenous, intramuscular, or subcutaneous administration. We only included studies that distinguished tension-type headache from other primary headache disorders, such as migraine. The primary outcome for this review was measures of efficacy one hour after medication administration. Data abstraction was performed by two authors. Disagreements were resolved by a third author. We assessed the internal validity of trials using the Cochrane Collaboration risk of bias tool. Because of the small number of trials identified, and the substantial heterogeneity among study design and medications, we decided that combining data and reporting summary statistics would serve no useful function. The results of individual studies are presented using Number Needed to Treat (NNT) with 95%CI when dichotomous outcomes were available and continuous outcomes otherwise.
RESULTS
Our search returned 640 results. One hundred eighty-seven abstracts were reviewed, and 8 studies involving 486 patients were included in our analysis. The most common reasons for exclusion of abstracts were no assessment of acute pain relief, use of nonparenteral medications only, and no differentiation of headache type. Risk of bias ranged from low to high. The following medications were more effective than placebo for acute pain (NNT, 95%CI): metamizole (4, 2-26), chlorpromazine (4, 2-26), and metoclopramide (2, 1-3). The combination of metoclopramide + diphenhydramine was superior to ketorolac (4, 2-8) The following medications were not more effective than placebo: mepivacaine, meperidine + promethazine, and sumatriptan.
CONCLUSIONS
Various parenteral medications other than salicylates or nonsteroidals provide acute relief of tension-type headache. Comparative efficacy studies are needed.
Topics: Administration, Intravenous; Chlorpromazine; Dipyrone; Humans; Injections, Intramuscular; Injections, Subcutaneous; Metoclopramide; Tension-Type Headache; Treatment Outcome
PubMed: 24433525
DOI: 10.1111/head.12287 -
The Cochrane Database of Systematic... 2004Treatment of cancer is increasingly effective but associated with short and long-term side effects. Oral side effects, including oral mucositis (mouth ulceration),... (Review)
Review
BACKGROUND
Treatment of cancer is increasingly effective but associated with short and long-term side effects. Oral side effects, including oral mucositis (mouth ulceration), remain a major source of illness despite the use of a variety of agents to treat them.
OBJECTIVES
To assess the effectiveness of interventions for treating oral mucositis or its associated pain in patients with cancer receiving chemotherapy and/or radiotherapy.
SEARCH STRATEGY
Computerised searches of Cochrane Oral Health Group's Trials Register, CENTRAL, MEDLINE and EMBASE were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information. Date of the most recent searches August 2003: (CENTRAL) (The Cochrane Library Issue 3, 2003).
SELECTION CRITERIA
All randomised controlled trials comparing agents prescribed to treat oral mucositis in people receiving chemotherapy and/or radiotherapy. Outcomes were oral mucositis, time to heal mucositis, oral pain, duration of pain control, dysphagia, systemic infection, amount of analgesia, length of hospitalisation, cost and quality of life.
DATA COLLECTION AND ANALYSIS
Data were independently extracted, in duplicate, by two reviewers. Authors were contacted for details of randomisation, blindness and withdrawals. Quality assessment was carried out on these three criteria. The Cochrane Oral Health Group statistical guidelines were followed and relative risk values calculated using fixed effect models.
MAIN RESULTS
Twenty-five trials involving 1292 patients satisfied the inclusion criteria. Three agents, each in single trials, were found to be effective for improving (allopurinol RR 3.33, 95% CI 1.06 to 10.49; immunoglobulin RR 1.81, 95% CI 1.24 to 2.65; human placentral extract RR 4.50, 95% CI 2.29 to 8.86) or eradicating mucositis (allopurinol RR 19.00, 95% CI 1.17 to 307.63). Two of these trials were rated as at moderate risk of bias and one as at high risk of bias. The following agents were not found to be effective: benzydamine HCl, sucralfate, tetrachlorodecaoxide, chlorhexidine and 'magic' (lidocaine solution, diphenhydramine hydrochloride and aluminum hydroxide suspension). Six trials compared the time to heal and mucositis was found to heal more quickly with two interventions: Granulocyte Macrophage-Colony Stimulating Factor when compared to povidone iodine, with mean difference -3.5 days (95% CI -4.1 to -2.9) and allopurinol compared to placebo, with mean difference -4.5 days (95% CI -5.8 to -3.2). Three trials compared patient controlled analgesia (PCA) to the continuous infusion method for controlling pain. There was no evidence of a difference, however, less opiate was used per hour for PCA, and the duration of pain was shorter. One trial demonstrated that pharmacokinetically based analgesia (PKPCA) reduced pain compared with PCA, however more opiate was used with PKPCA.
