anurajms/meta_analysis huggingface dataset:
primary outcome:
Branched‐chain amino acids for people with hepatic encephalopathy
Mortality (all‐cause).Hepatic encephalopathy (number of people without improved manifestations of hepatic encephalopathy).Adverse events: any untoward medical occurrence that, at any dose, resulted in death, was life‐threatening, required hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability or incapacity, or was a congenital anomaly/birth defect, or any medical event that might have jeopardised the person, or required intervention to prevent it (ICH GCP 1997).
primary outcome:
Therapeutic ultrasound for venous leg ulcers
time to complete wound healing (correctly analysed using survival, time‐to‐event approaches). Ideally the outcome would be adjusted for appropriate covariates, e.g. baseline ulcer area/duration.proportion of wounds completely healed during follow‐up (frequency of complete healing), within a trial time period, or at maximal follow‐up. We planned to use and report authors’ definitions of complete wound healing.
primary outcome:
Effect of cocoa on blood pressure
Difference between cocoa and control group in systolic and diastolic blood pressure at final follow‐up, and adjusted for baseline differences.
primary outcome:
Vitamin E for Alzheimer's dementia and mild cognitive impairment
For MCI studies, development of, or time to development of, possible or probable AD.Cognitive function.Adverse eventsDeath.
primary outcome:
Arginine supplementation for prevention of necrotising enterocolitis in preterm infants
Incidence of NEC (any stage and specific stage (1, 2 or 3)) based on Bell's criteria (Bell 1978; Walsh 1986) and diagnosed before discharge.
primary outcome:
L‐carnitine for cognitive enhancement in people without cognitive impairment
Cognitive function as measured by psychometric tests. These should be validated for use in healthy populations and may include comprehensive neuropsychological test batteries or tests of individual cognitive domains (e.g. memory functions including verbal memory, visual memory, immediate or delayed recall, executive function, attention, etc.).Incidence and severity of adverse effects.
primary outcome:
Calcium and phosphorus supplementation of human milk for preterm infants
Growth to discharge (including weight and z score, length and z score, head circumference and z score)Growth at 12 to 18 months (including weight and z score, length and z score, head circumference and z score)Bone metabolism (including serum alkaline phosphatase (ALP), bone mineral content (BMC), timing defined by the trialist)
primary outcome:
Different types of dietary advice for women with gestational diabetes mellitus
For this update, we used the standard outcome set agreed by consensus between review authors of Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of GDM and pre‐existing diabetes.
primary outcome:
Probiotics for people with hepatic encephalopathy
All‐cause mortality: number of participants dead.Number of participants who did not recover from hepatic encephalopathy (defined as incomplete resolution of clinical symptoms). We considered an individual to be 'completely resolved' if he or she was not in a state of hepatic encephalopathy based on the trial’s definition of hepatic encephalopathy used in the inclusion process.Adverse events: number and type of adverse events, defined as participants with any untoward medical occurrence. We summarised adverse events that led to treatment discontinuation and those that did not lead to treatment discontinuation separately. We defined serious adverse events according to the International Conference on Harmonisation (ICH) guidelines (ICH‐GCP 1997), as any event that led to death, was life‐threatening, required inpatient hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability, and any important medical event that may have jeopardised the patient or required intervention to prevent it. We considered all other adverse events as non‐serious.Quality of life: as measured by the 36‐Item Short Form Health Survey (SF‐36) or other similar validated scales, such as the Sickness Impact Profile (SIP) (Brazier 1992; Ware 1994).
primary outcome:
Acupuncture for acute hordeolum
The primary outcome for this review was the proportion of participants with complete resolution of an acute hordeolum no more than seven days after diagnosis. In this review, when we refer to early resolution of acute hordeolum, we mean resolution of acute hordeolum within seven days after diagnosis. The resolution of an acute hordeolum refers to the complete resolution of the redness, swelling, and pain at the eyelid, or drainage of the abscess with complete healing of the sore. We chose the time closest to seven days after diagnosis, or as defined by each individual RCT, since most cases of hordeola resolve on their own after seven days (between one and two weeks). If an RCT reported complete early resolution of a hordeolum at multiple time points, we chose the outcome measured at the time point closest to seven days after diagnosis.
primary outcome:
Music interventions for acquired brain injury
Improvement in gait, measured by changes in gait velocity, cadence, stride length, stride symmetry, stride timing, general gait, balance.Improvement in upper extremity function (UEF), measured by general UEF, timing of UEF, range of motion, hand function, upper limb strength, manual dexterity, and elbow extension.
primary outcome:
Topical capsaicin (high concentration) for chronic neuropathic pain in adults
Participant‐reported pain intensity reduction (PIR) of 30% or greater.Participant‐reported PIR of 50% or greater.Patient Global Impression of Change (PGIC) much or very much improved.PGIC very much improved.
primary outcome:
Dietary advice interventions in pregnancy for preventing gestational diabetes mellitus
For this update, we used the core outcome set agreed by consensus between review authors of Cochrane Pregnancy and Childbirth systematic reviews for prevention and treatment of gestational diabetes mellitus (GDM) and pre‐existing diabetes.Fraser 1983 did not report on any of the primary outcomes: GDM; hypertensive disorders of pregnancy; perinatal mortality (stillbirth or neonatal mortality); large‐for‐gestational age; neonatal mortality or morbidity composite.
primary outcome:
Longchain polyunsaturated fatty acid supplementation in preterm infants
Trials with clinical outcomes (visual development, neurodevelopment and physical growth) were included. Trials reporting only biochemical outcomes were not included.
