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Antipyretic measures for treating fever in malaria

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Official websites use. Share sensitive information only on official, secure websites. Fever is common in malaria, and drugs and sponging are widely used for symptomatic relief. Some researchers have suggested that fever reduction may prolong malaria illness. We aimed to assess whether treatments to reduce fever in malaria influence the course of the illness. We contacted researchers and organisations working in the field to enable us identify other unpublished or ongoing trials. Randomized controlled trials of fever reduction measures in adults or children with confirmed malaria. Inclusion criteria were independently applied by two authors. GRADE was used to evaluate and summarize the quality of the evidence. Ten randomized controlled trials with participants including both adults and children met our inclusion criteria. All were small scale trials with methodological limitations and were conducted in a variety of patients. Some trials detected an impact of antipyretic drugs on fever clearance time, while others did not. No difference in the number or severity of adverse events between antipyretic drugs and control was detected. We do not know whether antipyretics alter parasite clearance time. Whether further trials are worthwhile to investigate this or not would require a judgement of whether this was an important question to resolve using interventional trials. Fever is a common symptom of malaria. Some researchers have questioned the belief that treating fever with antipyretic drugs is beneficial. They suggest that it may actually prolong the time taken for the malaria parasite to be cleared from the blood system. This review looked for evidence from appropriate types of research that addressed these issues. We found only a few small trials and could not obtain sufficient information from these trials to reach a conclusion on whether the antipyretic drugs actually help to resolve malaria symptoms or prolong the illness. Allocation concealment was unclear. Trial was an open trial and blinding of outcome assessors was not done. One of the trials Matsegui included only children while the other Krishna a included only adults. The common symptoms of malaria include fever, poor appetite, vomiting, malaise and convulsions. Fever is the most common of the symptoms of malaria. Simple febrile convulsions are generally known not to cause serious morbidity or fatality. Fever in malaria is believed to be associated with release of toxins and antigenic substances which induce the release of cytokines by white blood cells. In the thermoregulatory centre of the brain, prostaglandin E 2 acts on thermosensitive cells to induce fever. Fever is postulated to be a host response to curb infections and achieve recovery but its role in defence against malaria is unclear. Thus more harm than good may be done by blunting the febrile host response by administering antipyretic drugs to people with fever due to malaria. However, other treatments are often required to ameliorate the symptoms of malaria and its complications. Fever, aches, convulsions and dehydration are some of the symptoms and signs of malaria that often require treatment. Measures to treat fever are thought to make the patients feel better and prevent febrile convulsions in children. Paracetamol, also known as acetaminophen, is an antipyretic drug commonly used in children Prescott and for treating fever in malaria WHO It also has analgesic effects. It is administered via the enteral and parenteral routes. Its side effects include vomiting, diarrhoea and abdominal pain. In overdose, paracetamol causes hepatotoxicity which can rapidly progress to hepatic failure if appropriate treatment is not commenced early Prescott They are weak organic acids with wide chemical diversity and include aspirin, ibuprofen, metamizol, naproxen etc. Reye's syndrome is associated with aspirin use in paediatric age groups. Physical antipyretic measures such as tepid sponging, fanning and cooling blankets induce reduction in body temperature by conduction, convection or by evaporation. Paracetamol is the most commonly used antipyretic agent. The mode of action of paracetamol is poorly understood, but it is thought to achieve this effect by blocking the effects of endogenous pyrogens on the hypothalamus Prescott NSAIDs exert their antipyretic effect by deactivating the cycloxygenase pathway with subsequent inhibition of prostaglandin production Lell In recent times, the role of antipyretic measures in treatment of infections has been called into question Warwick ; Kramer This is particularly important in malaria cases as there is evidence that febrile temperatures inhibit in vitro growth of Plasmodium falciparum Long A study of people infected with malaria showed that paracetamol prolonged parasitaemia Brandts Recent studies have shown that although NSAIDs such as ibuprofen, metamizol and naproxen reduce fever peaks, they do not play