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selection\nOur primary search identified 2599 studies ( Figure 1). After the evaluation process, 109 studies were included in the final review 2, 4, 6– 9, 16– 118.\nFigure 1. PRISMA flow diagram.\n\nGastrointestinal reactions\nGastrointestinal adverse reactions were reported in 61 studies. Of these, 10 studies were randomized controlled trials 16, 30, 33, 55, 57, 59, 67, 79, 93, 95, 49 were cohort studies 2, 4, 7, 9, 18, 19, 23, 25– 27, 29, 35, 38– 43, 45, 46, 48, 50– 54, 58, 60, 66, 68, 69, 71, 73, 83, 85– 88, 90, 94, 97, 98, 101, 104, 105, 112, 113, 115, 118, and 2 were case series 84, 109. Most studies reported the number of patients experiencing an adverse reaction ( Table 1). Other studies reported adverse reactions observed in relation to the number of treatments given ( Table 2).\nTable 1. Gastrointestinal adverse reactions observed per number of patients.\nAdverse reaction Studies Total patients, n Patients with adverse reaction, n (%) (%, min-max) †\nNausea (overall incidence) [ 2, 18, 27, 33, 45, 46, 48, 53, 55, 57, 59, 60, 67, 84, 90, 93, 109, 118] 2214 257 (12) (2–41) [ 55] - [ 48]\n  Intravenous administration [ 18, 27, 33, 46, 48, 53, 59, 90, 118] 1154 199 (17) (2–41) [ 59] - [ 48]\n  Transdermal application [ 2, 45, 55, 57, 67, 93, 109] 1039 51 (5) (2–32) [ 55] - [ 2]\n  \u003e1 administration route [ 60, 84] 21 7 (33) (29–36) [ 84] - [ 60]\nVomiting (overall incidence) [ 2, 18, 27, 33, 46, 48, 55, 57, 59, 118] 1611 115 (7) (0–64) [ 55] - [ 48]\n  Intravenous administration [ 18, 27, 33, 46, 48, 59, 118] 972 108 (11) (2–64) [ 59] - [ 48]\n  Transdermal application [ 2, 55, 57] 639 7 (1) (0–6) [ 55] - [ 2]\nNausea and vomiting ‡ [ 7, 38, 41, 54, 66, 69, 73, 85, 87, 115] 4529 591 (13) (0–46) [ 66] - [ 73]\nAbdominal cramps/stomach ache (overall incidence) [ 18, 26, 27, 39, 41, 54, 55, 59, 73, 85, 87, 93, 115] 1629 88 (5) (1–52) [ 117] - [ 116]\n  Intravenous administration [ 18, 26, 27, 39, 41, 54, 59, 73, 85, 87, 115] 1253 72 (6) (1–52) [ 18] - [ 26]\n  Transdermal application [ 55, 93] 376 16 (4) (2–16) [ 55] - [ 93]\nHalitosis/garlic-like breath (overall incidence) [ 4, 9, 16, 19, 29, 30, 35, 42, 43, 45, 50, 52, 55, 57, 58, 66– 68, 79, 83, 85, 88, 94, 95, 97, 98, 109, 112, 113] 5782 607 (11) (0–100) [ 30] - [ 19, 43, 45, 83, 98]\n  Intravenous administration [ 16, 85, 94, 98] 239 14 (6) (1–100) [ 85] - [ 98]\n  Transdermal application [ 4, 19, 29, 30, 42, 45, 50, 52, 55, 57, 58, 66, 67, 79, 83, 88, 95, 109, 112, 113] 5333 556 (10) (0–100) [ 30] - [ 19, 45, 83]\n  Intravesical administration [ 35, 43, 97] 165 33 (20) (1–100) [ 35] - [ 43]\n  Oral administration [ 9] 15 4 (27)\nDiarrhea (overall incidence) [ 2, 18, 41, 54, 57, 85, 93] 1107 27 (2) (1–6) [ 85] - [ 93]\n  Intravenous administration [ 18, 41, 54, 85] 744 15 (2) (1–6) [ 85] - [ 41]\n  Transdermal application [ 2, 57, 93] 363 12 (3) (2–6) [ 57] - [ 93]\n†Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\n‡ Nausea and vomiting are reported as one combined adverse reaction in some studies.\nTable 2. Gastrointestinal adverse reactions observed per number of treatments.\nAdverse reaction Studies Total treatments, n Adverse reactions observed, n (%) (min%–max%) †\nNausea (overall incidence) [ 40, 51, 68, 84, 105] 474 161 (34) (16–57) [ 105] - [ 40]\n  Intravenous administration [ 40, 51, 68] 323 137 (42) (41–57) [ 68] - [ 40]\n  Intravesical administration [ 105] 151 24 (16)\nVomiting ‡ [ 51, 68] 316 112 (35) (29 - 71) [ 68] - [ 51]\nNausea and/or vomiting ‡ [ 25, 74, 101] 1557 220 (14) (8–17) [ 25] - [ 101]\nAbdominal cramps/stomach ache ‡ [ 51, 68, 101] 495 16 (5) (1–19) [ 68] - [ 51]\nHalitosis ‡ [ 68] 262 4 (2)\nDiarrhea ‡ [ 51, 101] 233 2 (1) (1–2) [ 101] - [ 51]\n† Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction.\n‡ Intravenous administration. The most commonly reported gastrointestinal adverse reactions were nausea and vomiting. The incidence of nausea seems to be less common with the transdermal administration of DMSO compared with intravenous administration. The majority of studies reported an incidence of nausea between 2–14%, with the exception of one study, reporting an incidence of 32% 2. In one study that failed to specify the dose, 8 of 42 patients reported nausea and anorexia, but the symptoms disappeared in five of the eight patients when the dose of DMSO was reduced 45.\nOften the studies had short follow-up periods (less than 24 hours), especially when DMSO was used as a cryoprotectant. The study reporting the highest incidence of nausea had a follow-up period of 5 days 48, and the authors concluded that the high incidence of nausea observed might be due to the long follow-up period 48. In another article using the same data 119, it was suggested that the delayed nausea was due to gastrointestinal mucosal damage, and only the initial nausea could be related to DMSO, and therefore we decided only to include the data from the first 2 days after infusion 48.\nHalitosis was reported in 29 studies 4, 9, 16, 19, 29, 30, 35, 42, 43, 45, 50, 52, 55, 57, 58, 66– 68, 79, 83, 85, 88, 94, 95, 97, 98, 109, 112, 113. In five studies, patients discontinued treatment due to halitosis 9, 45, 83, 94. In five studies, all patients experienced halitosis 9, 45, 83, 94. Unlike halitosis, other gastrointestinal side effects were reported more often when DMSO was administered intravenously, than transdermally or intravesically.