sábado, 9 de maio de 2015

OSTEOARTHRITIS HAND




Systematic review of therapies for osteoarthritis of the hand1

T.E. Towheed, M.D., M.Sc., F.R.C.P.C., F.A.C.P. (Associate Professor of Medicine and of Epidemiology)correspondence
Department of Medicine, Queen's University, Kingston, Ontario, Canada


Summary

Objective

To systematically review published randomized controlled trials (RCTs) evaluating pharmacological and non-pharmacological therapies in patients with hand osteoarthritis (OA), with an emphasis on trial methodology.

Methods

RCTs published between 1966 and August 2004 were identified by searching several electronic data sources as well as by searching reference lists. Details of study demographics, methodology, quality and outcomes were analyzed. A meta-analysis was planned, if feasible.

Results

Thirty-one RCTs evaluating various pharmacological and non-pharmacological therapies in hand OA were analyzed in this systematic review. When compared with hip and knee OA, there are surprisingly few published RCTs in hand OA. Generally, these RCTs are of low quality. RCTs are weakened by a lack of consistent case definition and by a lack of standardized outcome assessments. The methods used for randomization, blinding, and allocation concealment were rarely described. The number and location of symptomatic hand joints per treatment group at baseline was usually not stated. The number and location of evaluated hand joints at the end of the study was also usually not stated. A meta-analysis could not be performed since most of the treatments studied did not have more than one identical comparison to allow pooling of the data.

Conclusion

It is apparent that hand OA is a more complex area in which to study the efficacy of therapies when compared to hip and knee OA. Consensus guidelines are urgently needed to help improve the design and conduct of RCTs in hand OA. Additional RCTs of high quality that follow consensus recommendations are needed to evaluate the wide range of possible therapeutic options available for patients with hand OA.

Key words:

Osteoarthritis, Hand, Digital, Therapy, Systematic review


Introduction

Osteoarthritis (OA) of the hand is a common problem that has received relatively little attention when compared to OA of the hip and knee. Data from the Framingham Study revealed that in the age group of 71–100 years, the prevalence of symptomatic hand OA was 26% in females and 13% in males1. Compared to those without symptomatic hand OA, subjects with the disease had reduced maximal grip strength and reported more difficulty in writing, handling, or fingering small objects1. Results from the Framingham study, along with the results from other clinical studies2, 3, 4, confirm that hand OA is similar to other forms and locations of OA, in that the end result is often pain and stiffness, which can often result in functional limitation and an impaired quality of life.
Despite the high prevalence of symptomatic hand OA, there is a remarkable paucity of published clinical research pertaining to the clinical impact, epidemiology, and therapy of the condition. In terms of epidemiology, the following risk factors are felt to be of etiologic importance: age, genetics, gender, hormonal factors, obesity, and mechanical factors5, 6.
Two systematic reviews evaluating randomized controlled trials (RCTs) in hand OA have been published7, 8. These reviews analyzed trials published within the time period of 1983 to 2000. The main findings of these two reviews were that there are very few published RCTs evaluating therapies in hand OA, and that these RCTs are weakened by numerous methodological flaws. The authors also emphasized the great importance and urgent need for developing consensus guidelines on how future RCTs in hand OA should be done.

Objective

The objective of this paper is to systematically review all published RCTs evaluating pharmacological and non-pharmacological therapies in patients with hand OA, with an emphasis on trial methodology. Only RCTs published between 1966 and August 2004 were considered.

Criteria for inclusion



Types of studies

Only RCTs evaluating a therapeutic intervention in subjects with hand OA are included in this systematic review. The trial report must have explicitly stated that a randomized method of allocation to a treatment group was employed. There were no language restrictions in the electronic searches. Trials of any methodological quality were included.

Types of participants

Adults with hand OA. Hand OA may have been defined by any method or by no method at all.

Types of intervention

Any therapeutic intervention was considered. However, RCTs evaluating surgical therapies were excluded.

Types of outcome measures

Data pertaining to all outcomes presented in the trial report were extracted. However, the greatest importance was given to those outcomes currently recommended by both Osteoarthritis Research Society International and Outcome Measures in Arthritis Clinical Trials9, 10. These outcomes include pain, functional status, patient global assessment, physician global assessment, radiological progression, and health-related quality of life.

