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The Cochrane Database of Systematic... Jan 2010Sickle 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 STRATEGY
We searched the Cochrane Cystic Fibrosis and Genetic Disorders Group's Haemoglobinopathies Trials Register.Last search of the Group's Trials Register: 22 May 2009.
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 47 studies identified, two 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 (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 had to be stopped prematurely due to lack of reduction in the number of painful crisis.
AUTHORS' CONCLUSIONS
While the results of zinc for reducing sickle-related crises are encouraging, larger and longer-term multicentre studies are needed to evaluate the effectiveness of this therapy for people with sickle cell disease.Though the phase II study of senicapoc showed that the drug improved red cell survival, depending on dose, this did not lead to fewer painful crises; a subsequent phase III study was terminated prematurely for this reason.
Topics: Acetamides; Anemia, Sickle Cell; Antisickling Agents; Dehydration; Erythrocyte Aging; Erythrocytes; Humans; Randomized Controlled Trials as Topic; Trityl Compounds; Zinc Sulfate
PubMed: 20091545
DOI: 10.1002/14651858.CD003426.pub3 -
Journal of the American Academy of... Aug 2007Cutaneous leishmaniasis (CL) is caused by different species of Leishmania and transmitted by the bite of infected sand flies. It is a health problem in many countries. (Review)
Review
BACKGROUND
Cutaneous leishmaniasis (CL) is caused by different species of Leishmania and transmitted by the bite of infected sand flies. It is a health problem in many countries.
OBJECTIVE
This study was performed to assess the evidence for the efficacy of different therapeutic modalities for acute Old World CL, which is usually caused by L major and L tropica.
METHODS
Evidence was reviewed according to the hierarchy of evidence. Because there have been no published systematic reviews on this topic to date, the primary source of evidence was individual randomized controlled trials (RCTs). Multiple databases were systematically searched. Using independent double review and published quality review criteria, articles were rated as good, fair, or poor. Treatment benefit data were tabulated, and conclusions were based on the rated strength of published evidence.
RESULTS
In all, 50 RCTs met inclusion criteria consisting of 5515 patients in 119 study arms. Reviewed trials were highly variable in quality and methods and generally provide weak evidence for treatment of acute Old World CL.
LIMITATIONS
The quality of included studies was generally poor.
CONCLUSIONS
Well-designed randomized, double-blind, controlled trials should be designed and conducted to find better evidence for the treatment of acute Old World CL.
Topics: Administration, Topical; Antimony; Azoles; Cryotherapy; Humans; Leishmaniasis, Cutaneous; Paromomycin; Randomized Controlled Trials as Topic; Zinc Sulfate
PubMed: 17337090
DOI: 10.1016/j.jaad.2007.01.016 -
Archives of Dermatology Dec 1998To determine whether oral zinc sulfate is an effective treatment for promoting healing of venous or arterial leg ulcers. (Clinical Trial)
Clinical Trial Randomized Controlled Trial Review
OBJECTIVE
To determine whether oral zinc sulfate is an effective treatment for promoting healing of venous or arterial leg ulcers.
DATA SOURCES
The search strategy of the Cochrane Wounds Group was used. This includes searches of electronic databases, conference proceedings, relevant bibliographies, and hand searching of journals.
STUDY SELECTION
Studies were included if they were randomized controlled trials of oral zinc sulfate in the treatment of chronic venous or arterial ulcers with objective measures of healing. Six of the 10 studies initially identified were included in the review.
DATA EXTRACTION
The trial method, participants, interventions, outcomes, baseline comparability, adequate reporting of withdrawals, and blinding of assessment were extracted by 2 reviewers independently.
DATA SYNTHESIS
No trial showed a statistically significant benefit of zinc sulfate for healing leg ulcers. There is limited evidence to suggest that zinc might increase healing in individuals with a low serum zinc level, but more evidence is needed.
CONCLUSIONS
There is no evidence of benefit from the general use of zinc sulfate in patients with chronic leg ulcers. There is a need for further research to see if oral zinc sulfate is beneficial in the treatment of patients with leg ulcers who have a low serum zinc level. If it is demonstrated to be beneficial, further trials are required to establish dose and duration of treatment.
Topics: Astringents; Humans; Leg Ulcer; Zinc Sulfate
PubMed: 9875193
DOI: 10.1001/archderm.134.12.1556