\nOne study reported a severe case of nausea, vomiting, and abdominal cramps in one patient with an acute allergic reaction 59. However, in most studies the reported gastrointestinal reactions were transient and mild, often lasting only minutes to a couple of hours 16, 38, 41, 68, 85, 87, 90. Several studies reported a relationship between the dose of DMSO and the occurrence of gastrointestinal adverse reactions 26, 33, 53, 73, 83, 85.\n\nCardiovascular and respiratory reactions\nCardiovascular and respiratory adverse reactions were reported in 33 studies. Of these, two were randomized controlled trials 33, 59, 30 were cohort studies 7, 18, 23, 25– 27, 36, 39– 41, 51, 54, 61, 65, 66, 68, 73, 74, 80, 85– 87, 90, 100– 102, 104, 115, 117, and one was a preliminary report 91. Except for one study 66, all studies reporting cardiovascular and respiratory reactions administered DMSO intravenously ( Table 3 and Table 4).\nTable 3. Cardiovascular and respiratory adverse reactions observed per number of patients.\nAdverse reaction Studies Total patients, n Patients with adverse reactions, n (%) (min%–max%) †\nCardiac\n   Hypotension ‡ [ 7, 18, 23, 33, 71, 73, 87, 104, 115] 2752 115 (4) (1–14) [ 18, 71] - [ 87]\n   Hypertension § [ 7, 18, 23, 33, 41, 54, 61, 73, 85, 87, 102] 2998 385 (13) (2–95) [ 85] - [ 61]\n   Bradycardia (mild and severe) ‡ [ 23, 36, 54, 61, 65, 85, 90, 91, 115, 117] 882 94 (11) (0–49) [ 36] - [ 61]\n   Decrease in heart rate ‡ [ 41, 54, 61, 80] 193 152 (79) (11–94) [ 80] - [ 41]\n   Tachycardia ‡ [ 23, 27, 36] 565 13 (2) (0–6) [ 36] - [ 23]\n   Ventricular extrasystoles ‡ [ 73] 22 11 (50)\n   Cardiac event, unspecified ‡ [ 26, 86] 165 18 (11) (5–12) [ 26] - [ 86]\n   Asystole ¶ [ 91, 100] 45 3 (7) (3–20) [ 100] - [ 91]\n   Left cardiac insufficiency [ 85] 194 1 (1)\n   Chest discomfort/tightness ‡ [ 18, 27, 54, 73, 87, 91, 115] 901 22 (2) (1–10) [ 27] - [ 54]\nRespiratory\n   Unspecified respiratory symptoms ‡ [ 26, 86] 165 43 (26) (21–62) [ 86] - [ 26]\n   Dyspnea d [ 18, 27, 54, 66, 85] 2748 26 (1) (0–10) [ 66] - [ 54]\n   Cough [ 85, 101] 373 52 (14) (5–22) [ 101] [ 85]\n   Lung edema ‡ [ 59, 85] 241 3 (1) (1–2) [ 85] - [ 59]\n†Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction.\n‡ DMSO was administered intravenously in all studies.\n§ DMSO was administered intravenously in all studies. Horacek et al. [ 102] measured 42 patients with an increase in systolic blood pressure, and 31 patients with an increase in diastolic blood pressure. This was counted as 73 cases of hypertension.\n¶ In both studies, asystole occurred because of DMSO effect on the trigeminal nerve and activation of the trigeminal cardiac reflex. d) in one study DMSO was administered transdermally\nTable 4. Cardiovascular and respiratory adverse reactions observed per number of treatments.\nAdverse reaction Studies Total number of treatments Adverse reactions observed, n (%) (min%–max%) †\nCardiac\n   Hypotension ‡ [ 40, 51, 68] 323 10 (3) (2–14) [ 68] - [ 40]\n   Hypertension ‡ [ 25, 51, 68] 425 60 (14) (3–21) [ 25] - [ 68]\n   Bradycardia (mild and severe) ‡ [ 51] 54 4 (7)\n   Decrease in heartrate ‡ [ 39] 32 30 (94)\n   Tachycardia ‡ [ 51] 54 4 (7)\n   Cardiac event, unspecified ‡ [ 74] 1269 35 (3)\n   Chest discomfort/tightness ‡ [ 25, 68, 74] 1640 83 (5) (0–6) [ 68] - [ 74]\nRespiratory\n   Dyspnea [ 25, 68] 371 3 (1) (0–2) [ 68] - [ 25]\n   Shortness of breath ‡ [ 74] 1269 40 (3)\n†Incidences of the adverse reactions have been calculated for all the individual studies. (%, min-max) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\n‡ DMSO was administered intravenously. Bradycardia was defined as a heart rate less than 60 beats per minute 41, 61 and was often transient 23, 61, 90, 115, but cases where atropine was needed are described 49, 96. A lowered heart rate not enough to be considered bradycardia was observed in four studies 39, 41, 54, 61.\nIn some studies, hypertension did not require intervention 61, 102, but cases where medication was needed to control the hypertension, or where treatment was stopped due to hypertension, are described 41, 54, 85. Hypotension was also described as transient most of the time 18, 23, 68, 87, 104, with some cases needing intervention 40, 51, 54.\nOne study reported 11 cases of transient extrasystoles in 22 patients receiving cryopreserved autologous blood stem cells, monitored with Holter during infusion 73. There were two studies reporting cases of asystole during embolization of dural arteriovenous fistulas with a substance called Onyx, a non-adhesive liquid embolic agent dissolved in DMSO 91, 100.\nDyspnea was reported in seven studies 18, 25, 27, 54, 66, 68, 85. A single study reported eight patients with transient shock after stem cell transfusion 51. Some of these patients developed loss of consciousness and cyanosis but recovered promptly and had no need for additional therapy, whereas the rest of the patients developed severe hypotension or transient dyspnea, which was described as the reason for the transient shock. Further description of the condition was not provided.