Synopsis pending.
Schistosomiasis is a parasite that is carried by freshwater snails. The intestinal form infects the intestine, liver and spleen and can be fatal.
The objective of this review was to assess the effects of oxamniquine or praziquantel for treating Schistosomiasis mansoni
We searched the Cochrane Infectious Diseases Group trials register, the Cochrane Controlled Trials Register, Medline, Lilacs and reference lists of articles. The Revista da Sociedade Brasileira de Medicina Tropical and Brazilian Tropical Medicine Congress abstracts were handsearched
Randomised and quasi-randomised trials comparing oxamniquine and/or praziquantel to placebo for the treatment of Schistosomiasis mansoni.
Two reviewers independently assessed trial quality and extracted data.
Thirteen trials met the inclusion criteria. Praziquantel and oxamniquine were effective in curing Schistosoma mansoni infection when compared to placebo. In Africa, praziquantel 40 mg/Kg is more effective than oxamniquine 15 mg/Kg in individuals older than 14 years (OR 3.54, 95%CI 1.70, 7.38), but no difference was found when compared with oxamniquine 30 mg/Kg (OR 0.29, 95%CI 0.08, 1.01). In Brazil, praziquantel was equally effective when compared with oxamniquine in individuals older than 14 years (OR 1.70, 95%CI 0.83, 3.49). Both drugs appear safe. There was no difference in reinfection rate between zinc supplementation and placebo (OR 0.82, 95%CI 0.47, 1.41).
Praziquantel and oxamniquine both appear to be effective for the treatment of Schistosomiasis mansoni, although lower doses of oxamniquine (less than 30 milligrams per kilogram) may not be as effective.
People become infected with Schistosoma mansoni when they come into contact with water contaminated with the parasite that is carried by freshwater snails. The disease occurs in the tropics, including countries in South America, the Caribbean, Africa, and the eastern Mediterranean (WHO 1993). Infections usually occur in recognised geographical areas, and in these sometimes 80% of inhabitants in a village may be infected (Elliott 1996).
The life cycle of Schistosoma mansoni is complicated, and it has two hosts. A particular species of snail (Biomphalaria genus) release larvae (called cercariae) into surrounding fresh water. The larvae swim seeking a host, attracted by body heat in the water. Larvae can survive up to 48 hours in water, but their infectiousness drops after four hours of leaving the snail.
The oral sucker of the larvae attaches to human skin. Enzymes assist the parasite to migrate through the epidermis into the blood stream. From here, the worms migrate along the pulmonary capillaries to enter the left side of the heart. Schistosomula - the parasite with a protective shell - are carried with the arterial blood flow through the aorta to the mesenteric arteries, splanchnic capillaries and portal veins. As schistosomula mature in the blood vessels of the liver, they pair with the opposite sex. The female is carried by the male worm, migrating against the blood flow to the mesenteric veins, where the female worms lay hundreds to thousands of eggs per day (Elliott 1996).
Schistosomiasis infects the intestine, liver and spleen. It can cause bloody diarrhoea, bloody stools, and abdominal pain (Gryseels 1992, WHO 1993). Infection of the liver and spleen causes liver fibrosis and portal hypertension which are generally irreversible in the late stages and kill patients, sometimes from haemorrhage from varices (WHO 1993). Liver failure may also occur, especially when schistosomiasis mansoni is associated with viral hepatitis (Pereira 1994).
Diagnosis of infection is through direct microscopy for parasite eggs in the stool or rectal mucosa (Rabello 1992). Quantitative methods are recommended for epidemiological purposes, because is possible to estimate the worm burden and to evaluate the impact of control programmes (WHO 1985). Among the quantitative methods of stool examination, the Kato/Katz technique is preferable, because it has the greatest capacity to concentrate eggs (Costa 1984) and the estimate of intensity of infection remains constant for periods of days and months (Rabello 1992).
Currently, doctors use either oxamniquine and praziquantel for treatment, both given by mouth, although food appears to retard absorption of oxamniquine and limits the concentration achieved in plasma (Tracy 1996). With oxaminquine, lower doses are given in South America, the Caribbean islands, and West Africa, from where the New World parasites were introduced, a single dose of 15 mg/Kg for adult patients and 20 mg/Kg for children. In other countries of Africa and the Arabian peninsula, higher doses are given, the total dose varying from 30 mg/Kg to 60 mg/Kg (Foster 1987). Differences in the susceptibility of parasites to the drug seem to account for the variation in dosage (Tracy 1996).
Development of drug-resistant parasites, poor absorption, drug malabsorption, or immunosupressed host status are involved with reduced efficacy of schistosomicidal drugs. Moreover, susceptibility to schistosomicides is related to sex and age of parasites. Adult male Schistosoma mansoni are more sensitive than are the female worms, and immature worms are more resistant to oxamniquine and praziquantel than adult worms (Brindley 1994).
As the morbidity of Schistosoma mansoni infection is associated with worm burden, chemotherapy plays an important role in the strategy of control and in the reduction and prevention of morbidity. Periodic treatment has been established as a central component of schistosomiasis control. Several useful approaches for community-based chemotherapy have been developed (WHO 1993). These include:
1. Mass treatment: Treatment of the entire population without regard to individual infection status.
2. Selective population treatment: Treatment of infected persons identified by a diagnostic survey of the entire population.
3. Selective group treatment: Treatment of all, or infected members, of a high-risk age or occupational group.
4. Phased treatment: Use of the above strategies in a sequence of progressively greater selectivity.
High prevalence areas may justify treatment of entire populations without further individual diagnosis. If there is some impact on infection, programmes can move to a selective approach (WHO 1993). However, programmes have not always had the impact that was expected. Environmental change is required to reduce exposure, and chemotherapeutic programmes are hampered by reinfection (WHO 1993).
As there was no systematic review evaluating the effectiveness of oxamniquine and praziquantel in the treatment of schistosomiasis mansoni, we decided to review the effectiveness of these two drugs, and seek information on comparative effectiveness. We also analysed the role of zinc supplementation in the prevention of Schistosoma mansoni reinfection.
1. To evaluate whether oxamniquine and praziquantel are effective in treating schistosomiasis mansoni infection.
2. To compare the effectiveness of oxamniquine and praziquantel in Schistosmiasis mansoni treatment.
3. To evaluate whether zinc supplementation is effective to prevent reinfection of Schistosoma mansoni.
Effectiveness was evaluated in terms of parasitic cure, clinical improvement and tolerability.
All randomised controlled clinical trials or pseudo-randomised (individuals or group) on oxamniquine and/or praziquantel.
Randomised controlled comparing zinc supplementation with placebo.
Any adults or children with schistosomiasis mansoni diagnosed by positive stool examination for viable eggs.
Oxamniquine or praziquantel vs. placebo.
Oxamniquine vs. praziquantel.Zinc supplementation vs. placebo
Parasitic
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Cure: The absence of viable eggs of Schistosoma mansoni in the stool or through biopsy of the rectal mucosa.
Reinfection: The presence of viable eggs of Schistosoma mansoni in successfully treated individuals.
Clinical
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a) diarrhoea
b) bloody diarrhoea
c) abdominal pain
d) spleen and liver size reductions measured by ultrasound or physical examination
Tolerability
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Adverse clinical events
a) Neurological: headache, seizures, sleepiness, dizziness.
b) Gastrointestinal: nausea; vomiting; diarrhoea; abdominal pain.
c) Systemic side-effects: skin rash; fever; myalgia; asthenia.
Laboratory
The time interval from the start of drug use to the development of biochemical abnormalities was estimated in the assessment of drug toxicity. The laboratory tests to be analysed include:
a) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and alkaline phosphatase in the serum to evaluate hepatotoxicity. Only elevations twofold the upper limit of normal were considered in the evaluation of possible drug-induced liver disease in the analysis.
b) Serum creatinine to evaluate nephrotoxicity.
The trials register of the Cochrane Infectious Diseases Group was searched for trials (published or in progress). The topic search terms used were: Schistosoma mansoni, schistosomiasis, bilharziasis, esquistossomose, schistosomicides, praziquantel, oxamniquine and zinc supplementation.
The reviewers searched The Cochrane Controlled Trials Register, published on The Cochrane Library. This is a compilation of about 224, 300 published trials identified by hand-searching by various individuals within The Cochrane Collaboration.