Criteria for exclusion

The following exclusion criteria were applied: (1) RCTs evaluating surgical therapy, (2) RCTs presented in duplicate, (3) non-English RCTs were included only if their English abstracts contained sufficient details pertaining to trial methodology and outcomes, and (4) unpublished RCTs were excluded.

Search strategy and study identification

The following electronic data sources were systematically searched: (1) MEDLINE (1966 to January week 2, 2004), (2) PREMEDLINE (January week 2, 2004), (3) EMBASE (1980 to January week 2, 2004, (4) Cochrane Central Register of Controlled Trials (CCTR) (January 2004). Reference lists of all retrieved articles were also manually searched to identify additional potential trials. The initial search was devised and carried out by a librarian scientist (J. McGowan, MLS).
All searches were updated in August 2004. It is important to note that the search strategy did not include the following: (1) hand searching of conference proceedings, and (2) personal communication with experts. The flow chart summarizing study identification and retrieval is shown in Fig. 1. The search strategy used in MEDLINE is shown below:
  • 1.
    osteoarthritis/
  • 2.
    (osteoarthritis or osteoarthrosis or degenerative arthritis).tw.
  • 3.
    1 or 2
  • 4.
    exp hand/
  • 5.
    (hand$ or finger$ or wrist$ or digit$).tw,sh.
  • 6.
    4 or 5
  • 7.
    3 and 6
  • 8.
    meta-analysis.pt,sh.
  • 9.
    (meta-anal: or metaanal:).tw.
  • 10.
    (quantitativ: review: or quantitativ: overview:).tw.
  • 11.
    (methodologic: review: or methodologic: overview:).tw.
  • 12.
    (systematic: review: or systematic: overview).tw.
  • 13.
    review.pt. and medline.tw.
  • 14.
    or/8-13
  • 15.
    clinical trial.pt.
  • 16.
    randomized controlled trial.pt.
  • 17.
    tu.fs.
  • 18.
    dt.fs.
  • 19.
    random$.tw.
  • 20.
    (double adj blind$).tw.
  • 21.
    placebo$.tw.
  • 22.
    or/15-21
  • 23.
    7 and 14
  • 24.
    7 and 22
  • 25.
    23 or 24
A total of 31 RCTs were included in this systematic review11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31,32, 33, 34, 35, 36, 37, 38, 39, 40 (Table I, Table II). Twenty-two of the RCTs were indexed in MEDLINE. An additional five RCTs were identified from searching EMBASE. No additional trials were identified by searching PREMEDLINE or the CCTR. Four additional RCTs were identified by searching the reference lists of the two previously published systematic reviews of therapies of hand OA7, 8.

