BackgroundThis study was designed to assess the quality of reporting on randomized controlled trials (RCTs) of scalp acupuncture for the treatment of stroke.MethodsThe 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.ResultsThe 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.ConclusionThe 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.Electronic supplementary materialThe online version of this article (10.1186/s12906-017-1950-6) contains supplementary material, which is available to authorized users.
BackgroundThis study aimed to evaluate the quality of reports about randomized controlled trials (RCTs) of scalp acupuncture (SA) for the treatment of vascular dementia (VD).MethodA systematic search of reports published through to December 2015 was performed in eight databases. The quality of RCTs that used SA as an intervention for VD was evaluated based on the 2010 Consolidated Standards for Reporting of Trials (CONSORT) and 2010 Standards for Reporting Interventions in Controlled Trials of Acupuncture (STRICTA) guidelines. Thirteen items from the CONSORT guideline were scored to give an overall quality score (OQS, range 0–13), and a combined key methodological index score (MIS) (range 0–5) of five key methodological items was measured. The OQS of 17 items from the STRICTA guideline (range 0–17) was also measured.ResultsIn total, 26 reports were evaluated. The median OQS based on the CONSORT guideline was 8 (minimum 5, maximum 11), and “trial design,” “sample size,” “ancillary analyses,” and “harms” had a positive rate of less than 10%. The median MIS was 2 (minimum 0, maximum 5), with “allocation concealment and implementation,” “blinding,” and “intent-to-treat analysis” having a positive rate of less than 15%. The median OQS based on the STRICTA guideline was 12 (minimum 8, maximum 14), with “extent to which treatment was varied (1c),” “number of needle insertions per subject per session (2a),” and “setting and context of treatment (4b)” having a positive rate of less than 10%.ConclusionsThe overall quality of reports on RCTs of SA treatment for VD was moderate to low. The quality of methodological items was markedly lower than that of other items. The CONSORT and STRICTA guidelines should be used more frequently to standardize the quality of RCT reports of SA treatment for VD.
This outcome assessor-blinded, randomized controlled clinical trial investigated the effects of electroacupuncture combined with computer-based cognitive rehabilitation (EA-CCR) on mild cognitive impairment (MCI). A per-protocol analysis was employed to compare the efficacy of EA-CCR to that of computer-based cognitive rehabilitation (CCR). Thirty-two patients with MCI completed the trial (EA-CCR group, 16; CCR group, 16). Patients received EA-CCR or CCR treatment once daily three days per week for eight weeks. Outcome (primary, ADAS-K-cog; secondary, MoCA-K, CES-D, K-ADL, K-IADL, and EQ-5D-5L) measurements were performed at baseline (week 0), at the end of the intervention (week 8), and at 12 weeks after completion of the intervention (week 20). Both groups showed significant changes in ADAS-K-cog score (EA-CCR, p < 0.001; CCR, p < 0.001) and MoCA-K (EA-CCR, p < 0.001; CCR, p < 0.001). Only the EA-CCR group had a significant change in CES-D (p = 0.024). No significant differences in outcomes and in the results of a subanalysis based on age were noted between the groups. These results indicate that EA-CCR and CCR have beneficial effects on improving cognitive function in patients with MCI. However, electroacupuncture in EA-CCR showed no positive add-on effects on improving cognitive function, depression, activities of daily living, and quality of life in patients with MCI.
Background Chronic non-specific low back pain (CLBP) is a common musculoskeletal disorder for which patients seek complementary and alternative medical treatments, including laser acupuncture (LA). Invasive LA (ILA) involves the simultaneous application of invasive acupuncture treatment at acupoints and focused laser irradiation. The efficacy of ILA for CLBP remains controversial owing to the insufficient clinical trial data. We intend to obtain basic data regarding the efficacy and safety of ILA for CLBP by comparing the effects of different wavelengths of ILA on CLBP. Methods This will be a prospective, patient-blinded, parallel-arm, single-center (DongShin University Gwangju Korean Medicine Hospital, Republic of Korea), pilot randomized controlled clinical trial. Forty-five participants with CLBP will be randomized in equal numbers into the control, 650-nm ILA (650 ILA), or 830-nm ILA (830 ILA) group. The control group will receive sham ILA for 10 min and real electroacupuncture (EA) for 10 min. The 650 and 830 ILA groups will receive real ILA (i.e., 650 ILA group, 650-nm wavelength; 830 ILA group, 830-nm wavelength) for 10 min and real EA for 10 min once/day, twice a week for 4 weeks, at bilateral Shenshu (BL23), Qihaishu (BL24), Dachangshu (BL25), and Huantiao (GB30). The primary outcome will be an improvement in pain intensity assessed using the visual analog scale. Scores in the Korean version of the Oswestry Disability Index and the European Quality of Life Five Dimension Five Level scale will be recorded as secondary outcome measures. All scores will be recorded at baseline (before intervention), 4 weeks after the first intervention (at the end of the intervention), and 4 weeks after completion of the intervention. Discussion The study is expected to provide preliminary evidence regarding the efficacy, safety, and usefulness of ILA for the treatment of CLBP. Trial registration This trial was registered with the Clinical Research Information Service (registration No. KCT0004610; http://cris.nih.go.kr). Registered on 7 January 2020.
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