\nSeveral of the studies found a correlation between the dose of DMSO used and the incidence of cardiovascular adverse reactions 41, 67, 71, 75, 78, 85, 86, 93, 101, 115.\n\nDermatological reactions\nDermatological side effects are common when DMSO is administered transdermally. Skin reactions or allergic reactions were reported in 58 studies. DMSO was applied transdermally in 43 studies 2, 4, 6, 17, 19– 22, 24, 28– 32, 37, 44, 45, 52, 55, 57, 63, 64, 66, 67, 69, 72, 75, 76, 78, 79, 82, 83, 88, 89, 93, 95, 96, 106, 108, 109, 111– 113, intravenously in 14 studies 25, 40, 41, 51, 59, 73, 74, 77, 85, 86, 92, 98, 101, 110 and intraarticular in one 103 ( Table 5).\nTable 5. Dermatological and allergic adverse reactions observed per number of patients.\nAdverse reactions Studies Total patients, n Patients with adverse reactions, n (%) (%, min-max) †\nSkin reactions\n   Erythema ‡ [ 19, 32, 64, 66, 82, 95] 2352 201 (9) (3–95) [ 95] - [ 82]\n   Itching/Pruritus ‡ [ 6, 55, 57, 64, 66, 72, 82, 93] 3421 215 (6) (0–70) [ 55] - [ 82]\n   Urticaria ‡ [ 24, 31, 83] 58 9 (16) (4–59) [ 24] - [ 83]\n   Rash [ 29, 30, 55, 57, 64, 93, 101, 111] 2682 121 (5) (1–40) [ 30] - [ 93]\n   Paresthesia/burning or stinging sensation § ‡ [ 17, 21, 24, 28, 30, 44, 45, 55, 57, 67, 69, 79, 91, 93, 106] 2141 335 (16) (0–100) [ 30] - [ 45]\n   Scaling of skin/desquamation/ dry skin/local irritant ‡ [ 22, 29, 30, 37, 52, 55, 57, 64, 66, 69, 75, 82, 88, 89, 106] 4739 731 (15) (1–96) [ 66] - [ 52]\n   Blistering ‡ [ 31, 32, 66, 69, 93, 112] 2038 79 (4) (3–20) [ 66] - [ 112]\n   Roughness and/or thickening of skin ‡ [ 66, 82, 93] 1986 191 (10) (6–10) [ 93] - [ 82]\n   Bullous dermatitis/dermatitis with vesicles ‡ [ 20, 29, 64] 1116 79 (7) (1–9) [ 64] - [ 29]\n   Contact dermatitis ‡ [ 6, 20, 28– 30, 64, 111] 2587 161 (6) (1–13) [ 28] - [ 29]\n   Skin reaction, unspecified ‡ [ 2, 78, 96, 113] 457 159 (35) (4–48) [ 96] - [ 113]\n   Increase in skin pigmentation ‡ [ 6] 548 28 (5)\n   Peripheral edema ‡ [ 45, 55, 66, 109] 2291 22 (0) (1–14) [ 66] - [ 109]\nAllergic reactions [ 37, 44, 59, 86, 98, 110] 309 75 (24) (3–55) [ 44, 110] - [ 86]\n  Intravenous administration [ 59, 86, 98, 110] 229 66 (29) (2–55) [ 59] - [ 86]\n  Transdermal application [ 37, 44] 86 9 (10) (3–19) [ 44] - [ 37]\n  Flushing ¶ [ 41, 54, 73] 292 34 (12) (2–9) [ 54] - [ 73]\n†Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\n‡ Transdermal application only.\n§ One study administered DMSO through intraarticular injection [ 38].\n¶ DMSO was administered intravenously in all studies. The most common skin reaction was a local burning sensation reported in 13 studies 17, 21, 24, 28, 30, 45, 55, 57, 67, 69, 79, 93, 106. In one study, all participants experienced this burning sensation 45. In the same study, four participants experienced a transient peripheral edema associated with itching and erythema 45. A single study described a burning sensation in four of 669 patients when DMSO was given as a local injection 92; another study described burning in two out of 17 patients when DMSO was injected intraarticularly 103.\nMost skin reactions were transient, only lasting minutes 17, 24, 32, 67, 72, but some studies reported cases described as serious, causing discontinuation of treatment 2, 6, 52, 63, 78, 96. There were two studies describing that skin reactions to DMSO would disappear after days of continuous treatment 45, 83. Another study reported that 1 of 18 patients treated for psoriasis with DMSO was hospitalized due to exfoliative erythroderma 63. In another study, two patients, diagnosed with dermographia developed prominent areas of weals after DMSO application 95.\nAcute allergic reactions due to use of DMSO were reported in six studies 37, 44, 59, 86, 98, 110. One study reported that 63 of 144 patients experienced allergic reactions, which was not described as serious adverse events (bronchospasms, facial flushing, rash) 86. In two other studies, acute allergic reactions were characterized as serious adverse events 59, 110.\nFlushing was regarded as an allergic reaction in this review and was only reported when DMSO was administered intravenously 25, 40, 41, 51, 54, 73, 74. A total of four studies, not depicted in Table 5, reported 204 cases of flushing during 1439 stem cell infusions 25, 40, 51, 74. Several studies observed a relationship between the dose of DMSO and the occurrence of adverse reactions 67, 75, 78, 83, 88, 93.\n\nNeurological reactions\nHeadache is the most common neurological adverse reaction reported. In one study, headache was the reason for withdrawal of 2 out of 21 patients being treated with DMSO 116.\nThree studies using DMSO as a cryoprotectant in stem cell transfusions described seizures after administration 18, 36, 47. Severe encephalopathy was observed in one patient 99, and transient cranial nerve III and IV palsy was observed in one patient after Onyx embolization 34. One study described neurological symptoms occurring during and after transfusion, but they did not define neurological symptoms in detail 86.