Afzali 2008.

Study characteristics
Methods	Study design: quasi‐randomised controlled trial (alternate allocation) Duration of study: 3 months Number of centres: 1 Location: Iran Study setting: recruitment in ED of Sina Hospital, Hamadan Date of study: September 2003 to October 2005
Participants	Study inclusion criteria: no formal selection criteria were given; investigators apparently intended to limit recruitment to patients with moderate to severe (but not fulminant) poisoning by the following means (emphasis added): "Sodium dithionite reaction test was done on the urine samples of all patients as soon as possible. ... Navy blue (NB) or dark blue (DB) colors usually indicate significant PQ poisoning. The studied patients were divided into three groups on the basis of clinical manifestations and test results: 1) Fulminant poisoning: The urine test was NB color. All of these patients died during the first few days (three to four days) after poisoning because of multiorgan involvement, such as acute tubular necrosis, myocarditis, hepatic necrosis, and pulmonary bleeding. 2) Moderate to severe poisoning: The urine test color was NB or DB and the clinical manifestations were oropharyngeal burns, pharyngeal pseudomembranes, vomiting, severe diarrhoea, and acute renal and hepatic failure 3) Mild poisoning: The urine test was colourless or light blue and the clinical manifestations included transient diarrhoea, vomiting, and buccal hyperemia, which mostly resolved without further sequelae. Of the 45 patients assessed in this study, 15 patients with mild and 10 patients with fulminant poisoning were excluded. So, 20 patients remained. Of them 11 patients received 'conventional treatment' (group 1) and nine patients received 'conventional' treatment plus 'new treatment' (group 2) randomly" (Afzali 2008, p 388). Study exclusion criteria: no formal criteria given bar those implied above Number of participants: 45 screened; 15 excluded due to mild and 10 due to fulminant status. 20 were randomised (9 to intervention group, 11 to conventional treatment). Age in years, mean (∓): intervention: 27 years (∓ 10); control: 25 years (∓ 10) Gender, n (%): intervention: female 1 (11.1%), male 8 (88.9%); control: female 3 (27.3%), male 8 (72.7%) Severity (urine colour): intervention group: 3 NB, 6 DB; control group: 4 NB, 7 DB "In our study, all patients used PQ in order to commit suicide and there were no cases of homicide or accidental use" (Afzali 2008, p 390)
Interventions	Intervention: "Conventional treatment included fixation of a nasogastric tube, gastric lavage with normal saline, charcoal‐sorbitol gavage [sic] every two to four hours for three days, forced alkalinized diuresis in the first day of admission to the hospital, and haemodialysis of four hours duration for both groups. In addition, 15 mg/kg of CP [cyclophosphamide] in dextrose saline (200 mL) was infused in two hours for two days in [the intervention group] ... MP (methylprednisolone), one gram in 200 mL dextrose saline was also infused for four hours and was repeated for three consecutive days ... as well. Meanwhile, 15 mg/kg of MESNA was prescribed (for four days) in order to avoid the side effects of CP" (Afzali 2008, p 388). Control: "Conventional treatment" (as above) alone
Outcomes	Primary outcome: not stated. Would appear to be mortality in‐hospital, prior to discharge (referred to in document as "during the admission") Secondary outcomes: none specifically stated. Investigators reported that creatinine > 1.4 mg/dL, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) > 70 IU/L, and PaO2 < 70 mmHg (in the room air) were considered asacute renal failure (ARF), hepatitis, and hypoxia, respectively (emphasis added). Information was provided concerning daily in‐hospital assessments: "laboratory tests included liver function tests (LFT), complete blood count (CBC), arterial blood gas (ABG), blood urea nitrogen (BUN), and creatinine"; chest radiography was repeated every 2 days. Finally, autopsies were conducted for "all expired patients". Data on adverse effects do not appear to have been rigorously sought, but investigators mention that there were "no severe complications ... in the new treatment group" (Afzali 2008, p 390).
Notes	Funding: none reported. Registration: none reported (though it is noted that "this survey [sic] was approved by the Ethics Committee of Hamadan University of Medical Sciences") (Afzali 2008, p 388). Interests: none declared.
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Unclear risk	"11 patients received 'conventional treatment' ... and nine patients received 'conventional' treatment plus 'new treatment' ... randomly" (Afzali 2008, p 388) We contacted the first author of the study, who informed us that alternate allocation was used (Afzali 2010 ‐ personal correspondence between lead investigator and previous review author Emma Sydenham. Correspondence details are no longer available). Whilst we initially considered this domain as at high risk of bias, given the long period of the study (25 months, in which only 45 patients were screened), we reconsidered that the danger of manipulation of the allocation of successive participants was not serious.
Allocation concealment (selection bias)	High risk	Concealment of allocation is not mentioned in the paper, and is not possible with use of alternate allocation.
Blinding (performance bias and detection bias) All outcomes	Low risk	Blinding was not reported, and according to the author was not done (Afzali 2010 ‐ personal correspondence ‐ see above). Given that the main outcome of interest (mortality) is objective, we did not consider it likely that the lack of blinding introduced bias.
Incomplete outcome data (attrition bias) All outcomes	Low risk	The main outcome was death at discharge from hospital, which appears to be reported in full.
Selective reporting (reporting bias)	Unclear risk	The study reported the main outcome for this review (mortality) in full; however, in the absence of a trial protocol or evidence of prospective registration, we are obliged to report the risk of bias as unclear.
Other bias	High risk	Investigators acknowledged the "limitation" that they "did not check plasma PQ" in participants on entry to the study (or at any other point).