a significant role in reducing fever clearance time in malaria Matsegui ; Lell The prevention of febrile convulsions is one of the reasons practitioners use antipyretic measures, but there is no evidence to show that antipyretic drugs prevent febrile convulsions Strengell It has been postulated that the convulsions associated with fever in malaria may be due to systemic pathophysiological changes caused by these infections Waruiru Paracetamol and ibuprofen are widely used in fever management, and have been recommended by the WHO malaria treatment guideline group WHO Paracetamol is generally known to be safe and well tolerated when used in the recommended doses but the controversies regarding observations that antipyresis may prolong malaria parasitaemia remain unresolved Hayward The first version of this systematic review aimed to test the null hypothesis that paracetamol and other fever control measures do not prolong malaria illness Meremikwu This review found insufficient data to confirm or refute an impact of antipyretic measures on parasitaemia or malarial illness Meremikwu and did not make a head to head comparison of the effects of paracetamol and NSAIDs. Since the completion of that review, more studies that addressed this question have been conducted. The WHO malaria treatment guideline recommends ibuprofen along with paracetamol for treating fever in malaria but acknowledges the fact that experience with use of ibuprofen is limited WHO Considering that available evidence of any advantage of one antipyretic measure over the other is inconclusive, we have decided in the update of this systematic review to also study the comparative effectiveness of the various antipyretic measures on the treatment of malaria. Children or adults with fever due to malarial illness confirmed by microscopic examination of blood slides or antigen detection techniques. Physical methods such as tepid sponging, fanning, cooling blankets. Fever clearance time FCT the time between onset of treatment and sustained resolution of fever i. Parasite clearance time PCT time between onset of treatment and clearance of malaria parasites from peripheral blood film. Proportion of participants without fever within six and twelve hours of starting treatment. Fever is defined as a temperature above Fever time duration in hours that an individual's temperature was above an indicated fever threshold. We attempted to identify all relevant studies regardless of language or publication status published, unpublished, in press and in progress. We used the following search terms for all trial registers and databases: pyrexia, fever, antipyretic and malaria. We contacted researchers and organisations working in the field for information on unpublished and ongoing trials. Two reviewers BN,EU applied the inclusion criteria to all potential trials. Where there was any doubt, we consulted the third reviewer CO. We assessed the study quality using the standard methods of the Cochrane Collaboration as stipulated in the latest edition of Cochrane Reviewers' Handbook. We planned to explore potential sources of heterogeneity such as type, dosage, route and method of administration of antipyretic measures, age of participants adults versus children and site of temperature measurement core or axillary. Two authors BN and EU independently applied the inclusion criteria to all identified studies and made a decision on which studies to include. We retrieved the full papers and we applied the eligibility criteria to all potentially relevant papers. When disagreement occured, we consulted a third author CO. There were no language restrictions in the search or the selection of articles. Data extraction was performed by two authors BN and CO using a standard data extraction form. The data we extracted from studies that qualified for inclusion included:. Methods: generation of allocation sequence, method of allocation concealment, blinding, study duration. Intervention: nature of intervention delivered to the treatment and control groups, route of administration, dosage and duration. Outcome measures and results: differences between intervention and control groups in terms of parasite clearance time, fever clearance time,. Missing data: we extracted information on missing data arising from participant attrition or missing statistical information. We judged the risk of bias within each included study in relation to six domains; sequence generation, allocation concealment, blinding, incomplete outcome data, selective outcome reporting and other sources of bias using ratings of 'Yes' low risk of bias , 'No' high risk of bias and 'Unclear' unknown risk of bias. We extracted and analysed continuous data if mean and standard deviation values were available and there was no clear evidence of skewed distribution. If the mean difference values had been provided, we would have extracted and utilized this information for the analysis irrespective of provision of mean and standard deviation. Four studies had multiple groups Hemmer ; Lell ; Walker ; Hugosson We combined the relevant