Assessing the reporting quality in randomized controlled trials of acupuncture for postherpetic neuralgia using the CONSORT statement and STRICTA guidelines

Kun Liu, Jingchun Zeng, Wenya Pei, Siyu Chen, Zhenke Luo, Liming Lu, Guohua Lin, Kun Liu, Jingchun Zeng, Wenya Pei, Siyu Chen, Zhenke Luo, Liming Lu, Guohua Lin

Abstract

Background: This study evaluates the reporting quality of randomized controlled trials (RCTs) on acupuncture use for the treatment of postherpetic neuralgia and explores related factors.

Methods: The following six databases PubMed, Embase, Cochrane Library, VIP, CNKI, and SinoMed, were systematically searched from their inception to December 2018. RCTs using acupuncture as an intervention for postherpetic neuralgia were selected and incorporated in this study. The reporting quality was assessed based on the CONSORT statement and the STRICTA guidelines. Regression analyses were also conducted on pre-specified study characteristics searching for factors associated with reporting quality.

Results: A total of 137 RCTs were included in this study. The CONSORT based median OQS was 12 (minimum 3, maximum 29). Of the items comprised in the statement, ten were sufficiently reported (reported in over 70% of trials). The remaining fifty-five items were poorly reported (reported by fewer than 5% of trials). The STRICTA based median OQS was 9 (minimum 2, maximum 15). The results showed that eight of the comprised items were well reported (reported in over 70% of trials), and only three were incompletely reported (reported in fewer than 20% of trials). Based on the CONSORT statement related analysis, a post-2010 publication (β coefficient 2.394, 95% confidence interval [CI] 1.168-3.620) and funding (β coefficient 4.456, 95% CI: 3.009-5.903) represented independent and significant predictors of a high overall reporting quality. However, only a funding source (β coefficient 1.305, 95% CI 0.219-2.391) was associated with an increased OQS based on STRICTA analysis.

Conclusion: The findings indicated that RCTs on acupuncture for PHN generally had a sub-optimal reporting quality, a situation that improved for those published after 2010 or with funding sources. Therefore, rigorous adherence to the CONSORT statement and the STRICTA guidelines should be emphasized in future studies.

Keywords: CONSORT; STRICTA; acupuncture; postherpetic neuralgia; randomized controlled trials.

Conflict of interest statement

The authors report no conflicts of interest in this work.

Figures

Figure 1
Figure 1
Flow chart of the performed search and selection process.
Figure 2
Figure 2
Distribution of RCT scores with complete reporting of the CONSORT statement items. The blue and red bars represent the before and after 2010 RCT score means according to the CONSORT statement, with 95% CI.
Figure 3
Figure 3
Distribution of RCT scores with complete reporting of the STRICTA checklist items. The blue and red bars represent the before and after 2010 RCT score means with 95% CI according to the STRICTA checklist.

