We reviewed evidence on the effect of medical treatment on human botulism.
Botulism is a serious illness that starts suddenly and causes paralysis (an inability to use muscles). A germ called Clostridium botulinum is the cause. If left untreated, a lot of people who have botulism die. There are four main types, adult and infant types where the intestine (gut) is infected; botulism from contaminated food; and wound botulism. We assessed the evidence on the effect of medical treatment on human botulism.
We searched for clinical trials of medicines for any of the four major types of botulism. We decided to assess the effects of treatment on the rate of deaths in hospital from any cause within four weeks. We were also interested in deaths within 12 weeks, length of hospital stay, the need for a ventilator to help with breathing (mechanical ventilation), feeding by tube, and harmful events.
Once we had searched the medical literature and checked the results, we found only one randomized controlled trial (RCT), which was in infant botulism. The treatment was a single dose of a medicine made from human immune proteins (human-derived botulinum immune globulin or BIG). In the trial, 59 participants received BIG and 63 received an inactive treatment.
Key results and quality of the evidence
There were no deaths in either group in the trial. Infants treated with BIG were in hospital for three weeks less, on average, and spent a shorter time on a ventilator. The average length of tube feeding in the BIG group was over six weeks less than in the control group. The risk of harmful effects was no greater with BIG than with the inactive treatment. The evidence was of high quality overall (moderate for time spent on a ventilator).
The review shows that there is evidence for the use of BIG to treat infant botulism. On the other hand, there is no evidence for or against botulism antitoxin or other medical treatments.
The evidence was up to date to March 2013, when we updated the searches and found no new trials.
There is evidence supporting the use of human-derived botulinum immune globulin (BIG) in infant intestinal botulism. A single randomized controlled trial demonstrated significant decreases in the duration of hospitalization, mechanical ventilation and tube or parenteral feeding with BIG treatment. This evidence was of moderate quality for effects on duration of mechanical ventilation but was otherwise of high quality. Our search did not reveal any evidence examining the use of other medical treatments including serum trivalent botulism antitoxin.
Botulism is an acute paralytic illness caused by a neurotoxin produced by Clostridium botulinum. Supportive care, including intensive care, is key but the role of other medical treatments is unclear. This is an update of a review first published in 2011.
To assess the effects of medical treatments on mortality, duration of hospitalization, mechanical ventilation, tube or parenteral feeding and risk of adverse events in botulism.
On 30 March 2013, we searched the Cochrane Neuromuscular Disease Group Specialized Register (30 March 2013), CENTRAL (2013, Issue 3) in The Cochrane Library, MEDLINE (January 1966 to March 2013) and EMBASE (January 1980 to March 2013). We reviewed bibliographies and contacted authors and experts.
Randomized and quasi-randomized controlled trials examining the medical treatment of any of the four major types of botulism (infant intestinal botulism, food-borne botulism, wound botulism and adult intestinal toxemia). Potential medical treatments included equine serum trivalent botulism antitoxin, human-derived botulinum immune globulin, plasma exchange, 3,4-diaminopyridine and guanidine.
Two authors independently selected studies, assessed risk of bias and extracted data onto data extraction forms.
Our primary outcome was in-hospital death from any cause occurring within four weeks. Secondary outcomes were death occurring within 12 weeks, duration of hospitalization, mechanical ventilation, tube or parenteral feeding and risk of adverse events.
A single randomized controlled trial met the inclusion criteria. We found no additional trials when we updated the searches in 2013. This trial evaluated human-derived botulinum immune globulin (BIG) for the treatment of infant botulism and included 59 treatment participants as well as 63 control participants. The control group received a control immune globulin which did not have an effect on botulinum toxin. In this trial there was some violation of intention-to-treat principles, and possibly some between-treatment group imbalances among those participants admitted to the intensive care unit (ICU) and mechanically ventilated, but overall we judged the risk of bias to be low. There were no deaths in either group, making any treatment effect on mortality inestimable. There was a significant benefit in the treatment group on mean duration of hospitalization (BIG: 2.60 weeks, 95% CI 1.95 to 3.25; control: 5.70 weeks, 95% CI 4.40 to 7.00; mean difference (MD) 3.10 weeks, 95% CI 1.68 to 4.52), mechanical ventilation (BIG: 1.80 weeks, 95% CI 1.20 to 2.40; control: 4.40 weeks, 95% CI 3.00 to 5.80; MD 2.60 weeks, 95% CI 1.14 to 4.06), and tube or parenteral feeding (BIG: 3.60 weeks, 95% CI 1.70 to 5.50; control: 10.00 weeks, 95% CI 6.85 to 13.15; MD 6.40 weeks, 95% CI 2.80 to 10.00) but not on risk of adverse events or complications (BIG: 63.08%; control: 68.75%; risk ratio 0.92, 95% CI 0.72 to 1.18; absolute risk reduction 0.06, 95% CI 0.22 to -0.11).