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Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke

BMC Complementary and Alternative Medicine volume 17, Article number: 452 (2017) Cite this article

Abstract

Background

This study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke.

Methods

The following 8 databases were systematically investigated from their inception to December 2015: PubMed, Embase, Cochrane Library, China National Knowledge Infrastructure, National Institute of Informatics Scholarly and Academic Information Navigator, National Digital Science Library, Korean Traditional Knowledge Portal, and Korean Studies Information Service System. RCTs utilizing scalp acupuncture as an intervention for stroke were selected, and the quality of reports was assessed based on the Consolidated Standards of Reporting Trials 2010 statement (CONSORT) and Standards for Reporting Interventions in Controlled Trials of Acupuncture 2010 (STRICTA). For each study, the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items were measured.

Results

The original reports of 63 RCTs were ultimately obtained, and the median CONSORT OQS was 7 (minimum 2, maximum 11). Particularly, the items ‘trial design’, ‘sample size’, ‘ancillary analyses’, and ‘harms’ had a positive rate of less than 10%. The median MIS was 1 (minimum 0, maximum 5), with ‘allocation concealment and implementation’ and ‘intent-to-treat analysis (ITT) analysis’ having a positive rate of less than 10%. The median STRICTA OQS was 11 (minimum 6, maximum 14), and only the items ‘sample size’ and ‘intent-to-treat analysis’ were reported, with a positive rate of less than 10%. The mean CONSORT OQS increased by approximately 0.81 for each 5-year period in which manuscripts were published (95% confidence interval: 0.43 to 1.19; p < 0.001). No variable was significantly associated with MIS in the ordinal regression model.

Conclusion

The quality of reports on RCTs investigating scalp acupuncture treatment for stroke was moderate to low. Furthermore, reporting of some items was either insufficient or inadequate in the majority of studies. In order to improve and standardize the quality of RCTs investigating scalp acupuncture for stroke, CONSORT and STRICTA guidelines should be utilized more frequently.

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Background

Stroke is one of the three leading causes of death in China as well as in western countries [1,2,3]. In Korea, mortality due to stroke is 80 per 100,000 people, with 25,000 deaths attributed to cerebrovascular diseases including stroke in 2014 alone [1]. Globally, stroke causes 6.2 million mortalities per year and is the second leading cause of death after ischemic heart disease including heart failure [4]. Once stroke occurs, its mortality rate is high, and the likelihood of patients returning to active social life is low; therefore, its socio-economic impact is also high [5].

Scalp acupuncture is a modality that treats diseases of the entire body by placing a needle on a corresponding area of the scalp based on the functional principle of cerebral cortex location and the Standard International Acupuncture Nomenclature (SIAN) proposed by World Health Organization, which were developed in 1991 [6,7,8]. Scalp acupuncture has proven effective for the treatment of cerebrovascular diseases, neurodegenerative disorders, and diseases of the central nervous system [6, 9,10,11,12]. Furthermore, a number of clinical trials have reported therapeutic effects of scalp acupuncture for the treatment of stroke [13,14,15].

Randomized controlled trials (RCTs) are considered the optimal study design to examine the therapeutic effects and efficacy of scalp acupuncture [16]. However, even with an RCT design, inappropriate study methodology can affect the reliability and validity of the results and thus the quality of its findings [17]. Therefore, it is necessary to evaluate the quality of RCTs based on systematic quality control standards and assessment of their design, implementation, and analysis [18].

The Consolidated Standards of Reporting Trials (CONSORT), developed in 2001 and revised in 2010, provide guidelines to improve clinical trial reporting in order to identify biased results, with the purpose of facilitating the assessment and interpretation of RCTs [19]. The STandards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) were developed in 2001 and revised in 2010 to improve the reporting of acupuncture implemented in clinical trials [20]. The combination of these two guidelines can aid in the assessment of the completeness as well as transparency of RCTs [21].

The aims of this study were to assess the quality and limitations of articles reporting RCTs of scalp acupuncture treatment for stroke published through December 2015 by using CONSORT and STRICTA, and to further promote improvement in the quality of future clinical trials.

