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Study Title and Description

Effects of Ivermectin with and without doxycycline on clinical symptoms of onchocerciasis.



Key Questions Addressed
1 What is the effect of doxycycline plus ivermectin versus ivermectin alone for treatment of patients with onchocerciasis?
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Primary Publication Information
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TitleData
Title Effects of Ivermectin with and without doxycycline on clinical symptoms of onchocerciasis.
Author Masud H., Qureshi TQ., Dukley M.
Country Department of Eye, Combined Military Hospital, Nowshera. hannanmasud@hotmail.com
Year 2009
Numbers Pubmed ID: 19149978

Secondary Publication Information
There are currently no secondary publications defined for this study.


Extraction Form: Doxycycline plus ivermectin versus ivermectin alone for treatment of patients with onchocerciasis 2016
Arms
Number Title Description Comments
1 Doxycyline + Ivermectin 100 mg/d doxycycline for 6 weeks, followed by a single dose of 0.15 mg/kg ivermectin
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2 Ivermectin single dose of 0.15 mg/kg ivermectin
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Design Details
Question... Follow Up Answer Follow-up Answer
Page 34-8
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Study design parallel-group quasi-randomized controlled trial
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Number randomly assigned 240 total participants; 120 in each group
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Exclusions after randomization none reported
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Losses to follow-up none reported
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Number analyzed total 240, ivermectin 120; doxycycline + ivermectin 120
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Unit of analysis individual
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Power calculation not reported
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Country Liberia
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Mean age 34 years; per group not provided
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Gender 157 (65.4%) men, 83 (34.6%) women; per group not provided
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Inclusion criteria &";history of exposure to blackfly in endemic area, symptoms of generalized and ocular itching, visual impairment associated with pannus/perilimbal pigmentation, punctuate/sclerosing keratitis, iridocyclitis, chorioretinitis and optic atrophy&";; &";lesions suggestive of onchodermatitis and subcutaneous nodules&";
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Exclusion criteria &";allergic conjunctivitis, history of measles and rubella, pregnant/breast-feeding women and children under 16 years of age&";
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Equivalence of baseline characteristics not reported
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Intervention 1 100 mg/d doxycycline for 6 weeks, followed by a single dose of 0.15 mg/kg ivermectin
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Intervention 2 single dose of 0.15 mg/kg ivermectin
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Intervention 3
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Length of follow-up Planned: 6 months; Actual: 6 months
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Primary outcome, as defined in study report Primary and secondary outcomes not differentiated
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Secondary outcomes, as defined in study report Primary and secondary outcomes not differentiated
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Adverse events reported none reported
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Intervals at which outcomes assessed 6 months
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Subgroup analyses none reported
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Study period March to December 2005
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Trial registration none reported
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Funding sources not reported
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Disclosures of interest &";The authors indicate no financial conflict of interest involved in design and conduct of study, collection of data, analysis and interpretation of data, preparation of the manuscript and literature search, review of the manuscript, and final approval of the manuscript. This study was performed with the approval of the Ministry of Health of Liberia&";
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Main outcomes, as reported in study improvement in clinical symptoms (itching and visual impairment), improvement in ocular signs (perilimbal pigmentation, pannus, punctuate keratitis, sclerosing keratitis, iridocyclitis, chorioretinitis, and optic atrophy) and dermal signs (dermatitis and nodules)
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Study design issues
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Random sequence generation (selection bias):Authors' judgement High risk
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Random sequence generation (selection bias):Support for judgement Participants' registration numbers were used to assign treatments (email communication)
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Allocation concealment (selection bias):Authors' judgement High risk
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Allocation concealment (selection bias):Support for judgement Participants' registration numbers were used to assign treatments (email communication)
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Masking of participants and personnel (performance bias):Authors' judgement High risk
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Masking of participants and personnel (performance bias):Support for judgement &";It was a prospective, randomized, comparative trial without blinding&";
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Masking of outcome assessment (detection bias):Authors' judgement High risk
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Masking of outcome assessment (detection bias):Support for judgement &";It was a prospective, randomized, comparative trial without blinding&";
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Incomplete outcome data (attrition bias):Authors' judgement Low risk
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Incomplete outcome data (attrition bias):Support for judgement No missing data reported
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Selective reporting (reporting bias):Authors' judgement High risk
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Selective reporting (reporting bias):Support for judgement No study protocol available (email communication), but nodulectomies and skin snips were performed in selected cases, and these data were not reported
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Other bias:Authors' judgement Low risk
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Other bias:Support for judgement None identified
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Results & Comparisons


Results Data
Outcome: Clinical      Population: All Participants
Time Point Measure Doxycyline + Ivermectin Ivermectin


6 months

N Analyzed 120 120
Mean 0 0
SD
SE
95% CI low 95% CI high RR
Outcome: Improvement in iridocyclitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Doxycyline + Ivermectin Ivermectin Comparison Measure Doxycyline + Ivermectin vs. Ivermectin


6 months

N Analyzed 120 120 0.69
Mean 18% 14% 2.22
SD 1.24
SE
95% CI low 95% CI high RR
Outcome: Improvement in punctate keratitis      Population: All Participants Between-Arm Comparisons
Time Point Measure Doxycyline + Ivermectin Ivermectin Comparison Measure Doxycyline + Ivermectin vs. Ivermectin


6 months

N Analyzed 120 120 1.02
Mean 44% 31% 2.00
SD 1.43
SE
95% CI low 95% CI high RR
Outcome: Improved visual impairment      Population: All Participants Between-Arm Comparisons
Time Point Measure Doxycyline + Ivermectin Ivermectin Comparison Measure Doxycyline + Ivermectin vs. Ivermectin


6 months

N Analyzed 120 120 0.80
Mean 57 54 1.39
SD 1.06
SE

Adverse Events
Arm or Total Title Description Number of events Comments