安慰剂调节正畸牙移动疼痛的随机交叉对照试验

doi:10.7518/gjkq.2020081

摘要/Abstract

摘要：

目的探讨安慰剂对正畸牙移动导致的疼痛的治疗效果及作用机制。方法招募60名志愿者作为受试者,随机分为2组。采用维生素B药片作为安慰剂。通过将正畸用分牙橡皮圈放置在左侧下颌第一磨牙的近中侧和远中侧来激发正畸疼痛,安慰剂组在放置分牙橡皮圈0.5 h后服用安慰剂,非安慰剂组只放置分牙橡皮圈。分别在放置分牙橡皮圈前（基线）和放置24 h后,采用视觉模拟评分法（VAS）测量受试者的疼痛水平,采用状态焦虑量表检测焦虑水平,采集唾液样本检测唾液α-淀粉酶（sAA）和皮质醇的分泌水平。经过1个月洗脱期,再次通过放置分牙橡皮圈对两组受试者进行交叉实验。结果与基线相比,放置分牙橡皮圈后安慰剂和非安慰剂组的疼痛水平、焦虑水平均增加;与非安慰剂组相比,安慰剂组的疼痛水平和焦虑水平均明显减少且差异有统计学意义（P<0.05）。放置分牙橡皮圈后,皮质醇和sAA分泌水平均有不同程度的增加,安慰剂组皮质醇分泌水平较非安慰剂组减少且差异有统计学意义（P<0.05）,而两组sAA分泌水平的差异无统计学意义（P>0.05）。结论放置分牙橡皮圈能激发正畸疼痛,使疼痛和焦虑水平增加,皮质醇和sAA分泌水平也随之增加。sAA和皮质醇可作为客观的生物学指标用于疼痛强度和焦虑水平的评估。安慰剂可以有效降低由于正畸加力激发的疼痛和焦虑。

关键词: 正畸学, 安慰剂, 疼痛, 焦虑, 皮质醇, 唾液α-淀粉酶

Abstract:

Objective This study aims to explore the therapeutic effect of placebo on orthodontic pain and its mechanism. Methods Sixty volunteers were recruited and randomly divided into two groups. Vitamin B tablets were used as placebo. At baseline, orthodontic separators were placed between the left lower molars, and subjects in the placebo group took pla-cebos after half an hour. Only orthodontic separators were placed in the non-placebo group. Pain level (visual analogue scales), anxiety level, and salivary alpha-amylase (sAA) and saliva cortisol of the subjects were measured at baseline and 24 hours after separation. After 1 month of wash-out period, the orthodontic separators were placed between the left lower molars again, and subjects in the two groups were cross-experimented. Results The pain and anxiety levels in the placebo and non-placebo groups increased after placement of orthodontic separators. The pain and anxiety levels in the placebo group were significantly lower than those in the non-placebo group (P<0.05). The levels of cortisol and sAA increased in varying degrees, and the expression of cortisol in the placebo group was lower than that in the non-placebo group (P<0.05). No significant difference was observed in the level of sAA expression between two groups (P>0.05). Conclusion The placement of orthodontic separators can stimulate orthodontic pain. The levels of pain and anxiety increased similar to the levels of cortisol and salivary amylase. Cortisol and sAA can be used as objective biological indicators to evaluate pain intensity and anxiety level, respectively. Placebo can effectively reduce the pain and anxiety caused by orthodontic pain.

Key words: orthodontics, placebo, pain, anxiety, cortisol, salivary alpha-amylase

中图分类号:

R783.5

杨虹,晋瑜,赖文莉. 安慰剂调节正畸牙移动疼痛的随机交叉对照试验[J]. 国际口腔医学杂志, 2020, 47(4): 424-430.

Yang Hong,Jin Yu,Lai Wenli. Randomized cross-control trial of placebo in the regulation of orthodontic tooth movement pain[J]. Int J Stomatol, 2020, 47(4): 424-430.

