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The Cochrane Database of Systematic... Jul 2020Foot ulcers in people with diabetes are non-healing, or poorly healing, partial, or full-thickness wounds below the ankle. These ulcers are common, expensive to manage... (Meta-Analysis)
Meta-Analysis
BACKGROUND
Foot ulcers in people with diabetes are non-healing, or poorly healing, partial, or full-thickness wounds below the ankle. These ulcers are common, expensive to manage and cause significant morbidity and mortality. The presence of a wound has an impact on nutritional status because of the metabolic cost of repairing tissue damage, in addition to the nutrient losses via wound fluid. Nutritional interventions may improve wound healing of foot ulcers in people with diabetes.
OBJECTIVES
To evaluate the effects of nutritional interventions on the healing of foot ulcers in people with diabetes.
SEARCH METHODS
In March 2020 we searched the Cochrane Wounds Specialised Register; the Cochrane Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase and EBSCO CINAHL Plus. We also searched clinical trials registries for ongoing and unpublished studies, and scanned reference lists of relevant included studies as well as reviews, meta-analyses and health technology reports to identify additional studies. There were no restrictions with respect to language, date of publication or study setting.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) that evaluated the effect of nutritional interventions on the healing of foot ulcers in people with diabetes.
DATA COLLECTION AND ANALYSIS
Two review authors, working independently, assessed included RCTs for their risk of bias and rated the certainty of evidence using GRADE methodology, using pre-determined inclusion and quality criteria.
MAIN RESULTS
We identified nine RCTs (629 participants). Studies explored oral nutritional interventions as follows: a protein (20 g protein per 200 mL bottle), 1 kcal/mL ready-to-drink, nutritional supplement with added vitamins, minerals and trace elements; arginine, glutamine and β-hydroxy-β-methylbutyrate supplement; 220 mg zinc sulphate supplements; 250 mg magnesium oxide supplements; 1000 mg/day omega-3 fatty acid from flaxseed oil; 150,000 IU of vitamin D, versus 300,000 IU of vitamin D; 250 mg magnesium oxide plus 400 IU vitamin E and 50,000 IU vitamin D supplements. The comparator in eight studies was placebo, and in one study a different dose of vitamin D. Eight studies reported the primary outcome measure of ulcer healing; only two studies reported a measure of complete healing. Six further studies reported measures of change in ulcer dimension, these studies reported only individual parameters of ulcer dimensions (i.e. length, width and depth) and not change in ulcer volume. All of the evidence identified was very low certainty. We downgraded it for risks of bias, indirectness and imprecision. It is uncertain whether oral nutritional supplement with 20 g protein per 200 mL bottle, 1 kcal/mL, nutritional supplement with added vitamins, minerals and trace elements, increases the proportion of ulcers healed at six months more than placebo (risk ratio (RR) 0.80, 95% confidence interval (CI) 0.42 to 1.53). It is also uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement increases the proportion of ulcers healed at 16 weeks compared with placebo (RR 1.09, 95% CI 0.85 to 1.40). It is uncertain whether the following interventions change parameters of ulcer dimensions over time when compared with placebo; 220 mg zinc sulphate supplement containing 50 mg elemental zinc, 250 mg magnesium oxide supplement, 1000 mg/day omega-3 fatty acid from flaxseed oil supplement, magnesium and vitamin E co-supplementation and vitamin D supplementation. It is also uncertain whether 150,000 IU of vitamin D, impacts ulcer dimensions when compared with 300,000 IU of vitamin D. Two studies explored some of the secondary outcomes of interest for this review. It is uncertain whether oral nutritional supplement with 20 g protein per 200 mL bottle, 1 kcal/mL, nutritional supplement with added vitamins, minerals and trace elements, reduces the number of deaths (RR 0.96, 95% CI 0.06 to 14.60) or amputations (RR 4.82, 95% CI 0.24 to 95.88) more than placebo. It is uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement increases health-related quality of life at 16 weeks more than placebo (MD -0.03, 95% CI -0.09 to 0.03). It is also uncertain whether arginine, glutamine and β-hydroxy-β-methylbutyrate supplement reduces the numbers of new ulcers (RR 1.04, 95% CI 0.71 to 1.51), or amputations (RR 0.66, 95% CI 0.16 to 2.69) more than placebo. None of the included studies reported the secondary outcomes cost of intervention, acceptability of the intervention (or satisfaction) with respect to patient comfort, length of patient hospital stay, surgical interventions, or osteomyelitis incidence. One study exploring the impact of arginine, glutamine and β-hydroxy-β-methylbutyrate supplement versus placebo did not report on any relevant outcomes.