REVIEWERS' CONCLUSIONS
There is weak and unreliable evidence that allopurinol mouthwash, vitamin E, immunoglobulin or human placental extract improve or eradicate mucositis. There is no evidence that patient controlled analgesia (PCA) is better than continuous infusion method for controlling pain, however, less opiate was used per hour, and duration of pain was shorter, for PCA. Further, well designed, placebo-controlled trials assessing the effectiveness of allopurinol mouthwash, immunoglobulin, human placental extract, other interventions investigated in this review and new interventions for treating mucositis are needed.
Topics: Humans; Mouth Diseases; Mouth Mucosa; Neoplasms; Pain; Pain Management; Randomized Controlled Trials as Topic; Stomatitis
PubMed: 15106165
DOI: 10.1002/14651858.CD001973.pub2 -
The Cochrane Database of Systematic... 2002Treatment of cancer is increasingly effective but associated with short and long-term side effects. Oral side effects, including oral mucositis (ulceration), remain a... (Review)
Review
BACKGROUND
Treatment of cancer is increasingly effective but associated with short and long-term side effects. Oral side effects, including oral mucositis (ulceration), remain a major source of illness despite the use of a variety of agents to treat them.
OBJECTIVES
To assess the effectiveness of interventions for treating oral mucositis or its associated pain in patients with cancer receiving chemotherapy and/or radiotherapy.
SEARCH STRATEGY
Computerised searches of Cochrane Oral Health Group Specialised Register, CCTR, MEDLINE and EMBASE were undertaken. Reference lists from relevant articles were searched. Authors of eligible trials were contacted to identify trials and obtain additional information. Date of most recent searches: May 2001 (CCTR 2001, issue 3)
SELECTION CRITERIA
All randomised controlled trials comparing agents prescribed to treat oral mucositis in people receiving chemotherapy and/or radiotherapy. Outcomes were oral mucositis, oral pain, dysphagia, systemic infection, amount of analgesia, length of hospitalisation, cost and quality of life.
DATA COLLECTION AND ANALYSIS
Data were independently extracted, in duplicate, by two reviewers. Authors were contacted for details of randomisation, blindness and withdrawals. Quality assessment was carried out on these three criteria. Cochrane Oral Health Group statistical guidelines were followed and relative risk values calculated using fixed effects models as no significant heterogeneity was detected (P>0.1).
MAIN RESULTS
Fifteen trials involving 876 patients satisfied the inclusion criteria. Two agents, each in single trials, were found to be effective for improving (allopurinol RR=0.63 95%CI 0.42 to 0.96) or eradicating mucositis (allopurinol RR=0.59 95%CI 0.42 to 0.84; vitamin E RR=0.38 95%CI 0.14 to 0.97). The following agents were not found to be effective: benzydamine HCl, sucralfate, tetrachlorodecaoxide, chlorhexidine and "magic" (lidocaine solution, diphenhydramine hydrochloride and aluminum hydroxide suspension). Three trials compared patient controlled analgesia (PCA) to the continuous infusion method for controlling pain. There was no evidence of a difference, however, less opiate was used per hour for PCA. One trial demonstrated that pharmacokinetically based analgesia (PKPCA) reduced pain compared with PCA, however more opiate was used with PKCA.
REVIEWER'S CONCLUSIONS
There is weak and unreliable evidence that allopurinol mouthwash and vitamin E improves or eradicates mucositis. There is no evidence that patient controlled analgesia (PCA) is better than continuous infusion method for controlling pain, however, less opiate was used per hour for PCA. Further, well designed, placebo-controlled trials assessing the effectiveness of allopurinol mouthwash, vitamin E and new interventions for treating mucositis are needed.
Topics: Humans; Mouth Diseases; Mouth Mucosa; Neoplasms; Pain; Pain Management; Randomized Controlled Trials as Topic; Stomatitis
PubMed: 11869616
DOI: 10.1002/14651858.CD001973 -
The Cochrane Database of Systematic... Nov 2015Nausea and vomiting are common symptoms in patients with terminal, incurable illnesses. Both nausea and vomiting can be distressing. Haloperidol is commonly prescribed... (Review)
Review
BACKGROUND
Nausea and vomiting are common symptoms in patients with terminal, incurable illnesses. Both nausea and vomiting can be distressing. Haloperidol is commonly prescribed to relieve these symptoms. This is an updated version of the original Cochrane review published in Issue 2, 2009, of Haloperidol for the treatment of nausea and vomiting in palliative care patients.
