Chen 2010a.
Methods | That "computer randomisation form was used to allocate the participants" was mentioned in the text. Traditional Chinese medicine (TCM) plus placebo group versus oseltamivir group | |
Participants | Participants were confirmed with influenza A H1N1 according to the Diagnostic Standard by Ministry of Health, China (Second edition, 2009). Ages ranged from 5 to 65 years and temperature was above 37.5 degrees Celsius. Patients had influenza symptoms. Patients with serious diseases of any origin, for example, kidney, heart, lung, blood vessel, nervous system, metabolic diseases, immunodeficiency diseases, tumours, hepatitis or cirrhosis, pregnant woman, or accepting hormone or immune inhibitor therapy, were excluded. In total 55 participants were included. 31 (male 18, female 13) were allocated to the TCM plus placebo group, 22 (male 9, female 13) to the control group | |
Interventions | Participants in the TCM group were given modified Yin Qiao Shan or Huo Bo Xia Lin Tang or Pu Ji Xiao Du Yin for the acute phase of the influenza and placebo (simulation agent of oseltamivir) 75 mg, twice a day for 5 days. In the convalescent phase, participants were given 150 ml Shang Ju Yin in the morning and evening in the TCM group. Oseltamivir was given to participants in the control group (75 mg) twice a day | |
Outcomes | Primary outcome: 1. Length of disease (time to symptom clearance) Secondary outcomes: 1. Length of hospitalisation 2. Rate of complications 3. Adverse events |
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Notes | Adverse reaction mentioned: 1 participant had diarrhea in the TCM group, 1 case of rash and 1 case of vomiting in the control group. There was no statistically significant difference between the 2 groups | |
Risk of bias | ||
Bias | Authors' judgement | Support for judgement |
Random sequence generation (selection bias) | High risk | Who generated the randomisation sequence and which software was used was not mentioned; the numbers of participants in the 2 arms were not balanced (31:22). This suggests that the randomisation is questionable |
Allocation concealment (selection bias) | High risk | Allocation concealment not described |
Blinding (performance bias and detection bias) All outcomes | High risk | No TCM placebo was used |
Selective reporting (reporting bias) | Unclear risk | There was potential selective reporting bias due to the imbalanced numbers of participants in the 2 arms 2 participants withdrew due to allergic reactions or adverse reactions |
Other bias | High risk | The prescriptions were made by the authors |
Blinding of participants and personnel (performance bias) All outcomes | High risk | Although a placebo was used, the participants still knew which intervention was the TCM |
Blinding of outcome assessment (detection bias) All outcomes | High risk | The outcome assessors knew who took the TCM |