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. 2023 Mar 28;2023(3):CD006127. doi: 10.1002/14651858.CD006127.pub3

Rachmani 2002.

Study characteristics
Methods Study design: parallel‐group RCT
Unit of randomization and analysis: individual
Number randomized:

  • Total: 141

  • Per group: 71 intensive, 70 standard


Sample size calculation: type I error = 0.05, 0.80 power, 5% difference in GFR or 20 difference in ACR between groups yielded 45 participants per group
Participants Country: Israel
Study period: 1995 to 2000?
Type of diabetes: type 2
Participants' status at baseline:

  • Age, years, mean (SD): 57.4 (4.2) intensive, 56.8 (4.0) standard, 57.1 overall

  • Gender, % women: 49% intensive, 53% standard, 51% overall

  • Race/ethnicity: not reported

  • Duration of diabetes, years, mean (SD): 6.2 (2.5) intensive, 6.3 (1.0) standard, 6.2 overall

  • Smokers, % current: 0%

  • Blood pressure, mean (SD):

    • SBP 162 (7.3) mmHg intensive, 160 (6.9) mmHg standard, 161 mmHg overall

    • DBP 96 (2.4) mmHg intensive, 95 (2.0) mmHg standard, 96 mmHg overall

  • Hypertension, %: 100% (> 150/90 mmHg for eligibility)

  • Glycated hemoglobin, mean (SD): 9.5 (1.6) intensive, 9.6 (1.9) standard

  • BMI, mean (SD): 28.4 (2.4) intensive, 28.7 (2.3) standard, 28.6 overall

  • Severity of retinopathy: any DR 15.5% intensive, 14.3% standard, 14.9% overall

  • Medical history:

    • Myocardial infarction, %: 0%

    • Stroke, %: 0%


Equivalence of groups a baseline: well balanced
Inclusion criteria: type 2 diabetes mellitus, hypertension, and hyperlipidemia
Exclusion criteria: age < 45 or > 70 years, smoking, duration of diabetes > 10 years, BMI > 35, serum creatinine > 2 mg/dL, ACR ≥ 200 mg/g, history of stroke, acute MI, unstable angina, vascular surgery, malignance, liver disease, autoimmune disease, life‐threatening condition, life expectancy < 5 years
Interventions Intervention 1: intensive: patient participation program (supported self‐management): measurement of seated BP at 9 a.m. daily (given portable mercury manometer); education, targets for BP (≤ 130/85 mmHg), glycated hemoglobin (≤ 7.0), BMI (< 25 men, < 24 women), lipids, exercise, medication compliance
Intervention 2: standard: explanation to participant of problems related to diabetes, letter for primary care physician with examination and laboratory findings
Length of follow‐up:

  • Planned:  4 years

  • Actual:  4 years
Outcomes Primary outcome, as specified for this review: incidence of DR
Secondary outcome(s), as specified for this review: progression to PDR
Other diabetic retinopathy outcomes: none
Retinopathy diagnosis and monitoring: "The data available at each visit included ... a written report of funduscopy by an ophthalmologist."
Participants (eyes) examined for outcomes: 129
Intervals at which outcomes were assessed: annually
Cost of interventions: not reported; intensive group of participants averaged 2 extra visits per year, 486 total for group
Quality of life: not reported
Adverse outcomes: death
Other outcomes reported from the study: changes in kidney function parameters, BP, glycated hemoglobin, lipid levels
Notes Source of funding: not reported
Declaration(s) of interest: not reported
Run‐in length: not applicable
Class(es) of antihypertensive agents assigned: none (by end of study. 100% of intensive group on ACEi or ARB and 97% on hydrochlorothiazide vs 54% and 37% in standard care group)
Degree of blood pressure control achieved: at 4 years, intensive group BP 142 (5.8)/84 (1.8), standard group 148 (6.1)/88 (1.7), i.e. decrease of 20/12 mmHg from baseline in intensive group, 12/8 mmHg in standard group
Trial registration: not reported or found
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk "The randomization was carried out on a 1:1 basis by using a table of random numbers."
Allocation concealment (selection bias) Unclear risk No information given.
Masking (performance bias and detection bias)
Primary outcomes Unclear risk Personal primary care physicians were masked, but study personnel and participants were not. No information about masking of non‐study ophthalmologist who performed fundoscopy
Masking (performance bias and detection bias)
Secondary outcomes Unclear risk Same rationale as for primary outcome
Incomplete outcome data (attrition bias)
Primary outcome Unclear risk 13 (9.2%) of 141 participants enrolled missed 1 or more of 4 annual examinations and were excluded from analysis of outcomes.
Incomplete outcome data (attrition bias)
Secondary outcomes Unclear risk Same as for primary outcome
Selective reporting (reporting bias) Low risk No protocol or registry record available; all outcomes mentioned were reported.