AUTHORS' CONCLUSIONS
Evidence for the impact of nutritional interventions on the healing of foot ulcers in people with diabetes compared with no nutritional supplementation, or compared with a different dose of nutritional supplementation, remains uncertain, with eight studies showing no clear benefit or harm. It is also uncertain whether there is a difference in rates of adverse events, amputation rate, development of new foot ulcers, or quality of life, between nutritional interventions and placebo. More research is needed to clarify the impact of nutritional interventions on the healing of foot ulcers in people with diabetes.
Topics: Arginine; Diabetic Foot; Dietary Proteins; Dietary Supplements; Fatty Acids, Omega-3; Female; Glutamine; Humans; Magnesium; Magnesium Oxide; Male; Middle Aged; Minerals; Randomized Controlled Trials as Topic; Trace Elements; Valerates; Vitamins; Wound Healing; Zinc Sulfate
PubMed: 32677037
DOI: 10.1002/14651858.CD011378.pub2 -
BMJ Clinical Evidence Sep 2009Warts are caused by the human papillomavirus (HPV), of which there are over 100 types, which probably infects the skin via areas of minimal trauma. Risk factors include... (Review)
Review
INTRODUCTION
Warts are caused by the human papillomavirus (HPV), of which there are over 100 types, which probably infects the skin via areas of minimal trauma. Risk factors include use of communal showers, occupational handling of meat, and immunosuppression. In immunocompetent people, warts are harmless and resolve as a result of natural immunity within months or years.
METHODS AND OUTCOMES
We conducted a systematic review and aimed to answer the following clinical question: What are the effects of treatments for warts (non-genital)? We searched: Medline, Embase, The Cochrane Library, and other important databases up to June 2008 (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 12 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: intralesional bleomycin; cimetidine; contact immunotherapy; cryotherapy; duct tape occlusion; formaldehyde, glutaraldehyde; homeopathy; photodynamic treatment; pulsed dye laser; surgical procedures; topical salicylic acid; and zinc sulphate.
Topics: Administration, Oral; Bandages; Bleomycin; Cimetidine; Cryosurgery; Cryotherapy; Humans; Warts; Zinc Sulfate
PubMed: 21726478
DOI: No ID Found -
Journal of International Society of... 2023The use of medicinal herbs to prevent gingival and periodontal diseases has become increasingly popular due to their anti-inflammatory and antioxidant properties. This... (Review)
Review
AIMS AND OBJECTIVES
The use of medicinal herbs to prevent gingival and periodontal diseases has become increasingly popular due to their anti-inflammatory and antioxidant properties. This systematic review aims to provide the current literature to validate the traditional use of medicinal herbs in the management of gingival and periodontal diseases.
MATERIALS AND METHODS
An online literature search was conducted to identify research papers published from 2010 to 2022 in three major scientific databases, PubMed, Scopus, and Web of Science, in June 2022. Original research studies, case reports, and systematic reviews on medicinal plants' application in oral health care were selected to be included in this systematic review. Only high-quality articles identified in the quality assessment were included for evidence synthesis.
RESULTS
Initial keyword research yielded 726 free-text articles published between 2010 and 2022. Of these, 14 articles (8 research papers and 6 reviews) were included for evidence synthesis. The review's findings indicate that the antibacterial property of medicinal plants is due to their alkaline nature and prevents plaque and calculus formation by maintaining acid-alkali balance in saliva. Various parts of medicinal plants help maintain periodontal health. , , and effectively inhibit primary plaque colonizers and periodontal pathogens. , Miller, and have excellent applications in treating periodontal diseases. , , the husk of , the root of and , leaves of and , fruits of and , Ocimum extract, and pomegranate peel extract can serve as a promising alternative in managing chronic gingivitis.
CONCLUSION
The anti-inflammatory, antioxidant, antibacterial, and astringent action of extracts obtained from various parts of medicinal plants make them effective in reducing gingival and periodontal diseases. Herbal medicine may be a viable alternative to contemporary pharmaceuticals as an adjuvant to scaling and root planning procedures.
