Treatment of Schistosoma Mekongi with Praziquantel: a Double-Blind Study *

Nash, Tony; Hofstetter, M.; Cheever, Allen W.; Ottesen, Eric A.

doi:10.4269/ajtmh.1982.31.977

Cited by 17 publications

(6 citation statements)

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“…Studies based on fewer Kato-Katz thick smears are more likely to overestimate cure rate and be less diagnostically sensitive to detect any differences in dose comparisons. Two small studies carried out in the 1980s on S. mekongi infection reported high cure rates with 60 mg/kg PZQ (90.9% and 97.5%, respectively) [5], [6] when analyzing 2–3 stool specimens but using different stool diagnostic techniques (Kato-Katz+modified Ritchie's and Stoll's, respectively). Similarly in a recent multi-country randomized trial comparing single 40 mg/kg and 60 mg/kg PZQ in children aged 10–19 years, with infections diagnosed by two stool specimens (duplicate Kato-Katz thick smears per specimen), the 21-day posttreatment follow-up was reported as 92.8% with 60 mg/kg, which was not a significant improvement against S. mansoni , S. haematobium , or S. japonicum infections compared to the standard 40 mg/kg [31].…”

Section: Discussionmentioning

confidence: 99%

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Efficacy of Praziquantel against Schistosoma mekongi and Opisthorchis viverrini: A Randomized, Single-Blinded Dose-Comparison Trial

et al. 2012

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BackgroundSchistosomiasis and opisthorchiasis are of public health importance in Southeast Asia. Praziquantel (PZQ) is the drug of choice for morbidity control but few dose comparisons have been made.MethodologyNinety-three schoolchildren were enrolled in an area of Lao PDR where Schistosoma mekongi and Opisthorchis viverrini coexist for a PZQ dose-comparison trial. Prevalence and intensity of infections were determined by a rigorous diagnostic effort (3 stool specimens, each examined with triplicate Kato-Katz) before and 28–30 days after treatment. Ninety children with full baseline data were randomized to receive PZQ: the 40 mg/kg standard single dose (n = 45) or a 75 mg/kg total dose (50 mg/kg+25 mg/kg, 4 hours apart; n = 45). Adverse events were assessed at 3 and 24 hours posttreatment.Principal FindingsBaseline infection prevalence of S. mekongi and O. viverrini were 87.8% and 98.9%, respectively. S. mekongi cure rates were 75.0% (95% confidence interval (CI): 56.6–88.5%) and 80.8% (95% CI: 60.6–93.4%) for 40 mg/kg and 75 mg/kg PZQ, respectively (P = 0.60). O. viverrini cure rates were significantly different at 71.4% (95% CI: 53.4–84.4%) and 96.6% (95% CI: not defined), respectively (P = 0.009). Egg reduction rates (ERRs) against O. viverrini were very high for both doses (>99%), but slightly lower for S. mekongi at 40 mg/kg (96.4% vs. 98.1%) and not influenced by increasing diagnostic effort. O. viverrini cure rates would have been overestimated and no statistical difference between doses found if efficacy was based on a minimum sampling effort (single Kato-Katz before and after treatment). Adverse events were common (96%), mainly mild with no significant differences between the two treatment groups.Conclusions/SignificanceCure rate from the 75 mg/kg PZQ dose was more efficacious than 40 mg/kg against O. viverrini but not against S. mekongi infections, while ERRs were similar for both doses.Trial RegistrationControlled-Trials.com ISRCTN57714676

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Section: Discussionmentioning

confidence: 99%

“…However there have been just two small published clinical trials on PZQ cure rates against Schistosoma mekongi [5], [6]. Both were non-randomized studies involving individuals relocated to non-endemic areas and given 60 mg/kg PZQ divided into two or three doses.…”

Section: Introductionmentioning

confidence: 99%

Efficacy of Praziquantel against Schistosoma mekongi and Opisthorchis viverrini: A Randomized, Single-Blinded Dose-Comparison Trial

et al. 2012

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“…S. mekongi , as well as other forms of schistosomiasis, is generally treated with the drug praziquantel [19] , [20] . Single dose cure rates for S. mekongi in one study of schoolchildren were 75.0% and 80.8% for 40 mg/kg and 75 mg/kg doses [19] .…”