primary outcome:
Nutrient‐enriched formula versus standard formula for preterm infants following hospital discharge
Growth: weight, length, head growth, skinfold thickness, BMI and measures of body composition (lean/fat mass) and growth restriction (proportion of infants who remain < 10th percentile for distribution of weight, length or head circumference in the index population). Long‐term growth and growth restriction (proportion of infants who remain below the 10th percentile for distribution of weight, height or head circumference in the index population)DevelopmentNeurodevelopmental outcomes assessed by validated tools at ≥ 12 months' corrected age; classifications of disability, including non‐ambulant cerebral palsy, developmental delay and auditory and visual impairmentCognitive and educational outcomes at ≥ 5 years: intelligence quotient and/or indices of educational achievement measured by a validated tool (including school examination results)
primary outcome:
Electrical stimulation with non‐implanted electrodes for overactive bladder in adults
Perception of cure (number of participants without OAB symptoms; number of participants without self‐reported UUI)Perception of improvement (number of participants with improvement in OAB symptoms; number of participants with improvement in self‐reported UUI)Condition‐related quality‐of‐life measures (however defined by authors or by any validated measurement scales such as the International Consultation on Incontinence Questionnaire (ICIQ))
primary outcome:
Zinc supplementation for the prevention of pneumonia in children aged 2 months to 59 months
Numbers of new episodes of pneumonia in children aged from two months to 59 months.
primary outcome:
Oral Astragalus (Huang qi) for preventing frequent episodes of acute respiratory tract infection in children
The primary outcome was acute respiratory tract infection (ARTI) frequency in children during the study period.The diagnostic criteria for ARTI were in accordance with the Chinese Paediatrics Antibiotics Application Guideline of Acute Respiratory Tract Infection (CPSCMA 1999). We accepted a broad definition of ARTI, using different specific diagnoses, such as the common cold, influenza, sinusitis, tonsillitis, laryngitis, pharyngitis, bronchitis and pneumonia. ARTI could be either clinically confirmed or self‐reported by parents in studies.
primary outcome:
Nutritional supplementation for hip fracture aftercare in older people
All cause mortalityMorbidity, postoperative complications (e.g. wound infections, pressure sores, deep venous thromboses, respiratory and urinary infections, cardiovascular events)'Unfavourable outcome'. This was defined as the number of trial participants who died plus the number of survivors with complications. Alternatively, where these data were unavailable, we accepted a slightly different definition (mortality or survivors with a major complication or two or more minor complications) originally presented in Delmi 1990.
primary outcome:
Zinc supplementation for tinnitus
Improvement in tinnitus severity and disability, measured by a validated tinnitus‐specific questionnaire (Appendix 1).Adverse effects of treatment with oral zinc supplementation.
primary outcome:
Transcutaneous electrical stimulation (TES) for treatment of constipation in children
Primary outcomes included the following.1. Global or clinical improvement in constipation as defined by the included studies. For example, clinical improvement could be measured by the frequency of defaecations per week and could potentially be expressed as a mean number of defaecations or as the proportion of patients who meet a pre‐specified threshold (e.g. greater than three defaecations per week).2. Spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM). SBM is defined as the passage of a stool without the use of laxative, and CSBM is defined as SBM associated with a sense of complete evacuation (Mueller‐Lissner 2010). SBM and CSBM could be measured by frequency per week and could be expressed as a mean number of SBM or CSBM or as the proportion of patients who meet a pre‐specified threshold (e.g. greater than three SBM or CSBM per week).
primary outcome:
Vitamin D supplementation for preventing infections in children under five years of age
Incidence rate (number of cases or episodes per total child‐years) of the following.Pneumonia.Tuberculosis (TB).
primary outcome:
Hyperbaric oxygen therapy for people with autism spectrum disorder (ASD)
The core features of ASD, which include impaired social interaction and communication and behavioral problems such as stereotypy or restricted repetitive patterns of behavior, interests, or activities, as measured by validated instruments and behavioral observation tools such as the Aberrant Behavior Checklist (ABC) (Aman 1987), the Ritvo‐Freeman Real Life Rating Scale (RFRLRS) (Freeman 1986), the Autism Treatment Evaluation Checklist (ATEC) (Rimland 1999), and the ADOS (Lord 1997).
primary outcome:
Methods of milk expression for lactating women
Indicators of maternal satisfaction (or lack of) with method, including acceptability, comfort, ease of use, and achievement of the woman's goal for expressing or pumping.Indicators of possible adverse outcomes for mother or infant as a result of pumping or expressing, including contamination of milk, injury to mother's breast or other anatomy, reduction or cessation of pumping or expressing due to difficulties with pumping or expressing.
primary outcome:
Vitamin A supplementation for the prevention of morbidity and mortality in infants one to six months of age
All‐cause mortality during infancy, in the period between initiation of intervention and the last follow‐up, until the age of one year.
primary outcome:
Polyunsaturated fatty acids (PUFAs) for children with specific learning disorders
Reading, writing, spelling or mathematics scores measured by standardised tests such as:Weschsler Objective Reading Dimensions (Weschler 1993);Woodcock Reading Mastery Tests (Woodcock 2011);Gray Oral Reading Test (Bryant 2011);Wide Range Achievement Test (Robertson 2006);Young's Group Mathematics Test (Young 1996);Neuropsychological Test Battery for Number Processing and Calculation in Children (von Aster 2006);British Ability Scales (BAS3 2011);Test of Handwriting Skills ‐ Revised (Milone 2007); andother similar tests, provided they are standardised for the population intended.Reports of adverse effects, including:bleeding manifestation such as prolonged bleeding time or haemorrhagic stroke;reduction of immunity such as increased incidence of infection; andother minor adverse effects such as hypersensitivity or gastrointestinal disturbances.
