Table 24.
Certainty assessment | Impact | Certainty | Importance | ||||||
---|---|---|---|---|---|---|---|---|---|
№ of studies | Study design | Risk of bias | Inconsistency | Indirectness | Imprecision | Other considerations | |||
Weight (assessed with: BMI), Psychological Symptoms, Side Effects | |||||||||
1 | randomised trials | not serious | not serious | not serious | not serious | none | RCT with 10 subjects in olanzapine group and 10 in placebo group. No differences were found between groups in rate of weight restoration or final weight. Difference in BMI was 0.4 kg/m2 and was not significant. Mean dose was 8.5 mg/day. |
⨁⨁⨁⨁ HIGH |
CRITICAL |
not serious | not serious | not serious | not serious | none | No differences in eating disorder symptoms or psychological functioning. |
⨁⨁⨁⨁ HIGH |
CRITICAL | ||
not serious | not serious | not serious | not serious | none | A trend of increasing fasting glucose and insulin levels were found in the olanzapine group. |
⨁⨁⨁⨁ HIGH |
CRITICAL | ||
Weight gain, activity levels, side effects | |||||||||
3 | Case Control | serious a | not serious | not serious a | not serious | none | There are three non randomized case control studies. One of the studies found the rate of weight gain was greater in the olanzapine group, while another study found no differences between cases and controls in terms of weight gain. |
⨁◯◯◯ VERY LOW |
CRITICAL |
serious a | not serious | not serious a | not serious | none | Reduced activity levels were observed in one study. |
⨁◯◯◯ VERY LOW |
CRITICAL | ||
serious a | not serious | not serious a | not serious | none | Sedation and dyslipidemia was found in 56% of patients in one study. One study found that 32% of patients discontinued the treatment due to a side effect. |
⨁◯◯◯ VERY LOW |
CRITICAL | ||
Weight, hyperactivity, side effects | |||||||||
2 | Case Series | very serious a | not serious | not serious | not serious | none | 60 patients total involved in these two case series. Improvements in weight noted. |
⨁◯◯◯ VERY LOW |
CRITICAL |
very serious a | not serious | not serious | not serious | none | Improvements in hyperactivity are noted. |
⨁◯◯◯ VERY LOW |
CRITICAL | ||
very serious a | not serious | not serious | not serious | none | No long term adverse effects were seen 3 months after discontinuing medication. |
⨁◯◯◯ VERY LOW |
CRITICAL | ||
Weight, side effects | |||||||||
13 | Case Reports | very serious a | not serious | not serious | not serious | none | Thirteen studies report on 30 cases. All studies report improvement in weight. |
⨁◯◯◯ VERY LOW |
CRITICAL |
very serious a | not serious | not serious | not serious | none | One case study reports on QTc prolongation (a problem on the ECG), another reports a case with neuroleptic malignant syndrome. |
⨁◯◯◯ VERY LOW |
CRITICAL |
Explanations
aobservational study, non randomized
Bibliography:
RCT - Kafantaris 2011 [137]
Case Control - Spettigue 2018 [138], Norris 2011 [139], Hillebrand 2005 [140]
Case Series -Swenne 2011 [141], Leggero 2010 [142]
Case Reports - Pisano 2014 [143], Duvvuri 2012 [42], Dennis 2006 [144], Boachie 2003 [145], Mehler 2001 [146], La Via 2000 [147], Dadic-Hero 2009 [148], Hein 2010 [149], Tateno 2008 [150], Ercan 2003 [151], Dodig-Curkovic 2010 [152], Ayyildiz 2016 [153], Ritchie 2009 [154]