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Ukw Thera. 2024; 24(10): 1-22. Published Online 2024 October 16
UkwSciID: USThera3
INTERMITTENT PREVENTIVE TREATMENT USING SULPHADOXINE-PYREMETHAMINE (SP) IS MORE SUPERIOR FOR ALLEVIATING PLACENTAL PARASITEMIA, MATERNAL ANEMIA, AND ADVERSE OUTCOMES IN PREGNANCY IN SUB-SAHARA AFRICA: A SYSTEMATIC REVIEW AND META-ANALYSIS
Edmund Ikpechi Ukwuru, and Onyinye Lydia Okeke
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1, 2
Ukwuru, E.I. and . (2024). Intermittent Preventive Treatment using Sulphadoxine-Pyremethamine (SP) is more superior for alleviating Placental Parasitemia, Maternal Anemia, and Adverse Outcomes in Pregnancy in Sub-Sahara Africa: A Systematic Review and Meta-Analysis. Ukwuru Therapeutics, 24(10): 1-22.
Abstract
Background
Efforts to prevent malaria in pregnancy and any adverse outcomes that might emerge, led to the policy on Intermittent preventive treatment in pregnancy (IPTp). Medicines such as Sulphadoxine-pyrimethamine have been the most recommended options. However, in light of growing resistance and a number of other factors, the efficacy of sulphadoxine-pyrimethamine has been questioned. This systematic review and meta-analysis set out to confirm the effectiveness of sulphadoxine-pyrimethamine for IPTp in sub-Saharan Africa.
Method
Twenty-three studies were identified from PubMed, Clinicaltrials.gov, and Google Scholar. These studies were screened using the PRISMA flowchart to identify five studies that met the eligibility criteria. Review Manager version 5.4.1 was used to carry out odds ratio and fixed effects meta-analysis. Significance was tested at 0.00001.
Findings
SP was better for preventing placental parasitaemia (Z = 6.70; p < 0.00001), maternal anaemia (p < 0.00001), and adverse outcomes (p < 0.00001), but not low-birth-weight (p=0.08).
Conclusion
Sulphadoxine-pyrimethamine is more suitable for intermittent preventive treatment in pregnancy in sub-Saharan Africa.
Recommendations
Administration of sulphadoxine/pyrimethamine should be reconsidered in favour of other treatment options for intermittent preventive therapy.
Keywords: Sulphadoxine-pyrimethamine, placental parasitemia, maternal anemia, low birth weight
Introduction
Malaria remains a major disease of concern to public health professionals. Nonetheless, in recent times, successful development of a malaria vaccine has begun to prove effective as a preventive measure. Other therapeutic approaches include the use of various types and groups of anti-malarial medicines. Generally, people who have visited or are living in tropical regions around the world are at risk of experiencing malaria (Yaro et al., 2022). This is because the pathogen is commonly spread by a vector (Mosquitoes) that is widely abundant within the tropics due to favourable environmental conditions. (Walker et al., 2017; Aguzie, 2018; Ndu et al., 2020; Kumah et al., 2022). Pregnant women within this region are potentially at risk of getting infected with malaria (Yoah et al., 2018; Anto et al., 2019; Pons-Duran et al., 2020).
Malaria in pregnancy is an important subject because it presents with various adverse outcomes that include; anemia in pregnancy, low birth weight, and miscarriage (Kakuru et al., 2016). Akin to this challenges, the need to take preventing measures has been part of the policy for preventing malaria in pregnancy. Medicines such as dihydroartemisinin piperaquine Kakuru et al. (2016); artemisinin combination therapy Gutman et al. (2021) and sulphadoxine-pyrimethamine have been used extensively. Based on the policy for prevention of malaria in pregnancy; often referred to as, intermittent preventive treatment in pregnancy (IPTp), the aforementioned medicines have served effectively (Guure and Afagbedzi, 2022; Mama et al., 2022).
