Faramarzi Mahbobeh, Yazdani Shala, Barat Shahnaz
Infertility and Reproductive Health Research Center, Health Research Institute, Babol University of Medical Sciences, Babol, Iran.
Infertility and Reproductive Health Research Center, Health Research Institute, Obstetrics & Gynecology Department, Babol University of Medical Science, Babol, Iran
Hum Reprod. 2015 Dec;30(12):2764-73. doi: 10.1093/humrep/dev248. Epub 2015 Oct 13.
Does adding psychological intervention to medical therapy improve nausea/vomiting, psychological symptoms, and pregnancy distress in women with moderate nausea and vomiting of pregnancy (NVP)?
Three weeks of medical therapy plus psychotherapy yielded statistically and clinically significant improvements in NVP-specific symptoms, anxiety/depression symptoms, and pregnancy distress, compared with medical therapy alone.
Pregnancy with nausea/vomiting is associated with psychiatric morbidity. Evidence supports the exploration of psychosocial reactions in addition to biochemical markers related to NVP.
STUDY DESIGN, SIZE, DURATION: This prospective, open-label, randomized, controlled, parallel-group study was performed at two obstetrics clinics in Iran. A total of 86 women, aged 18-40 years, between 6 and 12 weeks pregnant with moderate NVP, more than 5 years of education, and not currently practicing any relaxation techniques or undergoing any psychotherapy, were enrolled from June 2013 to November 2014.
PARTICIPANTS/MATERIALS, SETTING, METHODS: A total of 86 moderate NVP women were randomly allocated to either a control (medical therapy alone) or experimental (medical therapy plus psychotherapy) group. Block randomization was achieved using a paper list prepared by an investigator with no clinical involvement in the trial. The experimental group was given pyridoxine hydrochloride (40 mg daily) for 3 weeks, and also received intensive mindfulness-based cognitive therapy (MBCT) in eight individual sessions (50 min each) over 3 weeks. The control group was given pyridoxine hydrochloride (40 mg daily tablet) for 3 weeks alone. All participants completed the Rhodes index of nausea, vomiting and retching (RINVR), the hospital anxiety and depression scale (HADS), and the prenatal distress questionnaire (PDQ) at baseline, 3 weeks after baseline at the end of the study, and at a 1 month post-treatment follow-up. Linear mixed-effects models were used, in an intention-to-treat analysis.
In the psychotherapy plus medical therapy group, the mean relative difference between baseline and post-treatment decreased for RINVR; nausea 8.2 (95% confidence interval (CI) 4.1, 10.2), vomiting 3.5 (95% CI 1.5, 5.8), and total RINVR 11.7 (95% CI 6.5, 16.5), for HADS; anxiety 5.1 (95% CI 3.2, 9.2), depression 3.5 (95% CI 2.4, 7.3), total HADS 7.2 (95% CI 4.4, 12.1), for PDQ; birth concerns 3.3 (95% CI 1.3, 9.1), body concerns 1.5 (95% CI 0.9, 5.1), relationship concerns 2.1 (95% CI 1.2, 5.9), and total PDQ 5.9 (95% CI 3.5, 10.6). At 1 month after treatment, the statistically significant improvement in RINVR, HADS and PDQ, as well as clinical improvement in severity of symptoms, persisted. Medical therapy plus psychotherapy also improved nausea/vomiting symptoms, psychological symptoms, and reduced pregnancy distress more than medical therapy alone, with an effect size of 0.42-0.72 over the trial period.
LIMITATIONS, REASONS FOR CAUTION: The conclusions were limited to a small number of women with moderate NVP. It is unclear whether the difference between the outcomes in the different groups was related to MBCT alone, or to the extra time and attention paid to patients in the medical therapy plus psychotherapy. The participants in the study did not remain blind to the treatment and the outcome may only be representative of women with moderate NVP who have been referred to obstetrics clinics.