PubMed: 37153928
DOI: 10.4103/jispcd.JISPCD_210_22 -
The Cochrane Database of Systematic... Apr 2015This Cochrane Review was withdrawn in April 2015, and this withdrawal notice was updated in September 2016. The review was withdrawn as result of comments submitted... (Meta-Analysis)
Meta-Analysis Review
This Cochrane Review was withdrawn in April 2015, and this withdrawal notice was updated in September 2016. The review was withdrawn as result of comments submitted via the Cochrane Library by Harri Hemilä in February 2015. Hemilä identified multiple errors in this Cochrane Review and made allegations of plagiarism of text and data from a previously published systematic review (Hemilä H. Zinc Lozenges may shorten the duration of colds: a systematic review. 2011;5:51‐58. dx.doi.org/10.2174/1874306401105010051). The comments referred to the version of this review first published in June 2013 (Singh M, Das RR. Zinc for the common cold. 2013;(6):CD001364. http://onlinelibrary.wiley.com/doi/10.1002/14651858.CD001364.pub4/full). The Cochrane Acute Respiratory Infections Group, which maintains the review, withdrew the review in April 2015, pending an assessment of the errors reported, and the group referred the allegations of plagiarism to the Editor in Chief. The Editor in Chief notified the authors of the concerns, and followed the Committee for Publication Ethics (COPE) guidelines. Replication of text was identified in the Cochrane Review. This was limited to copying of short phrases and was acknowledged by the authors. The level of text plagiarism was minor and at a level that would be addressed by a correction. The Editor in Chief carried out further investigation into the alleged plagiarism of data, with the co‐operation of the review authors, who provided supplementary information in support of their work. The allegations related to the derivation of means and standard deviations of data from some of the included studies. Although the authors acknowledge and cite the Hemilä 2011 review, the Editor in Chief considered that the authors’ explanation regarding some similarities in presented data between the two reviews was not conclusive. This version of the review will therefore remain withdrawn. This review was withdrawn due to concerns raised via the feedback mechanism regarding the calculation and analysis of data in the review in April 2015. Whilst it is not unusual for reviews to be withdrawn, the editorial group took the view that it would be better to take a cautious approach and explore the source and calculation of data used in the analysis in more detail, rather than keep the review on the Cochrane Database of Systematic Reviews for the time being. The editorial group responsible for this previously published document have withdrawn it from publication.
Topics: Common Cold; Dosage Forms; Gluconates; Humans; Randomized Controlled Trials as Topic; Severity of Illness Index; Zinc; Zinc Acetate; Zinc Compounds; Zinc Sulfate
PubMed: 25924708
DOI: 10.1002/14651858.CD001364.pub5 -
The Cochrane Database of Systematic... Jun 2014Otitis media is inflammation of the middle ear and is usually caused by infection. It affects people of all ages but is particularly common in young children. Around 164... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Otitis media is inflammation of the middle ear and is usually caused by infection. It affects people of all ages but is particularly common in young children. Around 164 million people worldwide have long-term hearing loss caused by this condition, 90% of them in low-income countries. As zinc supplements prevent pneumonia in disadvantaged children, we wanted to investigate whether zinc supplements could also prevent otitis media.
OBJECTIVES
To evaluate whether zinc supplements prevent otitis media in adults and children of different ages.
SEARCH METHODS
We searched CENTRAL (2014, Issue 1), MEDLINE (1950 to February week 4, 2014) and EMBASE (1974 to March 2014).
SELECTION CRITERIA
Randomised, placebo-controlled trials of zinc supplements given at least once a week for at least a month for preventing otitis media.
DATA COLLECTION AND ANALYSIS
Two review authors independently assessed the eligibility and methodological quality of the included trials and extracted and analysed data. We summarised results using risk ratios (RRs) or rate ratios for dichotomous data and mean differences (MDs) for continuous data. We combined trial results where appropriate.
MAIN RESULTS
No new trials were identified for inclusion in this update. We identified 12 trials for inclusion, 10 of which contributed outcomes data. There were a total of 6820 participants. In trials of healthy children living in low-income communities, two trials did not demonstrate a significant difference between the zinc-supplemented and placebo groups in the numbers of participants experiencing an episode of definite otitis media during follow-up (3191 participants); another trial showed a significantly lower incidence rate of otitis media in the zinc group (rate ratio 0.69, 95% confidence interval (CI) 0.61 to 0.79, n = 1621). A small trial of 39 infants undergoing treatment for severe malnutrition suggested a benefit of zinc for the mean number of episodes of otitis media (mean difference (MD) -1.12 episodes, 95% CI -2.21 to -0.03). Zinc supplements did not seem to cause any serious adverse events but a small minority of children were reported to have vomited shortly after ingestion of the supplements. The trial evidence included is generally of good quality, with a low risk of bias.
