3. Adverse effects in the included studies.
Study number | Study name | Intervention | Adverse effects |
1 | AMDSG 1996 | Multivitamin (Ocuguard) | One person developed an "allergic reaction", although it was not clear whether or not this was related to the treatment. |
2 | AREDS 2001 | Multivitamin and zinc | Over 100 comparisons of zinc versus no zinc and antioxidants versus no antioxidants. Participants in the antioxidant arms more frequently reported yellow skin (8.3% versus 6.0%, P = 0.008). No important effect on mortality associated with multivitamin use (hazard ratio for mortality 0.87, 95% CI 0.60 to 1.25). Participants in the zinc arms reported more anaemia (13.2% versus 10.2%, P = 0.004), however, serum haematocrit levels were the same. They found that participants taking zinc had a lower mortality. Later follow‐up of the cohort of people taking part in the AREDS study found that there was a significant increase in hospital admissions due to genitourinary diseases in people taking zinc supplements (11.1% versus 7.6%, P = 0.0003). |
3 | AREDS2 2013 | Lutein and zeaxanthin | Quote "No clinically or statistically significant differences in reported serious adverse events, including rates of development of neoplasms, were noted across the treatment groups in the primary randomization. However, secondary randomization excluding participants who were smokers showed more lung cancers in the beta carotene group than in the no beta carotene group (23 [2.0%] vs 11 [0.9%]) (nominal P=.04)." and "Rates of reported gastrointestinal disorders and hospitalizations for genitourinary diseases were similar in the 2 randomly assigned groups (high‐dose zinc, low‐dose zinc) in AREDS2" "The HR for mortality comparing lutein zeaxanthin vs no lutein zeaxanthin was 1.06 (95% CI, 0.87‐1.31;P=.56) for lutein zeaxanthin vs no lutein zeaxanthin" |
4 | Bartlett 2007 | Multivitamin | "There were no reported adverse effects from any of the study participants." |
5 | Berrow 2013 | Multivitamin (Ocuvite) | Did not report adverse effects. |
6 | CARMA 2013 | Multivitamin (Ocuvite) | Did not report adverse effects. |
7 | CARMIS 2011 | Multivitamin | Quote "There were no significant systemic or ocular adverse events related to the nutritional supplementation." |
8 | CLEAR 2013 | Lutein | 3/42 in the lutein group and 1/42 in the placebo group "discontinued due to medical reasons", but it was unclear if these were complications, per se. |
9 | France 1998 | Zinc | Unpublished study, no data available. |
10 | Holz 1993 | Zinc | Quote "the zinc therapy was well‐tolerated". |
11 | Kaiser 1995 | Multivitamin | Did not report adverse effects. |
12 | LISA 2011 | Lutein (Lutamax) | Quote "In two subjects, the withdrawal was due to serious adverse events. One subject had a myocardial infarction, and the other subject developed CNV in the study eye." |
13 | Ma 2012 | Lutein and zeaxanthin | Quote "No adverse events were observed or reported." and "No significant adverse events or changes in biochemical or hematologic profiles were observed or reported in any subject throughout the study. No subject developed or reported occasional skin pigmentation (carotenodermia)." |
14 | Newsome 1988 | Zinc | Did not report adverse effects. |
15 | Newsome 2008 | Zinc mono‐cysteine | Quote "ZMC (zinc mono‐cysteine) appeared to be well tolerated"; 1/40 had gastrointestinal symptoms attributable to treatment. |
16 | Stur 1996 | Zinc | 4/56 in the zinc‐treated group and 2/56 in the placebo group withdrew because of gastrointestinal symptoms. |
17 | VECAT 2002 | Vitamin E | 11 in the vitamin E and 7 in the control group died; 16 in the vitamin E group and 17 in the control group had an adverse reaction. |
18 | Veterans LAST study 2004 | Multivtamin (OcuPower) and lutein (FloraGlo) | The number of adverse effects were tabulated, but the study was underpowered to detect any differences. |
19 | Wang 2004 | Multivitamin and zinc | Did not report adverse effects. |