\n\nUrogenital reactions\nFew urogenital reactions were described ( Table 6 and Table 7). Hemoglobinuria was described as an adverse reaction seen after transfusion of stem cell products 39, 51, 56, 73. However, hemoglobinuria is often attributed to erythrocyte debris in the transplant material and has thus not been interpreted as being caused by DMSO 39, 73. The other urogenital reactions ( Table 6 and Table 7) all occurred after DMSO instillation in the bladder 38, 49, 97.\nTable 6. Neurological and urogenital adverse reactions observed per number of patients.\nAdverse reaction Studies Total patients, n Patients with adverse reactions, n (%) (min%–max%) †\nNeurological\n   Headache [ 2, 18, 29, 33, 38, 41, 55, 59, 70, 71, 81, 84, 85, 98, 101, 104, 116] 2516 150 (6) (1–50) [ 101] - [ 70]\n  Intravenous administration [ 18, 33, 41, 59, 70, 71, 81, 85, 98, 101, 104] 1271 42 (3) (1–50) [ 101] - [ 70]\n  Transdermal application [ 2, 29, 55] 1197 102 (8) (5–35) [ 55] - [ 2]\n  Intravesical administration [ 38] 20 1 (5)\n  Rectal administration [ 116] 21 3 (14)\n  \u003e1 administration route [ 84] 7 2 (29)\n   Seizures [ 18, 36, 47] 301 2 (1) (0–2) [ 18] - [ 47]\n   Neurological symptoms, unspecified [ 86] 144 5 (3)\n   Transient CN III and IV palsy [ 34] 12 1 (8)\n   Severe encephalopathy [ 99] 124 1 (1)\nUrogenital\n   Pelvic discomfort/pain/ irritation [ 38, 49, 97] 107 10 (9) (6–30) [ 49] - [ 38]\n   Dysuria/strangury [ 49] 36 6 (17)\n   Renal and urinary disorder [ 49] 36 8 (22)\n†Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\nTable 7. Neurological and urogenital adverse reactions observed per number of treatments.\nAdverse reaction Studies Total treatments, n Adverse reactions observed, n (%) (min%–max%) †\nNeurological\n   Headache [ 39, 51] 86 40 (47) (6 - 73) [ 39] - [ 51]\nUrogenital\n   Urethral irritation [ 73] 151 110 (73)\n†Incidences of the adverse reactions have been calculated for all the individual studies. (%, min-max) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\n\nOther reactions\nOnly one study in this review administered DMSO as eye-drops 114. In this study, two patients experienced severe conjunctival hyperemia due to allergic reactions, and 25% of patients experienced a stinging sensation when eye-drops were applied 114. Other studies performed eye examinations to determine whether DMSO caused changes in the lens; however, no such cases were observed 2, 45.\nHyponatremia occurred in six patients after they received large doses of DMSO as treatment for cranial hypertension 62. This adverse reaction was not reported in other studies ( Table 8).\nTable 8. Other adverse reactions observed per number of patients.\nAdverse reaction Studies Total patients, n Patients with reaction, n (%) (min%–max%) †\nFever [ 27, 71, 73, 77, 101] 547 44 (8) (2–19) [ 27] - [ 77]\nChills [ 27, 33, 70, 71, 81, 85, 101] 852 60 (7) (1–31) [ 101] - [ 71]\nDizziness [ 2, 46, 55, 85, 101] 885 18 (2) (1–15) [ 55] - [ 2]\nWeakness [ 33, 45, 46] 293 19 (6) (1–29) [ 46] - [ 45]\nSedation [ 2] 78 34 (44)\nHyponatremia [ 62] 6 6 (100)\n†Incidences of the adverse reactions have been calculated for all the individual studies. (%, min-max) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included. Very few cases of serious adverse reactions associated with DMSO have been described 18, 36, 51, 59.\nOverall, most studies administered DMSO intravenously or transdermally ( Table 9)\nTable 9. Way of administration of DMSO in included studies.\nAdministration Number of studies References\nIntravenous 49 [ 7, 16, 18, 23, 25, 26, 33, 34, 36, 39– 41, 46– 48, 51, 53, 54, 56, 59, 61, 62, 65, 68, 70– 74, 77, 80, 81, 84– 87, 90, 91, 94, 98– 102, 104, 110, 115, 117, 118]\nTransdermal 48 [ 2, 4, 6, 17, 19– 22, 24, 28– 32, 37, 42, 44, 45, 50, 52, 55, 57, 58, 63, 64, 66, 67, 69, 72, 75, 76, 78, 79, 82– 84, 88, 89, 93, 95, 96, 106– 109, 111– 113]\nIntravesical 7 [ 8, 35, 38, 43, 49, 97, 105]\nOral 2 [ 9, 60]\nEye-drops 1 [ 114]\nLocal injection 1 [ 92]\nIntra-articular 1 [ 103]\nRectal 1 [ 116]\n\nRisk of bias within studies\nIn this review, we included 76 cohort studies, of which 64 were prospective 2, 4, 6, 7, 20, 22, 24– 27, 29, 31, 32, 34– 38, 40– 45, 48, 50– 54, 56, 58, 60, 63, 65, 66, 68– 70, 72, 73, 77, 80, 81, 83, 85, 88, 90, 92, 94, 97, 98, 101– 104, 107, 108, 110, 112, 115, 117, 118 and 13 were retrospective 9, 18, 23, 39, 46, 47, 61, 71, 74, 86, 87, 100, 105. Bias was assessed using The Newcastle-Ottawa-Scale 14. Using this scale, studies were given zero to nine stars. A high number of stars equals low risk of bias and vice versa. The studies in this review had a median value of 5 stars, with a range of 2–8. No studies received the highest possible value of nine stars. Very few studies had a comparison group that did not receive DMSO, and often the occurrence of adverse reactions was poorly described. There were 24 randomized controlled trials ( Figure 2). Many studies received an unclear risk of bias because often it was vaguely described how adverse reactions were reported.\nFigure 2. Risk of bias in randomized controlled trials. Overall, there was a high risk of bias when assessing the description of adverse reactions. Some studies were not assessed for bias due to being case-reports, preliminary trials, or because they included more than one study design 17, 19, 28, 62, 84, 91, 99, 109, 111, 113."}

