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14 Hyperbaric Oxygenation Therapy KCE Reports 74 3.2 LITERATURE SEARCHES ON CLINICAL EFFECTIVENESS Most of the randomised clinical trials have been done in small groups and for many of the indications no proper randomised trials have been performed. We therefore focussed our search on meta-analyses and systematic reviews. Relevant literature was sought in Medline, Embase, the Cochrane Database of Systematic Reviews (CDSR), and the DARE, NHS-EED and HTA databases of the Centre for Reviews and Dissemination (CRD). We also searched for ongoing clinical trials in the Cochrane Central Register for Controlled Trials. Details of strategy and search results can be found in the appendix. In addition we searched http://www.hboevidence.com/, a specialized site for EBM information on HBOT for the most recent information. 3.3 DATA SOURCES From the 372 references of potential systematic reviews and meta-analyses retrieved originally, we selected, based on title and abstract, 104 articles for further consideration. From these we finally selected 54 references (see Figure 1 for details on selection). We also identified an additional article and a thesis through hand searching. 1, 19 Figure 1. Identification and selection of systematic reviews and Meta- Analyses Hand searching: 2 Potentially relevant citations identified (Medline, Embase, Cochrane, CRD): 372 Studies retrieved for more detailed evaluation: 104 Relevant publications 54 Publications selected: 56 Based on title and abstract evaluation, citations excluded: 268 Reasons: - Duplicate references (8) - Language (1) - Prior to 2000 (8) - Not relevant (56) - Single Clinical Trial (195) Based on full text evaluation, studies excluded: 50 Reasons: - Not relevant (6) - Language (4) - Narrative review (30) - Guideline (2) - Duplicate content (8) The retained references included 17 Cochrane reviews published since 2002 and an Australian doctoral thesis from Michael Bennett who co-authored many of the Cochrane reviews. These 18 key references are listed in Table 4.
KCE Reports 74 Hyperbaric Oxygenation Therapy 15 Table 4. Cochrane reviews and thesis on various indications for hyperbaric oxygenation Title Year Recompression and adjunctive therapy for decompression illness. 20 2007 Hyperbaric oxygen for idiopathic sudden sensorineural hearing loss and 2007 tinnitus. 21 Normobaric and hyperbaric oxygen therapy for migraine and cluster 19, 22 headache (Protocol)*. 2007 Hyperbaric oxygen as an adjuvant treatment for malignant otitis externa. 23 2005 Hyperbaric oxygen for carbon monoxide poisoning. 24 2005 Hyperbaric oxygen therapy for acute ischemic stroke. 25 2005 Hyperbaric oxygen therapy for promoting fracture healing and treating fracture non-union. 26 2005 Hyperbaric oxygen therapy for late radiation tissue injury. 27 2005 Hyperbaric oxygen therapy for acute coronary syndrome. 28 2005 Hyperbaric oxygenation for tumour sensitisation to radiotherapy. 29 2005 Hyperbaric oxygen therapy for delayed onset muscle soreness and closed soft tissue injury. 30 2005 Hyperbaric oxygen therapy for thermal burns. 31 2004 Hyperbaric oxygen therapy for chronic wounds. 32 2004 Hyperbaric oxygen therapy for the adjunctive treatment of traumatic brain 2004 injury. 33 Hyperbaric oxygen therapy for multiple sclerosis. 34 2004 Non surgical interventions for late radiation proctitis in patients who have received radical radiotherapy to the pelvis. 35 2002 Interventions for replacing missing teeth: hyperbaric oxygen therapy for irradiated patients who require dental implants. 36 2002 Thesis: The Evidence Basis of Diving and Hyperbaric Medicine 1 2006 * The formal Cochrane review is in press but results have been published by Schnabel et al. 19 Our search also yielded several HTA reports. A few of the recent technology assessments covered the whole domain of HBOT. 14, 37, 38 Other HTA reports focussed on specific indications only, and will be addressed with the specific indications where relevant. The Cochrane Central Register for Controlled Trials reveals 20 registered RCTs between 2005 and 2007. Most of these trials investigate miscellaneous indications not-accepted by the two large hyperbaric medical communities, or therapies adjuvant to HBOT. Only two of these deal with CO intoxication (one RCT, 39 and a longitudinal study on affective outcome 40 ) one deals with radio induced lesion, 17 and two with diabetic ulcers. 18, 41 The RCT database from the National Institutes of Health (NIH, www.clinicaltrials.gov) lists 31 ongoing or recently completed trials on HBOT. A European Cost B14 program was started in 1998 and after prolongation ended in March 2005. 42 In addition to the development of a database, a common website (www.oxynet.org, a function now largely taken over by www.echm.org) and safety protocols for hyperbaric facilities, this collaboration also developed several research protocols for RCTs that were reportedly started in 2001 and 2002 (http://www.oxynet.org/ProtocolsIndex.htm). The status of these studies remains, however, unclear and it was confirmed that these RCTs were delayed due to lack of funding and are unlikely to provide results within the next 2 or 3 years (personal communication D. Mathieu). Table 5 lists the RCTs currently in the NIH clinical trials database.
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KCE reports 33 Effects and costs of
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