primary outcome:
Routine vitamin A supplementation for the prevention of blindness due to measles infection in children
Blindness as defined by the WHO: corrected visual acuity in the better eye of less than 3/60 (Gilbert 2001).
primary outcome:
Acupuncture for stroke rehabilitation
Death or dependency at the end of follow‐up (at least three months or longer after stroke onset). We defined dependency as dependent on others in activities of daily living, based on the correlated definition of the Barthel scores (Activities of Daily Living, ADL) as a score of less than 60 or an Oxford handicap grade 3 to 6 (Sulter 1999), or the trialists' own definition.
primary outcome:
Kangaroo mother care to reduce morbidity and mortality in low birthweight infants
Mortality.At discharge or at 40 to 41 weeks' postmenstrual age (from randomization until discharge or 40 to 41 weeks' postmenstrual age).At six months of age or at six months' follow‐up (from randomization until six months of age or six months' follow‐up).At 12 months' corrected age (from randomization until 12 months' corrected age).At latest follow‐up (from randomization until last follow‐up).Severe infection/sepsis (as defined in individual studies).Severe illness (as defined in individual studies).Infant growth.Weight at discharge or at 40 to 41 weeks' postmenstrual age, and at six and 12 months' corrected age.Weight gain at latest follow‐up.Length at discharge or at 40 to 41 weeks' postmenstrual age, and at six and 12 months' corrected age.Length gain at latest follow‐up.Head circumference at discharge or at 40 to 41 weeks' postmenstrual age, and at six and 12 months' corrected age.Head circumference gain at latest follow‐up.Neurodevelopmental and neurosensory impairment.Psychomotor development (measured by a validated tool/instrument).Cerebral palsy.Deafness.Visual impairment.
primary outcome:
Vitamin A supplementation to prevent mortality and short‐ and long‐term morbidity in very low birth weight infants
Death (at 28 days and at hospital discharge)Chronic lung disease (defined as oxygen use at 28 days or at 36 weeks' postmenstrual age)Death or chronic lung disease (defined as oxygen use at 28 days or at 36 weeks' postmenstrual age)
primary outcome:
Fish oil for kidney transplant recipients
For dichotomous outcomes, the events were combined to 12 months (or earlier for shorter studies). For continuous outcomes, the data was assessed at the 12‐month time point (or earlier time point for shorter studies).
primary outcome:
Polyunsaturated fatty acid supplementation for drug‐resistant epilepsy
Seizure freedom: proportion of participants with complete cessation of seizures during the treatment period.Seizure reduction: proportion of participants with at least 50% or greater reduction in seizure frequency at the end of the study compared with baseline.Potential adverse effects related to PUFA supplementation due to reduced platelet aggregation, such as bleeding symptoms.
primary outcome:
Cycled light in the intensive care unit for preterm and low birth weight infants
Growth at three and six months' CA (grams/d, or actual weight).
primary outcome:
Xylitol for preventing acute otitis media in children up to 12 years of age
Number of children (healthy children, children with a respiratory infection, and otitis‐prone children) with at least one AOM episode during the follow‐up period.
primary outcome:
Transcranial direct current stimulation (tDCS) for idiopathic Parkinson's disease
Impairment/disability, measured by the Unified Parkinson's Disease Ranking Scale (UPDRS; Fahn 1987).Reduction in off time (when the symptoms are not controlled by the medication)Reduction in on time with dyskinesia (time that symptoms are controlled but the person still experiences involuntary muscle movements) .
primary outcome:
Nutritional supplements for people being treated for active tuberculosis
All‐cause death.Cure (completed treatment and sputum‐smear or sputum‐culture negative) at six and 12 months.
primary outcome:
Acupuncture and related interventions for symptoms of chronic kidney disease
Change in pain (e.g. bone and joint pain, neuropathic pain, headache or other types of bodily pain perceived by patients) measured as a dichotomous outcome (e.g. improvement: yes or no) or on a self‐rating scale such as the visual analogue scale (VAS), a numerical rating scale or other questionnaire scoresChange in depression symptomatology measured as a dichotomous outcome (e.g. improvement: yes or no), on a self‐rating scale such as the Beck Depression Inventory (Beck 1961), or on a clinician‐rated scale such as the Hamilton Rating Scale for Depression (Hamilton 1960).Beck Depression Inventory: minimal depression (0‐13); mild depression (14‐19); moderate depression (20‐28); severe depression (29‐63)Hamilton Rating Scale for Depression: normal (0‐7); mild depression (8‐13); moderate depression (14‐18); severe depression (18‐22); very severe depression (≥ 23)The occurrence of serious adverse events, including hospitalisation, surgery other than scheduled transplantation, and death.
primary outcome:
Acupuncture for the prevention of episodic migraine
The primary efficacy outcome of our systematic review was headache frequency at completion of treatment and at follow‐up. The primary safety/acceptability outcomes were the number of participants dropping out due to adverse effects and the number of participants reporting at least one adverse event or effect (see Measures of treatment effect for details).