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selection\nOur primary search identified 2599 studies ( Figure 1). After the evaluation process, 109 studies were included in the final review 2, 4, 6– 9, 16– 118.\nFigure 1. PRISMA flow diagram.\n\nGastrointestinal reactions\nGastrointestinal adverse reactions were reported in 61 studies. Of these, 10 studies were randomized controlled trials 16, 30, 33, 55, 57, 59, 67, 79, 93, 95, 49 were cohort studies 2, 4, 7, 9, 18, 19, 23, 25– 27, 29, 35, 38– 43, 45, 46, 48, 50– 54, 58, 60, 66, 68, 69, 71, 73, 83, 85– 88, 90, 94, 97, 98, 101, 104, 105, 112, 113, 115, 118, and 2 were case series 84, 109. Most studies reported the number of patients experiencing an adverse reaction ( Table 1). Other studies reported adverse reactions observed in relation to the number of treatments given ( Table 2).\nTable 1. Gastrointestinal adverse reactions observed per number of patients.\nAdverse reaction Studies Total patients, n Patients with adverse reaction, n (%) (%, min-max) †\nNausea (overall incidence) [ 2, 18, 27, 33, 45, 46, 48, 53, 55, 57, 59, 60, 67, 84, 90, 93, 109, 118] 2214 257 (12) (2–41) [ 55] - [ 48]\n  Intravenous administration [ 18, 27, 33, 46, 48, 53, 59, 90, 118] 1154 199 (17) (2–41) [ 59] - [ 48]\n  Transdermal application [ 2, 45, 55, 57, 67, 93, 109] 1039 51 (5) (2–32) [ 55] - [ 2]\n  \u003e1 administration route [ 60, 84] 21 7 (33) (29–36) [ 84] - [ 60]\nVomiting (overall incidence) [ 2, 18, 27, 33, 46, 48, 55, 57, 59, 118] 1611 115 (7) (0–64) [ 55] - [ 48]\n  Intravenous administration [ 18, 27, 33, 46, 48, 59, 118] 972 108 (11) (2–64) [ 59] - [ 48]\n  Transdermal application [ 2, 55, 57] 639 7 (1) (0–6) [ 55] - [ 2]\nNausea and vomiting ‡ [ 7, 38, 41, 54, 66, 69, 73, 85, 87, 115] 4529 591 (13) (0–46) [ 66] - [ 73]\nAbdominal cramps/stomach ache (overall incidence) [ 18, 26, 27, 39, 41, 54, 55, 59, 73, 85, 87, 93, 115] 1629 88 (5) (1–52) [ 117] - [ 116]\n  Intravenous administration [ 18, 26, 27, 39, 41, 54, 59, 73, 85, 87, 115] 1253 72 (6) (1–52) [ 18] - [ 26]\n  Transdermal application [ 55, 93] 376 16 (4) (2–16) [ 55] - [ 93]\nHalitosis/garlic-like breath (overall incidence) [ 4, 9, 16, 19, 29, 30, 35, 42, 43, 45, 50, 52, 55, 57, 58, 66– 68, 79, 83, 85, 88, 94, 95, 97, 98, 109, 112, 113] 5782 607 (11) (0–100) [ 30] - [ 19, 43, 45, 83, 98]\n  Intravenous administration [ 16, 85, 94, 98] 239 14 (6) (1–100) [ 85] - [ 98]\n  Transdermal application [ 4, 19, 29, 30, 42, 45, 50, 52, 55, 57, 58, 66, 67, 79, 83, 88, 95, 109, 112, 113] 5333 556 (10) (0–100) [ 30] - [ 19, 45, 83]\n  Intravesical administration [ 35, 43, 97] 165 33 (20) (1–100) [ 35] - [ 43]\n  Oral administration [ 9] 15 4 (27)\nDiarrhea (overall incidence) [ 2, 18, 41, 54, 57, 85, 93] 1107 27 (2) (1–6) [ 85] - [ 93]\n  Intravenous administration [ 18, 41, 54, 85] 744 15 (2) (1–6) [ 85] - [ 41]\n  Transdermal application [ 2, 57, 93] 363 12 (3) (2–6) [ 57] - [ 93]\n†Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\n‡ Nausea and vomiting are reported as one combined adverse reaction in some studies.\nTable 2. Gastrointestinal adverse reactions observed per number of treatments.\nAdverse reaction Studies Total treatments, n Adverse reactions observed, n (%) (min%–max%) †\nNausea (overall incidence) [ 40, 51, 68, 84, 105] 474 161 (34) (16–57) [ 105] - [ 40]\n  Intravenous administration [ 40, 51, 68] 323 137 (42) (41–57) [ 68] - [ 40]\n  Intravesical administration [ 105] 151 24 (16)\nVomiting ‡ [ 51, 68] 316 112 (35) (29 - 71) [ 68] - [ 51]\nNausea and/or vomiting ‡ [ 25, 74, 101] 1557 220 (14) (8–17) [ 25] - [ 101]\nAbdominal cramps/stomach ache ‡ [ 51, 68, 101] 495 16 (5) (1–19) [ 68] - [ 51]\nHalitosis ‡ [ 68] 262 4 (2)\nDiarrhea ‡ [ 51, 101] 233 2 (1) (1–2) [ 101] - [ 51]\n† Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction.\n‡ Intravenous administration. The most commonly reported gastrointestinal adverse reactions were nausea and vomiting. The incidence of nausea seems to be less common with the transdermal administration of DMSO compared with intravenous administration. The majority of studies reported an incidence of nausea between 2–14%, with the exception of one study, reporting an incidence of 32% 2. In one study that failed to specify the dose, 8 of 42 patients reported nausea and anorexia, but the symptoms disappeared in five of the eight patients when the dose of DMSO was reduced 45.\nOften the studies had short follow-up periods (less than 24 hours), especially when DMSO was used as a cryoprotectant. The study reporting the highest incidence of nausea had a follow-up period of 5 days 48, and the authors concluded that the high incidence of nausea observed might be due to the long follow-up period 48. In another article using the same data 119, it was suggested that the delayed nausea was due to gastrointestinal mucosal damage, and only the initial nausea could be related to DMSO, and therefore we decided only to include the data from the first 2 days after infusion 48.\nHalitosis was reported in 29 studies 4, 9, 16, 19, 29, 30, 35, 42, 43, 45, 50, 52, 55, 57, 58, 66– 68, 79, 83, 85, 88, 94, 95, 97, 98, 109, 112, 113. In five studies, patients discontinued treatment due to halitosis 9, 45, 83, 94. In five studies, all patients experienced halitosis 9, 45, 83, 94. Unlike halitosis, other gastrointestinal side effects were reported more often when DMSO was administered intravenously, than transdermally or intravesically.