AUTHORS' CONCLUSIONS
Evidence on whether zinc supplementation can reduce the incidence of otitis media in healthy children under the age of five years living in low- and middle-income countries is mixed. There is some evidence of benefit in children being treated for marasmus (severe malnutrition), but this is based on one small trial and should therefore be treated with caution.
Topics: Child Nutrition Disorders; Child, Preschool; Chlorides; Developing Countries; Dietary Supplements; Female; Gluconates; Humans; Infant; Infant Nutrition Disorders; Male; Otitis Media; Randomized Controlled Trials as Topic; Trace Elements; Zinc; Zinc Acetate; Zinc Compounds; Zinc Sulfate
PubMed: 24974096
DOI: 10.1002/14651858.CD006639.pub4 -
The Cochrane Database of Systematic... Sep 2014Leg ulcers affect up to one percent of people at some time in their life. Leg ulceration is chronic in nature and ulcers may be present for months or even years without... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Leg ulcers affect up to one percent of people at some time in their life. Leg ulceration is chronic in nature and ulcers may be present for months or even years without healing. After healing there is a high risk of recurrence. Treatments include wound dressings alongside the treatment of underlying medical problems such as poor blood supply, infection and poor nutrition.
OBJECTIVES
To assess the effectiveness of oral zinc in healing arterial or venous leg ulcers.
SEARCH METHODS
For this seventh update we searched The Cochrane Wounds Group Specialised Register (searched 02 September 2014) and The Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library 2014, Issue 8). In the original version of the review a company manufacturing zinc sulphate tablets was asked for references to relevant trials.
SELECTION CRITERIA
Randomised controlled trials comparing oral zinc sulphate with placebo or no treatment in people with arterial or venous leg ulcers were eligible for inclusion. There were no restrictions on date or language of publication. The main outcome measure used was complete healing of the ulcers. Trials were eligible for inclusion if they measured ulcer healing objectively by documenting time to complete healing, proportion of ulcers healed during the study, or healing rates of ulcers.
DATA COLLECTION AND ANALYSIS
All data extraction and assessment of trial quality was done by both authors independently.
MAIN RESULTS
Six small trials (183 participants) were eligible for inclusion. Four trials considered people with venous ulcers, one trial involved people with arterial ulcers and one people with mixed aetiology ulcers. Serum zinc was measured in four trials and four trials compared oral zinc sulphate with placebo in people with venous ulcers; pooling these trials indicated no statistically significant difference between the two groups for healing (RR 1.22, 95%CI 0.88 to 1.68). Overall, there is no evidence that oral zinc increases the healing of arterial or venous leg ulcers.
AUTHORS' CONCLUSIONS
Oral zinc sulphate does not appear to aid the healing of arterial and venous leg ulcers, however all included studies were small and at unclear risk of bias (due to poor reporting).
Topics: Administration, Oral; Astringents; Humans; Leg Ulcer; Randomized Controlled Trials as Topic; Wound Healing; Zinc; Zinc Sulfate
PubMed: 25202988
DOI: 10.1002/14651858.CD001273.pub3 -
Annals of Gastroenterology 2014Gelatin tannate (GT) is a complex of tannic acid, which possesses astringent, antibacterial, and anti-inflammatory properties, and a protective gelatin. It is... (Review)
Review
Gelatin tannate (GT) is a complex of tannic acid, which possesses astringent, antibacterial, and anti-inflammatory properties, and a protective gelatin. It is increasingly being marketed as an antidiarrheal drug. Our aim was to review data on the effectiveness of GT in treating acute gastroenteritis (AGE) in children and adults. The MEDLINE, EMBASE, and the Cochrane Library databases were searched in July 2013, with no language restrictions, for controlled clinical trials. Additional references were obtained from reviewed articles. Two trials met the inclusion criteria. In adults, one randomized controlled trial involving 40 subjects (mean age: 43±13 years) found that, compared with placebo, GT may be more effective at reducing some symptoms of AGE in the first 48 h after initiation of treatment. In children, one poor quality study (no randomization and no blinding) involving 211 children (mean age: 2.5±2.4 years) reported some beneficial effect of GT at 12 h after initiation of treatment. None of the studies evaluated the effect of GT on the primary outcome measures for this review such as stool output, duration of diarrhea, admission to hospital, duration of hospital stay, and (in children) weight gain after rehydration. Currently, there is no evidence to support the use of GT for treating AGE in children and only sparse evidence to support the use of GT in adults. Further well-designed trials, with sufficient power, adequate follow-up periods, and clinically relevant outcome measures, are needed. These include stool volume, duration of diarrhea, admission to hospital, duration of hospital stay, weight gain after rehydration, and adverse effects.
