8. Mefloquine versus doxycycline; characteristics of included studies for safety.
Study ID | Participants | Number enrolled | Method of adverse event monitoring | Significant exclusions for psychiatric adverse effects | Duration of travel | Source of funding |
Randomized controlled trials | ||||||
Arthur 1990 | USA soldiers | 270 | Blood tests, stool samples. Interview with study personnel | None | 5 weeks | Not mentioned |
Ohrt 1997 | Indonesian soldiers | 204 | Interview with study personnel. Exit questionnaire | " History of underlying illness" | 13 weeks | Pfizer and Roche |
Schlagenhauf 2003 | Non‐immune adult short‐term travellers | 674 | Participant self‐reported questionnaire | History of seizures or psychiatric disorders | 4 to 6 weeks | GlaxoSmithKline and Roche |
Weiss 1995 | Kenyan children | 169 | Interview with study personnel | None | 4 months | Government funding |
Non‐randomized studies | ||||||
Participants | Number enrolled | Method of adverse event monitoring | Factors influencing drug allocation | Duration of travel | Source of funding | |
Cunningham 2014 | UK Foreign and Commonwealth Office staff | 327 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | 0 to 36 months | Not mentioned |
Eick‐Cost 2017 | USA s oldiers | 367,840 | Data from the Defense Medical Surveillance System, the Pharmacy Data Transaction Service and the Theater Medical Data Store | No information available | Various, not specified | Not mentioned |
Goodyer 2011 | UK adult short‐term travellers | 185 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | < 28 days | GlaxoSmithKline |
Korhonen 2007 | Peace Corps volunteers | 2701 | Participant self‐reported questionnaire | Allocation based on guidelines and participan t preference | ≥ 6 months | Two staff employed by Peace Corps |
Landman 2015 | Peace Corps volunteers | 1184 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | Various, not specified | Not mentioned |
Laver 2001 | Adult short‐term travellers | 660 | Participant self‐reported questionnaire | No information available | 93% < 4 weeks | " No financial interests to disclose" |
Lobel 2001 | Adult short‐term travellers | 5626 | Participant self‐reported questionnaire | No information available | < 5 weeks | " No financial interests to disclose" |
Meier 2004 | UK adults enrolled in UK g eneral p ractice research database | 35,370 | Incident cases of depression, psychoses and panic attacks within the UK general practice research database | No information available | Various, not specified | Roche |
Napoletano 2007 | Italian short‐term travellers | 1906 | Telephone interview | Allocation based on guidelines and participant preference | Mean 2 weeks, range 0 to > 35 days | Not mentioned |
Philips 1996 | Australian short‐term travellers | 741 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | Various, mean 3 weeks, maximum 3 months | Roche and Pfizer |
Saunders 2015 | USA soldiers | 2351 | Participant self‐reported questionnaire | Primarily doxycycline, soldiers with contra‐indications received mefloquine | > 90% for 10 months or more | Not mentioned |
Schwartz 1999 | Israeli short‐term travellers | 158 | Participant self‐reported questionnaire | "... daily doxycycline or daily primaquine... was recommended" | 14 to 20 days | Not mentioned |
Shamiss 1996 | Israeli soldiers | 45 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | "... an average of 4 hours stay in the field over a period of 2 months" | Not mentioned |
Sharafeldin 2010 | Dutch medical students | 180 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | Mean 74 days (range 10 to 224 days) | No dedicated funding |
Sonmez 2005 | Turkish soldiers | 1400 | Participant self‐reported questionnaire | Prior to March 2002: doxycyline After July 2002: mefloquine |
A pprox. 6 months | Not mentioned |
Stoney 2016 | USA short‐term travellers | 370 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | Median duration 13 days | Government funding |
Tan 2017 | Peace Corps volunteers | 8931 | Participant self‐reported questionnaire | No information available | Various, not specified | No dedicated funding |
Terrell 2015 | UK soldiers | 2032 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | Median duration 13 days | "... not funded by an external body" |
Tuck 2016 | UK soldiers | 151 | Participant self‐reported questionnaire | Allocation based on guidelines and participant preference | Various, not specified | No dedicated funding |
Waner 1999 | Adult short‐term travellers | 3051 | Participant self‐reported questionnaire | No information available | A pprox. 6 weeks | Not mentioned |