Thumbnail image of Fig. 1. Opens large image

Fig. 1

Flow chart of search strategy.
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Table IPublished RCTs in OA of the hand
Study (authors and year)GroupsNo. randomizedNo. completedDesignDuration (weeks)Overall efficacy
Verbruggen et al., 200211Chondroitin polysulphate (CPS) vs placebo13092Parallel156CPS>placebo
Verbruggen et al., 200211Chondroitin sulphate (CS) vs placebo9273Parallel156CS>placebo
Rothacker et al., 199412Trolamine salicylate vs placebo5049Cross-overNA*Trolamine>placebo
Pastinen et al., 198813Glycosaminoglycan polysulphate (GAGPS) vs placebo3029Parallel52GAGPS>placebo
Thorpe, 197014Fiorinal vs fipa vs placebo109Cross-over6(Fiorinal=fipa)>placebo
Weiss et al., 200015Short splint vs long splint vs no splint2626Cross-over2Short splint>long splint>no splint
Berggren et al., 200116OT vs OT+textile splint vs OT+leather splint3333Parallel28All groups had less hand surgery
Reeves and Hassanein, 200017Dextrose prolotherapy (DP) vs placebo2725Parallel24DP>placebo
Buurke et al., 199918Uriel splint vs sporlastic splint vs gibortho splint1010Cross-over12Uriel splint>others
Seiler, 198319Meclomen vs placebo4122Parallel4Meclomen>placebo
Rothacker et al., 199820Trolamine vs placebo8681Parallel0.012Trolamine>placebo
Dreiser et al., 199321Ibuprofen vs placebo6054Parallel2Ibuprofen>placebo
Randall et al., 200022Stinging nettle leaf vs placebo2724Cross-over12Stinging nettle leaf>placebo
Schnitzer et al., 199423Capsaicin vs placebo5948Parallel9Capsaicin>placebo
Rovetta et al., 200424CS+naproxen vs naproxen alone2424Parallel104CS+naproxen>naproxen alone
Verbruggen and Veys, 199325GAGPS vs placebo9268Parallel260GAGPS>placebo
*NA=not available.
Table IIPublished RCTs in OA of the hand
Study (authors and year)GroupsNo. randomizedNo. completedDesignDuration (weeks)Overall efficacy
Thiesce and Dougados, 199526Topical diclofenac vs placebo2020Cross-over1.5Equal
Dougados and Nguyen, 199527Topical niflumic acid vs placebo186186Parallel1Equal
Flynn et al., 199428Folate vs folate+B12 vs placebo3026Cross-over24Folate+B12>(placebo=folate)
Basford et al., 198729Helium neon laser vs placebo8181Parallel3Laser>placebo
Lisse et al., 200330Rofecoxib vs naproxen910NAParallel12Equal
Garfinkel et al., 199431Yoga vs no therapy2625Parallel10Yoga>no therapy
McCarthy and McCarty, 199232Capsaicin vs placebo1414Parallel4Capsaicin>placebo
Stamm et al., 200233Joint protection exercise (JPE) vs info only4040Parallel12JPE>info only
Swezey et al., 197934Pressure glove vs control glove vs no glove55Cross-over6Equal
Graber-Duvernay et al., 199735Berthollet spa vs topical ibuprofen116107Parallel24Spa>ibuprofen
Zacher et al., 200136Topical diclofenac vs oral ibuprofen321NAParallel3Equal
Renklitepe et al., 199537Tens electrode glove vs carbon electrode36NAParallel0.7Glove electrode>carbon electrode
Talke, 198538Topical etofenamate vs oral indomethacinNANAParallel3Equal
Caruso and Pietrogrande, 198739SAMe vs naproxen vs placebo51NAParallel4Equal
Punzi et al., 199640Hydroxychloroquine (HQ) vs NSAID+analgesics1515Parallel52HQ>NSAID+analgesic
Twenty-five reports evaluating therapies in hand OA were excluded from this review since they did not meet one or more of the stated inclusion criteria of this systematic review41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, 63,64, 65. Most of these reports were either not randomized or had an unclear randomization status (n=18 reports). Nine reports were non-English publications. Two reports enrolled subjects with OA at multiple sites and did not present efficacy data specific to the hand. Three reports did not clearly specify the site(s) of OA that was studied. Two reports represented duplicate publications to those already included in the review.

Methods

A data abstraction form, modified from the form used in our previous Cochrane reviews evaluating OA therapies, was used to extract information pertaining to trial demographics, methodology, quality, and outcomes66, 67. Study quality was evaluated by using the Jadad's scoring checklist68. The Jadad checklist comprises three questions which evaluate different aspects of quality of an RCT: (1) Was the study described as randomized?, (2) Was the study described as double-blind?, and (3) Was there a description of drop-outs and withdrawals?. A score of 1 is awarded for each question if this aspect of trial quality is satisfied. An additional 1 point is awarded if the method of randomization is described and is appropriate. An additional 1 point is awarded if the method of blinding is described and is appropriate. One point is deducted if the method of randomization is described and is inappropriate. One point is also deducted if the method of blinding is described and is inappropriate. The final score ranges from 0 to 5, with a higher score reflecting higher methodological quality.
Allocation concealment was specifically evaluated for each RCT. Allocation concealment can be defined as the method used by the authors to prevent foreknowledge of treatment group assignment in an RCT69. Allocation concealment is a critical aspect of the quality of any RCT. Studies that do not ensure appropriate allocation concealment are associated with inflated measures of treatment effect and may be biased70.
A formal meta-analysis will be performed, if feasible. For the quantitative outcomes, standardized mean differences (SMD) will be used to pool across RCTs71. End of study means and standard deviations will be used for calculation of the SMDs. For dichotomous outcomes, relative risks (RR) will be used to pool across RCTs. Heterogeneity will be evaluated with a chi-square test. In order to calculate clinical improvement, the number needed to treat (NNT) will be calculated for dichotomous outcomes. Fixed effect models will be used unless heterogeneity is statistically significant, in which case, random effects models will be used. Where possible, data from an intention-to-treat analysis will be extracted.