intervention groups into a single group for extraction of data and reporting in an additional table Table 2. The same was done for the relevant control groups. In Lell , we divided the shared intervention groups approximately evenly among comparison groups. Since asymmetry of funnel plots may result from publication bias, heterogeneity or poor methodological quality, we planned to examine funnel plots using Review Manager RevMan. However, we found an insufficient number of trials to do this. We planned to assess selective outcome reporting by checking the protocols of included trials if possible within trial registries, conference proceedings, etc but found no protocols for any of the included trials. We found no internal evidence of selective outcome reporting within published trials. We used Review Manager RevMan to perform statistical analyses. We assesed the quality of the evidence and constructed a summary of findings table using the GRADE method. We had planned to perform a subgroup analysis. However, no subgroup analysis was done due to insufficient trials. We had planned to perform a sensitivity analysis to investigate the impact of adequate allocation concealment and other indicators of high methodological quality on the results. However, this was not possible as the number of trials that used adequate allocation concealment was insufficient to allow for sensitivity analysis to assess the possible influence of high risk of bias in trials that did not apply allocation concealment. We identified 22 clinical trials, of which ten met the criteria for inclusion Characteristics of included studies , 12 were excluded Characteristics of excluded studies. There were a total of participants in the 10 trials that met the inclusion criteria, but only patients were relevant to the research question of the review. Three randomized patients were excluded from the analysis of intervention efficacy. All had confirmed P. Krishna a in Thailand studied a total of 21 adult cases of uncomplicated P. The group which received quinine followed by paracetamol after two hours was excluded from the review, while the group that received paracetamol followed by quinine and the control group which had no antipyretic were included. Matsegui in Gabon compared the effect of ibuprofen versus placebo on fever in 50 children aged 2 to 7 years with uncomplicated malaria. Three were withdrawn. The groups included 56, 41, 40 and 38 participants respectively. Thus, only 79 participants were included out of the total Krishna b in Thailand studied a total of 16 patients with uncomplicated malaria in two groups who received either ibuprofen or paracetamol. Lell in Gabon studied 90 children with uncomplicated malaria in three groups who received metamizol, naproxen or physical methods treatment alone. Walker in Nigeria studied patients with malaria and compared piroxicam to paracetamol and aspirin. Krudsood in Thailand studied 60 patients with uncomplicated malaria in two groups who received intravenous ibuprofen and placebo intravenous infusion. Kofoed in Guinea Bissau randomized children with uncomplicated malaria to either paracetamol or placebo. Five trials Brandts ; Hugosson ; Lell ; Matsegui ; Kofoed included children aged between one and seven years and the other five included adults. Walker included patients with ages ranging from 11 to 67 years. Only one trial included patients who had severe malaria Hemmer Three trials Hemmer ; Krishna a ; Krudsood that involved adults excluded pregnant patients. All the trials excluded patients who had underlying diseases, had taken previous effective antimalarial or antipyretic treatment close to the time of entry to the study, or had a history of allergy to a drug in the same class as the study drug. All trials that included children included those of an age susceptible to febrile convulsion, mainly between the ages of six months and six years. Kofoed included children up to 15 years of age. Paracetamol plus physical methods versus physical methods alone Brandts Ibuprofen plus physical methods versus placebo plus physical methods Matsegui Paracetamol plus quinine versus quinine alone Krishna a. Metamizol plus physical methods versus naproxen plus physical methods versus physical methods alone Lell Piroxicam versus aspirin versus paracetamol Walker For purposes of meta analysis and reporting of data in an additional tables Table 2 , we subdivided the trials into three groups:. We did not find any trials that directly compared an antipyretic drug to physical methods for the group of patients of interest to the review. Our primary outcomes on FCT and PCT were defined and assessed in such a way that we could extract data on them from seven trials but only two trials Krishna a ; Matsegui assessed the outcomes and reported the data in a way that permitted a meta analysis. Lell ; Brandts and Krishna b assessed these outcomes but did not report the respective standard deviations to permit meta analysis. One trial Hemmer reported the FCT as the median with the range. Krudsood reported PCT in a similar