Improving reporting of adverse events and adverse drug reactions following injections of Chinese materia medica

Abstract

The current reporting format of ADR/AE in clinical CM injections is not standardized. Much fundamental information of ADR/AE following CM injection is therefore missing. A standard reporting format for ADR should be developed, and should include the following: (1) a title mentioning adverse effects and safety; (2) a structured abstract including adequate information about the patient and the disease treated, the drug used, the specific ADR/AE, physician response to the ADR/AE, and result of management; (3) demographic characteristic of the patients (gender, age, etc.); (4) clinical characteristics of patients (disease, syndrome, etc); (5) allergic history of patients; (6) diagnosis and syndrome based on Chinese medicine theory; (7) detailed information about the CM intervention (the manufacturer of the drug, series number, valid dates, dosage, route of administration, menstruum, dripping speed, etc.); (8) concomitant drug use; (9) time and symptoms of ADR/AE; (10) type and grading of ADR/AE; (11) physiological systems affected by ADR/AE; (12) specific treatment and prognosis for ADR/AE; (13) evidence of the cause and effect of ADR/AE; and (14) any other possibility of ADR/AE. Also, a ADR/AE registration system should be established.

Effectiveness of ultrasound-guided vs direct approach corticosteroid injections for carpal tunnel syndrome: A double-blind randomized controlled trial

“…Secondly, the reported discomforts within 1 week after injections for CTS in the present study were different from the complications or discomforts described in other studies (18,19). This discrepancy could be avoided in the future by developing a standardized method for reporting CTS injection complications (42)(43)(44). Thirdly, the dropout rates of both groups in our study were higher than the accepted values in other randomized controlled trials.…”

An Overview of Systematic Reviews of Shenmai Injection for Healthcare

“…While reporting of ADR following CHM injection is becoming more and more common, the reporting quality is of concern. A standard reporting format for ADR has been developed [44] and we suggested that improvement of reporting of adverse events and ADRs of SMI may follow up. Fourth, SMI is widely used in the treatment of various disorders and seems generally safe.…”

Promoting blood circulation for removing blood stasis therapy for acute intracerebral hemorrhage: a systematic review and meta-analysis

“…In addition, the safety of herbal patent injection itself has become a major concern to both national health authorities and the general public [59] . A standard reporting format for adverse drug reactions (ADR) has been developed [60] , and we suggest that improvement of the reporting of adverse events and ADRs of PBCRBS should be closely followed. Fourthly, improvement in the methodological quality of primary RCTs is still crucial for future clinical studies.…”