PubMed: 24733622
DOI: No ID Found -
Current Opinion in Food Science Jun 2019Oral tribology is rapidly entering into the food scientists' toolbox because of its promises to predict surface-related mouthfeel perception. In this systematic review,... (Review)
Review
Oral tribology is rapidly entering into the food scientists' toolbox because of its promises to predict surface-related mouthfeel perception. In this systematic review, we discuss how oral tribology relates to specific sensory attributes in model and real foods focussing on recent literature from 2016 onwards. Electronic searches were conducted in four databases, yielding 4857 articles which were narrowed down to a set of 16 articles using pre-specified criteria. New empirical correlations have emerged between friction coefficients in the mixed lubrication regime and fat-related perception (e.g. smoothness) as well as non-fat-related perception (e.g. pastiness, astringency, stickiness). To develop mechanistically supported generalized relationships, we recommend coupling tribological surfaces and testing conditions that are harmonized across laboratories with temporal sensory testing and multivariate statistical analysis.
PubMed: 31903320
DOI: 10.1016/j.cofs.2019.05.007 -
The Cochrane Database of Systematic... Sep 2022Loss of olfactory function is well recognised as a symptom of COVID-19 infection, and the pandemic has resulted in a large number of individuals with abnormalities in... (Review)
Review
BACKGROUND
Loss of olfactory function is well recognised as a symptom of COVID-19 infection, and the pandemic has resulted in a large number of individuals with abnormalities in their sense of smell. For many, the condition is temporary and resolves within two to four weeks. However, in a significant minority the symptoms persist. At present, it is not known whether early intervention with any form of treatment (such as medication or olfactory training) can promote recovery and prevent persisting olfactory disturbance. This is an update of the 2021 review with four studies added.
OBJECTIVES
1) To evaluate the benefits and harms of any intervention versus no treatment for people with acute olfactory dysfunction due to COVID-19 infection. 2) To keep the evidence up-to-date, using a living systematic review approach. SEARCH METHODS: The Cochrane ENT Information Specialist searched the Cochrane ENT Register; Central Register of Controlled Trials (CENTRAL); Ovid MEDLINE; Ovid Embase; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the latest search was 20 October 2021.
SELECTION CRITERIA
We included randomised controlled trials (RCTs) in people with COVID-19 related olfactory disturbance, which had been present for less than four weeks. We included any intervention compared to no treatment or placebo. DATA COLLECTION AND ANALYSIS: We used standard Cochrane methods. Our primary outcomes were the presence of normal olfactory function, serious adverse effects and change in sense of smell. Secondary outcomes were the prevalence of parosmia, change in sense of taste, disease-related quality of life and other adverse effects (including nosebleeds/bloody discharge). We used GRADE to assess the certainty of the evidence for each outcome. MAIN RESULTS: We included five studies with 691 participants. The studies evaluated the following interventions: intranasal corticosteroid sprays, intranasal corticosteroid drops, intranasal hypertonic saline and zinc sulphate. Intranasal corticosteroid spray compared to no intervention/placebo We included three studies with 288 participants who had olfactory dysfunction for less than four weeks following COVID-19. Presence of normal olfactory function The evidence is very uncertain about the effect of intranasal corticosteroid spray on both self-rated recovery of olfactory function and recovery of olfactory function using psychophysical tests at up to four weeks follow-up (self-rated: risk ratio (RR) 1.19, 95% confidence interval (CI) 0.85 to 1.68; 1 study; 100 participants; psychophysical testing: RR 2.3, 95% CI 1.16 to 4.63; 1 study; 77 participants; very low-certainty evidence). Change in sense of smell The evidence is also very uncertain about the effect of intranasal corticosteroid spray on self-rated change in the sense of smell (at less than 4 weeks: mean difference (MD) 0.5 points lower, 95% CI 1.38 lower to 0.38 higher; 1 study; 77 participants; at > 4 weeks to 3 months: MD 2.4 points higher, 95% CI 1.32 higher to 3.48 higher; 1 study; 100 participants; very low-certainty evidence, rated on a scale of 1 to 10, higher scores mean better olfactory function). Intranasal corticosteroids may make little or no difference to the change in sense of smell when assessed with psychophysical testing (MD 0.2 points, 95% CI 2.06 points lower to 2.06 points higher; 1 study; 77 participants; low-certainty evidence, 0- to 24-point scale, higher scores mean better olfactory function). Serious adverse effects The authors of one study reported no adverse effects, but their intention to collect these data was not pre-specified so we are uncertain if these were systematically sought and identified. The remaining two studies did not report on adverse effects. Intranasal corticosteroid drops compared to no intervention/placebo We included one study with 248 participants who had olfactory dysfunction for ≤ 15 days following COVID-19. Presence of normal olfactory function Intranasal corticosteroid drops may make little or no difference to self-rated recovery at > 4 weeks to 3 months (RR 1.00, 95% CI 0.89 to 1.11; 1 study; 248 participants; low-certainty evidence). No other outcomes were assessed by this study. Data on the use of hypertonic saline nasal irrigation and the use of zinc sulphate to prevent persistent olfactory dysfunction are included in the full text of the review.