manner with median and range. Hugosson assessed the proportion of patients who had experienced parasite clearance at 72 hours post treatment. However this outcome must be interpreted in light of the fact that this trial included the administration of an effective antimalarial agent which was taken by the patients in both groups that are of relevance to this review. Two trials measured axillary temperatures Hugosson ; Kofoed , three trials measured oral temperatures Krishna a ; Krishna b ; Krudsood while three trials measured rectal temperatures Brandts ; Lell ; Matsegui The site of temperature measurement was not reported in two trials Hemmer , Walker This has permitted the inclusion of Krishna b and Walker in this review as these trials were excluded from the previous version of this review. All the trials were described as randomized. See Figure 1 and Figure 2. Methodological quality summary: review authors' judgments about each methodological quality item for each included study. Methodological quality graph: review authors' judgments about each methodological quality item presented as percentages across all included studies. Generation of allocation sequence: four trials stated the method of generation of allocation sequence; Brandts ; Krudsood ; Lell used a table of random numbers while Matsegui used computer generated random numbers. Generation of allocation sequence was unclear in the other studies although they were described as randomized. Allocation concealment: this was adequate in three trials Hemmer ; Matsegui ; Kofoed in which sealed envelopes were used or randomization numbers kept separately and unclear in the other trials. Krishna a and Walker were open trials. Three trials Krishna b ; Matsegui ; Krudsood were double blinded trials where the participants and study personnel were blinded. In Hugosson , outcome assessors only were blinded. Kofoed did not explicitly state who was blinded but described the administration of numbered boxes that had paracetamol or indistinguishable placebo tablets. Blinding was not feasible in the other trials as they included dissimilar comparisons of antipyretics versus mechanical methods. A range of primary outcomes was reported by the trials. However, they reported primary and secondary outcomes specified in the methods section of the trials. It was not clear if the trials had other sources of bias such as early stopping, influence of funders and deviation from trial protocol. With regard to funding, most of the trials were funded by university research project grants although the trialists did not explicitly state that the funders had no role in the design, analysis and interpretation of the trial findings. Three trials Walker Krudsood ; Kofoed were funded by the pharmaceutical companies who manufactured the drugs used for the trial. In Krudsood , the funders played a role in trial design, data collection and analysis as well as approval of the published report although the authors claim autonomy to the contents of the report. We have judged this as high risk in these two trials. However in Kofoed the authors explicitly stated that the funders had no role in the design, analysis and interpretation of trial data. We assessed eight trials under this comparison group Brandts ; Hemmer ; Hugosson ; Lell ; Krishna a ; Matsegui ; Krudsood ; Kofoed This was measured in a variety of ways: FCT the time between onset of treatment and sustained resolution of fever without recurrence during same illness and fever time FT duration in hours that a patient's temperature was above an indicated fever threshold. Krishna a did not detect a difference 60 versus 44 hours; mean difference MD Hemmer and Brandts reported no difference detected although they provided no measures of variance. Matsegui reported a difference ibuprofen However, this difference was not statistically significant. We are unable to include this in a meta analysis because the trialists did not report standard deviation or standard error. Krudsood reported that time from onset of treatment to fall of the mean temperature below The temperature values were However, these trials did not specifically define FCT. Kofoed did not report FCT. Krudsood PCT was also delayed in the antipyretic arm. In the ibuprofen treatment group, it was in the range of While in the placebo treatment group, it was in the range of In Matsegui , PCT was shorter in the ibuprofen group In view of the high statistical hetrogeneity and clinical heterogeneity , we opted to report the meta analysis graph without the pooled estimate of effects Analysis 1. Hemmer provided no data but reported that PCT did not differ between the aspirin group and controls. Comparison 1 Antipyretic drugs versus no antipyretic drug or placebo, Outcome 2 Parasite Clearance Time. There was no significant difference in the two groups. Kofoed reported that 19 out of patients who were randomized to paracetamol against 21 out of patients randomized to placebo still had parasites three days after treatment early treatment failure. These results were not statistically