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Internet-based randomised controlled trials for the evaluation of complementary and alternative medicines: Probiotics in spondyloarthropathy
This report has been verified
by one or more authors of the
original publication.
OrthoEvidence Journal (OE Journal) - ACE Report
OE Journal. 2013;1(2):158 BMC Musculoskelet Disord. 2008 Jan 11;9:4.140 participants, >18 years of age, with spondyloarthropathy (SpA) were randomized to receive either a probiotic drink or a placebo over a 12 week period. The probiotic drinks were not any superior in improving well-being or bowel symptoms. Internet-based randomized controlled trial was a suitable economical method with a potential applicability in examining the complementary and alternative medicine interventions at low cost.
Was the allocation sequence adequately generated?
Was allocation adequately concealed?
Blinding Treatment Providers: Was knowledge of the allocated interventions adequately prevented?
Blinding Outcome Assessors: Was knowledge of the allocated interventions adequately prevented?
Blinding Patients: Was knowledge of the allocated interventions adequately prevented?
Was loss to follow-up (missing outcome data) infrequent?
Are reports of the study free of suggestion of selective outcome reporting?
Were outcomes objective, patient-important and assessed in a manner to limit bias (ie. duplicate assessors, Independent assessors)?
Was the sample size sufficiently large to assure a balance of prognosis and sufficiently large number of outcome events?
Was investigator expertise/experience with both treatment and control techniques likely the same (ie.were criteria for surgeon participation/expertise provided)?
はい = 1
不確実＝0.5
無関係 = 0
いいえ = 0
報告基準評価では、著者が出版物内で試験の方法論的特徴や試験特性を報告する際の透明性を評価します。評価は以下の5つのカテゴリーに分類されます。
4/4
Randomization
3/4
Outcome Measurements
4/4
Inclusion / Exclusion
4/4
Therapy Description
4/4
Statistics
Detsky AS, Naylor CD, O'Rourke K, McGeer AJ, L'Abbé KA. J Clin Epidemiol. 1992;45:255-65
Fragility Indexは、重要な所見の解釈を助けるツールで、結果の強さの尺度を提供します。Fragility Indexは、その所見が有意でなくなるために、二項対立の結果に追加する必要がある連続した事象の数を表します。数値が小さいほど弱い所見を表し、数値が大きいほど強い所見を表します。
なぜ今この研究が必要なのですか？
Complementary and alternative medicines (CAMs) are used in chronic and acute health conditions for maintaining wellness. However, the use of CAMs is limited, since there have not been many clinical trials performed on CAMs. This study evaluated the effectiveness of probiotics in the symptom control of spondyloarthropathy.
主な研究課題は何ですか？
Is the probiotic use superior to placebo in terms of well-being, bowel symptoms, and arthritis severity (disease activity and function) after 12 weeks of treatment?
重要な知見は？
- 65% (96/147) completed the entire 3 month long trial.
- CAM Outcome: No clinically significant differences were observed in the global well-being, bowel symptoms, or severity of arthritis between the two groups.
- Adherence to medication was comparable in both the groups, placebo=3938/5796 (67.9%) and intervention group= 3748/5544 (67.6%).
- No difference in the adverse event rates between the groups were recorded
最も覚えておくべきことは？
Internet-based tools were useful and economical for conducting a successful randomized controlled trials in low risk interventions. The probiotic did not improve well-being, disease activity, or function compared to placebo.
それが私の患者ケアにどのように影響するか？
The internet-based RCT is a feasible method to examine the CAM intervention. it is also is a cost-effective approach for assessing low-risk interventions.
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