Methods

Literature search methods

The following 8 databases were searched from their inception through December 2015 for published articles and databases: PubMed, Embase, the Cochrane Library, China National Knowledge Infrastructure (CNKI), National Institute of Informatics Scholarly and Academic Information Navigator (CiNii), National Digital Science Library (NDSL), Korean Traditional Knowledge Portal (KTKP), and Korean Studies Information Service System (KISS). The terms “stroke”, “hemiplegia”, “cerebral”, “infarction”, “cerebral infarction”, “cerebrovascular”, “apoplexy” were searched in combination with each of the following: “acupuncture”, “scalp acupuncture”, “head acupuncture”, “skull acupuncture”, “brain acupuncture”, “cerebral acupuncture”, “cranial acupuncture”. No limits were applied for language and country.

Literature selection and exclusion criteria

Types of studies

We looked at RCTs that assessed the effect of a scalp acupuncture treatment in stroke patients. Non-randomized, cross-over RCTs, case reports, and case-control studies were excluded.

Types of participants

All study subjects with a clinical diagnosis of acute and chronic stroke were included regardless of age, sex, or other demographic factors. Stroke was diagnosed according to the Chinese Medical Association diagnostic standards [22,23,24] or confirmed by magnetic resonance imaging (MRI) or computed tomography (CT).

Types of interventions

Interventions consisting of a combination of scalp acupuncture treatment with another acupuncture modality (e.g., electro-acupuncture, body acupuncture, and ear acupuncture), and western medicine, Chinese herbal medicine, and rehabilitation were included.

Evaluation of report quality

Rating of overall reporting quality

For overall quality score (OQS) based on the CONSORT 2010 guidelines, 13 items (range, 0 to 13) were graded [25]. The items in the CONSORT discussion session were excluded, as they involved subjective evaluation (Table 1). Seventeen items based on the STRICTA guidelines (range, 0 to 17) were also graded (Table 2) [21]. To grade the quality of reports, 1 point was assigned if information for each item was stated, and 0 points were assigned if the item was not addressed or uncertain.

Table 1 Overall quality score of reporting using items from the CONSORT statement (n = 63)
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Table 2 Overall quality score of reporting using items from STRICTA guidelines (n = 63)
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Rating of key methodological items

Because five major methodological items (‘randomization’, ‘allocation concealment’, ‘blinding’, ‘baseline characteristics’, and ‘ITT analysis’) included in the CONSORT 2010 guidelines were related to potential factors causing bias, they were evaluated separately for each study (Table 3) [26,27,28]. One point was assigned for each item that was reported, and 0 points were assigned if the item was not reported or uncertain (range, 0 to 5).

Table 3 Reporting quality of key methodological items (n = 63)
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Data extraction and analysis

Each report was independently evaluated by two reviewers (YNY and MYS) in reference to each item’s definition and detailed description in the CONSORT and STRICTA statements, and in cases of disagreement between these reviewers, final scores were determined through agreement with a third reviewer (MRC) (Tables 1, 2 and 3) [29].

Cohen’s κ-statistic was calculated in order to evaluate the degree of agreement between the two evaluators. A κ of 0.20 or lower was defined as ‘poor’ agreement, between 0.20 and 0.40 as ‘low’, between 0.40 and 0.60 as ‘moderate’, between 0.60 and 0.80 as ‘substantial’, and greater than 0.80 as ‘good’, with 1 representing perfect agreement [30]. Cohen’s κ-statistical analysis was performed using SAS software, version 9.3 (SAS Institute, Inc., Cary, NC, USA) [21, 25].

In order to evaluate the overall quality of reported RCTs and relevant factors, OQS was used as a dependent variable modeled using linear regression. Only variables with p ≤ 0.10 on univariate analysis were included in the multivariate regression model to identify significant variables (p ≤ 0.05). To analyze the factors related to methodological quality, MIS was used as an outcome variable in regression analysis. Linear and ordinal regression analysis was performed using SPSS software version 20.0 (SPSS, Chicago, IL, USA) [21, 25].