The following databases were also searched: MEDLINE 1966-1999; EMBASE 1988-1999; LILACS 33a January 1999, using The Cochrane search strategy described in the Cochrane Collaboration Handbook. The specific search terms used were: Schistosoma mansoni, schistosomiasis, bilharziasis, esquistossomose, schistosomicides, praziquantel, oxamniquine and zinc supplementation.
The bibliographic references of books and review articles related to schistosomiasis and tropical diseases were searched in order to find randomised controlled trials not already identified by electronic search.
In addition, the Revista da Sociedade Brasileira de Medicina Tropical and Brazilian Tropical Medicine Congress' abstracts were handsearched.
The main reviewer applied inclusion criteria to all potential studies. Independently, a second reviewer applied the same inclusion criteria. When a discrepancy occurred, a third person was asked for an opinion in order to reach consensus. Methodological quality was assessed using the standard approach of the Infectious Diseases Group (see module editorial information for details). Prespecified trial characteristics were extracted from each included study.
Studies were excluded if they reported more than 20% drop-out or were duplicate publications of a study already included.
Thirteen randomised controlled trials met the inclusion criteria. Six studies were carried out in Brazil, and seven in Africa. Follow-up period varied between 1 - 12 months. In six studies the follow-up was greater than one month. These studies were analysed separately, because in this instance there is a greater probability of understimated results because the reinfection rate may be high.
Six studies examined only children younger than 15 years old, and two other studies evaluated individuals older than 14 years old. Five studies evaluated both children and adults simultaneously. Different dosage schedules of praziquantel and oxamniquine were compared according to age. The schedules also varied according to geographic area, and the African studies used higher doses than the studies carried out in Brazil.
Stool examinations, according with Kato or Kato/Katz methods, were used as the assessment method in ten studies. The number of stool samples varied between 1-3 samples, but the results of each sample were not always reported. In Cunha et al 's trial (1986), stool examinations were performed according to Hoffman, Pons & Janer and Kato-Katz methods, and a rectal mucosa biopsy was also done.
Two clinical trials compared the effectiveness of oxamniquine with placebo (Ayele 1986, de Jonge 1991). Comparison between praziquantel and placebo was performed in two trials (de Jonge 1991, Jaoko 1996). However, the Jaoko et al' s trial evaluated only side-effects.
Clinical improvement through physical examination was evaluated in only one trial (Sukwa 1993). In this study, schoolchildren were allocated to receive praziquantel or placebo, and physical examination was performed at enrolment, and six months and twelve months after the treatment. However, the cure rate was not provided.
De Jonge et al.' s trial (1991) was carried out in individuals with mixed Schistosoma haematobium and Schistosoma mansoni infections. This study evaluated the effects of metrifonate, praziquantel, oxamniquine by measuring the serum level of circulating anodic antigens and comparing cure rate based on stool examinations.
Friis et al' s trial (1997) evaluated reinfection rate of Schistosoma mansoni after zinc supplementation in children.
The included studies did not provide clear descriptions of allocation concealment and randomisation methods. The loss of follow-up varied considerably, especially when control cure was achieved after three months of follow-up.
Five studies employed double-blind methods. In two trials, the outcome measurement was blinded, but there was no indication if the patients were blinded. Double-blind method was not described in five trials.
Dropout rate was variable. In most of the included studies, the loss to follow-up was more than 10 percent, and three clinical trials were excluded from the efficacy analysis because the loss was more than 20 percent after three months of follow-up. These studies were included in the analysis of tolerance, because such analysis was performed from 1-7 days after treatment, when the drop-out was minimal.
Any drug versus placebo
Two clinical trials compared oxamniquine (60 mg/kg) with placebo (Ayele 1986, de Jonge 1991), showing the drug to be effective (OR 17.7, 95% CI 9.0, 34.6). The de Jonge trial included patients with mixed Schistoma haematobium and Schistosoma mansoni infections.
Only one clinical trial compared praziquantel (40 mg/Kg) with placebo (de Jonge 1991). As mentioned above, infections in this trial were mixed haematobium/mansoni, and cure in mansoni was higher than in the placebo group (OR 13.10, 95%CI 4.71, 36.44).
Praziquantel versus oxamniquine - parasitological cure after 1 month
One clinical trial comparing praziquantel 40 mg/Kg with Oxamniquine 20 mg/Kg in an area where cure rate with praziquantel is low was evaluated. Parasitological cure was higher in the group using oxamniquine 20 mg/Kg than Praziquantel 40 mg/Kg. This difference was statistically significant (OR 0.17, 95%CI 0.09, 0.34).
The comparison between praziquantel 40 mg/Kg with oxamniquine in the dosage of 15 mg/Kg was reported in the Taddese trial. Here, praziquantel had a higher cure rate than oxamniquine (OR 3.54, 95%CI 1.70, 7.38). When the dosage of oxamniquine was increased to 30 mg/Kg, the numbers are such that no difference was detected between praziquantel and oxamniquine (OR 0.29, 95%CI 0.08, 1.01).
Only one clinical trial evaluated praziquantel in the dosage of 40 mg/Kg with oxamniquine in the dosage of 60 mg/Kg in mixed Schistosoma haematobium and Schistosoma mansoni infections. Again, numbers were such that there was no statistically significant difference shown (OR 1.87, 95%CI 0.85, 4.09).
Praziquantel versus oxamniquine - parasitological cure at 3 months or more
In adults, praziquantel 40 mg/Kg was more effective than oxamniquine 15 mg/Kg (OR 2.06, 95%CI 1.32, 3.22) (Taddese 1988). However, there was no difference when praziquantel 40 mg/Kg was compared with oxamniquine 30 mg/Kg (OR 0.59, 95%CI, 0.34, 1.01) (Taddese 1988).
Higher dosage of praziquantel (between 50 mg/Kg and 70 mg/Kg) did not result in a higher cure rate than oxamniquine 15 to 19 mg/Kg in individuals older than 14 years (OR 1.70, 95%CI 0.83, 3.49) (Cunha 1986, Fernandes 1988).
In one study performed in Africa, praziquantel 40 mg/Kg was shown to be more effective than oxamniquine 15 mg/Kg, but no difference was shown with higher dosage of oxamniquine. In Brazil, higher dosage of praziquantel (between 50 mg/Kg and 70 mg/Kg) was equally effective when compared with oxamniquine 15-19 mg/Kg.
There were no trials to allow us to explore differences between praziquantel and oxamniquine in children.
Adverse effects
There were several adverse clinical effects, but no deaths, after administration of oxamniquine or praziquantel. The most serious side-effect reported was seizure, and this was observed in two patients using oxamniquine out of a total of 372 patients (Taddese 1988, Rezende 1985).
Headache, dizziness and sleepiness were commonly reported with both drugs. However, there was no statistical difference in incidence of neurological side-effects, such as headache, dizziness, seizures or sleepiness in individuals taking oxamnquine or praziquantel.
Diarrhoea and abdominal pain were slightly more frequent in the praziquantel group (abdominal pain: 42% (240/563) compared with 20% (115/571) (OR 2.94, 95%CI 2.27, 3.79); and diarrhoea 14% (74/536) compared with 7% (38/544) (OR 2.08, 95%CI 1.41, 3.08).
Other systemic side-effects, such as asthenia, skin rash were distributed equally between the two treatments. Myalgia did not occur with oxamniquine (0/327) but did occur with praziquantel (7/352) (OR 0.13, 95%CI 0.03, 0.59). Fever was more frequent in the group using praziquantel 1.5% (4/267) compared with 0% (0/272) (OR 7.61, 95%CI 1.07, 54.36).
Only one clinical trial comparing side effects between praziquantel and placebo was included. Abdominal pain, headaches, nausea, dizzines were most frequently reported in the group using praziquantel. Others side effects reported was fever and urticaria.
Biochemical
There was no difference between praziquantel and oxamniquine in the development of biochemical abnormalities reported in one study. Both drugs appeared to be safe, and no abnormality suggesting nephrotoxicity or hepatotoxicity was observed after administration of praziquantel oroxamniquine.