These findings show that adding 3 weeks of psychological intervention to medical therapy may appear to produce positive therapeutic outcomes upon conclusion of treatment, and 1 month after treatment. This suggests that psychotherapy should be considered as an adjunctive treatment option for women with moderate NVP. In future studies, however, a group of patients who are receiving placebo psychotherapy along with medical treatment should be included. Furthermore, an economic evaluation of the addition of psychological intervention to standard medical therapy would be useful.
对于患有中度妊娠恶心和呕吐（NVP）的女性，在药物治疗基础上增加心理干预是否能改善恶心/呕吐、心理症状以及妊娠困扰？
与单纯药物治疗相比，为期三周的药物治疗加心理治疗在NVP特异性症状、焦虑/抑郁症状以及妊娠困扰方面产生了具有统计学意义和临床意义的改善。
伴有恶心/呕吐的妊娠与精神疾病发病率相关。有证据支持除了探索与NVP相关的生化标志物外，还应研究心理社会反应。
研究设计、规模、持续时间：这项前瞻性、开放标签、随机、对照、平行组研究在伊朗的两家产科诊所进行。2013年6月至2014年11月期间，共招募了86名年龄在18 - 40岁之间、怀孕6至12周且患有中度NVP、接受过五年以上教育、目前未采用任何放松技巧或未接受任何心理治疗的女性。
参与者/材料、设置、方法：86名患有中度NVP的女性被随机分配到对照组（单纯药物治疗）或实验组（药物治疗加心理治疗）。采用由一名未参与该试验临床工作的研究者编制的纸质列表进行区组随机化。实验组服用盐酸吡哆醇（每日40毫克），为期3周，并在3周内接受八次基于正念的认知疗法（MBCT）个体治疗（每次50分钟）。对照组仅服用盐酸吡哆醇（每日40毫克片剂），为期3周。所有参与者在基线、研究结束时基线后3周以及治疗后1个月随访时完成恶心、呕吐和干呕的罗兹指数（RINVR）、医院焦虑和抑郁量表（HADS）以及产前困扰问卷（PDQ）。采用意向性分析，使用线性混合效应模型。
在心理治疗加药物治疗组中，治疗后与基线相比，RINVR的平均相对差异降低；恶心为8.2（95%置信区间（CI）4.1，10.2），呕吐为3.5（95%CI 1.5，5.8），总RINVR为11.7（95%CI 6.5，16.5）；HADS方面，焦虑为5.1（95%CI 3.2，9.2），抑郁为3.5（95%CI 2.4，7.3），总HADS为7.2（95%CI 4.4，12.1）；PDQ方面，对分娩的担忧为3.3（95%CI 1.3，9.1），对身体的担忧为1.5（95%CI 0.9，5.1），对人际关系的担忧为2.1（95%CI 1.2，5.9），总PDQ为5.9（95%CI 3.5，10.6）。在治疗后1个月，RINVR、HADS和PDQ在统计学上的显著改善以及症状严重程度的临床改善持续存在。与单纯药物治疗相比，药物治疗加心理治疗在改善恶心/呕吐症状、心理症状以及减轻妊娠困扰方面也更有效，在试验期间效应大小为0.42 - 0.72。
局限性、注意事项：结论仅限于少数患有中度NVP的女性。不同组结果之间的差异是仅与MBCT有关，还是与药物治疗加心理治疗中给予患者的额外时间和关注有关尚不清楚。该研究的参与者并非对治疗不知情，且结果可能仅代表被转诊至产科诊所的患有中度NVP的女性。
这些发现表明，在药物治疗基础上增加为期3周的心理干预在治疗结束时以及治疗后1个月可能会产生积极的治疗效果。这表明心理治疗应被视为患有中度NVP女性的辅助治疗选择。然而，在未来的研究中，应纳入一组接受安慰剂心理治疗加药物治疗的患者。此外，对在标准药物治疗基础上增加心理干预进行经济评估将是有益的。