primary outcome:
Tai Chi for chronic obstructive pulmonary disease (COPD)
Level of dyspnoea: All measures related to dyspnoea were considered (e.g. Borg Scale, Modified Medical Research Council (MMRC) Dyspnoea Scale, Dyspnoea Visual Analogue Scale (DVAS)).Functional capacity or aerobic capacity: Both clinical and field tests were included (e.g. distance walked in six‐minute walk test (6MWT) or incremental shuttle walk test (ISWT), or volume of oxygen (VO2) consumption measured during exercise testing).
primary outcome:
Hypnosis for pain management during labour and childbirth
Use of pharmacological pain relief or anaesthesia at any time during labour and childbirth (as defined by trialists)Satisfaction with pain relief (as defined by trialists)Sense of coping with labour (as defined by trialists)Spontaneous vaginal birth
primary outcome:
Yoga for asthma
Self reported quality of life measured by validated questionnaires (e.g. Asthma Quality of Life Questionnaire (AQLQ))Self reported symptom scores (e.g. asthma symptom scale)
primary outcome:
Acupuncture for the prevention of tension‐type headache
Response (at least 50% reduction of headache frequency) after completion of treatment (three to four months after randomisation).
primary outcome:
Glutamine supplementation to prevent morbidity and mortality in preterm infants
Death prior to hospital discharge.Neurodevelopment:Neurodevelopmental outcomes assessed using validated tools at ≥ 12 months post term.Classifications of disability, including non‐ambulant cerebral palsy, developmental delay and auditory and visual impairment.Cognitive and educational outcomes at ≥ 5 years: intelligence quotient and indices of educational achievement measured using a validated tool (including school examination results).
primary outcome:
Omega‐3 fatty acids for the treatment of dementia
Changes in global and specific cognitive function measured by validated tools such as:Alzheimer's Disease Assessment Scale ‐ Cognitive subscale (ADAS‐Cog) (Rosen 1984);Mini‐Mental State Examination (MMSE) (Folstein 1975);Rey Auditory Verbal Learning Test (RAVLT) (Schmidt 1996);Wechsler Memory Scale (Wechsler 2010).Changes in functional outcomes (e.g. activities of daily living (ADL)) measured by validated tools such as:Alzheimer's Disease Cooperative Study ‐ Activities of Daily Living (ADCS‐ADL) (Galasko 1997);Gottries‐Brane‐Steen‐Skala, ADL subscale (GBS‐ADL) (Bråne 2001).Overall dementia severity measured by validated tools such as:Clinical Dementia Rating ‐ Sum of Boxes (CDR‐SOB) (O'Bryant 2008),Alzheimer's Disease Cooperative Study ‐ Clinical Global Impression of Change (CIBIC‐Plus) (Schneider 1997).Adverse effects of the intervention such as:gastrointestinal effects;dermatological effects;taste disturbance;infection.
primary outcome:
Padma 28 for intermittent claudication
Pain‐free walking distance (PFWD) or the initial claudication distance (ICD), which is the distance walked on a treadmill before the onset of pain.Maximum walking distance (MWD) or total walking distance (TWD) or the absolute claudication distance (ACD), which is the maximum or absolute distance walked on a treadmill.
primary outcome:
Melatonin for women in pregnancy for neuroprotection of the fetus
Primary outcomes were chosen to be most representative of the clinically important measures of effectiveness and safety, including serious outcomes and adverse effects.
primary outcome:
Vitamin A supplementation for postpartum women
We reviewed most outcomes for up to 12 months postpartum, with the exception of adverse effects close to the time of vitamin supplementation.
primary outcome:
Dietary advice for people with schizophrenia
We selected the following main outcomes for inclusion in this review.
primary outcome:
Dietary supplements for dysmenorrhoea
Pain (measured either by a visual analogue scale (VAS), other validated scales, or as a dichotomous outcomes);adverse effects from treatment (incidence and duration of side effects and types of side effects).
primary outcome:
Blood pressure lowering efficacy of coenzyme Q10 for primary hypertension
Change in systolic and diastolic blood pressure from baseline, or difference in endpoint (end‐of‐treatment) systolic and diastolic blood pressure. Both were considered acceptable outcomes, but if possible, end‐of‐treatment SBP and DBP values were preferred over change in baseline results. If blood pressure measurements were available at more than one time within the acceptable window, the means of blood pressures taken in the 3 to 12 week range were used.
primary outcome:
Puerarin for ischaemic stroke
The primary outcome measure was death or dependency at the end of the scheduled follow‐up period. We defined dependency as severely dependent on others in activities of daily living, for example a Barthel Index score of 60 or less, or the Modified Rankin Scale graded 3 to 6 (Sulter 1999).
primary outcome:
Antioxidant treatments for schizophrenia
We grouped outcomes into immediate (four weeks or less), short‐term (4‐12 weeks), medium‐term (13‐26 weeks) and long‐term (over 26 weeks).
primary outcome:
Chinese herbal medicines for unexplained recurrent miscarriage
Pregnancy rate.Live birth rate.Maternal adverse effect and toxicity rate.Perinatal adverse effect and toxicity rate.
primary outcome:
Normobaric and hyperbaric oxygen therapy for the treatment and prevention of migraine and cluster headache
We anticipated that short‐term response would be of greatest clinical importance. Primary outcome assessments were generally made during or immediately following therapy.For outcomes relating to headache intensity, we preferred those that measured headache relief or change in headache intensity, since these are more comparable among participants with different baseline scores. The outcomes we considered eligible for inclusion in this review were:
primary outcome:
Interventions for central serous chorioretinopathy: a network meta‐analysis
Mean change in BCVA of CSC eyes from baseline (before treatment) to 12 months, measured by a LogMAR (logarithm of the minimal angle of resolution) chart or equivalent.