significant. Hemmer and Matsegui assessd this outcome and reported no significant difference in length of hospital stay between the treatment groups. Headache: One trial reported that paracetamol alleviated headache but gave no data or comparative analysis Krishna a. Convulsions: One trial reported the occurrence of convulsions in one participant Matsegui ; this was seen as an adverse event and led to the exclusion of the participant from the trial. Kofoed reported that two paracetamol patients as against six placebo patients had convulsions following treatment. However this difference was not statistically significant. Krishna a reported adverse effects such as urticarial rash, abdominal pain and diarrhoea. Seven of the 25 patients who received ibuprofen in the Matsegui trial had adverse events. The events that were reported included vomiting, headache, abdominal pain, fatigue, diarrhoea, cough, fever and conjunctivitis. One child in the ibuprofen group experienced convulsions. The trialists noted that the incidence of adverse events was not statistically different between the ibuprofen and placebo groups. The number of patients who experienced an adverse effect, such as gastrointestinal disorders abdominal pain and respiratory disorders nasal congestion , on receiving Ibuprofen was similar to those who received placebo in Krudsood None of the patients in both treatment arms reported a gastrointestinal haemorrhage. There was no report on adverse events in the Hemmer trial, which included aspirin. We assessed two trials Krishna b and Walker under this comparison group. The trialists in Krishna b assessed mean temperature response for which they reported that the mean temperature nadir was significantly lower in the ibuprofen group compared to the paracetamol group. Walker reported that there was no difference in mean FCT between the patients treated with paracetamol, piroxicam or acetylsalicylic acid, but did not give any data. Walker reported no difference between the three groups in the trial, but no data was given. Krishna b reported that alleviation of headache by ibuprofen was sustained over a longer period of time than paracetamol. Paracetamol did not abolish headache in all patients and the incidence of headaches increased after one hour of symptomatic improvement. Walker reported the effect of the study medications on mean ache scores for generalized joint aches. A similar trend was also observed for mean headache scores except that there was still residual headache by Day 4 in all the groups, which was cleared by Day 7. Krishna b reported adverse effects such as urticarial rash, abdominal pain and diarrhoea. Walker reported adverse events like diarrhoea in one patient who received piroxicam, abdominal discomfort, dizziness and itching. The trialists reported that there were no statistically significant differences between drug treatments in the incidence of the reported adverse events. The major objective of this review was to ascertain from reliable research whether antipyretic measures impact on the treatment of malaria. Biological theory led researchers to ask if fever control could prolong parasitaemia and do harm in patients with malaria. We set out to confirm or refute our apriori hypotheses. We were unable to demonstrate a clinically meaningful or statistically significant effect of the antipyretic drugs under review on FCT and PCT. This was mainly due to the small size of the studies, and the level of heterogeneity between them. For FCT ie time to sustained resolution of fever during an episode of malaria , most trials did not detect an impact of antipyretic drugs on this outcome. As regards our hypothesis that antipyretic measures do not prolong malaria parasitemia, we are unable to make any meaningful conclusion as we found an inconsistent pattern of the effects of antipyretics on this outcome. Some of the trials reported no significant difference in PCT while others found a significant difference due to the fact that antipyretics prolonged PCT. Also statistical and clinical heterogeneity made it inappropriate to pool data from the included studies. Many clinicians treat febrile children with antipyretics because of the risk of febrile convulsions Strengell , and we had hoped to inform this practice by seeking data that would either support or discourage this practice. However, trials were too small to examine the incidence of febrile convulsions and most of the included trials did not report this outcome. In Kofoed , more patients in the placebo arm had convulsions but this was not statistically significant. Only one participant in the Matsegui trial had a convulsion. We found insufficient data to show whether the antipyretic effects of ibuprofen and paracetamol differed significantly when used to treat fever in patients with malaria. Only one trial with few participants reported this comparison; there is a need for this to be replicated in larger, better powered trials. The studies we included in this review were mostly for patients with uncomplicated P. The studies did not assess the effect of