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参考文献 29

[1]	Rakhshan H, Rakhshan V. Pain and discomfort per-ceived during the initial stage of active fixed ortho-dontic treatment[J]. Saudi Dent J, 2015,27(2):81-87. doi: 10.1016/j.sdentj.2014.11.002 pmid: 26082574
[2]	Bergius M, Berggren U, Kiliaridis S. Experience of pain during an orthodontic procedure[J]. Eur J Oral Sci, 2002,110(2):92-98.
[3]	Kaptchuk TJ, Miller FG. Placebo effects in medicine[J]. N Engl J Med, 2015,373(1):8-9. doi: 10.1056/NEJMp1504023 pmid: 26132938
[4]	Zubieta JK, Stohler CS. Neurobiological mechanisms of placebo responses[J]. Ann N Y Acad Sci, 2009,1156:198-210. doi: 10.1111/j.1749-6632.2009.04424.x pmid: 19338509
[5]	Alqareer A, Alyahya A, Al-Anezi SA, et al. Efficacy of chewing gum to reduce orthodontic pain compared to placebo: a blinded, parallel-group, preliminary clinical trial[J]. J Oral Facial Pain Headache, 2019,33(3):301-307. doi: 10.11607/ofph.2192 pmid: 30978268
[6]	Kaur H, Bansal N, Abraham R. A randomized, single-blind, placebo-controlled trial to evaluate the effec-tiveness of verbal behavior modification and aceta-minophen on orthodontic pain[J]. Angle Orthod, 2019,89(4):617-623. doi: 10.2319/080518-570.1 pmid: 30753091
[7]	Long H, Wang Y, Jian F, et al. Current advances in orthodontic pain[J]. Int J Oral Sci, 2016,8(2):67-75. pmid: 27341389
[8]	Hannibal KE, Bishop MD. Chronic stress, cortisol dysfunction, and pain: a psychoneuroendocrine ra-tionale for stress management in pain rehabilitation[J]. Phys Ther, 2014,94(12):1816-1825. doi: 10.2522/ptj.20130597 pmid: 25035267
[9]	Lee KC, Bassiur JP. Salivary alpha amylase, dental anxiety, and extraction pain: a pilot study[J]. Anesth Prog, 2017,64(1):22-28. doi: 10.2344/anpr-63-03-02 pmid: 28128662
[10]	Marković E, Fercec J, Šćepan I, et al. The correlation between pain perception among patients with six different orthodontic archwires and the degree of dental crowding[J]. Srp Arh Celok Lek, 2015,143(3/4):134-140.
[11]	Wang J, Jian F, Chen J, et al. Cognitive behavioral therapy for orthodontic pain control: a randomized trial[J]. J Dent Res, 2012,91(6):580-585.
[12]	Hjermstad MJ, Fayers PM, Haugen DF, et al. Studies comparing numerical rating scales, verbal rating scales, and visual analogue scales for assessment of pain intensity in adults: a systematic literature review[J]. J Pain Symptom Manage, 2011,41(6):1073-1093.
[13]	Schlaeger JM, Cain KC, Myklebust EK, et al. Hospi-talized patients quantify verbal pain intensity descri-ptors: methodological issues and values for 26 des-criptors[J]. Pain, 2020,161(2):281-287. doi: 10.1097/j.pain.0000000000001716 pmid: 31599851
[14]	Julian LJ. Measures of anxiety: state-trait anxiety inventory (STAI), beck anxiety inventory (BAI), and hospital anxiety and depression scale-anxiety (HADS- A)[J]. Arthritis Care Res (Hoboken), 2011,63(Suppl 11):S467-S472.
[15]	Guillén-Riquelme A, Buela-Casal G. Meta-analysis of group comparison and meta-analysis of reliability generalization of the State-Trait Anxiety Inventory Questionnaire (STAI)[J]. Rev Esp Salud Publica, 2014,88(1):101-112.
[16]	Sandhu SS, Piepho HP, Khehra HS. Comparing the effectiveness profile of pharmacological interven-tions used for orthodontic pain relief: an arm-based multilevel network meta-analysis of longitudinal data[J]. Eur J Orthod, 2017,39(6):601-614. doi: 10.1093/ejo/cjw088 pmid: 28204189
[17]	Gupta M, Kandula S, Laxmikanth SM, et al. Con-trolling pain during orthodontic fixed appliance the-rapy with non-steroidal anti-inflammatory drugs (NSAID): a randomized, double-blinded, placebo-controlled study[J]. J Orofac Orthop, 2014,75(6):471-476. doi: 10.1007/s00056-014-0243-7 pmid: 25355194