primary outcome:
Stimulation of the wrist acupuncture point PC6 for preventing postoperative nausea and vomiting
Incidence of postoperative nausea.Incidence of postoperative vomiting, defined as either retching or vomiting, or both.
primary outcome:
Ozone therapy for treating foot ulcers in people with diabetes
Time taken to achieve complete ulcer healing.Number of ulcers healed.Change in area of ulcer.
primary outcome:
Vitamin A supplementation during pregnancy for maternal and newborn outcomes
Maternal mortality (defined as the death of a woman while pregnant or within 42 days of termination of pregnancy, irrespective of the duration and site of the pregnancy, from any cause related to, or aggravated by, the pregnancy or its management but not from accidental or incidental causes (ICD‐10 2007)).Perinatal mortality (defined as number of stillbirths and deaths in the first week of life per 1000 live births (HAP 2008; PNM 2005)).
primary outcome:
Yoga versus standard care for schizophrenia
If possible, we proposed to divide all outcomes into short term (less than 6 months), medium term (7 to 12 months), and long term (over 1 year).
primary outcome:
Cordyceps sinensis (a traditional Chinese medicine) for kidney transplant recipients
All‐cause mortalityIncidence of graft failure (defined as creatinine clearance/glomerular filtration rate (CrCl/GFR) < 15 mL/min or need for dialysis)Incidence of acute rejection (biopsy proven/clinical suspicion)Incidence and degree of chronic allograft injury (biopsy proven/clinical suspicion).
primary outcome:
Interventions for preventing and treating low‐back and pelvic pain during pregnancy
Pain intensity (pain levels).Back‐ or pelvic‐related functional disability/functional status (ability to perform daily activities).Days off work/sick leave.Adverse effects for women and infants; as defined by trialist.
primary outcome:
Vitamin C supplementation in pregnancy
No clear differences were seen between women supplemented with vitamin C, either alone or in combination with other supplements compared with placebo or no control for the risk of stillbirth (risk ratio (RR) 1.15, 95% confidence intervals (CI) 0.89 to 1.49; 20,038 participants; 11 studies; I² = 0%) (Analysis 1.1), neonatal death (RR 0.79, 95% CI 0.58 to 1.08; 19,575 participants; 11 studies; I² = 0%) (Analysis 1.2), or intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06; 20,361 participants; 12 studies; I² = 15%) (Analysis 1.4), when using a fixed‐effect model. Substantial heterogeneity was found for perinatal death, preterm birth, preterm and term prelabour rupture of fetal membranes (PROM), and clinical pre‐eclampsia. No clear difference was found between women supplemented with vitamin C alone or in combination with other supplements compared with placebo or no control for the risk of perinatal death (average RR 1.07, 95% CI 0.77 to 1.49; 17,271 participants; seven studies; I² = 35%) (Analysis 1.3), preterm birth (average RR 0.99, 95% CI 0.90 to 1.10; 22,250 participants; 16 studies; I² = 49%) (Analysis 1.5), preterm PROM (average RR 0.98, 95% CI 0.70 to 1.36; 16,825 participants; 10 studies; I² = 70%) (Analysis 1.6), term PROM (average RR 1.23, 95% CI 0.61 to 2.47; 3230 participants; three studies; I² = 86%) (Analysis 1.7), or clinical pre‐eclampsia (average RR 0.92, 95% CI 0.80 to 1.05; 21,956 participants; 16 studies; I² = 41%) (Analysis 1.8), when using a random‐effects model.
primary outcome:
Nut consumption for the primary prevention of cardiovascular disease
Cardiovascular mortality.All‐cause mortality.Non‐fatal endpoints such as MI, CABG, PCI, angina or angiographically defined CHD, stroke, carotid endarterectomy and peripheral arterial disease (PAD).
primary outcome:
Vitamin K for the primary prevention of cardiovascular disease
Cardiovascular mortality.All‐cause mortality.Non‐fatal endpoints such as MI, hospitalisation due to coronary revascularisation (CABG or PTCA), unstable angina and any type of stroke.
primary outcome:
Interventions for nausea and vomiting in early pregnancy
Symptomatic relief (specifically a reduction or cessation in nausea, retching and/or vomiting).Adverse maternal and fetal/neonatal outcomes.Adverse maternal outcomes included pregnancy complications (antepartum haemorrhage, hypertension, pre‐eclampsia).Adverse fetal/neonatal outcomes included fetal or neonatal death, congenital abnormalities, low birthweight or early preterm birth.
