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

Qiu 2012.

Methods
  • Study design: parallel RCT

  • Duration of the study: June 2008 to January 2010

  • Study follow‐up: 24 weeks

Participants
  • Country: China

  • Setting: inpatient or outpatient not reported; multicentre (HD centres in three hospitals)

  • Inclusion criteria: ESKD defined by NKF K/DOQI guideline; aged 18 to 80 years; maintenance HD at least 3 months ago with dialysis adequacy (Kt/V ≥ 1.2; URR ≥ 65%); patient's compliance to Chinese and Western medicine treatments; written informed consent; one of TCM symptom classification: spleen‐kidney qi deficiency, spleen‐kidney yang deficiency, spleen‐kidney qi and yin deficiency or yin‐yang deficiency

  • Number: treatment group (58); control group (51)

  • Mean age ± SD (years): treatment group (57.78 ± 12.83); control group (57.54 ± 11.87)

  • Sex (M/F): 47/62

  • Exclusion criteria: malignancy, poorly controlled diabetes, acute infection or acute cardiovascular diseases; skin irritability or local infection on acupoints

Interventions Treatment group
  • Moxibustion


Control group
  • Routine care


Duration of intervention: 12 weeks
Outcomes
  • Nutritional status

    • Measured by the MQSGA. MQSGA included the history and physical examination in two parts. Scores ranged from 7 to 35 points (7‐10; normal nutrition, 11‐20; mild to moderate malnutrition, 21‐30; severe malnutrition, 31‐35; extremely severe malnutrition)

  • Hand grip strength

    • TKK5001 GRIP‐A grip strength metre (HKBG., Ltd, Sweden), measurement of grip strength three times as the average

  • Biological parameters (Hb, Serum albumin, dry weight)

    • Blood samples collected in accordance with the United States Renal Disease Foundation, published in 2001 of kidney disease prognosis Quality Guidelines (NKF‐K/DOQI)


Time points measured (or reported) in the study: post‐treatment (12 weeks), follow‐up (24 weeks)
Notes
  • Four studies were published by the same research group over three years, and enrolled the same participants at different time points. The review authors regarded them as one study and used the most collective and representative information

Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk Random number table was used
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 Low risk Intention‐to‐treat analysis
Selective reporting (reporting bias) Unclear risk No study protocol available
Other bias Low risk Study appears free of other biases