[18]	Monk AB, Harrison JE, Worthington HV, et al. Phar-macological interventions for pain relief during or-thodontic treatment[J]. Cochrane Database Syst Rev, 2017, 11: CD003976. doi: 10.1002/14651858.CD003976.pub2 pmid: 29182798
[19]	Sandhu SS, Sandhu J. Effect of physical activity level on orthodontic pain perception and analgesic consumption in adolescents[J]. Am J Orthod Dento-facial Orthop, 2015,148(4):618-627.
[20]	Qamruddin I, Alam MK, Mahroof V, et al. Effects of low-level laser irradiation on the rate of orthodontic tooth movement and associated pain with self-liga-ting brackets[J]. Am J Orthod Dentofacial Orthop, 2017,152(5):622-630. doi: 10.1016/j.ajodo.2017.03.023 pmid: 29103440
[21]	Probst T, Jank R, Dreyer N, et al. Early changes in pain acceptance predict pain outcomes in interdisci-plinary treatment for chronic pain[J]. J Clin Med, 2019,8(9):E1373. pmid: 31480798
[22]	Schmitz J, Müller M, Stork J, et al. Positive treat-ment expectancies reduce clinical pain and perceived limitations in movement ability despite increased experimental pain: a randomized controlled trial on sham opioid infusion in patients with chronic back pain[J]. Psychother Psychosom, 2019,88(4):203-214. doi: 10.1159/000501385 pmid: 31302644
[23]	Shaefer JR, Khawaja SN, Bavia PF. Sex, gender, and orofacial pain[J]. Dent Clin North Am, 2018,62(4):665-682.
[24]	Chamessian A, van de Ven T, Buchheit T, et al. Dif-ferential expression of systemic inflammatory me-diators in amputees with chronic residual limb pain[J]. Pain, 2017,158(1):68-74. doi: 10.1097/j.pain.0000000000000728 pmid: 27682210
[25]	de la Rubia Ortí JE, García-Pardo MP, Iranzo CC, et al. Does music therapy improve anxiety and depres-sion in Alzheimer’s patients[J]. J Altern Complement Med, 2018,24(1):33-36.
[26]	Schmid J, Theysohn N, Gaß F, et al. Neural mechanisms mediating positive and negative treatment expec-tations in visceral pain: a functional magnetic re-sonance imaging study on placebo and nocebo effects in healthy volunteers[J]. Pain, 2013,154(11):2372-2380. doi: 10.1016/j.pain.2013.07.013 pmid: 23867733
[27]	Agostinho MF, Moreira A, Julio UF, et al. Monitoring internal training load and salivary immune-endocrine responses during an annual judo training periodization[J]. J Exerc Rehabil, 2017,13(1):68-75. doi: 10.12965/jer.1732850.425 pmid: 28349036
[28]	Hill CM, Walker RV. Salivary cortisol determinations and self-rating scales in the assessment of stress in patients undergoing the extraction of wisdom teeth[J]. Br Dent J, 2001,191(9):513-515. pmid: 11726064
[29]	Ivars K, Nelson N, Theodorsson A, et al. Develop-ment of salivary cortisol circadian rhythm and re-ference intervals in full-term infants[J]. PLoS One, 2015,10(6):e0129502. pmid: 26086734

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测量项目	干预措施	非安慰剂组	安慰剂组
VAS值	放置前	1.138±1.198	1.581±1.654
	放置后	2.641±2.046	2.407±2.016
	放置后-放置前	1.432±1.970	0.716±1.854
S值	放置前	25.900±9.432	26.780±11.370
	放置后	28.820±10.170	27.120±10.950
	放置后-放置前	2.918±6.763	0.3469±4.437

测量项目	干预措施	非安慰剂组	安慰剂组
sAA	放置前	0.356±2.022	0.3581±1.998
	放置后	0.374±2.021	0.3662±1.865
	放置后-放置前	0.031±2.176	0.027±2.177
皮质醇	放置前	4.672±5.299	4.565±5.413
	放置后	5.130±5.757	4.778±5.355
	放置后-放置前	1.159±3.149	0.031±3.075

测量项目	男性	女性
年龄/岁	21.00±0.70	20.87±1.01
VAS值差值	1.0±1.9	0.7±1.5
S值差值	1.21±6.57	3.63±12.26
SAA差值/（nmol·L^-1）	-0.006 2±0.087 0	0.007 4±0.082 0
皮质醇差值/（nmol·L^-1）	0.24±2.56	0.60±3.56