OBJECTIVES
To evaluate the efficacy and adverse events associated with the use of haloperidol for the treatment of nausea and vomiting in palliative care patients.
SEARCH METHODS
For this updated review, we performed updated searches of CENTRAL, EMBASE and MEDLINE in November 2013 and in November 2014. We searched controlled trials registers in March 2015 to identify any ongoing or unpublished trials. We imposed no language restrictions. For the original review, we performed database searching in August 2007, including CENTRAL, MEDLINE, EMBASE, CINAHL and AMED, using relevant search terms and synonyms. Handsearching complemented the electronic searches (using reference lists of included studies, relevant chapters and review articles) for the original review.
SELECTION CRITERIA
We considered randomised controlled trials (RCTs) of haloperidol for the treatment of nausea or vomiting, or both, in any setting, for inclusion. The studies had to be conducted with adults receiving palliative care or suffering from an incurable progressive medical condition. We excluded studies where nausea or vomiting, or both, were thought to be secondary to pregnancy or surgery.
DATA COLLECTION AND ANALYSIS
We imported records from each of the electronic databases into a bibliographic package and merged them into a core database where we inspected titles, keywords and abstracts for relevance. If it was not possible to accept or reject an abstract with certainty, we obtained the full text of the article for further evaluation. The two review authors independently assessed studies in accordance with the inclusion criteria. There were no differences in opinion between the authors with regard to the assessment of studies.
MAIN RESULTS
We considered 27 studies from the 2007 search. In this update we considered a further 38 studies from the 2013 search, and two in the 2014 search. We identified one RCT of moderate quality with low risk of bias overall which met the inclusion criteria for this update, comparing ABH (Ativan®, Benadryl®, Haldol®) gel, applied to the wrist, with placebo for the relief of nausea in 22 participants. ABH gel includes haloperidol as well as diphenhydramine and lorazepam. The gel was not significantly better than placebo in this small study; however haloperidol is reported not to be absorbed significantly when applied topically, therefore the trial does not address the issue of whether haloperidol is effective or well-tolerated when administered by other routes (e.g. by mouth, subcutaneously or intravenously). We identified one ongoing trial of haloperidol for the management of nausea and vomiting in patients with cancer, with initial results published in a conference abstract suggesting that haloperidol is effective for 65% of patients. The trial had not been fully published at the time of our review. A further trial has opened, comparing oral haloperidol with oral methotrimeprazine (levomepromazine) for patients with cancer and nausea unrelated to their treatment, which we aim to include in the next review update.
AUTHORS' CONCLUSIONS
Since the last version of this review, we found one new study for inclusion but the conclusion remains unchanged. There is incomplete evidence from published RCTs to determine the effectiveness of haloperidol for nausea and vomiting in palliative care. Other than the trial of ABH gel vs placebo, we did not identify any fully published RCTs exploring the effectiveness of haloperidol for nausea and vomiting in palliative care patients for this update, but two trials are underway.
Topics: Antiemetics; Diphenhydramine; Gels; Haloperidol; Humans; Lorazepam; Nausea; Palliative Care; Randomized Controlled Trials as Topic; Vomiting
PubMed: 26524474
DOI: 10.1002/14651858.CD006271.pub3 -
The Cochrane Database of Systematic... Jun 2010Allergic and febrile non-haemolytic transfusion reactions (NHTRs) are the two most common forms of transfusion reaction. Pretransfusion medication with anti-inflammatory... (Review)
Review
BACKGROUND
Allergic and febrile non-haemolytic transfusion reactions (NHTRs) are the two most common forms of transfusion reaction. Pretransfusion medication with anti-inflammatory drugs is used in NHTR prevention, however its efficacy and safety remains unclear.
OBJECTIVES
To assess the clinical effects and safety of pharmacological interventions for preventing NHTR in patients with and without a history of transfusion reactions.
SEARCH STRATEGY
The search strategy included The Cochrane Central Register of Controlled Trials (CENTRAL) on The Cochrane Library (Issue 4, 2008), Cochrane Injuries Group's Specialised Register (December 17, 2008), MEDLINE (1950 to November (week 3) 2008), EMBASE (1988 to November (week 3) 2008), LILACS (1982 to January 12, 2009), CINAHL (1982 to December 2008), ISI Web of Science: Science Citation Index Expanded (SCI-EXPANDED): 1970 to December 2008). There was no language restriction.