Various studies have confirmed the effectiveness of sulphadoxine-pyrimethamine (SP) for IPTp (Fehintola and Balogun, 2012; Peter, 2013). Contrasting findings have been identified by Tan et al. (2014) noting that SP resistance has emerged in Zambia, and pregnant women still presented with parasitemia. Similar observations were identified by Gutman et al. (2013) among pregnant women in Malawi; however, the medicine resulted in improved birth outcomes. Improvement in the outcomes of pregnancy were also identified by Anto et al. (2019) among women in sub-Saharan Africa. Also, Htay et al. (2020) confirmed the effectiveness of SP for management of IPTp.
Considering the plethora of contrasting evidences and the rising effect of resistance to antimalarials, we carried out a systematic review and meta-analysis to assess the effectiveness of SP for IPTp. We assessed whether using SP for IPTp could result in reduction of placental malaria, low birth weight, and anemia.
Method
Since the study involves a meta-analysis of studies, it was based on quantitative research method. The systematic process is explained below.
Search Strategy
The research framework that was adopted was the Population, Intervention, Comparator, and Outcomes (PICO). The population was pregnant women, while the intervention was the administration of SP as an IPTp. The comparator was the use of other anti-malarial medicines for IPTp. The outcomes were low birth weight, placental parasitemia, and anemia.
Keywords and Search String
Keywords were identified from the research questions, and these were used to form search strings that were implemented in the search strategy. The databases searched included; PubMed, Medline, Scopus, Web of Science, and clinicaltrials.gov. After studies were identified, they were screened in line with the requirements of the PRISMA flowchart (Figure I).
Figure I: PRISMA checklist
Twenty-three studies were identified from the databases. Five studies were included in the meta-analysis.
Critical Appraisal
The JADAD and CASP tools were used for assessing the quality of the included studies.
Data Extraction and Data Analysis
Data was extracted from the five included studies by using the PICO framework (Table 1). The data was then analysed using Review Manager version 5.4.1. Odds ratio, risk ratio, and fixed effects meta-analysis were performed. Confidence interval was set to 95%, and significance was tested at p<.00001.
Results
Description of Studies
We included five (5) studies in the meta-analysis. These studies are; Gonzalez et al. (2014), Kajubi et al. (2019), Kimani et al. (2016), Labama Otuli et al. (2019) and Mlugu et al. (2021). These five studies were mainly randomised controlled trial studies. Asides Labama Otuli et al. (2019), the other four studies had a score of five out of five points on the JADAD scale. In all four of these studies, the method of randomised controlled trials was fully adhered to. The study by Labama Otuli et al. (2019) carried out a single blinded study in which the administrators were not blinded to the administration of the medicines. In all five studies, the population type was the same; pregnant women above the age of 16 years who were receiving either sulphadoxine-pyrimethamine or another drug as an IPTp, and they were living in sub-Saharan Africa during the period of the study. The CASP analysis returned an 11 out of 11 score for all questions. The PICO characteristics of the included studies are presented on table I, while description of included studies are available on table II.
Table I: PICO Analysis of selected studies
Table II: Description of included studies
Table II
Table III: The Outcome of Intervention and Comparator of the included studies
The Effectiveness of the Treatment against placental malaria
The meta-analysis for placental malaria is statistically significant in favour of the comparator. This implies that patients or pregnant women who were administered other antimalarials as an IPTp were more likely to present with placental malaria than those who received sulphadoxine-pyrimethamine. The finding affirms that SP is still highly effective for prevention of placental malaria. Except for two studies, Gonzalez et al. (2014) and Kimani et al. (2016); the other three studies were statistically significant in favour of the comparator. Meaning that aside these two studies, the difference between the effectiveness of SP and other antimalarials used for prevention was significantly large (Figure IIA).
Table III
Figure IIA: Sulphadoxine-pyrimethamine is effective for preventing placental parasitemia
Figure IIA shows that studies by Gonzalez et al. (2014) and Kimani et al. (2016) are not statistically significant because their confidence interval arms made contact with the line of no effect. Both studies had the highest study weights 40.8% and 38.5% respectively. By making contact with the line of no effect, it implies the presence of a small margin between the effectiveness of SP and the comparator for achieving reduction in placental malaria. The overall effect of the meta-analysis given by the black diamond shows that the meta-analysis was statistically significant (Z = 6.70 (p < 0.00001)). However the studies were statistically significant for being heterogeneous [Chi2 = 36.06; degrees of freedom = 4; p < 0.00001; I2 = 89%].
