Table 2 Characteristics of studies of N-of-1 tests in developing countries

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)