Results



Overview of study demographics

A total of 31 RCTs were analyzed in this systematic review11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31,32, 33, 34, 35, 36, 37, 38, 39, 40 (Table I, Table II). Two RCTs were published in the 1970s, five were published in the 1980s, 14 were published in the 1990s and 10 were published in the year 2000 or beyond. Twenty-four RCTs were available as English full paper reports, four were non-English reports with English abstracts, and three RCTs were only available as English abstracts.
Symptom modifying therapy was evaluated in 26 RCTs, whereas a structural modifying therapy was evaluated in three RCTs11, 25. Two RCTs evaluated both a symptom modifying as well as a structural modifying therapy17, 24. A parallel, independent group study design was used in 24 RCTs and a cross-over design was used in seven RCTs. The median number of subjects randomized per study was only 38, with a range of 5 to 910. The median number of subjects completing the trials was 27, with a range of 5 to 186. Thus, 71% of those randomized completed the RCT.
The median duration of the RCTs was 9.5 weeks, with a range of 2 h to 260 weeks. Females were over represented, in terms of the expected population prevalence of symptomatic hand OA1, since 81% of the subjects randomized were females. The mean age of randomized subjects in the RCTs was 61.5 years, with a range of 53 to 69 years. Subjects had a mean duration of OA hand symptoms of 6.2 years, with a range of 2 to 10 years.
Three RCTs had an open follow-up period after study discontinuation. Twenty-one RCTs had a placebo group/arm. Four RCTs were multi-center. The country of origin was heterogeneous with the US having the greatest number of RCTs (11), followed by France (4), Belgium (3), and Italy (3).
Eight RCTs had an oral non-steroidal anti-inflammatory drug (NSAID) treatment group/arm. The individual NSAIDs evaluated were: ibuprofen, naproxen, meclomen, rofecoxib and indomethacin. Five RCTs had a topical NSAID treatment group/arm. The individual topical NSAID preparations evaluated were: topical ibuprofen, topical etofenamate, topical diclofenac, and topical niflumic acid. Two RCTs had a topical acetylsalicylic acid (ASA) group/arm. Both studies evaluated topical trolamine salicylate in comparison to a placebo. Four RCTs evaluated occupational therapy interventions. These included the following: joint protection exercises, splints of various kinds and technical accessories. Other active agents tested included (number of trials): capsaicin cream (2), glycosoaminoglycan polysulfate (GAGPS) (2) and chondroitin sulfate (2). Several RCTs evaluated unconventional OA therapies (number of trials): folate and cobalamin vitamin therapy (1), laser therapy (1), yoga (1), dextrose prolotherapy (1), pressure gradient gloves (1), spa therapy (1), stinging nettle leaf (1), fiornal (1) and hydroxychloroquine (1).