AUTHORS' CONCLUSIONS
There is very limited evidence available on the efficacy and harms of treatments for preventing persistent olfactory dysfunction following COVID-19 infection. However, we have identified a number of ongoing trials in this area. As this is a living systematic review we will update the data regularly, as new results become available.
Topics: Adrenal Cortex Hormones; COVID-19; Chronic Disease; Humans; Olfaction Disorders; Randomized Controlled Trials as Topic; Rhinitis; Smell; Zinc Sulfate
PubMed: 36063364
DOI: 10.1002/14651858.CD013877.pub3 -
The Cochrane Database of Systematic... Jul 2012Sickle cell disease is an inherited disorder of hemoglobin, resulting in abnormal red blood cells. These are rigid and may block blood vessels leading to acute painful... (Meta-Analysis)
Meta-Analysis Review
BACKGROUND
Sickle cell disease is an inherited disorder of hemoglobin, resulting in abnormal red blood cells. These are rigid and may block blood vessels leading to acute painful crises and other complications. Recent research has focused on therapies to rehydrate the sickled cells by reducing the loss of water and ions from them. Little is known about the effectiveness and safety of such drugs.
OBJECTIVES
To assess the relative risks and benefits of drugs to rehydrate sickled red blood cells.
SEARCH METHODS
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register.Last search of the Group's Trials Register: 25 October 2011.
SELECTION CRITERIA
Randomized or quasi-randomized controlled trials of drugs to rehydrate sickled red blood cells compared to placebo or an alternative treatment.
DATA COLLECTION AND ANALYSIS
Both authors independently selected studies for inclusion, assessed study quality and extracted data.
MAIN RESULTS
Of the 51 studies identified, three met the inclusion criteria. The first study tested the effectiveness of zinc sulphate to prevent sickle cell-related crises in a total of 145 participants and showed a significant reduction in painful crises over one and a half years, mean difference -2.83 (95% confidence interval -3.51 to -2.15). However, analysis was restricted due to limited statistical data. Changes to red cell parameters and blood counts were inconsistent. No serious adverse events were noted in the study.The second study was a Phase II dose-finding study of senicapoc (a Gardos channel blocker) compared to placebo. Compared to the placebo group the high dose senicapoc showed significant improvement in change in hemoglobin level, number and proportion of dense red blood cells, red blood cell count and indices and hematocrit. The results with low-dose senicapoc were similar to the high-dose senicapoc group but of lesser magnitude. There was no difference in the frequency of painful crises between the three groups. A subsequent Phase III study of senicapoc was terminated early since there was no difference observed between the treatment and control groups in the primary end point of painful crises.
AUTHORS' CONCLUSIONS
While the results of zinc for reducing sickle-related crises are encouraging, larger and longer-term multicenter studies are needed to evaluate the effectiveness of this therapy for people with sickle cell disease.While the Phase II and the prematurely terminated phase III studies of senicapoc showed that the drug improved red cell survival (depending on dose), this did not lead to fewer painful crises.
Topics: Acetamides; Anemia, Sickle Cell; Antisickling Agents; Clinical Trials, Phase II as Topic; Clinical Trials, Phase III as Topic; Dehydration; Early Termination of Clinical Trials; Erythrocyte Aging; Erythrocytes; Humans; Piracetam; Randomized Controlled Trials as Topic; Trityl Compounds; Zinc Sulfate
PubMed: 22786485
DOI: 10.1002/14651858.CD003426.pub4