Results

Report selection

A total of 2569 relevant reports were identified, among which 207 reports related to the study topic were selected based on review of the title and abstract. A total of 63 relevant RCTs were ultimately extracted for final analysis (Additional file 1). The RCT selection process is outlined in Fig. 1.

Fig. 1
figure 1

Flow chart of the article selection process

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Characteristics of the reports included in this study

The 63 reports of RCTs evaluated in this study included 3 (4.8%) published prior to 2000, 14 (22.2%) published in 2001–2005, 14 (22.2%) published in 2006–2010, and 32 (50.8%) published in 2011–2015 (Fig. 2). The languages of the published articles included 1 in Korean (1.6%), 7 in English (11.1%), and 55 in Chinese (87.3%), and 60 articles (95%) were published in China by mainly Chinese authors. Control group interventions included 28 instances of western medication (44.4%), 14 instances of body acupuncture (22.2%), 3 instances of western medication with body acupuncture (4.8%), 2 instances of scalp electro acupuncture (3.2%), 2 instances of rehabilitation (3.2%), 2 instances of scalp acupuncture with rehabilitation (3.2%), 1 instance of scalp acupuncture with body acupuncture and rehabilitation (1.6%), 1 instance of body acupuncture with rehabilitation (1.6%), 1 instance of scalp acupuncture with body acupuncture (1.6%), 1 instance of scalp acupuncture with body acupuncture and western medication (1.6%), 1 instance of sham scalp acupuncture (1.6%), 1 instance of scalp acupuncture at the contralateral side (1.6%), 1 instance of scalp acupuncture with western medication (1.6%), 1 instance of scalp acupuncture with western medication and Chinese herbal medicine (1.6%), 1 instance of western medication with Chinese herbal medicine and rehabilitation (1.6%), 1 instance of ear acupuncture (1.6%), 1 instance of oral administration (1.6%), and 1 instance of Chinese herbal medicine (1.6%). The sample size of control groups ranged from 22 to 330 (Additional file 2).

Fig. 2
figure 2

Number of publications

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Evaluation of report quality

Rating of overall reporting quality using CONSORT

The graded quality of reports based on the CONSORT guidelines is presented in Table 1. The mean OQS was 7, ranging from 2 to 11 (Additional file 3). ‘Trial design’, ‘sample size’, ‘ancillary analyses’, and ‘harms’ were reported by fewer than 10% of articles, with information about these items insufficient or not articulated in most studies. Items 4 and 14 had a moderate degree of agreement; items 5, 6, and 17 had a substantial degree of agreement; items 2, 12, 13, and 14 had a good degree of agreement; and items 1, 3, 7, 18, and 19 had perfect agreement between reviewers (Table 1).

Rating of overall quality score using STRICTA

The results of the graded quality scoring of reports based on STRICTA guidelines are shown in Table 3. The median OQS was 11, ranging from 6 to 14 (Additional file 3). Items 1c and 4b were adequately reported by fewer than 10% of articles, ‘number of needle insertions’ (item 2a) was reported by 14%, and ‘rationale for the control or comparator’ (item 6a) was reported by 35%.

Items 2c, 4a, and 6a had a ‘moderate’ degree of agreement; items 1c, 2 g, 3b, 4b, 5, and 6b had a ‘substantial’ degree of agreement; items 1b, 2a, 2d, 2e, 2f, and 3a had a ‘good’ degree of agreement, and items 1a and 2b had a ‘perfect’ agreement between reviewers (Table 2).

Rating of key methodological items

The median MIS of five key methodological items based on the CONSORT guidelines was 1, ranging from 0 to 5 (Additional file 3). ‘Allocation concealment and implementation’ and ‘ITT analysis’ were reported by fewer than 10% of articles, and information was either insufficient or not articulated in the rest. Items 8 and 15 had a ‘substantial’ degree of agreement, items 11 and 16 had a ‘good’ degree of agreement, and item 9 and 10 had a ‘perfect’ agreement between reviewers (Table 3).