Clinical
Only Sukwa's clinical trial was included in the analysis of clinical improvement, and it was not possible to conclude if praziquantel was more effective than placebo in the reduction of morbidity when the control cure was achieved after six months and twelve months.
Zinc supplementation
Only one clinical trial was included comparing zinc supplementation with placebo to prevent reinfection of Schistosoma mansoni. However, there was no statistical difference in incidence of reinfection rate between zinc supplementation and placebo (OR 0.82, 95%CI 0.47, 1.41).
The methodological quality of studies included was poor. Many trials did not clearly describe concealment and allocation procedures. Few studies used double-blind method and losses of follow-up was as high as 20%.
An important question is the ideal dose for a patient's age, and whether different doses are required in different geographic areas. Lack of data precluded exploring these questions.
Time of follow-up more than six weeks does not appear appropriate (Stelma 1997), because the probability of underestimation of treatment's effects may occur as the reinfection rate could be high after this period.
Praziquantel (40 mg/kg) and oxamniquine (60 mg/Kg) are effective in the cure of Schistosoma mansoni infection when compared with placebo. Praziquantel 40 mg/Kg was more effective than oxamniquine 15 mg/Kg in individuals older than 14 years, but when the dosage of oxamniquine was increased to 30 mg/Kg, there was no statistical difference between the two drugs. Both praziquantel and oxamniquine were demonstrated to be safe, and there was no difference in tolerability between the two drugs.
In mixed Schistosoma haematobium and Schistosoma mansoni infections, praziquantel 40 mg/Kg and oxamniquine was shown to be more effective than placebo to cure Schistosoma mansoni infection. There is no difference between praziquantel and oxamniquine in mixed infections of the two parasites.
1. Praziquantel and oxamniquine are effective in the treatment of Schistosoma mansoni infection. No compelling evidence shows a difference between the two drugs. However, praziquantel 40 mg/Kg was more effective than oxamniquine 15 mg/Kg in one trial.
2. In mixed Schistosoma mansoni and Schistosoma haematobium infections, praziquantel appears to be equally effective when compared with oxamniquine 60 mg/Kg.
3. It is not possible to conclude whether praziquantel has an effect on morbidity due to infection.
4. Two patients given oxaminquine had seizures, suggesting that it is less safe than praziquantel.
5. It is not possible to conclude whether zinc supplementation is effective to prevent reinfection of Schistosoma mansoni.
1. A systematic review of observational studies, including case reports, is required to document potential toxicity and tolerability of the two drugs.
2. A good trial examining clinical effectiveness, in terms of morbid outcomes, is required.
3. Further work exploring varying effectiveness with geographic area may be useful.
We thank Iain Chalmers and Paul Garner for their support.
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 (e.g. employment, consultancy, stock ownership, honoraria, expert testimony).
| Study | Methods | Participants | Interventions | Outcomes | Notes | Allocation concealment |
| Ayele 1986 | Random allocation, but the method of randomisation not clearly described. Blinded outcome measurement (stool examination), but blinding patients is not described. | n= 162 patients children below 15 years of age. | 1. Oxamniquine 15 mg/Kg twice daily for two days (total = 60mg/Kg) 2. Oxamniquine 20 mg/Kg twice daily for one day (total = 40mg/Kg) 3. Oxamniquine 15 mg/Kg twice daily for one day (total = 30mg/Kg) 4. Placebo | Stool examinations according Kato to evaluate parasitic cure or improvement after 4 months of the treatment | Setting: Ethiopia | B |
| Branchini 1982 | Random allocation, but method of randomisation unspecified. Double blind. | n= 101 patients, age varied from 10 to 65 years, mean age 29.7 years. | 1. Oxamniquine an average dose of 13.8 mg/Kg 2. Praziquantel an average dose of 45.4 mg/Kg | Stool examinations according Kato/Katz to evaluate parasitic cure or improvement after 4 months of the treatment. Clinical and biochemical tolerance. | Setting: Brazil Follow-up: 6 months. Drop-out in the end of the study higher than 20%. Not included in the efficacy analysis | B |
| Cunha 1986 | Random allocation, but method of randomisation unspecified. Double blind. | n= 54 patients between 15 and 55 years of age. Intestinal and hepatointestinal forms were present in 54% and 46 % of the individuals, respectively. | 1. Oxamniqiune an average dose of 18 mg/Kg 2. Praziquantel an average dose of 65 mg/Kg | Stool examinations according Kato/Katz and spontaneous sedimentation methods; Rectal mucosa biopsy. Tolerance: clinical | Setting: Brazil Parasitological control at the end of 1, 2, 4 and 6 months, but they present analysis of the 6th month. Drop-out= 14.81% | B |
| de Jonge 1991 | Random allocation, but the method of randomisation not clearly described. Double blind method not described. | n= 160 children with mixed Schistosoma haematobium and Schistosoma mansoni infections. | The patients were divided in four groups: 1. Metrifonate 20mgKg: 38 patients 2. Oxamniquine 60mg/Kg single-dose: 53 patients; 3. Praziquantel 40mg/Kg single dose : 48 patients 4. Placebo: 21 patients. | Stool examinations using Kato method. Urine examination. Blood samples to determine circulating anodic antigen. | Setting: Sudan. Follow-up: one and five months after treatment. Drop-out: 14.4% after one month, and 18.8% after 5 months | B |
| Fernandes 1986 | Random allocation, but the method of randomisation not clearly described. Double blind method not described. | n= 120 patients with egg counts in the range 112-1296 eggs/g of S. mansoni in the stool. | 1. Oxamniquine: 15 mg/Kg single dose 2. Praziquantel: 70 mg/Kg in a single dose 3. Praziquantel: 35 mg/Kg twice daily. | Stool examinations according Kato/Katz. Clinical improvement | Setting: Brazil. Parasitological control after 2, 4 and 6 month. | B |
| Friis 1997 | Random allocation by "simple randomization". Details of the allocation concealment is not described. Double-blind. | n= 313 children with Schistosoma mansoni and/or Schistoma haematobium infections | Supplementation with zinc sulphate (30 or 50 mg according of weight of children) Placebo with identical-looking of zinc sulphate tablets | Schistoma mansoni and Schistosoma haematobium reinfections | Setting: Zimbabwe Parasitological examiantion was done six weeks and three, six and 12 months after treatment. Compliance rate was 47% among children in whom reinfections could be assessed. Drop-out rate: 17% | B |
| Jaoko 1996 | Random allocation but allocation concealment is not described. Double-blind is not mentioned | N= 320 children with Schistosoma mansoni infection. | 1. Praziquantel: 40 mg/Kg 2. Placebo | Prevalence of side-effects | Setting: Kenya | B |
| Katz 1982 | Random allocation, but method of randomisation unspecified. Double blind. | n= 120 children with active schistosomiasis mansoni living in two endemic areas. | Oxamniquine 20 mg/Kg single dose Praziquantel 65 mg/Kg single dose | Three consecutive daily stool examinations according Kato/Katz method. Clinial and laboratorial tolerance. | Setting: Brazil. Follow-up: 6 months. Drop-out rate higher than 20% Not included in the efficacy analysis | C |
| Rezende 1985 | Random allocation, but randomisation method is not describred. Double blind | n= 539 adults and children, no previous anti-schistosomiasis treatment. | 1. Oxamniquine an average dose of 16 mg/Kg 2. Praziquantel an average dose of 55 mg/Kg | Three consecutive daily stool examinations according Kato/Katz method. Clinical and biochemical side-effects | Setting: Brazil. Follow-up of six months. | B |
| Silva 1986 | Random allocation, but the method of randomisation not clearly described. Double blind method. | n= 120 patients selected by three pre-treatment egg counts according to Kato/Katz method. Only intestinal and hepatointestinal forms were included | 1. Oxamniquine 15 mg/Kg single dose 2. Praziquantel 55 mg/Kg single dose | Stool examinations according Kato/Katz method; Rectal mucosa biopsy with negative stool examination in the 6th month Side effects | Setting: Brazil. Follow-up: 10 months Drop-out: 21.7% Not included in the efficacy analysis | B |
| Stelma 1997 | Random allocation, but allocation concealment is not descibed. Double-blind method is not described. | n= 138 patients. The participants were prestratified by age, intensity of infection, and history of previous praziquantel treatment. | 1. Praziquantel 40 mg/Kg 2. Oxamniquine 20 mg/Kg | Parasitological cure after 6 weeks according stool examinations by Kato method. | Setting: Senegal The study were performed in a area where cure rate with praziquantel is low. Follow-up: 6 weeks Drop-out: no mention | B |
