Zhao - Revision history

M.bennett at 04:27, 10 January 2020

2020-01-10T04:27:39Z

M.bennett at 04:18, 10 January 2020

2020-01-10T04:18:26Z

M.bennett: Created page with " Hyperbaric oxygen reduced ulcer size but unclear effects on healing and major amputation risk compared to a mixed bag of alternative treatmen..."

2020-01-10T04:14:11Z

Created page with " Hyperbaric oxygen reduced ulcer size but unclear effects on healing and major amputation risk compared to a mixed bag of alternative treatmen..."

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Hyperbaric oxygen reduced ulcer size but unclear effects on healing and major amputation risk compared to a mixed bag of alternative treatments (Systematic Review)

'''Citation:'''  

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Zhao D, Luo S, Xu W, Hu J, Lin S, Wang N. Efficacy and safety of hyperbaric oxygen therapy used in patients with diabetic foot: a meta-analysis of randomized clinical trials. Clinical therapeutics. 2017 Oct 1;39(10):2088-94.

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'''Purpose:'''

The efficacy and safety profile of hyperbaric oxygen therapy (HBOT) in patients with diabetic foot ulcer have been controversial in recent years. Our meta-analysis was undertaken to evaluate the efficacy and safety profile of HBOT in patients with diabetic foot ulcer.

'''Methods:'''

We searched the PubMed, Cochrane Library, EMBASE, and Clinical Trials.gov databases for controlled trials. The efficacy end points included the incidence of healed ulcers, major amputations, minor amputations, and reduction in the ulcer wound area. The tolerability end point was the incidence of adverse events.

'''Findings:'''

Nine randomized clinical trials involving 526 patients met the inclusion criteria. No difference was found in the incidence of healed ulcers (risk ratio [RR] ¼ 2.22; 95% CI, 0.87–5.62; P ¼ 0.32; I 2 ¼ 81%), minor amputations (RR ¼ 0.95; 95% CI, 0.39–2.29; P ¼ 0.91; I 2 ¼ 74%), major amputations (RR ¼ 0.47; 95% CI, 0.17–1.28; P ¼ 0.14; I 2 ¼ 61%), and adverse events (RR ¼ 1.00; 95% CI, 0.64– 1.56; P ¼ 0.99; I 2 ¼ 26%) between the HBOT and standard therapy (ST) groups.

HBOT was associated with a greater reduction in the ulcer wound area versus ST (standard mean difference ¼ 1.12; 95% CI, 0.20–2.04; P ¼ 0.04; I 2 ¼ 70%). Implications:

'''Conclusion:'''

No differences existed between HBOT and ST with respect to the incidence of healed ulcers, risk of minor or major amputations, and adverse events. HBOT was associated with a greater reduction in the ulcer wound area than ST. HBOT is a clinically meaningful adjuvant therapy for patients with diabetic foot ulcer. (Clin Ther. 2017;39:2088–2094) & 2017 Elsevier HS Journals, Inc. All rights reserved.\

 

'''Appraiser comment:'''

#Generally sound meta-analysis.
#Search strategies not given so we cannot comment on reliability of the search.
#Time to outcome not stated. This is particularly problematic for DFU. Evidence suggests that in the short term there is no advantage with HBOT but potentially the longer term (months to years) there may be a benefit.
#Authors have combined the outcomes ‘indication for [major] amputation’ and ‘major amputation’ here. The former is an outcome from Fedorko 2016 and has been questioned. See 6 below.
#Authors conclusions ignore the direction of pooled effects and concentrate on the ‘not statistically significant character’ of the result
#Of interest: Fedorko 2016 scores very well RoB but this trial has received vigorous criticism in the way it was conducted (seeMurad MH. Comment on Fedorko et al. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e135-; Huang ET. Comment on Fedorko et al. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e133-4.; Response from Fedorko et al here: Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O’Reilly DJ. Response to Comments on Fedorko et al. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e136-7.

@@ Line 42: / Line 42: @@
 #<span style="font-size:12.0pt"><span style="line-height:107%">Authors have combined the outcomes ‘indication for [major] amputation’ and ‘major amputation’ here. The former is an outcome from Fedorko 2016 and has been questioned. See 6 below.</span></span>
 #<span style="font-size:12.0pt"><span style="line-height:107%">Authors conclusions ignore the direction of pooled effects and concentrate on the ‘not statistically significant character’ of the result</span></span>
 #<span style="font-size:12.0pt"><span style="line-height:107%">Of interest: Fedorko 2016 scores very well RoB but this trial has received vigorous criticism in the way it was conducted (see&nbsp;</span></span><span style="font-size:medium;"><span style="color:#222222">Murad MH. Comment on Fedorko et al. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e135-; Huang ET. Comment on Fedorko et al. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e133-4.; Response from Fedorko et al here: Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O’Reilly DJ. Response to Comments on Fedorko et al. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e136-7.)</span></span>