Section: Discussionmentioning

confidence: 99%

Rectal carcinoma arising in a patient with intestinal and hepatic schistosomiasis due to Schistosoma mekongi

Burky

Trembath

Bookhout

2022

IDCases

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Schistosomiasis is a parasitic trematode infection spread by snails with multiple species causing human disease. Infection can cause liver disease, including fibrosis and portal hypertension, and has been linked to malignancies such as bladder and colorectal cancer. We describe a case of Schistosoma mekongi, a geographically limited form of schistosomiasis, in a Laotian immigrant who presented with both hepatic fibrosis and rectal cancer, with numerous schistosome eggs present in the patient’s rectal resection. We believe this case is the first report of a rectal carcinoma arising in the setting of S. mekongi infection.

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“…The search retrieved 3202 studies; 3047 studies from electronic databases and 155 studies from other sources including grey literature and contacts with experts. Seventy-three ( 73 Ninety-four of the 134 studies (70.1%) were conducted in Africa; 17 studies (12.7%) in Asia of which eight were conducted in Philippines (Belizario et al 2007;Olds et al 1999c;Olliaro et al 2011c;Olveda et al 2016;Santos et al 1979;Santos et al 1984;Watt 1986;Watt et al 1988), seven in China (Fu-Yuan et al 1984;Hou et al 2008;Minggang et al 1983;Minggang et al 1985;Ming-he 1991;Olds et al 1999a;Qian 2016), one in Japan (Ishizaki 1979) and one in Thailand (Na-bangchang et al 2006); 15 studies (11.2%) were conducted in the Americas, 14 in Brazil Carvalho et al 1984;Coutinho et al 1983;Da Cuhna et al 1987;da Cunha and Pedrosa 1986;da Silva et al 1981;da Silva et al 1986;de Quieroz et al 2010;Ferrari et al 2003;Katz et al 1979;Katz et al 1982;Katz et al 1983;Olliaro et al 2011a) and one in the USA (Nash et al 1982); four studies (3.0%) in the Middle East, two in Saudi Arabia (Al-Aska et al 1990;Azher et al 1990), one in Israel (Cherit et al 2014) and one in Yemen (Groning et al 1985); and three studies (2.2%) in Europe, one each France, Germany and Spain (Bagheri et al 2004;Bada et al 1988) (Table 1<...>…”

Section: Description Of Studiesmentioning

confidence: 99%

Safety of praziquantel in persons with and without schistosomiasis: systematic review and meta-analysis