| Sukwa 1993 | Random allocation, but the method of randomisation not clearly described. Blinded outcome measurement (physical examination), but blinding patients is not described. | n= 377 children. All elegible children received a initial dose of 40mg/Kg of praziquantel. After initial treatment, 190 children were retreated with praziquantel at six month follow-up, irrespective of Schistosoma mansoni infection status; and 187 children received placebo at the same time. | 1. Praziquantel: 40 mg/Kg 2. Placebo | Physical examination to evaluate clinical improvement. | Setting: Zambia. Follow-up: 12 months. Drop-out less than 10%. | B |
| Taddese 1988 | Random allocation, but the method of randomisation not clearly described. Double blind method not described. | n= 200 individuals with a geometric mean egg excretion rate of at least 50 eggs/g of faeces aged from 17-52 years. | 1. Oxamniquine 15 mg/Kg single dose 2. Oxamniquine 30 mg/Kg twice 3. Praziquantel 40 mg/Kg single dose 4. Praziquantel 40 mg/Kg twice | Stool examinations according Kato/Katz were performed 1, 3 and 6 months after treatment. Spleen and liver size | Setting: Ethiopia. Drop-out: 9%. | B |
| Study | Reason for exclusion |
| Abu-Ely-Azeed 1993 | The study is a randomised double-blind controlled trial evaluating the effectiveness and safety of 1% niclosamide skin lotion in the prevention of the penetration of Schistosoma mansoni cercariae. |
| Barakat 1995 | This is not a randomised controlled trial. The study design is a cross-sectional. |
| Bella 1982 | The study compares different dosages of oltipraz. There was no description of randomisation method. |
| Coutinho 1983 | Randomised study comparing two different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Coutinho 1984 | Randomised study comparing two different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Creasey 1986 | This is a randomised controlled trial, but the comparison was between a combination of oxamniquine plus praziquantel with placebo. |
| Cunha 1982 | Compares different dosages of oxamniquine, however, there was no comparison between oxamniquine and praziquantel or placebo, and the authors did not describe the allocation method, and there was no description whether random method had been used. |
| Cunha 1987 | Randomised study comparing two different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Cury 1986 | The study is not a randomised controlled trial comparing oxamniquine with placebo, and the drop-out rate was 61.6%. |
| De Clerq 1997 | This is not randomised controlled trial. |
| El Tayeb 1988 | This is a randomised controlled trial, but the comparison was between praziquantel and oltipraz, and there was no comparison between praziquantel and oxamniquine or placebo. |
| Emanuel 1983a | Randomised study comparing different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Emanuel 1983b | The study is not a randomised controlled trial. |
| Gryseels 1989 | Three villages were evaluated. Residents of two villages received different regimens of oxamniquine and residents of the other received two different regimens of praziquantel, and the study compared the prevalence and morbidity in each village. They did not compare praziquantel with oxamniquine in each village. |
| Guiniady 1994 | Does not meet inclusion criteria. This study evaluated the pharmacokinetics of praziquantel and did not compare praziquantel with placebo or oxamniquine. The was no description of random allocation method. |
| Guisse 1997 | Randomised study comparing two different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Guyatt 1998 | This is a decision analysis. The study analyses the interaction between drug efficacy and drug price of different brands of praziquantel in determining the cost-effectiveness of treatment of schistosomiasis mansoni. This is not a randomised controlled trial. |
| Igail 1985 | The study is a randomised controlled trial comparing different dosages of oltipraz in the treatment of Schistosoma mansoni infection. Praziquantel or oxamniquine were not evaluated. |
| Kardman 1983 | Randomised study comparing two different regimens of praziquantel, a single dose of 40 mg/Kg body-weight, and a divided dose 2 x 20 mg/Kg body-weight. However, there was no comparison between praziquantel and oxamniquine or placebo. |
| Kardman 1985 | Randomised study comparing two different regimens of praziquantel, a single dose of 40 mg/Kg body-weight, and a divided dose 2 x 20 mg/Kg body-weight. However, there was no comparison between praziquantel and oxamniquine or placebo. |
| Katz 1979 | The study compares different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. Furthermore, the authors did not describe the allocation method, and there was no description whether a random method had been used. |
| Katz 1983 | The study compares praziquantel with oxamniquine, but the authors did not describe the allocation method, and there was no description whether a random method had been used. |
| Katz 1991 | The study compare praziquantel with oxamniquine, but the authors did not describe the allocation method, and there was no description whether a random method had been used. |
| Kilpatrick 1982 | This is a randomised controlled trial, but the comparison was between oxamniquine and niridazole; there was no comparison between oxamniquine and praziquantel or placebo. |
| Lapierre 1983 | This study do not appear to be a randomised controlled trial, and there was no description of how the treatment was allocated. |
| Lieshout 1994 | The study compares praziquantel 60 mg/Kg of body weigth (Group 1) with praziquantel 40 mg/Kg of body weigth (Group 2), but the authors did not describe if the patients were randomly allocated. |
| McMahon 1981 | Randomised study comparing different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Mohamed-Ali 1991 | Randomised study comparing different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Nozais 1979 | Randomised study comparing two different dosages of oxamniquine, however, there was no comparison between praziquantel and praziquantel or placebo. |
| Nozais 1980 | The study evaluated oxamniquine in dosage of 15-20mg/Kg, however, there was no comparison between praziquantel or placebo. It is a descriptive study. There was no description of randomisation method. |
| Odongo-Aginya 1996 | This is not randomised controlled trial. All of the people infected with Schistosoma mansoni were treated with praziquantel 40 mg/Kg of body weight. |
| Omer 1981 | Randomised study comparing different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Pedroso 1987 | The study compared oxamniquine with placebo in pulmonary schistosomiasis mansoni. However, the authors did not describe the allocation method, and there was no description whether random method had been used. |
| Picquet 1998 | This is not a randomised controlled trial. |
| Polderman 1988 | This study did not appear to be a randomised controlled trial, and there was no description of how the treatment was allocated. |
| Prata 1982 | Randomised study comparing three different dosages of praziquantel. However, there was no comparison between praziquantel and oxamniquine or placebo. |
| Rahim 1988 | Randomised study comparing three different dosages of oxamniquine, however, there was no comparison between oxamniquine and praziquantel or placebo. |
| Rees 1975 | This is a randomised controlled trial, but the comparison was between oxamniquine and hycanthone; there was no comparison between oxamniquine and praziquantel or placebo. |
| Rouquayrol 1976 | This is a randomised controlled trial, but the comparison was between oxamniquine and hycanthone; there was no comparison between oxamniquine and praziquantel or placebo. |
| Rugemalila 1984 | Drop-out rate higher than 20%, and the study did not evaluated cure rate. |
| Saladin 1983 | This study is not a randomised controlled trial. |
| Santos 1986 | Randomised controlled trial comparing oxamniquine with placebo, but the drop-out rate was higher than 20%. |
| Schwerdtfeger 1992 | Randomised study comparing two different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. |
| Shafei 1979 | This study is not randomised controlled trial. |
| Strickland 1982 | The authors wrote that two subjects were randomly chosen in each group of six to receive placebo or oxamniquine, but they did not clearly state the allocation method, nor was it possible to determine whether the study was randomised. |
| Taylor 1988 | Randomised study comparing four different dosages of praziquantel, however, there was no comparison between praziquantel and oxamniquine or placebo. One group did not receive praziquantel, but the author did not say if this group received placebo or not. |
| Teesdale 1984 | Drop-out rate higher than 20 per cent. |
| Zwingenberger 1987 | This study is a randomised controlled trial, but the comparison was between a low-dosage combination of oxamniquine plus praziquantel against oxamniquine or praziquantel alone, and the drop-out rate was more than 20%. |
Ayele T. Preliminary clinical trial of oral oxamniquine in the treatment of Schistosoma mansoni in children in Ethiopia. East Afr Med J 1986;63:291-294.