antipyretics in severe malaria, as severe illness was an exclusion criteria in almost all of the studies. We therefore cannot answer the question as to the benefit or otherwise of antipyretic intervention in this group of patients. Therefore, we are unable to comment on the superiority or otherwise of antipyretic drugs over physical methods or vice versa. Some of the trials used physical methods in both the treatment and control arms as the baseline standard of care. This review included data from randomized controlled trials but about half did not report the method of randomization. The quality of the evidence for fever clearance time and parasite clearance time was categorised as 'very low'. Fever management in malaria with antipyretic drugs remains a common practice in both mild and severe disease. There is currently insufficient evidence to recommend a change in practice. This review shows that evidence on potential harms of using antipyretic drugs in the treatment of malaria is scanty. It highlights a significant gap in knowledge and lack of reliable data to inform a common clinical practice for a disease that affects several millions of people every year. Additional research evidence will be needed to draw reliable conclusions on the questions addressed in this review. There is also a need for primary research to assess the effects of antipyretic measures on the treatment of fever in severe malaria. An important outcome to incoporate into these trials would be the patients' views with regard to antipyretics leading to faster resolution of symptoms. The funders take no responsibility for the data presented or the views expressed. Comparison 1 Antipyretic drugs versus no antipyretic drug or placebo, Outcome 1 Fever Clearance Time. Comparison 1 Antipyretic drugs versus no antipyretic drug or placebo, Outcome 3 Mean drop in temperature within first 6 hrs of starting treatment. Comparison 1 Antipyretic drugs versus no antipyretic drug or placebo, Outcome 4 Length of Hospital stay. Clinical response to multiple doses of mg of IV ibuprofen versus placebo assessed as the area above the FCT defined as duration in hours from admission to the first time a patient's temperature stabilized below an indicated fever threshold. PCT time in hours from admission until the first of two consecutive negative thick blood smears. Scores were reported and used to evaluate progression of clinical symptoms headache, arthralgia. Bridget Nwagbara and Chibuzo Odigwe performed data extraction. Martin Meremikwu and Chibuzo Odigwe performed data analysis. All the authors contributed to the preparation of the review. Provides salary cost for Prof Martin Meremikwu and office space, electricity and other utilities for the four authors based in Nigeria. We certify that we have no affiliations with or involvement in any organisation or entity with a direct financial interest in the subject matter of the review eg employment, consultancy, stock ownership, honoraria, expert testimony. As a library, NLM provides access to scientific literature. Cochrane Database Syst Rev. Find articles by Martin M Meremikwu. Find articles by Chibuzo C Odigwe. Find articles by Bridget Akudo Nwagbara. Find articles by Ekong E Udoh. Collection date Sep. This article is an update of ' Antipyretic measures for treating fever in malaria. Moderate quality: Further research is likely to have an important impact on our confidence in the estimate of effect and may change the estimate. Low quality: Further research is very likely to have an important impact on our confidence in the estimate of effect and is likely to change the estimate. Very low quality: We are very uncertain about the estimate. Open in a new tab. Krishna b No difference in adverse events one in the ibuprofen group and one in the paracetamol group. Walker No statistically significant difference in the three treatment arms in the number of reported adverse effects. Krudsood No significant difference in incidence of adverse events were noted between the ibuprofen and placebo groups. A total of 31 adverse events were reported in 26 patients with 16 of the adverse events reported by 14 patients who received ibuprofen and 15 reported by 12 patients who received placebo. GI disorders particularly abdominal pain was the commonest. No GI hemorrhage was noted. Date Event Description 29 May New search has been performed New search and seven new studies added. Author team changed. GRADE has been used to grade the evidence. Review methods slightly changed to allow inclusion of trials with head to head comparison of antipyretic drugs. Outcome or subgroup title No. Methods Randomized from random numbers table. Allocation concealment unclear, unblinded. Informed consent was sought from patients. Participants 50 children with uncomplicated P. Study was conducted in Gabon, West Africa. B control : mechanical antipyretic therapy as above without paracetamol. Methods Randomized, method of randomization not specified, separate randomization for complicated and uncomplicated. Allocation adequately concealed in sealed