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Rates and odds ratios (OR) were compared using random effects analysis.<\/jats:p><\/jats:sec><jats:sec><jats:title>Results<\/jats:title><jats:p>Seven studies, all randomized, double\u2010blind, sham surgery\u2013controlled trials, with 309 patients with PD, were qualitatively and quantitatively analyzed: 141 patients in sham groups and 168 patients in the experimental arms of gene or cell therapy trials. Sham subjects had lower rates of gastrointestinal, positioning, incision\u2010site, respiratory (hypoxic or hypercapnic respiratory failure), cardiovascular, thromboembolism, postoperative cognitive decline, skull fracture, and intracranial or spinal complications when compared with active treatment subjects. Sham subjects, however, had a higher rate of perioperative respiratory infections, such as pneumonia or sinusitis. Further, sham subjects were less likely to experience postoperative cognitive decline (OR, 0.23; 95% confidence interval [CI]: 0.11\u20130.47), intracranial or spinal complications (OR, 0.10; 95% CI: 0.01\u20130.75), total major morbidity (OR, 0.30; 95% CI: 0.19\u20130.47), or overall complications (OR, 0.59; 95% CI: 0.47\u20130.75) when compared with patients receiving experimental therapy.<\/jats:p><\/jats:sec><jats:sec><jats:title>Conclusions<\/jats:title><jats:p>Patients with PD in the sham surgery control arm of cell transplantation or gene therapy clinical trials have a low risk of procedure\u2010related adverse events overall and fewer complications than patients in the experimental groups. There were no reported deaths attributed to sham surgery\u2013controlled PD clinical trials. \u00a9 2023 International Parkinson and Movement Disorder Society.<\/jats:p><\/jats:sec>","DOI":"10.1002\/mds.29406","type":"journal-article","created":{"date-parts":[[2023,5,11]],"date-time":"2023-05-11T06:14:23Z","timestamp":1683785663000},"page":"1223-1235","update-policy":"https:\/\/doi.org\/10.1002\/crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Procedure\u2010Related Complications in Sham Surgeries for Parkinson's Clinical Trials: A Meta\u2010analysis"],"prefix":"10.1002","volume":"38","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-1868-9075","authenticated-orcid":false,"given":"James C.","family":"Mamaril\u2010Davis","sequence":"first","affiliation":[{"name":"College of Medicine University of Arizona  Tucson Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Adrian W.","family":"Gelb","sequence":"additional","affiliation":[{"name":"Department of Anesthesia and Perioperative Care University of California San Francisco Medical Center  San Francisco California USA"}],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Paul S.","family":"Larson","sequence":"additional","affiliation":[{"name":"Department of Neurosurgery Banner University Medical Center\/University of Arizona  Tucson Arizona USA"}],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"311","published-online":{"date-parts":[[2023,5,11]]},"reference":[{"key":"e_1_2_9_2_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1474-4422(18)30295-3"},{"key":"e_1_2_9_3_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1474-4422(06)70471-9"},{"key":"e_1_2_9_4_1","doi-asserted-by":"publisher","DOI":"10.1016\/j.ncl.2009.04.004"},{"key":"e_1_2_9_5_1","doi-asserted-by":"publisher","DOI":"10.3233\/jpd-171077"},{"key":"e_1_2_9_6_1","doi-asserted-by":"publisher","DOI":"10.1002\/mds.26338"},{"key":"e_1_2_9_7_1","doi-asserted-by":"publisher","DOI":"10.1590\/S1980-57642015DN91000005"},{"key":"e_1_2_9_8_1","doi-asserted-by":"publisher","DOI":"10.1002\/mdc3.12592"},{"key":"e_1_2_9_9_1","doi-asserted-by":"publisher","DOI":"10.1056\/nejm200103083441002"},{"key":"e_1_2_9_10_1","doi-asserted-by":"publisher","DOI":"10.1002\/ana.10720"},{"key":"e_1_2_9_11_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-133-6-200009190-00014"},{"key":"e_1_2_9_12_1","doi-asserted-by":"publisher","DOI":"10.7326\/0003-4819-133-6-200009190-00015"},{"key":"e_1_2_9_13_1","doi-asserted-by":"publisher","DOI":"10.1126\/science.1060937"},{"key":"e_1_2_9_14_1","doi-asserted-by":"publisher","DOI":"10.1002\/mds.27438"},{"key":"e_1_2_9_15_1","doi-asserted-by":"publisher","DOI":"10.1016\/s1474-4422(02)00038-8"},{"issue":"4","key":"e_1_2_9_16_1","first-page":"207","article-title":"The placebo response in Parkinson's disease","volume":"22","author":"Shetty N","year":"1999","journal-title":"Parkinson Study Group Clin Neuropharmacol"},{"key":"e_1_2_9_17_1","volume-title":"Developing a Protocol for Observational Comparative Effectiveness Research: A User's Guide. 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