Features specific to hand OA trials

No consistent definition of hand OA was used in these RCTs. Most trials (n=22) did not explicitly distinguish between primary (idiopathic) and secondary OA. Seven RCTs evaluated exclusively subjects with primary hand OA. One RCT enrolled subjects with both primary and secondary hand OA. Erosive hand OA which is considered to be a subset of primary hand OA was studied exclusively in two RCTs24, 40. Only five RCTs used a validated hand OA classification scheme for study entry. These five studies used the ACR classification criteria72. Most often, hand OA was defined by the authors themselves with descriptions that lacked sufficient detail and precision (n=17 RCTs). Radiographs were taken at baseline in 15 RCTs. However, detailed X-ray criteria were explicitly stated in nine of these 15 RCTs.
The distribution of affected hand OA joints was quite variable and was also inconsistently presented in the trial reports. For example, eight RCTs did not specify which joints were being evaluated in the hand. Four RCTs evaluated exclusively subjects with 1st CMC OA15, 16, 18, 22. Ten RCTs evaluated subjects with interphalangeal proximal interphalangeal (PIP) and/or distal interphalangeal (DIP) OA, but not 1st CMC OA. Eight RCTs evaluated all three joint areas (PIP, DIP and 1st CMC).
Only five RCTs presented detailed information pertaining to the number and location of symptomatic hand joints per treatment group at baseline. In four of these RCTs, only the 1st CMC joint was evaluated. This information is important to include so that the reader can assess if the groups were indeed evenly matched following randomization. Only 10 RCTs specified the number and location of evaluated hand joints at the end of the study. Only six RCTs specified a priori a hand joint site for efficacy analysis.
Six RCTs did not specify whether one hand or both hands were evaluated. Seven RCTs evaluated one hand only, whereas, 17 RCTs evaluated both hands. Nine RCTs specified a minimum entry criterion for symptoms and/or objective findings, including specific X-ray criteria at baseline.
There was a lack of standardization of outcomes across the 31 RCTs. Moreover, some outcome variables used in these RCTs have not been validated in OA trials. Pain, function, and patient global assessments were evaluated in 25, 23 and 13 RCTs, respectively. Physician global assessments and health-related quality of life were evaluated in five and two RCTs, respectively. Examples of outcome variables used in these trials that have not been validated in OA trials include joint swelling, joint tenderness, need for OA related surgery, analgesic usage, sleep quality and range of motion. A standardized, validated questionnaire (generic and/or disease specific) was used for outcome assessment in 11 RCTs. This included the disease specific Australian Canadian Osteoarthritis Hand Index (AUSCAN) questionnaire73 and the Dreiser's Functional Index74.

Features of trial quality

Pre-randomization inclusion criteria were clearly specified in 23 RCTs. Pre-randomization exclusion criteria were clearly specified in 18 RCTs. Subjects were blinded in 20 RCTs and investigators were blinded in 21 RCTs. Only nine RCTs were associated with a pharmaceutical company or manufacturer. Four RCTs excluded subjects for protocol violation. Six RCTs excluded subjects for adverse effects. Twenty-three RCTS did not specify as to whether subjects had prior exposure to the test agents. Eleven RCTs controlled for supplementary analgesic usage or co-intervention during the trial duration. Five RCTS presented sample size calculations. Six RCTs provided a clearly stated rationale for the chosen dosage of at least one active agent. Six RCTs described the method of randomization. Nine RCTs described the method of blinding. Nine RCTs defined a priori a main outcome variable. The success of the blinding was not evaluated at the end of the study in any of the included RCTs. Eleven RCTs presented sufficiently detailed baseline data allowing the reader to ensure that the groups were comparable at baseline. Fifteen RCTs used appropriate statistical analyses. Examples of inappropriate statistical analyses included: (1) using a parametric statistical test for non-parametric data, (2) Stating that a marginally insignificant statistical test was still statistically “significant”, (3) using a paired statistical test for independent groups, (4) using multiple comparisons without employing any statistical correction. For example, one RCT evaluated several outcome variables, at separate time points, for the right hand, left hand, both hands, and the dominant hand. Thirteen RCTs either had no withdrawals or used an intention-to-treat analysis. Only two RCTs adequately described the method used to ensure allocation concealment.

Methodological quality based on Jadad's scores

The median Jadad score for the entire group of RCTs was 3, with a range of 0 to 5. Twenty RCTs received a score of 1 for being double-blinded. Twenty RCTs received a score of 1 for providing an adequate description of withdrawals and drop-outs. All RCTs were randomized as per the inclusion criteria of the systematic review and therefore all received a score of 1 for this criterion.

Meta-analysis

A formal meta-analysis could not be performed for a number of reasons. First and most important, most of the therapies studied did not have more than one identical comparison to allow pooling of the data. Second, studies were too clinically diverse making a meta-analysis inappropriate. Third, generally these were low quality studies, and this can adversely affect the validity of a meta-analysis. Fourth, there was probable significant publication bias, as 24 of the 31 RCTs reported a positive outcome (77%).

Summary of results of therapies

Due to the inherent methodological limitations in these studies, it is difficult to offer any reliable practical recommendations for the choice of appropriate therapy in subjects with clinically significant hand OA (Table I, Table II). Clinicians will need to use their own judgment when selecting appropriate treatments for symptomatic hand OA. However, based on these 31 analyzed RCTs, one can conclude that there is at least some evidence from a published RCT for the efficacy for the following therapies: trolamine salicylate, GAGPS, fiornal and FIPA, splints for 1st CMC OA, occupational therapy, dextrose prolotherapy, oral NSAIDs, stinging nettle leaf, topical capsaicin, vitamin B12 with folate, yoga, and spa therapy. At leastsome evidence also exists from a published RCT for structural efficacy in hand OA for the following therapies: chondroitin sulfate, chondroitin polysulfate, and GAGPS.