primary outcome:
Vitamin E supplementation in pregnancy
No clear difference was found between women supplemented with vitamin E in combination with other supplements compared with placebo for the risk of stillbirth (risk ratio (RR) 1.17, 95% confidence intervals (CI) 0.88 to 1.56, nine trials, 19,023 participants, Analysis 1.1), neonatal death (RR 0.81, 95% CI 0.58 to 1.13, nine trials, 18,617 participants, Analysis 1.2), infant death (RR 3.02, 95% CI 0.12 to 74.12, one trial, 2694 participants, Analysis 1.4) or infant hyperbilirubinaemia (RR 0.78, 95% CI 0.59 to 1.04, one trial, 725 participants, Analysis 1.7), using fixed‐effect models. Substantial heterogeneity was detected for perinatal death (I² = 43%). When using a random‐effects model, there was no clear difference in the risk of perinatal death between treatment groups (average RR 1.09, 95% CI 0.77 to 1.54,six trials, 16,923 participants, Analysis 1.3). No trials reported the outcomes haemolytic anaemia, reticulocytosis or maternal or infant haemoglobin concentrations.Substantial heterogeneity was identified for the outcomes preterm birth (I² = 52%) and clinical pre‐eclampsia (I² = 48%). When using a random‐effects model, no clear difference was found between women supplemented with vitamin E in combination with other supplements compared with placebo or no control for the risk of preterm birth (average RR 0.98, 95% CI 0.88 to 1.09, 11 trials, 20,565 participants, Analysis 1.9) or clinical pre‐eclampsia (average RR 0.91, 95% CI 0.79 to 1.06, 14 trials, 20,878 participants, Analysis 1.10). The funnel plot of preterm birth did not show any publication bias, however, the plot for clinical pre‐eclampsia was visually asymmetric (Figure 3, Figure 4, respectively).No clear difference was found for the risk of intrauterine growth restriction (RR 0.98, 95% CI 0.91 to 1.06, 11 trials, 20,202 participants, Analysis 1.11) between women supplemented with vitamin E in combination with other supplements compared with placebo or no control. Substantial heterogeneity was detected for birthweight (I² = 68%). When using a random‐effects model, there was no clear difference between women supplemented with vitamin E in combination with other supplements compared with placebo or no control for birthweight (mean difference (MD) 22.17, 95% CI ‐23.01 to 67.36, 10 trials, 16,888 participants, Analysis 1.12). The funnel plots for intrauterine growth restriction did not show any publication bias (Figure 5).
primary outcome:
Electromagnetic therapy for treating pressure ulcers
proportion of ulcers healed within trial period;rate of change in ulcer area; andtime to complete healing.
primary outcome:
Massage for low‐back pain
Short‐term: when the outcome assessment was taken ≤ six months after randomization.Long‐term: when the outcome assessment was taken > six months after randomization. We also extracted data regarding adverse effects and complications related to massage.
primary outcome:
Transcranial magnetic stimulation (TMS) for schizophrenia
We classified outcomes in the eight categories detailed below:
primary outcome:
Alginate dressings for venous leg ulcers
time to complete wound healing (correctly analysed using censored data and preferably with adjustment for prognostic covariates such as baseline size);the proportion of ulcers healed during follow‐up (frequency of complete healing);and change (and rate of change) in wound size, with adjustment for baseline size.
primary outcome:
Transcutaneous electrical nerve stimulation (TENS) for phantom pain and stump pain following amputation in adults
Patient‐reported pain using standard subjective validated scales (e.g. visual analogue scales (VAS) or numerical rating scales (NRS)).
primary outcome:
Effects of total fat intake on body weight
The main outcomes were measures of body fatness, including body weight, body mass index, waist circumference, skinfold thickness or percentage fat. Studies had to report at least one of these measures, or a change in these measures, to be included in the review.
primary outcome:
Selenium supplementation for critically ill adults
Overall mortality (longest follow‐up, regardless of the period of follow‐up).Mortality by duration (studies reporting mortality for 28 and 90 days).
primary outcome:
Hyperbaric oxygen therapy for acute coronary syndrome
Death rate at any time following presentation;Rate of Major Adverse Cardiac Events (MACE), this includes death, recurrent MI, urgent revascularization (CABG or PTCA).Risk of death (time of outcome was determined by trial data). The RR for survival with HBOT was established using the intention to treat data of the HBOT versus the control group. Where there were withdrawals without an indication as to group allocation, we divided them in the proportions intended by randomisation. Analyses were performed with RevMan 5.0.23 software. As an estimate of the statistical significance of a difference between experimental interventions and control interventions we calculated RR, with 95% confidence intervals (CI), for survival using HBOT. A statistically significant difference between experimental intervention and control intervention was assumed if the 95% CI of the RR did not include the value 1.0. As an estimate of the clinical relevance of any difference between experimental intervention and control intervention we calculated the number‐needed‐to‐treat (NNT) with 95% CI as appropriate;Risk of suffering Major Adverse Cardiac Event (MACE ‐ includes death, recurrent MI and urgent revascularization (CABG or PTCA)). The RR for MACE with and without HBOT was calculated using the methods described in (1) above;
primary outcome:
Oral zinc for the prevention of hyperbilirubinaemia in neonates
for term and near‐term neonates (neonates ≥ 35 weeks' gestation): STB level that would qualify for phototherapy requirement as described in American Academy of Pediatrics 2004's guidelines or absolute STB level ≥ 15 mg/dL;for preterm neonates (< 35 weeks' gestation): STB level > 1% of body weight.)
primary outcome:
Supplementation with long chain polyunsaturated fatty acids (LCPUFA) to breastfeeding mothers for improving child growth and development
Child neurodevelopment outcomes measured by different scales (e.g. Bayley scale, including the Mental Development Index (MDI) and Psychomotor Development Index (PDI); Gesell scale for gross motor development (Infant Planning Test); or as specified in the original trial reports).For this outcome, we considered eight areas of neurodevelopment: language development, intelligence or problem‐solving ability, psychomotor development, motor development, general movements, child attention, working memory and inhibitory control, and neurological optimality score. The concept of general movements was described in Hadders‐Algra 2010.