SELECTION CRITERIA
Randomised controlled trials (RCTs) assessing the effectiveness of interventions for the prevention of NHTR.
DATA COLLECTION AND ANALYSIS
Authors independently selected studies, assessed the risks of bias and extracted data. Relative risks (RR) were estimated in RCTs with parallel design (PD). Odds ratio (OR) was estimated for one RCT with crossover design (CD). No meta-analysis was attempted due to differences in the pharmacotherapy of pre-transfusion medication and methodology between the studies; a per-protocol analysis was used.
MAIN RESULTS
This review includes three RCTs (two PD and one CD). The PD-RCTs employed disparate units of randomisation (UofR); patient or transfusion, while the CD-RCT applied the patient as the UofR. The PD-RCTs administered leukodepleted blood products. Both PD-RCTs compared acetaminophen plus diphenhydramine (ApD) at different regimens with placebo, while the CD-RCT contrasted hydrocortisone pharmacotherapy with diphenhydramine. Both PD-RCTs found no statistically significant difference in allergic reactions (RR 0.13, 95% confidence interval (CI) 0.01 to 2.39, RR 1.46, 95% CI 0.78 to 2.73) and febrile reactions (RR 0.52, 95% CI 0.22 to 1.26). The CD-RCT found a statistically significant difference in the odds of febrile reactions (OR 2.38, 95% CI 1.07 to 5.27). The trials did not report anaphylactic reactions, deaths related to transfusion reactions or other adverse events.
AUTHORS' CONCLUSIONS
None of the three studies found that medication prior to transfusion reduces NHTR. This applied regardless of the patient's history of NHTR and the use of leukodepleted blood products in the transfusion. However, this conclusion is based on three trials of moderate to low quality. A better-powered RCT is necessary to evaluate the role of pretransfusion medication in the prevention of NHTR. Inclusion criteria should be restricted to patients at high risk of developing NHTR, with no restriction by age, history of transfusion reactions and type of blood products (leukodepleted or not).
Topics: Acetaminophen; Anti-Inflammatory Agents, Non-Steroidal; Diphenhydramine; Fever; Histamine H1 Antagonists; Humans; Hydrocortisone; Hypersensitivity; Premedication; Randomized Controlled Trials as Topic; Transfusion Reaction
PubMed: 20556779
DOI: 10.1002/14651858.CD007539.pub2 -
The Cochrane Database of Systematic... Apr 2007Treatment of cancer is increasingly effective but associated with short and long term side effects. Oral side effects, including oral mucositis (mouth ulceration),... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Treatment of cancer is increasingly effective but associated with short and long term side effects. Oral side effects, including oral mucositis (mouth ulceration), remain a major source of illness despite the use of a variety of agents to treat them.
OBJECTIVES
To assess the effectiveness of interventions for treating oral mucositis or its associated pain in patients with cancer receiving chemotherapy or radiotherapy or both.
SEARCH STRATEGY
Computerised searches of Cochrane Oral Health Group's Trials Register; Cochrane Pain, Palliative and Supportive Care Group's Trials Register; CENTRAL; MEDLINE and EMBASE were undertaken. Reference lists from relevant articles were searched and the authors of eligible trials were contacted to identify trials and obtain additional information. Date of the most recent searches June 2006: CENTRAL (The Cochrane Library 2006, Issue 2).
SELECTION CRITERIA
All randomised controlled trials comparing agents prescribed to treat oral mucositis in people receiving chemotherapy or radiotherapy or both. Outcomes were oral mucositis, time to heal mucositis, oral pain, duration of pain control, dysphagia, systemic infection, amount of analgesia, length of hospitalisation, cost and quality of life.
DATA COLLECTION AND ANALYSIS
Data were independently extracted, in duplicate, by two review authors. Authors were contacted for details of randomisation, blindness and withdrawals. Quality assessment was carried out on these three criteria. The Cochrane Oral Health Group statistical guidelines were followed and risk ratio (RR) values calculated using fixed effect models.