envelopes by another department Blinding was unclear. Heparin group excluded. All were treated in Hamburg, Germany 18 African, 79 European. All had history of fever 1 to 30 days. Interventions Antipyretics: Control: No antipyretic. Methods Randomized, unblinded, method of randomization not stated. Concealment of allocation unclear. Attrition not clearly stated. All had uncomplicated malaria with fever. Patients were excluded if they had any of the signs of severe malaria eg. Group B: Single dose of 1. Methods Randomized controlled trial Participants Children aged between 3 and months, weighing at least 7. Patients were excluded if they had convulsions, severe vomitting, severe anemia, severe concurrent infection or needed hospital care for any other reason. Outcomes Early treatment failure, late parasitological failure, adequate clinical and parasitologial response PCR adjusted , incidence of convulsions. Other bias Unclear risk No information provided on this. The study was approved by the ethical review subcommittee of the Ministry of Health, Tanzania. Participants 14 patients were included out of 21 adults 7 per group. All had uncomplicated P. Methods Randomized, double blind trial. Method of randomization not stated. Participants 16 patients with uncomplicated P. Patients enrolled into the study had uncomplicated P. Outcomes Clinical features, which included temperature responses to ibuprofen and paracetamol Parasite clearance Adverse events Notes Outcome assessments were not reported in a way that would allow for a meaningful analysis of its results in the context of this review. Other bias Unclear risk No information. Randomization was done using table of random numbers. Allocation concealment was not stated. This study and its report were supported by Cumberland Pharmaceuticals Inc. Nashville, TN. Informed consent was obtained before enrolment into the trial. Participants 60 patients with uncomplicated malaria. Patients were included if they had microscopically proven P. Outcomes Primary Endpoints Clinical response to multiple doses of mg of IV ibuprofen versus placebo assessed as the area above the Secondary Endpoints P. They also approved the study for publishing although the authors claim autonomy for contents of the report. Methods Randomized controlled trial. Generation of allocation sequence was done using a table of random numbers. Participants 90 children with uncomplicated P. Outcomes FCT defined as duration in hours from admission to the first time a patient's temperature stabilized below an indicated fever threshold. FT duration in hours that individuals temperature was above an indicated fever threshold. Immunological markers cytokines and oxygen free radicals. Notes This study investigated metamizole dipyrone which has been banned by the National regulating bodies of many countries because of its risk of agranulocytosis. Methods Randomized double blind placebo trial. Method of randomization was computer generated. Allocation was concealed using sealed envelopes. Per protocol analysis was done for primary outcome while intention to treat analysis was done for adverse effects. Three participants were withdrawn one had a convulsion after randomization and two violated the protocol. Some form of support was obtained from the University of Tubingen, Germany. Aged 2 to 7 years. Gabon, West Africa. Outcomes Primary outcomes : Fever clearance time in hours at a threshold of Methods Open randomized controlled trial. Method of sequence generation unclear, no allocation concealment Study was conducted in Nigeria. Study was funded by Pfizer. Participants participants were randomized. Participants were aged between 11 and 67 years, and all had parasitologically proven P. Three patients were subsequently withdrawn because of associated sickle cell anemia and parasitological failure of antimalarial drug, leaving for analysis. Exclusion criteria for this trial included: history of allergy or hypersensitivity to analgesics, peptic ulceration or significant gastrointestinal disease, renal or hepatic failure, history of alcoholism or drug abuse, concurrent medication with anticoagulants or lithium, presence of any febrile illness in addition to malaria or chronic musculoskeletal disease or sickle cell disease. Study Reason for exclusion Agbolosu Randomized trial of paracetamol versus tepid sponging, but Aksoylar Randomized trial of tepid sponging versus antipyretic drugs but participants did not have malaria. Fasan Clinical trial of a combination of paracetamol and chloroquine; included no placebo or mechanical antipyretic group. Ismail Randomized trial of paracetamol in regimens of artemisinin derivatives; did not compare paracetamol with placebo or mechanical antipyretic group. Mahar Open randomized comparison of paracetamol and tepid sponging; participants had fever of presumed viral origin and not malaria. Newman Not confirmed malaria patients. Sharber Randomized trial but both arms received paracetamol alone or with tepid sponging. Steele Not confirmed malaria patients. Tarimo Compared sulphadoxine and