Branchini 1982 {published data only}
Branchini M, Pedro R de J, Dias LC, Deberaldini ER. Double-blind clinical trial comparing praziquantel with oxamniquine in the treatment of patients with schistosomiasis mansoni. Rev Inst Med Trop S�o Paulo 1982;24:315-321.
Cunha 1986 {published data only}
Cunha AS, Pedrosa RC. Double-blind therapeutical evaluation based on the quantitative oogram technique comparing praziquantel and oxamniquine in human schistosomiasis mansoni. Rev Inst Med Trop S�o Paulo 1986;28:337-351.
de Jonge 1991 {published data only}
de Jonge N, Schommer G, Feldmeier H, Krijer FW, Dafalla AA, Bienzle U, Deelder AM. Mixed Schistosoma haematobium and S. mansoni infection: Effect of different treatments on the serum level of circulating anodic antigen (CAA). Acta Trop 1991;48:25-35.
Fernandes 1986 {published data only}
Fernandes P, Oliveira CC. Estudo comparativo da efic�cia do praziquantel, em dois esquemas posol�gicos, e da oxamniquina no tratamento da esquistossomose mans�nica. F M�d 1986;93:389-393.
Friis 1997 {published data only}
Friis H, Ndhlovu P, Mduluza T, Kaondera K, Sandstr�m B, Michaelson KF, Vennervald BJ, Christensen NO. The impact of zinc supplementation on Schistosoma mansoni reinfection rate and intensities: A randomized, controlled trial among rural Zimbabwean schoolchildren. Eur J Clin Nutr 1997;51:33-37.
Jaoko 1996 {published data only}
Jaoko WG, Muchemi G, Oguya FO. Praziquantel side effects during treatment of Schistosoma mansoni infected pupils in Kibwezi, Kenya. East Afr Med J 1996;73:499-501.
Katz 1982 {published data only}
Katz N, Rocha RS. Double-blind clinical trial comparing praziquantel with oxamniquine in schistosomiasis mansoni. Rev Inst Med Trop S�o Paulo 1982;24:310-314.
Rezende 1985 {published data only}
Rezende GL. Survey on the clinical trial results achieved in Brazil comparing praziquantel and oxamniquine in the treatment of mansoni schistosomiasis. Rev Inst Med Trop S�o Paulo 1985;27:328-336.
Silva 1986 {published data only}
da Silva LC, Zeitune JMR, Rosa-Eid LMF, Lima DMC, Antoneli RH, Christo CH, Saez-Alquezar A, Carboni AC. Treatment of patients with schistosomiasis mansoni: a double-blind clinical trial comparing praziquantel with oxamniquine. Rev Inst Med Trop S�o Paulo 1986;28:174-180.
Stelma 1997 {published data only}
Stelma FF, Sall S, Daff B, Sow S, Niang M, Gryseels B. Oxamniquine cures Schistosoma mansoni infection in a focus in which cure rates with praziquantel are unusually low. J Infect Dis 1997;176:304-307.
Sukwa 1993 {published data only}
Sukwa TY. A community-based randomized trial of praziquantel to control schistosomiasis morbidity in schoolchildren in Zambia. Ann Trop Med Parasitol 1993;87:185-194.
Taddese 1988 {published data only}
Taddese K, Zein Z. Comparison between the efficacy of oxamniquine and praziquantel in the treatment of Schistosoma mansoni infection on a sugar estate in Ethiopia. Ann Trop Med Parasitol 1988;82:175-180.
Abu-Ely-Azeed R, Podgore JK, Mansour NS, Kilpatrick ME. Field trial of 1% niclosamide as a topical antipenetrant to Schistosoma mansoni cercariae. Am J Trop Med Hyg 1993;49:403-409.
Barakat 1995 {published data only}
Barakat R, El Masry AG, Farghaly A, El Morshidy HN, El Sayed MK, Husein MH, Miller FD. Impact of population-based selective chemotherapy on prevalence and intensity of Schistosoma mansoni infections in the Nile Delta: Kafr El Sheikh. Trop Geogr Med 1995;47:266-270.
Bella 1982 {published data only}
Bella H, Rahim AGA, Mustafa MD, Ahmed MAM, Wasfi S, Bennett JL. Oltipraz - Antischistosomal efficacy in sudanese infected with Schistosoma mansoni. Am J Trop Med Hyg 1982;31:775-778.
Coutinho 1983 {published data only}
Coutinho A, Domingues ALC, Neves J, Almeida ST. Treatment of hepatosplenic schistosomiasis mansoni with praziquantel (preliminary report on tolerance and efficacy). Arzneim Forsch 1983;33(I):787-791.
Coutinho 1984 {published data only}
Coutinho AD, Domingues AL, Florencio JN, Almeida ST. Tratamento da esquistossomose mansonica com praziquantel [Treatment of hepatosplenic schistosomiasis mansoni with praziquantel]. Rev Inst Med Trop S�o Paulo 1984;26:38-50.
Creasey 1986 {published data only}
Creasey AM, Taylor P, Thomas JEP. Dosage trial of a combination of oxamniquine and praziquantel in the treatment of schistosomiasis in Zimbabwean schoolchildren. Cent Afr J Med 1986;32:165-167.
Cunha 1982 {published data only}
Cunha AS. A avalia��o terap�utica da oxamniquine na esquistossomose mansoni humana pelo m�todo do oograma por biopsia de mucosa retal. Rev Inst Med Trop S�o Paulo 1982;24:88-94.
Cunha 1987 {published data only}
Cunha AS, Can�ado JR, Rezende GL. Therapeutical evaluation of different dose regimens of praziquantel in schistosomiasis mansoni, based on the quantitative oogram technique. Rev Inst Med Trop S�o Paulo 1987;29:295-304.
Cury 1986 {published data only}
Cury AA, Nogueira JER. Avalia��o do �ndice de cura da esquistossomose mansoni (E.M.) com utiliza��o da oxamniquine em zona end�mica. Rev Bras Clin Terap 1986;15:63-64.
De Clerq 1997 {published data only}
De Clerq D, Sacko M, Vercruysse J, Bussche V, Landour� A, Diarra A, Gryseels B, Deelder A. Assessement of cure by detection of circulating antigens in serum and urine, following schistosomiasis mass treatment in two villages of Office du Niger, Mali. Acta Tropica 1997;68:339-346.
El Tayeb 1988 {published data only}
El Tayeb TM, Dafalla A, Kardman M, See R, Fenwick A. Praziquantel and oltipraz: the treatment of schoolchildren infected with schistosomiasis mansoni and/or schistosomiasis haematobium in Gezira, Sudan. Ann Trop Med Parasitol 1988;82:53-57.
Emanuel 1983a {published data only}
Emanuel A, Prata A. Praziquantel no tratamento da esquistossomose mansoni em crian�as. Rev Inst Med Trop S�o Paulo 1983;25:178-181.
Emanuel 1983b {published data only}
Emanuel A, Prata A. Compara��o entre praziquantel e oxamniquine no tratamento da esquistossomose mansoni. Rev Soc Bras Med Trop 1983;16:90-93.
Gryseels 1989 {published data only}
Gryseels B, Nkulikyinka L. Two year follow up of Schistosoma mansoni infection and morbidity after treatment with different regimens of oxamniquine and praziquantel. Trans R Soc Trop Med Hyg 1989;83:219-228.
Guiniady 1994 {published data only}
Guiniady MAE, Touny MAE, Abdel-Bary MA, Abdel-Fatah SA, Metwally A. Clinical and pharmacokinetic study of praziquantel in egyptian schistosomiasis patients with and without liver cell failure. Am J Trop Med Hyg 1994;51:809-818.
Guisse 1997 {published data only}
Guisse F, Polman K, Stelma FF, Mbaye A, Talla I, Niang M, Deelder AM, Ndir O, Gryseels B. Therapeutic evaluation of two different dose regimens of praziquantel in a recent Schistosoma mansoni focus in Nothern Senegal. Am J Trop Med Hyg 1997;56:511-514.
Guyatt 1998 {published data only}
Guyatt HL, Chan M-S. An investigation into the interaction between drug efficacy and drug price of praziquantel in determining the cost-effectiveness of school-target treatment for Schistosoma mansoni using a population dynamic model. Trop Med Internt Health 1998;3:425-435.