Exploratory analysis: Factors associated with better reporting quality

On univariate analysis, year of publication was associated with increased OQS based on the CONSORT guidelines. After adjustment in the multivariate linear regression model, OQS significantly increased by approximately 0.81 for each 5-year period of manuscript publication (95% confidence interval: 0.43 to 1.19; p < 0.001) (Table 4). On univariate analysis, no factors were significantly related to OQS based on STRICTA guidelines. In the analysis of MIS, there was no statistically significant variable in the ordinal regression model (p > 0.05).

Table 4 Multivariate linear regression analysis for factors associated with better OQS based on the CONSORT statement (n = 63)
Full size table

Discussion

The main strength of this study is that RCTs related to scalp acupuncture treatment were selected through a comprehensive and systematic search of 8 databases. Furthermore, the quality of RCTs included in this study was assessed by using the CONSORT and STRICTA guidelines. These two instruments were developed to identify issues underlying the unreliability of RCTs and have been broadly applied to assess the quality of reports in acupuncture research. Moreover, these guidelines are powerful tools, as evidenced by the fact that the majority of their items were well reported [31].

For the 63 RCTs included in this study, the median OQS for the reporting quality of CONSORT items was 7, out of a total of 13. For STRICTA items, the median OQS was 11, corresponding to approximately 60% of the total possible score of 17. However, reports of some items were found to be either inappropriate or insufficient in most of the examined studies, including ‘trial design’, ‘sample size’, ‘ancillary analyses’, and ‘harms’ among the CONSORT guidelines and ‘extent to which treatment was varied’ and ‘setting and context of treatment’ among the STRICTA guidelines.

For ‘trial design’, it is important to clearly articulate several aspects of RCT design (such as parallel, double-blind, placebo, and sham designs). Even if the same randomization ratio (such as 8:8 for two groups) was used, providing the allocation ratio is helpful in improving the quality of reports. Particularly in cases of atypical clinical trials requiring complicated analyses and interpretation or large sample sizes, the need to clearly establish the clinical design increases [32].

Sample size calculation is required for the statistical consideration of differences in therapeutic effects between a treatment group and a control group. A significant clinical difference between the intervention group and control group can only be detected reliably if the number of examinees is sufficient [21]. However, due to the challenge of collecting subjects meeting the study criteria within a certain period, it can be difficult to achieve the designed sample size [33, 34]. In addition, very small RCTs carry the risk of bias or may be insufficient for measuring a therapeutic benefit [29]. Therefore, in order to identify a significant difference with high reliability between the intervention and control groups, sample size determination should be the focus of increased attention through consultation with clinical statisticians.

‘Ancillary analyses’ refer to repeated analyses of the same data, which can become a source of bias through over-interpretation of the results [35], and reporting analysis results that have not been pre-established in the design of a clinical trial introduces bias through being selective [36]. Therefore, authors should report the results of analyses that have been predetermined to have high reliability, and clearly articulate the reason and purpose of any supplemental group analysis performed.

Although an RCT is the best method to generate efficacy and safety data, it is difficult to detect rare adverse events. Many RCTs present inappropriate [37] or low-quality reporting of adverse effects [38]. Additionally, the number of articles reporting severe adverse effects and information about subjects excluded from analysis due to adverse effects is very low [39]. However, in order for clinical trial participants to make a balanced and reasonable decision to participate, not only the benefits of the intervention but also information about its risks must be provided, and the existence and nature of adverse effects has a significant impact on whether a specific intervention can be considered allowable and useful [21].

The STRICTA item ‘extent to which treatment was varied’ (1c) was positively reported by only 3% of articles included in this study, similar to previous findings [40]. The variability of treatments in clinical trials must be minimized through standardized protocols, and the degree of personalized treatment should be discussed between a patient and their physician [41].

The STRICTA item ‘setting and context of treatment’ (4b) can also provide important additional components to treatment [42]. Because treatment by a physician or a change in the treatment situation of a patient can affect test results [43], information related to patient treatment as well as control group intervention should be reported [21].

