Table 2.

Characteristics of studies of N-of-1 tests in developing countries

1st author, country	Design	Rationale	Participants	Measures	Intervention	Outcomes
Huang, et al., China (2014) [32]	Randomized, double-blind, crossover, within individual patient	Lack of sufficient evidence on effectiveness of the therapy	1 man, 2 women, aged 18–75 years, diagnosed with stable bronchiectasis	Primary: patient self-rated symptom score for cough, expectoration, shortness of breath, chest pain and fatigue Secondary: 24-h sputum volume and drug safety	Herbal decoction vs control decoction	All three patients showed non-significant improvement from the test TCM. One patient preferred the herbal decoction over the standard one after trial completion
Yuhong, et al,, China, (2012) [33]	Randomized, double-blind, crossover, within individual patient	Lack of sufficient evidence on effectiveness of the therapy	15 men, 35 women, aged 25–65 years, with a clinical diagnosis of deficiency of kidney-Yin	Primary: individual completion rates, response rate, and post-N-of-1 RCT decision Secondary: self-rated symptom score on Likert scale and SF-36 questionnaire to measure perceived health and quality of life	Liuwei Dihuang decoction (LDD) vs placebo	Only 3 (6.38%) responded, 28 (59.57%) did not respond, and 16 (34.05%) were possible responders. 29 (66%) patients changed medication after the trial
Wang et al., China (2010) [35]	Randomized, double-blind, crossover, within individual patient	Lack of sufficient evidence on effectiveness of the therapy	6 men, 5 women, aged 45–66 years, with diagnosis of mild-moderate hypertension	Effectiveness: change in blood pressure (home and clinic measurements) Safety: respiratory rate, heart rate, routine blood test for liver and kidney function, urine test, routine ECG	High-dose vs low-dose Bezoar anti-hypertension capsule plus simulation placebo	Home BP measurements showed significant reduction only in SBP. Clinic BP measurements showed significant reduction both in SBP and DBP from the high-dose TCM (P < 0.001) There was no increased risk of adverse events from high-dose Bezoar
Yu et al,, China (2012) [36]	Randomized, crossover, within individual patient	Lack of sufficient evidence on effectiveness of the therapy	3 men, aged 52, 57 and 59 years with diagnosis of chronic kidney disease (CKD) of third stage	Individual patient main symptom score. Change in serum creatinine and creatinine clearance rate	Chinese medicinal decoctions plus the routine basic treatment vs only the routine basic treatment	Individual patients’ main symptom was significantly improved in the treatment phase (P < 0.01). Two patients showed improved serum creatinine and creatinine clearance rate
Zhang, et al., China (2012) [37]	Randomized, crossover, within individual patient	Lack of sufficient evidence on effectiveness of the therapy	4 patients, all male, ages 50, 61, 68 and 76 years, with diagnosis of hypertensive intracerebral haemorrhage	Patient main symptoms; IL-6, morphology index and clinical curative effect evaluation (the degree of encephaloedema and cerebral infarction)	Standard treatment plus TCM, acupuncture and moxibustion; Traditional Chinese manipulation vs standard treatment plus TCM	TCM symptom scores of all patients were significantly improved (P < 0.01). IL-6 of all patients was significantly reduced (P < 0.01). Scores of Morphology Index and Clinical Curative Effect were also improved from the treatment phase
Louly et al., Brazil (2009) [34]	Randomized, double-blind, crossover, within individual patient	Lack of optimal therapy to treat cough in patient	55-year-old female patient with dry cough secondary to interstitial pneumopathy	Primary outcome: the intensity of daytime and night-time cough measured by a visual analog scale and patient’s perception regarding her health state	Tramadol 50 mg compared with placebo	The patient’s condition as measured by visual analog scale significantly improved compared with the test drug (P < 0.001)

BP blood pressure, DBP diastolic blood presure, RCT randomized controlled trial, SBP systolic blood pressure, TCM Traditional Chinese Medicine