For the pooled analysis of these studies, where there was evidence of heterogeneity, we performed a random‐effects model meta‐analysis and expressed the result as standardised mean difference (SMD), because different instruments were used to measure the outcomes among the retrieved studies.
primary outcome:
Capsaicin for non‐allergic rhinitis
Overall symptom score (e.g. global symptom scores, daily record chart score)Individual symptom scores (e.g. nasal congestion, rhinorrhoea, sneezing, nasal itching), measured by visual analogue scale (VAS)Adverse events
primary outcome:
Pilates for low back pain
Pain intensity measured by any reliable and valid self report outcome measure.Disability measured by any reliable and valid self report outcome measure.Global impression of recovery measured by any reliable and valid type of Global Perceived Effect Scale.Quality of life (measured by any reliable and valid instrument).
primary outcome:
Electromagnetic therapy for treating venous leg ulcers
Proportion of ulcers healed within trial periodRate of change in ulcer areaTime to complete healing
primary outcome:
Massage therapy for preventing pressure ulcers
The proportion of people developing a new pressure ulcer of any grade at any point during the study (pressure ulcers are defined as a localised injury to the skin, underlying tissue, or both, usually over a bony prominence) (EPUAP/NPUAP 2009; Moore 2014).
primary outcome:
Transcutaneous electrical nerve stimulation for acute pain
Standard subjective scales for pain intensity, pain relief or both (e.g. visual analogue scales (VAS), numerical rating scales (NRS); verbal rating scales (VRS) McGill Pain Questionnaire (MPQ)).
primary outcome:
Qigong for the primary prevention of cardiovascular disease
Cardiovascular mortality.All‐cause mortality.Non‐fatal endpoints such as MI, CABG, PTCA, angina, angiographically defined CHD, stroke, carotid endarterectomy or peripheral arterial disease (PAD).
primary outcome:
Vitamin K for upper gastrointestinal bleeding in people with acute or chronic liver diseases
Mortality.Early re‐bleeding.Serious adverse events. We used the International Conference on Harmonisation (ICH) Guidelines for Good Clinical Practice's definition of a serious adverse event (ICH‐GCP 1997), that is, any untoward medical occurrence that resulted in death, was life threatening, required hospitalisation or prolongation of existing hospitalisation, resulted in persistent or significant disability or incapacity, or was a congenital anomaly or birth defect. We considered all other adverse events as non‐serious.
primary outcome:
Chinese herbal medicine for treating recurrent urinary tract infections in women
Reduction in both symptomatic episodes, including urinary frequency, urgency, dysuria or haematuria, and bacteriologically‐confirmed episodes of UTI during the studyRates of relapse within 12 months of completing the study.
primary outcome:
Zinc supplementation for the prevention of type 2 diabetes mellitus in adults with insulin resistance
Incidence of type 2 diabetes mellitus.Adverse events.
primary outcome:
Oral protein calorie supplementation for children with chronic disease
Change in nutritional indicesweightheightbody mass indexz scoreother indices of nutrition (including blood biochemistry if appropriate) or growth, including anthropometric measures of body compositionCalorie and nutritional intake from food measured by diet diary or weighed food intake daily, weekly or over some other time intervaltotal energy intaketotal fat intaketotal protein intakeCalorie and nutritional intake from oral protein calorie supplements measured by diet diary or weighed food intake daily, weekly or over some other time intervaltotal energy intaketotal fat intaketotal protein intake
primary outcome:
Alginate dressings for treating pressure ulcers
Time to complete wound healing (correctly analysed using censored data and preferably adjusted for prognostic co‐variates such as baseline size). We considered mean or median time to healing without survival analysis as a valid outcome only if reports specified that all wounds healed (i.e. if the trial authors regarded time to healing as a continuous measure, as there is no censoring).Proportion of ulcers healed during follow‐up (frequency of complete healing).
primary outcome:
Tong‐xin‐luo capsule for patients with coronary heart disease after percutaneous coronary intervention
Occurrence of angiographic restenosisAdverse events
primary outcome:
L‐acetylcarnitine for treating fragile X syndrome
Psychological and learning capabilities (assessed through validated tools such as Stanford‐Binet, Leiter, or Wechsler intelligence (IQ) tests, or Peabody Picture Vocabulary Test ‐ Revised).*Behaviour or social performance (assessed through validated questionnaires such as Autistic Descriptors Checklist, Autism Behaviour Checklist, Childhood Autism Rating Scale, or Conners’ Parent and Teaching Rating Scales, and activities of daily living (assessed through validated scales such as Katz Index of Independence in Activities of Daily Living or Lawton Instrumental Activities of Daily Living).*Adverse effects (i.e. safety)Number of participants reporting severe adverse side effects.*Number of participants leaving the study early due to side effects.
primary outcome:
Chelation for autism spectrum disorder (ASD)
Changes in the following core symptoms of ASD, using any measure (e.g. the Aberrant Behavior Checklist (ABC), CARS), as assessed separately.Social interaction.Communication.Stereotypy.Adverse events.
primary outcome:
Vitamin D for the treatment of chronic painful conditions in adults
Number of participants with at least 50% pain relief.Number of participants reporting a global impression of change of "much" or "very much" improvement.Number of participants with undefined (any) improvement in pain.
primary outcome:
Saline nasal irrigation for acute upper respiratory tract infections
Change in severity of acute URTI‐related symptoms (for example, nasal discharge, congestion, sneezing, headache, sore throat) over periods up to 28 days.Time to resolution of symptomatic illness.
primary outcome:
Feverfew for preventing migraine
Frequency of migraine attacks
primary outcome:
Chinese medicinal herbs for mumps
Mortality caused by secondary complications during treatment.