Regarding the reporting quality of methodological items in the CONSORT guidelines, the median MIS was very low at 1, and most trials had insufficient or inadequate information about ‘allocation concealment and implementation’, ‘blinding’, and ‘ITT analysis’. Other published studies also reported similar findings [21, 31, 44,45,46]. These key methodological items are critical to avoid bias in selection, performance/detection, and attribution. Ultimately, clinical trials with inadequate methodological design can overestimate therapeutic effects [47]. In order to resolve these problems, more researchers involved in clinical trials must be trained in study design and RCT reporting. Additionally, more high-quality research articles must be published in international journals after accurate peer review.

Although there was no significant predictor of improved methodological quality among variables in the regression model, OQS based on the CONSORT guidelines was associated with year of publication. This finding indicates that the mean OQS increased by approximately 0.81 in articles published in successive 5-year periods and improved over time. This finding has also been reported in some previous studies [29, 45], indicating that the application of CONSORT guidelines and the quality of RCT reporting have increased.

Limitations

Some limitations of this study should also be addressed. First, although it is not difficult to search most studies published in China, it was difficult to obtain the full text of all articles required for this study, as described in Fig. 1. Second, we had difficulty searching for papers published in languages other than Chinese or English. However, most RCTs about trials for scalp acupuncture were reported in Chinese or English [48]. Third, CONSORT and STRICTA were first published in 2001, and there is a high possibility that articles published prior to 2001 may not comply with these guidelines with regard to study design, randomization, and result reporting. Although some articles still do not conform to the guidelines, this situation is gradually improving.

Conclusions

This study demonstrates the reporting quality of RCTs investigating scalp acupuncture for stroke. Our study demonstrated that the overall quality of reporting on RCTs of scalp acupuncture for stroke was moderate to low. However, the quality of the reporting of key methodological items is particularly lacking. In this field, these findings stress the need to improve methodological quality through increased compliance with the CONSORT and STRICTA guidelines.

Abbreviations

CiNii:

National institute of informatics scholarly and academic information navigator

CNKI:

China national knowledge infrastructure

CONSORT:

Consolidated standards of reporting trials

ITT:

Intention to treat

KISS:

Korean studies information service system

KTKP:

Korean traditional knowledge portal

MIS:

Methodological index score

NDSL:

National digital science library

OQS:

Overall quality score

RCT:

Randomized controlled trial

STRICTA:

Standards for reporting interventions in controlled trials of acupuncture

References

  1. Korea S. Life Tables [In Korean]. 2013:2014. http://kostat.go.kr/portal/korea/kor_ko/5/2/index.board?bmode=read&aSeq=332455. Accessed 31 Mar 2016

  2. He J, Gu D, Wu X, Reynolds K, Duan X, Yao C, et al. Major causes of death among men and women in China. N Engl J Med. 2005;353:1124–34.

    Article  CAS  PubMed  Google Scholar 

  3. Feigin VL. Stroke epidemiology in the developing world. Lancet. 2005;365:2160–1.

    Article  PubMed  Google Scholar 

  4. Lee WH, Kim JS. A review study of stroke in Korea. Korean J Epidemiol. 1981;3:1–22.

    Google Scholar 

  5. Gorelick PB, Sacco RL, Smith DB, Alberts M, Mustone-Alexander L, Rader D, et al. Prevention of a first stroke: a review of guidelines and a multidisciplinary consensus statement from the National Stroke Association. JAMA. 1999;281:1112–20.

    Article  CAS  PubMed  Google Scholar 

  6. Liu Z, Guan L, Wang Y, Xie CL, Lin XM, Zheng GQ. History and mechanism for treatment of intracerebral hemorrhage with scalp acupuncture. Evid Based Complement Alternat Med. 2012;2012:895032.

    PubMed  PubMed Central  Google Scholar 

  7. WHO Scientific Group on International Acupuncture Nomenclature. A proposed standard international acupuncture nomenclature. Report of a WHO scientific group. Geneva: World Health Organization; 1991.

    Google Scholar 

  8. Dharmananda S, Vickers E. Synopsis of scalp acupuncture. 2000. http://www.itmonline.org/arts/newscalp.htm Accessed 31 Mar 2016.

  9. Beak KM, Kim MJ, Lee HU, Lim SM, Yoo HR, Jo HK, et al. A clinical study of 3 cases of stroke patients with dysphagia treated by simultaneous scalp-acupuncture and electroacupuncture. Korean J Orient Int Med. 2007;28:632–44.