\nOne study reported a severe case of nausea, vomiting, and abdominal cramps in one patient with an acute allergic reaction 59. However, in most studies the reported gastrointestinal reactions were transient and mild, often lasting only minutes to a couple of hours 16, 38, 41, 68, 85, 87, 90. Several studies reported a relationship between the dose of DMSO and the occurrence of gastrointestinal adverse reactions 26, 33, 53, 73, 83, 85.\n\nCardiovascular and respiratory reactions\nCardiovascular and respiratory adverse reactions were reported in 33 studies. Of these, two were randomized controlled trials 33, 59, 30 were cohort studies 7, 18, 23, 25– 27, 36, 39– 41, 51, 54, 61, 65, 66, 68, 73, 74, 80, 85– 87, 90, 100– 102, 104, 115, 117, and one was a preliminary report 91. Except for one study 66, all studies reporting cardiovascular and respiratory reactions administered DMSO intravenously ( Table 3 and Table 4).\nTable 3. Cardiovascular and respiratory adverse reactions observed per number of patients.\nAdverse reaction Studies Total patients, n Patients with adverse reactions, n (%) (min%–max%) †\nCardiac\n   Hypotension ‡ [ 7, 18, 23, 33, 71, 73, 87, 104, 115] 2752 115 (4) (1–14) [ 18, 71] - [ 87]\n   Hypertension § [ 7, 18, 23, 33, 41, 54, 61, 73, 85, 87, 102] 2998 385 (13) (2–95) [ 85] - [ 61]\n   Bradycardia (mild and severe) ‡ [ 23, 36, 54, 61, 65, 85, 90, 91, 115, 117] 882 94 (11) (0–49) [ 36] - [ 61]\n   Decrease in heart rate ‡ [ 41, 54, 61, 80] 193 152 (79) (11–94) [ 80] - [ 41]\n   Tachycardia ‡ [ 23, 27, 36] 565 13 (2) (0–6) [ 36] - [ 23]\n   Ventricular extrasystoles ‡ [ 73] 22 11 (50)\n   Cardiac event, unspecified ‡ [ 26, 86] 165 18 (11) (5–12) [ 26] - [ 86]\n   Asystole ¶ [ 91, 100] 45 3 (7) (3–20) [ 100] - [ 91]\n   Left cardiac insufficiency [ 85] 194 1 (1)\n   Chest discomfort/tightness ‡ [ 18, 27, 54, 73, 87, 91, 115] 901 22 (2) (1–10) [ 27] - [ 54]\nRespiratory\n   Unspecified respiratory symptoms ‡ [ 26, 86] 165 43 (26) (21–62) [ 86] - [ 26]\n   Dyspnea d [ 18, 27, 54, 66, 85] 2748 26 (1) (0–10) [ 66] - [ 54]\n   Cough [ 85, 101] 373 52 (14) (5–22) [ 101] [ 85]\n   Lung edema ‡ [ 59, 85] 241 3 (1) (1–2) [ 85] - [ 59]\n†Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction.\n‡ DMSO was administered intravenously in all studies.\n§ DMSO was administered intravenously in all studies. Horacek et al. [ 102] measured 42 patients with an increase in systolic blood pressure, and 31 patients with an increase in diastolic blood pressure. This was counted as 73 cases of hypertension.\n¶ In both studies, asystole occurred because of DMSO effect on the trigeminal nerve and activation of the trigeminal cardiac reflex. d) in one study DMSO was administered transdermally\nTable 4. Cardiovascular and respiratory adverse reactions observed per number of treatments.\nAdverse reaction Studies Total number of treatments Adverse reactions observed, n (%) (min%–max%) †\nCardiac\n   Hypotension ‡ [ 40, 51, 68] 323 10 (3) (2–14) [ 68] - [ 40]\n   Hypertension ‡ [ 25, 51, 68] 425 60 (14) (3–21) [ 25] - [ 68]\n   Bradycardia (mild and severe) ‡ [ 51] 54 4 (7)\n   Decrease in heartrate ‡ [ 39] 32 30 (94)\n   Tachycardia ‡ [ 51] 54 4 (7)\n   Cardiac event, unspecified ‡ [ 74] 1269 35 (3)\n   Chest discomfort/tightness ‡ [ 25, 68, 74] 1640 83 (5) (0–6) [ 68] - [ 74]\nRespiratory\n   Dyspnea [ 25, 68] 371 3 (1) (0–2) [ 68] - [ 25]\n   Shortness of breath ‡ [ 74] 1269 40 (3)\n†Incidences of the adverse reactions have been calculated for all the individual studies. (%, min-max) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\n‡ DMSO was administered intravenously. Bradycardia was defined as a heart rate less than 60 beats per minute 41, 61 and was often transient 23, 61, 90, 115, but cases where atropine was needed are described 49, 96. A lowered heart rate not enough to be considered bradycardia was observed in four studies 39, 41, 54, 61.\nIn some studies, hypertension did not require intervention 61, 102, but cases where medication was needed to control the hypertension, or where treatment was stopped due to hypertension, are described 41, 54, 85. Hypotension was also described as transient most of the time 18, 23, 68, 87, 104, with some cases needing intervention 40, 51, 54.\nOne study reported 11 cases of transient extrasystoles in 22 patients receiving cryopreserved autologous blood stem cells, monitored with Holter during infusion 73. There were two studies reporting cases of asystole during embolization of dural arteriovenous fistulas with a substance called Onyx, a non-adhesive liquid embolic agent dissolved in DMSO 91, 100.\nDyspnea was reported in seven studies 18, 25, 27, 54, 66, 68, 85. A single study reported eight patients with transient shock after stem cell transfusion 51. Some of these patients developed loss of consciousness and cyanosis but recovered promptly and had no need for additional therapy, whereas the rest of the patients developed severe hypotension or transient dyspnea, which was described as the reason for the transient shock. Further description of the condition was not provided.