References

    1. Solomon CG, Johnson RW, Rice AS. Postherpetic neuralgia. N Engl J Med. 2014;371:1526e1533. doi:10.1056/NEJMoa1410490
    1. Cohen JI. Clinical practice: herpes zoster. N Engl J Med. 2013;369:255e263. doi:10.1056/NEJMcp1302674
    1. US Food and Drug Administration (FDA). FDA Approves New Drug Treatment for Long-Term Pain Relief after Shingles Attacks. MD: Silver Spring; 2009.
    1. Yawn BP, Saddier P, Wollan PC, St Sauver JL, Kurland MJ, Sy LS. A population-based study of the incidence and complication rates of herpes zoster before zoster vaccine introduction. Mayo Clin Proc. 2007;82:1341–1349. doi:10.4065/82.11.1341
    1. Baron R, Wasner G. Prevention and treatment of postherpetic neuralgia. Lancet. 2006;367:186–188. doi:10.1016/S0140-6736(06)68010-0
    1. Ghanavatian S, Wie CS, Low RS, et al. Premedication with gabapentin significantly reduces the risk of postherpetic neuralgia in patients with neuropathy. Mayo Clin Proc. 2019;01:1–6.
    1. Argoff CE. Review of current guidelines on the care of postherpetic neuralgia. Postgrad Med. 2011;123:134–142. doi:10.3810/pgm.2011.09.2469
    1. Friesen KJ, Falk J, Alessi-Severini S, Chateau D, Bugden S. Price of pain: population-based cohort burden of disease analysis of medication cost of herpes zoster and postherpetic neuralgia. J Pain Res. 2016;9:543–550. doi:10.2147/JPR.S107944
    1. Rice AS, Maton S, Postherpetic Neuralgia Study Group. Gabapentin in postherpetic neuralgia: a randomised, double blind, placebo controlled study. Pain. 2001;94:215–224.
    1. Goßrau G. Postherpetic neuralgia. Schmerz. 2014;28:93–102. doi:10.1007/s00482-013-1346-6
    1. Avijgan M, Hajzargarbashi ST, Kamran A, Avijgan M. Postherpetic neuralgia: practical experiences return to traditional Chinese medicine. J Acupunct Meridian Stud. 2017;10(3):157e164. doi:10.1016/j.jams.2017.02.003
    1. Toroski M, Nikfar S, Mojahedian MM, Ayati MH. Comparison of the cost-utility analysis of electroacupuncture and nonsteroidal antiinflammatory drugs in the treatment of chronic low back pain. J Acupunct Meridian Stud. 2018;11(2):62–66. doi:10.1016/j.jams.2018.01.003
    1. Wang Y, Li W, Peng W. Acupuncture for postherpetic neuralgia: systematic review and meta-analysis. Medicine. 2018;97:34.
    1. Son C. Overview for pattern and results of moxibustion-derived clinical trials. J Meridian Acupoint. 2009;26:41–49.
    1. Chung W, Lee KW, Hwang IH, Lee DH, Kim SY. Quality assessment of randomized controlled trials in the journal of the Korean academy of family medicine. Korean J Fam Med. 2009;30:626–631. doi:10.4082/kjfm.2009.30.8.626
    1. Moher D, Schulz KF, Altman DG. The CONSORT statement: revised recommendations for improving the quality of reports of parallel group randomized trials. BMC Med Res Methodol. 2001;1:2. doi:10.1186/1471-2288-1-2
    1. Schulz KF, Altman DG, Moher D, et al. CONSORT 2010 statement: updated guidelines for reporting parallel group randomised trials. BMJ. 2010;340:c332. doi:10.1136/bmj.c293
    1. Park J, Kang K, Choi S. Assessing methodological quality of acupuncture clinical trials of Korea. J Korean Acupunct Moxibust Soc. 2007;24:127–135.
    1. MacPherson H, White A, Cummings M, Jobst K, Rose K, Niemtzow R. Standards for reporting interventions in controlled trials of acupuncture: the STRICTA recommendations. Complement Ther Med. 2001;9:246–249. doi:10.1054/ctim.2001.0488
    1. MacPherson H, Altman DG, Hammerschlag R, et al. Revised Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7:e1000261. doi:10.1371/journal.pmed.1000261
    1. Zeng J, Lin G, Lixia L, et al. Assessment of reporting quality in randomised controlled trials of acupuncture for post-stroke rehabilitation using the CONSORT statement and STRICTA guidelines. Acupunct Med. 2016;35:1–7.
    1. Jia P, Tang L, Yu J, Liu J, Kang D, Sun X. The quality of reporting in randomized controlled trials of acupuncture for knee osteoarthritis: A cross-sectional survey. PLoS One. 2018;13(4):e0195652. doi:10.1371/journal.pone.0195652
    1. Kim KH, Kang JW, Lee MS, et al. Assessment of the quality of reporting in randomised controlled trials of acupuncture in the Korean literature using the CONSORT statement and STRICTA guidelines. BMJ Open. 2014;4:e005068. doi:10.1136/bmjopen-2014-005068
    1. NICE. NICE clinical guideline 96. Neuropathic pain: the pharmacological management of neuropathic pain in adults in non-specialist settings. National Institute for Health and Clinical Excellence Available from: . Accessed June5, 2010.
    1. Nalamachu S, Morley-Foster P. Diagnosing and managing postherpetic neuralgia. Drugs Aging. 2012;29:863–869. doi:10.1007/s40266-012-0014-3
    1. Chon TY, Lee MC. Acupuncture. Mayo Clin Proc. 2013;88(10):1141–1146. doi:10.1016/j.mayocp.2013.06.009
    1. Tang Y, Yin H-Y, Rubini P, et al. Acupuncture-induced analgesia: a neurobiological basis in purinergic signaling. Neuroscientist. 2016;22(6):563–578
    1. Zhuang L, He J, Zhuang X, Lu L. Quality of reporting on randomized controlled trials of acupuncture for stroke rehabilitation. BMC Complement Altern Med. 2014;14:151. doi:10.1186/1472-6882-14-151
    1. Wei J-J, Yang W-T, Yin S-B, Wang C, Wang Y, Zheng G-Q. The quality of reporting of randomized controlled trials of electroacupuncture for stroke. BMC Complement Altern Med. 2016;16:512. doi:10.1186/s12906-016-1497-y
    1. Wenting L, Pengqian F. The importance of blinding for patients in randomized controlled trials of interventions for pain: a meta analysis. Chi J Med Manage Sci. 2016;6(4):68–72.
    1. You Y-N, Cho M-R, Kim J-H, et al. Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke. BMC Complement Altern Med. 2017;17:452. doi:10.1186/s12906-017-1950-6
    1. Bondemark L, Abdulraheem S. Intention to treat (ITT) analysis as reported in orthodontic randomized controlled trials-evaluations of methodology and recommendations for the accurate use of ITT analysis and handling dropouts. Eur J Orthod. 201. 8;40(4):409–413. doi:10.1093/ejo/cjx084
    1. Al-Badriyeh D, Alameri M, Al-Okka R. Cost-effectiveness research in cancer therapy: a systematic review of literature trends, methods and the influence of funding. BMJ Open. 2017;7(1):e012648. doi:10.1136/bmjopen-2016-012648

Source: PubMed

Sponsors et collaborateurs

Les conditions médicales

Interventions en matière de drogue

3
S'abonner