    Google Scholar 

  10. Cho TS, Son IS, Park IB, Kim SW, Seo JC, Youn HM, et al. Effects of scalp acupuncture on short-term NIHSS and MBI in stroke patients. J Korean Orient Med. 2003;24:65–73.

    Google Scholar 

  11. Ha CH, Han SG, Cho MR, Ryu CR, Lee BR. A clinical study on 29 cases with stroke treated by body acupuncture therapy and scalp acupuncture. J Korean Acupunct Moxibust Soc. 2001;18:82–90.

    Google Scholar 

  12. Kim JH, Park GC. A case report of central post-stroke pain patient treated with SA (MS6 and MS7) and usual treatment of Korean medicine. J Korean Acupunct Moxibust Soc. 2014;31:57–65.

    Google Scholar 

  13. Wang Y, Shen J, Wang X-M, Fu D-L, Chen C-Y, Lu L-Y, et al. Scalp acupuncture for acute ischemic stroke: a meta-analysis of randomized controlled trials. Evid Based Complement Alternat Med. 2012;2012:1–9.

    Google Scholar 

  14. Lee SJ, Shin BC, Lee MS, Han CH, Kim JI. Scalp STRICTA recommendations for stroke recovery: a systematic review and meta-analysis of randomized controlled trials. Eur J Integr Med. 2013;5:87–99.

    Article  Google Scholar 

  15. Kong JC, Lee MS, Shin BC, Song YS, Ernst E. Acupuncture for functional recovery after stroke: a systematic review of sham-controlled randomized clinical trials. CMAJ. 2010;182:1723–9.

    Article  PubMed  PubMed Central  Google Scholar 

  16. Son C. Overview for pattern and results of moxibustion-derived clinical trials. J Meridian Acupoint. 2009;26:41–9.

    Google Scholar 

  17. 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;30:626–31.

    Article  Google Scholar 

  18. Park J, Kang K, Choi S. Assessing methodological quality of acupuncture clinical trials of Korea. J Korean Acupunct Moxibust Soc. 2007;24:127–35.

    Google Scholar 

  19. Schulz KF, Altman DG, Moher D, CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152:726–32. https://doi.org/10.7326/0003-4819-152-11-201006010-00232.

    Article  PubMed  Google Scholar 

  20. MacPherson H, Altman DG, Hammerschlag R, Youping L, Taixiang W, White A, et al. Revised STandards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. PLoS Med. 2010;7:e1000261.

    Article  PubMed  PubMed Central  Google Scholar 

  21. 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.

    Article  PubMed  PubMed Central  Google Scholar 

  22. The Chinese Medical Association of the Fourth National Cerebrovascular Disease Conference. Essentials of diagnosis of all kinds of cerebrovascular diseases. Chin J Neurol. 1996;29:379.

    Google Scholar 

  23. Li P, Wu ZZ, Zhang YR, Li BZ, Hua RC, Wei JN, et al. Criterion of diagnosis and therapeutic effect of apoplexy. J Beijing Univ Tradit Chin Med. 1996;19:55–6.

    Google Scholar 

  24. The Forth National Cerebrovascular Diseases Conference. Classification, diagnostic criteria and evaluation of neurological impairment for stroke patients. Chin J Neurol. 1996;29:381–3.

    Google Scholar 

  25. Chen ZW, Chen YC, Zeng JC, Wang Y, Ye T, Zhou QC, et al. Quality of randomized controlled trials reporting in the treatment of melasma conducted in China. Trials. 2015;16:156.

    Article  PubMed  PubMed Central  Google Scholar 

  26. Hollis S, Campbell F. What is meant by intention to treat analysis? Survey of published randomized controlled trials. BMJ. 1999;319:670–4.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  27. Gluud LL, Thorlund K, Gluud C, Woods L, Harris R, Sterne JA. Correction: reported methodologic quality and discrepancies between large and small randomized trials in meta-analyses. Ann Intern Med. 2008;149:219.

