Review Article

Systematic Review of Randomized Clinical Trials on Safety and Efficacy of Pharmacological and Nonpharmacological Treatments for Retinitis Pigmentosa

Table 3

Summary of results of the randomized clinical trials included in the systematic review.

StudyBCVAVisual fieldContrast
sensitivity
ERGDark adaptometryNumber of adverse events per group (experimental/control)

Chatzinoff et al. 1968 [28]No differencesNo differencesNANANo differencesNA

Newsome et al. 1987 [32]NANo differences
(Goldman perimetry)
NANot recordable in most patientsNA3 minor AEs

Berson et al. 1993 [8] and Sibulesky et al. 1999 [33]No differences (ETDRS)No differences
(Goldman perimetry)
NASlower rate of decline in vitamin A and vitamin A + E groups, faster decline in vitamin E group (30 Hz ERG)NA4 severe AEs (total), no differences between groups in minor and severe AE

Vingolo et al. 1998 [6]NANANAImprovement in maximal ERG amplitude recorded with low-noise method in HBO groupNANA

Berson et al. 2004 [27]No differences (ETDRS)No differences
(Humphrey visual field analyzer)
NANo differences (30 Hz ERG)NA1 severe AE in the placebo group

Berson et al. 2004a [26]No differences (ETDRS)Slower decline in no vitamin A prior to entry + DHA group
(Humphrey visual field analyzer)
NASlower decline in no vitamin A prior to entry + DHA group (30 Hz ERG)NA1 severe AE in the placebo group

Hoffman et al. 2004 [30] and Wheaton et al. 2003 [34]No differences (logMAR)No differences
(Humphrey visual field analyzer)
NANo differences (light-adapted cone 31 Hz, rod, or maximal ERG amplitudes)No differencesMinor AE in 4 patients in DHA and 6 in placebo groups.
No severe AE

Bahrami et al. 2006 [9] No differences (ETDRS)Positive effect on preserving VF
(Goldman perimetry)
No differencesNANAMinor AE, 1/2

Merin et al. 2008 [14]No differences (LogMar)No differences
(Goldman perimetry)
No differencesNANANo severe AE  
Allergic reaction in 3

Vingolo et al. 2008 [5]Slower decline in HBO group (Snellen chart)Higher percentage of stabilization of Goldmann perimetry-target I4 and HFA 10-2 visual fields in the HBO group versus control group NAStatistically significant improvement of ERG b-wave amplitude recorded with low-noise method in HBO group versus controlsNANA

Berson et al. 2010 [10]No differences (ETDRS)No differences
(Humphrey visual field analyzer)
NANo differences

Nakazawa et al. 2011 [13]NASlower progression of central VF in treatment group
(Humphrey visual field analyzer)
NANANANo severe AE

Rotenstreich et al. 2013 [11]No differences (ETDRS) No differences in dark- and light-adapted VF
(Goldmann perimetry)
NASignificant increase of dark- and light-adapted ERG b-wave amplitude in treatment group versus placeboNANo AE

Birch et al. 2013 [15]No differences (ETDRS)No differences with low dose; significant worsening in high dose versus sham
(Humphrey visual field analyzer)
NANo differences (30 Hz flicker and single-flash ERG)NALow dose: 5 ocular AEs
High dose: 37 ocular AEs (26 mioses)
No severe AE

Hoffman et al. 2014 [29]NANANANo differences (31 Hz flicker ERG)NA22/20 TEAEs
No severe AE

Hughbanks-Wheaton et al. 2014 [31] NANANANANA22/20 TEAEs
No severe AE
1 dropout due to gastrointestinal symptoms

Kumar et al. 2014 [12]Significant improvement in treatment groupNANASignificant improvement in treatment groupNA3 gastrointestinal symptoms
No severe AE

AE: Adverse event.
NA: Not assessed.
HBO: Hyperbaric oxygen therapy.