The heterogeneity of the studies is high, evident from the I2 value (98%) obtained in the meta-analysis. In the funnel plot, the studies are randomly distributed but three of the studies are not within the funnel, they crossed the confidence interval arms of the funnel.
Figure IIB: Funnel plots for placental parasitaemia
Figure IIB: the studies with the highest weights; Gonzalez et al. (2014) and Kimani et al. (2016) can be seen near the top of the funnel, they are also around the confidence interval line of the funnel plot, which is a representation of their lack of statistical significance. The low weighted studies are distributed on either side of the line of average except in the case of Labama Otuli et al. (2019) (the least weighted study) which is located outside the confidence interval arm of the funnel.
The Effectiveness of the Treatments against Low birthweight
There is no statistically significant association between using SP or the comparator drugs in relation to low birthweight. This implies that the margin of difference is small, therefore, neither SP nor the comparator medicines could prevent low birthweight.
Figure IIIA: Low birth weight is neither prevented by sulphadoxine-pyrimethamine nor other medicines
Figure IIIA shows that the first three studies Gonzalez et al. (2014); Kajubi et al. (2019); and Kimani et al. (2016) made contact with the lines of average. Hence, they are not statistically significant. This has resulted in a meta-analysis that is statistically insignificant and therefore inconclusive.
The level of heterogeneity is considerably low among the studies; hence, an I square value of 68% was obtained in the meta-analysis.
Figure IIIB : Funnel Plot for Low Birth Weight
Figure IIIB: The studies are organised within the funnel, two studies are on the confidence interval arms of the funnel plot; these corresponds to Gonzalez et al. (2014) which is at the top, Kajubi et al. (2019) and Labama Otuli et al. (2019) which is at the bottom.
Effectiveness of treatments against Maternal Anaemia at Delivery
The difference is statistically significant in favour of comparator medicines (figure IVA). Meaning that pregnant women who receive comparator medicines are more likely to present with maternal anaemia at pregnancy than those who receive SP. Thus, SP should be administered as a preferred option for managing maternal anaemia.
Figure IVA: Sulphadoxine-pyrimethamine is superior for prevention of maternal anemia
Figure IVA: A statistically insignificant difference is evident for Gonzalez et al. (2014); Kimani et al. (2016); Labama Otuli et al. (2019); and Mlugu et al. (2021). This is because the studies made contact with the line of no effect. However, a statistically significant difference was obtained because the black diamond at the base did not make contact with the line of no effect. Also, because the plots are on the side that favours the comparator, it means that maternal anaemia is in favour of the comparator or associated with the comparator and this was statistically significant (p < 0.00001). The level of heterogeneity (overlap between the studies) is statistically significant; Chi-square analysis [Chi2 = 61.69; degrees of freedom = 4; p < 0.00001].
The level of heterogeneity between the studies is high (I2 = 94%). The implication is that there is evidence of potential bias between the studies or the differences is likely to arise from the sample sizes, or the nationalities included in the study.
Figure IVB: Funnel Plot for Maternal Anaemia
Figure IVB shows that Gonzalez et al. (2014); Kimani et al. (2019); and Mlugu et al. (2021) are along confidence interval arms of the funnel plot. Kajubi et al. (2019) can be seen outside the funnel plot (down right).
The Occurrence of Adverse Events due to the Drugs
There is a statistically significant difference between adverse events SP (p<.00001). Meaning that pregnant women are least likely to present with adverse events if they are administered SP.
Figure VA: Sulphadoxine-pyrimethamine is superior for reducing the number of adverse events
Figure VA shows that the studies by Labama Otuli et al. (2019) and Mlugu et al. (2021) have crossed the line of no effect; hence they are statistically insignificant. Also, asides Mlugu et al. (2021), the other four studies are on the side that favours the intervention (SP). The Z score value (11.93) for the meta-analysis is statistical significant (p < 0.00001). The level of heterogeneity is given by Chi-square analysis [Chi2 = 22.14; degrees of freedom = 4; p<0.0002]. the level of heterogeneity between the studies is statistically significant.