    Article  PubMed  Google Scholar 

  28. Montori VM, Bhandari M, Devereaux PJ, Manns BJ, Ghali WA, Guyatt GH. In the dark: the reporting of blinding status in randomized controlled trials. J Clin Epidemiol. 2002;55:787–90.

    Article  PubMed  Google Scholar 

  29. Gao J, Deng G, Hu Y, Huang Y, Lu L, Huang D, et al. Quality of reporting on randomized controlled trials on recurrent spontaneous abortion in China. Trials. 2015;16:172.

    Article  PubMed  PubMed Central  Google Scholar 

  30. Lai R, Chu R, Fraumeni M, Thabane L. Quality of randomized controlled trials reporting in the primary treatment of brain tumors. J Clin Oncol. 2006;24:1136–44.

    Article  PubMed  Google Scholar 

  31. Lu X, Hongcai S, Jiaying W, Jing H, Jun X. Assessing the quality of reports about randomized controlled trials of acupuncture treatment on mild cognitive impairment. PLoS One. 2011;6:e16922.

    Article  PubMed  PubMed Central  Google Scholar 

  32. Moher D, Hopewell S, Schulz KF, Montori V, Gøtzsche PC, Devereaux PJ, et al. CONSORT 2010 explanation and elaboration: updated guidelines for reporting parallel group randomized trials. BMJ. 2010;340:c869.

    Article  PubMed  PubMed Central  Google Scholar 

  33. Mcdonald AM, Knight RC, Campbell MK, Entwistle VA, Grant AM, Cook JA, et al. What influences recruitment to randomized controlled trials? A review of trials funded by two UK funding agencies. Trials. 2006;7:9.

    Article  PubMed  PubMed Central  Google Scholar 

  34. Chen X, Zhai X, Wang X, Su J, Li M. Methodological reporting quality of randomized controlled trials in three spine journals from 2010 to 2012. Eur Spine J. 2014;23:1606–11.

    Article  PubMed  Google Scholar 

  35. Tukey JW. Some thoughts on clinical trials, especially problems of multiplicity. Science. 1977;117:916–21.

    Google Scholar 

  36. Hahn S, Williamson PR, Hutton JL, Garner P, Flynn EV. Assessing the potential for bias in meta-analysis due to selective reporting of subgroup analyses within studies. Stat Med. 2000;19:3325–36.

    Article  CAS  PubMed  Google Scholar 

  37. Ioannidis JP, Lau J. Completeness of safety reporting in randomized trials: an evaluation of 7 medical areas. JAMA 1999;281:1110-1.

  38. Scharf O, Colevas AD. Adverse event reporting in publications compared with sponsor database for cancer clinical trials. J Clin Oncol. 2006;24:3933–8.

    Article  PubMed  Google Scholar 

  39. Pitrou I, Boutron I, Ahmad N, Ravaud P. Reporting of safety results in published reports of randomized controlled trials. Arch Intern Med. 2009;169:1756–61.

    Article  PubMed  Google Scholar 

  40. Bo C, Xue Z, Yi G, Zelin C, Yang B, Zixu W, et al. Assessing the quality of reports about randomized controlled trials of acupuncture treatment on diabetic peripheral neuropathy. PLoS One. 2012;7:e38461.

    Article  PubMed  PubMed Central  Google Scholar 

  41. Lee HS, Cha SJ, Park HJ, Seo JC, Park JB, Lee HJ. Revised STandards for reporting interventions in clinical trials of acupuncture (STRICTA): extending the CONSORT statement. Korean J Acupunct. 2010;27:1–23.

    Google Scholar 

  42. Di Blasi Z. Kleijnen J. Context effects. Powerful therapies or methodological bias? Eval Health Prof. 2003;26:166–79.

    Article  PubMed  Google Scholar 

  43. Baer H. The emergence of integrative medicine in Australia: the growing interest of biomedicine and nursing in complementary medicine in a southern developed society. Med Anthropol Q. 2008;22:52–66.

    Article  PubMed  Google Scholar 

  44. Lu L, Liao M, Zeng J, He J. Quality of reporting and its correlates among randomized controlled trials on acupuncture for cancer pain: application of the CONSORT 2010 statement and STRICTA. Expert Rev Anticancer Ther. 2013;13:489–98.

