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. 2016 Jun 28;2016(6):CD009440. doi: 10.1002/14651858.CD009440.pub2

Cheng 2012.

Methods

  • Study design: parallel RCT

  • Duration of the study: March 2010 to December 2011

  • Study follow‐up: 10 days
Participants

  • Country: China

  • Setting: inpatients; single centre, Chinese‐Western Integrative Medicine Hospital, Wuchang, China

  • Inclusion criteria: patients undergoing CAPD and diagnosed as spleen‐kidney yang deficiency syndrome in traditional Chinese medicine

  • Number: treatment group (30); control group (30)

  • Mean age ± SD (years): treatment group (57.2 ± 8.2); control group (56.9 ± 7.9)

  • Sex (M/F): 29/31

  • Exclusion criteria: pregnancy; gastrointestinal bleeding or electrolyte imbalance as a complication CAPD; severely impaired heart function
Interventions Treatment group

  • Indirect moxibustion on ginger slices


Control group

  • Western conventional care

    • Metoclopramide: 10 mg (IM injection once/d)

    • Domperidone: 10 mg (oral administration 3 times/d)


Duration of intervention: 7 to 10 days
Outcomes

  • GI symptom scores (anorexia, nausea/vomiting, bloating and watery stools)

    • Measured by severity of symptoms. This score consisted of 4 separate components including anorexia, nausea/vomiting, bloating and watery stools. Severity of these 4 components was assessed as follows: none (0), mild (1), moderate (2) and severe (3)

  • Overall improvement rates

    • Calculated as follows: complete recovery (improvement of clinical symptoms and recovery of baseline symptoms more than 95%), improvement (improvement of clinical symptoms and recovery of baseline symptoms > 70% and < 95%), slight improvement (improvement of clinical symptoms and recovery of baseline symptoms more than 30% but less than 70%) and no improvement (no improvement of clinical symptoms and recovery of baseline symptoms < 30%)

  • Biological parameters (total Kt/V, residual kidney function (Kt/V), total CrCl, residual kidney function CrCl, dialysate/plasma ratio of creatinine, peritoneal dialysate volume, urinary volume, SCr, carbon dioxide combining power, albumin, K+, Hb)


Time points measured (or reported) in the study: post‐treatment (10 days)
Notes

  • The number of patients in subjective outcomes (i.e., total symptom scores and symptom response rates) was substantially different from those randomised. Thus, we did not analyse those outcomes in the review
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Unclear risk Not reported
Allocation concealment (selection bias) Unclear risk Not reported
Blinding of participants and personnel (performance bias) 
 All outcomes High risk Unable to be blinded (open‐label study)
Blinding of outcome assessment (detection bias) 
 All outcomes Unclear risk Not reported
Incomplete outcome data (attrition bias) 
 All outcomes High risk Total number of assessed patients exceeds the total number of included patients in each group
Selective reporting (reporting bias) Unclear risk No study protocol available
Other bias Low risk Study appears free of other biases