@@ Line 23: / Line 23: @@
 '''<span style="font-size:12.0pt"><span style="line-height:107%">Findings:</span></span>'''
-<span style="font-size:12.0pt"><span style="line-height:107%">Nine randomized clinical trials involving 526 patients met the inclusion criteria. No difference was found in the incidence of healed ulcers (risk ratio [RR] ¼ 2.22; 95% CI, 0.87–5.62; P ¼ 0.32; I 2 ¼ 81%), minor amputations (RR ¼ 0.95; 95% CI, 0.39–2.29; P ¼ 0.91; I 2 ¼ 74%), major amputations (RR ¼ 0.47; 95% CI, 0.17–1.28; P ¼ 0.14; I 2 ¼ 61%), and adverse events (RR ¼ 1.00; 95% CI, 0.64– 1.56; P ¼ 0.99; I 2 ¼ 26%) between the HBOT and standard therapy (ST) groups.</span></span>
+<span style="font-size:12.0pt"><span style="line-height:107%">Nine randomized clinical trials involving 526 patients met the inclusion criteria.</span></span>
-<span style="font-size:12.0pt"><span style="line-height:107%">HBOT was associated with a greater reduction in the ulcer wound area versus ST (standard mean difference ¼ 1.12; 95% CI, 0.20–2.04; P ¼ 0.04; I 2 ¼ 70%). Implications:</span></span>
+<span style="font-size:12.0pt"><span style="line-height:107%">No difference was found in the incidence of healed ulcers (risk ratio [RR]:&nbsp;2.22; 95% CI, 0.87–5.62; P:&nbsp;0.32; I-sq&nbsp;81%), minor amputations (RR: 0.95; 95% CI, 0.39–2.29; P:&nbsp;0.91; I-sq&nbsp;74%), major amputations (RR:&nbsp;0.47; 95% CI, 0.17–1.28; P:&nbsp;0.14; I-sq:&nbsp;61%), and adverse events (RR:&nbsp;1.00; 95% CI, 0.64– 1.56; P:&nbsp;0.99; I-sq:&nbsp;26%) between the HBOT and standard therapy (ST) groups.</span></span>
 '''<span style="font-size:12.0pt"><span style="line-height:107%">Conclusion:</span></span>'''
-<span style="font-size:12.0pt"><span style="line-height:107%">No differences existed between HBOT and ST with respect to the incidence of healed ulcers, risk of minor or major amputations, and adverse events. HBOT was associated with a greater reduction in the ulcer wound area than ST. HBOT is a clinically meaningful adjuvant therapy for patients with diabetic foot ulcer. (Clin Ther. 2017;39:2088–2094) & 2017 Elsevier HS Journals, Inc. All rights reserved.\</span></span>
+<span style="font-size:12.0pt"><span style="line-height:107%">No differences existed between HBOT and ST with respect to the incidence of healed ulcers, risk of minor or major amputations, and adverse events. HBOT was associated with a greater reduction in the ulcer wound area than ST. HBOT is a clinically meaningful adjuvant therapy for patients with diabetic foot ulcer.</span></span>
 &nbsp;
-'''<span style="font-size:14.0pt"><span style="line-height:107%">Appraiser comment:</span></span>'''
+'''<span style="font-size:14.0pt"><span style="line-height:107%">Appraiser comments:</span></span>'''
 #<span style="font-size:12.0pt"><span style="line-height:107%">Generally sound meta-analysis.</span></span>
@@ Line 40: / Line 42: @@
 #<span style="font-size:12.0pt"><span style="line-height:107%">Authors have combined the outcomes ‘indication for [major] amputation’ and ‘major amputation’ here. The former is an outcome from Fedorko 2016 and has been questioned. See 6 below.</span></span>
 #<span style="font-size:12.0pt"><span style="line-height:107%">Authors conclusions ignore the direction of pooled effects and concentrate on the ‘not statistically significant character’ of the result</span></span>
-#<span style="font-size:12.0pt"><span style="line-height:107%">Of interest: Fedorko 2016 scores very well RoB but this trial has received vigorous criticism in the way it was conducted (see</span></span><span style="color:#222222">Murad MH. Comment on Fedorko et al. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e135-; Huang ET. Comment on Fedorko et al. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e133-4.; Response from Fedorko et al here: Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O’Reilly DJ. Response to Comments on Fedorko et al. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e136-7.</span>
+#<span style="font-size:12.0pt"><span style="line-height:107%">Of interest: Fedorko 2016 scores very well RoB but this trial has received vigorous criticism in the way it was conducted (see&nbsp;</span></span><span style="font-size:medium;"><span style="color:#222222">Murad MH. Comment on Fedorko et al. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e135-; Huang ET. Comment on Fedorko et al. Hyperbaric oxygen therapy does not reduce indications for amputation in patients with diabetes with nonhealing ulcers of the lower limb: a prospective, double-blind, randomized controlled clinical trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e133-4.; Response from Fedorko et al here: Fedorko L, Bowen JM, Jones W, Oreopoulos G, Goeree R, Hopkins RB, O’Reilly DJ. Response to Comments on Fedorko et al. Hyperbaric Oxygen Therapy Does Not Reduce Indications for Amputation in Patients With Diabetes With Nonhealing Ulcers of the Lower Limb: A Prospective, Double-Blind, Randomized Controlled Clinical Trial. Diabetes Care 2016; 39: 392–399. Diabetes care. 2016 Aug 1;39(8):e136-7.)</span></span>