    Article  CAS  PubMed  Google Scholar 

  45. Tang JL, Zhan SY, Ernst E. Review of randomized controlled trials of traditional Chinese medicine. BMJ. 1999;319:160–1.

    Article  CAS  PubMed  PubMed Central  Google Scholar 

  46. Lu L, Zeng J, Chen Y. Quality of reporting in randomized controlled trials conducted in China on the treatment of cancer pain. Expert Rev Anticancer Ther. 2011;11:871–7.

    Article  PubMed  Google Scholar 

  47. Chen B, Liu J, Zhang C, Li M. A retrospective survey of quality of reporting on randomized controlled trials of metformin for polycystic ovary syndrome. Trials. 2014;15:128.

    Article  PubMed  PubMed Central  Google Scholar 

  48. Chen B, Zhao X, Guo Y, Chen Z, Bai Y, Wang Z, Wang Y. Assessing the quality of reports about randomized controlled trials of acupuncture treatment on diabetic peripheral neuropathy. PLoS One. 2012;7:e38461.

    Article  CAS  Google Scholar 

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Acknowledgments

The authors would like to express sincere thanks to our colleagues and staff at the College of Korean Medicine Dong-Shin University, DongShin University Gwangju Oriental Hospital, and Chonnam National University Medical School & Hospital for their support.

Funding

This study was supported by the Traditional Korean Medicine R&D program funded by the Ministry of Health & Welfare through the Korea Health Industry Development Institute (KHIDI) (HB16C0026).

Availability of data and materials

The datasets supporting the conclusions of this article are presented in this main paper.

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Author notes

    Authors and Affiliations

    1. Clinical Research Center, DongShin University Gwangju Oriental Hospital, Gwangju City, Republic of Korea

      Young-Nim You, Jae-Hong Kim, Ju-Hyung Park & Gwang-Cheon Park

    2. Department of Acupuncture and Moxibustion Medicine, College of Korean Medicine Dong-Shin University, Naju City, Republic of Korea

      Myung-Rae Cho & Jae-Hong Kim

    3. Department of Korean Rehabilitation Medicine, College of Korean Medicine Dong-Shin University, Naju City, Republic of Korea

      Min-Yeong Song & Jin-Bong Choi

    4. Department of Physical & Rehabilitation Medicine, Chonnam National University Medical School and Hospital, Gwangju City, Republic of Korea

      Jae-Young Han

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    Contributions

    JHK, JBC, MRC, and JYH planned and designed the study. YNY, MRC, and MYS contributed to the acquisition of data. JHP and GCP analyzed the data and provided statistical support throughout the research process. YNY and JHK were primarily responsible for writing the paper. All authors were involved in the drafting and revision of the paper and approved the final version of the manuscript for submission. All authors read and approved the final manuscript.

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    Correspondence to Jae-Hong Kim.

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    The authors declare that they have no competing interests.

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    Additional files

    Additional file 1:

    List of RCTs reporting in the scalp acupuncture treatment of stroke (n = 63). (DOCX 28 kb)

    Additional file 2:

    Summary of the RCTs reporting in the scalp acupuncture treatment of stroke (n = 63). (DOCX 36 kb)

    Additional file 3:

    Measure the overall quality score (OQS) of 13 CONSORT items, a combined key methodological index score (MIS) of 5 CONSORT items, and the OQS of 17 STRICTA items of the randomized control trials of SA for stroke included in this study(n = 63). (DOCX 126 kb)

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    Cite this article

    You, YN., Cho, MR., Kim, JH. et al. Assessing the quality of reports about randomized controlled trials of scalp acupuncture combined with another treatment for stroke. BMC Complement Altern Med 17, 452 (2017). https://doi.org/10.1186/s12906-017-1950-6

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    • DOI: https://doi.org/10.1186/s12906-017-1950-6

    Keywords

    • Randomized controlled trials
    • Scalp acupuncture
    • Stroke
    • Consort
    • STRICTA

    BMC Complementary Medicine and Therapies

    ISSN: 2662-7671

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