Meta-analysis of pain and function placebo responses in pharmacological osteoarthritis trials

被引:18
作者
Huang, ZeYu [1 ]
Chen, Jing [2 ]
Hu, Qin Sheng [1 ]
Huang, Qiang [1 ]
Ma, Jun [1 ]
Pei, Fu Xing [1 ]
Shen, Bin [1 ]
Kraus, Virginia Byers [3 ]
机构
[1] Sichuan Univ, West China Med Sch, West China Hosp, Dept Orthoped Surg, 37 Wainan Guoxue Rd, Chengdu, Sichuan, Peoples R China
[2] Sichuan Univ, West China Sch Stomatol, Chengdu, Sichuan, Peoples R China
[3] Duke Univ, Div Rheumatol, Sch Med, Dept Med,Duke Mol Physiol Inst, POB 104775,Room 51-205,Carmichael Bldg, Durham, NC 27701 USA
基金
美国国家科学基金会;
关键词
Placebo response; Osteoarthritis; Treatment; Trial; Pain; Function; Outcome measures; CONTROLLED CLINICAL-TRIAL; ORAL CHONDROITIN SULFATE; KNEE OSTEOARTHRITIS; DOUBLE-BLIND; EFFICACY; GLUCOSAMINE; DRUG; HIP; SUPPLEMENT; INJECTIONS;
D O I
10.1186/s13075-019-1951-6
中图分类号
R5 [内科学];
学科分类号
1002 ; 100201 ;
摘要
ObjectiveTo evaluate contextual effects in the form of placebo responses (PRs) for patient-reported pain and function and objectively measured function in osteoarthritis (OA) clinical trials.MethodsTwo authors independently searched major electronic databases from inception to 20 May 2019. Included studies were randomized, placebo-controlled OA trials of pharmacological agents reporting both patient-reported and objectively measured outcomes. PRs for each type of outcome measure were compared by standardized mean differences (SMDs). The placebo response ratio (PRR) assessed the placebo to treatment effect size. The effect sizes of PRs and PRRs were pooled using a random effects model.ResultsTwenty-one trials met the inclusion criteria; 20 were double-blinded with one not reporting on blinding status. Compared with patients' self-reported outcome (PRO) pain, PRs were significantly lower for PRO function (SMD -0.16 [95% CI=-0.28, -0.05], p=0.006), objectively measured muscle strength (SMD -0.34 [95% CI -0.58, -0.10], p=0.006), and range of motion (SMD=-0.31 [95% CI=-0.54, -0.08], p=0.008) function. Generally, PRs for function outcomes (patient-reported and objectively measured) were similar. The overall PRR for different measures ranged from the smallest (most favorable) for walking time/distance (0.30, 95% CI 0.16 to 0.43) to the largest for PRO pain (0.44, 95% CI 0.23 to 0.65).ConclusionFunction measures both subjective and objective had less contextual effects than pain measures in OA trials. Our results support the OMERACT-OARSI recommendations to include measures of physical function in all clinical trials of hip and knee OA and suggest that a greater use of function measures might enhance the success rates of pharmacological OA trials. Increasing the availability of mobile health apps should facilitate the acquisition of measured function data.
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页数:10
相关论文
共 59 条
[1]   RETRACTED: Effect of Low-dose Oral Prednisolone on Symptoms and Systemic Inflammation in Older Adults with Moderate to Severe Knee Osteoarthritis: A Randomized Placebo-controlled Trial (Retracted Article) [J].
Abou-Raya, Anna ;
Abou-Raya, Suzan ;
Khadrawi, Tarek ;
Helmii, Madihah .
JOURNAL OF RHEUMATOLOGY, 2014, 41 (01) :53-59
[2]  
[Anonymous], 2001, JAMA, V285, P1571
[3]   Evaluation of the placebo effect and reproducibility of blood pressure measurement in hypertension [J].
Asmar, R ;
Safar, M ;
Queneau, P .
AMERICAN JOURNAL OF HYPERTENSION, 2001, 14 (06) :546-552
[4]   Effectiveness and Implications of Alternative Placebo Treatments A Systematic Review and Network Meta-analysis of Osteoarthritis Trials [J].
Bannuru, Raveendhara R. ;
McAlindon, Timothy E. ;
Sullivan, Matthew C. ;
Wong, John B. ;
Kent, David M. ;
Schmid, Christopher H. .
ANNALS OF INTERNAL MEDICINE, 2015, 163 (05) :365-U109
[5]   Chronic musculoskeletal pain and its impact on older people [J].
Blyth, Fiona M. ;
Noguchi, Naomi .
BEST PRACTICE & RESEARCH IN CLINICAL RHEUMATOLOGY, 2017, 31 (02) :160-168
[6]   Differences in mobile health app use: A source of new digital inequalities? [J].
Bol, Nadine ;
Helberger, Natali ;
Weert, Julia C. M. .
INFORMATION SOCIETY, 2018, 34 (03) :183-193
[7]   Engineered Nanotopographic Structures for Applications in Tissue Engineering and Regenerative Medicine [J].
Borenstein, Jeffrey T. ;
Bettinger, Christopher J. .
2009 IEEE/NIH LIFE SCIENCE SYSTEMS AND APPLICATIONS WORKSHOP, 2009, :21-+
[8]  
Brühlmann P, 2003, CLIN EXP RHEUMATOL, V21, P193
[9]   MEMORY FOR PAIN AND AFFECT IN CHRONIC PAIN PATIENTS [J].
BRYANT, RA .
PAIN, 1993, 54 (03) :347-351
[10]   Efficacy and tolerability of oral chondroitin sulfate as a symptomatic slow-acting drug for osteoarthritis (SYSADOA) in the treatment of knee osteoarthritis [J].
Bucsi, L ;
Poór, G .
OSTEOARTHRITIS AND CARTILAGE, 1998, 6 :31-36