pyremethamine with chloroquine. Thomas Randomized trial but had paracetamol in both arms. Compared paracetamol only with paracetamol and tepid sponging. Similar articles. Add to Collections. Create a new collection. Add to an existing collection. Choose a collection Unable to load your collection due to an error Please try again. Add Cancel. Antipyretic drugs compared to no antipyretic drug or placebo for treating fever in malaria. CI: Confidence interval;. Brandts Hemmer No significant difference in defervescence time in the two groups. Hugosson Krishna b. The reduction in fever by ibuprofen was significantly greater than that in paracetamol. Lell Walker No difference in mean FCT between the patients treated with paracetamol, piroxicam or acetylsalicylic acid. Krudsood Time for the mean temperature to fall below Parasite clearance time was significantly longer in the paracetamol teatment group. No significant difference in parasite clearance in the two groups. No significant difference in parasitaemia reduction in the two groups. PCT was longer in the ibuprofen treated group compared to the placebo group. Fever time was significantly lower in the naproxen group than for those in metamizol and mechanical antipyretic groups at wide range of fever tresholds 4. Matsegui Occurence of adverse effects was similar in the ibuprofen and placebo group 7 versus 9 respectively. No difference in adverse events one in the ibuprofen group and one in the paracetamol group. No statistically significant difference in the three treatment arms in the number of reported adverse effects. No significant difference in incidence of adverse events were noted between the ibuprofen and placebo groups. New search and seven new studies added. Randomized from random numbers table. Three participants reported as withdrawn from the treatment group and reasons for withdrawal given; one from the paracetamol treatment group and two from the mechanical antipyretics control group. However data on 47 patients were available for per protocol analysis. Randomized, method of randomization not specified, separate randomization for complicated and uncomplicated. Antipyretics: Control: No antipyretic. Randomized, unblinded, method of randomization not stated. For purposes of this review, we were interested in extracting data for the patients in the sulphadoxine pyrimethamine alone group versus the sulphadoxine pyrimethamine plus paracetamol group. Children aged between 3 and months, weighing at least 7. Early treatment failure, late parasitological failure, adequate clinical and parasitologial response PCR adjusted , incidence of convulsions. Randomization numbers were kept separately at the Department of Pediatrics in Kolding, Denmark. Although we do not have the protocol, we have no reason to believe the authors selectively reported the study outcomes. Randomized, double blind trial. Clinical features, which included temperature responses to ibuprofen and paracetamol Parasite clearance Adverse events. Outcome assessments were not reported in a way that would allow for a meaningful analysis of its results in the context of this review. Primary Endpoints Clinical response to multiple doses of mg of IV ibuprofen versus placebo assessed as the area above the Table of random numbers was used for allocation sequence generation. Double blinding patients, investigators, nursing staff and study monitoring staff, including microscopists, were all blinded to study treatments. Only one patient withdrew from the study due to social reasons. Funders played a role in study design, data collection and analysis. Randomized controlled trial. This study investigated metamizole dipyrone which has been banned by the National regulating bodies of many countries because of its risk of agranulocytosis. No attrition was reported as the children were seen to have all recovered completely. Randomized double blind placebo trial. Primary outcomes : Fever clearance time in hours at a threshold of Three participants were withdrawn and the reasons were stated. Open randomized controlled trial. Three patients were excluded from the study and reason for exclusion was stated and they were not randomized into any of the groups. Agbolosu Randomized trial of paracetamol versus tepid sponging, but Aksoylar Randomized trial of tepid sponging versus antipyretic drugs but participants did not have malaria. Fasan Clinical trial of a combination of paracetamol and chloroquine; included no placebo or mechanical antipyretic group. Ismail Randomized trial of paracetamol in regimens of artemisinin derivatives; did not compare paracetamol with placebo or mechanical antipyretic group. Kramer Mahar Open randomized comparison of paracetamol and tepid sponging; participants had fever of presumed viral origin and not malaria. Newman Nwanyanwu Sharber Randomized trial but both arms received paracetamol alone or with tepid sponging. Steele Tarimo Compared sulphadoxine and pyremethamine with chloroquine. Randomized trial but had paracetamol in both arms.

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