\nSeveral of the studies found a correlation between the dose of DMSO used and the incidence of cardiovascular adverse reactions 41, 67, 71, 75, 78, 85, 86, 93, 101, 115.\n\nDermatological reactions\nDermatological side effects are common when DMSO is administered transdermally. Skin reactions or allergic reactions were reported in 58 studies. DMSO was applied transdermally in 43 studies 2, 4, 6, 17, 19– 22, 24, 28– 32, 37, 44, 45, 52, 55, 57, 63, 64, 66, 67, 69, 72, 75, 76, 78, 79, 82, 83, 88, 89, 93, 95, 96, 106, 108, 109, 111– 113, intravenously in 14 studies 25, 40, 41, 51, 59, 73, 74, 77, 85, 86, 92, 98, 101, 110 and intraarticular in one 103 ( Table 5).\nTable 5. Dermatological and allergic adverse reactions observed per number of patients.\nAdverse reactions Studies Total patients, n Patients with adverse reactions, n (%) (%, min-max) †\nSkin reactions\n   Erythema ‡ [ 19, 32, 64, 66, 82, 95] 2352 201 (9) (3–95) [ 95] - [ 82]\n   Itching/Pruritus ‡ [ 6, 55, 57, 64, 66, 72, 82, 93] 3421 215 (6) (0–70) [ 55] - [ 82]\n   Urticaria ‡ [ 24, 31, 83] 58 9 (16) (4–59) [ 24] - [ 83]\n   Rash [ 29, 30, 55, 57, 64, 93, 101, 111] 2682 121 (5) (1–40) [ 30] - [ 93]\n   Paresthesia/burning or stinging sensation § ‡ [ 17, 21, 24, 28, 30, 44, 45, 55, 57, 67, 69, 79, 91, 93, 106] 2141 335 (16) (0–100) [ 30] - [ 45]\n   Scaling of skin/desquamation/ dry skin/local irritant ‡ [ 22, 29, 30, 37, 52, 55, 57, 64, 66, 69, 75, 82, 88, 89, 106] 4739 731 (15) (1–96) [ 66] - [ 52]\n   Blistering ‡ [ 31, 32, 66, 69, 93, 112] 2038 79 (4) (3–20) [ 66] - [ 112]\n   Roughness and/or thickening of skin ‡ [ 66, 82, 93] 1986 191 (10) (6–10) [ 93] - [ 82]\n   Bullous dermatitis/dermatitis with vesicles ‡ [ 20, 29, 64] 1116 79 (7) (1–9) [ 64] - [ 29]\n   Contact dermatitis ‡ [ 6, 20, 28– 30, 64, 111] 2587 161 (6) (1–13) [ 28] - [ 29]\n   Skin reaction, unspecified ‡ [ 2, 78, 96, 113] 457 159 (35) (4–48) [ 96] - [ 113]\n   Increase in skin pigmentation ‡ [ 6] 548 28 (5)\n   Peripheral edema ‡ [ 45, 55, 66, 109] 2291 22 (0) (1–14) [ 66] - [ 109]\nAllergic reactions [ 37, 44, 59, 86, 98, 110] 309 75 (24) (3–55) [ 44, 110] - [ 86]\n  Intravenous administration [ 59, 86, 98, 110] 229 66 (29) (2–55) [ 59] - [ 86]\n  Transdermal application [ 37, 44] 86 9 (10) (3–19) [ 44] - [ 37]\n  Flushing ¶ [ 41, 54, 73] 292 34 (12) (2–9) [ 54] - [ 73]\n†Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\n‡ Transdermal application only.\n§ One study administered DMSO through intraarticular injection [ 38].\n¶ DMSO was administered intravenously in all studies. The most common skin reaction was a local burning sensation reported in 13 studies 17, 21, 24, 28, 30, 45, 55, 57, 67, 69, 79, 93, 106. In one study, all participants experienced this burning sensation 45. In the same study, four participants experienced a transient peripheral edema associated with itching and erythema 45. A single study described a burning sensation in four of 669 patients when DMSO was given as a local injection 92; another study described burning in two out of 17 patients when DMSO was injected intraarticularly 103.\nMost skin reactions were transient, only lasting minutes 17, 24, 32, 67, 72, but some studies reported cases described as serious, causing discontinuation of treatment 2, 6, 52, 63, 78, 96. There were two studies describing that skin reactions to DMSO would disappear after days of continuous treatment 45, 83. Another study reported that 1 of 18 patients treated for psoriasis with DMSO was hospitalized due to exfoliative erythroderma 63. In another study, two patients, diagnosed with dermographia developed prominent areas of weals after DMSO application 95.\nAcute allergic reactions due to use of DMSO were reported in six studies 37, 44, 59, 86, 98, 110. One study reported that 63 of 144 patients experienced allergic reactions, which was not described as serious adverse events (bronchospasms, facial flushing, rash) 86. In two other studies, acute allergic reactions were characterized as serious adverse events 59, 110.\nFlushing was regarded as an allergic reaction in this review and was only reported when DMSO was administered intravenously 25, 40, 41, 51, 54, 73, 74. A total of four studies, not depicted in Table 5, reported 204 cases of flushing during 1439 stem cell infusions 25, 40, 51, 74. Several studies observed a relationship between the dose of DMSO and the occurrence of adverse reactions 67, 75, 78, 83, 88, 93.\n\nNeurological reactions\nHeadache is the most common neurological adverse reaction reported. In one study, headache was the reason for withdrawal of 2 out of 21 patients being treated with DMSO 116.\nThree studies using DMSO as a cryoprotectant in stem cell transfusions described seizures after administration 18, 36, 47. Severe encephalopathy was observed in one patient 99, and transient cranial nerve III and IV palsy was observed in one patient after Onyx embolization 34. One study described neurological symptoms occurring during and after transfusion, but they did not define neurological symptoms in detail 86.\n\nUrogenital reactions\nFew urogenital reactions were described ( Table 6 and Table 7). Hemoglobinuria was described as an adverse reaction seen after transfusion of stem cell products 39, 51, 56, 73. However, hemoglobinuria is often attributed to erythrocyte debris in the transplant material and has thus not been interpreted as being caused by DMSO 39, 73. The other urogenital reactions ( Table 6 and Table 7) all occurred after DMSO instillation in the bladder 38, 49, 97.