Igail 1985 {published data only}
Igail ABE, El Tayeb M, Kardman MW, Daffalla AA, Dixon HG, Fenwick A. Dose-finding trial using Oltipraz to treat schoolchildren infected with Schistosoma mansoni in Gezira, Sudan. J Trop Med Hyg 1985;88:101-104.
Kardman 1983 {published data only}
Kardman MW, Amin MA, Fenwick A, Cheesmond AK, Dixon HG. A field trial using praziquantel (Biltricide) to treat Schistosoma mansoni and Schistosoma haematobium infection in Gezira, Sudan. Ann Trop Med Parasitol 1983;77:297-304.
Kardman 1985 {published data only}
Kardman MW, Fenwick A, El IA, El TM, Dafalla A, Dixon H. Treatment with praziquantel of schoolchildren with concurrent Schistosoma mansoni and S. haematobium infections in Gezira, Sudan. J Trop Med Hyg 1985;88:105-109.
Katz 1979 {published data only}
Katz N, Rocha RS, Chaves A. Clinical trials with praziquantel in human infections due to Schistosoma mansoni. Bull World Health Organ 1979;57(5):781-785.
Katz 1983 {published data only}
Katz N, Rocha AS, Lambertucci JB, Greco DB, Pedroso ERP, Rocha MOC, Flan S. Clinical trial with oxamniquine and praziquantel in the acute and chronic phases of schistosomiasis mansoni. Rev Inst Med Trop S�o Paulo 1983;25:173-177.
Katz 1991 {published data only}
Katz N, Rocha RS, Souza CP, Coura Filho P, Bruce JI, Coles GC, Kinoti GK. Efficacy of alternating therapy with oxamniquine and praziquantel to treat Schistosoma mansoni in children following failure of first treatment. Am J Trop Med Hyg 1991;44:509-512.
Kilpatrick 1982 {published data only}
Kilpatrick ME, Masry NAE, Bassily S, Farid Z. Oxamniquine versus niridazole for treatment of uncomplicated Schistosoma mansoni infection. Am J Trop Med Hyg 1982;31:1164-1167.
Lapierre 1983 {published data only}
Lapierre J, Keita A, Faurant C, Heyer F, Tourte-Schaefer C, Angelle T, Dupouy-Camet J. A propos du traitement de 700 cas de bilharziose par les medicaments r�cents: oxamniquine, oltipraz, praziquantel. Bull Soc Pathol Ex 1983;76:526-533.
Lieshout 1994 {published data only}
Lieshout L, Jonge N, El-Masry N, Mansour MM, Bassily S, Krijger FW, Deelder AM. Monitoring the efficacy of different doses of praziquantel by quantification of circulating antigens in serum and urine of schistosomiasis patients. Parasitology 1994;108:519-526.
McMahon 1981 {published data only}
McMahon JE. Praziquantel: a new schistosomicide against Schistosoma mansoni. Arzneim Forsch 1981;31(I):592-596.
Mohamed-Ali 1991 {published data only}
Mohamed-Ali Q, Doehring-Scwerdtfeger E, Abdel-Rahim IM, Schlake J, Kardorff R, Franke D, Kaiser C, Elsheikh M, Abdalla M, Schafer P, Ehrich HH. Ultrasonographical investigation of periportal in children with Schistosoma mansoni infection: Reversibility of morbidity seven months after treatment with praziquantel. Am J Trop Med Hyg 1991;44:444-451.
Nozais 1979 {published data only}
Nozais JP, Geunier M. �tude de l'efficacit� de L'UK 4271 (Oxamniquine, Pfizer) dans la bilharziose a Schistosoma mansoni en afrique de L'Ouest. Bull Soc Pathol Exot Filiales 1979;72:153-164.
Nozais 1980 {published data only}
Nozais JP. A fifteen-month study on the efficacy of a single 15 mg/kg dose of oxamniquine (Vansil) in Schistosoma mansoni in an endemic area. Rev Inst Med Trop S�o Paulo 1980;22(suppl 4):52-57.
Odongo-Aginya 1996 {published data only}
Odongo-Aginya EI, Doehring M, Lakwo TL, Etyono S, Luyinda LB, Roth J, Doehring E. Integrated control trial of schistosomiasis at Nakiwogo fishing village near Entebbe, Uganda. East Afr Med J 1996;73:495-498.
Omer 1981 {published data only}
Omer AHS. Praziquantel in the treatment of mixed S. haematobium and S. mansoni infections. Arzneim Forsch 1981;31(I):605-608.
Pedroso 1987 {published data only}
Pedroso ERP, Lambertucci JR, Greco DB, Rocha MOC, Ferreira S, Raso P. Pulmonary schistosomiasis mansoni: post-treatment pulmonary clinico-radiological alterations in patients in the chronic phase: double-blind study. Trans R Soc Trop Med Hyg 1987;81:778-781.
Picquet 1998 {published data only}
Picquet M, Vercruysse J, Shaw DJ, Diop M, Ly A. Efficacy of praziquantel against Schistosoma mansoni in northern Senegal. Trans R Soc Trop Med Hyg 1998;92:90-93.
Polderman 1988 {published data only}
Polderman A, Gryseels B, De Calwe P. Cure rates and egg reduction in treatment of intestinal schistosomiasis with oxamniquine and praziquantel in Maniema, Zaire. Trans R Soc Trop Med Hyg 1988;82:115-116.
Prata 1982 {published data only}
Prata A, Castro CN, Silva AE, Paiva M, Macedo V, Junqueira Jr LF. Praziquantel no tratamento da esquistossomose mansoni. Rev Inst Med Trop S�o Paulo 1982;24:95-103.
Rahim 1988 {published data only}
Rahim IMA, Haridi AAM, Abdel-Hameed AA. Field study of different oxamniquine dose for Schistosoma mansoni in Gezira, Sudan. J Trop Med Hyg 1988;91:131-137.
Rees 1975 {published data only}
Rees P, Bowry H, Roberts J, Thuku J. The treatment of schistosomiasis mansoni in Murang'a District, Kenya: a double-blind controlled trial of three hycanthone regimens and oxamniquine. Am J Trop Med Hyg 1975;24:823-826.
Rouquayrol 1976 {published data only}
Rouquayrol MZ, Almeida YM, Oliveira EG, Silva ZF, Pinto VAM, Alencar JE. Hycanthone e oxamniquine no tratamento de crian�as portadoras de S. mansoni. Rev Soc Bras Med Trop 1976;10:91-101.
Rugemalila 1984 {published data only}
Rugemalila JB, Asila J, Chimbe A. Randomised comparative trials of the newer antischistosomal drugs at Mwanza, Tanzania. I. Praziquantel and oxamniquine for the treatment of schistosomiasis mansoni. J Trop Med Hyg 1984;87:231-235.
Saladin 1983 {published data only}
Saladin B, Saladin K, Holzer B, Dennis E, Hanson A, Degremont A. A pilot control trial of schistosomiasis in central Liberia by mass chemotherapy of target populations, combined with focal application of moluscicide. Acta Trop 1983;40:271-295.
Santos 1986 {published data only}
Santos ML, Coura JR. Morbidade da esquistossomose no Brasil. IV - Evolu��o em pacientes tratados e seus controles. Mem Inst Oswaldo Cruz 1986;81:53-60.
Schwerdtfeger 1992 {published data only}
Doehring-Schwerdtfeger E, Abdel-Rahim IM, Kardorff R, Kaiser C, Franke D, Schlake J, Richter J, Elsheikh M, Mohamed-Ali Q, Ehrich JHH. Ultrasonographical investigation of periportal fibrosis in children with Schistosoma mansoni infection: Reversibility of morbidity twenty-three months after treatment with praziquantel. Am J Trop Med Hyg 1992;46:409-415.
Shafei 1979 {published data only}
Shafei A. A preliminary report on the treatment of intestinal schistosomiasis with oxamniquine. J Trop Med Hyg 1979;82:18-20.
Strickland 1982 {published data only}
Strickland GT, Merritt W, El-Sahly A, Abdel-Wahab F. Clinical characteristics and response to therapy in Egyptian children heavily infected with Schistosoma mansoni. J Infect Dis 1982;146:20-29.