primary outcome:
Exercise programs for people with dementia
The primary outcomes concerned the person with dementia, and included: cognition, ADLs, neuropsychiatric symptoms (e.g. agitation, aggression), depression, and mortality.
primary outcome:
Omega 3 fatty acids for preventing or slowing the progression of age‐related macular degeneration
risk of developing incident AMD or new visual loss attributed to AMD; andrisk of progression of AMD in people previously diagnosed with the disease.
primary outcome:
Reiki for depression and anxiety
The primary outcome measure in this review is the relief of symptoms, usually measured using rating scales. Depression is measured using self‐rating scales such as the Beck Depression Inventory (BDI) (Beck 1961); or clinician‐rated scales, such as the Hamilton Rating Scale for Depression (HRSD) (Hamilton 1960). Anxiety is measured using a self‐rating scale such as the Spielberger State‐Trait Anxiety Inventory (STAI) (Spielberger 1983).The primary adverse event outcome is the acceptability of the treatments, measured by the dropout rates.
primary outcome:
Xylitol‐containing products for preventing dental caries in children and adults
Change in dental caries increment (dental caries is defined as clinical or radiographic lesions or both recorded at the dentine level), determined by change from baseline in the following: decayed‐filled teeth/surfaces (DFT/DFS) or decayed‐missing‐filled teeth/surfaces (DMFT/DMFS) for permanent teeth; or dmfs/d(e)fs and dmft/d(e)ft for deciduous teeth (where the 'e' indicates an extracted tooth). Data on permanent and deciduous teeth were to be analysed separately. The summary statistics for the indices were those for all permanent and deciduous teeth erupted at the start and erupting over the course of the study.Number of participants with and without dental caries increment.
primary outcome:
Honey as a topical treatment for wounds
Time to complete wound healing;proportion of participants with completely healed wounds.
primary outcome:
Muscle energy technique for non‐specific low‐back pain
Pain measured by a visual analogue scale (VAS), number rating scale (NRS) or McGill Pain QuestionaireResults of functional disability questionnaires (Roland‐Morris Disability Questionnaire (RMDQ), Oswestry Disability Index (ODI) or another valid instrument)If available, scales of general well‐being (e.g., quality of life measured with the Short Form‐36 (SF‐36), SF‐12 or EuroQuol)
primary outcome:
Morita therapy for anxiety disorders in adults
1. Global state ‐ clinical response. Criteria of response was scored using the Clinical Global Impression (CGI) scale (Guy 1976), a widely used global outcome measure, or defined by individual studies.2. Acceptability: drop‐outs for any reason as proxy measure of total acceptability.
primary outcome:
Dance movement therapy for depression
Level of depression, as measured through a valid and reliable scale or self‐rated measurement such as, but not limited to: the Beck Depression Inventory (Beck 1961); the Symptom Check List‐90‐Revision (SCL‐90‐R) (Derogatis 1977); or a clinician‐rated scale such as the Hamilton Rating Scale for Depression (HAM‐D) (Hamilton 1960). Continuous outcomes of depression improvement were used; we also planned to analyse outcomes which the trialist had dichotomised. We referred to the literature on the standardised measure used in order to determine what was a Minimal Clinically Important Difference (MCID) between baseline and post‐treatment score.We also planned to report drop‐out rates, where available, as a measure of treatment acceptability (high drop‐out rates being seen as a measure of potential harm because they suggest unacceptability).Level of depression
primary outcome:
Ganoderma lucidum mushroom for the treatment of cardiovascular risk factors
Blood glucose level (for example, fasting blood glucose/glycosylated haemoglobin (HbA1c)/postprandial glucose test).Blood pressure (systolic/diastolic/mean blood pressure).Lipid profile (total triglycerides, total cholesterol, high density lipoprotein cholesterol, low density lipoprotein cholesterol, very low density lipoprotein cholesterol).Prevalence of any of the above.
primary outcome:
Chinese herbal medicines for hypothyroidism
Hypothyroidism‐related symptoms.Serum thyroid hormone levels.Adverse events.
primary outcome:
Acupuncture for mumps in children
Swelling and pain in the parotid gland area.Time until the body temperature returns to normal.Number of days absent from school.
primary outcome:
Homeopathic Oscillococcinum® for preventing and treating influenza and influenza‐like illness
Occurrence of influenza (either symptomatic or laboratory‐confirmed)Patient‐reported absence of influenza symptoms at 48 hours
primary outcome:
Complementary therapies for acne vulgaris
Improvement of clinical signs assessed through skin lesion counts (total of inflamed and non‐inflamed counted separately) and acne severity scores.Adverse effects assessed by reporting early study discontinuations, the worsening of acne in participants, and other adverse events during the treatment and follow‐up period.
primary outcome:
Vitamin B and its derivatives for diabetic kidney disease
All‐cause mortalityCardiovascular mortality.
primary outcome:
Mailuoning for acute ischaemic stroke
Death or dependency at the end of long‐term follow‐up or the scheduled follow‐up. We defined dependency as dependent on others in activities of daily living ‐ for example, the Barthel Index score of 60 or less, the modified Rankin Scale graded 3 to 5 (Sulter 1999), or the trialist's own definition.
primary outcome:
Immunonutrition as an adjuvant therapy for burns
All‐cause mortality.
primary outcome:
Creatine for women in pregnancy for neuroprotection of the fetus
We chose primary outcomes that were felt to be most representative of the clinically important measures of effectiveness and safety, including serious outcomes and adverse effects.