\nTable 6. Neurological and urogenital adverse reactions observed per number of patients.\nAdverse reaction Studies Total patients, n Patients with adverse reactions, n (%) (min%–max%) †\nNeurological\n   Headache [ 2, 18, 29, 33, 38, 41, 55, 59, 70, 71, 81, 84, 85, 98, 101, 104, 116] 2516 150 (6) (1–50) [ 101] - [ 70]\n  Intravenous administration [ 18, 33, 41, 59, 70, 71, 81, 85, 98, 101, 104] 1271 42 (3) (1–50) [ 101] - [ 70]\n  Transdermal application [ 2, 29, 55] 1197 102 (8) (5–35) [ 55] - [ 2]\n  Intravesical administration [ 38] 20 1 (5)\n  Rectal administration [ 116] 21 3 (14)\n  \u003e1 administration route [ 84] 7 2 (29)\n   Seizures [ 18, 36, 47] 301 2 (1) (0–2) [ 18] - [ 47]\n   Neurological symptoms, unspecified [ 86] 144 5 (3)\n   Transient CN III and IV palsy [ 34] 12 1 (8)\n   Severe encephalopathy [ 99] 124 1 (1)\nUrogenital\n   Pelvic discomfort/pain/ irritation [ 38, 49, 97] 107 10 (9) (6–30) [ 49] - [ 38]\n   Dysuria/strangury [ 49] 36 6 (17)\n   Renal and urinary disorder [ 49] 36 8 (22)\n†Incidences of the adverse reactions have been calculated for all the individual studies. (min%–max%) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\nTable 7. Neurological and urogenital adverse reactions observed per number of treatments.\nAdverse reaction Studies Total treatments, n Adverse reactions observed, n (%) (min%–max%) †\nNeurological\n   Headache [ 39, 51] 86 40 (47) (6 - 73) [ 39] - [ 51]\nUrogenital\n   Urethral irritation [ 73] 151 110 (73)\n†Incidences of the adverse reactions have been calculated for all the individual studies. (%, min-max) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included.\n\nOther reactions\nOnly one study in this review administered DMSO as eye-drops 114. In this study, two patients experienced severe conjunctival hyperemia due to allergic reactions, and 25% of patients experienced a stinging sensation when eye-drops were applied 114. Other studies performed eye examinations to determine whether DMSO caused changes in the lens; however, no such cases were observed 2, 45.\nHyponatremia occurred in six patients after they received large doses of DMSO as treatment for cranial hypertension 62. This adverse reaction was not reported in other studies ( Table 8).\nTable 8. Other adverse reactions observed per number of patients.\nAdverse reaction Studies Total patients, n Patients with reaction, n (%) (min%–max%) †\nFever [ 27, 71, 73, 77, 101] 547 44 (8) (2–19) [ 27] - [ 77]\nChills [ 27, 33, 70, 71, 81, 85, 101] 852 60 (7) (1–31) [ 101] - [ 71]\nDizziness [ 2, 46, 55, 85, 101] 885 18 (2) (1–15) [ 55] - [ 2]\nWeakness [ 33, 45, 46] 293 19 (6) (1–29) [ 46] - [ 45]\nSedation [ 2] 78 34 (44)\nHyponatremia [ 62] 6 6 (100)\n†Incidences of the adverse reactions have been calculated for all the individual studies. (%, min-max) are the lowest and highest observed incidence of an adverse reaction observed in the group of studies included. Very few cases of serious adverse reactions associated with DMSO have been described 18, 36, 51, 59.\nOverall, most studies administered DMSO intravenously or transdermally ( Table 9)\nTable 9. Way of administration of DMSO in included studies.\nAdministration Number of studies References\nIntravenous 49 [ 7, 16, 18, 23, 25, 26, 33, 34, 36, 39– 41, 46– 48, 51, 53, 54, 56, 59, 61, 62, 65, 68, 70– 74, 77, 80, 81, 84– 87, 90, 91, 94, 98– 102, 104, 110, 115, 117, 118]\nTransdermal 48 [ 2, 4, 6, 17, 19– 22, 24, 28– 32, 37, 42, 44, 45, 50, 52, 55, 57, 58, 63, 64, 66, 67, 69, 72, 75, 76, 78, 79, 82– 84, 88, 89, 93, 95, 96, 106– 109, 111– 113]\nIntravesical 7 [ 8, 35, 38, 43, 49, 97, 105]\nOral 2 [ 9, 60]\nEye-drops 1 [ 114]\nLocal injection 1 [ 92]\nIntra-articular 1 [ 103]\nRectal 1 [ 116]\n\nRisk of bias within studies\nIn this review, we included 76 cohort studies, of which 64 were prospective 2, 4, 6, 7, 20, 22, 24– 27, 29, 31, 32, 34– 38, 40– 45, 48, 50– 54, 56, 58, 60, 63, 65, 66, 68– 70, 72, 73, 77, 80, 81, 83, 85, 88, 90, 92, 94, 97, 98, 101– 104, 107, 108, 110, 112, 115, 117, 118 and 13 were retrospective 9, 18, 23, 39, 46, 47, 61, 71, 74, 86, 87, 100, 105. Bias was assessed using The Newcastle-Ottawa-Scale 14. Using this scale, studies were given zero to nine stars. A high number of stars equals low risk of bias and vice versa. The studies in this review had a median value of 5 stars, with a range of 2–8. No studies received the highest possible value of nine stars. Very few studies had a comparison group that did not receive DMSO, and often the occurrence of adverse reactions was poorly described. There were 24 randomized controlled trials ( Figure 2). Many studies received an unclear risk of bias because often it was vaguely described how adverse reactions were reported.\nFigure 2. Risk of bias in randomized controlled trials. Overall, there was a high risk of bias when assessing the description of adverse reactions. Some studies were not assessed for bias due to being case-reports, preliminary trials, or because they included more than one study design 17, 19, 28, 62, 84, 91, 99, 109, 111, 113."}