The heterogeneity of the studies is high (I square = 82%). The studies are distributed within the funnel plot except for the study by Labama Otuli et al. (2019) which can be spotted outside the plot.
Figure VB: Funnel Plot for Number of Adverse Events
Figure VB: The largest study is Kimani et al. (2016) and it is visible at the top. The rest of the studies are distributed beneath it. Labama Otuli et al. (2019) is visible outside the plots.
Discussion
The evidence from the analysis shows that SP is superior to the comparator medicines for preventing incidence of placental parasitemia, maternal anaemia, and adverse events but not low birth weight. The evidence is different from that of Chu et al. (2022) in which ACT was confirmed for high level of effectiveness in the prevention of any king of parasitemia in pregnancy (Relative Risk =0.46; 95% Confidence Interval 0.22 to 0.96, p=0.039; I2=90.50%, p<0.001). The difference in finding may be associated with the study locations and the number of included studies. Study location may influence the outcome of studies on the basis that malaria parasite within the location may be resistant to SP. Hence, suggestions to carry out intermittent screening and treatment were made by Olaleye et al. (2019); this proved to be effective in the administration of dihydroarminisini-piperaquine phosphate for IPTp. Findings by Muanda et al. (2015) support the claim that SP is just as effective as other medicines for preventing or failing to prevent low birth weight. Apparently, if a pregnant woman is already infected with malaria parasite, the level of virulence and pathogenicity may lead to poor birth weight that neither SP nor other medicines can correct. On the other hand, early arrest or intervention to prevent increase in infectious dose of malaria parasite may improve outcomes for patients. In addition, increasing the number of doses or adhering to the IPTp regiment may influence positive outcomes; Kayentao et al. (2013) found that pregnant women who received at least three doses of IPTp were more likely to present with favourable outcomes (RR, 0.80; 95% CI, 0.69-0.94; I 2 = 0%).
Conclusion
SP was found to be very effective in lowering incidence of placental parasitemia, maternal anemia, and adverse events but not low birth weight in pregnant women. The meta-analysis resulted in findings that address the discrepancies between studies. The quality of the included studies was addressed using the JADAD and CASP assessments. Hence, the findings of the studies are not biased by methodological limitations but by apparent differences in study location and wide discrepancies in sample size. Consistent with quantitative studies, larger studies are more reliable, and the pooled prevalence obtained from a combination of both small and large studies ensured that the findings in this study are also highly reliable. This study concludes that Sulphadoxine-pyrimethamine is better for achieving reduced placental parasitemia, maternal anemia, and adverse outcomes through intermittent preventive treatment in pregnancy in sub-Saharan Africa.
Limitations
The limitation of the study is related to the level of experience of the researcher, the study duration and the lack of sufficient time. Access to databases.
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Acknowledgements
We acknowledge the efforts of Ukwuru Science Management team and Ukwuru Science Study Group in bringing this study to reality.
Funding
Funding was provided by Ukwuru Science.
Author Information
Edmund Ikpechi, Ukwuru is the research director at Ukwuru Science Lagos. He works with a number of private organisations and individuals, consulting on public health and biomedical science research. He is also a Management Consultant and holds a Honorary Doctor of Business Administration (DBA) for his expertise in business practices.
Corresponding Author
Edmund Ikpechi, Ukwuru
Competing Interests
There are no competing interests for this study.
Rights
The publication is open for public use; credits must be provided by acknowledging the authors of the study.
Cite as
Ukwuru, E.I. and . (2024). Intermittent Preventive Treatment using Sulphadoxine-Pyremethamine (SP) is more superior for alleviating Placental Parasitemia, Maternal Anemia, and Adverse Outcomes in Pregnancy in Sub-Sahara Africa: A Systematic Review and Meta-Analysis. Ukwuru Therapeutics, 24(10): 1-22.
Received: 1 August 2024
Accepted: 1 October 2024
Published: 10 October, 2024
Keywords: Sulphadoxine-pyrimethamine, placental parasitemia, maternal anemia, low birth weight.