Taylor 1988 {published data only}
Taylor P, Murare H, Manomano K. Efficacy of low doses of praziquantel for Schistosoma mansoni and S Haematobium. J Trop Med Hyg 1988;91:13-17.
Teesdale 1984 {published data only}
Teesdale CH, Chitsulo L, Pugh RNH. Oxamniquine dosage in Malawi. East Afr Med J 1984;61:40-44.
Zwingenberger 1987 {published data only}
Zwingenberger K, Queiroz JA, Poggensee U, Alencar JE, Valdegunas J, Esmeralda F, Feldmeier H. Efficacy of oxamniquine, praziquantel and a combination of both drugs in schistosomiasis mansoni in Brazil. Inst Med Trop S�o Paulo 1987;29:305-311.
Butterworth AE, Sturrock RF, Ouma JH, Mbugua GG, Fulford AJC, Kariuki HC, Koech D. Comparison of different chemotherapy strategies against Schistosoma mansoni in Machakos District, Kenya: Effects on human infection and morbidity. Parasitology 1991;103:339-355.
Lambertucci 1982 {published data only}
Lambertucci JR, Grecco DB, Pedroso ER, Costa da Rocha MO, Salazar HM, Lima DP. A double-blind trial with oxamniquine in chronic schistosomiasis mansoni. Trans R Soc Trop Med Hyg 1982;76:751-755.
* indicates the primary reference for the study
Brindley PJ. Relationship between chemotherapy and immunity in schistosomiasis. Adv Parasitol 1994;34:133-161.
Costa MFFL, Rocha RS, Katz N. Avalia��o da estabilidade na contagem de ovos de Schistosoma mansoni pelo m�todo de Kato-Katz em uma zona end�mica. Rev Soc Bras Med Trop 1984;17:7-12.
Elliott DE. Schistosomiasis. Pathophysiology, diagnosis, and treatment. Gastroenterol. Clin North America 1996;25:599-526.
Foster R. A review of clinical experience with oxamniquine. Trans R Soc Trop Med Hyg 1987;81:55-59.
Gryseels B. Morbidity due to infection with Schistosoma mansoni: an update. Trop Geogr Med 1992;44:189-200.
Pereira LMMB, Melo MCV, Lacerda C, Spinelli V, Domingues ALC, Massarolo P, Mies S, Saleh MG, McFarlane IG, Williams R. Hepatitis B virus infection in schistosomiasis mansoni. J Med Virol 1994;42:203-206.
Rabello ALT. Parasitological diagnosis of schistosomiasis mansoni: fecal examination and rectal biopsy. Mem Inst Oswaldo Cruz 1992;87(suppl II):325-331.
Rabello ALT, Rocha RS, Mendes de Oliveira JP, Katz N, Lambertucci JR. Stool examination and rectal biopsy in the diagnosis and evaluation of therapy of schistosomiasis mansoni. Rev Inst Med Trop S�o Paulo 1992;34:601-608.
Tracy JW, Webster Jr LT. Drugs used in the chemotherapy of helminthiasis. In: Hardman JG, Limbrid LE, Molinoff PB, Puddon RW, Gilman AG, editor(s). The pharmacological basis of therapeutics. 9th edition. New York: McGraw-Hill Co. Inc, 1996:1009-1026.
World Health Organization. The control of schistosomiasis. Geneva, WHO; 1985. (Technical Report Series, No. 728).
World Health Organization. The control of schistosomiasis. Geneva, WHO; 1993. (Technical Report Series, No.830).
01.01 Parasitological cure
01.01.01 Oxamniquine 30 mg/Kg
01.01.02 Oxamniquine 40 mg/Kg
01.01.03 Oxamniquine 60 mg/Kg
| Study ID | n | N | Control n | Control N |
| Ayele 1986 | 35 | 40 | 1 | 40 |
| de Jonge 1991 | 26 | 53 | 0 | 21 |
02 Praziquantel vs. placebo
02.01 Parasitological cure
02.01.01 Praziquantel 40 mg/Kg vs. placebo
| Study ID | n | N | Control n | Control N |
| de Jonge 1991 | 31 | 48 | 0 | 21 |
02.02 Clinical improvement after 6 months
02.02.01 Diarrhoea
| Study ID | n | N | Control n | Control N |
| Sukwa 1993 | 23 | 52 | 20 | 49 |
02.02.02 Bloody diarrhoea
| Study ID | n | N | Control n | Control N |
| Sukwa 1993 | 16 | 26 | 16 | 24 |
02.02.03 Abdominal pain
02.02.04 Hepatomegaly
| Study ID | n | N | Control n | Control N |
| Sukwa 1993 | 43 | 89 | 36 | 79 |
02.02.05 Splenomegaly
| Study ID | n | N | Control n | Control N |
| Sukwa 1993 | 17 | 28 | 20 | 31 |
02.02.06 Liver size (mean and SD)
02.02.07 Spleen size (mean and SD)
02.03 Clinical improvement after 12 months
02.03.01 diarrhoea
| Study ID | n | N | Control n | Control N |
| Sukwa 1993 | 42 | 52 | 42 | 49 |
02.03.02 bloody diarrhoea
| Study ID | n | N | Control n | Control N |
| Sukwa 1993 | 1 | 26 | 1 | 24 |
02.03.03 Hepatomegaly
| Study ID | n | N | Control n | Control N |
| Sukwa 1993 | 60 | 89 | 52 | 79 |
02.03.04 Splenomegaly
| Study ID | n | N | Control n | Control N |
| Sukwa 1993 | 20 | 28 | 16 | 31 |
02.03.05 Liver size (mean and SD)
02.03.06 Spleen size (mean and SD)
03 Praziquantel 40 mg/Kg vs. Oxamniquine 15 mg/Kg
03.01 Parasitological cure after 1 month
03.01.01 Praziquantel 40mg/Kg single dose vs. Oxamniquine 15 mg/Kg
| Study ID | n | N | Control n | Control N |
| Taddese 1988 | 47 | 50 | 37 | 50 |
03.01.02 Praziquantel 2 x 20 mg/Kg vs. Oxamniquine 15 mg/Kg
| Study ID | n | N | Control n | Control N |
| Taddese 1988 | 45 | 50 | 37 | 50 |
04 Praziquantel 40 mg/Kg vs. Oxamniquine 30 mg/Kg
04.01 Parasitological cure after 1 month
04.01.01 Praziquantel 40 mg/Kg vs. Oxamniquine 30 mg/Kg
| Study ID | n | N | Control n | Control N |
| Taddese 1988 | 47 | 50 | 49 | 50 |
04.01.02 Praziquantel 2 x 20 mg/Kg vs. Oxamniquine 30 mg/Kg
| Study ID | n | N | Control n | Control N |
| Taddese 1988 | 45 | 50 | 49 | 50 |
05 Praziquantel 40 mg/Kg vs. Oxamniquine 20 mg/Kg
05.01 Parasitological cure after 1 month
05.01.01 Praziquantel 40 mg/Kg vs. Oxamniquine 20 mg/Kg
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Stelma 1997 | 24 | 66 | 57 | 72 |
06 Praziquantel 40 mg/Kg vs. Oxamniquine 60 mg/Kg
06.01 Parasitological cure after 1 month
06.01.01 Praziquantel 40 mg/Kg vs. Oxamniquine 60 mg/Kg
| Study ID | n | N | Control n | Control N |
| de Jonge 1991 | 31 | 48 | 26 | 53 |
07 Praziquantel 40 mg/Kg vs. Oxamniquine 15 mg/Kg
07.01 Parasitological cure - follow-up greater than 2 months
07.01.01 Praziquantel 40 mg/Kg vs. Oxamniquine 15 mg/Kg
| Study ID | n | N | Control n | Control N |
| Taddese 1988 | 78 | 100 | 67 | 100 |
07.01.02 Praziquantel 2 x 20 mg/Kg vs. Oxamniquine 15 mg/Kg