MAIN RESULTS
Twenty-six trials involving 1353 patients satisfied the inclusion criteria. Four agents, each in single trials, were found to be effective for improving (allopurinol RR 3.33, 95% confidence interval (CI) 1.06 to 10.49; granulocyte macrophage-colony stimulating factor RR 4.23, 95% CI 1.35 to 13.24; immunoglobulin RR 1.81, 95% CI 1.24 to 2.65; human placentral extract RR 4.50, 95% CI 2.29 to 8.86) or eradicating mucositis (allopurinol RR 19.00, 95% CI 1.17 to 307.63). Three of these trials were rated as at moderate risk of bias and one as at high risk of bias. The following agents were not found to be effective: benzydamine HCl, sucralfate, tetrachlorodecaoxide, chlorhexidine and 'magic' (lidocaine solution, diphenhydramine hydrochloride and aluminum hydroxide suspension). Six trials compared the time to heal and mucositis was found to heal more quickly with two interventions: granulocyte macrophage-colony stimulating factor when compared to povidone iodine, with mean difference -3.5 days (95% CI -4.1 to -2.9) and allopurinol compared to placebo, with mean difference -4.5 days (95% CI -5.8 to -3.2). Three trials compared patient controlled analgesia (PCA) to the continuous infusion method for controlling pain. There was no evidence of a difference, however, less opiate was used per hour for PCA, and the duration of pain was shorter. One trial demonstrated that pharmacokinetically based analgesia (PKPCA) reduced pain compared with PCA: however, more opiate was used with PKPCA.
AUTHORS' CONCLUSIONS
There is weak and unreliable evidence that allopurinol mouthwash, granulocyte macrophage-colony stimulating factor, immunoglobulin or human placental extract improve or eradicate mucositis. There is no evidence that patient controlled analgesia (PCA) is better than continuous infusion method for controlling pain, however, less opiate was used per hour, and duration of pain was shorter, for PCA. Further, well designed, placebo-controlled trials assessing the effectiveness of allopurinol mouthwash, granulocyte macrophage-colony stimulating factor, immunoglobulin, human placental extract, other interventions investigated in this review and new interventions for treating mucositis are needed.
Topics: Humans; Mouth Diseases; Mouth Mucosa; Neoplasms; Pain; Pain Management; Randomized Controlled Trials as Topic; Stomatitis
PubMed: 17443514
DOI: 10.1002/14651858.CD001973.pub3 -
The Journal of Emergency Medicine Feb 2021Neuroleptics are commonly prescribed drugs to treat acute conditions (e.g., migraines) in the emergency department, but can cause serious adverse effects. Using... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Neuroleptics are commonly prescribed drugs to treat acute conditions (e.g., migraines) in the emergency department, but can cause serious adverse effects. Using diphenhydramine to prevent these adverse effects is very common but remains controversial.
OBJECTIVE
We performed a systematic review to determine whether prophylactic administration of diphenhydramine reduces the incidence of neuroleptic adverse effects in patients with acute conditions.
METHODS
Medline, Embase, Cochrane, PsycInfo, and Web of Science were searched for randomized controlled trials evaluating any neuroleptic with diphenhydramine vs. the same neuroleptic with any inactive agent. Primary outcome was incidence of any extrapyramidal adverse effect. Secondary outcomes were akathisia, rescue medication, subjective restlessness, neuroleptic malignant syndrome, and sedation. Independent reviewers scanned identified citations, extracted data, and assessed risk of bias. Meta-analysis was performed using random effect models.
RESULTS
Of 1566 identified citations, nine studies (n = 1648 patients) met eligibility criteria. Four studies were specifically designed to compare the incidence of neuroleptic adverse effects with and without co-administration of diphenhydramine. Four studies were at high risk of bias. In primary analysis, diphenhydramine had no effect on the incidence of extrapyramidal symptoms (7 studies, n = 1393, risk ratio [RR] 0.75; 95% confidence interval [CI] 0.44-1.31) or akathisia (5 studies, n = 1094; RR 0.78; 95% CI 0.33-1.82) or any of the secondary outcomes. In subgroup analysis, diphenhydramine was associated with a significant decrease in extrapyramidal adverse effects compared with placebo (4 studies, n = 705; RR 0.61; 95% CI 0.41-0.90). Dosage analysis yielded no further information.
CONCLUSIONS
When compared with placebo, diphenhydramine was associated with a significant reduction of extrapyramidal adverse effects. Overall quality of evidence is low. Further studies are warranted.
Topics: Antipsychotic Agents; Basal Ganglia Diseases; Diphenhydramine; Drug-Related Side Effects and Adverse Reactions; Humans; Psychomotor Agitation
PubMed: 33131965
DOI: 10.1016/j.jemermed.2020.09.031