Discussion

Results of this systematic review allows for a number of general conclusions. First, there are surprisingly few published RCTs evaluating the wide range of therapies available for hand OA. Second, RCTs in hand OA are weakened by a lack of consistent case definition and by a lack of standardized outcome assessments. RCTs in hand OA are also weak methodologically in other important aspects. The most important issues relate to deficiencies in allocation concealment, inadequate description of the methods of randomization and blinding, failure to use intention-to-treat analyses, inappropriate statistical analyses, and failure to provide sample size calculations. Third, a number of more specific methodological limitations related to hand OA are also apparent. The number and location of symptomatic joints per treatment group at baseline was usually not stated. In addition, the number and location of evaluated joints per treatment group at the end of study was also usually not stated. RCTs were often lacking important details regarding whether one or both hands were evaluated, whether the 1st CMC joint and/or IP joints were evaluated, and the selection a priori of both a target joint site (1st CMC vs IP joints) and a principal outcome measure for efficacy evaluation.
Compared to knee and hip OA, hand OA is a more complex area to evaluate therapy by using an RCT. The increased complexity results from a number of unique aspects. First, there are a large number of possibly affected joints (10 joints per hand). This complicates the processes of patient selection and outcome evaluation. Second, one has to make an a priori decision as to whether the efficacy evaluation will focus on one hand, both hands, the dominant hand or the most symptomatic hand. This is not necessarily an easy distinction to make especially in light of the paucity of published research. Third, it is not known whether 1st CMC OA patients can be combined with patients having IP OA. One published study by Spacek et al.75 suggests these two groups should not be considered different during trials assessing treatments for hand OA, when the primary outcome measure evaluates disability. However, it is not clear if this also holds true when the primary outcome measure is pain or a measure of radiological progression. Fourth, it is believed by many that the natural history of hand OA, in contrast to hip and knee OA, tends to be more variable with spontaneous intermittent exacerbations and improvements76, 77. Moreover, pain, stiffness, and dexterity also show circadian rhythms in subjects with hand OA76. These are some of the issues that will need to be addressed by the Osteoarthritis Research Society International (OARSI) task force which is currently in the process of developing Consensus Guidelines for the Design and Conduct of trials in subjects with hand OA77.
Results of this systematic review are consistent with the results obtained from the two previously published reviews evaluating therapies for hand OA7, 8. It is now widely agreed that consensus guidelines are urgently needed as to how future RCTs in hand OA ought to be done. A similar approach has proven to be very successful in the past with the development of the OARSI guidelines for the design and conduct of trials in hip and knee OA9.
A number of limitations of this systematic review are recognized. First, non-published trials were not systematically searched for or analyzed and this exclusion may have resulted in a biased selection of trials which were more likely to include positive trials. Second, conference proceedings were not manually searched. Third, non-English publications were only included if they had an accompanying English abstract which summarized sufficient details of the trial report.
A number of useful starting points for the development of consensus guidelines should include the following publications: (1) the current OARSI guidelines for the design and conduct of hip and knee OA RCTs9, (2) the OMERACT guidelines outlining the choice of preferred outcome variables in OA trials10, (3) the Consolidated Standards of Reporting Trials (CONSORT) statement which outlines the preferred method for reporting RCTs78, and (4) the recently published Clinical Trials Registration Initiative which encourages the registration of future RCTs79.
Only a few published papers which discuss recommendations for OA hand RCTs are currently available80, 81, 82, 83, 84 and these would also represent useful starting points for the development of consensus guidelines.
It is clear that additional RCTs of high quality that follow consensus recommendations will be needed to evaluate the wide range of possible treatment options in subjects with hand OA.

Conflict of interest

There are no known conflicts of interests pertaining to the work of this systematic review.


Acknowledgment

The author is grateful to Jessie McGowan, MLIS, AHIP, Senior Information Scientist, Institute of Population Health/Ottawa Health Research Institute, Trials Search Coordinator, EPOC (The Cochrane Collaboration) for the design and execution of the electronic searches.

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