Danso‐Appiah

Owiredu

Akuffo

et al. 2022

Preprint

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Background Millions of praziquantel doses have been delivered in schistosomiasis endemic populations through preventive chemotherapy. However, no comprehensive assessment of short and long-term safety has been conducted. This systematic review assessed safety of praziquantel in persons with and without schistosome infections who received praziquantel treatment. Methods We identified relevant studies (published, unpublished, in press or preprint) that assessed safety of praziquantel without language restriction. We searched MEDLINE, EMBASE, CINAHL, and LILACS from 1978 to 31st October 2021, using well-formulated and piloted search strategy. We also searched the Cochrane Infectious Diseases Group Specialized Register, CENTRAL (The Cochrane Library 2021), mRCT, Google Scholar, Hinari and Africa Journals Online. References of relevant studies were checked and experts were contacted for additional studies. One author searched and managed the search output. Two authors selected studies, extracted data and assessed quality of the included studies for risk of bias. Activities at all stages were checked independently by a third reviewer. Discrepancies were resolved through discussion among the authors. Data were analysed with RevMan v5.4 and STATA v17. Binary outcomes were reported as risk ratio using random-effects model and continuous outcomes as mean difference, all presented with their 95% confidence intervals. P-value was set at 0.05. Heterogeneity was assessed using I2-static and where possible sensitivity analysis was conducted. When pooling of data was not possible, we presented data in a narrative synthesis and as tables. Main results The search retrieved 3202 studies of which 134 met the inclusion criteria; 94 (70.1%) were conducted in Africa, 17 (12.7%) in Asia, 15 (11.2%) in the Americas (14 from Brazil), 4 (3.0%) in the Middle East and 3 (2.2%) in Europe. Praziquantel mostly resulted in mild-to-moderate and transient adverse events, however, majority of the included studies had design issues, including very short follow-up times (mostly few hours) for assessing incidence of adverse events. Less than <10% of the studies reported severe or serious adverse events. The subgroup analyses of twenty studies comparing school age children (SAC) and adults, and involved over one million participants found no difference in the nature of adverse events, but SAC experienced higher incidence than adults: headache (RR 3.07, 95% CI 2.32 to 4.06, twenty studies, I2 = 98%, p < 0.00001), dizziness (RR 1.80, 95% CI 1.36 to 2.37, p = 0.0001), vomiting (RR 2.43, 95% CI 1.87 to 3.14, I2 = 98%; p < 0.00001), four time for abdominal pain (RR 3.97, 95% CI 3.09 to 5.10, I2 = 96%, p < 0.00001), nausea (RR 1.67, 95% CI 1.32 to 2.12, I2 = 97%, p < 0.0001), general discomfort (RR 1.32, 95% CI 1.03 to 1.68, I2 = 97%, p < 0.00001), fever (RR 4.78, 95% CI 3.04 to 7.52, I2 = 98%, p < 0.00001), diarrhoea (RR 1.41, 95% CI 1.12 to 1.78, I2 = 92%, p < 0.00001), itching (RR 2.42, 95% CI 1.58 to 3.70, I2 = 93%, p <0.0001) and breathing difficulty (RR 2.46, 95% CI 1.41 to 4.29, I2 = 92%, p = 0.002). There was no statistically significant difference in incidence of swelling. Some of the studies that assessed safety in pregnant women reported serious events including miscarriages, foetal deaths and congenital anomalies, but the evidence is incoclusive given the limited numbers. Some studies reported praziquantel-related visual adverse events, but evidence is limited and remains inconclusive. There was paucity of data on long term adverse events, and events in co-morbidity, polypharmacy, co-infection with taeniasis. Generally, adverse events research in this area lacked methodological rigour. Conclusions The evidence generated from this review involving millions of people and millions of doses from different geographic locations with mostly mild-to-moderate and transient adverse events shows praziquantel is safe. However, given that the primary studies included in the review had design issues, including over 95% assessing adverse events over very short follow-up times, means serious long-term adverse events would have been missed. Also, the fact that some pregnant women who received praziquantel experienced serious events including miscarriages, foetal deaths and congenital anomalies calls for caution in the inclusion of pregnant women, particularly in their first trimester, in preventive chemotherapy campaigns. Additionally, the studies that reported severe visual adverse events raise safety concerns. Praziquantel is now offered repeatedly in endemic communities and the fact that in some settings up to 90% of those without infection could be offered the drug and the fact that there was no study that compared safety between infected and non-infected recipients, warrants further research. Evidence on safety in pregnant women and their foetuses, co-morbidity, polypharmacy, co-infection with taeniasis, as well as co-administration with drugs used in other preventive chemotherapy programmes, remain inconclusive and further research with long follow-up that should include blood chemistry analysis to provide additional evidence on long term safety, is warranted. This systematic review has exposed the lack of methodological rigour in adverse events studies and recommends future research should use robust and standardized design, methods, conduct and reporting.

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Treatment of Schistosoma Mekongi with Praziquantel: a Double-Blind Study *

Cited by 17 publications

References 0 publications

Efficacy of Praziquantel against Schistosoma mekongi and Opisthorchis viverrini: A Randomized, Single-Blinded Dose-Comparison Trial

Efficacy of Praziquantel against Schistosoma mekongi and Opisthorchis viverrini: A Randomized, Single-Blinded Dose-Comparison Trial

Rectal carcinoma arising in a patient with intestinal and hepatic schistosomiasis due to Schistosoma mekongi

Safety of praziquantel in persons with and without schistosomiasis: systematic review and meta-analysis

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