Reference
No. of studies Confirmatory studies
ITT analysis
Study duration Outcome measures
No. of study medications Primary Secondary [3 ] (5/2011) Irritable bowel syndrome
Not stated if hypothesis clinically relevant
9 days to 18 wks Global improvement of symptoms Quality of life No. of recurrent episodes Predominant symptom Cost-effectiveness Adverse events
[4 ] (9/2012) Advanced colon cancer
7–126 days Mean 54 days Mortality** Survival time Relative response
Oral
Injection
[5 ] (4/2006) Low back pain
Mean 3.5 weeks Pain intensity, function Overall improvement Return to work
Oral
External
[6 ] (1/2009) Type 2 diabetes
Not stated if hypothesis clinically relevant
2–6 months Mean 2.6 months Mortality* Diabetic complications* Quality of life* Fasting glucose, HbA1C BMI Fasting insulin AEs and costs
Oral
Injection
[7 ] (10/2005) Schizophrenia
20 days–6 months Clinical response subscores Various
[8 ] (5/2012) Threatened Miscarriage
No dropouts reported in any study Not stated in all Continuation of pregnancy after 28 wks of gestation During treatment After treatment Foetus
[9 ] (1/2010) Chronic neck pain
4 wks Pain (VAS) Functional status Patient satisfaction Neurologic outcomes Adverse events
[10 ] (4/2006) Pre-eclampsia
— — — Maternal: for example, death Neonatal: for example, death Various — [11 ] (11/2010) Primary dysmenorrhea
Up to 6 cycles Approx. 6 months Menstrual pain Menstruation-related symptoms, AEs Laboratory values Additional medications Satisfaction
Oral
External
Rectal
Sublingual
[12 ] (6/2011) Diabetic neuropathy
At least 4 wks 30% improvement in global score (e.g., VAS) Quality of life Nerve conduction AEs
Oral
Injection
Either or
[13 ] (8/2011) Hyper cholesterolaemia
Mean 2.3 months Cardiovascular event Serum cholesterol Death, quality of life Serum triglycerides, BMI, AEs, and so forth