| Study ID | n | N | Control n | Control N |
| Taddese 1988 | 84 | 100 | 67 | 100 |
08 Praziquantel 40 mg/Kg vs. Oxamniquine 30 mg/Kg
08.01 Parasitological cure - follow-up after 3 months or more
08.01.01 Praziquantel 40 mg/Kg vs. Oxamniquine 30 mg/Kg
| Study ID | n | N | Control n | Control N |
| Taddese 1988 | 78 | 100 | 88 | 100 |
08.01.02 Praziquantel 2 x 20 mg/Kg vs. Oxamniquine 30 mg/Kg
| Study ID | n | N | Control n | Control N |
| Taddese 1988 | 84 | 100 | 88 | 100 |
09 Praziquantel 40 mg/Kg vs. Oxamniquine 60 mg/Kg
09.01 Parasitological cure - follow-up after 3 months or more
09.01.01 Praziquantel 40 mg/Kg single dose vs. Oxamniquine 60 mg/Kg
10 Praziquantel 50 - 70 mg/Kg vs. Oxamniquine 15 - 19 mg/Kg
10.01 Parasitological cure - follow-up greater than 2 months
10.01.01 Praziquantel 50 - 70 mg/Kg vs. Oxamniquine 15-19 mg/Kg
| Study ID | n | N | Control n | Control N |
| Cunha 1986 | 22 | 27 | 19 | 27 |
| Fernandes 1986 | 35 | 40 | 33 | 40 |
10.01.02 Praziquantel 50-70 mg/Kg in two doses vs. Oxamniquine 15-19 mg/Kg
| Study ID | n | N | Control n | Control N |
| Fernandes 1986 | 36 | 40 | 33 | 40 |
11 Praziquantel 50 - 70 mg/Kg vs. Oxamniquine greater than 19 mg/Kg
11.01 Parasitological cure - follow-up after 3 months or more
11.01.01 Praziquantel 50-70 mg/Kg vs. Oxamniquine greater than 19 mg/Kg
12 Praziquantel vs. Oxamniquine: clinical side-effects
12.01 Any side-effects
| Study ID | n | N | Control n | Control N |
| Cunha 1986 | 10 | 27 | 13 | 27 |
| Katz 1982 | 45 | 60 | 48 | 60 |
| Rezende 1985 | 197 | 267 | 187 | 269 |
| Silva 1986 | 53 | 60 | 51 | 59 |
12.02 Neurological side-effects
12.02.01 Headache
| Study ID | n | N | Control n | Control N |
| Branchini 1982 | 2 | 49 | 0 | 52 |
| Cunha 1986 | 1 | 27 | 0 | 27 |
| Fernandes 1986 | 1 | 80 | 3 | 40 |
| Katz 1982 | 4 | 60 | 13 | 60 |
| Rezende 1985 | 26 | 267 | 36 | 272 |
| Silva 1986 | 36 | 60 | 38 | 60 |
| Taddese 1988 | 10 | 100 | 3 | 100 |
12.02.02 Seizures
| Study ID | n | N | Control n | Control N |
| Rezende 1985 | 0 | 267 | 1 | 272 |
| Taddese 1988 | 0 | 100 | 1 | 100 |
12.02.03 Dizziness
| Study ID | n | N | Control n | Control N |
| Branchini 1982 | 23 | 49 | 23 | 52 |
| Cunha 1986 | 5 | 27 | 8 | 27 |
| Fernandes 1986 | 15 | 80 | 6 | 40 |
| Katz 1982 | 9 | 60 | 18 | 60 |
| Rezende 1985 | 90 | 267 | 116 | 272 |
| Silva 1986 | 36 | 60 | 38 | 60 |
| Taddese 1988 | 44 | 100 | 38 | 100 |
12.02.04 Sleepiness
| Study ID | n | N | Control n | Control N |
| Cunha 1986 | 2 | 27 | 6 | 27 |
| Fernandes 1986 | 2 | 80 | 0 | 40 |
| Katz 1982 | 5 | 60 | 7 | 60 |
| Rezende 1985 | 39 | 267 | 38 | 272 |
| Silva 1986 | 21 | 60 | 16 | 60 |
12.03 Gastrointestinal side-effects
12.03.01 Nausea
| Study ID | n | N | Control n | Control N |
| Cunha 1986 | 4 | 27 | 2 | 27 |
| Fernandes 1986 | 4 | 80 | 7 | 40 |
| Katz 1982 | 3 | 60 | 3 | 60 |
| Rezende 1985 | 32 | 267 | 28 | 272 |
| Silva 1986 | 14 | 60 | 11 | 60 |
12.03.02 Vomitting
| Study ID | n | N | Control n | Control N |
| Branchini 1982 | 2 | 49 | 1 | 52 |
| Katz 1982 | 4 | 60 | 7 | 60 |
| Rezende 1985 | 15 | 267 | 19 | 272 |
| Silva 1986 | 7 | 60 | 9 | 60 |
| Taddese 1988 | 6 | 100 | 1 | 100 |
12.03.03 Diarrhoea
| Study ID | n | N | Control n | Control N |
| Branchini 1982 | 6 | 49 | 2 | 52 |
| Katz 1982 | 8 | 60 | 4 | 60 |
| Rezende 1985 | 32 | 267 | 14 | 272 |
| Silva 1986 | 12 | 60 | 4 | 60 |
| Taddese 1988 | 16 | 100 | 14 | 100 |
12.03.04 Abdominal pain
| Study ID | n | N | Control n | Control N |
| Branchini 1982 | 12 | 49 | 6 | 52 |
| Cunha 1986 | 0 | 27 | 2 | 27 |
| Katz 1982 | 30 | 60 | 12 | 60 |
| Rezende 1985 | 122 | 267 | 46 | 272 |
| Silva 1986 | 29 | 60 | 10 | 60 |
| Taddese 1988 | 47 | 100 | 39 | 100 |
12.04 Systemic others side-effects
12.04.01 Myalgia
| Study ID | n | N | Control n | Control N |
| Rezende 1985 | 0 | 267 | 4 | 272 |
| Silva 1986 | 0 | 60 | 3 | 60 |
12.04.02 Asthenia
| Study ID | n | N | Control n | Control N |
| Fernandes 1986 | 0 | 80 | 3 | 40 |
| Katz 1982 | 2 | 60 | 1 | 60 |
| Rezende 1985 | 20 | 267 | 15 | 272 |
12.04.03 Fever
| Study ID | n | N | Control n | Control N |
| Rezende 1985 | 4 | 267 | 0 | 272 |
12.04.04 Skin rash
| Study ID | n | N | Control n | Control N |
| Cunha 1986 | 0 | 27 | 1 | 27 |
| Katz 1982 | 1 | 60 | 0 | 60 |
| Rezende 1985 | 2 | 267 | 0 | 272 |
13 Praziquantel vs. Placebo: clinical side-effects
13.01 Clinical Side Effects
13.01.01 Headache
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Jaoko 1996 | 116 | 320 | 7 | 116 |
13.01.02 Abdominal pain
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Jaoko 1996 | 113 | 320 | 17 | 116 |
13.01.03 Nausea
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Jaoko 1996 | 42 | 320 | 3 | 116 |
13.01.04 Dizziness
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Jaoko 1996 | 31 | 320 | 5 | 116 |
13.01.05 Fever
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Jaoko 1996 | 25 | 320 | 3 | 116 |
13.01.06 Urticaria
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Jaoko 1996 | 1 | 320 | 0 | 116 |
13.01.07 Bloody diarrhoea
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Jaoko 1996 | 1 | 320 | 0 | 116 |
14 Praziquantel vs. Oxamniquine: biochemical side-effects
14.01 Hepatotoxicity
14.01.01 ALT
| Study ID | N | Mean | SD | Control N | Control Mean | Control SD |
| Silva 1986 | 60 | 16.00 | 14.96 | 60 | 12.17 | 8.74 |
14.01.02 AST
| Study ID | N | Mean | SD | Control N | Control Mean | Control SD |
| Silva 1986 | 60 | 10.40 | 5.58 | 60 | 9.92 | 4.45 |
14.01.03 Gama-glutamyl transpeptidase
| Study ID | N | Mean | SD | Control N | Control Mean | Control SD |
| Silva 1986 | 60 | 28.71 | 28.71 | 60 | 25.69 | 28.32 |
15 Zinc suppplementation
15.01 Reinfection rate
15.01.01 Zinc vs. Placebo
| Study ID | Treatment n | Treatment N | Control n | Control N |
| Friis 1997 | 33 | 131 | 38 | 130 |